28 Pa. Code | Title 28 Pa. Code — Health and Safety

Part I General Health

Chapter 1 Administration of Vital Records

28 Pa. Code § 1.1 Filing of birth certificates.

A certificate of birth shall be filed with the local registrar of vital records within 10 days after each birth has occurred.

History

Authority: The provisions of this Chapter 1 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 1 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 1.2 Filing registrations of foundling births.

(a) A registration form for each foundling child shall be filed within 10 days after the child has been first delivered to the custody of a person, agency or institution.

(b) The place where the child was found shall be entered on the form as the place of birth and the date of birth shall be by approximation.

(c) If the child is later identified and an original certificate of birth is found or created, the foundling certificate shall be sealed and filed and may be opened only by court order.

History

Authority: The provisions of this Chapter 1 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 1 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 1.3 Amendments to birth certificates.

The following documentary proof shall be required of persons making application for an amendment of a birth certificate following a change in civil status:

(1) When the change involves a person whose birth is registered as illegitimate but who is legitimated by the subsequent marriage of his natural parents, a copy of the marriage certificate of the natural parents shall be submitted together with a joint affidavit of the husband and wife signifying that they are the natural parents of the child.

(2) When the parentage of the child has been determined by a court of competent jurisdiction a certified copy of the court order shall be submitted.

(3) When the child has been legally adopted a certified copy of the decree of adoption or an official notice from the court of the fact of adoption shall be submitted. The notice shall include all facts necessary to locate, identify and amend the original certificate of birth of the person adopted.

(4) When the name of a person is changed by order of a court of competent jurisdiction a certified copy of the court order shall be submitted.

History

Authority: The provisions of this Chapter 1 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 1 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 1.4 Delayed registrations.

(a) If there is no record of birth on file with the Division of Vital Records and the birth occurred in this Commonwealth, a delayed registration of birth may be placed on file by the parents of a child up to 7 years of age without documentary evidence.

(b) Delayed registrations filed for children from 7 to 18 years of age or deceased persons may be executed by either parent or someone familiar with the facts of birth at the time of birth.

(d) The face of the delayed registration form shall be completed and sworn to in the presence of a notarizing official and submitted to the Division of Vital Records in Harrisburg, together with one of the following pieces of documentary evidence:

(1) A certified copy of a county record showing the facts of birth.

(2) A notarized statement sworn to by the doctor or midwife who delivered the child.

(3) A baptismal certificate showing the facts of birth and certified by a priest or minister. The baptism shall have occurred 5 years prior to the date of application for delayed registration.

(4) A decree or certificate of adoption which shows the name of the child and the date and place of birth.

(e) In the event that none of the documents listed in subsection (d) are available, one recorded document at least 5 years old which conclusively establishes the correct name, date and place of birth shall be submitted.

(f) In every instance, there shall appear on the delayed registration of birth a notation as to the nature and date of the documentary evidence which was submitted and the certificate and copies thereof shall be marked ‘‘delayed.’’

The provisions of this § 1.4 amended July 6, 1979, effective July 7, 1979, 9 Pa.B. 2250. Immediately preceding text appears at serial page (3356).

History

Authority: The provisions of this Chapter 1 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 1 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 1.5 Registration as other than the child of the mother’s husband.

(a) The child of a married woman and a man who is not the mother’s husband, may be registered as the child of the biological father if under the following conditions:

(1) The mother signs, in the presence of a witness; the following statement: ‘‘I, (mother’s name), do hereby acknowledge that (biological father’s name) and I are the true and biological parents of (infant’s name) born in the (hospital’s name) on (date of birth) at (time). I hereby authorize and direct the (hospital’s name) to submit a birth certificate to the Division of Vital Records identifying (biological father’s name) as the father of the above infant’’; and

(2) The mother’s husband signs the following statement in the presence of a witness: ‘‘I, (husband’s name), the undersigned, do hereby authorize the (hospital’s name) to submit to the Division of Vital Records a birth certificate which identifies (biological father’s name) as the father of (infant’s name), who is the child of (mother’s name), my lawful wife.’’

(b) A form shall be sent by certified mail return receipt requested to the last known address of the mother’s husband. The form shall contain a clear explanation of these regulations and the statement set out in subsection (a)(2). The statement shall be printed in such a way that the husband, by inserting the word ‘‘not’’ after the word ‘‘do’’ within the statement, may withhold his authorization.

(d) If the postal service is unable to effect delivery to the mother’s husband, or if he makes no response within 10 days of receipt, his authorization may not be necessary to registering the child in accordance with the provisions of subsection (a)(1).

The provisions of this § 1.5 adopted November 7, 1975, 5 Pa.B. 2926, amended July 6, 1979, effective July 7, 1979, 9 Pa.B. 2250. Immediately preceding text appears at serial page (3356).

This section cited in 28 Pa. Code § 1.8 (relating to application).

History

Authority: The provisions of this Chapter 1 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 1 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 1.6 Registration of the child of an unmarried woman.

The child of an unmarried woman may be registered with any surname requested by the mother. If no other surname is so requested, the child shall be registered with the mother’s surname.

The provisions of this § 1.6 adopted November 7, 1975, 5 Pa.B. 2926.

This section cited in 28 Pa. Code § 1.8 (relating to application).

In a disagreement over a child’s name, the best interests of the child standard applies, not 28 Pa. Code § 1.6 which impermissibly distinguishes between unwed mothers and unwed fathers in violation of the Equal Rights Amendment to the Pennsylvania Constitution (Article 1, section 28) In re Mull, 18 D. & C.3d 290, 294 (1981).

History

Authority: The provisions of this Chapter 1 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 1 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 1.7 Registration of children born in wedlock.

(a) The designation of a child’s name, including surname, is the right of the child’s parents. Thus, a child’s surname as recorded on its birth certificate may be the surname of either or both of the child’s parents, a surname formed by combining the surname of the parents in hyphenated or other form, or a name which bears no relationship to the surname of either parent.

(b) If the parents are divorced or separated at the time of the child’s birth, the choice of surname rests with the parent who has custody of the newborn child.

The provisions of this § 1.7 adopted November 7, 1975, 5 Pa.B. 2926.

The appellee did not lack standing to bring a name change action 18 months after birth against a custodial parent notwithstanding the provision of 28 Pa. Code § 1.7(b) vesting the custodial parent with the right to choose a newborn’s surname. Petition of Schidlemeir by Koslof, 496 A.2d 1249 (Pa. Super. 1985).

This section cited in 28 Pa. Code § 1.8 (relating to application).

History

Authority: The provisions of this Chapter 1 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 1 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 1.8 Application.

(a) Sections 1.5—1.7 (relating to registration as other than the child of the mother’s husband; registration of the child of an unmarried woman; and registration of children born in wedlock), shall apply to children born on or after September 27, 1975.

(b) The birth certificate of a child born before September 27, 1975, but no earlier than September 27, 1968, may be amended upon application of the child’s mother or custodial parent, under § § 1.5, 1.6 or 1.7(b) or by the child’s parents, under § 1.7(a), at a time up to the child’s 7th birthday.

(c) The birth certificate of a person whose paternity has been established by court order or decree may be amended under § § 1.5 or 1.6 upon application by that person, or if a minor, by the custodial parent. A certified copy of the court order or decree shall be attached to the request for amendment.

The provisions of this § 1.8 adopted November 7, 1975, 5 Pa.B. 2926.

History

Authority: The provisions of this Chapter 1 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 1 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 1.10 Free certified copies to parents of newborns.

Upon receipt of each birth certificate of a living child, the Division of Vital Records shall send to the custodial parent of the child a certified copy of the original birth certificate of the child free of charge.

The provisions of this § 1.10 adopted July 6, 1979, effective July 7, 1979, 9 Pa.B. 2250.

History

Authority: The provisions of this Chapter 1 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 1 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 1.11 Issuance of certificates of death.

(a) Local registrars shall issue certificates of death from original certificates of death in their possession upon completion of a period of instruction on the preparation of certificates by representatives of the Division of Vital Records.

(b) For each certificate issued the local registrar shall receive a fee of $2.00.

The provisions of this § 1.11 amended July 6, 1979, effective July 7, 1979, 9 Pa.B. 2250. Immediately preceding text appears at serial page (24401).

History

Authority: The provisions of this Chapter 1 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 1 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 1.21 Depth of graves.

(a) The distance from parts of the top of the outer case containing the casket may not be less than 1.5 feet (18 inches) from the natural surface of the ground.

(b) When a casket is not placed in an outer case or when a body is not placed in a casket, the distance from parts of the casket or body may be no less than 2 feet—24 inches—from the natural surface of the ground.

(c) The superintendent, sexton, caretaker or other person in charge of the cemetery shall be responsible for graves being dug to the depths required by subsections (a) and (b) and maintaining the depth requirements.

(d) This section does not apply to crypts for which there are no depth requirements.

The provisions of this § 1.21 issued under the sections 2104 and 2111 of The Administrative Code of 1929 (71 P. S. § § 534 and 541); and section 506 of the Vital Statistics Law of 1953 (35 P. S. § 450.506).

The provisions of this § 1.21 amended April 26, 1985, effective April 27, 1985, 15 Pa. B. 1523. Immediately preceding text appears at serial page (43927).

History

Authority: The provisions of this Chapter 1 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 1 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 1.22 Structures for the dead.

(a) Crypts. No dead human body shall be placed in a permanent crypt unless the crypt is fitted with a durable covering which may be tightly sealed after each interment, or unless the remains are encased in a sealed container from which no evidence of dissolution may escape.

(b) Mausoleums. No dead human body shall be placed in a permanent overground mausoleum or other structure for the dead unless the remains are encased in a container so sealed that no evidence of dissolution may escape.

(c) Receiving vaults. Receiving vaults may be used for the temporary reception of dead bodies, if the bodies are properly embalmed, for a period not exceeding 30 days, beyond which period special permission from the Department of Health shall be required. The responsible person in charge of a dead human body which is placed in a temporary vault shall make application for special permission at least 1 week prior to the expiration of the 30-day period. Bodies retained in a temporary vault may, within the initial 30-day period, be removed and interred in a cemetery in this Commonwealth or shipped, on the authority of the original burial permit. In every case the death certificate shall be filed within 96 hours after death. A new burial permit shall be secured by the person responsible for the final disposition of each dead human body which has been retained in a temporary vault beyond the 30-day period.

The provisions of this § 1.22 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P. S. § § 534 and 541); and section 506 of the Vital Statistics Law of 1953 (35 P. S. § 450.506).

The provisions of this § 1.22 amended April 26, 1985, effective April 27, 1985, 15 Pa.B. 1523. Immediately preceding text appears at serial page (43927).

This section cited in 49 Pa. Code § 13.184 (relating to prompt disposal of a deceased body).

History

Authority: The provisions of this Chapter 1 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 1 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 1.23 Shipment of bodies dead of noncontagious diseases.

(a) Human bodies, dead of noncontagious diseases, which are to be shipped by common carrier to a point which cannot be reached within 24 hours after death shall be either embalmed or placed in a metal or metal-lined, hermetically sealed container. Bodies which remain unclaimed for 36 hours after death shall fall under the jurisdiction of the Humanity Gifts Registry and shall be shipped in accordance with its procedures.

(b) Except for bodies shipped by air, embalmed bodies shall be shipped by placing the casket in a strong outer box made of lumber not less than 7/8 inch thick, bearing at least four carrying handles, two on each side, or six handles when the box is over 5 feet 6 inches in length, or an approved metal shipping case.

The provisions of this § 1.23 amended July 6, 1979, effective July 7, 1979, 9 Pa.B. 2250. Immediately preceding text appears at serial page (3359).

History

Authority: The provisions of this Chapter 1 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 1 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 1.24 Transit permit.

In addition to the burial permit, in all cases where dead human bodies are to be shipped by common carrier, or transferred while in shipment, a transit permit shall be securely attached to the outside case as authority for the shipment or transfer.

History

Authority: The provisions of this Chapter 1 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 1 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 1.25 Disinterment of dead human bodies.

(a) Permit. No dead human body shall be removed from its place of interment unless a disinterment permit is first secured from a local registrar who is authorized to issue a disinterment permit, according to the following requirements:

(1) The funeral director or cemetery official making the application shall present to the local registrar the correct name, date of death and cause of death of the body to be disinterred and written consent of next of kin, or appropriate order from a court of competent jurisdiction.

(2) No disinterred body shall be reinterred either in the same cemetery or another cemetery located in this Commonwealth unless a burial or removal permit is obtained.

(3) Disinterment permits shall be void after the expiration of 72 hours from the date of issue and no disinterment may be made between sunset and sunrise.

(4) Disinterment permits shall be delivered to the sexton or other person in charge of burial grounds in which the disinterments are to be made and shall be returned by him to the local registrar of the district where the body is reinterred within 30 days from the date the permit was issued.

(b) Authorization. Disinterments shall be authorized during any month of the year.

(c) Transportation. Except when the remains are found to be thoroughly desiccated, the transportation by public conveyance or common carrier of a disinterred body shall be forbidden unless the remains are encased in a hermetically sealed container. When a disinterred body is to be transported by common carrier, certification as to the facts in the case shall be presented by the qualified person in charge of the removal to the local registrar of the district in which the disinterment is made and from which the body is to be transported. The local registrar shall issue a proper permit and no disinterred body may be transported without the permit.

(d) Exhumation and exposure. The remains of a dead body may not be exhumed and exposed to view without an order from a court of competent jurisdiction.

The provisions of this § 1.25 amended July 6, 1979, effective July 7, 1979, 9 Pa.B. 2250. Immediately preceding text appears at serial pages (3359) and (3360).

History

Authority: The provisions of this Chapter 1 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 1 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 1.31 General.

(a) Certificates corrected without a court order shall be marked ‘‘corrected.’’

(b) The Division of Vital Records may require additional evidence to substantiate a correction when it is deemed necessary and proper to preserve the integrity of the records.

The provisions of this § 1.31 amended July 6, 1979, effective July 7, 1979, 9 Pa.B. 2250. Immediately preceding text appears at serial page (3360).

History

Authority: The provisions of this Chapter 1 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 1 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 1.32 Correction or addition of names.

Corrections or additions of the name of the subject on a birth certificate shall be made in compliance with the following:

(1) If the subject is less than 1 year of age, correction may be accomplished by a statement signed by both parents.

(2) If the subject is over 1 year of age, correction may be accomplished by an affidavit of both parents or the subject, if of legal age.

History

Authority: The provisions of this Chapter 1 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 1 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 1.33 Correction of date of birth.

Corrections in the date of birth on a birth certificate shall be made in compliance with the following:

(1) If the subject is less than 1 year of age, correction may be accomplished by a statement signed by both parents together with a statement of the hospital, the attending physician or midwife.

(2) If the subject is over 1 year of age, correction may be accomplished by an affidavit of both parents or of the subject, if of legal age, together with the baptismal record of the subject, early school record or other acceptable documents which shall conclusively prove the correct date. The supporting document shall be at least 5 years old.

History

Authority: The provisions of this Chapter 1 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 1 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 1.34 Correction of spelling of names.

Changes in the spelling of names on birth certificates shall be made in compliance with the following:

(1) If the subject is less than 1 year of age, correction may be accomplished by a statement signed by both parents.

(2) If the subject is over 1 year of age, correction may be accomplished by an affidavit of the parents or of the subject, if of legal age.

(3) If the correction requested suggests a change in surname rather than the correction of the spelling of a surname, then the Department of Health may require additional recorded evidence or an order from a court of competent jurisdiction if it is deemed necessary to preserve the integrity of the records.

History

Authority: The provisions of this Chapter 1 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 1 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 1.35 Changing names of children under the age of 15.

(a) When a child of at least 7 but no more than 14 years of age has established through usage a name different from the name originally recorded on the birth certificate, the Division of Vital Records may, upon application therefor by the subject’s custodial parent, guardian or legal representative, issue a regular certificate in the name the subject is actually using. Before the certificate is issued, the applicant shall submit to the Division of Vital Records adequate proof establishing usage of the name.

(b) Adequate proof shall consist of documents or official records demonstrating actual use of the name by the child during at least half of the child’s lifetime.

The provisions of this § 1.35 amended July 6, 1979, effective July 7, 1979, 9 Pa.B. 2250. Immediately preceding text appears at serial page (3361).

History

Authority: The provisions of this Chapter 1 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 1 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 1.36 Addition or correction of information on death certificates.

(a) To add to or correct information pertaining to the deceased person except the medical certification and the place and date of death on a death or fetal death certificate, a signed statement covering the necessary corrections or additions shall be submitted by the informant who signed the original certificate or by the funeral director who filed such certificate.

(b) To add to or correct information pertaining to date or place of burial on a death or fetal death certificate a written statement covering the necessary corrections or additions shall be submitted by the funeral director.

History

Authority: The provisions of this Chapter 1 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 1 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 1.37 Changes in the medical certification of cause of death.

(a) To add to or correct information pertaining to the medical certification of cause of death or date or place of death, a written statement covering the necessary corrections or additions shall be submitted by the physician or coroner who signed the medical certification on the original certificate.

(b) If the correction requested changes the medical certification from a death due to natural causes to a death due to other than natural causes, then the affidavit of the person who signed the medical certification shall be requested.

History

Authority: The provisions of this Chapter 1 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 1 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 1.41 Qualifications for registrar.

The following qualifications shall be required of a person who is appointed local registrar or deputy registrar:

(1) Legibility of hand writing or ability to use a typewriter.

(2) Training or experience in simple office procedures, such as filing, indexing and the handling of valuable documents.

(3) The ability to transcribe accurately from original documents.

History

Authority: The provisions of this Chapter 1 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 1 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 1.42 Responsibilities of local registrars.

(a) Verifications. Local registrars in cities of the third class shall be authorized to verify the place and date of birth of a child for representatives of the Department of Education when they receive a signed request from an official of the school district.

(b) Disclosures. Local registrars shall be authorized to disclose information contained in vital statistics records to persons who have been supplied with an authorization card signed by the Secretary of Health.

(c) Motor vehicle deaths. The local registrar shall report to the Bureau of Highway Safety in Harrisburg the following facts copied from the death certificate received by the local registrar, and concerning deaths resulting from motor vehicle accidents:

(1) Name and address of deceased.

(2) Date and place of accident.

(3) Date of death.

The provisions of this § 1.42 amended through July 6, 1979, effective July 7, 1979, 9 Pa.B. 2250. Immediately preceding text appears at serial page (24403).

History

Authority: The provisions of this Chapter 1 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 1 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 1.43 Designation of registrars.

The Secretary of Health may designate a medical director of a county department of health to act as local registrar within his registration district, with the authority to certify records, as long as the director shall have agreed, in writing, to be bound by the rules, regulations and directives of the Department of Health concerning records.

History

Authority: The provisions of this Chapter 1 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 1 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 1.44 Penalties for unauthorized duplication.

Subject to the penalties provided in sections 901 and 902 of the Vital Statistics Law of 1953 (35 P. S. § § 450.901 and 450.902), no person may photograph, photostat, duplicate or issue what purports to be a certified copy, certification or certificate of birth, death or fetal death except for authorized employes of the Department of Health or its local registrars of vital statistics acting in accordance with directives, regulations or law governing their official duties.

History

Authority: The provisions of this Chapter 1 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 1 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 1.45 Supplemental reports.

Information omitted from original certificates of birth, death or fetal death may be added to the original certificate within 6 months after the date of filing of the certificate.

History

Authority: The provisions of this Chapter 1 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 1 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 1.46 Fees for copies.

(a) A fee of $4.00 shall be paid by the applicant for each certified copy and for each No-Record Certification (NC-8) of a birth record issued to the applicant by the Division of Vital Records.

(b) A fee of $3.00 shall be paid by the applicant for each certified copy and for each No-Record Certification (NC-8) of a death record issued to the applicant by the Division of Vital Records.

(c) A No-Record Certification shall be issued in each instance in which a thorough search of the records reveals that the certificate requested by the applicant is not on file with the Division of Vital Records.

The provisions of this § 1.46 amended through March 28, 1980, effective March 29, 1980, 10 Pa.B. 1386. Immediately preceding text appears at serial page (43933).

History

Authority: The provisions of this Chapter 1 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 1 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 1.47 Burial permits.

No burial permit may be issued until the local registrar has been satisfied that the funeral director has complied with this chapter.

History

Authority: The provisions of this Chapter 1 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 1 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 1.48 Maximum fees payable to local registrar.

A local registrar may not receive an aggregate amount of fees in excess of $20,000 in any one calendar year.

The provisions of this § 1.48 added September 11, 1970, effective September 12, 1970, 1 Pa.B. 356.

History

Authority: The provisions of this Chapter 1 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 1 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 1.49 Access by adoptees to identification of biological parents.

(a) As used in this section, the term ‘‘biological parent’’ means natural parent as used in 23 Pa.C.S. § § 2101—2910 (relating to the Adoption Act).

(b) A biological parent may consent to the disclosure of his identity by filing a Biological Parent Registration Identification Form with the Division of Vital Records. Each biological parent shall complete a separate form and each form shall be notarized. The Biological Parent Registration form is available from the Division of Vital Records.

(c) A biological parent may update his identifying information by filing an additional Biological Parent Registration Form with the Division of Vital Records.

(d) A biological parent may withdraw his consent to the disclosure of identifying information by filing a Withdrawal of Biological Parent Consent Form with the Division of Vital Records. Each biological parent shall complete a separate form and each form shall be notarized. The Withdrawal of Biological Parent Consent Form is available from the Division of Vital Records.

(e) The Division of Vital Records will release a biological parent’s identifying information if the following requirements are met:

(1) The information is requested by an adoptee who is at least 18 years old or the information is requested by the adoptive parent or legal guardian of an adoptee who is less than 18 years old.

(2) A Biological Parent Registration Form is on file with the Division of Vital Records.

(f) If one biological parent has filed a Biological Parent Registration Form, only the name and address of that parent will be released. If both biological parents have filed Biological Parent Registration Identification Forms, information from the Certificate of Live Birth may be released.

(g) A biological parent may consent to the disclosure of his identity by the court where the permanent records of the adoption are located, by following the procedures set forth by the appropriate court.

The provisions of this § 1.49 amended under 23 Pa.C.S. § 2905; and section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

The provisions of this § 1.49 adopted December 24, 1981, effective December 26, 1981, 11 Pa.B. 4437; amended May 1, 1987, effective May 2, 1987, 17 Pa.B. 1736. Immediately preceding text appears at serial page (104776).

History

Authority: The provisions of this Chapter 1 issued under sections 2104 and 2111 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 1 adopted October 30, 1959, unless otherwise noted.

Chapter 4 Head Injury Program

28 Pa. Code § 4.1 Scope and purpose.

(a) This chapter establishes standards for the Department to administer the Fund.

(b) The Department will use the Fund to administer a head injury program, as set forth in this chapter, to pay for medical, rehabilitation and attendant care services for persons with traumatic brain injury.

History

Authority: The provisions of this Chapter 4 issued under section 14(e) of the Emergency Medical Services Act (35 P.
Source: The provisions of this Chapter 4 adopted July 27, 2001, effective August 27, 2001, 31 Pa.

28 Pa. Code § 4.2 Definitions.

The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise: Agency head—The Secretary or a deputy secretary designated by the Secretary. Alternative financial resources—

(i) All income subject to tax under section 61 of the Internal Revenue Code (26 U.S.C.A. § 61).

(ii) Funds which are available to the applicant or client by virtue of experiencing a TBI. These include, but are not limited to, court awards, insurance settlements and other financial settlements made as a result of the TBI and received by any person on behalf of or for the use of the applicant or client.

(iii) Funds which are available to the applicant or client through other State or Federal programs including, but not limited to, Medicaid, Medicare, Social Security Disability Insurance (Title II), Supplemental Security Income (Title XVI), veterans’ benefits, workers’ compensation insurance and unemployment compensation insurance. Applicant—An individual for whom a completed application for enrollment in HIP has been submitted to the Department. Authorized representative—An individual who is authorized by law to make a decision for, or enter into an agreement on behalf of, an applicant or client. The term does not include an employee of the provider unless the employee is appointed by a court to serve as the legal guardian of the applicant or client. Case management services—Services to be offered by the provider to a client during the enrollment period. Case manager—An individual who delivers case management services to a client through a provider. Client—An individual enrolled in HIP. Day services—Nonresidential services intended to improve the physical, cognitive, behavioral or functional abilities of the client through therapeutic intervention and supervised activities which are provided on an outpatient basis at a facility belonging to a provider. Department—The Department of Health of the Commonwealth. Division—The Division of Child and Adult Health Services. Enrollment period—The period of time, comprised of the rehabilitation period and the transition period, during which a client is enrolled in HIP. Fund—The Catastrophic Medical and Rehabilitation Fund. HIP—Head Injury Program—The traumatic brain injury program of the Department. HIP Peer Review Committee—A committee, composed of professionals and representatives of organizations offering rehabilitation services in this Commonwealth to persons with traumatic brain injury, whose members are appointed by the Department to review rehabilitation plans and services offered to clients and to recommend actions to improve services. HIP services—Rehabilitation and case management services for which the Department authorizes payment through HIP. Home facilitation—A formal rehabilitation program which provides a community reentry specialist in the client’s home to continue therapy learned by the client and to assist the client in the practice of techniques and strategies for living independently. Immediate family—A parent, spouse, child, brother, sister, grandparent or grandchild and, when living in the family household (or under a common roof), all other individuals related by blood or marriage. Peer review—A review of services and rehabilitation service plans for clients conducted by the HIP Peer Review Committee for the purpose of advising the Department on best practices to be followed in offering services to clients. Provider—An individual, organization or facility that delivers rehabilitation and case management services to clients under a contractual agreement with the Department. Rehabilitation period—The period of time that a client receives rehabilitation services through HIP. Rehabilitation service plan—The written plan developed by the provider, which states specific goals to be achieved and expected time frames for achievement of each goal. Rehabilitation services—Services provided to assist the client to recover from TBI, improve the client’s health and welfare, and realize the client’s maximum physical, social, cognitive, psychological and vocational potential for useful and productive activity. These services include neuropsychological evaluation, physical therapy, occupational therapy, speech or language therapy, behavior management, home facilitation, therapeutic recreation, prevocational services, case management services and psychological services which may include cognitive remediation. Secretary—The Secretary of the Department. TBI—traumatic brain injury—An insult to the brain, not of a degenerative or congenital nature, caused by an external physical force that may produce a diminished or altered state of consciousness, which results in impairment of cognitive abilities or physical functioning or in the disturbance of behavioral or emotional functioning. These impairments may be either temporary or permanent and cause partial or total functional disability or psychosocial maladjustment. Transition period—The period of time following the rehabilitation period during which a client receives case management services through HIP to guide and assist the client to make the transition out of HIP.

History

Authority: The provisions of this Chapter 4 issued under section 14(e) of the Emergency Medical Services Act (35 P.
Source: The provisions of this Chapter 4 adopted July 27, 2001, effective August 27, 2001, 31 Pa.

28 Pa. Code § 4.3 Services eligible for payment.

HIP will pay for the following:

(1) Assessments of applicants by providers.

(2) Development of rehabilitation service plans by providers.

(3) Rehabilitation services.

(4) Case management services.

History

Authority: The provisions of this Chapter 4 issued under section 14(e) of the Emergency Medical Services Act (35 P.
Source: The provisions of this Chapter 4 adopted July 27, 2001, effective August 27, 2001, 31 Pa.

28 Pa. Code § 4.4 Requirements for provider participation.

(a) Providers of residential, outpatient, day and home-based rehabilitation services shall be accredited by a National accrediting body as approved by the Department. From time to time, the Department will publish a list of approved National accrediting bodies in the Pennsylvania Bulletin.

(b) Providers shall provide rehabilitation services in accordance with their contractual agreements with the Department.

History

Authority: The provisions of this Chapter 4 issued under section 14(e) of the Emergency Medical Services Act (35 P.
Source: The provisions of this Chapter 4 adopted July 27, 2001, effective August 27, 2001, 31 Pa.

28 Pa. Code § 4.5 Application for enrollment as a HIP client.

(a) Initial contact. An individual who is interested in enrolling in HIP or in arranging for another individual to be enrolled in HIP shall contact the Eligibility Specialist of the Division by writing to: Eligibility Specialist, Department of Health, Division of Child and Adult Health Services, Post Office Box 90, 7th Floor East Wing, Health And Welfare Building, Harrisburg, Pennsylvania 17108. Contact may also be made by facsimile or electronic mail.

(b) Funding. The Division will accept an application for enrollment in HIP only if the funds designated to HIP from the Catastrophic Medical and Rehabilitation Appropriation exceed projected expenditures in providing HIP services to current clients.

(c) Waiting list. If the funds designated to HIP from the Catastrophic Medical and Rehabilitation Appropriation are not adequate to enable the Division to accept an application for an individual for whom enrollment in HIP is sought, the Division will place the individual on a waiting list if the individual so elects. The individual on the waiting list or the authorized representative shall immediately notify the Division of any change in mailing address. The Division will request an individual on the waiting list, or the authorized representative, to submit an application for enrollment as funding becomes available. Except as otherwise provided in this chapter, the Division will request individuals on the waiting list, or their authorized representatives, to submit applications in the order that the requests to be placed on the waiting list were received by the Division. Individuals who are receiving case management services through HIP as of August 27, 2001, but who have never received rehabilitation services through HIP, will be given first priority on the waiting list.

(d) Application. When an individual qualifies to receive an application for enrollment in HIP, the Division will send to that individual or the person who sought to enroll that individual in HIP, at the mailing address provided to the Division, information on HIP and application materials. If the individual is on a waiting list, the Division will also request that the individual notify the Division in writing whether the individual is still seeking enrollment in HIP. The notification shall be timely only if it is postmarked within 21 days after the date the materials were sent by the Division. If the Division receives a timely notification that enrollment in HIP is desired, the Division will proceed with the application process. If the Division is apprised that enrollment in HIP is no longer desired, or if the Division does not receive timely notification of continued interest in enrollment, the Division will remove the individual from the waiting list, contact the next person on the waiting list and repeat the process.

(e) Request and application for reenrollment. A request for reenrollment may be filed for an individual who was previously enrolled in HIP. If there is a waiting list, the Division will not accept an application for reenrollment. Instead, it will place the individual on the waiting list. The Division will give priority to individuals on the waiting list who have not previously received rehabilitation services from HIP. The Division will request individuals who have previously received rehabilitation services from HIP who are on the waiting list, or their authorized representatives, to submit applications for reenrollment. The Division’s requests for these applications will be made in the order that the requests for reenrollment were received. Except as provided in subsection (c), the Division will only accept a request or application for reenrollment for an individual who is not a client at the time the request or application is made.

(f) Acceptance of application. The Division will accept an application for enrollment only from the individual for whom enrollment is sought or from an authorized representative.

History

Authority: The provisions of this Chapter 4 issued under section 14(e) of the Emergency Medical Services Act (35 P.
Source: The provisions of this Chapter 4 adopted July 27, 2001, effective August 27, 2001, 31 Pa.

28 Pa. Code § 4.6 Assessment.

(a) Eligibility for assessment. The Division will review an application for enrollment in HIP to determine whether the applicant is eligible for an assessment, as follows:

(1) General criteria. An applicant shall be eligible for an assessment only if all of the following requirements are met:

(i) The applicant sustained a TBI after July 2, 1985.

(ii) The applicant is a citizen of the United States and was domiciled in this Commonwealth at the time of the injury and at the time of application for enrollment in HIP.

(iii) The applicant is 21 years of age or older.

(iv) The application is completed and is accompanied by the documentation that is requested to verify the applicant’s satisfaction of the eligibility criteria in this subsection.

(v) The applicant’s alternative financial resources are at or below 300% of the Federal Poverty Income Guidelines.

(A) The applicant’s income will be assessed using the applicant’s most recent Federal Income Tax form, which the applicant shall provide. If that form is unavailable, the Division may request other documentation of income. If the most recent Federal Income Tax form is not representative of the applicant’s income at the time of application, the applicant may submit documents to that effect in support of the application.

(B) The applicant shall provide, on forms provided by the Division, information about any court award or financial settlement made or pending as a result of the TBI, and any other funds which are available to the applicant. If all or part of the award, settlement or other funds is unavailable to the applicant to use for HIP services, the applicant may submit documents to that effect in support of the application.

(2) Condition criteria. An applicant shall be eligible for an assessment only if the applicant’s impairment is not the result of one or more of the following conditions:

(i) Cognitive or motor dysfunction related to congenital or hereditary birth defects.

(ii) Putative birth trauma or asphyxia neonatorum (hypoxic-ischemic-encephalopathy).

(iii) Hypoxic encephalopathy unrelated to TBI.

(iv) Significant preexisting psychiatric, organic or degenerative brain disorder.

(v) Stroke.

(vi) Spinal cord injury in the absence of TBI.

(3) Symptom criteria. An applicant shall be eligible for an assessment only if the applicant does not manifest any symptom, such as a comatose condition, which would prevent the applicant from participating in the assessment in a meaningful way or prevent the provider from doing a full and complete assessment.

(4) Assignment agreement. An applicant shall be eligible for an assessment only if the applicant or authorized representative completes an assignment agreement which, conditioned upon the applicant’s receipt of HIP services, would assign to the Department rights in future court awards, insurance settlements or any other proceeds which have accrued or will accrue to the applicant as a result or by virtue of the applicant’s TBI, up to the amount expended for HIP services on behalf of that individual.

(b) Assessment process. The Division will refer an applicant who is eligible for an assessment to a provider. The provider shall assess the applicant for the following:

(1) To corroborate the Division’s determination that the applicant satisfies the condition and symptom criteria in subsection (a)(2) and (3).

(2) To determine that the applicant has the physical, social, cognitive, psychological and vocational potential for useful and productive activity which can be nurtured by rehabilitation services available through HIP so as to enable the applicant to progress toward a higher level of functioning and transition to a less restrictive environment.

(3) To determine that the applicant has needs that can be addressed by HIP services, that will not be addressed by any other services to which the applicant is entitled.

(4) To determine that the applicant does not manifest suicidal or homicidal ideation, or potentially harmful aggressive behavior, to such a degree that HIP cannot provide the appropriate services through its providers to sufficiently address these ideations or behaviors.

(c) Forms and procedure. The provider shall complete the assessment on forms provided by the Division. A provider conducting an assessment shall:

(1) Review the applicant’s medical records.

(2) Review all pertinent documentation submitted by physicians on behalf of the applicant.

(3) Evaluate the applicant’s ability to benefit from rehabilitation services, performed in accordance with standards prevailing in the field.

(d) Development of rehabilitation service plan. If the provider corroborates the Division’s initial determination under subsection (a)(2) and (3), and determines that the applicant meets the criteria in subsection (b)(2)—(4), the provider shall develop a rehabilitation service plan for the applicant as specified in § 4.8 (relating to rehabilitation service plan).

(e) Assessment period. The provider shall complete its assessment and give written notification of its determination to the Division and the applicant or authorized representative within 14 days after the provider begins to conduct an assessment of the applicant. If the provider determines that the applicant is eligible for enrollment in HIP, the provider shall also complete a rehabilitation service plan for the applicant within that 14-day period.

(f) Reapplication. If the Division determines that an individual is not eligible for an assessment or that an applicant is not eligible for enrollment in HIP after an assessment has been completed, the individual may repeat the process for seeking enrollment in HIP when the individual or authorized representative believes that the factors which rendered the individual ineligible for enrollment in HIP have been eliminated.

This section cited in 25 Pa. Code § 4.7 (relating to enrollment).

History

Authority: The provisions of this Chapter 4 issued under section 14(e) of the Emergency Medical Services Act (35 P.
Source: The provisions of this Chapter 4 adopted July 27, 2001, effective August 27, 2001, 31 Pa.

28 Pa. Code § 4.7 Enrollment.

(a) Notification of decision. The Division will notify an applicant or authorized representative in writing of its decision regarding an application for enrollment within 16 days after receiving from the provider the completed assessment and, if applicable, its decision regarding the rehabilitation service plan. If the Division determines that the applicant is ineligible, the notice will include the reason for that determination and will advise of appeal rights.

(b) Provider determination that applicant is not eligible for enrollment. If, after assessing the applicant the provider determines that the applicant does not satisfy the condition and symptom criteria in § 4.6(a)(2) and (3) (relating to assessment), lacks the potential to benefit or the need described in § 4.6(b)(2) and (3) or manifests ideation or behavior which would render the applicant unfit to participate in HIP under § 4.6(b)(4), the provider shall share its findings with the Division and the applicant or authorized representative. The Division will provide the applicant or authorized representative the opportunity to rebut the provider’s findings, and then will make a determination as to whether the applicant is eligible for enrollment in HIP.

(c) Overturning provider determinations. If the Division determines that an applicant is eligible for enrollment in HIP despite the provider’s determination to the contrary, or that a rehabilitation service plan is unacceptable, the Division will direct the provider, or another provider at the Division’s discretion, to develop a rehabilitation service plan for the applicant within 14 days of receiving the Division’s decision. The Division will act on the revised rehabilitation service plan within 16 days after receipt.

(d) Commencement of enrollment. A client’s enrollment begins on the first day that a client receives rehabilitation services from a provider after the Division issues its written notification granting enrollment in HIP.

(e) Duration of enrollment. The enrollment period of a client shall be specified in the client’s rehabilitation service plan. It may not exceed 18 consecutive months, comprised of a maximum rehabilitation period of 12 consecutive months followed by a maximum transition period of 6 consecutive months. A client’s enrollment shall end prior to the time designated in the client’s rehabilitation service plan when one of the following occurs:

(1) The Division determines that the continuation of HIP services will not enable the client to progress to a higher level of functioning and transition to a less restrictive environment.

(2) The client fails to cooperate or exhibits unmanageable behavior so that HIP cannot provide the appropriate services to meet the client’s needs under § 4.6(b)(4).

(3) The maximum funds available for allocation to the client under § 4.12 (relating to funding limits) are exhausted.

(4) The client becomes eligible for other services offered as a result of the TBI, which services will meet the client’s needs or duplicate HIP services so that HIP services are rendered unnecessary.

(f) Notification of discharge from HIP. The Division will notify a client or authorized representative in writing of its decision to terminate the client’s participation in HIP. The notice will include the reason for the decision and will advise of appeal rights.

(g) Grandfather clause. Clients who are receiving rehabilitation services as of August 27, 2001 are eligible for the maximum enrollment period, beginning on August 27, 2001. Clients who are receiving only case management services as of August 27, 2001 are eligible for the maximum transition period.

This section cited in 28 Pa. Code § 4.15 (relating to administrative review).

History

Authority: The provisions of this Chapter 4 issued under section 14(e) of the Emergency Medical Services Act (35 P.
Source: The provisions of this Chapter 4 adopted July 27, 2001, effective August 27, 2001, 31 Pa.

28 Pa. Code § 4.8 Rehabilitation service plan.

(a) Development of rehabilitation service plan. The provider shall collaborate with the applicant or authorized representative, and may collaborate with other individuals identified by the applicant, to develop a rehabilitation service plan for the applicant.

(b) Goal. The primary goal of the rehabilitation service plan shall be to enable the client to progress to a higher level of functioning, which will, in turn, enable the client to transition to a less restrictive environment.

(1) A description of desirable goals and the anticipated outcomes in objective and measurable terms, including the expected time frames for the achievement of each goal and outcome, for the entire enrollment period.

(2) A specification of the HIP services necessary to attain the agreed-upon goals.

(3) A specification of any other services to which the applicant is entitled and a description of the impact of those services upon the attainment of the agreed-upon goals.

(4) Beginning and ending dates of each HIP service.

(5) The terms and conditions for HIP service delivery.

(6) The specific responsibilities of the applicant and service provider relative to implementation of each HIP service.

(7) The extent of financial responsibility of the applicant, HIP and any third party.

(d) Quarterly review. The rehabilitation service plan shall include a procedure and schedule for quarterly review and evaluation of progress towards the specified goals. These written reviews shall be submitted to the Division.

(e) Modifications. The provider shall make modifications to the rehabilitation service plan as often as necessary, and in accordance with subsections (a)—(d). Modifications shall indicate whether previously set goals were met. When goals were not met, modifications shall address the reasons why, and modify or change goals appropriately.

This section cited in 28 Pa. Code § 4.6 (relating to assessment).

History

Authority: The provisions of this Chapter 4 issued under section 14(e) of the Emergency Medical Services Act (35 P.
Source: The provisions of this Chapter 4 adopted July 27, 2001, effective August 27, 2001, 31 Pa.

28 Pa. Code § 4.9 Rehabilitation period.

(a) Provision of rehabilitation services. During the rehabilitation period a provider shall coordinate the provision of rehabilitation services to a client to ensure achievement of goals consistent with the rehabilitation service plan, and as appropriate to the needs of the client to improve the client’s health, welfare and the realization of the client’s maximum physical, social, cognitive, psychological and vocational potential for useful and productive activity.

(b) Supervision. Rehabilitation services shall be provided or their provision shall be supervised by a physician or other appropriate health professional qualified by training or experience to provide or supervise these services.

(c) Purpose. If authorized under the rehabilitation service plan, rehabilitation services may be provided for the following purposes:

(1) Helping a client develop behaviors that enable the client to take responsibility for the client’s own actions.

(2) Facilitating a client’s successful community integration.

(3) Assisting a client to accomplish functional outcomes at home and in the community.

(4) Teaching a client skills to live independently.

(5) Supervising a client living in a home setting through the following:

(i) Home facilitation.

(ii) Physical rehabilitation.

(iii) Cognitive remediation.

(iv) Life-skills coaching.

(v) Assisting the client in maintaining independence.

(6) Providing transitional living services to assist a client with community reentry skills.

(7) Maximizing a client’s physical potential.

History

Authority: The provisions of this Chapter 4 issued under section 14(e) of the Emergency Medical Services Act (35 P.
Source: The provisions of this Chapter 4 adopted July 27, 2001, effective August 27, 2001, 31 Pa.

28 Pa. Code § 4.10 Transition period.

(a) Provision of case management services. Following the rehabilitation period, HIP will provide case management services to assist the client in making the transition out of HIP.

(b) Commencement of transition period. The transition period will commence immediately following the end of the rehabilitation period.

(c) Duration of transition period. The transition period may not exceed 6 consecutive months, and shall end when the maximum funds available for allocation to the client are exhausted under § 4.12 (relating to funding limits).

History

Authority: The provisions of this Chapter 4 issued under section 14(e) of the Emergency Medical Services Act (35 P.
Source: The provisions of this Chapter 4 adopted July 27, 2001, effective August 27, 2001, 31 Pa.

28 Pa. Code § 4.11 Case management services.

Case management services shall be provided by a case manager who has a minimum of 1 year of experience in TBI case management, and shall include the following activities by the case manager:

(1) Monitoring the client’s progress with respect to the rehabilitation service plan and collaborating with the client or authorized representative, the client’s significant others and the rest of the treatment team in the development and modification of the rehabilitation service plan.

(2) Assisting the client in gaining access to services from which the client may benefit and for which the client may be eligible.

(3) Monitoring and evaluating the client’s progress in transitioning to living in a home or community setting and ensuring that any necessary supports are in place, or facilitating placement of the client in a long-term care facility.

(4) Determining that the client has fully transitioned to the home or community or has been referred to the appropriate long-term care facility.

History

Authority: The provisions of this Chapter 4 issued under section 14(e) of the Emergency Medical Services Act (35 P.
Source: The provisions of this Chapter 4 adopted July 27, 2001, effective August 27, 2001, 31 Pa.

28 Pa. Code § 4.12 Funding limits.

(a) HIP will provide no more than $100,000 for case management and rehabilitation services for a client during a rehabilitation period. This amount will be reduced by any client share of costs under § 4.13(b) (relating to payment for HIP services).

(b) HIP will provide no more than $1,000 for case management services for a client during a transition period. This amount will be reduced by any client share of costs under § 4.13(b).

This section cited in 28 Pa. Code § 4.7 (relating to enrollment); 28 Pa. Code § 4.10 (relating to transition period); and 28 Pa. Code § 4.15 (relating to administrative review).

History

Authority: The provisions of this Chapter 4 issued under section 14(e) of the Emergency Medical Services Act (35 P.
Source: The provisions of this Chapter 4 adopted July 27, 2001, effective August 27, 2001, 31 Pa.

28 Pa. Code § 4.13 Payment for HIP services.

(a) Written authorization. The Division will provide written authorization, to the client and to the provider, as to HIP services for which the client is eligible and the maximum available funding and time limits for those services.

(b) Client responsibility for payment. If the Division determines that a client is responsible to pay for any part of HIP services, the client will be informed of that fact, and of the amount for which the client is responsible, as follows:

(1) The client shall be assessed a share of the cost of HIP based upon alternative financial resources between 185% and 300% of the Federal Poverty Income Guidelines. The patient’s share of the cost shall be determined using the Patient Share of Cost Table in Appendix A, as periodically updated and published in the Pennsylvania Bulletin.

(2) The client will be responsible to pay for HIP services up to the amount of alternative financial resources which exceed 300% of the Federal Poverty Income Guidelines.

(c) Notification of discontinuance of HIP funding. The Division will notify a client in writing of any discontinuance of funding. The notice will include the reason for the discontinuance and advise of appeal rights.

(d) Duty to update financial information. A client shall immediately report to the Division all changes in availability of alternative financial resources.

(e) Preexisting conditions. HIP will not pay for services to address conditions existing prior to the TBI.

(f) Services funded through other benefit programs. HIP will not pay for services available through other publicly funded programs. The provider will coordinate HIP with other public and private programs to assist clients to access benefits for which they may be eligible.

(g) Reimbursement. The Department may seek reimbursement for payments made with HIP funds on behalf of a client from an insurer that provides coverage to the client or from the proceeds of any litigation arising out of the injury which led to eligibility for enrollment in HIP.

This section cited in 28 Pa. Code § 4.12 (relating to funding limits).

History

Authority: The provisions of this Chapter 4 issued under section 14(e) of the Emergency Medical Services Act (35 P.
Source: The provisions of this Chapter 4 adopted July 27, 2001, effective August 27, 2001, 31 Pa.

28 Pa. Code § 4.14 Peer review.

(a) Purpose. The Department will appoint a peer review committee to conduct a review of services and rehabilitation service plans for clients. The HIP Peer Review Committee (Committee) shall advise the Department on best practices to be followed in offering services to clients.

(b) Procedures.

(1) The Committee shall meet quarterly and review selected client charts, including charts for at least one client from each provider providing services at the time of the quarterly meeting, to evaluate the appropriateness of provision of services and client progress.

(2) Within 30 days after it completes its review, the Committee shall provide to the Department, in writing, recommendations regarding the provision of services by each provider.

(3) A member of the Committee may not participate in a review conducted by the Committee that presents a conflict of interest for that member. Examples of conflicts include, but are not limited to, participating in a review conducted by the Committee for one of the following:

(i) A service provided to a client of that member, that member’s employer or that member’s immediate family.

(ii) A service provided by a person who is in the immediate family of the member.

(4) The Division will notify the Committee of any actions taken on the recommendations of the Committee.

History

Authority: The provisions of this Chapter 4 issued under section 14(e) of the Emergency Medical Services Act (35 P.
Source: The provisions of this Chapter 4 adopted July 27, 2001, effective August 27, 2001, 31 Pa.

28 Pa. Code § 4.15 Administrative review.

(a) Reconsideration by Division.

(1) An applicant, client or authorized representative may file with the Division a request for it to reconsider any of the following decisions made by the Division:

(i) An applicant is not eligible for an assessment.

(ii) An assessed applicant is not eligible for enrollment.

(iii) A disapproval or revision of a rehabilitation service plan.

(iv) A client is to be discharged from HIP prior to the date specified in the client’s rehabilitation service plan.

(v) Alternative financial resources are available so that the client must pay for HIP services.

(2) At the time a decision is made, the Division will notify the applicant, client or authorized representative in writing of the right to seek administrative review. The letter will advise the recipient to seek assistance from legal counsel, family and others who may serve in an advisory role, and include contact information for a HIP representative to answer questions.

(3) An applicant, client or authorized representative shall file a request for reconsideration within 15 calendar days after the mailing date of the Division’s determination. The request shall meet the following standards:

(i) State the specific legal and factual reasons for disagreement with the decision.

(ii) Identify the relief that is being sought for the applicant or client.

(iii) Include supporting documentation, if any, to support the factual averments made.

(4) The Division will notify the applicant, client or authorized representative in writing of its decision within 30 days after receiving the request for reconsideration.

(b) Administrative appeal.

(1) An applicant, client or authorized representative may file an administrative appeal to the Agency Head within 30 days after the mailing date of the Division’s decision on the request for reconsideration. An applicant, client, or authorized representative may not file an administrative appeal unless reconsideration has been sought and the requested relief has been denied.

(2) A hearing will be held only if a material issue of fact is in dispute.

(c) General rules. The General Rules of Administrative Practice and Procedure, 1 Pa. Code Part II, apply except when inconsistent with this section.

(d) Status of clients and applicants. A client shall continue to receive HIP services until the client’s right to administrative review has been exhausted, and until the maximum funds available to a client under § 4.12 (relating to funding limits) are exhausted, or the maximum duration for enrollment under § 4.7(e) (relating to enrollment) has expired. An applicant, including one who has completed the assessment period, will not receive HIP services pending the disposition of the administrative review.

Note: This table is revised each year based on the release of HHS Federal Poverty Income Guidelines by the United States Department of Health and Human Services. The figures above were published in the Federal Register: February 16, 2001 (Volume 66, Number 33) Notices: (pages 10695—10697).

History

Authority: The provisions of this Chapter 4 issued under section 14(e) of the Emergency Medical Services Act (35 P.
Source: The provisions of this Chapter 4 adopted July 27, 2001, effective August 27, 2001, 31 Pa.

Chapter 5 Clinical Laboratories

28 Pa. Code § 5.1 Definitions.

The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise: Act—The Clinical Laboratory Act (35 P. S. § § 2151—2165). Advisory committee—A group of persons as designated by the act who are experienced in the clinical laboratory field and appointed by the Secretary for the purpose of advising the Secretary in matters relating to the administration of the act. At least one member shall be qualified in the discipline of anatomic pathology and one in clinical pathology and licensed to practice medicine in this Commonwealth or eligible for licensure, one shall be qualified in the field of clinical chemistry, and one shall be qualified in the field of clinical microbiology. Clinical Laboratories Improvement Act of 1967 (CLIA)—Section 353 of the act of July 1, 1944, Pub. L. No. 90-174 (42 U.S.C.A. § 263), and the regulations which apply thereto. Clinical laboratory—Clinical laboratory includes the following:

(i) A place, establishment or institution organized and operated primarily for the performance of bacteriological, biochemical, microscopical, serological or parasitological tests by the practical application of one or more of the fundamental sciences to material originating from the human body, by the use of specialized apparatus, equipment and methods, for the purpose of obtaining scientific data which may be used as an aid to ascertain the state of health. The term includes, but is not limited to, independent, hospital, industrial, state, county and municipal laboratories and clinical laboratories operated in private offices and clinics of practitioners of the healing arts.

(ii) The term does not apply to the office or clinic of a licensed practitioner of the healing arts who performs only the following procedures as part of his or her examinations of the patient to obtain results which are essential for the immediate diagnosis and therapy of the patient:

(A) Chemical examinations of urine by ‘‘Dipstik’’ or tablet methods or both.

(B) Microscopic examination of urine sediment.

(D) Red and white blood cell counts.

(E) Sedimentation rate of blood.

(F) Gram stain.

(G) Primary culturing for transmittal to a licensed laboratory including pre-incubation, if required.

(H) Qualitative chemical examination of stool specimens.

(I) Test for pinworms.

(J) Test for Trichomonas vaginalis.

(iii) The list set forth in subparagraph (ii) may be revised by the Department in the event it is deemed advisable to add or eliminate specific procedures which either qualify or which no longer qualify as exempt items under the meaning and intent of this section.

(iv) Such procedures may be performed by the practitioners personally or with the aid of an assistant who need not be otherwise qualified.

(v) In the circumstances described in subparagraph (ii), the practitioner shall not be required to obtain a permit before carrying out such laboratory work. Department—The Department of Health of the Commonwealth. Director—The person designated by the registrant to be responsible for the daily technical and scientific operations of the laboratory including choice and application of methods, supervision of personnel and reporting of findings. Owner—Any individual, partnership, group, firm or corporation holding or claiming ownership of or title to a laboratory. Permit—A license issued by the Department which allows the operation of a clinical laboratory under the provisions of the act. Secretary—The Secretary of Health of the Commonwealth. Specimen—Only materials derived from the human body regardless of the physical character of such material. Supervisor—A properly qualified individual, who, under the direction of an authorized director, may supervise the general activities of a clinical laboratory, or a properly qualified individual who under the direction of an authorized director, may supervise the technical work in a laboratory category. Technologist—A properly qualified individual according to the provisions set forth in § 5.24 (relating to qualifications of technical personnel).

The provisions of this § 5.1 amended through February 26, 1976, 6 Pa.B. 392. Immediately preceding text appears at serial pages (23192) and (23193).

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.2 Scope and exception.

This chapter is applicable to all clinical laboratories operating within this Commonwealth except those specifically excluded under section 13 of the act (35 P. S. § 2163). A licensed laboratory approved to perform tests for syphilis under the act is also an approved laboratory to perform these tests under sections 12 and 13 of the Disease Prevention and Control Act of 1955 (35 P. S. § § 521.12 and 521.13).

The provisions of this § 5.2 amended July 6, 1979, effective July 7, 1979, 9 Pa.B. 2250. Immediately preceding text appears at serial page (37439).

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.11 Permit, requirements, application and conditions.

(a) No person, organization or establishment may operate a clinical laboratory in this Commonwealth without first obtaining a permit from the Department.

(b) Application for a permit to operate a clinical laboratory shall be made by the director thereof on forms provided by the Department. The application shall be accompanied by a filing fee of $25 payable to the Department; the fee will be retained by the Department.

(1) The name and address of the owner or his authorized agent and information regarding the owner as may be required.

(2) The name and address of the clinical laboratory director and other technical personnel to be employed.

(3) Name and address of the clinical laboratory for which the permit is requested and a description and plan of the premises to be occupied for the operation of the laboratory.

(4) A list of the major laboratory equipment to be utilized, including the manufacturer’s name and model number, and other pertinent specifications as may be required on the application form.

(5) The tests to be performed in the clinical laboratory.

(6) The internal and external quality control systems to be employed in the clinical laboratory.

(7) Answers to other questions required in the completion of the application form provided by the Department.

(d) A clinical laboratory director may obtain a permit for all or any designated part of one or more of the following categories:

(1) Microbiology, including the subcategories of bacteriology, virology, mycology, parasitology, syphilis serology and nonsyphilis serology.

(2) Hematology, including immunohematology.

(3) Clinical chemistry, including urinalysis.

(4) Tissue pathology, including exfoliative cytology.

(5) Radioisotope technics.

(e) A category, or subcategory (part), may be retained in a clinical laboratory permit as long as there is evidence that the laboratory functions actively in that category or subcategory and performs a reasonable number of tests to maintain its proficiency, as determined by the Department. Addition of a new category or subcategory may require a period of proficiency evaluation not to exceed 6 months before approval is granted.

(f) No clinical laboratory or other establishment may collect or receive specimens from patients in this Commonwealth for testing unless the laboratory possesses a valid permit issued under this chapter or holds an appropriate Federal license if the laboratory is located outside of this Commonwealth.

(g) A licensed clinical laboratory may send specimens or portions of specimens which it receives to a consulting or reference laboratory approved by the Department. However, the sending clinical laboratory may not serve primarily as a receiving or relay station. A collecting, receiving or relay station may not be maintained by a laboratory or agent of a laboratory which does not hold a currently valid permit to operate a clinical laboratory in this Commonwealth.

(h) In order for a permit to become and remain valid, an annual registration fee shall be paid in full to the Department on or before November 15, 1983, and August 15 of each year thereafter upon receipt of billing forms from the Department. The amount of the fee shall be $100 for each category for which approval is granted. The maximum fee required for each laboratory will not exceed $500 per annum.

The provisions of this § 5.11 amended through October 21, 1983, effective October 22, 1983, 13 Pa.B. 3218. Immediately preceding text appears at serial pages (43941), (66805), and (66806).

This section cited in 58 Pa. Code § 21.8 (relating to boxers).

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.21 Qualifications of director.

(a) No person shall be a director of a clinical laboratory unless he conforms with one of the following requirements:

(1) He shall hold a doctor of science degree or its equivalent in the basic sciences of chemistry, biology or microbiology or a doctoral degree in public health, medicine, osteopathy, pharmacy, dentistry or veterinary medicine from a college or university recognized by the National Committee of Regional Accrediting Agencies or the Department of Education of the Commonwealth of Pennsylvania, and who has had 2 years’ experience in a laboratory acceptable to the Department or is certified by the American Board of Pathology, American Osteopathic Board of Pathology, American Board of Microbiology, American Board of Bioanalysis. American Board of Clinical Chemistry, or other national accrediting board in laboratory specialties acceptable to the Department.

(2) He shall hold a master of science degree or its equivalent in the basic sciences from a college or university recognized by the National Committee of Regional Accrediting Agencies or the Department of Education of the Commonwealth, in chemistry, biology or microbiology, and who has had a minimum of 4 years’ experience in a laboratory acceptable to the Department.

(3) He shall hold a bachelor of science degree or its equivalent in the basic sciences from a college or university recognized by the National Committee of Regional Accrediting Agencies or the Department of Education, in chemistry, biology or microbiology, and who has had a minimum of 5 years experience in laboratory work in a laboratory acceptable to the Department.

(b) In addition, he may be required to pass a written, oral or practical qualifying examination in general laboratory science in one or more of the laboratory categories.

(c) On and after July 1, 1973, the proposed director of a clinical laboratory applying for a permit shall meet the requirements in subsection (a)(1) or (2).

(d) On and after July 1, 1974, the proposed director of a clinical laboratory applying for a permit shall meet the requirements in subsection (a)(1).

(e) The limitations of subsections (c) and (d) will not apply to those persons operating a clinical laboratory prior to February 6, 1973.

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.22 Responsibilities of owner and director.

(a) The owner and director, jointly and severally, shall be responsible for the proper maintenance and ethical operation of the clinical laboratory and for any violations of these and other existing provisions. The Department will be notified in writing within a 30-day period of changes in the directors or general supervisor, and of all other technical personnel changes on a 6-month basis. Significant changes in physical facilities shall be reported to the Department within 30 days after initiation of the changes.

(b) The owner shall be responsible that the clinical laboratory is at all times under the direction of a director acceptable to the Department as set forth in this section. Whenever the designated director is to be on leave from his duties for more than 30-calendar days, the registrant shall so notify the Department in advance and shall designate, subject to approval of the Department, an interim director of the laboratory.

(c) The owner shall notify the Department in advance whenever the designated director is expected to terminate his services with the laboratory. Permission may be granted to continue operation of a clinical laboratory for not more than 6-calendar weeks under a general supervisor who does not meet the qualifications of a director. In extenuating circumstances, permission to operate longer without a permanent director may be granted subject to conditions specified in writing by the Department.

(d) The owner and director shall, if different persons, be jointly and severally responsible for the operation of the clinical laboratory in compliance with this section and with other pertinent regulatory and statutory requirements. They shall be responsible for the employment of personnel meeting qualifications specified in this chapter. They shall submit to the Department, on forms provided by the Department, an annual report of the number and types of laboratory examinations performed during the preceding year.

(e) The director shall be responsible for the proper performance of all tests in the laboratory. He shall direct and supervise such tests and be responsible for the work of subordinates. He shall be responsible for the continuous application of quality control procedures to the work in accordance with recommendations and directives of the Department. Laboratory records of all work performed shall indicate the name of the director, and be signed by or otherwise indicate the person who actually performed the test.

(f) No person may act as a director of more than two clinical laboratories.

(g) A director shall be present for a reasonable period of each working day in each laboratory for which he is director.

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.23 Qualifications of a supervisor.

(a) No person shall be a supervisor in a clinical laboratory unless he conforms with one of the following requirements:

(1) He shall have an earned doctoral degree from an accredited institution and shall have gained at least 2 years’ experience acceptable to the Department in one or more of the applicable categories in the clinical laboratory.

(2) He shall hold a M.A. or M.S. degree from an accredited institution with a major in medical technology or one of the biological, physical or chemical sciences and shall have had at least 4 years’ experience acceptable to the Department in one or more of the applicable categories in the clinical laboratory.

(3) He shall hold a B.S. or A.B. degree from an accredited institution with a major in medical technology or one of the biological, physical or chemical sciences and shall have had at least 6 years’ experience acceptable to the Department in one or more of the applicable categories in the clinical laboratory.

(b) The following two categories of supervisors shall be recognized:

(1) A general supervisor who meets all the requirements of subsection (a)(1), (2) or (3) and is on the laboratory premises during all normal scheduled working hours in which tests are being performed. The director may also qualify as a general supervisor.

(2) A technical supervisor who meets the requirements of subsection (a)(1), (2) or (3) and provides direct supervision for the technical performance of the staff in one or more of the major categories, that is, microbiology, hematology and immunohematology, clinical chemistry and radioisotope technics during the periods in which tests are performed.

(c) Notwithstanding other provisions of this chapter, an individual who has been employed in a clinical laboratory as a supervisor prior to the effective date of this chapter may continue to act in that capacity after the date and may not be required to meet the requirements in subsection (a).

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.24 Qualifications of technical personnel.

(a) A clinical laboratory technologist shall perform clinical laboratory tests with minimal supervision by the director or supervisors, while working in those areas in which he is qualified by education or experience. A clinical laboratory technologist shall have the following qualifications:

(1) A baccalaureate degree in medical technology or in a chemical, physical or biological science and clinical education in a program accredited by an agency recognized by the Department which includes 1 year of experience acceptable to the Department.

(2) An individual without the baccalaureate degree may become qualified as a technologist according to the provisions of section 241 of Title XI of the Social Security Amendments of 1972 Public Law 92-603 (42 U.S.C.A. § 1320a-2).

(b) Technical personnel below the level of technologist shall be determined by the director to be fully qualified for all assigned technical duties.

(c) Notwithstanding any other provision of this chapter, an individual who has been employed in a clinical laboratory as a technologist prior to the effective date of this chapter may continue to act in that capacity and may not be required to meet the requirements of subsections (a) and (b).

Although the technologist who performed a blood alcohol test did not possess a baccalaureate degree, she had attended college for 3 years, served a 1-year clinical internship and practiced medical technology for the last 17 years, all of which qualified her as a technologist under this section which provides that a person may qualify by education or experience. Commonwealth v. O’Hayer, 497 A.2d 649 (Pa. Super. 1985).

This section cited in 28 Pa. Code § 5.1 (relating to definitions).

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.31 Working space and lighting.

Working space and lighting shall be adequate. Sufficient equipment in good condition and in working order shall be available for the tests performed. A preventive maintenance program for equipment shall be maintained, and appropriate records kept. Adequate fire prevention and other safety factors shall be present which meet applicable local building codes and ordinances.

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.32 Library.

A current library of books and journals shall be available to the director and other personnel to enable them to keep informed of advances in laboratory medicine. Approved procedural manuals for the work performed shall be immediately available to technical personnel in the laboratory working area.

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.41 Acceptance and collection of specimens.

(a) Specimens shall be accepted or collected from patients by a clinical laboratory only when tests are requested on the specimens by a member of the healing arts licensed to practice in this Commonwealth, or other persons authorized by statute, or authorized agents of the foregoing.

(b) No specimen shall be collected by an owner, an employe or other person associated with the clinical laboratory except under one of the following conditions:

(1) The person is a member of the healing arts licensed in this Commonwealth or a laboratory director qualified under the Clinical Laboratory Act of 1951 (P. L. 1539) (35 P. S. § 2151 et seq.).

(2) The person is collecting the specimen under the direction of a member of the healing arts licensed in this Commonwealth or a laboratory director qualified under the Clinical Laboratory Act.

(c) This section does not prohibit the transmission of specimens collected as set forth in subsection (b) under the following circumstances:

(1) To another laboratory licensed under the Clincial Laboratory Act.

(2) To a Federal laboratory.

(3) To a laboratory located in another state providing that laboratory has been issued a license or permit in conformity with the Clinical Laboratories Improvement Act of 1967 (35 P. S. § 2151) and related regulations.

(d) The acceptance of specimens submitted by a representative of the Department, or designated agent, for purposes of evaluation of testing procedures is not prohibited.

A blood test performed by a trained phlebotomist under standard hospital procedures under directors of a physician and met the requirements of this section. Commonwealth v. Dungan, 539 A.2d 817 (Pa. Super. 1988); appeal denied 559 A.2d 34 (Pa. 1989).

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.42 Transportation of specimens.

Procedures used for transporting specimens from collection points to the testing facilities of the clinical laboratory shall be such that the physical integrity and composition of the specimen remain intact, and changes do not occur in the specimen which will interfere with the validity of subsequent results. This includes factors of time, temperature and other environmental factors which are critical to the preservation of the specimen.

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.43 Identification of specimens.

Every specimen received for testing shall be numbered, listed in an accession book or otherwise marked so that it may be identified definitely and related to the patient, and the submitting member of the healing arts or the referring laboratory. An appropriate dated record of its receipt, disposition and examination, findings obtained, and charges assigned shall be made and kept on file for the minimum period required by statute. The records shall be available for inspection by authorized representatives of the Department.

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.44 Examination of specimens.

(a) No specimen shall be examined if unsuitable for testing because of improper collection, improper preservation, apparent spoilage, excessive time lapse between collection and examination, when applicable, or other reason sufficient to render the findings of doubtful validity.

(b) No specimen of excised tissue shall be subjected to pathological examination except by a person qualified in the field of anatomic pathology. No specimen of exfoliated tissue or cells shall be examined except under the supervision and review of a person qualified in cytopathology. Ten percent of negative cytology preparations and positive or suspicious preparations shall be reviewed by a person qualified in cytopathology. Technical procedures employed in a laboratory shall be the standard procedures which are generally accepted and approved by the Department. Proof that procedures varying from those commonly employed in laboratory practice are accurate may be required by the Department.

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.45 Onsite testing.

A clinical laboratory shall be prepared during the normal working hours to accept, perform and report promptly on specimens submitted by the Department for purpose of testing the adequacy and accuracy of its procedures.

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.46 Reagents and equipment.

Reagents, procedures or equipment which have been demonstrated to be inadequate for clinical laboratory use as evidenced by reliable data from generally acceptable scientific testing and evaluating sources shall be prohibited for use by clinical laboratories upon specific notification by the Department. Also, reagents, equipment and procedures which do not have substantial proof of efficacy either by trial or extended use experience shall be prohibited for routine use.

Inasmuch as each time it sent in proficiency test results, hospitals had notified Department of Health that it was using a particular type of machine, and inasmuch as the Department had not notified the hospital, under this section, that use of the machine was prohibited, the court could find that the equipment was acceptable. Commonwealth v. O’Hayer, 497 A.2d 649 (Pa. Super. 1985).

This section cited in 28 Pa. Code § 5.103 (relating to blood tests for blood alcohol content).

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.47 Report of findings.

Reports of clinical laboratory findings shall be made only to the person submitting the specimen or requesting the analysis, or his authorized agent. Nothing in this section shall prohibit the issuance of reports of clinical laboratory findings to town, city, borough or Commonwealth health officials as required by statute or the inspection or impounding of records of the reports by an authorized representative of the Department.

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.48 Disclosure of charges.

A notification of charges for laboratory tests performed for the patient shall be sent to the patient by the clinical laboratory unless the patient has been billed directly or otherwise notified of the charges by the laboratory.

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.49 Reportable diseases.

The director of a clinical laboratory shall report to the Department all laboratory findings which indicate the presumptive presence of any disease required to be reported by the provisions set forth in § 27.22 (relating to reporting of cases by clinical laboratories), or as required by other statutes or regulations of the Commonwealth or by Federal statutes.

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.50 Approval to provide special analytical services.

(a) The Department will approve qualified laboratories to perform certain specialized laboratory services. The Department’s Bureau of Laboratories will, from time to time, establish prerequisite requirements for admission to approval programs based on an evaluation of the personnel, equipment and procedures employed in the applicant laboratory. After the prerequisite requirements are satisfied, admission to approval programs will require demonstration of acceptable capability in the analysis of test samples. Continued approved status will require satisfactory performance in periodic evaluations conducted to monitor the reliability of participating laboratories.

(b) Lists of laboratories approved under this section to provide special analytical services will be prepared semiannually and will contain the names, addresses and directors of the facilities. Only approved facilities are permitted to offer the specified determinations to clients in this Commonwealth. If an approval is revoked or limited for reasons of unsatisfactory performance, reinstatement of approval will require demonstration of proficiency over a testing period not to exceed 6 months.

The provisions of this § 5.50 adopted January 27, 1978, effective January 28, 1978, 8 Pa.B. 247.

This section pertains to laboratories and equipment that are approved by the State Health Department to analyze the amount of alcohol in a person’s blood and this section satisfies the requirements of 75 Pa.C.S. § 1547 addressing the chemical tests used to determine blood-alcohol content. Commonwealth v. Bullock, 518 A.2d 824 (Pa. Super. 1986); appeal denied 531 A.2d 427 (Pa. 1987).

This section cited in 7 Pa. Code § 203.73 (relating to testing); 7 Pa. Code § 203.74 (relating to test results); 28 Pa. Code § 5.102 (relating to equipment and methods for laboratory analysis of breath samples); 28 Pa. Code § 5.103 (relating to blood tests for blood alcohol content); 58 Pa. Code § 15.1 (relating to definitions); 58 Pa. Code § 188.3 (relating to testing); and 58 Pa. Code § 188.4 (relating to test results).

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.51 Retention of reports.

Each clinical laboratory shall keep a record of the results of tests performed on each specimen. In cases in which the clinical laboratory is part of a hospital, the permanent laboratory record may be a part of the patient’s medical record.

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.52 Contents of records.

Each clinical laboratory shall have a readily available record indicating the daily accession of specimens containing the following information:

(1) The laboratory number identifying the specimen.

(2) The identification of the person from whom the specimen was taken. Specimens received by mail shall be accompanied by the name and address of the patient from whom the specimen was taken.

(3) The name and address of the licensed practitioner of the healing arts or other authorized person or clinical laboratory who submitted the specimen. Hospitals may follow their normal procedures associated with requests and records.

(4) The date and hour the specimen was collected by the licensed practitioner or other authorized person.

(5) The date and hour the specimen was received in the laboratory and date test was completed.

(6) The condition of the specimen when received that is, broken, leaked, hemolyzed, turbid, satisfactory and so forth.

(7) The analysis performed.

(8) The result of the laboratory test.

(9) The date a required report was sent to the Department, under § § 27.2—27.4 and 27.22, or other agencies in accordance with other statutes or provisions.

(10) The charges issued to the patient or his authorized agent for the laboratory services performed.

Effect of Failure to Record Information

The requirements of § 5.52(6) are only for recordkeeping and do not relate to the test procedures themselves. The appellant only alleges that the condition of the sample was not recorded. This did not create an added burden upon the Commonwealth to provide additional evidence of reliability of the blood alcohol content. Commonwealth v. Demark, 800 A.2d 947 (Pa. Cmwlth. 2002).

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.53 Confidentiality.

Records and reports of examinations of specimens shall be confidential.

Argument by a defendant, charged with driving under the influence, that medical purposes blood test should have been suppressed by hospital personnel in accordance with confidentiality regulations failed because the regulations governing confidentiality were subject to the exceptions contained in the Motor Vehicle Code which provide that no hospital or medical personnel may refuse to perform or provide the results of a blood alcohol test when requested by a police officer. Commonwealth v. Hipp, 551 A.2d 1086 (Pa. Super. 1988).

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.61 Quality control.

(a) Quality control procedures in chemistry, microbiology, hematology and other laboratory specialties shall be those approved by the Department.

(b) A degree of accuracy, specificity and precision satisfactory to the Department shall be shown in quality control records at all times.

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.62 Results of proficiency tests.

(a) Results of proficiency tests shall be maintained in the acceptable ranges statistically determined for each evaluation. Failure of a laboratory to satisfactorily perform in a proficiency test may be cause for revocation of approval of the specific tests involved.

(b) If a permit is revoked or limited for reasons of unsatisfactory performance, reinstatement of approval shall require demonstration of proficiency over a testing period, not to exceed 6 months.

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.71 Restrictions on solicitation.

No employe or representative of a laboratory, either personally or through an agent, may solicit referral of specimens to his or any other laboratory in a manner which offers or implies an offer of rebates to persons submitting specimens or other feesplitting inducements. This applies to contents of fee schedules, billing methods or personal solicitation. No person involved in the submission of specimens may receive payment or other inducement by the laboratory or its representative.

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.72 List of tests and fee schedules.

(a) No blanket contract fee service may be made. Per specimen cost may vary with volume, but the fee schedule shall be clearly stated, and offered equally to all persons using the services of the laboratory. Except for cost adjustments due to volume, only a single fee schedule shall be maintained and applied by a licensed laboratory.

(b) A copy of each list of tests and each fee schedule issued by a laboratory shall be placed on file with the Department prior to issuance, and changes in the schedules filed within 10 days of issuance. The record of fees shall include individual fees, contract fees and special volume prices.

(c) It shall be an unethical practice for a laboratory not to follow the practices in § 5.48 (relating to disclosure of charges).

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.73 Advertisements.

(a) Advertisements shall be reviewed by the Department and approved prior to publication. Failure of the Department to respond within 10 days after receipt of a submission shall constitute an approval. Advertising is permissible in official media if it is of an ethical nature and does not contain misleading statements or claims of unusual superiority. Personal solicitation by an owner or his agent shall be considered as advertising within the meaning of this section. No laboratory may advertise services which are not performed on its own premises. Advertising to the general public is not permitted.

(b) A laboratory requesting a permit shall submit with its application copies of all advertising, telephone listings, letterheads, cards and the like.

(c) Laboratories presently operating under permit shall also submit copies of the advertising, telephone listing and the like to the Department prior to publication.

(d) Signs of a descriptive character designed to identify the laboratory premises or access thereto are permissible except when their content, size or location is unethical or when they constitute a form of advertising of clinical laboratory procedures to the lay public.

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.81 Federal laboratories.

Laboratories operated by the Federal government, and located in Federal installations in this Commonwealth are exempt from this chapter.

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.82 Research laboratories.

Laboratories operated solely for research and teaching, and conducting analyses, the results of which are not used for clinical application, are exempt from the provisions of this chapter.

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.83 Laboratories outside the Commonwealth.

A laboratory located outside the Commonwealth may solicit and receive specimens originating within the Commonwealth if it has a currently valid license issued under the provisions of section 353 of the Clinical Laboratory Improvement Act of 1967 (42 U.S.C.A. § 263), and applicable regulations and, it complies with all regulations which exceed or differ from those of the Federal statute.

The provisions of this § 5.83 amended August 15, 1975, 5 Pa.B. 2129. Immediately preceeding text appears at serial page (16829).

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.91 Failure to maintain standards.

A permit shall be denied to a laboratory applying for same and a permit shall be suspended or revoked in the case of laboratories already operating, for failure to maintain proper standards of accuracy, for unethical practice, unethical advertising, or for any other cause deemed adequate by the Department, including failure to render required reports within the reasonable time limits set.

This section cited in 28 Pa. Code § 125.1 (relating to clinical and anatomical pathology services).

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.92 Change of director or change of location.

Permits shall become void upon change of director and also upon removal of the laboratory to other quarters.

This section cited in 28 Pa. Code § 125.1 (relating to clinical and anatomical pathology services).

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.93 Revocation of permit.

The following are prima facie reasons for the revocation of a permit:

(1) Dishonest reporting or consistent error based on faulty techniques.

(2) Permitting unauthorized persons to perform the technical procedures or to sign reports.

(3) Proof that a holder of a permit has made false statements on his application for a permit.

(4) The advertising of clinical laboratory procedures to the lay public in magazines, newspapers, directories, circulars, signs and the like.

(5) Knowingly accepting an assignment for a clinical laboratory test or a specimen from and the rendering of a report thereon to a person, other than the patient, not authorized to submit the specimen or assignment.

(6) The adjudication of insanity or mental illness involving personnel responsible for the direction of the laboratory.

(7) Violations of another provisions of this chapter, or of the statutes under which they are adopted.

This section cited in 28 Pa. Code § 125.1 (relating to clinical and anatomical pathology services).

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.94 Hearings and appeals.

If a license is denied or revoked, the applicant or holder of the license is entitled to the rights of hearings and appeals provided for in the Clinical Laboratory Act (35 P. S. § § 2151—2165) and other provisions of statutes related to 2 Pa.C.S. § § 501—508 and 701—704 (relating to practice and procedure of Commonwealth agencies and judicial review of Commonwealth agency action) and the Pa.R.C.P.

This section cited in 28 Pa. Code § 125.1 (relating to clinical and anatomical pathology services).

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.101 Purpose.

The purpose of § § 5.101—5.104 (relating to equipment to determine blood alcohol content under the Vehicle Code and the Fish and Boat Code) is to satisfy the requirements of 75 Pa.C.S. § 1547(c) and (k) and 30 Pa.C.S. § 5125(c) and (k) (relating to chemical testing to determine amount of alcohol or controlled substance).

The provisions of this § 5.101 issued under the Fish and Boat Code, 30 Pa.C.S. § 5125.

The provisions of this § 5.101 adopted January 27, 1978, effective January 28, 1978, 8 Pa.B. 247; amended through July 27, 1984, effective July 30, 1984, 14 Pa.B. 2759. Immediately preceding text appears at serial page (89897).

This section cited in 58 Pa. Code § 51.51 (relating to chemical tests); and 58 Pa. Code § 131.5 (relating to chemical tests).

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.102 Equipment and methods for laboratory analysis of breath samples.

Only equipment and methods approved by the Department may be used for the laboratory analysis of breath samples. Laboratories performing these analyses shall be licensed and specifically approved for blood alcohol analysis in accordance with § § 5.50 and 5.103 (relating to approval to provide special analytical services; and blood tests for blood alcohol content).

The provisions of this § 5.102 issued under section 2102 of The Administrative Code of 1929 (71 P. S. § 532); and the Vehicle Code, 75 Pa.C.S. § 1547(c).

The provisions of this § 5.102 amended through August 31, 1984, effective September 1, 1984, 14 Pa.B. 3156. Immediately preceding text appears at serial pages (89897) and (89898).

This section cited in 28 Pa. Code § 5.101 (relating to purpose); 58 Pa. Code § 51.51 (relating to chemical tests); and 58 Pa. Code § 131.5 (relating to chemical tests).

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.103 Blood tests for blood alcohol content.

Equipment used for blood analysis to determine the amount of alcohol in a person’s blood which performs the analysis by means of gas chromatography, enzymatic procedures, distillation procedures or diffusion procedures is approved by the Department provided that:

(1) The equipment is located within a clinical laboratory currently licensed by the Department.

(2) The particular brand or model of equipment used and a reagent or procedures relating thereto have not been prohibited by specific notification of the Department under § 5.46 (relating to reagents and equipment).

(3) A clinical laboratory performing blood analyses with the equipment has in effect an approval to provide the special analytical services under § 5.50 (relating to approval to provide special analytical services).

The provisions of this § 5.103 adopted January 27, 1978, effective January 28, 1978, 8 Pa.B. 247.

A blood serum analysis was erroneously suppressed since the trial court improperly concluded that regulations regarding blood alcohol testing had not been promulgated. Commonwealth v. Dagon, 605 A.2d 360 (Pa. Super. 1992).

A driver’s failure to provide two vials of blood for alcohol testing purposes under standard procedure of local police department, was not refusal to complete blood test for purposes of implied consent provisions since the Department failed to promulgate regulations for determining what constitutes completion of a blood test. Murray v. Commonwealth, 598 A.2d 1356 (Pa. Cmwlth. 1991).

Testimony from a hospital medical technologist regarding the hospital’s procedure for updating its renewal certificate from the Department of Health was sufficient to meet the licensing requirements of this section. Commonwealth v. Dungan, 539 A.2d 817 (Pa. Super. 1988).

A blood test utilizing an enzyme reaction was an analysis by ‘‘enzymatic procedures’’ which met the requirements of this section. Commonwealth v. Dungan, 539 A.2d 817 (Pa. Super. 1988); appeal denied 559 A.2d 34 (Pa. 1989).

This section cited in 28 Pa. Code § 5.101 (relating to purpose); 28 Pa. Code § 5.102 (relating to equipment and methods for laboratory analysis of breath samples); 58 Pa. Code § 51.51 (relating to chemical tests); and 58 Pa. Code § 131.5 (relating to chemical tests).

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

28 Pa. Code § 5.104 Prearrest breath tests for blood alcohol content.

(a) Equipment approval requirements.

(1) The Department will approve prearrest breath testing devices for use by police officers in conducting preliminary alcohol determinations on persons suspected of driving while under the influence of alcohol. Until performance standards for prearrest breath testing devices are promulgated by regulation, manufacturers who desire interim approval of their devices shall file the following information with the Department:

(i) A complete description of the device, including its principle of operation.

(ii) An operator’s manual for the device.

(iii) A maintenance and repair manual for the device, if applicable, including diagrams and lists of component parts.

(iv) Performance data derived from studies conducted by or for the manufacturer to support claims relating to the reliability of the device.

(v) The names and addresses of law enforcement agencies in this Commonwealth who have purchased the device. Manufacturers shall provide to the Department, on an annual basis, the names and addresses of new purchasers to whom the devices are sold.

(vi) A list and complete description, including applicable manuals, for breath simulators or other accessories intended for use with the prearrest breath testing device.

(vii) A list of authorized distributors and service representatives for the prearrest breath testing device.

(viii) The data and results of reviews or studies conducted by other State or Federal agencies, including certification or approval, if available.

(2) When the filing requirements in paragraph (1) have been met and the Department is satisfied that the information supplied by the manufacturer is complete, adequate and responsive; that the device has been properly tested; that the device is reliable and readily available; and that the device can be adequately serviced, the device will be issued an interim approval for use in this Commonwealth. The interim approval will remain in effect until performance standards are promulgated by regulation, or until unsatisfactory performance is demonstrated.

(b) Approved equipment list. Prearrest breath testing devices which meet subsection (a) will be placed on a list of approved equipment for preliminary breath alcohol testing purposes. This list will be revised semiannually. A certified copy of the list will be available upon request at the Bureau of Laboratories.

(c) Application for approval. Manufacturers of prearrest breath testing devices who are seeking approval from the Department for their instruments to be used by law enforcement officials shall submit information specified in subsection (a)(1) to: Division of Chemistry and Toxicology, Bureau of Laboratories, Department of Health, Pickering Way & Welsh Pool Road, Lionville, Pennsylvania 19353, (215) 363-8500.

The provisions of this § 5.104 adopted May 11, 1984, effective May 12, 1984, 14 Pa.B. 1644.

This section cited in 28 Pa. Code § 5.101 (relating to purpose); and 58 Pa. Code § 51.51 (relating to chemical tests); and 58 Pa. Code § 131.5 (relating to chemical tests).

History

Authority: The provisions of this Chapter 5 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 5 adopted May 25, 1962, amended June 14, 1974, effective June 15, 1974, 4 Pa.

Chapter 6 Drugs Which May Be Used by Certain Optometrists

28 Pa. Code § 6.1 Approved drugs.

(a) Administration and prescription of pharmaceutical agents. Optometrists who are certified to prescribe and administer pharmaceutical agents for therapeutic purposes under section 4.1 of the Optometric Practice and Licensure Act (35 P. S. § 244.4a), may prescribe and administer the drugs listed in subsection (b) in their practice of optometry under the following conditions:

(1) The drugs shall be approved by the Food and Drug Administration (FDA).

(2) Over-the-counter medications (per FDA listing) are fully authorized.

(3) An optometrist may not administer any drug parenterally.

(4) The treatment undertaken by an optometrist under this section:

(i) May not continue beyond 6 weeks from the initiation of treatment unless the prescribing optometrist documents consultation with a licensed physician.

(ii) May not include beta-blockers or steroids.

(iii) May not be prescribed for systemic conditions except as an adjunctive therapy and shall be limited to the anterior eye structures (and adnexa).

(5) An optometrist may not treat glaucoma.

(6) An optometrist may not prescribe or administer a Schedule I or II controlled substance.

(b) Allowable pharmaceutical products. Optometrists may prescribe and administer the following pharmaceutical products or the A-rated generic therapeutically equivalent drug:

(1) Topical anesthetics.

(i) Proparacaine.

(ii) Benoxinate.

(iii) Tetracaine.

(2) Topical ocular lubricants.

(3) Topical opthalmic dyes and stains.

(i) Fluorescein.

(ii) Rose Bengal.

(iii) Fluorexen.

(4) Topical hyperosmotic agents.

(5) Autonomic drugs—topical only.

(i) Cholinergic agonists.

(A) Pilocarpine nitrate and pilocarpine hydrochloride—diagnostic use only.

(B) Physostigmine.

(D) Echothiopate.

(ii) Cholinergic antagonists.

(A) Homatropine hydrobromide.

(B) Tropicamide.

(D) Cyclopentolate hydrochloride.

(E) Scopolamine hydrobromide.

(iii) Adrenergic agonists.

(A) Hydroxyamphetamine hydrobromide.

(B) Phenylephrine hydrochloride.

(D) Nefazoline.

(E) Oxymetazoline.

(iv) Adrenergic antagonists—diagnostic use only.

(A) Dapiprazole.

(B) Thymoxamine.

(6) Nonsteroidal antiinflammatory drugs—topical only.

(i) Diclofenac.

(ii) Ketorolac.

(iii) Flurbiprofen.

(iv) Suprofin.

(7) Antimicrobial agents.

(i) Antibacterial—topical use only.

(A) Cell wall inhibitors.

(I) Bacitracin.

(II) Cephalosporins.

(III) Penicillins.

(IV) Vancomycin.

(B) Protein synthesis inhibitors.

(I) Aminoglycosides.

(II) Tetracycline.

(III) Erythromycin.

(IV) Chloramphenicol.

(I) Sodium sulfacetamide and sulfisoxazole.

(II) Trimethoprim.

(D) DNA synthesis inhibitors.

(I) Ciprofloxacin.

(II) Norfloxacin.

(III) Ofloxacin.

(IV) Levofloxacin.

(E) Cell membrane permeability.

(I) Polymyxin B.

(II) Gramicidin.

(ii) Antibacterial—oral.

(A) Cell wall inhibitors.

(I) Penicillins—including in combination with clavulanic acid.

(II) Cephalosporins.

(-1-) First generation—cephalexin and cefadroxil.

(-2-) Second generation—cefaclor and cefuroxime.

(B) Protein synthesis inhibitors.

(I) Tetracycline.

(II) Doxycycline.

(III) Erythromycin.

(IV) Azithromycin.

(iii) Antivirals—topical only.

(A) Idoxurine.

(B) Vidarabine.

(iv) Antivirals—oral.

(A) Acyclovir.

(B) Valacyclovir.

(v) Antifungal and antiparasitic—topical only.

(A) Amphotericin B, nystatin, natamycin.

(B) Miconazole, ketoconazole, clotrimazole.

(D) Neomycin and polymyxin B.

(E) Paromycin.

(8) Analgesic drugs—oral and topical.

(i) Analgesic drugs—oral.

(A) Codeine in combination with acetaminophen or aspirin.

(B) Hydrocodone.

(D) Propoxyphene.

(E) Tramadol.

(ii) Antihistamines and mast cell stabilizers—topical only.

(A) Pheniramine.

(B) Pyrilamine.

(D) Levocarbastine.

(E) Cromolyn.

(F) Nedocromil.

(G) Lodoxamide.

(H) Olopatadine.

(I) Pemirolast potassium.

(J) Emedastine difumarate.

(K) Azelastine hydrochloride.

(L) Ketotifen fumerate.

(Editor’s Note: The act of December 16, 2002 (P. L. 1950, No. 225) that amended the Optometric Practice and Licensure Act (63 P. S. § § 244.1—244.12) allows the Secretary of the Department of Health to approve drugs which may be prescribed by optometrists. The list of drugs is now being published as a notice in the Pennsylvania Bulletin).)

The provisions of this § 6.1 amended under section 2 of the Optometric Practice and Licensure Act (63 P. S. § 244.2); and section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

The provisions of this § 6.1 amended November 21, 1997, effective November 22, 1997, 27 Pa.B. 6088; amended October 9, 1998, effective October 10, 1998, 28 Pa.B. 5094; amended July 19, 2002, effective July 20, 2002, 32 Pa.B. 3484. Immediately preceding text appears at serial pages (251627) to (251628) and (248717) to (248718).

History

Authority: The provisions of this Chapter 6 issued under section 244.
Source: The provisions of this Chapter 6 amended through March 14, 1986, effective March 15, 1986, 16 Pa.

Chapter 7 Primary Health Centers under the Health Care Services Malpractice Act

28 Pa. Code § 7.1 Statutory coverage.

The Department of Health will consider, for purposes of the Health Care Services Malpractice Act (40 P. S. § § 1301.101—1301.1006) (hereinafter, the act) and for no other purpose, that any Commonwealth community-based, nonprofit corporation meets the statutory description of a primary health center as defined in the act if the corporation provides preventive, diagnostic, therapeutic, and basic emergency health services by licensed practitioners who are employes of the corporation or under contract to the corporation to patients who are usually ambulatory and who may require any of a variety of medical or health related services and if the corporation makes application to the Department in the manner provided in this chapter and demonstrates compliance with § 7.2 (relating to minimum standards).

This section cited in 28 Pa. Code § 7.2 (relating to minimum standards).

History

Authority: The provisions of this Chapter 7 issued under section 2102(g) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 7 adopted April 8, 1977, 7 Pa.

28 Pa. Code § 7.2 Minimum standards.

The following minimum standards shall be maintained under § 7.1 (relating to statutory coverage):

(1) There is a governing authority legally responsible for the conduct of the center, a majority of the membership of which are residents of the area served by the center, are potential users of the service and are not employed by and do not have any other financial interest in the operation of the center.

(2) The center is managed by a specifically designated person responsible for operating the center in accordance with policies clearly enunciated by the Board of Directors of the corporation.

(3) Clear, precise, and complete financial records and other business records, such as Board meeting minutes, are kept in accordance with generally accepted accounting and business procedures.

(4) Clear, precise, and complete medical records are kept which include a record of a basic history and physical examination, a record of presenting complaints, laboratory studies, diagnoses, prescribed therapy, medications, progress and evaluation of the therapy prescribed, and summaries and evaluations of any and all specialized health services, including hospitalization, for which patients have been referred outside the center, and all entries in the records are dated and authenticated.

(5) When appropriate specialized services are not available at the primary health center, the patient is provided with a choice of referral to qualified specialists to whom the medical records of the patient are made available. If the primary health center is part of a closed panel group practice making its services available through a prepayment mechanism, such as a health maintenance organization, nothing in this paragraph shall be interpreted to obligate that organization to pay for specialist services if and when a patient chooses to be referred outside the panel.

(6) Patients are accorded an opportunity to have their own medical records explained to them by an appropriate health care professional as designated by a physician and qualified by training and skill to accurately interpret the records and counsel patients.

(7) The facilities in which the services are rendered are safe, sanitary, and adequately equipped.

(8) There is an organized medical or professional staff responsible for maintaining accepted standards of medical, surgical, or health-related care and for requiring staff members to participate in recognized continuing education programs.

This section cited in 28 Pa. Code § 7.1 (relating to statutory coverage); and 28 Pa. Code § 7.3 (relating to documentation to be submitted).

History

Authority: The provisions of this Chapter 7 issued under section 2102(g) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 7 adopted April 8, 1977, 7 Pa.

28 Pa. Code § 7.3 Documentation to be submitted.

(a) The Department of Health will request that the following documentation of adherence to the standards be submitted to the Department of Health:

(1) A statement that the corporation meets the eight standards prescribed in § 7.2 (relating to minimum standards) for a facility to qualify as a primary health center as defined in the act.

(2) A copy of the certificate of incorporation and bylaws along with a list of members of the Board of Directors identified by home address and principal occupation.

(3) The name and address of the person designated by the Board of Directors to manage the operation of the center with a copy of the Board resolution designating such person to perform this function.

(4) A sample of the principal business forms and a brief description of the accounting system and business procedures used.

(5) A sample of a patient chart, demonstrating the form in which the medical records are kept.

(6) A description of referral procedures and an identification of principal referral resources.

(7) A description of method utilized to inform patients of contents of their medical records.

(8) A copy of Certificate of Safety for Public Occupancy and Safety of Elevators, if elevators are utilized, and Laboratory and Pharmacy Certificates, if such exist.

(9) A list of professional staff members with brief indications of professional qualifications, such as degrees.

(10) A brief description of the continuing education program in which the professional staff members participate and a brief description of other quality assurance measures utilized.

(b) The items listed in subsection (a) shall be submitted under cover of a notarized letter from the chairman of the governing body of the facility or his designee, certifying as to the completeness and accuracy of all statements and information submitted.

This section cited in 28 Pa. Code § 7.4 (relating to issuance of a certificate).

History

Authority: The provisions of this Chapter 7 issued under section 2102(g) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 7 adopted April 8, 1977, 7 Pa.

28 Pa. Code § 7.4 Issuance of a certificate.

(a) Facilities seeking to qualify as primary health centers under the act shall submit the documentation required by § 7.3 (relating to documentation to be submitted) to the Division of Primary Care Development, Department of Health, Post Office Box 90, Harrisburg, Pennsylvania 17108.

(b) Upon review and approval by the Department of Health of the required documentation, the Secretary will issue a certificate to the facility. The certificate will be effective for 2 years from date of issuance and may be renewed for successive 2-year periods upon review and approval by the Department of Health of the documentation required by § 7.3. Whenever the Department intends to deny an application, the applicant will be notified and have the right to request, within 30 days, a hearing.

(c) For purposes of the act, the facility shall qualify as a ‘‘health care provider’’ from the date of issuance of the certificate. Notice of certification will be sent promptly to the Administrator for Arbitration Panels for Health Care and to the director of the Medical Professional Liability Catastrophe Loss Fund. Facilities which are certificated as ‘‘primary health centers’’ shall be required, in conformity with the act, to purchase and maintain a specific amount of malpractice insurance.

History

Authority: The provisions of this Chapter 7 issued under section 2102(g) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 7 adopted April 8, 1977, 7 Pa.

Chapter 8 Practice and Procedure

28 Pa. Code § 8.1 Applicability of general rules.

Under 1 Pa. Code 31.1 (relating to scope of part), 1 Pa. Code Part II (relating to general rules of administrative practice and procedure) is applicable to the activities of and proceedings before the Department of Health, except as otherwise provided in this title.

This section cited in 28 Pa. Code § 205.4 (relating to building plans).

History

Authority: The provisions of this Chapter 8 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 8 adopted August 18, 1978, effective August 19, 1978, 8 Pa.

28 Pa. Code § 8.11 Procedure for capital expenditure hearings under Federal law.

The rules of practice and procedure for fair hearings held under section 1122 of the Social Security Act (42 U.S.C.A. § 1320a-1) are found in § 301.7 (relating to fair hearing).

The provisions of this § 8.11 amended October 26, 1979, effective October 27, 1979, 9 Pa.B. 3563. Immediately preceding text appears at serial page (41243).

History

Authority: The provisions of this Chapter 8 issued under section 2102 of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 8 adopted August 18, 1978, effective August 19, 1978, 8 Pa.

Chapter 10 Designation of Medically Deprived Areas

28 Pa. Code § 10.1 Purpose.

(a) The 1977-78 appropriations acts, act of December 22, 1977 (P. L. 532, No. 27A) § 2 (Pennsylvania State University (Hershey)); act of December 22, 1977 (P. L. 537, No. 28A) § 2 (University of Pittsburgh); act of December 22, 1977 (P. L. 546, No. 30A) § 2 (Temple University); act of December 22, 1977 (P. L. 521, No. 16A) § 1 (Philadelphia College of Osteopathic Medicine); act of December 22, 1977 (P. L. 551, No. 31A) § 1 (Medical College of Pennsylvania); act of December 22, 1977 (P. L. 552, No. 32A) § 2 (University of Pennsylvania); act of December 22, 1977 (P. L. 555, No. 34A) § 1 (c) (Thomas Jefferson University); act of December 22, 1977 (P. L. 558, No. 36A) § 1 (c) (Hahnemann Medical College); act of June 20, 1978 (Act No. 19A) § 2 (Pennsylvania State University (Hershey)); act of June 20, 1978 (Act No. 21A) § 2 (University of Pittsburgh); act of June 20, 1978 (Act No. 20A) § 2 (Temple University); act of June 20, 1978 (Act No. 27A) § 2 (Philadelphia College of Osteopathic Medicine); act of June 20, 1978 (Act No. 30A) § 2 (Medical College of Pennsylvania); act of June 20, 1978 (Act No. 23A) § 2 (University of Pennsylvania); act of June 20, 1978 (Act No. 28A) § 2 (Thomas Jefferson University); and act of June 20, 1978 (Act No. 29A) § 2 (Hahnemann Medical College) which provide for funds for the Commonwealth’s medical and osteopathic schools require that as a condition of receiving its 1977-78 appropriation, on or after January 1, 1978, and as a condition its 1978-79 appropriation, on or after January 1, 1979, the schools shall, when accepting first-year students for the next term, set aside 10% of the total number of admissions for students who agree that upon the completion of their medical training, they shall engage in the practice of medicine for a period of four years in an area termed ‘‘medically deprived’’ by the Pennsylvania Department of Health.

(b) The purpose of this chapter is to fulfill the statutory requirement of the Department of Health to designate ‘‘medically deprived’’ areas in this Commonwealth.

History

Authority: The provisions of this Chapter 10 issued under act of December 22, 1977 (P.
Source: The provisions of this Chapter 10 adopted November 3, 1978, 8 Pa.

28 Pa. Code § 10.2 Definition of ‘‘medically deprived’’ areas.

(a) As used in this chapter, a ‘‘medically deprived’’ area is one in which there exists an inadequate availability of medical care to the general population, or parts thereof, or where such care is not readily accessible to the population being served, unless the context clearly indicates otherwise.

(b) This definition is based upon criteria published in 43 Fed. Reg. 1585 (1978) which were developed by the Federal government to implement 42 U.S.C. § 254e (1976).

History

Authority: The provisions of this Chapter 10 issued under act of December 22, 1977 (P.
Source: The provisions of this Chapter 10 adopted November 3, 1978, 8 Pa.

28 Pa. Code § 10.3 List of ‘‘medically deprived’’ areas.

(a) The areas designated in subsection (b) of this section have been determined to be ‘‘medically deprived’’ by the Department of Health. The areas are listed by county. Where applicable, the counties are broken down by civil division or census tract.

(b) The following areas are determined to be ‘‘medically deprived’’ by the Department of Health:

(c) The Department will periodically update the list of ‘‘medically deprived’’ areas. A copy of the current list will be provided to every medical and osteopathic school within this Commonwealth.

History

Authority: The provisions of this Chapter 10 issued under act of December 22, 1977 (P.
Source: The provisions of this Chapter 10 adopted November 3, 1978, 8 Pa.

28 Pa. Code § 10.4 Reporting.

A copy of any compliance report required to be provided to the Department of Education shall be simultaneously submitted to the Secretary of Health to assist the Department of Health in fulfilling its statutory requirement to designate ‘‘medically deprived’’ areas in this Commonwealth.

History

Authority: The provisions of this Chapter 10 issued under act of December 22, 1977 (P.
Source: The provisions of this Chapter 10 adopted November 3, 1978, 8 Pa.

Part II Local Health

Chapter 11 Sanitary and Health Officers

28 Pa. Code § 11.1 Examination.

(a) Applicants for the position of health officer for cities of the third class, boroughs, townships of the first class and sanitary officers in townships of the second class shall take and pass the State Civil Service examination for Environmental Protection Specialist. See 4 Pa. Code Chapters 19 and 20 (Reserved), except as otherwise provided in subsection (b).

(b) Physicians (M.D.’s) or osteopaths (D.O.’s), licensed to practice medicine in this Commonwealth, shall be exempt from examination.

History

Authority: The provisions of this Chapter 11 issued under The Borough Code (53 P.
Source: The provisions of this Chapter 11 adopted October 21, 1966, unless otherwise noted.

28 Pa. Code § 11.2 Special examination.

(a) The Department of Health may contract with the State Civil Service Commission to prepare, administer and score results of a special examination for the Department, as permitted under section 212 of the Civil Service Act (71 P. S. § 741.1).

(b) The examination shall be similar to the State Civil Service examination and may be used in lieu of qualification as a physician or a State Environmental Protection Specialist. See 4 Pa. Code Chapters 19 and 20 (Reserved).

History

Authority: The provisions of this Chapter 11 issued under The Borough Code (53 P.
Source: The provisions of this Chapter 11 adopted October 21, 1966, unless otherwise noted.

28 Pa. Code § 11.3 Admission to special examination.

Admission to the special examination shall be granted to the following:

(1) A registered nurse licensed in this Commonwealth.

(2) A holder of an associate degree from a recognized college or university.

(3) One who has completed 2 years of training in a recognized college or university with a total of 60 credit hours, including credits in the biological or physical sciences.

History

Authority: The provisions of this Chapter 11 issued under The Borough Code (53 P.
Source: The provisions of this Chapter 11 adopted October 21, 1966, unless otherwise noted.

28 Pa. Code § 11.4 Additional requirements.

(a) Any person having successfully completed the special examination shall be required to offer evidence of successful completion of the following:

(1) The basic environmental sanitation course conducted by the Department.

(2) The field training course, designated as such by the Department.

(b) Equivalent training or experience may be accepted in lieu of completion of the basic environmental sanitation course or the field training course, but the academic qualification shall be a basic requirement and no substitution shall be accepted.

History

Authority: The provisions of this Chapter 11 issued under The Borough Code (53 P.
Source: The provisions of this Chapter 11 adopted October 21, 1966, unless otherwise noted.

Chapter 13 Personnel Administration in County Health Departments

28 Pa. Code § 13.1 Definitions.

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.2 Applicability.

The provisions of this chapter applies to all persons who are employed by county health departments which are created and established in accordance with the provisions of the act.

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.3 Authority of Department.

The Department will prescribe standards for the recruitment, selection, tenure, removal and working conditions of all personnel employed by county departments of health, except that the Department shall have no authority to do any of the following:

(1) Direct or require the selection of any individual.

(2) Order the manner or amount of compensation of any employe.

(3) Direct or require the removal of any individual employed in accordance with the standards set forth in this chapter.

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.4 Authority of county health director.

In accordance with section 12(b) of the act (16 P. S. § 12012(b)), the county health director shall exercise the power conferred upon the county department of health to employ personnel.

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.5 Discrimination.

The county health director shall not discriminate against or in favor of any applicant or employe because of race, sex, National origin or religious or political opinions or affiliations.

The provisions of this § 13.5 amended April 14, 1978, 8 Pa.B. 1103. Immediately preceding text appears at serial page (3392).

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.11 Applicants.

Applicants for the position of health officer for counties of the third class which operate county departments of health under the provisions of the County Code (16 P. S. § § 101—2902), shall be physicians licensed to practice medicine or osteopathy, or eligible for such licensure, in this Commonwealth, and shall have four years of professional training or medical experience in the field of public health or a recognized area of public health specialization.

The provisions of this § 13.11 adopted February 28, 1969.

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.21 Excluded criteria.

No information or recommendation regarding any employe or prospective employe which involves a disclosure of his race or of his political or religious opinions or affiliations, or any political sponsorship, shall be requested or considered in the making of appointments, promotions, or other personnel actions, except where necessary to determine whether a person advocates the overthrow or destruction by force of the government of the United States or of this Commonwealth.

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.22 Veteran’s preference.

The county health director shall give preference to applicants who are veterans in accordance with 51 Pa.C.S. § § 7101—7109 (relating to Veteran’s Preference Act).

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.23 Other preference.

In accordance with section 12(b) of the act (16 P. S. § 12012(b)), in selecting employes of a county department of health, the county health director shall give preference to professional and technical personnel employed by municipal departments or boards of health at the time such departments or boards were dissolved in accordance with section 15 of the act (16 P. S. § 12015), and to professional and technical personnel employed by the Department whose positions in the county or counties served by the county department of health may have been terminated as a result of the establishment of the county department of health, if such personnel meet the qualifications prescribed by the Department.

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.31 General requirements.

(a) Position-classification plans for county departments of health shall be established after they have been approved by the Advisory Health Board of the Commonwealth.

(b) All subsequent changes to such plans shall be approved by the Advisory Health Board.

(c) These plans shall describe the duties and responsibilities, set forth the necessary minimum qualifications and designate an appropriate title for each class of positions existing in the county department of health.

This section cited in 28 Pa. Code § 13.32 (relating to selection of county health director); and 28 Pa. Code § 13.35 (relating to failure to comply).

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.32 Selection of county health director.

A county health director shall not be appointed by the county board of health until the Department first certifies that the proposed applicant possesses the required minimum qualifications set forth in the position-classification plan as described in § 13.31 (relating to general requirements).

This section cited in 28 Pa. Code § 13.35 (relating to failure to comply).

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.33 Selection of employes.

All employes selected by the county department of health shall be employed in accordance with these provisions and the position-classification plan for the county department of health.

This section cited in 28 Pa. Code § 13.35 (relating to failure to comply).

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.34 Notification to Department of selection.

Each county health director shall, within ten days after selection and appointment of an individual to a position in the county department of health, report in writing to the Department the name of such employe, his qualifications and the title of the position to which he was appointed.

This section cited in 28 Pa. Code § 13.35 (relating to failure to comply).

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.35 Failure to comply.

Failure to comply with § § 13.31—13.34 (relating to position-classification plans), shall result in the Department acting in accordance with the provision of section 26 of the act (16 P. S. § 12026).

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.41 County health director.

The county health director shall serve at the pleasure of the county board of health.

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.42 Other employes.

The tenure of office of every employe of a county department of health shall be during good behavior and the satisfactory performance of his duties except whenever it is necessary that an employe be separated without prejudice because of curtailment of work or lack of funds for the operations of the county department of health.

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.43 Conflicting employment.

No employe of a county department of health shall hold any conflicting employment while in the employ of a county department of health. Violation of this provision shall be cause for removal.

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.44 Probationary period.

(a) Any employe appointed to a position in a county department of health shall serve a probationary period of 6 month duration.

(b) The probationary period shall be utilized for the most effective adjustment of new employes and for the elimination of any probationary employe whose performance does not meet the required standard of work.

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.45 Removal during probation.

At any time during the probationary period, an employe may be removed from the employment of a county department of health. The removal of any employe shall be subject to the provisions of § 13.53(a) (relating to removal of employe).

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.46 Completion of probation.

Every employe shall be notified in writing when he successfully completes his probationary period. Thereafter, such employe shall be designated as a permanent employe and may be removed only in accordance with the provisions of § 13.53 (relating to removal of employe).

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.47 Waiver of probation.

Any employe of the Department who has achieved permanent status under the merit system of the Department and who is selected as an employe of a county department of health in accordance with section 12(b) of the act (16 P. S. § 12012(b)) may be appointed as a permanent employe of the county department of health without the necessity of completing a probationary period, if the position in the county department to which that employe is appointed is similar with respect to duties, responsibilities and minimum qualifications to the position under the Department in which that employe achieved permanent status and if the employe possesses the minimum qualifications established for the position.

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.48 Promotions, demotions and transfers.

(a) An employe of a county department of health may be promoted, demoted or transferred to another position if the employe possesses the minimum qualifications for the position to which he is promoted, demoted or transferred.

(b) The county director of health shall notify the Department in writing of the name of the employe so promoted, demoted or transferred, his qualifications and the title of the position to which he is promoted, demoted or transferred.

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.49 Separations.

(a) A permanent employe of a county department of health shall not be separated because of curtailment of work, or lack of funds for the operation of the county department while there are probationary employes serving in the same class of positions in that county department.

(b) The separation of permanent employes because of curtailment of work or lack of funds shall be based upon systematic consideration of efficiency and length of service as determined by the county health director.

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.50 Resignation of employe.

The county health director shall notify the Department in writing upon the resignation of any employe of a county department of health.

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.51 Retirement fund.

(a) All employes of county health departments established in accordance with the act may elect to become members of the State Employes’ Retirement Fund.

(b) The county department of health in which such persons are employed shall assume the contribution of the employer to the State Employes’ Retirement Fund, in the event such an employe elects to become a member.

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.52 Suspension of employe.

The county health director may, after written notice, suspend any employe without pay for misconduct or minor infraction of the causes for removal provided in § 13.53 (relating to removal of employe) for a period not to exceed an aggregate of more than 30 days in any 1 calendar year. A copy of the notice to the employe shall be forwarded to the Department.

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.53 Removal of employe.

(a) Cause. A county department of health, 15 days after notice in writing to an employe stating the specific reason for removal, may remove any employe for dishonesty, incompetence, inefficiency, insubordination, immorality, violation of the rules and regulations of the county department of health, physical or mental disability, addiction to the use of narcotics or the habitual use of intoxicating liquors to excess, advocating the overthrow or destruction by force of the government of the United States or of the Commonwealth, or for any other proper cause. In no case, however, shall an employe be removed for refusing to participate in any political activity or for refusing to make any contribution for political purposes.

(b) Investigation. The Department will not exercise any authority with respect to directing or requiring the removal of any individual employed by a county department of health in accordance with this chapter, but it shall be provided with a copy of the notice in writing to any employe who is being removed from his position and shall have the right to cause such investigations as it may deem proper to be made to determine whether the removal of the employe was for good cause.

This section cited in 28 Pa. Code § 13.45 (relating to removal during probation); 28 Pa. Code § 13.46 (relating to completion of probation); and 28 Pa. Code § 13.52 (relating to suspension of employe).

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.61 Right to appeal.

Any permanent employe of a county department of health, except the county health director, who is demoted, transferred or removed, or separated because of curtailment of work or lack of funds shall, within 30 days after the date of such action, have the right of appeal in writing to the county board of health for a public hearing which shall be conducted in a manner prescribed by the board of health.

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.62 Hearing.

The hearing shall be held within 30 days after receipt of the appeal of the employe and such employe shall be notified of the date and place of the hearing in writing.

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.63 Presence of counsel.

The employe shall have the right to appear at such hearing with counsel.

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.64 Notification of decision.

The county board of health shall notify the employe and the county health director, in writing of its decision within 30 days after the date of the hearing.

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.65 Further appeals.

Any employe aggrieved by any determination of the board of health shall have the right of appeal to the Court of Common Pleas of the county in which the county department of health exists or exercises jurisdiction.

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.71 Conventions.

No employe of a county department of health shall be a member of or delegate or alternate to any political convention, nor shall he participate at any such convention, except in the performance of his official duty or as a visitor.

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.72 Clubs and organizations.

No employe of a county department of health shall seek or accept election, nomination or appointment as an officer of a political club or organization, or serve as a member of a committee of any such club or organization.

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.73 Parties and campaigns.

No employe of a county department of health shall serve as a member of any committee of any political party, take an active part in political management or in political campaigns, or circulate or seek signatures to any nominations or other petition required by any primary or election law.

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.74 Polling place.

(a) No employe of a county department of health shall in any manner participate in or interfere with the conduct of any election or the preparation therefor at the polling place or with the election officers while counting the votes or returning the election material to the place provided by law for that purpose, except solely for the purpose of making and depositing his own ballot as speedily as it reasonably can be done.

(b) No employe of a county department of health shall be in, or within 50 feet of a polling place, except for the purpose of carrying out official duties and of ordinary travel or residence during the period of time beginning with one hour preceding the opening of the polls for holding such election and ending with the time when the election officers shall have finished counting the votes and shall have left the polling places to deposit the election material in the place provided by law for that purpose.

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.75 Influence.

(a) No employe of a county department of health shall use his office or position to influence political movements or to influence the political action of any officer or employe in the service of the Commonwealth.

(b) No employe of a county department of health shall use his official authority or influence for affecting the results of an election.

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.76 Assessment of employes.

(a) No person shall in any manner orally or by written or printed communication demand, solicit, collect or receive any money or valuable thing, whether voluntary or involuntary, from any employe of a county department of health for any political purpose.

(b) No person shall knowingly send or present, directly or indirectly, in person or by letter, any political assessment, subscription or contribution to, or request its payment by, any employe of a county department of health.

(c) No person shall take part in preparing any political assessment, subscription or contribution with the intent that the same shall be sent or presented to or collected from any employe of a county department of health.

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

28 Pa. Code § 13.77 Assessment by employes.

(a) No employe of a county department of health shall in any manner orally or by written or printed communication demand, solicit, collect or receive any money or valuable thing for any political purpose.

(b) No employe of a county department of health shall remove, suspend, furlough, demote or promote in any manner change the official status or compensation of any other employe of a county department of health or promise or threaten to do so for withholding or neglecting to make any contribution of money or service or other valuable thing for any political purpose.

History

Authority: The provisions of this Chapter 13 issued under The Local Health Administration Law (16 P.
Source: The provisions of this Chapter 13 adopted October 30, 1959, unless otherwise noted.

Chapter 15 State Aid to Local Health Departments

28 Pa. Code § 15.1 Definitions.

The following words and phrases, when used in this chapter, shall have the following meanings unless the context clearly indicates otherwise: Act—The Local Health Administration Law (16 P. S. § § 12001—12028). Board—The Advisory Health Board of the Commonwealth. Department—The Department of Health of the Commonwealth. Local health department—A county health department created pursuant to the act or the health department or board of health of any municipality entitled to receive Commonwealth grants under the act. Secretary—The Secretary of the Department of Health.

History

Authority: The provisions of this Chapter 15 issued under the Local Health Administration Law (16 P.
Source: The provisions of this Chapter 15 adopted October 30, 1959, amended June 2, 1978, 8 Pa.

28 Pa. Code § 15.2 Purpose.

The provisions of this chapter set forth the conditions under which local health departments may receive Commonwealth grants under the act.

History

Authority: The provisions of this Chapter 15 issued under the Local Health Administration Law (16 P.
Source: The provisions of this Chapter 15 adopted October 30, 1959, amended June 2, 1978, 8 Pa.

28 Pa. Code § 15.3 Applications for grants: filing.

Applications from local health departments for Commonwealth grants shall be received in triplicate by the Secretary within 30 days after passage of the budget of the local health department.

History

Authority: The provisions of this Chapter 15 issued under the Local Health Administration Law (16 P.
Source: The provisions of this Chapter 15 adopted October 30, 1959, amended June 2, 1978, 8 Pa.

28 Pa. Code § 15.4 Applications for grants: content.

(a) Each application shall contain, or be accompanied by, all of the following information:

(1) A detailed budget of proposed expenditures for public health programs.

(2) The subdivisions of the local health department.

(3) The title, annual salary rate, and amount for each position.

(4) The amounts allocated for equipment costs, automobile costs, rent, travel expenses and other expenses.

(5) An estimate of expected revenues.

(6) Copies of pertinent resolutions.

(7) Copies of pertinent contracts for services to be rendered.

(8) A program plan indicating measurable objectives for each program being funded and the evaluation criteria to be used to measure results.

(9) A completed budget summary on a form prescribed by the Department. This form shall also be used as an expenditure summary to accompany the end of year certified statement of expenditures.

(b) Any of the information required by subsection (a)(2)—(4) may be incorporated within the budget of proposed expenditures.

(c) The initial application from a local health department shall be accompanied by a narrative statement describing the functions of the subdivisions of the local health department. Subsequent applications shall describe the functions only insofar as they differ from those described in the initial application.

History

Authority: The provisions of this Chapter 15 issued under the Local Health Administration Law (16 P.
Source: The provisions of this Chapter 15 adopted October 30, 1959, amended June 2, 1978, 8 Pa.

28 Pa. Code § 15.11 Minimum public health programs.

Local health departments shall provide public health programs in the following areas: administrative and supportive services; personal health services; and environmental health services.

History

Authority: The provisions of this Chapter 15 issued under the Local Health Administration Law (16 P.
Source: The provisions of this Chapter 15 adopted October 30, 1959, amended June 2, 1978, 8 Pa.

28 Pa. Code § 15.12 Administrative and supportive services.

Administrative and supportive services shall include, but need not be limited to, the following: administration and program direction; budget; accounting; personnel administration including merit system supervision; public health education, public health statistics, public health laboratory services. Administrative staff shall include a director and necessary professional, technical and clerical personnel.

History

Authority: The provisions of this Chapter 15 issued under the Local Health Administration Law (16 P.
Source: The provisions of this Chapter 15 adopted October 30, 1959, amended June 2, 1978, 8 Pa.

28 Pa. Code § 15.13 Personal health services.

Personal health services shall include, but need not be limited to the follow- ing: chronic disease; communicable disease control, including tuberculosis control and venereal disease control; maternal and child health services; and public health nursing services.

History

Authority: The provisions of this Chapter 15 issued under the Local Health Administration Law (16 P.
Source: The provisions of this Chapter 15 adopted October 30, 1959, amended June 2, 1978, 8 Pa.

28 Pa. Code § 15.14 Environmental health services.

Environmental health services shall include, but need not be limited to, the following: food protection, water supply, water pollution control, bathing places, vector control, solid wastes, institutional environment, recreational environment and housing environment.

This section cited in 28 Pa. Code § 17.2 (relating to purpose and effect).

History

Authority: The provisions of this Chapter 15 issued under the Local Health Administration Law (16 P.
Source: The provisions of this Chapter 15 adopted October 30, 1959, amended June 2, 1978, 8 Pa.

28 Pa. Code § 15.15 Minimum standards of performance.

(a) Public health programs provided by local health departments shall comply with such minimum program standards as the Department may, by regulation, adopt through the Board. If all or any part of a public health program is performed by an entity other than the local health department pursuant to a contract or other formal agreement, the local health department shall develop procedures, satisfactory to the Department, to assure compliance with such standards.

(b) Local health departments are subject to annual program performance audits by the Department and by the Department of Environmental Resources. Detailed information concerning the performance of public health programs must be available for review.

(c) The act of December 3, 1970 (P. L. 834, No. 275) (71 P. S. § § 61, 62, 63, 66, 67, 145, 146, 148, 158, 180-1—180-5, 194, 199, 252, 510-1—510-25, 512, 522, 535, 669, 718-1—718-3, 510-101—510-108), recognizes the responsibility, interest, and expertise in the area of environmental health of the Department of Environmental Resources. In addition, it is recognized that local health departments which conduct these programs also have pertinent knowledge and experience. Therefore, the Department, in developing minimum standards for environmental health services as provided by the act, will do so in cooperation with the Department of Environmental Resources and local health departments in order to promote uniform standards for environmental health.

(d) The Secretary is responsible for assuring compliance by local health departments with minimum program standards, including minimum program standards for environmental health services.

This section cited in 28 Pa. Code § 17.2 (relating to purpose and effect).

History

Authority: The provisions of this Chapter 15 issued under the Local Health Administration Law (16 P.
Source: The provisions of this Chapter 15 adopted October 30, 1959, amended June 2, 1978, 8 Pa.

28 Pa. Code § 15.16 Confidentiality of information.

Local health departments shall comply with all Department regulations relating to the confidentiality of patient information.

History

Authority: The provisions of this Chapter 15 issued under the Local Health Administration Law (16 P.
Source: The provisions of this Chapter 15 adopted October 30, 1959, amended June 2, 1978, 8 Pa.

28 Pa. Code § 15.17 Reporting.

The director of a local health department shall report to the Department’s Commissioner of Local Health directly, by telephone or other immediate means, whenever he becomes aware of a public health hazard or communicable disease outbreak which, in the judgment of the director has potential Statewide significance or which, in his opinion, requires the critical comment or assistance of the Department. The Commissioner of Local Health may require a written report on a health problem or health hazard for which the director of a local health department has a responsibility, including the handling of consumer complaints.

History

Authority: The provisions of this Chapter 15 issued under the Local Health Administration Law (16 P.
Source: The provisions of this Chapter 15 adopted October 30, 1959, amended June 2, 1978, 8 Pa.

28 Pa. Code § 15.21 Personnel administration.

(a) Local health departments shall adopt written job specifications, satisfactory to the Department, for each local health department position. The specifications shall set forth, for each position, the minimum experience and education required of appointees to that position. Each employe of a local health department shall be qualified for the position to which the employe is appointed, and shall possess at the time of employment the required minimum experience and education indicated in the written job specification for the position.

(b) Local health departments shall not discriminate against or in favor of an applicant or employe because of race, sex, religion, National origin, or political opinions or affiliations.

(c) In order to enable the Department to evaluate compliance with paragraphs (a) and (b) of this section, local health departments shall provide the Department with all relevant information relating to the appointment, reclassification, transfer, suspension, or dismissal of employes within ten working days following such appointment, reclassification, transfer, suspension, or dismissal. The Department shall forward its evaluation of such information to the local health department within ten working days of its receipt thereof.

(d) The Secretary may waive the requirement of subsection (c) upon petition of a local health department and upon submission of an alternate plan containing assurances, satisfactory to the Secretary, that the merit principles described in subsections (a) and (b) are being followed.

History

Authority: The provisions of this Chapter 15 issued under the Local Health Administration Law (16 P.
Source: The provisions of this Chapter 15 adopted October 30, 1959, amended June 2, 1978, 8 Pa.

28 Pa. Code § 15.22 Director.

Each local health department shall be administered by a director. The director shall be employed full-time and shall work the usual full-time working hours established by the local health department, at the usual place of business of the local health department. The director shall be either a physician with a minimum of 2 years of supervisory or administrative experience in the field of public health, licensed to practice medicine or osteopathy in this Commonwealth, or eligible for licensure within 1 year of appointment, or, if not a physician, a person with at least 4 years of supervisory or administrative experience in the field of public health supplemented by a master’s degree in public health, hospital administration, public administration or a related discipline.

The provisions of this § 15.22 amended September 8, 1978, 8 Pa.B. 2526. Immediately preceding text appears at serial page (37460).

History

Authority: The provisions of this Chapter 15 issued under the Local Health Administration Law (16 P.
Source: The provisions of this Chapter 15 adopted October 30, 1959, amended June 2, 1978, 8 Pa.

28 Pa. Code § 15.23 Directors of nursing and environmental health services.

Each local health department shall employ a director of public health nursing and a director of environmental health services, who shall devote their entire time to those duties and who shall be under the supervision of the director of the local health department or his designee.

History

Authority: The provisions of this Chapter 15 issued under the Local Health Administration Law (16 P.
Source: The provisions of this Chapter 15 adopted October 30, 1959, amended June 2, 1978, 8 Pa.

28 Pa. Code § 15.24 Staffing levels.

Each local health department shall have adequate numbers of qualified personnel to assure that the minimum program standards for all mandated program services are met. The Department will make recommendations on staffing when a program audit determines that a program service is not adequately staffed.

History

Authority: The provisions of this Chapter 15 issued under the Local Health Administration Law (16 P.
Source: The provisions of this Chapter 15 adopted October 30, 1959, amended June 2, 1978, 8 Pa.

28 Pa. Code § 15.25 Employment of physician.

(a) Each local health department shall employ at least one full-time physician, who may be the director of the local health department.

(b) The Secretary may waive the requirement of subsection (a) upon petition of a local health department, if the local health department:

(1) Employs, on at least a half-time basis, a physician knowledgeable in the field of preventive medicine, epidemiology, and communicable disease control.

(2) Demonstrates the availability of a physician in case of medical emergencies.

(3) Submits to the Secretary a plan for the involvement of a physician in public health program development and evaluation.

History

Authority: The provisions of this Chapter 15 issued under the Local Health Administration Law (16 P.
Source: The provisions of this Chapter 15 adopted October 30, 1959, amended June 2, 1978, 8 Pa.

28 Pa. Code § 15.31 Limitations on Commonwealth grants.

(a) Commonwealth grants provided to local health departments under a section of the act may not be used for any of the following:

(1) The cost of hospital care and treatment given patients regardless of whether or not they are receiving welfare assistance.

(2) The construction of public hospitals, clinics, laboratories, dispensaries, health centers or similar public health facilities.

(3) The maintenance or operation of communicable disease hospitals, general hospitals and medical dispensaries, exclusive of diagnostic and preventive services usually considered general public health activity.

(4) Plumbing inspection for the purpose of checking conformity with building codes, exclusive of inspections for cross connections as covered by environmental program standards.

(5) Weights and measures control activities.

(6) Extermination of birds, insects, weeds and other similar nuisances, except as essential to protect the public health in accord with accepted public health practices. Advisory services or inspections are excluded from this exception.

(7) The purchase, maintenance or operation of ambulances.

(8) The construction, maintenance, or operation of the following: water and sewage treatment plants; swimming pools and bathing beaches; facilities for garbage and refuse collection, storage, transportation or disposal; public toilets and public bath houses.

(9) The cost of treatment of public water supplies, exclusive of cost to county or city health departments for inspection and advisory services which are a part of a control program undertaken in the supervision of environmental health services.

(10) Compensation or expenses paid any boards of examiners or authorities.

(11) Rentals space utilized for local health department purposes, if such rentals are payable to the county or municipality operating the local health department. This does not preclude reimbursement for the pro rata share of utility costs and janitorial services.

(12) Any other expenditure which the Secretary determines is not reasonably related to the purposes of the act.

(b) Commonwealth grants provided to local health departments under section 25(d) of the act (16 P. S. § 12025(d)), relating to grants for environmental health services, shall be used only for environmental health services and related administrative and supportive services as defined in the act or in this chapter, or as approved by the Secretary. These grants are not subject to a matching requirement.

History

Authority: The provisions of this Chapter 15 issued under the Local Health Administration Law (16 P.
Source: The provisions of this Chapter 15 adopted October 30, 1959, amended June 2, 1978, 8 Pa.

28 Pa. Code § 15.32 Fiscal audit.

Local health departments will be subject to annual fiscal audits by the Comptroller of the Department. Detailed records of expenditures, encumbrances and income must be available for review in both the fiscal office of the local health department and the County or Municipal Comptrollers office.

History

Authority: The provisions of this Chapter 15 issued under the Local Health Administration Law (16 P.
Source: The provisions of this Chapter 15 adopted October 30, 1959, amended June 2, 1978, 8 Pa.

Chapter 17 Standards for Environmental Health Services

28 Pa. Code § 17.1 Definitions.

The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise: Act—The Local Health Administration Law (16 P. S. § § 12001—12028). Board—The Advisory Health Board of the Commonwealth. Department—The Department of Health of the Commonwealth. DER—The Department of Environmental Resources of the Commonwealth. Local health department—A county health department created pursuant to the act or the health department or board of health of any municipality entitled to receive Commonwealth grants under the act. Secretary—The Secretary of the Department.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.2 Purpose and effect.

This chapter applies to all local health departments which receive Commonwealth grants under the act and sets forth the minimum standards of performance for those departments in the mandated programs in the area of environmental health services. Reference should be made to § § 15.14 and 15.15 (relating to environmental health services; and minimum standards of performance). Under an interdepartmental agreement, is responsible for conducting evaluations of the environmental programs carried out by the local health departments and for promptly reporting the results of such evaluations to the Secretary.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.3 Meetings.

(a) Local health departments shall be required to attend no more than four meetings per year.

(b) The Secretary of DER or his designee will call the meetings.

(c) The requirements of this section shall apply to the meetings referred to in § § 17.11(6), 17.21(6), 17.31(6), 17.41(5), 17.51(5), 17.61(6), 17.71(6), 17.82(6), 17.92(4), 17.102(5), 17.112(6), 17.122(9), 17.132(3)(iv) and 17.142(4).

The provisions of this § 17.3 adopted June 6, 1980, effective June 7, 1980, 10 Pa.B. 2329.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.11 Minimum program activities.

The following shall be considered minimum activities in the organized camp program:

(1) Issuance of permits. Issuance of permits shall conform with the following:

(i) It shall be the responsibility of local health departments to issue organized camp permits to all organized camp facilities within their jurisdictional boundaries based on compliance with all applicable laws, rules, regulations, and standards. This permit shall be issued for a period of one year.

(ii) DER will retain responsibility for issuing Certificates of Registration as required by the act of November 10, 1959 (P. L. 1400, No. 497) (35 P. S. § § 3001—3004); however, local health departments shall be responsible for making available Registration Applications which will be provided by DER. These application forms shall subsequently be forwarded to the DER Licensing Permit Unit for processing.

(2) Inspections. All existing organized camp facilities shall be inspected prior to issuing or renewing the permit. Regular inspections of organized camps shall be made throughout the year as often as is necessary to maintain satisfactory compliance with established rules, regulations and standards.

(3) Plan review. Plans and specifications for new and remodeled organized camps shall be reviewed prior to construction of such facilities to ensure compliance with the appropriate regulations and standards for the design, construction, and installation of facilities and equipment.

(4) Rules and regulations. The provisions of Chapter 19 (relating to organized camps and campgrounds) and 7 Pa. Code Chapter 79 (Reserved) shall be the basis for minimum requirements in the organized camp program. Local health departments may adopt and enforce that chapter in accordance with applicable laws or may adopt ordinances or regulations which are as stringent as and are consistent in intent and purpose with that chapter.

(5) Educational programs. Educational activities which may include training programs should be provided for organized camp operators, employes, and the public to increase the knowledge and awareness of operating principles and practices and thereby improve the operational level of the establishment.

(6) Meetings. Local health departments are required to attend periodic meetings with DER for the purpose of program planning, development, reporting, evaluation, and coordination to provide an orderly, efficient delivery of this environmental health program on a Statewide basis.

This section cited in 28 Pa. Code § 17.3 (relating to meetings).

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.12 Technical staff training requirements.

(a) Each staff member engaged in the organized camp sanitation program shall receive training in the area of camp sanitation. The training shall be received as soon as possible after the staff member is hired and shall consist of at least the following material:

(1) Insect and rodent control.

(2) Water supply and plumbing.

(3) Waste disposal (liquid and solid).

(4) Plan review.

(b) It is recommended that each staff member satisfactorily complete a Basic Sanitarian’s Training Course which would include the material listed in subsection (a).

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.13 Enforcement procedures.

Local health departments shall take any enforcement actions necessary, within the scope of their authority, to ensure compliance on the part of organized camp owners and operators.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.14 Evaluation procedures.

Evaluations of the organized camp program of the various county and local health agencies will be conducted by the Department at a frequency of one complete evaluation at least once every 5 years. In addition, the program will be reviewed annually by DER to determine compliance with overall program objectives, using annual or statistical reports prepared by the local health department.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.21 Minimum program activities.

The following shall be considered minimum activities in the vector control program:

(1) Surveys and investigations. Area surveys and investigations for vector infestation, sampling and identification of possible vectors, and vector control activities shall be conducted to maintain satisfactory compliance with established rules, regulations, and standards and to eliminate or prevent public health hazards and nuisances.

(2) Plan review. Review of plans and specifications for aspects of the physical environment as required by established rules, regulations and standards shall include evaluations of provisions for vector control.

(3) Educational programs. Press, radio and television spots shall be prepared for areawide releases; neighborhood presentations and school educational programs shall be developed; and citizen participation shall be promoted.

(4) Laboratory services. Adequate laboratory services must be available to make any determinations deemed necessary in respect to vector identification. The laboratory used must be acceptable to DER in terms of being readily available and capable of performing the necessary identifications.

(5) Rules and regulations. The provisions of 25 Pa. Code Chapter 243 (relating to nuisances) shall be the basis for minimum requirements in the vector control program. Local health departments may adopt and enforce that chapter in accordance with applicable laws or may adopt county ordinances or regulations which are as stringent and are consistent in intent and purpose with that chapter.

(6) Meetings. Local health departments are required to attend periodic meetings with DER for the purpose of program planning, development, re- porting, evaluation and coordination to provide an orderly, efficient delivery of this environment health program on a Statewide basis.

This section cited in 28 Pa. Code § 17.3 (relating to meetings).

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.22 Reporting procedures.

All suspected vector-borne illnesses shall be reported immediately to the Department. Any suspected illnesses from a vector source shall be investigated. The investigation shall include the collection and positive identification of suspected vector specimens. All vectors so identified shall be reported to DER.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.23 Technical staff training requirements.

(a) At least one staff member shall be certified in the use of public health pesticides.

(b) It is required that each staff member satisfactorily complete a basic course in vector control. In addition to the initial training, the following meetings and courses should be attended by vector control staff to ensure that the employes remain current in the field of vector control:

(1) Educational conferences held by the Pennsylvania Vector Control Association and workshops conducted by the Regional Vector Control Associations.

(2) Correspondence courses in vector control from recognized sources, such as the Pennsylvania State University and the National Center for Disease Control.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.24 Enforcement procedures.

Local health departments shall take whatever enforcement action is necessary to minimize or eliminate a vector problem. A policy and procedure shall be developed based on local ordinances, codes and State laws by which legal enforcement can be used to eliminate vectors when necessary.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.25 Evaluation procedures.

Evaluations of the vector control programs of the various counties and local health agencies will be conducted by the Department at least once every 5 years. Where the county or local health agency is receiving rat grant moneys awarded by DER, these programs will be evaluated by DER on a quarterly basis. In addition, the program will be reviewed annually by DER to determine compliance with overall program objectives using annual or statistical reports prepared by the local health agency.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.31 Minimum program activities.

The following shall be considered minimum activities in the recreation area program:

(1) Issuance of permits. Local health departments shall be responsible for issuing all applicable permits which apply to the recreation area; except that public bathing place permits and certificates of registration for organized camps will be issued by DER.

(2) Inspections. All existing recreation area facilities shall be inspected prior to the issuing or renewing of any applicable license, certificate or permit. Regular inspections of the establishments shall be made throughout the year as often as is necessary to maintain satisfactory compliance with established rules, regulations and standards.

(3) Plan review. Plans and specifications for new and remodeled recreation areas shall be reviewed prior to construction of such facilities to ensure compliance with the appropriate regulations and standards for the design, construction and installation of facilities and equipment.

(4) Rules and regulations. Chapter 19, 7 Pa. Code Chapter 79 (Reserved) and 25 Pa. Code Chapters 241 and 243 shall be the basis for minimum requirements in the recreation area program. Local health departments may adopt and enforce those chapters in accordance with applicable laws or may adopt county ordinances or regulations which are as stringent and are consistent in intent and purpose with those chapters.

(5) Educational programs. Educational activities which may include training programs should be provided for campground operators, employes, and the public to increase the knowledge and awareness of operating principles and practices and thereby improve the operational level of the establishment.

This section cited in 28 Pa. Code § 17.3 (relating to meetings).

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.32 Technical staff training requirements.

(a) Each staff member engaged in the campground sanitation program shall receive training in the area of camp sanitation. The training shall be received as soon as possible after the staff member is hired and shall consist of at least the following material:

(1) Insect and rodent control.

(2) Water supply and plumbing.

(3) Waste disposal (liquid and solid).

(4) Plan review.

(b) It is recommended that each staff member satisfactorily complete a Basic Sanitarian’s Training Course which would include the material set forth in subsection (a).

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.33 Enforcement procedures.

County and local health departments shall take any enforcement actions necessary within the scope of their authority to ensure compliance on the part of recreation area owners and operators.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.34 Evaluation procedures.

Evaluations of the recreation area programs of the various county and local health agencies will be conducted by the Department at a frequency of one complete evaluation at least once every 5 years. In addition, the program will be reviewed annually by DER to determine compliance with overall program objectives, using annual or statistical reports prepared by the local health agency.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.41 Minimum program activities.

The following shall be considered minimum activities in the institutional program:

(1) Inspections. Institutional facilities, including nursing homes, skilled and intermediate care facilities, child day care centers, head start, county detention centers, mental health inpatient, mental health/mental retardation day care, residential mental health/mental retardation general child-care institutions, adult day care centers, maternity homes and sheltered workshops, shall be inspected. The local health department shall respond to requests for inspections from DER. Requests for inspection for renewal of licenses/approvals will be forwarded by the Division of Facility Sanitation and Vector Control to the local health departments two months prior to the license/approval expiration date except in cases of new facilities or upon special request for an inspection at a facility identified as having a specific and serious health or sanitation problem. Inspections shall be made throughout the year as often as is necessary to maintain satisfactory compliance with applicable rules, regulations and standards of DER or with local health regulations in effect. Facilities to be excluded from inspection are State mental hospitals, State schools and hospitals, psychiatric units or emergency mental health/mental retardation units located within general hospitals, and group homes or boarding homes for children which provide room and board for 16 or less people who are not related to the owner or operator.

(2) Plan review. Upon referral from the licensing agency, plans and specifications for major alterations or for new construction shall be reviewed prior to construction to ensure compliance with the provisions of 25 Pa. Code Chapter 173 (Reserved) or other applicable regulations which may be in effect.

(3) Rules and regulations. The provisions of 25 Pa. Code Chapter 173 shall be the basis for minimum requirements in institutions. Local health department may adopt and enforce regulations which are as stringent and are consistent in intent and purpose with that chapter.

(4) Educational program. Educational activities may include training programs for institution owners, operators and employes to increase the knowledge and awareness of environmental health principles and practices.

(5) Meetings. Local health departments are required to attend periodic meetings with DER for the purpose of program planning, development, re- porting, evaluation and coordination to provide an orderly, efficient delivery of this environmental health program on a Statewide basis.

This section cited in 28 Pa. Code § 17.3 (relating to meetings).

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.42 Reporting procedures.

(a) Nursing homes. The local health department shall forward a memorandum recommending approval or disapproval of a given facility to: Licensing Officer; Division of Long Term Care; Pennsylvania Department of Health; Post Office Box 90; Harrisburg, Pennsylvania 17120. A copy of this memorandum shall also be sent to the Division of Facility Sanitation and Vector Control; Department of Environmental Resources; Post Office Box 2063; Harrisburg, Pennsylvania 17120.

(b) Child and adult day care centers, head start, county detention centers, mental health inpatient, mental health/mental retardation day care, residential mental health/mental retardation, general child-care institutions, maternity homes and sheltered workshops. The inspecting agency shall forward a memorandum recommending approval or disapproval of a given facility to the Regional Director of Licensing, Department of Public Welfare. A copy of this memorandum shall also be sent to the Division of Facility Sanitation and Vector Control, DER.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.43 Staff training requirements.

(a) Each staff member engaged in the institutional sanitation program shall receive training in areas which relate to the program. The training shall be received as soon as possible after the staff is hired and shall consist of at least the following material:

(1) All aspects of food preparation.

(2) Water supply and plumbing.

(3) Waste disposal (liquid and solid).

(4) Ventilation.

(5) Laundry practices.

(6) Housekeeping.

(7) Insect and rodent control.

(8) Isolation procedures.

(9) Sterilization principles.

(b) It is recommended that each staff member satisfactorily complete a Basic Sanitarian’s Training Course which would include the material set forth in subsection (a); the sanitarian should be knowledgeable in all of these areas to provide consultation to institutional personnel.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.44 Enforcement procedures.

The suspension of revocation of a license or Certificate of Approval lies within the authority of the issuing agency; however, local health departments shall take any enforcement actions within their authority. The Regional Licensing Officers from the Department of Public Welfare are available for administrative hearings and should be contacted when warranted.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.45 Evaluation procedures.

Evaluation of the institution program of the various local health departments shall be conducted by the Department at a frequency of once every 5 years, or sooner if conditions warrant. The program will be reviewed annually by DER using annual or statistical reports.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.51 Minimum program activities.

The following shall be considered minimum activities in the school sanitation program:

(1) Inspections. Inspections shall conform with the following:

(i) Inspections of public schools shall be made throughout the year as often as necessary to maintain satisfactory compliance with applicable rules, regulations, and standards of DER or with local health regulations in effect.

(ii) Licensed private academic schools shall be inspected as requested by the Division of Facility Sanitation and Vector Control, DER.

(iii) Schools operated by bona fide religious institutions shall be inspected upon receipt of a request or complaint.

(iv) Public school inspections should be scheduled in the fall and early winter to permit the districts sufficient time to incorporate expenditure of funds in their budgets. Inspection priority in schools shall be given to facilities having food service, private water supplies and onlot sewage disposal.

(2) Plan review. Plans and specifications for new and remodeled schools shall be reviewed prior to construction of such facilities to ensure compliance with the provisions of 25 Pa. Code (relating to environmental protection).

(3) Rules and regulations. The provisions of 25 Pa. Code Chapter 171 (relating to schools) shall be the basis for minimum requirements in schools.

(4) Educational programs. Educational activities should include training programs for school administrators, operators of licensed private academic schools, employes, and pupils in the schools to increase the knowledge and awareness of environmental health principles and practices.

(5) Meetings. Local health departments are required to attend periodic meetings with DER for the purpose of program planning, development, reporting, evaluation, and coordination to provide an orderly, efficient delivery of this environmental health program on a Statewide basis.

This section cited in 28 Pa. Code § 17.3 (relating to meetings).

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.52 Reporting procedures.

(a) Public schools. The local health department shall prepare one memorandum which covers each public school within a school district. In very large school districts, the number of schools covered by this memorandum may be limited by the local health department. The original memorandum shall be sent to the school district; and a copy shall be sent to: Director, Bureau of Educational Administration and Management Support Services; Department of Education; Harrisburg, Pennsylvania 17126. If a public school is not in satisfactory compliance, an additional copy of the cover memorandum and a copy of the inspection report for the school in question shall be sent to: Division of Facility Sanitation and Vector Control; Department of Environmental Resources; Harrisburg, Pennsylvania 17120.

(b) Licensed private academic schools. As requested by the Division of Facility Sanitation and Vector Control, a memorandum recommending approval or disapproval for licensing shall be prepared by the local health department for licensed private academic schools. The original memorandum shall be sent to: Office of Nonpublic Schools; Division of Private Academic Schools; Department of Education; Harrisburg, Pennsylvania 17126. A copy shall be sent to: Division of Facility Sanitation and Vector Control; Department of Environmental Resources; Harrisburg, Pennsylvania 17120.

(c) Schools operated by bona fide religious institutions. Whenever the local health department upon request or complaint has investigated a school operated by a bona fide religious institution and found a potential public nuisance, the local health department shall notify DER, Division of Facility Sanitation and Vector Control.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.53 Staff training requirements.

(a) Each staff member engaged in the school sanitation program shall receive training in areas which relate to the program. The training shall be received as soon as possible after the staff is hired and shall consist of at least the following material:

(1) All aspects of food protection.

(2) Water supply and plumbing.

(3) Waste disposal (liquid and solid).

(4) Lighting standards.

(5) Ventilation and heating.

(6) Housekeeping.

(7) Insect and rodent control.

(8) Plan review.

(b) It is recommended that each staff member satisfactorily complete a Basic Sanitarian’s Training Course which would include the material set forth in subsection (a).

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.54 Enforcement procedures.

(a) Public schools. Enforcement procedures in public schools shall conform with the following:

(1) Emergency environmental health orders shall be issued under section 12 of the act (16 P. S. § 12012).

(2) Public schools which continue in noncompliance with applicable requirements, after proper notice, shall be brought to the attention of the Division of Facility Sanitation and Vector Control, which will coordinate action with the Department of Education for abatement.

(b) Licensed private academic schools. The suspension or revocation of a license for a private academic school lies within the authority of the issuing agency; however, county and local health departments shall take enforcement actions under the act.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.55 Evaluation procedures.

Evaluation of the school program of the various county and local health agencies will be conducted by the Department at a frequency of once every 5 years, or sooner if conditions warrant. The program will be reviewed annually by DER using annual or statistical reports.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.61 Minimum program activities.

The following shall be considered minimum activities in the campground program:

(1) Issuance of permits. It shall be the responsibility of local health departments to issue campground permits to all campground facilities within their jurisdictional boundaries based on compliance with all applicable laws, rules, regulations and standards. This permit shall be issued for a period of 1 year.

(2) Inspections. All existing campground facilities shall be inspected prior to issuing or renewing the permit. Regular inspections of campgrounds shall be made throughout the year as often as is necessary to maintain satisfactory compliance with established rules, regulations and standards.

(3) Plan review. Plans and specifications for new and remodeled campgrounds shall be reviewed prior to construction of such facilities to ensure compliance with the appropriate regulations and standards for the design, construction and installation of facilities and equipment.

(4) Rules and regulations. The provisions of Chapter 19 (relating to organized camps and campgrounds) and 7 Pa. Code Chapter 79 (Reserved) shall be the basis for minimum requirements in the campground program. Local health departments may adopt and enforce that chapter in accordance with applicable laws or may adopt county ordinances or regulations which are as stringent and are consistent in intent and purpose with that chapter.

(5) Educational program. Educational activities, which may include training programs, should be provided for campground operators, employes, and the public to increase the knowledge and awareness of operating principles and practices and thereby improve the operational level of the establishment.

This section cited in 28 Pa. Code § 17.3 (relating to meetings).

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.62 Technical staff training requirements.

(a) Each staff member engaged in the campground sanitation program shall receive training in the area of camp sanitation. Such training shall be received as soon as possible after the staff member is hired and shall consist of at least the following material:

(1) Insect and rodent control.

(2) Water supply and plumbing.

(3) Waste disposal (liquid and solid).

(4) Plan review.

(b) It is recommended that each staff member satisfactorily complete a Basic Sanitarian’s Training Course which would include the material set forth in subsection (a).

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.63 Enforcement procedures.

Local health departments shall take any enforcement actions necessary within the scope of their authority to ensure compliance on the part of campground owners and operators.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.64 Evaluation procedures.

Evaluations of the campground program of the various county and local health agencies will be conducted by the Department at a frequency of one complete evaluation at least once every 5 years. In addition, the program will be reviewed annually by DER to determine compliance with overall program objectives, using annual or statistical reports prepared by the local health department.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.71 Minimum program activities.

The following shall be considered minimum activities in the mobile home park program:

(1) Issuance of certificates. It shall be the responsibility of local health departments to issue mobile home park Certificates of Registration to all such facilities within their jurisdictional boundaries based upon compliance with all applicable laws, regulations, and standards. This Certificate of Registration shall be issued for 1 year.

(2) Inspections. Mobile home parks shall be inspected prior to issuing or renewing certificates of registration. All existing mobile home parks shall be inspected throughout the year as often as is necessary to maintain satisfactory compliance with established rules, regulations, and standards.

(3) Plan review. Plans and specifications for new mobile home parks or additions or renovations of environmental health importance to existing parks shall be reviewed prior to construction of such facilities to ensure compliance with appropriate regulations and standards for the design, construction and installation of facilities and equipment.

(4) Rules and regulations. The provisions of 25 Pa. Code Chapter 179 (Reserved) shall be the basis for minimum requirements in the mobile home park program. Local health departments may adopt and enforce that chapter in accordance with applicable laws or may adopt ordinances or regulations which are as stringent and are consistent in intent and purpose with that chapter.

(5) Educational program. Public educational activities should be provided to increase the knowledge and awareness of mobile home park regulations. Areas of concern should include, but not be limited to, plan review, water supplies, liquid waste disposal, solid waste, insect and rodent control, and safety. This may include newspaper announcements, public presentation, and the like.

(6) Meeting. Local health departments are required to attend periodic meetings with DER for the purpose of program planning, development, reporting, evaluation and coordination to provide an orderly, efficient delivery of this environmental health program on a Statewide basis.

This section cited in 28 Pa. Code § 17.3 (relating to meetings).

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.72 Reporting.

An annual report of activities shall be submitted on forms provided by DER.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.73 Technical staff training.

(a) Each staff member engaged in the mobile home park program shall receive training in the areas which relate to the program. The training shall be received as soon as possible after the staff is hired and shall consist of at least the following material:

(1) Plan review.

(2) Water supply and plumbing.

(3) Sewerage facilities.

(4) Solid waste.

(5) Insect and rodent control.

(b) It is required that each staff member satisfactorily complete the Basic Sanitarian’s Training Course conducted by DER.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.74 Enforcement procedures.

Local health departments shall take any enforcement actions necessary within the scope of their authority to ensure compliance on the part of mobile home park owners and operators.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.75 Evaluation procedures.

Evaluation of the mobile home park program of the various county and local health agencies shall be conducted by the Department at a frequency of once every five years, or sooner if conditions warrant. The program will be reviewed annually by DER using annual or statistical reports.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.81 Authority for issuing licenses.

The act of May 23, 1945 (P. L. 926, No. 369) (35 P. S. § § 655.1—655.13) requires that all public eating and drinking places in this Commonwealth be licensed. That act and section 1910-A(11) of The Administrative Code of 1929 (71 P. S. § 510-1(11)) defines ‘‘licensor’’ as: the county department of health or joint-county department of health, whenever such public eating or drinking place is located in a political subdivision which is under the jurisdiction of a county department of health or joint-county department of health, or the health authorities of cities, boroughs, incorporated towns and first-class townships, whenever such public eating or drinking place is located in a city, borough, incorporated town or first-class township not under the jurisdiction of a county department of health or joint-county department of health; or the Department of Environmental Resources whenever such public eating or drinking place is located in any other area of the Commonwealth.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.82 Minimum program activities.

The following shall be considered minimum activities in the food service sanitation program:

(1) Inspections. Each food service establishment shall be inspected prior to issuing or renewing a license. Regular inspections of these establishments shall be made throughout the year as often as necessary to maintain satisfactory compliance with established rules, regulations and standards.

(2) Plan review. Plans and specifications for new and remodeled food service facilities shall be reviewed prior to construction of these facilities to insure compliance with appropriate regulations and standards for the design, construction and installation of facilities and equipment.

(3) Educational programs. Educational activities, which may include training programs, shall be provided for food establishment operators, employes and the public to increase the knowledge and awareness of food preparation principles and practices and thereby improve the operational level of food establishments and reduce the incidence of foodborne illness.

(4) Laboratory services. Adequate laboratory services must be available to make any analytical determinations deemed necessary, particularly in the area of foodborne illness investigations. The laboratory used must be acceptable to DER in terms of being readily available and capable of performing microbiological analyses to identify the genera of the microorganisms important to food protection and qualitative analysis for chemical contaminants and adulterants.

(5) Rules and regulations. Rules, regulations and standards for the conduct and operation of food service facilities shall be established and shall be revised as necessary to be current with accepted public health criteria.

(6) Meetings. Local health departments are required to attend periodic meetings with DER for the purpose of program planning, development, reporting, evaluation and coordination to provide an orderly, efficient delivery of this environmental health program on a Statewide basis.

This section cited in 28 Pa. Code § 17.3 (relating to meetings).

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.83 Staff training requirements.

(a) Each staff member engaged in a food service sanitation program shall receive training in the area of food protection. The training shall be received as soon as possible after the staff member is hired, and shall consist of at least the following material:

(1) Microbiological aspects of food protection.

(2) Foodborne diseases (investigation and control).

(3) Refrigeration of foods.

(4) Time temperature relationships.

(5) Personal hygiene.

(6) Cleaning and sanitization techniques.

(7) Equipment design and construction.

(8) Insect and rodent control.

(9) Water supply and plumbing.

(10) Ventilation.

(11) Waste disposal.

(12) Plan review.

(b) It is recommended that each staff member satisfactorily complete a Basic Sanitarian’s Training Course which would include the material set forth in subsection (a).

(c) In addition to the initial training for new employes, the following measures should be taken to ensure that the employes will remain current in the field of food protection:

(1) Food protection staff should attend at least one formal training program once every 3 years.

(2) At least one trade journal and one professional journal in the field of food sanitation should be available to the staff as well as access to textbooks and reference material.

(3) Each food sanitation staff member should participate at least once annually in joint inspections with the member’s supervisor or a State supervisor or consultant.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.84 Enforcement procedures.

The act of May 23, 1945 (P. L. 926, No. 369) (35 P. S. § § 655.1—655.13) provides several remedies for violations of the act or of the rules and regulations. County and local departments shall take any enforcement actions necessary within the scope of that act or any other applicable laws to ensure compliance on the part of food service establishments and proprietors.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.85 Evaluation procedures.

Evaluations of the food service sanitation programs of the local health departments will be conducted by the Department in cooperation with the Federal Food and Drug Administration in accordance with current ‘‘Procedure for Evaluating Food Service Sanitation Programs’’ as established by the USPHS. The evaluations may be conducted at a frequency of one complete evaluation of each food service sanitation program at least once every 5 years. In addition, the program will be reviewed annually by DER to determine compliance with overall program objectives, using annual or statistical reports prepared by the local health agency.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.91 Permits.

The provisions of 7 Pa. Code Chapter 49 (relating to shellfish) require that any person selling or offering shellfish for sale in this Commonwealth have a permit from DER. DER may issue such permits to those firms located in the county upon approval of the firm by the appropriate county department.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.92 Minimum program activities.

The following shall be considered minimum activities of the shellfish sanitation program:

(1) Inspections. Each shellfish permittee shall be inspected at least once each 6-month period. Regular inspections of such facilities shall be made as often as is necessary to maintain satisfactory compliance with established rules, regulations and standards.

(2) Laboratory services. Adequate laboratory services must be available to make any analytical determinations deemed necessary, particularly for standard plate count and coliform analysis. The laboratory used must be acceptable to DER in terms of being rapidly available and capable of performing microbiological analyses to identify the genera of the microorganisms important to shellfish sanitation and qualitative analysis for chemical contaminants and adulterants.

(3) Rules and regulations. The provisions of 7 Pa. Code Chapter 49 (relating to shellfish) shall apply. Local health departments shall adopt and enforce that chapter or may, at their discretion and in accordance with applicable laws, adopt ordinances or regulations which are at least as stringent as and are consistent in intent and purpose with that chapter.

(4) Meetings. Local health departments are required to attend periodic meetings with DER for the purpose of program planning, development, reporting, evaluation, and coordination to provide an orderly, efficient delivery of this environmental health program on a Statewide basis.

This section cited in 28 Pa. Code § 17.3 (relating to meetings).

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.93 Reporting procedures.

Copies of inspection reports on all shellfish facilities, as well as copies of any laboratory analyses, shall be forwarded to the Division of Food and Water Protection, Department of Environmental Resources. An annual program and statistical report shall be submitted to DER on forms provided.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.94 Staff training requirements.

Each staff member engaged in the shellfish sanitation program shall receive training in the area of shellfish sanitation. The training shall be received as soon as possible after the staff member is hired and shall consist of the following material:

(1) Microbiological aspects of shellfish sanitation.

(2) Interpretation of shellfish sanitation requirements.

(3) 7 Pa. Code Chapter 49 (relating to shellfish).

(4) Part 2, Regional Shellfish Sanitation Program Manual of Operations.

(5) Personal hygiene.

(6) Water supply and plumbing.

(7) Waste disposal.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.95 Enforcement procedures.

Local health departments shall take any enforcement actions necessary within the scope of their authority to ensure compliance on the part of shellfish permittees. DER may revoke any shellfish permit upon request of the local health department for failure to comply with regulations.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.96 Evaluation procedures.

Evaluations of the shellfish sanitation programs of the various county and local health agencies will be conducted by the Department in cooperation with the Federal Food and Drug Administration at a frequency of one complete evaluation at least once every 5 years. In addition, the program will be reviewed annually by DER to determine compliance with overall program objectives, using annual or statistical reports prepared by the local health agency.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.101 Permits.

The act of April 30, 1929 (P. L. 897, No. 396) (35 P. S. § § 1001—1006) requires that all persons, partnerships, associations or corporations manufacturing, bottling, selling or offering for sale bottled water in this Commonwealth must obtain a permit from DER. No provision is made in that act or in 25 Pa. Code Chapter 159 (Reserved) for permitting of bottled water plants by local health agencies. DER issues all bottled water plant permits after review by the appropriate local health agencies in those cases where the facility is located in a municipality having a local health department.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.102 Minimum program activities.

The following shall be considered minimum activities in the bottled water program:

(1) Inspections. Regular inspections of such facilities shall be made throughout the year as often as is necessary to maintain satisfactory compliance with established rules, regulations and standards.

(2) Plan review. Plans and specifications for new and remodeled bottled water facilities shall be reviewed prior to construction of such facilities to ensure compliance with appropriate regulations and standards for the design, construction, and installation of facilities and equipment.

(3) Laboratory services. Adequate laboratory services must be available to make any analytical determinations deemed necessary, particularly with regard to compliance with current Federal Safe Drinking Water Standards.

(4) Rules and regulations. The provisions of 25 Pa. Code Chapter 159 (Reserved) shall apply. Local health departments shall adopt and enforce that chapter or may, at their discretion and in accordance with applicable laws, adopt ordinances or regulations which are at least as stringent as and are consistent in intent and purpose with that chapter.

This section cited in 28 Pa. Code § 17.3 (relating to meetings).

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.103 Reporting procedures.

Copies of inspection reports on all bottled water facilities, as well as copies of any laboratory analysis reports of product water, shall be forwarded to the Division of Food and Water Protection, Department of Environmental Resources. An annual program and statistical report shall be submitted to DER on forms provided.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.104 Staff training requirements.

Each staff member engaged in the bottled water program shall receive training in the area of bottled water. The training shall be received as soon as possible after the staff member is hired and shall consist of the following material:

(1) Complete training in individual and semipublic water supplies.

(2) Interpretation of bottled water requirements.

(3) Bottle washing and sanitization.

(4) Bottle filling equipment.

(5) Capping operations.

(6) Labeling requirements.

(7) Plumbing.

(8) Waste disposal.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.105 Enforcement procedures.

The act of April 30, 1929 (P. L. 897, No. 396) (35 P. S. § § 1001—1006) provides several remedies for violations of the act or of the rules and regulations. County departments shall take any enforcement actions necessary, except permit revocation, within the scope of that act or other applicable laws to insure compliance on the part of bottled water facilities and proprietors. DER may revoke any permit for failure to comply with regulations or standards.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.106 Evaluation procedures.

Evaluation of the bottled water sanitation programs of the various county and local health agencies will be conducted by the Department at a frequency of one complete evaluation at least once every 5 years. In addition, the program will be reviewed annually by DER to determine compliance with overall program objectives, using annual or statistical reports prepared by the local health agency.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.111 Permits.

The Public Bathing Law (35 P. S. § § 672—680d) requires that all public bathing place owners/operators obtain a permit from DER. No provision is made in this law for issuing public place permits by local health departments.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.112 Minimum program activities.

Local health departments may choose to do application processing or surveillance and monitoring, or both; local health departments carrying out surveillance and monitoring activities must also carry out the enforcement activities. The following shall be considered minimum activities in the public bathing place—swimming pools and beaches—program.

(1) Application processing. Local health departments:

(i) Shall, in accordance with DER policies and procedures, review applications for permits for new and modified public bathing places for conformance with DER rules and regulations and standards.

(ii) Shall make recommendations to DER relative to permit issuance.

(2) Surveillance and monitoring. Surveillance and monitoring shall conform with the following:

(i) The following provisions apply:

(A) Inspections of public bathing places shall be made throughout the year during periods of use as often as necessary to determine compliance with established rules, regulations, standards, and permit conditions.

(B) Sanitary surveys of public bathing beaches shall be conducted at least annually.

(ii) All surveillance and monitoring shall be carried out in accordance with DER policies and procedures.

(3) Enforcement. Local health departments shall carry out any necessary enforcement activities within the scope of the act, the Public Bathing Law (35 P. S. § § 672—680(d)), and other applicable laws to ensure compliance on the part of public bathing place owners/operators.

(4) Laboratory services. Adequate laboratory services acceptable to DER must be readily available to make analytical determinations. These services may be provided by the local health department, DER or private laboratories. DER will be available for consultation.

(5) Rules and regulations. Local health departments shall enforce the provisions of Chapter 18 (relating to swimming and bathing places) or shall, in accordance with applicable laws, adopt ordinances or regulations which are as stringent as and are consistent in intent and purpose with that chapter.

This section cited in 28 Pa. Code § 17.3 (relating to meetings).

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.113 Data management.

(a) Narrative and statistical reports on program activities shall be periodically submitted to DER.

(b) All pertinent files and records are the property of DER and shall be:

(1) Maintained in a manner consistent with the intent and purpose of DER policies and procedures.

(2) Separate and distinct from other files and records maintained by the local health department.

(3) Promptly returned to DER upon request.

(c) Program activity data needed by DER for its information systems shall be submitted on forms or in the format established by DER policies and procedures. DER will provide management reports pertaining to the public bathing place program.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.114 Training.

(a) Training programs shall be provided for public bathing place operators and employes and other educational activities for the public to increase their knowledge and awareness of public bathing place sanitation and safety.

(b) Each staff member engaged in the public bathing place sanitation and safety program shall satisfactorily complete a Basic Sanitarian’s Training Course which shall include the following:

(1) Disease transmitted via public bathing places.

(2) Safety hazards related to public bathing places.

(3) Public bathing place design and construction.

(4) Recirculation equipment operation.

(5) Disinfectant equipment operation.

(6) Public bathing place water chemistry, bacteriology, water supply and plumbing.

(7) Waste disposal.

(8) Insect and rodent control.

(c) In addition to the initial training for new employes, the following measures should be taken to ensure that the employes will remain current in the public bathing place program:

(1) Public bathing place staff should attend at least one formal training program once every 3 years.

(2) At least one trade journal and one professional journal in the field of swimming pools and relevant textbooks and reference materials relating to swimming pools and beaches should be readily available and accessible to the staff.

(3) Each public bathing place staff member should participate at least once annually in joint inspections with the member’s supervisor or an appropriate DER staff member.

(d) DER will provide for staff training to local health departments to enhance technical knowledge and to promote uniformity in carrying out the public bathing place program.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.115 Evaluation.

Evaluations will be conducted by the Department to determine the adequacy and effectiveness of the program and to determine whether the local health departments have adhered to the performance standards in carrying out this program as agreed upon. One complete evaluation will be made at least once every five years. In addition, the program will be reviewed annually by DER to determine compliance with overall program objectives using annual reports prepared by the local health departments as a basis for this determination.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.121 Permits.

The act of April 22, 1905 (P. L. 260, No. 182) (35 P. S. § § 711—716) requires that purveyors of water to the public must obtain a permit from DER. No provision is made in this law for issuing public water supply permits by local health departments.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.122 Minimum program activities.

(1) Application processing. Local health departments:

(i) Shall, in accordance with DER policies and procedures, review applications for permits for new and modified water supply facilities for conformance with DER rules and regulations and standards.

(ii) Shall make recommendations to DER relative to permit issuance.

(2) Surveillance and monitoring. Surveillance and monitoring shall conform with the following:

(i) Each new or modified water supply facility should be inspected prior to being placed in service. Inspections shall be made throughout the year as often as necessary to determine compliance with established rules, regulations, standards, and permit conditions. The local health departments shall evaluate operations reports submitted by permittees. All surveillance and monitoring shall be carried out in accordance with DER policies and procedures.

(ii) Local health departments shall carry out a pollution incident response program to investigate spills and to evaluate public health and safety hazards. This activity shall be coordinated with DER and other appropriate agencies in accordance with DER rules and regulations and policies and procedures.

(iii) Local health departments shall participate in or conduct special studies or surveys as necessary to identify and evaluate problems relating to public water supplies.

(3) Enforcement. Local health departments shall carry out any necessary enforcement activities within the scope of the act, the act of April 22, 1905 (P. L. 260, No. 182) (35 P. S. § § 711—716) and other applicable laws to ensure compliance on the part of public water supply purveyors.

(4) Water supply extensions. Local health departments shall promote the extension of public water supplies in areas with unsafe or inadequate water supply systems and the interconnection of approved systems.

(5) Cross-connection control program. Local health departments shall promote educational opportunities for and assistance to water supply personnel and others involved in the identification and elimination of potentially hazardous cross connections in public water supply systems.

(6) Private individual water supplies. Local health departments shall make technical assistance, inspection and consultation services available to persons dependent upon private individual water supplies.

(7) Laboratory services. Adequate laboratory services acceptable to DER must be readily available to make analytical determinations. These services may be provided by the local health department, DER or private laboratories. DER will be available for consultation.

(8) Rules and regulations. Local health departments shall enforce the provisions of 25 Pa. Code Chapter 109 (relating to safe drinking water) or shall, in accordance with applicable laws, adopt ordinances or regulations which are as stringent as and are consistent in intent and purpose with that chapter.

(9) Meetings. Local health departments are required to attend periodic meetings with DER for the purpose of program planning, development, reporting, evaluation and coordination to provide an orderly, efficient delivery of this environmental health program on a Statewide basis.

This section cited in 28 Pa. Code § 17.3 (relating to meetings).

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.123 Data management.

(a) Narrative and statistical reports on program activities shall be periodically submitted to DER.

(b) All pertinent files and records are the property of DER and shall be:

(1) Maintained in a manner consistent with the intent and purpose of DER policies and procedures.

(2) Separate and distinct from other files and records maintained by the local health department.

(3) Promptly returned to DER upon request.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.124 Training.

(a) Educational opportunities shall be provided to the public to increase their knowledge and awareness of the principles of water supply. In addition, training programs for water supply operators and employes shall be promoted to improve the operational level of water systems and reduce the incidence of waterborne illness.

(b) Each staff member engaged in the water supply program shall satisfactorily complete a Basic Sanitarian’s Training Course which shall include the following:

(1) Water treatment plan design and construction.

(2) Aspects of waterborne illness.

(3) Sources of water supply.

(4) Water quality.

(5) Methods of water treatment.

(6) Evaluation of water systems.

(7) Water chemistry and bacteriology.

(8) Fluoridation.

(9) Cross connection control.

(10) Protection of water supplies.

(11) Water distribution.

(c) In addition to the initial training for new employes, the following measures should be taken to ensure that the employes will remain current in the water supply program.

(1) Water supply staff should attend at least one formal training program once every 3 years.

(2) At least one trade journal and one professional journal in the field of water supply and relevant textbooks and reference materials should be readily available and accessible to the staff.

(3) Each water supply staff member should participate at least once annually in joint inspections with the member’s supervisor or an appropriate DER staff member.

(4) DER will provide for staff training to local health departments to enhance technical knowledge and promote uniformity in carrying out the water supply program.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.125 Evaluation.

Evaluations shall be conducted by the Department to determine the adequacy and effectiveness of the program and to determine whether the local health departments have adhered to the performance standards in carrying out this program as agreed upon. One complete evaluation will be made at least once every five years. In addition, the program will be reviewed annually by DER to determine compliance with overall program objectives using annual reports prepared by the local health departments as a basis for this determination.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.131 Permits.

(a) The Clean Streams Law (35 P. S. § § 691.1—691.1001) requires that permits be obtained from DER prior to any discharge to the waters of this Commonwealth. No provision is made in this law for issuing permits by local health departments.

(b) The Pennsylvania Sewage Facilities Act (35 P. S. § § 750.1—750.20) authorizes county health departments to issue permits for onlot sewage disposal systems.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.132 Minimum program activities.

The following shall be considered minimum activities in the Water Pollution Control Program:

(1) Administration of The Clean Streams Law. Local health departments may choose to do application processing or surveillance and monitoring, or both; local health departments carrying out surveillance and monitoring must also carry out the enforcement activities.

(i) Application processing. Local health departments:

(A) Shall, in accordance with DER policies and procedures, evaluate applications for permits for sewer extensions, sewage treatment plants and industrial waste treatment facilities for conformance with DER rules and regulations and standards.

(B) Shall make recommendations to DER relative to permit issuance.

(ii) Surveillance and monitoring. Surveillance and monitoring shall conform with the following:

(A) In order to determine if dischargers are complying with established rules, regulations, standards and permit conditions and to see if stream quality is improving, local health departments shall inspect and sample all discharges, shall evaluate the operation of treatment facilities, and shall sample surface and groundwater within their jurisdiction on a timely basis. In addition, local health departments shall evaluate operations reports submitted by permittees. All surveillance and monitoring shall be carried out in accordance with DER policies and procedures.

(B) Local health departments shall carry out a pollution incident response program to investigate spills and to evaluate public health and safety hazards. This activity shall be coordinated with DER and other appropriate agencies in accordance with DER rules and regulations and policies and procedures.

(C) Local health departments shall participate in or conduct special studies or surveys as necessary to identify and evaluate problems relating to water pollution.

(iii) Enforcement. Local health departments shall carry out any necessary enforcement activities within the scope of the act, The Clean Streams Law (35 P. S. § § 691.1—691.1001), and other applicable laws to ensure compliance on the part of dischargers or potential dischargers to the waters of this Commonwealth.

(2) Administration of Pennsylvania Sewage Facilities Act. County health departments and such other local health departments as may have been designated as a local agency in accordance with the provisions of the Pennsylvania Sewage Facilities Act (35 P. S. § § 750.1—750.20) shall review official plans, revisions, and supplements for completeness and accuracy. Final approval or disapproval of official plans or revisions thereto will be made by DER after receipt of the comments from the county health department or the designated local agency.

(i) The county or other local health departments described in this paragraph shall administer section 7 of the Pennsylvania Sewage Facilities Act (35 P. S. § 750.7) and 25 Pa. Code Chapter 71, Subchapter B (relating to official plan requirements). Each staff member engaged in the issuance of permits must be certified by the State Board for Certification of Sewage Enforcement Officers.

(ii) Inspections and surveys of existing malfunctioning sewage disposal systems shall be made in those areas where malfunctioning is occurring and where complaints are received from the public. Appropriate action shall be taken to eliminate or minimize the malfunctions.

(iii) Enforcement procedures shall be implemented in accordance with sections 12, 13, 14 and 16 of the Pennsylvania Sewage Facilities Act (35 P. S. § § 750.12, 750.13, 750.14 and 750.16).

(3) General. General provisions shall be as follows:

(i) Comprehensive water quality management plan implementation. Local health departments shall initiate efforts within their jurisdiction to promote the implementation of comprehensive water quality management in accordance with the act, the Pennsylvania Sewage Facilities Act, The Clean Streams Law, the Federal Water Pollution Control Act and DER rules and regulations and policies and procedures.

(ii) Laboratory services. Adequate laboratory services acceptable to DER must be readily available to make analytical determinations. These services may be provided by the local health department, DER or private laboratories. DER will be available for consultation.

(iii) Rules and regulations. Local health departments shall enforce the rules and regulations of DER, or shall, in accordance with applicable laws, adopt ordinances or regulations which are at least as stringent as and are consistent in intent and purpose with the DER rules and regulations.

(iv) Meetings. Local health departments are required to attend periodic meetings with DER for the purpose of program planning, development, reporting, evaluation, and coordination to provide an orderly, efficient delivery of this environmental health program on a Statewide basis.

This section cited in 28 Pa. Code § 17.3 (relating to meetings).

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.133 Data management.

(a) Narrative and statistical reports on program activities shall be periodically submitted to DER.

(b) All pertinent files and records are the property of DER and shall be:

(1) Maintained in a manner consistent with the intent and purpose of DER policies and procedures.

(2) Separate and distinct from other files and records maintained by the local health department.

(3) Promptly returned to DER upon request.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.134 Training.

(a) Educational opportunities shall be provided to the public to increase their knowledge and awareness of The Clean Streams Law (35 P. S. § § 691.1—691.1001), the Pennsylvania Sewage Facilities Act (35 P. S. § § 750.1—750.20) and related statutes and regulations. In addition, training programs for water pollution control personnel shall be promoted to improve the operational level of water pollution control facilities and to reduce the incidence of water pollution.

(b) Each staff member engaged in the implementation of The Clean Streams Law shall receive training in the areas of water quality criteria, stream surveying, stream modeling and sewage and industrial waste treatment processes and in other areas of water pollution control. Each staff member shall be required to complete a basic water pollution control training course. In addition to initial training for new employes, the following measures should be taken to ensure that the employes will remain current in the field of water pollution control:

(1) Water quality staff should attend at least one formal training program every three years.

(2) At least one trade journal and one professional journal in the field of water pollution control and relevant textbooks and reference materials should be readily available and accessible to the staff.

(c) Each staff member engaged in issuing permits under the Pennsylvania Sewage Facilities Act shall successfully complete any training courses that DER may establish in its program of continuing education for Sewage Enforcement Officers.

(d) Each staff member engaged in the water pollution control program should participate at least once annually in joint inspections with the member’s supervisor or an appropriate DER staff member.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.135 Evaluations.

Evaluations will be conducted by the Department to determine the adequacy and effectiveness of the program and to determine whether the local health departments have adhered to the performance standards in carrying out the program as agreed upon. One complete evaluation will be made at least once every 5 years. In addition, the program will be reviewed annually by DER to determine compliance with overall program objectives using annual reports prepared by the local health departments as a basis for this determination.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.141 Permits.

The Pennsylvania Solid Waste Management Act (35 P. S. § § 6001—6017) requires DER to issue permits for solid waste facilities and sites. No legislative authority exists for delegation of the permit issuance requirements of this act.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.142 Minimum program activities.

The following activities are considered to be minimum activities in the solid waste program:

(1) Solid Waste Management Plan. All revisions to the existing Solid Waste Management Plan shall be reviewed by the county health department staff with comments submitted to the Regional Solid Waste Manager.

(2) Permit review. County health departments will provide all applicants for solid waste permits with the necessary DER forms and instructions for form completion. The county health departments shall review and comment on all solid waste management permit applications.

(3) Evaluations and consultations. County health department staff shall evaluate the entire solid waste system to determine whether municipalities are implementing the Solid Waste Management Plan. Necessary consultation shall be provided by the county health department to assist municipalities in implementing their Solid Waste Management Plan.

(4) Meetings. County health departments are required to attend periodic meetings with DER for the purpose of program planning, development, reporting, evaluation, and coordination to provide an orderly, efficient delivery of this environmental health program on a Statewide basis.

This section cited in 28 Pa. Code § 17.3 (relating to meetings).

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.143 Record system.

To provide input for DER data management systems, the county health departments shall maintain data reports as follows:

(1) Narrative statistical reports on program activities shall be periodically submitted to DER.

(2) All files and records shall be maintained in a manner consistent with the intent and purpose of DER policy and procedures.

(3) Program activity data needed by DER for its management information system shall be submitted on forms or in the format established by DER policy and procedures. DER will provide management reports pertaining to the delegated program.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.144 Staff training requirements.

Each staff member engaged in the solid waste management programs shall receive adequate training in the areas of solid waste management, sanitary landfill operations, waste disposal techniques, hazardous solid waste management, groundwater standards, leachate treatment processes, recycling, resource recovery and environmental law. In addition to the initial training, the following measures shall be taken to ensure that employes remain current in the field of solid waste management:

(1) Solid waste staff should attend at least one formal training program every 3 years.

(2) At least one trade journal and one professional journal in the field of solid waste management as well as textbooks and reference materials should be available to the staff.

(3) Each solid waste staff member shall participate at least once annually in joint inspections with the member’s supervisor and State solid waste program representative. DER will provide additional formal staff training to county health departments to enhance technical knowledge and ensure universal application of the rules and regulations.

(4) Solid waste program staff members from the county shall be invited to participate at staff meetings held by DER program staff on a regular basis in regional and central offices.

(5) County health departments will be provided with copies of the Pennsylvania Department of Environmental Resources, Division of Solid Waste Management’s Policy and Procedures.

(6) As a minimum, county health department staff members implementing the solid waste management program must complete a 30-hour course in Principles of Solid Waste Management under the direction and training of DER’s Division of Solid Waste Management.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

28 Pa. Code § 17.145 Evaluation procedures.

Evaluation of solid waste programs of the county health department will be conducted by the Department at least once every 5 years to determine conformance with these minimum program requirements, and an annual statistical audit will be conducted.

History

Authority: The provisions of this Chapter 17 issued under sections 2102(g) and 2111(c) and (d) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 17 adopted September 28, 1979, effective September 29, 1979, 9 Pa.

Chapter 18 Public Swimming and Bathing Places

28 Pa. Code § 18.1 Definitions.

The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise: Air gap—The unobstructed vertical distance through the free atmosphere between the lowest opening from a pipe or faucet supplying water to a tank, plumbing fixture or other device and the flood level rim of the receptacle. Backflow—The flow of water or other liquids, mixtures or substances into the distributing pipes of a potable supply of water from a source other than the approved source. Bather—A person using a recreational swimming establishment in the water or adjoining deck area for the purpose of swimming, water sports or other recreational activity. Bather load—The total number of bathers in a recreational swimming establishment. Bathing beach—A body of natural water, impounded or flowing, of a size in relation to the bathing load that the quality and quantity, confined or flowing, need be neither mechanically controlled for the purpose of purification nor contained in an impervious structure. Certified lifeguard—An individual who has a current certificate in lifeguarding, issued by a lifeguard certifying authority, as recognized by the Department of Health in a notice published yearly in the Pennsylvania Bulletin. Cross connection—A physical connection or arrangement between two otherwise separate piping systems, one of which contains potable water and the other steam, gas, a chemical or water of unknown or questionable safety, whereby there may be a flow from one system to the other, the direction depending on the pressure differential between the two systems. Department—The Department of Health of the Commonwealth. Garbage—Putrescible wastes, except sewage and body waste, including animal and vegetable offal. Local health department—Each county department of health under the Local Health Administration Law (16 P. S. § § 12001—12028), and each department of health in a municipality approved for a Commonwealth grant to provide local health services under section 25 of the Local Health Administration Law (16 P. S. § 12025). Maximum bather load—The maximum number of bathers that the recreational swimming establishment is designed to accommodate, as defined in the plans and specifications submitted as part of the permit application using the guidelines set forth in the Department’s publication, Public Bathing Place Manual. National Electrical Code—The National Electrical Code published by the National Fire Protection Association, 470 Atlantic Avenue, Boston, Massachusetts 02210. Person—An individual, partnership, corporation, association, municipality, county, authority, the Commonwealth or other private or public entity. Public bathing place—An outdoor or indoor place used for amateur, professional or recreative swimming or bathing whether or not a fee is charged for admission or for the use of the place, exclusive of a bathing place at a private, single-family residence which is used solely by the owner of the residence, his family and their personal guests. Recreational swimming establishment—A facility that is designed, constructed or designated for use by individuals for the primary purpose of swimming, if a fee is charged for admission.

(i) The term includes swimming pools, water rides, wave pools and swimming beaches and other outdoor swimming facilities.

(ii) The term excludes those facilities owned by condominiums, other property owner associations, rental arrangements that include three or more families or social units, hotels or motels, campgrounds, private clubs and private organizations which do not provide access to the general public, swimming facilities used exclusively for hydrotherapy and residential swimming facilities used solely by the owner of a residence, the owner’s family and personal guests. Refuse—Nonputrescible wastes generally regarded and classified as rubbish, trash, junk and similar designations which have been rejected by the owner or possessor thereof as useless or worthless to him. Rope and float line—A continuous line, at least 1/4 inch in diameter, that is supported by buoys and attached to opposite sides of a swimming pool. Sewage—A substance which contains the waste products or excrements or other discharges from the bodies of human beings or animals and a noxious or deleterious substance being harmful or inimical to the public health, or to animal or aquatic life, or to the use of water for domestic water supply or for recreation. Sewerage system—A community or individual system, whether publicly or privately owned, for the collection and disposal of sewage or industrial wastes of a liquid nature, including various devices for the treatment of sewage or industrial wastes. Source—A well, spring, cistern, infiltration gallery, stream, reservoir, pond or lake from which, by any means, water is taken either intermittently or continuously for use by the public. Swimming pool—A body of water of a size in relation to the bathing load that the quality and quantity of the water confined must be mechanically controlled for the purpose of purification and contained in an impervious structure. Turnover period—The number of hours required to completely replenish the water in a pool, or recirculate a quantity of water equal to the capacity of the pool. Wading pool—A body of water designed for use by children which is not deeper than 3 feet and of a size in relation to the bathing load that the quality and quantity of the water confined must be mechanically controlled for the purpose of purification and contained in an impervious structure. Waters of this Commonwealth—Rivers, streams, creeks, rivulets, lakes, dammed water, ponds, springs and other bodies of surface and underground water, or parts thereof, whether natural or artificial, within or on the boundaries of this Commonwealth. Water supply—A source or sources of water, as well as, water treatment, storage, transmission and distribution facilities.

The provisions of this § 18.1 amended under the Public Bathing Law (35 P. S. § § 672—680d); the Local Health Administration Law (16 P. S. § § 12001—12028); and section 1920-A of The Administrative Code of 1929 (71 P. S. § 510-20).

The provisions of this § 18.1 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921; amended November 29, 1974, effective December 16, 1974, 4 Pa.B. 2453; amended April 29, 1977, effective May 16, 1977, 7 Pa.B. 1172; amended July 16, 2004, effective July 17, 2004, 34 Pa.B. 3695; amended December 30, 2004, effective January 1, 2005, 35 Pa.B. 14. Immediately preceding text appears at serial pages (304621) to (304623).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.2 Posting of regulations.

A copy of this chapter, as well as the Certificate for Bathing Place, shall be posted conspicuously at the public bathing place for the information of the public.

The provisions of this § 18.2 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921; amended November 29, 1974, effective December 16, 1974, 4 Pa.B. 2453. Immediately preceding text appears at serial page (4790).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.3 Purpose.

The purpose of this chapter is to protect the public health through the proper design, operation and maintenance of public bathing places. The design shall be in accordance with sound engineering practice and shall protect the public health and safety.

The provisions of this § 18.3 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921; amended November 29, 1974, effective December 16, 1974, 4 Pa.B. 2453. Immediately preceding text appears at serial page (4790).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.4 Management of bathing place.

(a) A capable manager or caretaker shall be in charge of public bathing places and shall be responsible for the proper maintenance and use of the public bathing place as provided in the Public Bathing Law (35 P. S. § § 672—680d), the permit issued for the public bathing place and this chapter.

(b) The manager or caretaker shall be responsible for maintaining the public bathing place continually in good repair and in a clean, sanitary and healthful manner so that it does not constitute a menace to public health or promote immorality and is not a public nuisance.

The provisions of this § 18.4 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921; amended November 29, 1974, effective December 16, 1974, 4 Pa.B. 2453. Immediately preceding text appears at serial page (4790).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.5 Sewage disposal.

(a) Sewerage systems serving public bathing places shall be approved by the Department. The approval will be based upon satisfactory compliance with Chapter 73 (relating to standards for onlot sewage disposal facilities) and The Clean Streams Law (35 P. S. § § 691.1—691.1001).

(b) Discharge of filter backwash and other pool wastewater to the waters of this Commonwealth shall be approved in the permit.

The provisions of this § 18.5 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921; amended November 29, 1974, effective December 16, 1974, 4 Pa.B. 2453. Immediately preceding text appears at serial page (4790).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.6 Vector control.

Adequate measures for the control of arthropods and rodents which the Department deems a public health hazard shall be taken in a manner satisfactory to the Department.

The provisions of this § 18.6 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.7 Approval by Department.

A deviation from approved plans or specifications affecting the safety of bathers, treatment process or quality of water shall be approved by the Department in writing before the changes are made. A treatment process or protective measure may not be added to, altered or discontinued without securing appropriate approval from the Department.

The provisions of this § 18.7 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.11 General requirement.

A permit shall be obtained from the Department prior to construction or operation of a public bathing place. When the ownership of the public bathing place changes or if the public bathing place is leased by the owner, it is the responsibility of the new owner or lessee to secure a permit issued in his name.

The provisions of this § 18.11 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921; amended November 29, 1974, effective December 16, 1974, 4 Pa.B. 2453. Immediately preceding text appears at serial page (4791).

This section cited in 28 Pa. Code § 18.14 (relating to guidelines).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.12 Application and accompanying documents.

(a) The application for a permit shall be accompanied by the submission of plans, specifications, designer’s report and other data which may be needed to enable the Department to determine compliance with its requirements.

(b) Drawings, specifications and the report of the designer submitted as part of the application shall be prepared by or under the supervision of a registered professional engineer or registered architect legally qualified to practice in this Commonwealth.

(c) The front cover or flyleaf of each set of drawings, of each copy of the designer’s report, and of the specifications submitted shall bear the signature and the imprint of the seal of the registered engineer or architect by or under whom prepared. Each drawing shall bear an imprint or a legal facsimile of the seal.

The provisions of this § 18.12 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

This section cited in 28 Pa. Code § 18.14 (relating to guidelines).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.13 Application fee.

Each application shall be accompanied by a fee of $10 payable to the ‘‘Commonwealth of Pennsylvania.’’

The provisions of this § 18.13 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

This section cited in 28 Pa. Code § 18.14 (relating to guidelines).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.14 Guidelines.

The Department’s pamphlet, Bathing Place Manual, Bureau of Sanitary Engineering Publication No. 16, may be used as a guide for determining compliance with § § 18.11—18.17 (relating to permits).

The provisions of this § 18.14 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

Condominium swimming pools for private use by the residents are excluded from Department of Environmental Resources’ permit requirements under the Public Bathing Law (35 P. S. § § 672—680d). Nemacolin, Inc. v. Department of Environmental Resources, 541 A.2d 811 (Pa. Cmwlth. 1988).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.15 Issuance.

Construction of public bathing places, additions and alterations may start only upon issuance and receipt of a permit and shall be in compliance with plans, designs and other data approved by the Department.

The provisions of this § 18.15 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

This section cited in 28 Pa. Code § 18.14 (relating to guidelines).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.16 Inspection after completion.

The permittee shall notify the Department at the time of completion of the construction of the public bathing place to permit inspection before the public bathing place is placed in operation.

The provisions of this § 18.16 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921; amended November 29, 1974, effective December 16, 1974, 4 Pa.B. 2453. Immediately preceding text appears at serial page (4792).

This section cited in 28 Pa. Code § 18.14 (relating to guidelines).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.17 Suspension and revocation.

A permit may be suspended or revoked for failure to comply with this chapter.

The provisions of this § 18.17 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

This section cited in 28 Pa. Code § 18.14 (relating to guidelines).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.21 General standard.

The water used at public bathing places for swimming or recreative bathing shall meet the bacteriological, chemical, physical and radiological standards of the Department.

The provisions of this § 18.21 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921; amended November 29, 1974, effective December 16, 1974, 4 Pa.B. 2453. Immediately preceding text appears at (4792).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.22 Circulation.

Water shall be introduced to and withdrawn from the pool in a manner that provides uniform circulation and uniform disinfectant residual throughout the entire pool.

The provisions of this § 18.22 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

This section cited in 28 Pa. Code § 18.23 (relating to recirculation and filtration).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.23 Recirculation and filtration.

(a) A pool shall be provided with a recirculation and filtration system, except when there is a flow of water of the quality and quantity through the pool which at all times conforms to § § 18.22—18.29.

(b) When sand or anthrafilt filters are used, equipment shall be provided capable of continuously adding with reasonable accurate dosage, coagulant ahead of the filters.

The provisions of this § 18.23 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.24 Turnover period.

The turnover period for wading pools may not be longer than 2 hours, and the turnover period for other types of pools may not be longer than 8 hours.

The provisions of this § 18.24 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

This section cited in 28 Pa. Code § 18.23 (relating to recirculation and filtration).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.25 Clarity of the pool.

Water in the pool shall be sufficiently clear to permit a black disc, 6 inches in diameter on a white field, when placed on the bottom of the pool at the deepest point, to be clearly visible from the runway or deck around the deep area of the pool.

The provisions of this § 18.25 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

This section cited in 28 Pa. Code § 18.23 (relating to recirculation and filtration).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.26 Overflow facilities.

Overflow facilities shall be provided and water levels in the pool maintained to effectively remove scum, debris or other floating matter.

The provisions of this § 18.26 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

This section cited in 28 Pa. Code § 18.23 (relating to recirculation and filtration).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.27 Swimming pool contamination.

The water in a swimming pool or wading pool shall be considered contaminated when one of the following conditions exist:

(1) More than one 10-milliliter portion of a sample shows a positive test for coliform organisms when multitube fermentation technique is used or more than one coliform per 50 milliliters when the membrane filter test is used.

(2) Two consecutive samples show a positive test for coliform organisms in any 10-milliliter portion of a sample when the multitube fermentation technique is used or more than one coliform per 50 milliliters when the membrane filter test is used.

(3) Two of any 10 consecutive samples show a positive test for coliform organisms in any of the 10-milliliter portions of a sample when the multitube fermentation technique is used or more than one coliform per 50 milliliters when the membrane filter test is used.

The provisions of this § 18.27 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

This section cited in 28 Pa. Code § 18.23 (relating to recirculation and filtration); and 28 Pa. Code § 18.30 (relating to water samples).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.28 Bathing beach contamination.

(a) Use of a bathing beach found to be contaminated shall be discontinued until written approval to reopen the bathing beach for swimming or bathing is obtained from the Department. The permittee shall prominently post legible signs measuring at least 8" by 11" at all entrances to the bathing beach area informing the public that the bathing beach is closed and that swimming or bathing is prohibited. The approval will be given by the Department when the Department finds that the waters of the bathing beach are no longer contaminated.

(b) The water in bathing beaches will be considered contaminated for bathing purposes when one of the following conditions exists:

(1) The Department determines that a substance is being discharged or may be discharged into the water and is or may be hazardous to the health of persons using the bathing beach.

(2) The E. coli density of a water sample taken from the bathing beach exceeds 235 per 100 milliliters.

(3) The E. coli density in all water samples taken from the bathing beach, in any 30-day period during the bathing beach’s operating season, exceeds a geometric mean of 126 per 100 milliliters.

The provisions of this § 18.28 amended under the Public Bathing Law (35 P. S. § § 672—680d); the Local Health Administration Law (16 P. S. § § 12001—12028); and section 1920-A of The Administrative Code of 1929) (71 P. S. § 510-20).

The provisions of this § 18.28 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921; amended June 19, 1981, effective June 20, 1981, 11 Pa.B. 2133; amended July 16, 2004, effective July 17, 2004, 34 Pa.B. 3695. Immediately preceding text appears at serial pages (216884) to (216885).

This section cited in 28 Pa. Code § 18.23 (relating to recirculation and filtration); and 28 Pa. Code § 18.30 (relating to water samples).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.29 Disinfection of pool water.

(a) When chlorine or a hypochlorite compound is used for disinfection, the free chlorine residual in the water in all parts of the pool when in use shall be at least 0.4 milligram per liter and the pH value of the water shall be at least 7.2 and not more than 8.2.

(b) Other disinfecting materials or methods may be used after approval by the Department when they have been adequately demonstrated to:

(1) Provide a satisfactory residual effect which is easily measured.

(2) Work as effectively as the chlorine concentrations required by subsection (a).

(3) Create no danger to public health, create no objectionable physiological effects, or impart no toxic properties to the water.

(c) Testing kits shall be provided for making the necessary tests for residual disinfection and pH. The kit for disinfectant residual shall be accurate within 0.1 milligram per liter of chlorine or equivalent. The pH kit shall be accurate within 0.2 pH units. When the pool is in use tests shall be made at least twice daily or more often if required by the Department.

The provisions of this § 18.29 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

This section cited in 28 Pa. Code § 18.23 (relating to recirculation and filtration).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.30 Water samples.

(a) The permittee shall be responsible for the collection and examination of samples for the purity of the water used for swimming or bathing. The samples shall be examined by a laboratory which complies with § 18.31 (relating to laboratory testing).

(b) A sample shall be taken within 1 week prior to the opening of the bathing beach for the season.

(c) The permittee shall have a bacteriological analysis made at least once each week of a sample collected during the period of maximum use of the public bathing place. The permittee shall furnish additional analyses of samples as described under subsection (d)(3) upon written notification by the Department.

(d) Bathing water shall be sampled in accordance with the following requirements:

(1) Each sample shall be taken from water that is approximately 30 inches deep and at a midpoint between the bottom and the surface of the water.

(2) Each sample shall be tested individually for E. coli in accordance with § 18.31.

(3) The Department may require additional samples be taken based upon the size of the bathing area, bather loads, weather conditions, the bacteriological history of the water, as well as other factors that may influence the quality of the water.

(e) For a bathing beach located on Lake Erie, the bathing water shall be sampled in accordance with subsections (a), (b) and (d) and the following additional requirements:

(1) At least three samples of water shall be taken from each beach at least once a week. One sample shall be taken from approximately 50 feet from each end of the beach and the third sample shall be taken from the center of the beach.

(2) The arithmetic mean of the three samples from each beach shall be used to determine if the beach water is contaminated using the standards described in § 18.28 (relating to bathing beach contamination).

(3) A sample may not be taken when the beach is closed due to high wave activity, but shall be taken the day the beach is reopened for swimming and bathing.

(4) The Erie County Department of Health may impose additional requirements that are equal to or more stringent than the requirements of this section.

(f) For a swimming pool, specialty pool, spa and hot tub the bathing water shall be sampled at least once a week from the area of average depth, in accordance with § 18.27 (relating to swimming pool contamination).

(g) Copies of reports of analyses shall be maintained by the permittee for at least 2 years and made available to the Department upon request.

(h) The laboratory conducting the bacteriological testing shall report test results exceeding the criteria specified in § § 18.27 and 18.28 to the appropriate district office of the Department or the local health department within 24 hours of the availability of the laboratory result.

The provisions of this § 18.30 amended under the Public Bathing Law (35 P.S. § § 672—680d); the Local Health Administration Law (16 P.S. § § 12001—12028); and section 1920-A of The Administrative Code of 1929) (71 P.S. § 510-20).

The provisions of this § 18.30 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921; amended November 29, 1974, effective December 16, 1974, 4 Pa.B. 2453; amended July 16, 2004, effective July 17, 2004, Pa.B. 3695. Immediately preceding text appears at serial pages (216885) to (216886).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.31 Laboratory testing.

(a) Testing and analysis of water samples shall be performed by competent personnel at a drinking water environmental laboratory that is required to register with the Department of Environmental Protection and is in compliance with 27 Pa.C.S. Chapter 41 (relating to environmental laboratory accreditation), known as the Environmental Laboratory Accreditation Act, and the regulations promulgated thereunder. Testing of the water samples shall be performed in accordance with the procedure provided in the Standard Methods for the Examination of Water and Wastewater, 20th edition, published jointly by the American Public Health Association and the American Water Works Association, as amended, or in accordance with any other method approved by the United States Environmental Protection Agency for the testing of E. coli in water samples taken from waters designated for primary contact recreation.

(b) The laboratory shall document the method used to complete the tests of the water samples and make the documentation available to the Department upon request.

The provisions of this § 18.31 amended under the Public Bathing Law (35 P.S. § § 672—680d); the Local Health Administration Law (16 P.S. § § 12001—12028); and section 1920-A of The Administrative Code of 1929) (71 P.S. § 510-20).

The provisions of this § 18.31 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921; amended July 16, 2004, effective July 17, 2004, 34 Pa.B. 3695. Immediately preceeding text appears at serial page (216886).

This section cited in 28 Pa. Code § 18.30 (relating to water samples).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.32 Records of tests.

Daily records of tests and of the operation of the public bathing place shall be kept on forms satisfactory to the Department and copies thereof shall be filed monthly, or more often if required, with the appropriate office of the Department or county health department.

The provisions of this § 18.32 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921; amended November 29, 1974, effective December 16, 1974, 4 Pa.B. 2453. Immediately preceding text appears at serial page (4796).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.41 Reduction of hazards.

Construction, equipment, operation and maintenance at public bathing places shall be such as to reduce to a practical minimum the danger of injury to persons from drowning, falls, collisions, fires, nuisances or hazard of any kind.

The provisions of this § 18.41 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921; amended November 29, 1974, effective December 16, 1974, 4 Pa.B. 2453. Immediately preceding text appears at serial page (4796).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.42 Certified lifeguards.

(a) Recognized lifeguard certifying authorities.

(1) Organizations that intend to qualify as certifying authorities shall submit materials, on an annual basis, to the Department to establish that their lifeguard training courses satisfy the criteria in subsection (b).

(2) The materials shall be submitted to the Department on or before June 30 of each year and shall include a completed form entitled ‘‘Application for Recognition as a Lifeguard Certifying Authority’’ in the submission.

(3) This form is available from the Department.

(4) The Department will publish a list of approved certifying authorities annually, on or before December 1 of each year, in the Pennsylvania Bulletin.

(b) Requirements for a lifeguard certifying authority. The Department will consider approval of a lifeguard certifying authority if the certifying authority’s lifeguard training course satisfies the following requirements:

(1) The course is conducted pursuant to a written training plan, instructor’s manual and text book.

(2) The course provides for confirmation of course completion for certification in cardiopulmonary resuscitation.

(3) The course provides for certification in first aid.

(4) The course includes a system for evaluating swimming ability.

(5) The course provides for instruction in lifeguarding responsibilities.

(6) The course provides a method for testing and certification.

(7) The course includes a certificate which expires, in no longer than 3 years, if renewal criteria are not satisfied.

(8) The instructors of the course have successfully completed a training course that includes:

(i) Certification in lifeguard instruction.

(ii) Student evaluation.

(iii) Program planning.

(iv) Cardiopulmonary resuscitation.

(v) Conducting practice first aid and rescue sessions.

(c) Required number of lifeguards. A recreational swimming establishment shall have on duty an adequate number of certified lifeguards to protect the safety of users. To ensure an adequate number of certified lifeguards, the operator of a recreational swimming establishment shall comply with the following requirements:

(1) At least one certified lifeguard for every 4,000 square feet of water surface area, plus one certified lifeguard for any fraction thereof, equal to or greater than 1,000 square feet, shall be on duty at the waterside at all times the recreational swimming establishment is open to use by bathers for general swim purposes. At no time may there be less than two certified lifeguards present and available to aid bathers when the recreational swimming establishment is open to the general public for recreational swimming.

(i) The water surface area means the total surface area of water accessible to the bathers, including any wading pools.

(ii) The operator may reduce the water surface area by closing portions of the swimming area with a rope and float line, provided that the operator maintains adequate notification and supervision to prevent patrons from entering the closed portions of the swimming area. For the purposes of this section, ‘‘adequate’’ means sufficient to accomplish the task, but it does not require any additional certified lifeguards above the minimum number established in this section.

(iii) Under circumstances when the ability of a certified lifeguard to survey 4,000 square feet of water surface area is impaired, such as when the size or shape, or both, of the recreational swimming establishment prevents the certified lifeguard from monitoring the assigned area from a designated location, the Department may require additional certified lifeguards to assure the safety of the bathers.

(2) The bather load of the recreational swimming establishment may not exceed the maximum bather load as defined in the permit application.

(3) During periods when swim meets, swim team practices, learn-to-swim programs, lifeguard training, or other special events in which the use of the recreational swimming establishment is restricted to only those persons participating in the special events, at least one certified lifeguard, whose sole duty is to protect the bathers, shall be present at waterside during the event.

(4) When a wading pool is open to the public, the certified lifeguard shall have an unobstructed view of the entire wading pool from a certified lifeguard’s assigned station. If the certified lifeguard does not have an unobstructed view, an additional certified lifeguard shall be on duty to guard only the wading pool.

(5) If the recreational swimming establishment has a diving board or water slide, a certified lifeguard shall be on duty to monitor the diving well or catch area when the diving board or water slide is open to the public.

(i) The certified lifeguard shall be stationed within 50 feet of the diving well or slide catch area.

(ii) If the swimming area includes both a diving well and slide catch area, or the recreational swimming establishment has multiple slides or diving boards, the operator may not assign a certified lifeguard to monitor both areas unless that lifeguard is stationed within 50 feet of each and can monitor both areas simultaneously.

(iii) If the diving well or slide catch area is physically separated from the main swimming area, a certified lifeguard shall be assigned to monitor the diving well or slide catch area exclusively, and the operator shall exclude the water surface area of the diving well or slide catch area from the water surface area of the recreational swimming establishment for the purpose of determining the number of additional certified lifeguards required under paragraph (1).

(6) While on duty to watch bathers, a certified lifeguard may not be assigned other tasks which may divert attention from the safety of the bathers, or which are outside the lifeguard’s training and certification.

(d) Violation of certified lifeguard requirement. The Department may order to be closed to the public any recreational swimming establishment that it finds to be in violation of any of the provisions of subsection (c), until the Department has done the following:

(1) Performed a follow-up inspection.

(2) Found that the facility has met the requirements of subsection (c).

(3) Provided that facility with written authorization to reopen.

The provisions of this § 18.42 amended under the Public Bathing Law (35 P.S. § § 672—680d).

The provisions of this § 18.42 amended November 29, 1974, effective December 16, 1974, 4 Pa.B. 2453; amended December 30, 2004, effective January 1, 2005, 35 Pa.B. 14; amended September 15, 2023, effective September 16, 2023, 53 Pa.B. 5757. Immediately preceding text appears at serial pages (308854) to (308857) and (304633).

Parents of handicapped student who drowned in an unguarded pool failed to satisfy ‘‘dangerous condition of realty’’ exception to governmental immunity absent showing artificial condition or defects of land itself. Musheno v. Lock Haven University of Pennsylvania, 574 A.2d 129 (Pa. Cmwlth. 1990).

The Supreme Court affirmed the Commonwealth Court unreported opinion and order on motions for judgment on the pleadings which declared 25 Pa. Code § 193.42 (later redesignated 28 Pa. Code § 18.42) invalid and beyond the power granted to the Department of Environmental Resources. Spooner v. Secretary of Commonwealth, 574 A.2d 600 (Pa. 1990).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.43 Lifesaving equipment.

The following minimum lifesaving and first aid equipment shall be provided and shall be readily available for emergency use at each public bathing place:

(1) Reaching devices. One or more reaching devices. These devices may include, but are not limited to, poles, ropes and reasonable means to extend a person’s reach.

(2) Flotation devices. One or more buoys, life jackets or flotation devices that can support an adult in water.

(3) First aid kit. A standard 24-unit first aid kit, filled and readily accessible for emergency use.

The provisions of this § 18.43 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921; amended June 19, 1981, effective June 20, 1981, 11 Pa.B. 2133. Immediately preceding text appears at serial page (18984).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.44 Gas chlorination equipment.

If gas chlorination equipment is installed at either outdoor or indoor pools, the equipment shall be housed in a separate room equipped with an exhaust fan to reduce to a minimum the possibility of gas leakage into other rooms or areas where persons gather.

The provisions of this § 18.44 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.45 Gas masks.

(a) Where gas chlorination equipment is installed, a gas mask designed for use in a chlorine atmosphere and of a type approved by the National Institute of Occupational Safety and Health; Parklawn Building; 5600 Fisher Lane; Rockville, Maryland 20852 shall be provided.

(b) A replacement cannister shall be provided with the gas mask.

(d) The gas mask shall be kept in a closed cabinet, accessible without a key, located outside the room in which the chlorinator is maintained.

The provisions of this § 18.45 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921; amended June 19, 1981, effective June 20, 1981, 11 Pa.B. 2133. Immediately preceding text appears at serial page (18985).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.51 General.

The common use of drinking cups, towels, hairbrushes or other toilet articles is prohibited.

The provisions of this § 18.51 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.52 Employe health.

A person having a disease in a stage which is communicable or likely to become so, may not be employed at a public bathing place.

The provisions of this § 18.52 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.53 Bather health.

Persons with signs of illness or disease or with skin rashes or sores or with bandages shall be excluded from public bathing places, except when certified by a physician not to have a disease in a communicable stage.

The provisions of this § 18.53 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.54 Bathing suits and towels.

Bathing suits and towels furnished to bathers shall be thoroughly cleaned and dried each time they are used in a manner that precludes the transmission of disease, and they shall be stored in a clean and sanitary manner.

The provisions of this § 18.54 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.55 Food.

If food service is provided, the food service facilities and operations shall comply with 7 Pa. Code Chapter 78 (Reserved).

The provisions of this § 18.55 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.56 Water.

(a) Water used for drinking, food preparation, cleaning or personal hygiene purposes at public bathing places shall be provided from a supply approved by the Department. The approval shall be based upon satisfactory compliance with the construction standards for water supplies approved by the Department and the following:

(1) The water supply shall be adequate in quantity and shall meet the bacteriological and chemical water standards of the Department.

(2) An unapproved water supply shall be made inaccessible to the public in a manner deemed satisfactory to the Department.

(b) Drinking water facilities shall be provided at public bathing places.

The provisions of this § 18.56 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921; amended November 29, 1974, effective December 16, 1974, 4 Pa.B. 2453. Immediately preceding text appears at serial page (4799).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.61 Requirement.

Adequate bather preparation facilities shall be available to users of the public bathing place.

The provisions of this § 18.61 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921; amended November 29, 1974, effective December 16, 1974, 4 Pa.B. 2453. Immediately preceding text appears at serial page (4799).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.62 Dressing and toilet facilities.

Bather preparation facilities shall be provided with separate dressing facilities, showers, lavatories, toilets and appurtenances for each sex unless the facilities are otherwise readily available to users of the public bathing place, except that dressing facilities and showers may not be required at bathing beaches.

The provisions of this § 18.62 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921; amended November 29, 1974, effective December 16, 1974, 4 Pa.B. 2453. Immediately preceding text appears at serial page (4799).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.63 Construction and sanitation.

Bather preparation facilities shall be designed and constructed so that good sanitation may be maintained throughout the building at all times and so that injury to the bather is reduced to a practical minimum.

The provisions of this § 18.63 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.64 Walls and floors.

Interior walls and floors shall be surfaced with material which is readily cleanable and the floors drained to prevent standing water.

The provisions of this § 18.64 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.65 Lighting.

Sufficient lighting shall be provided to promote cleanliness.

The provisions of this § 18.65 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.66 Ventilation and heating.

Ventilation and heating shall be such as to provide for the comfort of the bather.

The provisions of this § 18.66 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.71 Plumbing.

Plumbing shall be sized, installed and maintained to carry adequate quantities of water to required locations throughout the public bathing place, to prevent contamination of the water supply, to properly convey sewage and liquid wastes from the establishment to the sewerage or sewage disposal system and to prevent creation of an unsanitary condition or nuisance.

The provisions of this § 18.71 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921; amended November 29, 1974, effective December 16, 1974, 4 Pa.B. 2453. Immediately preceding text appears at serial page (4800).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.72 Cross connections.

(a) Cross connections are not permitted.

(b) A cross connection is considered broken if a minimum air gap of at least twice the diameter of the water pipe is provided where potable water enters the pool and where pool water or water from the recirculation system is discharged to a sewer system.

The provisions of this § 18.72 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.73 Backflow prevention.

(a) Backflow is not permitted. A potable water distributing pipe is considered as protected against backflow from a plumbing fixture or other piece of equipment or from an appliance capable of affecting the quality of the water in the potable water supply where an air gap of at least twice the diameter of the water supply pipe has been provided.

(b) Where it is not practicable to provide the minimum air gap, the connection to the fixture, equipment or appliance shall be equipped with a backflow preventer assembly of a type and at a location approved by the Department.

(c) The Department may require that a backflow preventer assembly of a type and location approved by the Department be installed at a fixed potable water outlet to which a hose may be connected and used in contact with liquids or other substances.

The provisions of this § 18.73 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.81 General requirements.

Except where otherwise noted, the following requirements apply to electrical equipment and wiring at public bathing places:

(1) The installation and subsequent addition to or modification of electrical equipment or wiring at bathing beaches shall comply with and be maintained in accordance with the requirements of the edition of the National Electrical Code in effect at the time of the installation, addition or modification.

(2) The installation and subsequent addition to or modification of electrical equipment and wiring at swimming pools shall comply with and be maintained in accordance with the requirements of the edition of the National Electrical Code in effect at the time of the installation, addition or modification, provided that installation, modification or addition of electrical equipment and wiring occurring prior to 1962 shall comply with and be maintained in accordance with the 1962 National Electrical Code.

The provisions of this § 18.81 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921; amended November 29, 1974, effective December 16, 1974, 4 Pa.B. 2453; amended April 29, 1977, effective May 16, 1977, 7 Pa.B. 1172. Immediately preceding text appears at serial page (18988).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.82 Underwater lights.

(a) Underwater lights in swimming pools, regardless of the installation date, shall comply with the requirements for underwater lights contained in the 1975 edition of the National Electrical Code.

(b) The permittee shall provide for proper inspection of underwater lights, including, where requested by the inspection agency, draining of the pool.

(c) If electrical defects in the underwater lights are noted by the inspection agency, the lights shall be disconnected immediately and shall be repaired or removed within 30 days of the notice.

The provisions of this § 18.82 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921; amended April 29, 1977, effective May 16, 1977, 7 Pa.B. 1172. Immediately preceding text appears at serial page (18988).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.83 Wiring.

Electrical wiring, where exposed and accessible to bathers, shall be in rigid conduit or electrical metallic tubing, and boxes, fittings and accessories used in damp or wet locations shall be installed and equipped in a manner that prevents the entrance of water.

The provisions of this § 18.83 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.84 Distribution centers.

Distribution centers, where fused switches or circuit breakers are grouped, shall be enclosed and located so that they are accessible only to authorized persons.

The provisions of this § 18.84 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.85 Overhead conductors.

(a) The crossing of outdoor public bathing places by open overhead electrical conductors is prohibited.

(b) Overhead electrical conductors crossing playgrounds contiguous to outdoor public bathing places shall comply with the requirements of the National Electrical Safety Code.

The provisions of this § 18.85 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921; amended November 29, 1974, effective December 16, 1974, 4 Pa.B. 2453. Immediately preceding text appears at serial page (18988).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.86 Grounding requirements.

(a) Grounding shall conform with the following:

(1) Metal fences or railings on which a broken electrical conductor might fall shall be effectively grounded.

(2) A driven ground rod shall be placed at two locations close to and on either side of each crossing.

(3) A ground shall be provided for parallel exposure, near each end of the exposure and at intervals of not more than 300 feet within the exposure.

(b) Water and other piping to and from the public bathing place, including inlet and outlet pipes, shall be metallically bonded together and adequately connected to the same grounding electrode used to ground the neutral conductor of the electrical system. This shall be in addition to the grounding requirements for electrical equipment and circuits as required by the National Electrical Code.

The provisions of this § 18.86 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.87 Location of equipment.

(a) Pumps, filters and other mechanical and electrical equipment shall be enclosed to be accessible only to authorized persons.

(b) Construction and drainage shall avoid the entrance of and accumulation of water in the vicinity of the electrical equipment.

The provisions of this § 18.87 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.88 Inspection of installations.

The electrical installations at public bathing places, and future additions or modifications to the installations, prior to being placed in service and every 3 years thereafter, shall be inspected and approved in accordance with this chapter by an electrical inspection agency acceptable to the Department and evidence, in duplicate, of the approval by this agency forwarded to the appropriate office of the Department.

The provisions of § 18.88 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921; amended November 29, 1974, effective December 16, 1974, 4 Pa.B. 2453; amended April 29, 1977, effective May 16, 1977, 7 Pa.B. 1172. Immediately preceding text appears at serial page (18989).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.91 Collection.

The collection of garbage and refuse shall be conducted in a sanitary manner and as often as necessary in order to prevent a nuisance.

The provisions of this § 18.91 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.92 Storage.

(a) Garbage and refuse containing food wastes shall, prior to disposal, be kept in leak-proof, nonabsorbent, rust and corrosion-resistant containers of adequate number, which shall be kept covered with tight-fitting lids, when filled or stored or not in continuous use, but any other manner of garbage and refuse storage may be used if approved by the Department.

(b) Other refuse shall be stored in containers, rooms or areas of sufficient numbers and size in a manner so as to prevent arthropod or rodent problems and other nuisances.

The provisions of this § 18.92 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.93 Disposal.

If disposal of garbage or refuse is accomplished within or upon the premises of the public bathing place, the disposal facilities shall be operated and maintained in a manner that does not create a nuisance or a health hazard.

The provisions of this § 18.93 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921; amended November 29, 1974, effective December 16, 1974, 4 Pa.B. 2453. Immediately preceding text appears at serial page (14142).

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 18.94 Cleaning of area.

Adequate cleaning facilities shall be provided, and each container, room or area, shall be thoroughly cleaned after each emptying or removal of garbage and refuse.

The provisions of this § 18.94 adopted September 18, 1971, effective September 18, 1971, 1 Pa.B. 1921.

History

Authority: The provisions of this Chapter 18 issued under the Public Bathing Law (35 P.
Source: The provisions of this Chapter 18 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

Chapter 19 Organized Camps and Campgrounds

28 Pa. Code § 19.1 Definitions.

The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise: Campground—A portion of land used for the purpose of providing a space or spaces for trailers or tents, for camping purposes regardless of whether a fee has been charged for the leasing, renting or occupancy of the space. Garbage—Putrescible wastes, except sewage and body waste, including animal and vegetable offal. Organized camp—A combination of programs and facilities established for the primary purpose of providing an outdoor group living experience for children, youth and adults, with social, recreational and educational objectives and operated and used for 5 or more consecutive days during one or more seasons of the year. Person—An individual, firm, partnership, company, corporation, trustee, association, county, authority, the Commonwealth or a public or private entity. Refuse—Nonputrescible wastes generally regarded and classified as rubbish, trash, junk and similar designations which have been rejected by the owner or possessor as useless or worthless. Sanitary station—A facility used for disposing of sewage from trailer holding tanks. Sewage—A substance which contains any of the waste products or excrementitious or other discharge from the bodies of human beings or animals. Sewerage system—A community or individual system, publicly or privately owned, for the collection and disposal of sewage and industrial wastes of a liquid nature, including various devices for the treatment of the sewage or industrial wastes. Tent—A portable lodging unit usually made of skins, canvas, plastic or strong cloth stretched and usually sustained by poles, and dependent upon separate toilet and lavatory facilities. Trailer—A vehicular portable structure built on, or designed to be mounted, on a chassis or wheels, or constructed as an integral part of a self-propelled vehicle for use as a temporary dwelling for travel, recreation and vacation and commonly known as travel trailers, pick-up coaches, motor homes or camping trailers. Trailer or tent space—A parcel of land in an organized camp or campground for the placement of a single trailer or tent and the exclusive use of its occupants. Water supply—A source of water, and water treatment, storage, transmission and distribution facilities.

History

Authority: The provisions of this Chapter 19 issued under sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 19 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 19.2 Submission of plans to Department.

(a) Before work is begun in the construction, remodeling or alteration of an organized camp or campground or in the conversion of an existing establishment or facility to an organized camp or campground, properly prepared plans and specifications shall be submitted to and approved by the Department.

(b) The plans and specifications shall include, if applicable, data relating to the grounds, buildings, equipment, sewage disposal, water supply, including plumbing, refuse disposal and other information that may be required by the Department.

History

Authority: The provisions of this Chapter 19 issued under sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 19 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 19.3 Waiver of requirements.

The Department may waive compliance with one or more provisions of this chapter for specific events as long as the lives and health of the public or the persons on the premises will not be adversely affected thereby.

History

Authority: The provisions of this Chapter 19 issued under sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 19 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 19.4 Water supply.

(a) Water used in the operation of an organized camp or campground shall be provided from a supply approved by the Department. Approval of a water supply shall be based upon satisfactory compliance with construction standards for water supplies approved by the Department.

(b) The water supply shall be adequate in quantity and shall meet the bacteriological and chemical water standards of the Department.

(c) An unapproved water supply shall be made inaccessible to the public in a manner deemed satisfactory to the Department.

History

Authority: The provisions of this Chapter 19 issued under sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 19 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 19.5 Plumbing.

(a) Plumbing shall be sized, installed and maintained so as to carry adequate quantities of water to required locations throughout the organized camp or campground and to properly convey sewage and liquid wastes from the establishment of the sewerage or sewage disposal system.

(b) Plumbing shall serve to prevent contamination of the water supply and may not create an insanitary condition or nuisance.

History

Authority: The provisions of this Chapter 19 issued under sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 19 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 19.6 Sewage disposal.

Sewage disposal systems serving an organized camp or campground shall be approved by the Department. Approval shall be based upon satisfactory compliance with Chapter 73 (relating to standards for sewage disposal facilities) and The Clean Streams Law (35 P. S. § 691.1—691.1001).

History

Authority: The provisions of this Chapter 19 issued under sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 19 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 19.7 Bathing places.

The construction, modification, maintenance and operation of a bathing place in an organized camp or campground shall be subject to the provisions of the Public Bathing Law (35 P. S. § 672—680d) and the rules and regulations of the Department.

History

Authority: The provisions of this Chapter 19 issued under sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 19 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 19.8 Vector control.

Adequate measures for the control of arthropods and rodents which the Department deems a public health hazard shall be taken in a manner satisfactory to the Department.

History

Authority: The provisions of this Chapter 19 issued under sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 19 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 19.11 General requirement.

A person may not operate at a place within this Commonwealth, and a person may not permit to be operated on his premises within this Commonwealth, an organized camp or campground unless the operator or owner possesses a valid permit from the Department. The permit shall be in addition to the registration requirements of organized camps under act of November 10, 1959 (P. L. 1400, No. 497) (35 P. S. § § 3001—3004).

History

Authority: The provisions of this Chapter 19 issued under sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 19 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 19.12 Application.

Application for a permit shall be made to the Department on forms provided by the Department.

History

Authority: The provisions of this Chapter 19 issued under sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 19 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 19.13 Issuance.

(a) The Department will issue a permit for the operation of an organized camp or campground if it is satisfied that this chapter has been met.

(b) The permit shall be valid for 1 calendar year from date of issuance unless revoked or suspended by the Department.

(c) A separate permit shall be issued for each organized camp site or campground and may not be transferable or assignable.

History

Authority: The provisions of this Chapter 19 issued under sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 19 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 19.14 Revocation and suspension.

(a) A permit may be revoked or suspended at any time if the Department finds that the organized camp or campground is maintained, operated or occupied in violation of this chapter.

(b) The Department may order an organized camp or campground to close and cease operation if a situation is present which is inimical to the health of the occupants.

History

Authority: The provisions of this Chapter 19 issued under sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 19 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 19.21 General requirement.

Organized camps and campgrounds shall provide toilet facilities on the premises for the public which are separate for each sex.

History

Authority: The provisions of this Chapter 19 issued under sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 19 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 19.22 Design.

Toilet facilities, including rooms and fixtures, shall be of a sanitary design and readily cleanable.

History

Authority: The provisions of this Chapter 19 issued under sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 19 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 19.23 Maintenance.

Toilet facilities shall be kept in a clean condition and in good repair.

History

Authority: The provisions of this Chapter 19 issued under sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 19 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 19.24 Toilet room.

Each toilet room shall meet the following requirements:

(1) Doors shall be self-closing.

(2) Adequate ventilation to the outside shall be provided.

(3) Toilet tissue shall be provided.

(4) Easily cleanable receptacles shall be provided for waste materials.

(5) Receptacles for women shall be covered.

History

Authority: The provisions of this Chapter 19 issued under sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 19 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 19.25 Organized camps.

(a) Toilet facilities in organized camps shall be provided in the ratios indicated in the following table:

(b) Urinals for males or urinals specifically designed for females may be provided in lieu of toilet seats but may not consist of more than 1/3 of the required number of toilet seats.

(c) Organized camps which do not provide overnight lodging and serve a minimum of one meal per day are not subject to the requirements in subsection (a) but shall provide toilet and lavatory facilities as deemed adequate by the Department.

History

Authority: The provisions of this Chapter 19 issued under sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 19 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 19.26 Campgrounds.

(a) Toilet facilities in campgrounds shall be in addition to the requirements for sanitary stations as indicated in § § 19.31—19.34 (relating to sanitary stations) and shall be provided in the ratios indicated in the following table:

(b) Urinals specifically designed for females may also be provided in lieu of toilet seats, but for not more than 1/3 of the required number of toilet seats.

History

Authority: The provisions of this Chapter 19 issued under sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 19 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 19.27 Soap and towels.

(a) Lavatories in new and existing organized camps and campgrounds where campers do not provide their own soap and individual towels, soap and single-service towels shall be provided.

(b) The use of a common towel is prohibited.

History

Authority: The provisions of this Chapter 19 issued under sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 19 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 19.31 General requirement.

New organized camp or campground operations which provide parking spaces for trailers shall provide sanitary stations in order that the removal and disposing of sewage from trailer holding tanks shall be accomplished in a sanitary manner.

This section cited in 28 Pa. Code § 19.26 (relating to campgrounds).

History

Authority: The provisions of this Chapter 19 issued under sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 19 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 19.32 Ratio.

Each new organized camp or campground shall provide a sanitary station in the ratio of one for every 100 trailer spaces or fractional part thereof.

This section cited in 28 Pa. Code § 19.26 (relating to campgrounds).

History

Authority: The provisions of this Chapter 19 issued under sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 19 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 19.33 Construction.

Each sanitary station shall consist of at least the following:

(1) A 4-inch sewer pipe which shall be connected to an approved sewage disposal system, surrounded at the inlet end by a concrete apron sloped to the drain.

(2) A suitable fly-tight cover which shall be provided to the 4-inch sewer pipe.

(3) A water outlet, with the necessary appurtenances and connected to a water supply system to permit a washdown of the immediate adjacent areas after each use.

This section cited in 28 Pa. Code § 19.26 (relating to campgrounds).

History

Authority: The provisions of this Chapter 19 issued under sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 19 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 19.34 Public warning.

Each water outlet used for washdown purposes at sanitary stations shall conspiciously display at all times a sign stating: ‘‘Notice, This Water For Flushing and Cleaning Purposes Only.’’

This section cited in 28 Pa. Code § 19.26 (relating to campgrounds).

History

Authority: The provisions of this Chapter 19 issued under sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 19 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 19.41 Collection.

The collection of garbage and refuse shall be conducted in a sanitary manner and as often as necessary to prevent a nuisance.

History

Authority: The provisions of this Chapter 19 issued under sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 19 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 19.42 Storage.

(b) Other refuse shall be stored in containers, rooms or areas of sufficient number and size in a manner so as to prevent arthropod or rodent problems and other nuisances.

History

Authority: The provisions of this Chapter 19 issued under sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 19 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 19.43 Disposal.

When disposal of garbage or refuse is accomplished within or upon the premises of the organized camp or campground, the disposal facilities shall be operated and maintained so as not to create a nuisance or a health hazard.

History

Authority: The provisions of this Chapter 19 issued under sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 19 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

28 Pa. Code § 19.44 Cleaning of area.

Adequate cleaning facilities shall be provided, and each container, room or area shall be thoroughly cleaned after each emptying or removal of garbage and refuse.

History

Authority: The provisions of this Chapter 19 issued under sections 1917-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 19 adopted September 18, 1971, effective September 18, 1971, 1 Pa.

Chapter 20 Tenement, Lodging and Boarding Houses

28 Pa. Code § 20.1 Definitions.

The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise: Boarding house—A building or portion of a building occupied for human habitation in which five or more persons, not related to the proprietor or manager, are furnished with meals and lodging. Garbage—Putrescible wastes, except sewage and body waste, including animal and vegetable offal. Lodging house—A building or portion thereof in which five or more persons, not related to the proprietor or manager, are furnished with sleeping accommodations and shall include rooming houses, bachelor apartments, dormitories, barracks, bunk houses and other kinds of buildings used to furnish sleeping accommodations. Refuse—Nonputrescible wastes generally regarded and classified as rubbish, trash, junk and similar designations which have been rejected by the owner or possessor as useless or worthless. Sewage—A substance which contains the waste products or excrementitious or other discharge from the bodies of human beings or animals. Tenement house—A house or building, or portion thereof, which is intended or designed to be occupied or leased for occupation, or actually occupied, as a home or residence for three or more families, living in separate apartments and doing their cooking upon the premises and shall include apartment houses, apartment hotels and flats. Water supply—A source of water, and other water treatment, storage, transmission and distribution facilities.

History

Authority: The provisions of this Chapter 20 issued under sections 1919-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 20 adopted September 18, 1971, effective September 19, 1971, 1 Pa.

28 Pa. Code § 20.2 Scope.

This chapter applies to a building or portion of a building hereafter erected or altered and subsequently used as a tenement, lodging or boarding house in second and third class cities, boroughs, towns and townships of the first and second class of this Commonwealth.

History

Authority: The provisions of this Chapter 20 issued under sections 1919-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 20 adopted September 18, 1971, effective September 19, 1971, 1 Pa.

28 Pa. Code § 20.3 Responsibility of the owner.

The owner of a tenement, lodging or boarding house or the authorized agent of the owner, shall keep the entire building in repair including the plumbing, lighting, heating and ventilating systems, and shall also keep the entire building in a cleanly condition, free from an accumulation of dirt, garbage or other refuse matter.

History

Authority: The provisions of this Chapter 20 issued under sections 1919-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 20 adopted September 18, 1971, effective September 19, 1971, 1 Pa.

28 Pa. Code § 20.4 Responsibility of the tenant.

The tenant or other lessee of a tenement house shall keep in a clean condition, free from any accumulation of dirt, garbage or refuse matter, the portion of the tenement house occupied or used exclusively by the tenant or other lessee.

History

Authority: The provisions of this Chapter 20 issued under sections 1919-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 20 adopted September 18, 1971, effective September 19, 1971, 1 Pa.

28 Pa. Code § 20.11 General requirement.

Tenement, lodging and boarding houses shall be provided with an adequate quantity of pure and wholesome water for the use of the occupants.

History

Authority: The provisions of this Chapter 20 issued under sections 1919-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 20 adopted September 18, 1971, effective September 19, 1971, 1 Pa.

28 Pa. Code § 20.12 Source.

(a) Where water is obtained from a public waterworks system approved by the required State authorities, it shall be distributed by means of pipes as required.

(b) Where water is obtained from a private source, such as a well, spring or cistern, the source may not be polluted or contaminated nor may it be situated, constructed or maintained in such manner that it may become polluted or contaminated or rendered injurious to health.

History

Authority: The provisions of this Chapter 20 issued under sections 1919-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 20 adopted September 18, 1971, effective September 19, 1971, 1 Pa.

28 Pa. Code § 20.13 Location.

(a) Tenement houses. In tenement houses, each family shall be provided with a water supply for its separate use.

(b) Lodging and boarding houses. In lodging and boarding houses, if the rooms are not arranged in suites or groups provided with separate water supply and if the water is distributed by means of pipes there shall be at least one stationary washstand for each six occupants or fraction of six occupants.

History

Authority: The provisions of this Chapter 20 issued under sections 1919-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 20 adopted September 18, 1971, effective September 19, 1971, 1 Pa.

28 Pa. Code § 20.21 General requirement.

Tenement, lodging and boarding houses shall be provided with adequate and sanitary toilet facilities for the disposal of the excreta of the occupants but the facilities may not be located in a room used for living or sleeping purposes or in which food is prepared or handled.

History

Authority: The provisions of this Chapter 20 issued under sections 1919-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 20 adopted September 18, 1971, effective September 19, 1971, 1 Pa.

28 Pa. Code § 20.22 Sewer connections.

(a) Where the tenement, lodging or boarding house is accessible to a public sewer from which sewage is lawfully discharged, the tenement, lodging or boarding house shall be provided with water closet facilities which discharge to such sewer.

(b) Where the tenement, lodging or boarding house is not accessible to a public sewer, the means for excreta or sewage disposal shall be constructed and maintained in compliance with the provisions of Chapter 73 (relating to standards for sewage disposal facilities).

History

Authority: The provisions of this Chapter 20 issued under sections 1919-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 20 adopted September 18, 1971, effective September 19, 1971, 1 Pa.

28 Pa. Code § 20.23 Number.

(a) Flush toilets. One water flushed toilet or privy seat for common or general use of the occupants of a lodging or boarding house, shall be provided for each 12 persons or fraction of 12 persons.

(b) Urinals. One urinal or 24 inches of urinal trough for the use of men may be provided. Where the urinals are installed, the required number of water-flushed toilets or privy seats may be reduced by 1/3.

History

Authority: The provisions of this Chapter 20 issued under sections 1919-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 20 adopted September 18, 1971, effective September 19, 1971, 1 Pa.

28 Pa. Code § 20.24 Location.

(a) Family area. In tenement houses, each suite or group of rooms occupied by a family shall be provided with separate toilet facilities.

(b) Commercial area. Where the upper portion of a building is used as a tenement, lodging or boarding house and the lower portion is used for commercial or business purposes, toilet facilities for the use of the occupants of the upper portion shall be separate and independent from any toilet facilities provided for the use of the employes of the commercial or business establishment.

History

Authority: The provisions of this Chapter 20 issued under sections 1919-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 20 adopted September 18, 1971, effective September 19, 1971, 1 Pa.

28 Pa. Code § 20.31 General requirement.

In existing buildings the required ventilation and light shall be obtained by windows, opening directly to or communicating with the outside air, but in buildings hereafter erected the required ventilation and light shall be obtained solely by windows opening directly to the outside air.

History

Authority: The provisions of this Chapter 20 issued under sections 1919-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 20 adopted September 18, 1971, effective September 19, 1971, 1 Pa.

28 Pa. Code § 20.32 Living and sleeping areas.

(a) Rooms for living or sleeping purposes in tenement, lodging or boarding houses shall have ample ventilation and natural light and shall have windows with a sash so constructed and maintained that it may be easily opened.

(b) Rooms used for sleeping purposes in any tenement, lodging or boarding house shall provide the following minimum requirements per occupant:

(1) Rooms with window area in one wall shall have a 12 square feet window area, a 70 square feet floor area and a 600 cubic feet air space.

(2) Rooms with window area in two walls at right angles to each other shall have a 10 square feet window area, a 60 square feet floor area and a 560 cubic feet air space.

(3) Rooms with window area in two walls opposite each other shall have an 8 square feet window area, a 50 square feet floor area and a 520 cubic feet air space.

(4) Rooms with window area in three or more walls shall have a 6 square feet window area, a 40 square feet floor area and a 480 cubic feet air space.

(c) A cellar, basement or lower story may not be used for living or sleeping purposes if there is evidence of undue dampness.

History

Authority: The provisions of this Chapter 20 issued under sections 1919-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 20 adopted September 18, 1971, effective September 19, 1971, 1 Pa.

28 Pa. Code § 20.33 Bath and toilet areas.

Bathrooms, toilet rooms and water closet compartments in tenement, lodging and boarding houses, shall be provided with ample ventilation and light by means of window area at least equal to 1/10 of the floor area and opening directly to the outside air or by equivalent artificial means maintained in constant and satisfactory service.

History

Authority: The provisions of this Chapter 20 issued under sections 1919-A and 1920-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 20 adopted September 18, 1971, effective September 19, 1971, 1 Pa.

Part III Prevention of Diseases

Chapter 26 Opioid Treatment Agreements—Temporary Regulations

28 Pa. Code § 26.1 Purpose.

This chapter provides for the regulation of Opioid Treatment Agreements for those prescribers and individuals who are required to enter into these agreements when opioids are prescribed for the treatment of chronic pain.

28 Pa. Code § 26.2 Legal basis.

(a) This chapter is promulgated by the Department under the powers granted and the duties mandated by section 52B03 of the act of November 27, 2019 (P.L. 764, No. 112) (Act 112).

(b) The Department has the power to promulgate temporary regulations within 90 days of the effective date of Act 112. The temporary regulations shall not be subject to:

(1) Sections 201—205 of the act of July 31, 1968 (P.L. 769, No. 240), known as the Commonwealth Documents Law.

(2) Sections 204(b) and 301(10) of the act of October 15, 1980 (P.L. 950, No. 164), known as the Commonwealth Attorneys Act (71 P.S. § § 732-204(b) and 732-301(10)).

(3) The act of June 25, 1982 (P.L. 633, No. 181) (71 P.S. § § 745.1—745.14) known as the Regulatory Review Act.

28 Pa. Code § 26.3 Definitions.

The following words and phrases when used in this chapter have the following meanings unless the context clearly indicates otherwise: Acute pain—Pain that comes on quickly, may be severe, but lasts a relatively short time and is provoked by a specific condition or injury. Baseline test—The initial assessment through a urine drug test to:

(1) identify the presence of an illegal substance prior to prescribing a controlled substance; or

(2) assess the presence or absence of a prescribed drug or drug class. Chronic pain—Pain that persists or progresses over a period of time that may be related to another medical condition and is resistant to medical treatment. The term does not include acute pain. Controlled substance—A drug, substance or immediate precursor included in Schedules II—V of section 4 of the act of April 14, 1972 (P.L. 233, No. 64) (35 P.S. § § 780-101—780-144), known as The Controlled Substance, Drug, Device and Cosmetic Act. Definitive drug test—A qualitative or quantitative urine drug test used to identify specific drugs, specific drug concentrations and associated metabolites. Department—The Department of Health of the Commonwealth. Individual—A natural person who is at least 18 years of age. Medical emergency—A situation that, in the good faith professional judgment of the prescriber, creates a time sensitive threat of serious risk to the life or physical health of a person. The term includes treatment received in an emergency department or urgent care center under the act of November 2, 2016 (P.L. 976, No. 122), known as the Safe Emergency Prescribing Act (35 P.S. § § 873.1—873.9). Opioid—Any of the following:

(1) A preparation or derivative of opium.

(2) A synthetic narcotic that has opiate-like effects but is not derived from opium.

(3) A group of naturally occurring peptides that bind at or otherwise influence opiate receptors, including an opioid agonist. Periodic test—A urine drug test that screens for a selection of drugs. Prescriber—As defined in the act of October 27, 2014 (P.L. 2911, No. 191), known as the Achieving Better Care by Monitoring All Prescriptions Program (ABC-MAP) Act (35 P.S. § § 872.1—872.40). Prescription or prescription order—A written, oral or electronic order for a controlled substance, other drug or medication, or device for medication which is dispensed to or for an ultimate user but does not include an order for a controlled substance, other drug or medication, or device for medication which is dispensed for immediate administration to the ultimate user. Presumptive positive drug test—A urine drug test that is used to identify suspected possible use or nonuse of drugs or a drug class that may be followed by a definitive test to specifically identify drugs or metabolites. Targeted test—A urine drug test ordered at the discretion of a prescriber, based on observation of the prescriber and related circumstances that enhance clinical decision making. Treatment agreement—A document signed by a prescriber and individual that contains a statement to ensure that the individual understands:

(1) Treatment responsibilities.

(2) The conditions of medication use.

(3) The conditions under which the treatment of the individual may be terminated.

(4) The responsibilities of the prescriber.

28 Pa. Code § 26.4 Procedures.

(a) Prescriber requirements. Except as specified in subsection (c), before issuing an individual the first prescription in a single course of treatment for chronic pain with a controlled substance containing an opioid, regardless of whether the dosage is modified during that course of treatment, a prescriber shall:

(1) Assess whether the individual has taken or is currently taking a prescription drug for treatment of a substance use disorder.

(2) Discuss with the individual:

(i) The risks of addiction and overdose associated with the controlled substance containing an opioid.

(ii) The increased risk of addiction to a controlled substance if the individual suffers from a mental disorder or substance use disorder.

(iii) The dangers of taking a controlled substance containing an opioid with benzodiazepines, alcohol or other central nervous system depressants.

(iv) Other information deemed appropriate by the prescriber under 21 CFR 201.57(c)(18) (relating to specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1)).

(v) The nonopioid treatment options available for treating chronic noncancer pain, if applicable, that are consistent with the best practices per the Pennsylvania Opioid Prescribing Guidelines.

(3) Review and sign a treatment agreement form that includes:

(i) The goals of the treatment.

(ii) The consent of the individual to a targeted test in a circumstance where the physician or prescriber determines that a targeted test is medically necessary. The treatment of chronic pain shall be consistent with the Pennsylvania Opioid Prescribing Guidelines.

(iii) The prescription drug prescribing policies of the prescriber, which policies include:

(A) A requirement that the individual take the medication as prescribed.

(B) A prohibition on sharing the prescribed medication with other individuals.

(iv) A requirement that the individual inform the prescriber about any other controlled substances prescribed or taken by the individual.

(v) Any reason why the opioid therapy may be changed or discontinued by the prescriber.

(vi) Appropriate disposal methods for opioids that are no longer being used by the individual as specified in a consultation with the prescriber.

(vii) The brand name or generic name, quantity and initial dose of the controlled substance containing an opioid being prescribed.

(viii) A statement indicating that a controlled substance is a drug or other substance that the United States Drug Enforcement Administration has identified as having a potential for abuse.

(ix) A statement certifying that the prescriber engaged in the discussion under subsection (a)(2).

(x) The signature of the individual and the date of signing. The prescriber may utilize electronic methods to obtain the signature of the individual and the date of signing.

(4) Obtain written consent for the prescription from the individual. The prescriber may utilize electronic methods to obtain the written consent of the individual.

(5) Record the consent under subsection (a)(4) on the treatment agreement form in subsection (a)(3).

(b) The treatment agreement form under subsection (a)(3) shall be maintained by the prescriber in the medical record of the individual.

(1) A baseline test, periodic test or targeted test shall be used to establish a general assessment for an individual new to treatment for chronic pain and in monitoring adherence to an existing individual treatment plan, as well as to detect the use of a nonprescribed drug.

(2) A baseline test shall be required prior to the issuance of the initial prescription for chronic pain and shall include confirmatory or quantitative testing of presumptive positive drug test results.

(3) An individual who is treated for addiction or an individual who is considered moderate or high risk by the prescriber shall be tested at least once annually or as frequently as necessary to ensure therapeutic adherence.

(d) Exception. Subsection (c) shall not apply if the treatment of an individual with a controlled substance containing an opioid is associated with or incident to:

(1) A medical emergency documented in the medical record of the individual.

(2) The management of pain associated with cancer.

(3) The use in palliative or hospice care.

(4) The professional judgment of the prescriber under subsections (a)(1) and (2).

(e) Documentation of exception. If subsection (d) applies, the prescriber shall document in the individual’s medical record the factor under subsection (d) that the prescriber believes applies to the individual.

(f) A prescriber may terminate the treatment agreement form under subsection (a)(3) if the prescriber has reasonable belief, based on standards of professional practice, that the treatment agreement is no longer necessary.

(g) If a prescriber terminates a treatment agreement under subsection (f), the prescriber shall:

(1) Document the reason for the termination of the treatment agreement in the individual’s medical record.

(2) Inform the individual of the termination of the treatment agreement.

(3) If necessary, work with the individual, to the fullest extent possible, to ensure continuity of care as outlined under 49 Pa. Code § 16.61(a)(17) (relating to unprofessional and immoral conduct).

(h) Urine testing exception. If, because of a medical necessity, an individual is unable to produce urine for the urine drug testing required herein, a different type of drug test may be used that is at least equivalent in accuracy to a urine drug test approved by the Food and Drug Administration. Alternative drug tests may not be substituted for urine drug tests under any other circumstances.

28 Pa. Code § 26.5 Penalties.

(a) A violation of this chapter by a prescriber shall be subject to sanctions under the prescriber’s professional practice act and by the appropriate licensing board.

(b) The Department will refer a complaint of a violation of this chapter, if known to the Department, to the appropriate licensing board for sanctions under subsection (a).

Chapter 28 Screening and Follow-Up for Diseases of the Newborn

28 Pa. Code § 28.1 Definitions.

The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise: Abnormal confirmatory test result—A test result obtained from a specimen of blood, serum or plasma which is diagnostic of the newborn disease under investigation. Abnormal screening test result—A test result obtained from a specimen collected on a specimen collection form which is outside the parameters for a normal test result according to testing criteria applicable to the screening test result. Admission—The formal acceptance of custody or care by a birth center or hospital of a newborn child who is provided with bassinet or incubator, nutrition and continuous nursing service. Birth center—As defined in section 802a of the Health Care Facilities Act (35 P. S. § 448.802a). Days of age—The measurement of age of the newborn child in 24-hour periods so that a newborn child is one day of age 24 hours after the hour of birth. Department—The Department of Health of the Commonwealth. Discharge—The release of the newborn child from care and custody within and by birth center or hospital to the care and custody of the parent or guardian. Health care practitioner—A licensed physician or a practitioner licensed to deliver and care for pregnant women and newborn children. Health care provider—A birth center, hospital or health care practitioner. Hemoglobin diseases—Sickle cell (SS, SC, S + other variant, S ß Thalassemia, S O Arab) disease or trait or other clinically significant hemoglobin (CC, EE, F, H) disease or trait. Hospital—As defined in section 802a of the Health Care Facilities Act. Inconclusive screening test result—A test result obtained from a specimen collected on a specimen collection form that is equivocal according to criteria applicable to the screening test result and which indicates the need for a repeat specimen and repeat testing. Initial specimen—The first sample of blood collected from the newborn child and submitted for testing purposes on a specimen collection form. Newborn child—An infant less than 28 days of age. Newborn screening program—The association of the Department, the testing laboratory and the health care provider to ensure that every newborn child born in this Commonwealth has a blood specimen collected and screened for the newborn diseases in § 28.2 (relating to newborn diseases listed). Presumptive abnormal test result—An abnormal screening test result which is sufficiently abnormal to indicate the probable presence of a newborn disease listed in § 28.2. Repeat specimen—A specimen collected from a newborn child on a specimen collection form after the initial specimen. Repeat test—The laboratory testing performed on a repeat specimen. Specimen collection form—The official newborn screening program specimen form that includes both a multipart section for providing required information about the newborn child and a filter paper tab for application of blood. Testing laboratory—The licensed clinical laboratory under contract with the Department to perform testing for the newborn diseases listed in § 28.2. Transfer—The release of the newborn child from care and custody within and by a birth center or hospital and subsequent admission to another hospital. Treatment center—A center under contract with the Department to provide expert consultation, diagnosis and treatment for children with a presumptive abnormal test result. Unacceptable specimen—A blood specimen collected from a newborn child on a specimen collection form which is found to be unsuitable for testing in accordance with accepted laboratory testing standards as determined by the Department.

The provisions of this § 28.1 amended under section 16(a) of the Disease Control and Prevention Act of 1955 (35 P. S. § 521.16(a)); sections 2102(g) and 2111(b) of The Administrative Code of 1929 (71 P. S. § § 532(g) and 541(b)); and sections 3 and 5 of the Newborn Child Testing Act (35 P. S. § § 623 and 625).

The provisions of this § 28.1 amended May 17, 2002, effective May 18, 2002, 32 Pa.B. 2435. Immediately preceding text appears at serial pages (287186) and (240177).

History

Authority: The provisions of this Chapter 28 issued under the Disease Prevention and Control Law of 1955 (35 P.
Source: The provisions of this Chapter 28 adopted March 28, 1980, effective March 29, 1980, 10 Pa.

28 Pa. Code § 28.2 Newborn diseases listed.

A newborn child born in this Commonwealth shall be screened for the following diseases which may cause mental retardation, physical defects or death if not detected and treated soon after birth:

(1) Congenital adrenal hyperplasia (CAH).

(2) Galactosemia.

(3) Hemoglobin diseases.

(4) Maple syrup urine disease (MSUD).

(5) Phenylketonuria (PKU).

(6) Primary congenital hypothyroidism.

The provisions of this § 28.2 amended under section 16(a) of the Disease Control and Prevention Act of 1955 (35 P. S. § 521.16(a)); sections 2102(g) and 2111(b) of The Administrative Code of 1929 (71 P. S. § § 532(g) and 541(b)); and sections 3 and 5 of the Newborn Child Testing Act (35 P. S. § § 623 and 625).

The provisions of this § 28.2 amended May 17, 2002, effective May 18, 2002, 32 Pa.B. 2435. Immediately preceding text appears at serial page (240177).

This section cited in 28 Pa. Code § 28.1 (relating to definitions); 28 Pa. Code § 28.11 (relating to informing the parent or guardian); 28 Pa. Code § 28.21 (relating to responsibility for collecting and testing initial and repeat specimens); 28 Pa. Code § 28.22 (relating to timing of initial specimen collection by birth centers or hospitals); and 28 Pa. Code § 28.28 (relating to follow-up of symptoms consistent with newborn diseases).

History

Authority: The provisions of this Chapter 28 issued under the Disease Prevention and Control Law of 1955 (35 P.
Source: The provisions of this Chapter 28 adopted March 28, 1980, effective March 29, 1980, 10 Pa.

28 Pa. Code § 28.5 Confidentiality.

(a) A health care provider, testing laboratory, the Department or any other entity involved in the newborn screening program may not release any identifying information relating to any newborn child screened in the newborn screening program to anyone other than a parent or guardian of the newborn child or the health care provider for the newborn child designated by a parent or the guardian except as follows:

(1) As may be necessary to provide services to the newborn child.

(2) With the consent of the newborn child’s parent or guardian.

(3) With the child’s consent when the child is 18 years of age or older, has graduated from high school, has married or has been pregnant.

(b) Only the Department will have the authority to release or authorize the release of nonidentifying information concerning the newborn screening program.

The provisions of this § 28.5 amended under section 16(a) of the Disease Control and Prevention Act of 1955 (35 P. S. § 521.16(a)); sections 2102(g) and 2111(b) of The Administrative Code of 1929 (71 P. S. § § 532(g) and 541(b)); and sections 3 and 5 of the Newborn Child Testing Act (35 P. S. § § 623 and 625).

The provisions of this § 28.5 adopted May 17, 2002, effective May 18, 2002, 32 Pa.B. 2435.

History

Authority: The provisions of this Chapter 28 issued under the Disease Prevention and Control Law of 1955 (35 P.
Source: The provisions of this Chapter 28 adopted March 28, 1980, effective March 29, 1980, 10 Pa.

28 Pa. Code § 28.11 Informing the parent or guardian.

Prior to specimen collection, the health care provider shall provide the pregnant woman, prior to the infant’s birth, or the mother or guardian, after the infant’s birth, with a pamphlet supplied by the Department to explain the nature of the newborn screening blood tests for the diseases in § 28.2 (relating to newborn diseases listed).

The provisions of this § 28.11 amended under section 16(a) of the Disease Control and Prevention Act of 1955 (35 P. S. § 521.16(a)); sections 2102(g) and 2111(b) of The Administrative Code of 1929 (71 P. S. § § 532(g) and 541(b)); and sections 3 and 5 of the Newborn Child Testing Act (35 P. S. § § 623 and 625).

The provisions of this § 28.11 amended May 17, 2002, effective May 18, 2002, 32 Pa.B. 2435. Immediately preceding text appears at serial page (240178).

History

Authority: The provisions of this Chapter 28 issued under the Disease Prevention and Control Law of 1955 (35 P.
Source: The provisions of this Chapter 28 adopted March 28, 1980, effective March 29, 1980, 10 Pa.

28 Pa. Code § 28.12 Religious objections.

(a) A health care provider may not collect or cause to be collected, a specimen from a newborn child if the parent or guardian of the newborn child objects on the ground that the specimen collection conflicts with religious beliefs or practices held by the parent or guardian.

(b) If the parent or guardian of the newborn child objects to the collection of the specimen for screening on the ground that the specimen collection conflicts with religious beliefs or practices held by the parent or guardian, the health care provider shall ensure that the recorded objection of the parent or guardian is entered into the medical record of the newborn child. The entry shall include a written statement of the objection signed by the parent or guardian.

The provisions of this § 28.12 amended under section 16(a) of the Disease Control and Prevention Act of 1955 (35 P. S. § 521.16(a)); sections 2102(g) and 2111(b) of The Administrative Code of 1929 (71 P. S. § § 532(g) and 541(b)); and sections 3 and 5 of the Newborn Child Testing Act (35 P. S. § § 623 and 625).

The provisions of this § 28.12 amended May 17, 2002, effective May 18, 2002, 32 Pa.B. 2435. Immediately preceding text appears at serial page (240179).

History

Authority: The provisions of this Chapter 28 issued under the Disease Prevention and Control Law of 1955 (35 P.
Source: The provisions of this Chapter 28 adopted March 28, 1980, effective March 29, 1980, 10 Pa.

28 Pa. Code § 28.21 Responsibility for collecting and testing initial and repeat specimens.

(a) A birth center or hospital shall collect or cause to be collected from each newborn child delivered in that birth center or hospital, in accordance with instructions for newborn screening specimen collection in subsection (d), the initial and repeat specimens necessary to conduct the tests necessary for the detection of the newborn diseases specified in § 28.2 (relating to newborn diseases listed).

(b) When a newborn child is delivered other than in a birth center or hospital, the health care practitioner who delivered the newborn child shall collect or cause to be collected from the newborn child, in accordance with instructions for newborn screening specimen collection in subsection (d), the initial and repeat specimens necessary to conduct the tests necessary for the detection of the newborn diseases specified in § 28.2.

(1) Ensure that a specimen collection form contains correct and complete information.

(2) Ensure that the individual who collected the specimen records that act in the newborn child’s medical record.

(3) Send all specimens collected by first class mail to the testing laboratory within 24 hours of collection.

(4) Record the laboratory screening results in the newborn child’s medical records.

(5) Check each newborn child’s record prior to discharge or release to ensure that a specimen has been collected.

(6) Ensure, in the event of transfer of the newborn child prior to 48 hours of age, that the receiving health care provider has been notified that it has the responsibility to collect the initial specimen.

(7) Assist the Department in follow-up of an abnormal or presumptive abnormal test result.

(8) Follow-up inconclusive test results.

(9) Receive notification from the testing laboratory or from the Department of the need for a repeat specimen.

(d) The health care provider shall ensure that the individual responsible for specimen collection shall collect the specimen necessary to conduct tests in accordance with consensus standards developed by the National Committee for Clinical Laboratory Standards (NCCLS) and accepted by the Department. The Department will publish these standards, and any revisions thereto, in a notice in the Pennsylvania Bulletin.

The provisions of this § 28.21 amended under section 16(a) of the Disease Control and Prevention Act of 1955 (35 P. S. § 521.16(a)); sections 2102(g) and 2111(b) of The Administrative Code of 1929 (71 P. S. § § 532(g) and 541(b)); and sections 3 and 5 of the Newborn Child Testing Act (35 P. S. § § 623 and 625).

The provisions of this § 28.21 amended May 17, 2002, effective May 18, 2002, 32 Pa.B. 2435. Immediately preceding text appears at serial page (240179).

This section cited in 28 Pa. Code § 501.49 (relating to newborn infant care policies and procedures).

History

Authority: The provisions of this Chapter 28 issued under the Disease Prevention and Control Law of 1955 (35 P.
Source: The provisions of this Chapter 28 adopted March 28, 1980, effective March 29, 1980, 10 Pa.

28 Pa. Code § 28.22 Timing of initial specimen collection and handling in health care facilities.

(a) A birth center or hospital shall collect the initial specimen from each newborn child regardless of feeding history or medical condition, as close to 48 hours of age as possible but not later than 72 hours of age unless the newborn child falls into one of the following categories:

(1) Transfer. If the newborn child is transferred to another hospital for continuing care prior to 48 hours of age, the hospital to which the newborn child has been transferred shall collect a specimen from the newborn child, regardless of feeding history or medical condition, as close to 48 hours of age as possible but not later than 72 hours of age.

(2) Exchange transfusion. If the newborn child is to undergo an exchange transfusion, the birth center or hospital shall collect the initial specimen for testing immediately prior to the exchange transfusion.

(3) Early discharge. If the newborn child is discharged from the birth center or hospital before 24 hours of age, the birth center or hospital shall collect the initial specimen from the newborn child as close to the time of discharge as is practicable, regardless of feeding history or medical condition. The birth center or hospital shall give the parent or guardian in whose care and custody the newborn child is discharged written notification of the need for a repeat specimen and shall also provide instructions to the parent or guardian for obtaining a repeat specimen from the newborn child as described in § 28.26 (relating to timing of repeat specimen collection).

(b) When a newborn child, who was delivered other than in a birth center or hospital, is admitted to a hospital within the first 27 days of age and the hospital has received no record of results of an approved screening test for the newborn diseases in § 28.2 (relating to newborn diseases listed), the hospital to which the newborn child is admitted shall collect the initial specimen within 48 hours of admission to the hospital and shall send the specimen to the testing laboratory specified by the Department within 24 hours of collection.

The provisions of this § 28.22 amended under section 16(a) of the Disease Control and Prevention Act of 1955 (35 P. S. § 521.16(a)); sections 2102(g) and 2111(b) of The Administrative Code of 1929 (71 P. S. § § 532(g) and 541(b)); and sections 3 and 5 of the Newborn Child Testing Act (35 P. S. § § 623 and 625).

The provisions of this § 28.22 amended May 17, 2002, effective May 18, 2002, 32 Pa.B. 2435. Immediately preceding text appears at serial pages (240179) to (240180).

This section cited in 28 Pa. Code § 501.49 (relating to newborn infant care policies and procedures).

History

Authority: The provisions of this Chapter 28 issued under the Disease Prevention and Control Law of 1955 (35 P.
Source: The provisions of this Chapter 28 adopted March 28, 1980, effective March 29, 1980, 10 Pa.

28 Pa. Code § 28.23 Timing of initial specimen collection by health care practitioners.

A health care practitioner who delivers a newborn child other than in a birth center or hospital shall collect or cause to be collected the initial specimen from the newborn child, regardless of feeding history or medical condition, as close to 48 hours as possible but not later than 72 hours of age.

The provisions of this § 28.23 amended under section 16(a) of the Disease Control and Prevention Act of 1955 (35 P. S. § 521.16(a)); sections 2102(g) and 2111(b) of The Administrative Code of 1929 (71 P. S. § § 532(g) and 541(b)); and sections 3 and 5 of the Newborn Child Testing Act (35 P. S. § § 623 and 625).

The provisions of this § 28.23 amended May 17, 2002, effective May 18, 2002, 32 Pa.B. 2435. Immediately preceding text appears at serial page (240180).

This section cited in 28 Pa. Code § 501.49 (relating to newborn infant care policies and procedures).

History

Authority: The provisions of this Chapter 28 issued under the Disease Prevention and Control Law of 1955 (35 P.
Source: The provisions of this Chapter 28 adopted March 28, 1980, effective March 29, 1980, 10 Pa.

28 Pa. Code § 28.24 Normal test results.

(a) Within 7-calendar days following the day when the testing laboratory obtains the normal test results, the testing laboratory shall send those results to the health care provider that collected the specimen from the newborn child.

(b) The health care provider to whom the normal test results are reported shall record the test results in the medical record of the newborn child.

The provisions of this § 28.24 amended under section 16(a) of the Disease Control and Prevention Act of 1955 (35 P. S. § 521.16(a)); sections 2102(g) and 2111(b) of The Administrative Code of 1929 (71 P. S. § § 532(g) and 541(b)); and sections 3 and 5 of the Newborn Child Testing Act (35 P. S. § § 623 and 625).

The provisions of this § 28.24 amended May 17, 2002, effective May 18, 2002, 32 Pa.B. 2435. Immediately preceding text appears at serial page (240180).

This section cited in 28 Pa. Code § 501.49 (relating to newborn infant care policies and procedures).

History

Authority: The provisions of this Chapter 28 issued under the Disease Prevention and Control Law of 1955 (35 P.
Source: The provisions of this Chapter 28 adopted March 28, 1980, effective March 29, 1980, 10 Pa.

28 Pa. Code § 28.25 Circumstances require repeat specimens.

(a) The health care provider responsible for collecting the initial specimen shall collect or cause to be collected and submit for testing a repeat specimen if the initial specimen collected is either of the following:

(1) Unacceptable for testing.

(2) Yields an inconclusive screening test result.

(b) If a birth center or hospital collects the initial specimen from a newborn child prior to 24 hours of age because the newborn child is discharged from the birth center or hospital prior to 24 hours of age, the birth center or hospital shall collect or cause to be collected a repeat specimen.

(c) If the initial specimen collected yields an abnormal screening test result, the Department may require the health care provider responsible for collecting the initial specimen to collect a repeat specimen.

The provisions of this § 28.25 amended under section 16(a) of the Disease Control and Prevention Act of 1955 (35 P. S. § 521.16(a)); sections 2102(g) and 2111(b) of The Administrative Code of 1929 (71 P. S. § § 532(g) and 541(b)); and sections 3 and 5 of the Newborn Child Testing Act (35 P. S. § § 623 and 625).

The provisions of this § 28.25 amended May 17, 2002, effective May 18, 2002, 32 Pa.B. 2435. Immediately preceding text appears at serial page (240180).

This section cited in 28 Pa. Code § 501.49 (relating to newborn infant care policies and procedures).

History

Authority: The provisions of this Chapter 28 issued under the Disease Prevention and Control Law of 1955 (35 P.
Source: The provisions of this Chapter 28 adopted March 28, 1980, effective March 29, 1980, 10 Pa.

28 Pa. Code § 28.26 Timing of repeat specimen collection.

(a) When the newborn child has been discharged from a birth center or hospital before 24 hours of age, the birth center or hospital shall collect or cause to be collected a repeat specimen from the newborn child, regardless of feeding history or medical condition, as close to 48 hours of age as possible but not later than 72 hours of age.

(b) When the initial specimen is unacceptable or when the initial specimen yields an inconclusive screening test result, the Department or testing laboratory will notify the health care provider that collected the initial specimen. Within 72 hours of receipt of notice from the Department or testing laboratory, the health care provider that collected the initial specimen shall collect or cause to be collected from the newborn child a repeat specimen.

(c) If the health care provider cannot locate a parent or guardian of the newborn child within 4 days of notification of need for a repeat specimen, the health care provider shall contact the Department for consultation regarding additional means for locating a parent or guardian.

The provisions of this § 28.26 amended under section 16(a) of the Disease Control and Prevention Act of 1955 (35 P. S. § 521.16(a)); sections 2102(g) and 2111(b) of The Administrative Code of 1929 (71 P. S. § § 532(g) and 541(b)); and sections 3 and 5 of the Newborn Child Testing Act (35 P. S. § § 623 and 625).

The provisions of this § 28.26 amended May 17, 2002, effective May 18, 2002, 32 Pa.B. 2435. Immediately preceding text appears at serial pages (240180) to (240181).

This section cited in 28 Pa. Code § 28.22 (relating to timing of initial specimen collection and handling in health care facilities); and 28 Pa. Code § 501.49 (relating to newborn infant care policies and procedures).

History

Authority: The provisions of this Chapter 28 issued under the Disease Prevention and Control Law of 1955 (35 P.
Source: The provisions of this Chapter 28 adopted March 28, 1980, effective March 29, 1980, 10 Pa.

28 Pa. Code § 28.27 Abnormal screening test results.

(a) When testing of the initial or repeat specimen yields an abnormal screening test result, the Department will notify the health care provider that collected the specimen. The health care provider shall promptly notify a parent or guardian of the newborn child.

(b) If the health care provider cannot locate the newborn child’s parent or guardian within 48 hours of receiving notice from the Department, the health care provider shall contact the Department for consultation regarding additional means for locating a parent or guardian.

(d) If the result of the confirmatory test is abnormal, the Department will assist with referral for diagnosis, treatment, and other follow-up services for the newborn child through designated treatment centers or clinical specialists.

The provisions of this § 28.27 amended under section 16(a) of the Disease Control and Prevention Act of 1955 (35 P. S. § 521.16(a)); sections 2102(g) and 2111(b) of The Administrative Code of 1929 (71 P. S. § § 532(g) and 541(b)); and sections 3 and 5 of the Newborn Child Testing Act (35 P. S. § § 623 and 625).

The provisions of this § 28.27 amended May 17, 2002, effective May 18, 2002, 32 Pa.B. 2435. Immediately preceding text appears at serial page (240181).

This section cited in 28 Pa. Code § 501.49 (relating to newborn infant care policies and procedures).

History

Authority: The provisions of this Chapter 28 issued under the Disease Prevention and Control Law of 1955 (35 P.
Source: The provisions of this Chapter 28 adopted March 28, 1980, effective March 29, 1980, 10 Pa.

28 Pa. Code § 28.28 Followup of symptoms consistent with newborn diseases.

When a sick child exhibits symptoms suggestive of a newborn disease listed in § 28.2 (relating to newborn diseases listed) and has not already been determined to have one of those newborn diseases, the health care provider to whom care of the sick child has been entrusted by the parent or guardian shall collect and submit a blood specimen for newborn disease testing in accordance with standard diagnostic procedures.

The provisions of this § 28.28 amended under section 16(a) of the Disease Control and Prevention Act of 1955 (35 P. S. § 521.16(a)); sections 2102(g) and 2111(b) of The Administrative Code of 1929 (71 P. S. § § 532(g) and 541(b)); and sections 3 and 5 of the Newborn Child Testing Act (35 P. S. § § 623 and 625).

The provisions of this § 28.28 amended May 17, 2002, effective May 18, 2002, 32 Pa.B. 2435. Immediately preceding text appears at serial page (240181).

This section cited in 28 Pa. Code § 501.49 (relating to newborn infant care policies and procedures).

History

Authority: The provisions of this Chapter 28 issued under the Disease Prevention and Control Law of 1955 (35 P.
Source: The provisions of this Chapter 28 adopted March 28, 1980, effective March 29, 1980, 10 Pa.

28 Pa. Code § 28.41 Recordkeeping requirements.

A health care provider offering maternity and newborn services shall collect and forward data semiannually to the Department on the number of patients for whom specimens for newborn disease testing have been collected and the number of patients for whom the specimens have not been collected, together with the reason in each instance for the failure to collect.

The provisions of this § 28.41 amended under section 16(a) of the Disease Control and Prevention Act of 1955 (35 P. S. § 521.16(a)); sections 2102(g) and 2111(b) of The Administrative Code of 1929 (71 P. S. § § 532(g) and 541(b)); and sections 3 and 5 of the Newborn Child Testing Act (35 P. S. § § 623 and 625).

The provisions of this § 28.41 amended May 17, 2002, effective May 18, 2002, 32 Pa.B. 2435. Immediately preceding text appears at serial pages (240182) to (240183).

This section cited in 28 Pa. Code § 501.3 (relating to reports/contact person).

History

Authority: The provisions of this Chapter 28 issued under the Disease Prevention and Control Law of 1955 (35 P.
Source: The provisions of this Chapter 28 adopted March 28, 1980, effective March 29, 1980, 10 Pa.

Chapter 30 Blood Banks

28 Pa. Code § 30.1 Definitions.

The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise: Act—The Pennsylvania Blood Bank Act (35 P. S. § § 6501—6523). Blood bank—Any place, organization, institution or establishment that is operated wholly or in part for the purpose of obtaining, collecting, storing, processing, preparing for transfusing, or selling human blood or parts or fractions of single blood units or products derived from single blood units, including pools of such single units, whether such procedures are done for direct therapeutic use or for storage for future therapeutic or diagnostic use of such products and whether a place, organization, institution, or establishment is operated on a charitable, commercial, or nonprofit basis. Blood product—Any part or fraction of single units of whole human blood, including pools of such single units, or any material derived from single units, including pools of such single units, of such blood which is subsequently prepared for the purpose of administration to human subjects. Collection—The obtaining of human blood by the bleeding of donors by a phlebotomy or plasmapheresis. Department—The Department of Health of the Commonwealth. Distribution—The removal of blood and blood products from a blood bank to any other location for processing or storage for the purpose of providing the blood for diagnostic, therapeutic, or prophylactic purposes. Licensee—A person holding a license under the provisions of the act and this chapter. Person—Any natural person, partnership, association, corporation, institution, agency, or other similar entity. Processing—The standard technical procedures used to prepare blood and blood products, methods of identification, tests for suitability for intended purpose, and performance of tests for communicable diseases. Screening of donors—The evaluation of prospective donors by the blood bank to determine the acceptability of the donor by evaluating his past medical history, his present state of health, and laboratory studies. Secretary—The Secretary of the Department. Storage—The holding of blood and blood products for subsequent distribution and use.

History

Authority: The provisions of this Chapter 30 issued under section 14 of the Pennsylvania Blood Bank Act (35 P.
Source: The provisions of this Chapter 30 adopted May 13, 1977, 7 Pa.

28 Pa. Code § 30.2 Applicability and exemptions.

(a) Except as otherwise provided, this chapter applies to all blood banks operating in this Commonwealth.

(b) The provisions of this chapter shall not apply to blood banks operated by the Federal government, nor to any blood bank operated purely for research and teaching purposes, provided blood or blood products from such research or teaching are not injected into humans.

History

Authority: The provisions of this Chapter 30 issued under section 14 of the Pennsylvania Blood Bank Act (35 P.
Source: The provisions of this Chapter 30 adopted May 13, 1977, 7 Pa.

28 Pa. Code § 30.10 Licensing.

(a) Any person operating a blood bank in this Commonwealth shall be required to obtain a license in accordance with the provisions of this chapter.

(b) A license is valid for 1 year after issuance and shall be renewed on an annual basis.

(c) A blood bank participating in an inspection and evaluation program other than that of the Department shall be required to remit a fee of $50 per annum, payable to the Department. For all blood banks participating in the inspection and evaluation program of the Department, the fee shall be $200 per annum. A separate fee shall be charged for each permanent blood bank location.

(d) The application for license shall contain the following information:

(1) Name and location of blood bank.

(2) Name and address of person owning the blood bank.

(3) Name and address of person operating the blood bank.

(4) Name, education and experience of all persons having directoral, supervisory or technical duties in the blood bank.

(5) Description of physical facilities and equipment.

(6) Sources of materials and methods of storage and distribution of products.

(7) Description of technical procedures.

(8) Current blood bank licenses, approvals and certifications.

(e) Applications shall be made on forms provided by the Department.

History

Authority: The provisions of this Chapter 30 issued under section 14 of the Pennsylvania Blood Bank Act (35 P.
Source: The provisions of this Chapter 30 adopted May 13, 1977, 7 Pa.

28 Pa. Code § 30.11 Inspection and evaluation of blood banks.

(a) At least once each year, the blood bank will be inspected and evaluated by a representative of the Department.

(b) The Department may accept the inspection and evaluation of a private or Federal agency. The record of the inspection and evaluation must be made available in its entirety to the Department.

History

Authority: The provisions of this Chapter 30 issued under section 14 of the Pennsylvania Blood Bank Act (35 P.
Source: The provisions of this Chapter 30 adopted May 13, 1977, 7 Pa.

28 Pa. Code § 30.20 Personnel.

(a) Required staff. Each blood bank shall have a blood bank director, medical director, and supervisor. The medical director may also serve as the blood bank director and supervisor.

(b) Qualifications of medical director. The medical director must be a physician, licensed to practice in this Commonwealth, with at least 4 years full time postdoctoral clinical laboratory training which includes blood banking and related subjects acceptable to the Department or certified in blood banking by the American Board of Pathology.

(c) Qualifications of a blood bank director. A person may not be a director of a blood bank unless the person conforms with one of the following requirements:

(1) The person shall hold a doctoral degree in medicine, osteopathy, or one of the biological sciences, and shall have at least 2 years full time postdoctoral training and experience in blood bank operations and related subjects, acceptable to the Department.

(2) The person shall hold an M.A. or M.S. degree from an accredited institution with a major in medical technology or one of the biological sciences or Blood Bank certificates SBB (ASCP), and shall have at least 4 years’ experience in blood bank operations and related subjects, acceptable to the Department.

(3) The person shall hold a baccalaureate degree in medical technology or one of the biological sciences and shall have at least 6 years’ experience in blood bank operations and related subjects, acceptable to the Department.

(d) Qualifications of a blood bank supervisor. A person may not act as a supervisor of a blood bank unless the person conforms with one of the following requirements:

(1) The person shall hold a master’s degree in medical technology or one of the biological sciences or Blood Bank certification SBB (ASCP), and shall have at least 2 years’ experience and training in blood bank operations, acceptable to the Department.

(2) The person shall hold a baccalaureate degree in medical technology or one of the biological sciences and shall have at least 3 years’ experience and training in blood bank operations, acceptable to the Department.

(3) The person shall be a certified technician MLT (ASCP) or MLT (AMT), a nurse registered to practice in this Commonwealth, or an individual who has received a passing grade in the HEW proficiency examination, and shall have at least 4 years’ experience and training in blood bank operations, acceptable to the Department.

(e) Technical personnel. Technical personnel employed in a blood bank shall meet education and experience requirements consistent with the duties assigned specifically by the supervisor. In selection of technical employes, recognition shall be given to categories of medical laboratory personnel acceptable to the Department.

(f) Prior employment. Any individual employed in a blood bank as a director, medical director, supervisor, medical technologist or technician prior to the effective date of this chapter, may continue to act in the capacity and may not be required to meet subsections (b)—(d).

History

Authority: The provisions of this Chapter 30 issued under section 14 of the Pennsylvania Blood Bank Act (35 P.
Source: The provisions of this Chapter 30 adopted May 13, 1977, 7 Pa.

28 Pa. Code § 30.21 Responsibilities of directors and supervisors.

(a) The medical director shall be responsible for determining and establishing policies and procedures governing all phases of blood banking. The licensee is obliged to demonstrate that the medical director spends sufficient time on the premises to fulfill the requirements of this section.

(b) The blood bank director shall be responsible, under the direction of the medical director, for implementing policies and procedures governing all phases of blood banking.

(c) The supervisor shall be responsible, under the direction of the medical director and blood bank director, for application of policies and procedures governing all phases of blood banking. Depending upon the size and complexity of the establishment, there may be more than one level of technical and nursing supervisors.

(d) Any procedures involving the service of transfusing or injecting of blood products into humans must be under the supervision of the medical director.

(e) The supervisor must be present during the normal working hours of the blood bank, including mobile units.

(f) The medical director or properly qualified designee must be available for consultation at all times outside of regular working hours.

(g) Any time blood is being obtained from a human donor, a physician who is licensed to practice medicine in this Commonwealth shall be available within ten to 15 minutes so as to be able to handle emergencies which may arise.

History

Authority: The provisions of this Chapter 30 issued under section 14 of the Pennsylvania Blood Bank Act (35 P.
Source: The provisions of this Chapter 30 adopted May 13, 1977, 7 Pa.

28 Pa. Code § 30.30 Identification and screening of donors.

Selection for donor criteria shall at least be equivalent to all current Federal regulations and shall include the following:

(1) Donors must be identified by name, age, sex and address. There shall be a numerical system to positively identify and relate the donor, donor record, blood container and pilot tubes in each step from donor to recipient and including preparation of components.

(2) Donors shall be between the ages of 17 through 65. Donors between ages of 17 and 18 must have a written consent signed by a parent or guardian. Donors, after their 66th birthday, who meet all other criteria for acceptability may be accepted at the discretion of the medical director if they have obtained written consent from a physician within 2 weeks before the date of donation or if the medical director contacts the attending physician and secures concurrence.

(3) Intervals between donations of a full unit of blood shall be eight weeks except for autologous transfusion, and the interval between donations by plasmapheresis shall be at least 48 hours.

(4) Donors must be examined at the time of donation, and at least the following physical criteria must be within medically accepted limits for blood donors: temperature, blood pressure, and pulse. There must be no sign of acute disease or history of disease that will affect the normal use of blood. Any history of chronic disease shall disqualify the donor, unless specific approval is obtained from the donor and the medical director of the blood bank. Final acceptance of a donor is the responsibility of the medical director.

(5) Donors must weigh at least 110 pounds if they are to give a full donation of 480 milliliters. Donors weighing less than 110 pounds may be bled less than full amounts, when required, under the direct supervision of the medical director.

(6) All donors must be within normal limits of hemoglobin or hematocrit. Blood group and Rh type shall be determined and recorded for each donation. Blood group and Rh type determinations are not required for plasmapheresis donors.

(7) Donors shall be free from infectious diseases known to be transmissible by blood insofar as can be determined by usual examinations.

(i) Viral hepatitis. Donors with a history of viral hepatitis as well as those who, within 6 months, have had close contact with an individual having the disease, shall be excluded. A donor shall be excluded permanently if his was the only unit of blood, blood component, or derivative administered to a patient who, within 6 months, developed post-transfusion hepatitis and who received no other icterogenic blood fractions or his blood has ever been known to contain Hepatitis B Antigen (HBsAg). When hepatitis has developed after transfusion of blood, blood components, or derivatives from more than one donor, those donors who have not previously been suspected of hepatitis need not be rejected as future donors of whole blood; exclusion of other donors should be evaluated individually by the blood bank physician. The possible presence of the agent or viral hepatitis in donors cannot at present be detected with certainty by any available means, including history, physical examination, and laboratory tests, including a test for presence of HBsAg.

(ii) Malaria. Travelers who have been in areas considered endemic for malaria by the Malaria Program, Center for Disease Control, United States Department of Health, Education and Welfare, may be accepted as regular blood donors 6 months after return to the nonendemic area, provided they have been free of symptoms and have not taken antimalarial drugs in the interim. Prospective donors who have had malaria shall be deferred for 3 years either after becoming asymptomatic or after cessation of therapy, whichever is later. Prospective donors who have taken antimalaria prophylaxis or who have been military personnel in an endemic area shall be deferred for 3 years after cessation of therapy or after departure from the area if they have been asymptomatic in the interim. Immigrants or visitors from endemic areas may be accepted as blood donors three years after departure from the area if they have been asymptomatic in the interim. Donations to be used for the preparation of plasma, plasma components or fractions devoid of intact red blood cells are exempted from the restrictions set forth in this clause.

(iii) Syphilis and hepatitis. Donors must be nonreactive to standard serologic tests for syphilis and negative to (HBsAg) hepatitis antigen by acceptable systems of detection. If such tests are determined to be reactive or positive after blood has been obtained, the blood shall not be administered to humans. Source plasma obtained by plasmapheresis, intended for further manufacturing, may be utilized even if reactive to a standard serologic test for syphilis.

(8) Donors, other than plasmapheresis donors, shall be excluded if dental surgery has been performed within the past 72 hours.

(9) Known pregnancy shall exclude a donor. A donor shall be excluded for 6 weeks postpartum.

(10) Donors shall not give blood within 24 hours after immunization with inactivated vaccines or immunizing agents including prophylactic rabies and within 2 weeks after receiving live immunizing agents. Persons immunized for Rubella shall be acceptable as donors 2 months after receiving the last injection.

(11) Donors with a history of recent drug therapy shall be evaluated by a physician. Exceptions to this paragraph include ingestion of vitamins or oral contraceptives.

(12) Evidence of narcotic or alcoholic habituation or intoxication shall exclude a donor.

(13) Donors shall be excluded for a period of 6 months after receiving blood or blood components.

(14) The skin of the donor must be free of lesion at the site of phlebotomy.

(15) Donors with active tuberculosis shall be excluded.

History

Authority: The provisions of this Chapter 30 issued under section 14 of the Pennsylvania Blood Bank Act (35 P.
Source: The provisions of this Chapter 30 adopted May 13, 1977, 7 Pa.

28 Pa. Code § 30.31 Collection, processing, storage and distribution of blood products.

(a) The containers shall be pyrogen-free, sterile and free of foreign material and shall contain sufficient anticoagulant for the quantity of blood to be collected.

(b) Only anticoagulants which meet standards of Federal regulations shall be used, in the amounts necessary to give optimal proportion of blood to anticoagulant.

(c) Both donor and future recipient shall be protected by proper preparation of the site of the venipuncture. Preparation of the skin shall provide maximum assurance of an aseptic procedure and a sterile product. Care shall be taken to prevent contamination of the phlebotomy needle and the phlebotomy site.

(d) All instruments used in the bleeding and processing of blood shall be sterile and dry prior to use.

(e) Pilot samples shall be attached to the container and identified by a numerical system to relate directly to the donor or to the container.

(f) Specific instructions and appropriate materials for the handling and treatment of adverse donor reactions shall be readily available to all personnel in the blood bank.

(g) Blood shall be stored at temperatures between 1° and 6°C with avoidance of fluctuations of more than 2°C. The temperature of blood during shipment should be maintained between 1°C and 10°C.

(h) All equipment used in processing blood and blood products shall be in optimal working condition, checked, and calibrated. Maintenance and control data shall be recorded and available for inspection by the Department.

(i) The refrigerator in which blood is stored shall contain only blood and blood components. It shall be provided with a fan for circulating air or be of such capacity and design to ensure adequate circulation of air.

(j) Expiration rules shall be as follows:

(1) The expiration date for ACD or CPD whole blood (human) and red blood cells (human) shall be 21 days from date of collection. Expiration date for heparinized blood shall be 48 hours after collection provided the product is collected in a closed system and remains in the same bleeding container. If the seal is broken, blood must be transfused within 24 hours.

(2) The expiration date for platelet concentrate, room temperature storage, shall be 72 hours from time of collection, with storage at temperatures between 20° and 24°C.

(3) The expiration date for fresh frozen plasma and cryoprecipitate is 12 months from donation of original pint of blood, with storage at -18°C or lower.

(4) The expiration date for frozen blood cells is 3 years from the date of donation, stored at -65°C or colder. After reconstitution, expiration date is within 24 hours, stored at temperatures between 1° and 6°C.

(5) The expiration date for single donor plasma (human) is 6 weeks, stored at temperatures between 1° and 6°C. These expiration dates are in effect until modified by Federal Regulations. Reference should be made to 21 CFR Part 640.

(k) Before issuing blood from the blood bank, all data on the label shall be carefully checked and ascertained to be clear and legible.

(l) All procedures for the preparation of blood products shall meet standards acceptable to the Department. Complete protocols for these procedures shall be submitted to the Department at the time of license application or when any protocol is modified and when any amendment to the license is requested.

History

Authority: The provisions of this Chapter 30 issued under section 14 of the Pennsylvania Blood Bank Act (35 P.
Source: The provisions of this Chapter 30 adopted May 13, 1977, 7 Pa.

28 Pa. Code § 30.32 Quality control and proficiency evaluation of testing procedures.

(a) The blood bank shall participate in a continuing proficiency testing program for blood bank laboratory procedures. Private agency programs, or those provided by governmental agencies, shall be used, together with any additional requirements stipulated by the Department. All proficiency evaluation programs will be approved by the Department.

(b) A continuing internal program of quality control shall be maintained by each blood bank to include reagents, equipment, records, and personnel.

(c) All laboratory procedures used in a blood bank shall meet or exceed the standards of The Clinical Laboratory Act of 1951 (35 P. S. § § 2151—2164), and regulations promulgated pursuant thereto, and shall be in compliance with applicable Federal regulations.

History

Authority: The provisions of this Chapter 30 issued under section 14 of the Pennsylvania Blood Bank Act (35 P.
Source: The provisions of this Chapter 30 adopted May 13, 1977, 7 Pa.

28 Pa. Code § 30.40 Facilities.

The premises and equipment used by any blood bank shall meet the following minimum requirements:

(1) Provide adequate space for the following:

(i) Private and accurate examinations of individuals to determine their suitability as blood donors.

(ii) The withdrawal of blood from donors with minimal risk of contamination and equipment unrelated to blood collection.

(iii) The storage of blood or blood components pending completion of tests.

(iv) The quarantine storage of blood or blood components in a designated location pending repetition of those tests that initially gave questionable serological results.

(v) The storage of finished products prior to distribution.

(vi) The quarantine storage, handling, and disposition of products and reagents not suitable for use.

(vii) The orderly collection, processing, compatibility testing, storage and distribution of blood and blood components to prevent contamination.

(viii) The adequate and proper performance of all steps in plasmapheresis and leukapheresis procedures.

(ix) The orderly conduction of all packaging, labeling and other finishing operations.

(x) Provide adequate lighting, ventilation and screening of open windows and doors.

(2) Refrigeration equipment and facilities shall be provided to accommodate all blood, blood products and reagents. Refrigeration equipment shall be supplied with automatic temperature recording and alarm mechanisms where required. Temperature controls shall be within the limits of current Federal regulation for storage of blood and blood products.

(3) Fire prevention and other safety factors shall meet the requirements of applicable building codes and ordinances.

History

Authority: The provisions of this Chapter 30 issued under section 14 of the Pennsylvania Blood Bank Act (35 P.
Source: The provisions of this Chapter 30 adopted May 13, 1977, 7 Pa.

28 Pa. Code § 30.41 Records.

All licensed blood banks shall maintain records which are adequate to identify all data pertinent to donors, handling and testing of units of blood, disposition of blood from the blood bank, and related information. Records should enable tracing of all units from donor bleeding to final disposition. The records shall include the following:

(1) Donor history, physical examination, any reactions, and results of laboratory tests, including a test for hepatitis-associated antigen. Authorization for bleeding and identification of person taking history and performing the phlebotomy must also be included.

(2) Results of all tests performed on each unit of blood.

(3) Requests for transfusion of blood or blood products, including the full name of the recipient, hospital identification number, sex, amount of blood product required, and the name of the requesting physician.

(4) Disposition of all blood not used for transfusion, including persons or organizations receiving such material, dates, and amounts of the material.

(5) Disposition of all units of blood which are found to contain hepatitis-associated antigen or other contaminants.

(6) Record of transfusions.

(7) Records of adverse reactions to transfusions and subsequent investigations.

History

Authority: The provisions of this Chapter 30 issued under section 14 of the Pennsylvania Blood Bank Act (35 P.
Source: The provisions of this Chapter 30 adopted May 13, 1977, 7 Pa.

28 Pa. Code § 30.42 Registry of hepatitis cases.

(a) All licensed blood banks shall submit the following information on or before the 15th day of each month to the Bureau of Laboratories of the Department.

(1) Identification of all donors whose blood indicates, by a test approved by the Department, the presence of (HBsAg) hepatitis antigen. The identification shall include the name, address and age of donor, and date and place of bleeding and testing.

(2) Names of all donors whose blood was transfused into a recipient who subsequently developed hepatitis. Any related information requested by the Department shall also be supplied. Suitable forms for this purpose will be furnished by the Department.

(b) The Bureau of Laboratories will distribute, at least annually, to each licensed blood bank a list of donors whose blood has been found positive in an accepted test for hepatitis-associated antigen.

History

Authority: The provisions of this Chapter 30 issued under section 14 of the Pennsylvania Blood Bank Act (35 P.
Source: The provisions of this Chapter 30 adopted May 13, 1977, 7 Pa.

28 Pa. Code § 30.50 Plasmapheresis laboratories.

Plasmapheresis laboratories shall be in compliance with all requirements of the applicable Federal Food and Drug Administration Regulations.

History

Authority: The provisions of this Chapter 30 issued under section 14 of the Pennsylvania Blood Bank Act (35 P.
Source: The provisions of this Chapter 30 adopted May 13, 1977, 7 Pa.

28 Pa. Code § 30.51 Manufacture of blood products.

Persons and organizations engaged in the preparation of blood fractions or products for subsequent distribution shall show evidence of compliance with all requirements of the United States Public Health Service and applicable Federal and state regulations. Appropriate records of manufacturing procedures shall be provided to the Department upon request.

History

Authority: The provisions of this Chapter 30 issued under section 14 of the Pennsylvania Blood Bank Act (35 P.
Source: The provisions of this Chapter 30 adopted May 13, 1977, 7 Pa.

28 Pa. Code § 30.52 Compliance with other laws.

Blood banks licensed under this chapter shall be required to comply with all pertinent laws and regulations administered by the Federal Food and Drug Administration and any other Federal agency which regulates blood banks and transfusion services, and with The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. § § 780-101—780-144), and regulations issued thereunder.

History

Authority: The provisions of this Chapter 30 issued under section 14 of the Pennsylvania Blood Bank Act (35 P.
Source: The provisions of this Chapter 30 adopted May 13, 1977, 7 Pa.

28 Pa. Code § 30.60 Hearings and appeals.

If a license is denied or revoked, the applicant or holder of such license shall be entitled to the rights of notification hearings and appeals provided for in section 17 of the Pennsylvania Blood Bank Act (35 P. S. § 6517), and the Administrative Agency Law (71 P. S. § § 1710.1—1710.51) (Repealed), and all the regulations promulgated pursuant to them. The notification provided by section 17 of the Pennsylvania Blood Bank Act shall constitute an order to show cause within the meaning of 1 Pa. Code § 35.14 (relating to orders to show cause).

History

Authority: The provisions of this Chapter 30 issued under section 14 of the Pennsylvania Blood Bank Act (35 P.
Source: The provisions of this Chapter 30 adopted May 13, 1977, 7 Pa.

Part IV Health Facilities

Subpart A General Provisions

Chapter 51 General Information

28 Pa. Code § 51.1 Legal base, scope and definitions.

(a) This subpart implements the act.

(b) This subpart contains standards which are applicable to all entities licensed as health care facilities under the act. It also identifies specific health care services which are restricted to specified health care facilities.

(c) The following words and terms, when used in this subpart have the following meanings, unless the context clearly indicates otherwise: Act—The Health Care Facilities Act (35 P.S. § § 448.101—448.904b). Department—The Department of Health of the Commonwealth.

History

Authority: The provisions of this Chapter 51 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 51 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 51.1a Clarification of nursing qualifications—statement of policy.

For the purposes of applying statutory and regulatory nursing standards and qualifications in this Commonwealth, the following applies:

(1) For a licensed practical nurse, the term includes an individual licensed under the laws of this Commonwealth to practice practical nursing or an individual who holds a privilege to practice as a practical nurse under the Nurse Licensure Compact Act (35 P.S. § § 10291—10295).

(2) For a registered nurse, the term includes an individual licensed under the laws of this Commonwealth to practice professional nursing or an individual who holds a privilege to practice as a registered nurse under the Nurse Licensure Compact Act.

The provisions of this § 51.1a added under the Nurse Licensure Compact Act (35 P.S. § § 10291—10295).

The provisions of this § 51.1a added January 12, 2024, effective January 13, 2024, 54 Pa.B. 148.

History

Authority: The provisions of this Chapter 51 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 51 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 51.2 Licensed facilities.

The Department licenses the following health care facilities under the act:

(1) Ambulatory surgical facilities.

(2) General hospitals.

(3) Special hospitals.

(4) Long-term care nursing facilities.

(5) Birth centers.

(6) Home health care agencies.

(7) Cancer treatment centers.

History

Authority: The provisions of this Chapter 51 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 51 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 51.3 Notification.

(a) A health care facility shall notify the Department in writing at least 60 days prior to the intended commencement of a health care service which has not been previously provided at that facility.

(b) A health care facility shall notify the Department in writing at least 60 days prior to the intended date of providing services in new beds it intends to add to its approved complement of beds.

(c) A health care facility shall provide similar notice at least 60 days prior to the effective date it intends to cease providing an existing health care service or reduce its licensed bed complement.

(d) A health care facility shall submit to the Department architectural plans and blueprints of proposed new construction, alteration or renovation to the facility. This material shall be submitted at least 60 days before the initiation of construction, alteration or renovation. The Department will review these documents to assure compliance with relevant life safety code and other regulatory requirements. The Department will respond to the facility by either issuing an approval or disapproval or requesting further information within 45 days of receipt of the facility’s submission. The facility may not initiate construction, alteration or renovation until it has received an approval from the Department.

(e) If a health care facility is aware of information which shows that the facility is not in compliance with any of the Department’s regulations which are applicable to that health care facility, and that the noncompliance seriously compromises quality assurance or patient safety, it shall immediately notify the Department in writing of its noncompliance. The notification shall include sufficient detail and information to alert the Department as to the reason for the failure to comply and the steps which the health care facility shall take to bring it into compliance with the regulation.

(f) If a health care facility is aware of a situation or the occurrence of an event at the facility which could seriously compromise quality assurance or patient safety, the facility shall immediately notify the Department in writing. The notification shall include sufficient detail and information to alert the Department as to the reason for its occurrence and the steps which the health care facility shall take to rectify the situation. (Editor’s Note: Under section 314 of the Medical Care Availability and Reduction of Error (MCARE) Act (40 P.S. § 1303.314), subsection (f) is abrogated with respect to a medical facility upon the reporting of a serious event, incident or infrastructure failure pursuant to section 313 of the act. See 34 Pa.B. 2516 (May 8, 2004).)

(g) For purposes of subsections (e) and (f), events which seriously compromise quality assurance or patient safety include, but are not limited to, the following:

(1) Deaths due to injuries, suicide or unusual circumstances.

(2) Deaths due to malnutrition, dehydration or sepsis.

(3) Deaths or serious injuries due to a medication error.

(4) Elopements.

(5) Transfers to a hospital as a result of injuries or accidents.

(6) Complaints of patient abuse, whether or not confirmed by the facility.

(7) Rape.

(8) Surgery performed on the wrong patient or on the wrong body part.

(9) Hemolytic transfusion reaction.

(10) Infant abduction or infant discharged to the wrong family.

(11) Significant disruption of services due to disaster such as fire, storm, flood or other occurrence.

(12) Notification of termination of any services vital to the continued safe operation of the facility or the health and safety of its patients and personnel, including, but not limited to, the anticipated or actual termination of electric, gas, steam heat, water, sewer and local exchange telephone service.

(13) Unlicensed practice of a regulated profession.

(14) Receipt of a strike notice.

(Editor’s Note: Under section 314 of the Medical Care Availability and Reduction of Error (MCARE) Act (40 P.S. § 1303.314), subsection (g) is abrogated with respect to a medical facility upon the reporting of a serious event, incident or infrastructure failure pursuant to section 313 of the act. See 34 Pa.B. 2516 (May 8, 2004).)

(h) A health care facility shall send the written notification required under subsections (a)—(f) to the director of the division in the Department responsible for the licensure of the health care facility.

(i) Information contained in the notification submitted to the Department by a facility under subsection (e) or (f) may not, unless otherwise ordered by a court for good cause shown, be produced for inspection or copying by, nor may the contents thereof be disclosed to, a person other than the Secretary, the Secretary’s representative or another government agency, without the consent of the facility which filed the report.

(j) The Secretary and the Secretary’s representative shall use the information contained in the notification from the facility only in connection with the enforcement of the Department’s responsibilities under the act, or other applicable statutes within the Department’s jurisdiction.

(k) The notification requirements of this section do not require a facility, in providing a notification under subsection (e) or (f), to include information which is deemed confidential and not reportable to the Department under other provisions of Federal or State law or regulations.

(l) A health care facility may not commence the provision of new health care services or provide services in new beds until it has been informed by the Department that it is in compliance with all licensure requirements.

The provisions of this § 51.3(f) and (g) abrogated in part under section 314 of the Medical Care Availability and Reduction of Error (MCARE) Act (40 P.S. § 1303.314). See 34 Pa.B. 2516 (May 8, 2004).

The provisions of this § 51.3(f) and (g) abrogated in part June 7, 2004 (40 P.S. § 1303.314). See 34 Pa.B. 2516 (May 8, 2004). Immediately preceding text appears at serial pages (413943) to (413944).

This section cited in 28 Pa. Code § 201.14 (relating to responsibility of licensee); and 28 Pa. Code § 204.2 (relating to building plans).

History

Authority: The provisions of this Chapter 51 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 51 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 51.4 Change in ownership; change in management.

(a) A health care facility shall notify the Department in writing at least 30 days prior to transfer involving 5% or more of the stock or equity of the health care facility.

(b) A health care facility shall notify the Department in writing at least 30 days prior to a change in ownership or a change in the form of ownership or name of the facility. A change in ownership shall mean any transfer of the controlling interest in a health care facility.

(c) A health care facility shall notify the Department in writing within 30 days after a change of management of a health care facility. A change in management occurs when the person responsible for the day to day operation of the health care facility changes.

History

Authority: The provisions of this Chapter 51 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 51 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 51.5 Building occupancy.

(a) New construction, alterations or renovations that provide space for patient or resident rooms or services may not be used or occupied until authorization for the occupancy has been received from the Department.

(b) A health care facility shall request a preoccupancy survey at least 30 days prior to the anticipated occupancy of the facility or an addition or remodeled part thereof. The Department will conduct an onsite survey of the new or remodeled portion of the health care facility prior to granting approval for occupancy. The Department may give the authorization to occupy the new or remodeled portion of the health care facility by an interim written authorization. If interim authorization for occupancy is given, the Department will provide the health care facility with formal authorization within 30 days.

This section cited in 28 Pa. Code § 571.11 (relating to principle); and 34 Pa. Code § 403.22 (relating to health care facilities).

History

Authority: The provisions of this Chapter 51 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 51 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 51.6 Identification of personnel.

(a) When working in a health care facility and when clinically feasible, the following individuals shall wear an identification tag which displays that person’s name and professional designation:

(1) Health care practitioners licensed or certified by Commonwealth agencies.

(2) Health care providers employed by health care facilities.

(b) The identification tag shall include the individual’s full name. Abbreviated professional designations may be used only when the designation indicates licensure or certification by a Commonwealth agency, otherwise the full title shall be printed on the tag.

(c) The last name of the individual may be omitted or concealed when treating patients who exhibit symptoms of irrationality or violence.

This section cited in 28 Pa. Code § 53.2 (relating to requirements).

History

Authority: The provisions of this Chapter 51 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 51 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 51.11 Civil rights compliance

A health care facility shall comply with all civil rights laws. The Department may make onsite visits at its discretion to verify the civil rights compliance status of the health care facility.

History

Authority: The provisions of this Chapter 51 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 51 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 51.12 Nondiscriminatory policy.

(a) A health care facility shall have a nondiscriminatory policy which applies to all patients or residents and staff. The policy shall include a prohibition on the segregation of buildings, wings, floors and rooms for reasons of race, color, national origin, ancestry, age, sex, religion, handicap or disability. The nondiscriminatory policy shall also address the following:

(1) Inpatient or outpatient admission or care.

(2) Assigning patients or residents to rooms, floors and sections.

(3) Asking patients or residents about roommate preferences.

(4) Assignments of staff to patient or resident services.

(5) Staff privileges of professionally qualified personnel.

(6) Utilization of the health care facility.

(7) Transfers of patients or residents from their rooms.

(b) A health care facility is required to comply with Title VI of the Civil Rights Act of 1964 (42 U.S.C.A. § § 2000e—2000e-17) and the Pennsylvania Human Relations Act (43 P. S. § § 951—962.2) and to sign the following statement prior to receiving an initial license:

‘‘This facility has agreed to comply with the provisions of the Federal Civil Rights Act of 1964 and the Pennsylvania Human Relations Act and all requirements imposed pursuant thereto to the end that no person shall, on the grounds of race, color, national origin, ancestry, age, sex, religious creed, or disability, be excluded from participation in, be denied benefits of, or otherwise be subject to discrimination in the provision of any care or service.’’

This section cited in 28 Pa. Code § 51.13 (relating to civil rights compliance records).

History

Authority: The provisions of this Chapter 51 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 51 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 51.13 Civil rights compliance records.

(a) A health care facility shall maintain the following records to show compliance with § 51.12 (relating to nondiscriminatory policy):

(1) A copy of the health care facility’s admission policy which includes the date of its adoption, which sets forth in clear terms nondiscriminatory practices with regard to race, color, national origin, creed, ancestry, age, sex, religion, handicap or disability.

(2) A copy of a signed and dated notification to employes of the health care facility’s nondiscrimination policy.

(3) Evidence that the nondiscriminatory practices of the health care facility have been publicized in the community at least every 3 years by one of the following methods: newspapers, television, radio, brochure or yellow pages.

(b) Copies of the health care facility’s nondiscriminatory policy shall be posted in locations accessible to the facility’s staff and the general public.

(c) The health care facility shall provide the Department with a signed and dated copy of the nondiscriminatory policy within 30 days of the effective date of any change in the policy.

History

Authority: The provisions of this Chapter 51 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 51 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 51.21 Surgery.

Surgery shall be performed only in an acute care hospital or in a Class A, Class B or Class C ambulatory surgical facility.

History

Authority: The provisions of this Chapter 51 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 51 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 51.22 {Abrogated}.

The provisions of this § 51.22 abrogated under section 2 of the act of July 11, 2022 (P.L. 1575, No. 87).

The provisions of this § 51.22 abrogated July 11, 2022 (P.L. 1575, No. 87), effective September 9, 2022. Immediately preceding text appears at serial page (413945).

History

Authority: The provisions of this Chapter 51 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 51 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 51.23 Positron emission tomography.

Positron emission tomography (PET) scanning services shall be provided only in a hospital which complies with the regulations of the Department governing radiology and nuclear medicine services.

History

Authority: The provisions of this Chapter 51 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 51 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 51.24 Lithotripsy.

Lithotripsy services shall be provided only in a hospital or ambulatory surgical facility authorized to provide anesthesia services under its license.

History

Authority: The provisions of this Chapter 51 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 51 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 51.31 Principle.

The Department may grant exceptions to this part when the policy and objectives contained therein are otherwise met, or when compliance would create an unreasonable hardship and an exception would not impair or endanger the health, safety or welfare of a patient or resident. No exceptions or departures from this part will be granted if compliance with the requirement is provided for by statute.

This section cited in 28 Pa. Code § 136.11 (relating to director); 28 Pa. Code § 138.11 (relating to director); 28 Pa. Code § 139.3 (relating to director); 28 Pa. Code § 158.11 (relating to medical director); and 28 Pa. Code § 201.2 (relating to requirements).

History

Authority: The provisions of this Chapter 51 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 51 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 51.32 Exceptions for innovative programs.

This part is not intended to restrict the efforts of a health care facility to develop innovative and improved programs of management, clinical practice, physical renovation or structural design. Whenever this part appears to preclude a program which may improve the capacity of the health care facility to deliver higher quality care and services or to operate more efficiently without compro-mising patient or resident care, the Department encourages the health care facility to request appropriate exceptions under this chapter.

Generally

Multiple hospitals filed petition for review in the nature of an action for mandamus against the Department of Health and others to require the Department to comply with provision in the 2005 General Appropriation Bill compelling Department and others to use portion of appropriations for the ‘‘negotiation of criteria under the angioplasty demonstration project’’; however, because bill sought to compel Department to undertake actions in particular way, the appropriation conflicted with the Health Care Facilities Act that gave Department exclusive jurisdiction over health care providers and was, therefore, unconstitutional. Uniontown Hospital v. Department of Health, 905 A.2d 560, 565 (Pa. Cmwlth. 2006).

This section cited in 28 Pa. Code § 51.13 (relating to civil rights compliance records); 28 Pa. Code § 136.11 (relating to director); 28 Pa. Code § 138.11 (relating to director); 28 Pa. Code § 139.3 (relating to director); 28 Pa. Code § 158.11 (relating to medical director); and 28 Pa. Code § 201.2 (relating to requirements).

History

Authority: The provisions of this Chapter 51 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 51 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 51.33 Requests for exceptions.

(a) A health care facility shall make requests for exceptions to the Department in writing.

(b) The Department will retain the requests on file and document whether they have been approved or disapproved.

(c) Upon receipt of a request for exceptions, the request will be published in the Pennsylvania Bulletin with a public comment period. The Department will review these comments before making a determination to approve or disapprove an exception. The Department will publish requests for exceptions in emergency situations, but will not include a public comment period.

(d) The Department will publish notice of all approved exceptions in the Pennsylvania Bulletin on a periodic basis.

(e) The health care facility shall retain approved requests on file during the period the exception remains in effect.

History

Authority: The provisions of this Chapter 51 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 51 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 51.34 Revocation of exceptions.

(a) An exception granted under this chapter may be revoked by the Department for justifiable reason. The Department will provide notice of the revocation in writing and will include the reason for the revocation and the date upon which the exception will be terminated.

(b) In revoking an exception, the Department will provide for a reasonable period of time between the date of written notice of the revocation and the date of termination of an exception to afford the health care facility an opportunity to come into compliance with the applicable regulations.

(c) If a health care facility wishes to request a reconsideration of a denial or revocation of an exception, it shall do so in writing to the director of the appropriate division within 30 days after service of the adverse notification.

History

Authority: The provisions of this Chapter 51 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 51 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 51.41 Violations, penalties.

(a) When appropriate, the Department will work with the health care facility to rectify a violation of this part.

(b) A health care facility that violates this part may be subject to sanctions by the Department, which include:

(1) Suspension of its license.

(2) Revocation of its license.

(3) Refusal to renew its license.

(4) Limitation of its license as to operation of a portion of the health care facility or to the services which may be provided at the health care facility.

(5) Issuance of a provisional license.

(6) Submission of a plan of correction.

(7) Limitation or suspension of admissions to the health care facility.

History

Authority: The provisions of this Chapter 51 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 51 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

Chapter 53 Photo Identification Badges

28 Pa. Code § 53.1 Legal basis, scope and definitions.

(a) This chapter implements section 809.2 of the act (35 P.S. § 448.809b).

(b) This chapter contains standards which are applicable to the following:

(1) All entities licensed as health care facilities under the act.

(2) The private practice of a physician.

(c) The following words and terms, when used in this chapter, have the following meanings: Direct care—The actual delivery of health care services or assistance with activities of daily living to a consumer or patient. Employee—An employee or a physician of any of the following who delivers direct care to a consumer:

(i) A health care facility.

(ii) A health care provider.

(iii) The private practice of a physician.

(iv) An employment agency. Employment agency—A public or private organization that provides employment services for persons seeking employment and for potential employers seeking employees who provide direct care to consumers. Employment status—Full-time, part-time, temporary, contractual or other classification of work that indicates the relationship between the employee and the health care facility, health care provider or employment agency. Health care facility—A facility licensed by the Department under the act. Health care provider—An individual, a trust or estate, a partnership, a corporation (including associations, joint stock companies and insurance companies), the Commonwealth or a political subdivision or instrumentality (including a municipal corporation or authority) thereof, that operates a health care facility. Outside of the health care facility or employment agency—Health care services that are provided to patients and consumers at a location other than a health care facility or employment agency, such as at the patient or consumer’s residence. Private practice of a physician—

(i) A circumstance in which a health care practitioner or an employee under a health care practitioner’s supervision provides direct care to a patient or consumer.

(ii) This does not include a physician practice group which is owned and operated by a health care provider. Title—A license, certification or registration held by the employee.

28 Pa. Code § 53.2 Requirements.

(a) This chapter applies to an employee who delivers direct care as follows:

(1) Outside of a health care facility or employment agency.

(2) In a health care facility.

(3) At the private practice of a physician.

(b) An employee who delivers direct care outside of a health care facility or employment agency or at the private practice of a physician shall wear a photo identification badge that meets the requirements in § 53.3 (relating to contents of photo identification badge).

(c) An employee who delivers direct care in a health care facility shall wear an identification badge that meets the requirements in § 51.6 (relating to identification of personnel).

28 Pa. Code § 53.3 Contents of photo identification badge.

(a) An employee’s photo identification badge must include the following:

(1) A recent photograph of the employee, updated as provided for in subsection (c).

(2) The employee’s full name to include, at a minimum, the full first and last name.

(3) The employee’s title.

(4) The name of the employee’s health care facility or employment agency.

(b) The identification badge issued by an employment agency for an employee who is providing direct care for a health care facility must include the items in subsection (a). In addition, the health care facility where the employee of the employment agency is working shall issue the employee an identification badge that contains the name of the health care facility, the employment status of the employee at that facility and the employee’s title.

This section cited in 28 Pa. Code § 53.2 (relating to requirements); and 28 Pa. Code § 53.5 (relating to exceptions).

28 Pa. Code § 53.5 Exceptions.

(a) Photograph. A health care facility, health care provider, employment agency or private practice of a physician may permit an employee to wear an identification badge without a photograph if having a photograph taken would violate the tenets of the employee’s religion or religious beliefs.

(b) Policies and procedures for exemption. A health care facility, health care provider, employment agency or private practice of a physician shall establish policies and procedures in the event that an employee requests an exception under subsection (a), which, at a minimum:

(1) Require the employee to submit a signed and notarized statement that the taking of a photograph would violate the employee’s religion or religious beliefs.

(2) Ensure that the employee wears an identification badge that contains the information in § 53.3(a)(2)—(4) (relating to contents of photo identification badge).

(3) Contain the employee’s height and eye color.

(c) Use of identification badge not clinically feasible. An employee may not be required to wear an identification badge while delivering direct care to a patient or consumer if not clinically feasible.

(d) Employee safety. The last name of the employee may be omitted or concealed when delivering direct care to a patient or consumer who exhibits symptoms of irrationality or violence.

(e) Policies and procedures for exemption. A health care facility, health care provider, employment agency or private practice of a physician shall establish policies and procedures in the event that an employee requires an exception under subsection (d), which, at a minimum describe:

(1) The process to be followed in the event that an employee requires an exception.

(2) How employees with the same first name will be differentiated.

Subpart B General and Special Hospitals

Chapter 101 General Information

28 Pa. Code § 101.1 Legal base.

(a) This subpart implements the powers and duties of the Department contained in Chapter 8 of the act of July 19, 1979 (P.L. 130, No. 48) added by the act of July 12, 1980 (P.L. 655, No. 136) (35 P.S. § § 448.801—448.821) known as the Health Care Facilities Act and contained in article II of the act (62 P.S. § § 201—209), as transferred to the Department in Reorganization Plan No. 5 of 1973 (71 P.S. § 755-5).

(b) This subpart establishes standards which the Department hereby brings to the attention of the officers or other persons having the management of licensed general and special hospitals and which, it is the duty of such officers or such other persons to adopt and to put into practice, pursuant to sections 803 and 806 of the act (35 P.S. § § 448.803 and 448.806).

(c) This subpart establishes the rules and regulations for visitation, examination, and inspection of all licensed general and special hospitals, pursuant to sections 810 and 813 of the act (35 P.S. § § 448.810 and 448.813).

(d) This subpart establishes provisions for minimum standards in the construction, maintenance, and operation of hospitals and for the issuance of licenses for general and special hospitals pursuant to sections 803 and 806 of the act.

The provisions of this § 101.1 issued under section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)); and under 803 of the Health Care Facilities Act (35 P.S. § 448.803).

The provisions of this § 101.1 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129 and 4281. Immediately preceding text appears at serial pages (52712) to (52713).

This chapter cited in 55 Pa. Code § 6100.2 (relating to applicability).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.2 Construction and amendment.

This subpart establishes minimum standards with which licensed hospitals must comply. This subpart is subject to revision and reasonable interpretation by the Department in accordance with the changing needs for health services in this Commonwealth.

The provisions of this § 101.2 issued under section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)); and under 803 of the Health Care Facilities Act (35 P.S. § 448.803).

The provisions of this § 101.2 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129 and 4281. Immediately preceding text appears at serial page (52713).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.3 Affected institutions.

This subpart shall apply to all general and special hospitals within this Commonwealth except those hospitals operated by the United States.

The provisions of this § 101.3 issued under section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)); and under 803 of the Health Care Facilities Act (35 P.S. § 448.803).

The provisions of this § 101.3 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129 and 4281. Immediately preceding text appears at serial page (52713).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.4 Definitions.

The following words and terms, when used in this subpart, have the following meanings, unless the context clearly indicates otherwise: Act—Health Care Facilities Act (35 P.S. § § 448.101—448.904). Advanced life support—The invasive prehospital and interhospital emergency medical care of serious illness or injury by trained health professional and allied health professional personnel under the medical command of a physician. Anesthetist—A generic term used to identify anesthesiologists, other qualified physician anesthetists, or qualified nurse or dentist anesthetists. Authenticate—To verify authorship, for example, by written signature, identifiable initials, or computer key; the use of rubber stamp signatures shall be acceptable under the following strict conditions:

(i) The practitioner whose signature the rubber stamp represents is the only one who has possession of the stamp and is the only one who uses it.

(ii) The hospital maintains in its administrative offices a signed statement by the practitioner to the effect that he is the only person who possesses the stamp and is the only one who will use it. Certified medical records practitioner—Either an Accredited Records Technician or a Registered Records Administrator, approved by the American Medical Records Association. Chairman, chief—The director of a medical, clinical service; the term always connotes a physician unless otherwise stated. Chief executive officer—A job descriptive term used to identify the individual appointed by the governing body to act in its behalf in the overall management of the hospital. Clinical privileges—Permission to render medical care in the granting institution rendered pursuant to Chapter 107 (relating to medical staff). Compliance directive—A directive issued by the Department citing deficiencies which have come to the attention of the Department through the survey process or by on-site inspection and directing the hospital to take corrective action as the Department directs or to submit a plan of correction. Consultant—One who provides professional advice or services on request. Deficiency—Any condition which exists contrary to, in violation of, or in noncompliance with this subpart. Department—The Department of Health of the Commonwealth. Where a provision of this subpart confers powers or imposes duties upon the Department, which under a statute may be exercised by or imposed on only the Secretary, the reference to the Department shall be construed to mean the Department acting by and through the Secretary, or the person for the time being acting as the Secretary, personally. Dietetic assistant—A person who has completed a program in food service administration and nutritional care which meets the training standards established by the American Dietetic Association and provides at least 90 clock hours of coursework. Dietetic technician—A person who has completed an associate degree program which meets the educational standards established by the American Dietitian Association; this person works under the direction of a qualified dietitian. Direction—Authoritative policy or procedural guidance for the accomplishment of a function or activity. Director—An individual with administrative responsibility for the direction of a division or service of the hospital. When this term is used in connection with a medical, clinical service, it is synonymous with chairman and does not necessarily imply a salaried or otherwise remunerated individual. Division—An organizational division in the hospital. Drug administration—An act in which a single dose of an identified drug is given to a patient. Drug dispensing—The issuance of floor stocks or of one or more doses of a prescribed medication in containers that are correctly labeled to indicate the name of the patient, the contents of the container, and all other vital information needed to facilitate correct patient usage and drug administration. Emergency contraception—

(i) A drug, drug regime or device approved by the Food and Drug Administration that is used after sexual intercourse to inhibit or prevent ovulation or fertilization.

(ii) The term also includes a drug, drug regime or device approved by the Food and Drug Administration that is used after sexual intercourse to inhibit or prevent the implantation of a fertilized ovum within the uterus. Existing hospital—A facility erected or remodeled for use as a hospital prior to the effective date of this subpart. Ex officio—Position by virtue of or because of an office, with no reference to specific voting power. Facilities—Buildings, equipment, and supplies necessary for implementation of hospital services by personnel. Full-time—The normal or standard working period established by the hospital. General hospital—A hospital equipped and staffed for the treatment of medical or surgical conditions, or both, in the acute or chronic stages, on an inpatient basis of 24 or more hours. Graduate nurse—A graduate of an approved program of professional nursing practicing his profession pursuant to and in accordance with The Professional Nursing Law (63 P. S. § § 211—225). Graduate social worker—A person qualified by a graduate degree from a school of social work accredited by the Council on Social Work Education. Hospital—A facility having an organized medical staff and providing equipment and services primarily for inpatient care to persons who require definitive diagnosis or treatment, or both, for injury, illness, pregnancy, or other disability. House staff/House staff officers—Physicians in training whose clinical privileges are delineated pursuant to Chapter 107. Licensed practical nurse—A person licensed to practice practical nursing pursuant to The Practical Nurse Law (63 P. S. § § 651—667). May—A term used to indicate an acceptable but not mandatory standard, method, process, or result. Medical—Of, pertaining to, or dealing with the healing art and the science of medicine or osteopathy. Must—Synonymous with shall. New construction—New buildings, additions to existing buildings, conversion of existing buildings or portions thereof, or portions of buildings undergoing alterations other than repair. Nuclear medicine—The scientific and clinical discipline concerned with diagnostic, therapeutic-exclusive of sealed radium sources, and investigative use of radionuclides. Nursing care unit—An organized jurisdiction of nursing service in which nursing services are provided on a continuous basis. Nursing service—Patient care services pertaining to the curative, restorative, and preventative aspects of nursing that are performed or supervised by a registered nurse pursuant to the medical care plan of the practitioner and the nursing care plan. Nursing station—The physical area within a patient care unit from which nursing services are provided and where nursing records and supplies are maintained. Organized—Administratively and functionally structured. Organized medical staff—A formal organization of physicians, and dentists with the delegated responsibility and authority to maintain proper standards for medical care. Outpatient service—An organizational unit of the hospital which is designed to support the provision of nonemergency health care services to patients who do not remain in the hospital overnight; the term includes a short-term procedure unit when applicable. Paramedic—An emergency medical technician specifically trained in an advanced program of emergency cardiac and noncardiac care and certified by the Department as qualified to render the services enumerated in section 3 of the act of November 30, 1976 (P. L. 1205, No. 264) (35 P. S. § 6803) otherwise known as an emergency medical technician—paramedic or EMT—paramedic. Patient care unit—A designated area of the hospital where nursing services are provided on a continuous basis. Pharmacy—Any place where the practice of pharmacy is conducted pursuant to the Pharmacy Act (63 P. S. § § 390-1—390-13). Physician—A person licensed to practice medicine or osteopathy. The term is more fully defined in 1 Pa.C.S. § 991. Policy—A heading designating a section of this subpart which is a duty or responsibility only of the Department. Policy regulations carry the force of law when applied to the Department but do not apply to hospitals under this subpart. Practice privileges—Synonymous with clinical privileges. Practitioner—A licensed physician, dentist, or podiatrist. Principle—A term used to indicate the general approach or objective to be accomplished by meeting the standards or other regulations appearing after the stated principle. Professional nurse/registered professional nurse—A person licensed to practice professional nursing pursuant to The Professional Nursing Law (63 P. S. § § 211—225). Provider—An individual; a trust or estate; a partnership; a corporation including associations, joint stock companies, and insurance companies; and the Commonwealth or a political subdivision or instrumentality thereof including a municipal corporation or authority that operates a health care facility. Qualified dietitian—A person who:

(i) Is registered or eligible for registration by the Commission on Dietetic Registration and has at least one year of experience in clinical dietetics and nutrition; or

(ii) Has a baccalaureate degree or advanced degree with major studies in food or nutrition of dietetics and who has at least one year of clinical experience. Qualified nurse anesthetist—A nurse who has been certified as a nurse anesthetist by the American Association of Nurse Anesthetists or who has the equivalent training and experience. Qualified records administrator—Either an Accredited Records Technician or a Registered Records Administrator, approved by the American Medical Records Association. Radiologic technologist—An individual who is a graduate of a program in radiologic technology approved by the Council on Medical Education of the American Medical Association or who has the equivalent of such education and training. Rape crisis center—An office, institution or center that offers assistance to a sexual assault victim or the victim’s family through crisis intervention, medical and legal accompaniment and follow-up counseling. Reportable communicable disease—Any disease for which reports are required pursuant to the provisions of the Disease Prevention and Control Law of 1955 (35 P. S. § § 521.1—521.21). Reference should also be made to Chapter 27, Subchapters B, E and F (relating to selected procedures for preventing disease transmission; and miscellaneous provisions). Respiratory therapy—The provision of ventilatory support and associated services to patients. Secretary—The Secretary of the Department. Service—Used to indicate a functional division of the hospital or of the nursing or medical staff; also used to indicate the delivery of care. Sexual assault—Any offense specified in 18 Pa.C.S. Chapter 31, Subchapter B (relating to definition of offenses), except that the term does not include indecent exposure as defined in 18 Pa.C.S. § 3127 (relating to indecent exposure) or sexual intercourse with an animal as defined in 18 Pa.C.S. § 3129 (relating to sexual intercourse with animal). Sexual assault counselor—A person who is engaged or employed by a rape crisis center that arranges for the provision of services to a sexual assault victim, who has undergone at least 40 hours of sexual assault training and is under the control of a direct services supervisor of a rape crisis center, whose primary purpose is the rendering of advice, counseling or assistance to victims of sexual assault. Sexual assault emergency services—A medical examination, forensic examination, or other procedure or service provided by a hospital to a sexual assault victim because of a sexual assault. Sexual assault victim or victim—A person who has been sexually assaulted. Short-term procedure unit—A unit organized for the delivery of nonemergency surgical services to patients who do not remain in the hospital overnight. Small hospital—A hospital maintaining 100 beds or less, as licensed by the Department. Special care unit—An appropriately equipped area of the hospital where provision has been made for a concentration of physicians, nurses, and others who have special skills and experiences to provide medical care for critically ill patients. Special hospital—A hospital equipped and staffed for the treatment of disorders within the scope of specific medical specialties or for the treatment of limited classifications of diseases in their acute or chronic stages on an inpatient basis of 24 or more hours. Survey—The process of evaluation or reevaluation of the compliance of a hospital with this subpart. Undergraduate social worker—A person qualified by a bachelor’s degree from an undergraduate program in social work accredited by the Council on Social Work Education. Unit—A functional facility of the hospital.

The provisions of this § 101.4 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and under 803 of the Health Care Facilities Act (35 P. S. § 448.803); amended under sections 102, 201(12), 801.1 and 803(2) of the Health Care Facilities Act (35 P. S. § § 448.102, 448.201(12), 448,801a and 448.803(2)); and under section 2102(a) and (g) of The Administrative Code of 1929 (71 P. S. § 532(a) and (g)).

The provisions of this § 101.4 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4192 and 4281; amended January 25, 1985, effective March 27, 1985, 15 Pa.B. 250; amended January 25, 2008, effective January 26, 2008, 38 Pa.B. 573. Immediately preceding text appears at serial pages (244992) to (244994), (287187) to (287188) and (244997).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.6 Contact person.

Any person having questions or comments concerning this subpart may address those questions or comments to:

Bureau of Quality Assurance

Pennsylvania Department of Health

Post Office Box 90

Harrisburg, Pennsylvania 17108

The provisions of this § 101.6 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and under 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 101.6 adopted December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129.

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.11 Principle.

The Department may, and for justifiable reason, grant exceptions to and departures from this subpart when the policy objectives and intentions of this subpart are otherwise met or when compliance would create an unreasonable hardship but would not impair the health, safety, or welfare of any patient.

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.12 Exceptions for innovative programs.

This subpart is not intended to restrict the efforts of any hospital to develop innovative and improved programs of management, clinical practice, physical renovation, or structural design. Whenever the provisions of this subpart appear to preclude any program which may improve the capacity of the hospital to deliver higher quality care and services or to operate more efficiently, the Department encourages the hospital to request appropriate exceptions pursuant to this chapter.

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.13 Requests for exceptions.

Requests for exceptions to this subpart shall be made in writing to the Department. Such requests, whether approved or not approved, will be documented and retained on file by the Department. Approved requests shall be retained on file by the hospital applicant during the period the exception remains in effect.

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.14 Revocation of exceptions.

(a) Any exception granted under this chapter may be revoked by the Department for any justifiable reason. Notice of revocation will be in writing and will include the reason for the action of the Department and a specific date upon which the exception will be terminated.

(b) In revoking an exception, the Department will provide for a reasonable time between the date of written notice of revocation and the date of termination of an exception for the hospital to come into compliance with the applicable regulations. Failure by the hospital to comply after the specified date may result in enforcement proceedings under this chapter.

(c) If a hospital wishes to request a reconsideration of a denial or revocation of an exception, it must do so in writing to the Director of the Bureau of Quality Assurance of the Department within 30 days of receipt of the adverse notification.

The provisions of this § 101.14 issued under 67 Pa.C.S. § § 6101—6104 (Repealed); and Reorganization Plan No. 2 of 1973 (71 P. S. § 755-2) (Renumbered).

The provisions of this § 101.14 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37757).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.21 Classification.

Every hospital licensed under this subpart shall be designated as either a general or special hospital, and this classification shall be noted on its license.

The provisions of this § 101.21 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 101.21 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (66821).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.31 Hospital requirements.

A hospital shall have all of the following:

(1) An organized governing body.

(2) A chief executive officer.

(3) An organized medical staff.

(4) An organized nursing staff.

(5) Medical services, continuous.

(6) Nursing services, continuous.

(7) Permanent on-site facilities for the care of patients 24 hours a day.

(8) A hospital-wide infection control program.

(9) Minimum on-site clinical provisions as follows:

(i) Inpatient care areas equipped with hospital furnishings.

(ii) Nursing care units.

(iii) Diagnostic and treatment areas.

(iv) Supplies and equipment to meet the medical and nursing needs of the patients within the scope of the services provided.

(v) Pharmaceutical services in compliance with Chapter 113 (relating to pharmacy services).

(vi) Facilities for the sterilization of equipment and supplies.

(vii) Treatment equipment for drug, blood, and parenteral fluid administration and for performance of medical or surgical nursing procedures.

(viii) Treatment equipment for the management of common medical or surgical, or both, emergencies, including facilities for cardio-pulmonary resuscitation.

(ix) Medical records services.

(x) Provision for medical social work services in compliance with Chapter 121 (relating to social work services).

(xi) Professional library services in compliance with Chapter 145 (relating to professional library services).

(xii) Provision for therapeutic diets.

(10) Minimum supportive capabilities or facilities as follows:

(i) A safe, structurally sound, habitable, sanitary, fire-resistant physical plant designed and equipped specifically for the delivery of contemporary forms of hospital care.

(ii) Facilities to provide adequate heat, light, ventilation, potable water, sewage disposal, electrical power, internal and external communications, and emergency utility services.

(iii) Sanitary garbage, trash, and waste disposal.

(iv) Internal and external environmental sanitation services.

(v) Sanitary laundry services for hospital garments and linens.

(vi) Sanitary hospital dietary services.

(vii) An internal fire and disaster plan, fire alarm system and evacuation plan.

(viii) Scheduled general and preventive maintenance services for building, services and biomedical equipment.

(ix) Participation with community agencies in the establishment of the role of the hospital in event of external disasters.

(x) Capability for obtaining police and fire protection, emergency transportation, grounds-keeping and snow removal.

(xi) Personnel recruitment, training and continuing education.

(xii) Business management capability.

(xiii) Short- and long-range planning capability.

(xiv) Fiscal services to assure continuity of operation under both normal and emergency conditions.

(xv) Comprehensive policies and standards for assuring the safety of patients, employes and visitors and for protection against malpractice and negligence.

The provisions of this § 101.31 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 101.31 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (66822).

This section cited in 55 Pa. Code § 1181.2 (relating to definitions); and 55 Pa. Code § 1187.2 (relating to definitions).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.41 Principle.

The Department will grant the initial license to operate a new hospital after a survey conducted by the Department indicates that the applicant is in compliance with applicable provisions of this subpart. Such survey shall include an on-site inspection and review of written approvals submitted to the Department by regulatory agencies responsible for building, electric, fire, and environmental safety.

The provisions of this § 101.41 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 101.41 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (66823).

This section cited in 28 Pa. Code § 101.43 (relating to request for application).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.42 Building occupancy.

New construction, alterations, or renovations that provide space for patient services or patient rooms shall not be used or occupied until authorization for such occupancy has been received by the hospital from the Department. It is the responsibility of the hospital to request a preoccupancy survey at least two weeks prior to the anticipated occupancy of a hospital or any addition or remodeled part thereof. The Department will conduct an on-site survey of the new or remodeled portion of the hospital prior to granting approval for occupancy. The Department, acting through the Director of the Division of Hospitals, may give such authorization orally, either in person or by telephone. The Department will provide the hospital with written confirmation of such oral authorization within 30 days.

The provisions of this § 101.42 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803), unless otherwise noted.

The provisions of this § 101.42 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial pages (66823) and (52722).

This section cited in 28 Pa. Code § 101.43 (relating to request for application).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.42a Code compliance.

A hospital shall meet the edition of the National Fire Protection Association 101, Life Safety Code and all applicable appendices which are currently enforced by the Federal government. Hospitals previously in compliance with prior editions of the Life Safety Code will be deemed in compliance with any subsequent edition with the exception of any new renovation or construction, which shall meet the current standard.

The provisions of this § 101.42a issued under section 803 of the Health Care Facilities Act (35 P. S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

The provisions of this § 101.42a adopted January 20, 1984, effective January 21, 1984, 14 Pa.B. 215.

This section cited in 28 Pa. Code § 101.43 (relating to request for application).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.43 Request for application.

The Department will supply the necessary forms for application under § § 101.41, 101.42 and 101.42a (relating to principle; building occupancy; and code compliance).

The provisions of this § 101.43 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 101.43 amended January 20, 1984, effective January 21, 1984, 14 Pa.B. 215. Immediately preceding text appears at serial page (77204).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.51 Policy.

The Department will issue a license valid for two years to any hospital which is in compliance with this subpart.

The provisions of this § 101.51 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 101.51 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (52722).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.52 Nontransfer of license.

A hospital shall advise the Department no later than 90 days prior to an intended change of ownership or control of the hospital. No license shall be transferable to new owners or controlling parties except upon a finding by the Department that they are responsible persons.

The provisions of this § 101.52 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § § 101.52 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (52722).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.53 Void license.

The license of a hospital becomes automatically void when any or all of the following occur:

(1) The license term expires.

(2) The hospital substantially changes its name or location, in which case a new license will be automatically issued upon application by a hospital if the hospital is otherwise in compliance with the applicable provisions of this subpart.

(3) If the hospital locates or relocates services at a site other than the current, contiguous site, it shall notify the Department 30 days prior to such change in order that the Department may determine if a new license is necessary.

The provisions of this § 101.53 issued under section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P.S. § 448.803).

The provisions of this § 101.53 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (52722).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.54 Inpatient bed complement.

A license is issued for approved existing facilities and bed complement. A hospital shall notify the Department when increases in bed complement are scheduled according to the following guidelines:

(1) If the increased bed complement will increase the total number of beds by more than ten beds or by more than 10% of the total bed capacity, the hospital shall not utilize the increased capacity until approval is obtained from the Department.

(2) If the hospital increases the bed complement by not more than ten beds or 10% of the total bed capacity, whichever is less, during a period of a license, prior approval of the Department is not required, although notification of the change must still be made. A hospital must at all times meet the physical plant, staffing, and all other requirements, as defined by this chapter, if additional beds are added.

The provisions of this § 101.54 issued under section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P.S. § 448.803).

The provisions of this § 101.54 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (52723).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.55 Display of license.

The current license shall be displayed in a public and conspicuous place in the hospital.

The provisions of this § 101.55 issued under section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P.S. § 448.803).

The provisions of this § 101.55 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (52723).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.56 Licensure information/application.

(a) Information regarding licensure must be completed annually on forms supplied by the Department. The Annual Hospital Questionnaire shall be completed each year; the Application for Hospital Licensure shall be completed biennially.

(b) If a hospital operates any number or variety of separate or distinct clinical facilities and has been issued a single license, information requested on the questionnaire and application forms must be separate and distinct according to location of facilities listed.

The provisions of this § 101.56 issued under section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P.S. § 448.803).

The provisions of this § 101.56 adopted December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129.

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.61 Policy.

Representatives of the Department will biennially conduct a survey of every hospital required to be licensed under this subpart or will conduct surveys in conjunction with representatives of accrediting agencies in Appendix A and in accordance with § 101.62 (relating to combined survey).

(Editor’s Note: Appendix A appears at the end of Subchapter B, Chapter 158.)

The provisions of this § 101.61 issued under section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P.S. § 448.803).

The provisions of this § 101.61 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (52723).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.62 Combined survey.

(a) A provider may request that the Department consider, during the determination of the Department whether a particular hospital is in compliance with these regulations, the survey report of the Federal government or a nationally recognized accrediting agency if the provider has been issued a regular license covering the particular hospital to be surveyed for the last 3 years.

(b) If a provider requests to be licensed in accordance with subsection (a), it must submit to the Department a copy of the accrediting survey report of the agency within 7 days of receipt.

(c) If a provider requests to be licensed in accordance with subsection (a), it must comply with all requirements of this subpart. The requirements that are not covered by the standard survey of each approved accrediting agency are listed in Appendix B.

(d) The Department will have the sole authority to accept or reject, in whole or in part, the findings of the accrediting agency.

(1) If the accrediting findings of the agency are rejected, a full or partial survey at the discretion of the Department will be conducted by the surveyors of the Department to determine whether a license can be issued.

(2) If the accrediting agency denies accreditation to a provider, a full State survey will be conducted to determine whether a license can be issued.

(3) If a provider chooses not to apply for a license through the accrediting procedure even though qualified to do so under this section, a full State survey will be conducted to determine whether a license can be issued.

(4) For those portions of the accrediting agency survey report which the Department accepts as evidence that the provider is meeting the provisions of this subpart, the provider will be considered to be in full compliance with the corresponding provisions of this subpart.

(Editor’s Note: Appendix B appears at the end of Subchapter B, Chapter 158.)

The provisions of this § 101.62 issued under section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P.S. § 448.803).

The provisions of this § 101.62 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129 and 4281. Immediately preceding text appears at serial pages (52723) to (52724).

This section cited in 28 Pa. Code § 101.61 (relating to policy).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.63 Department responsibilities.

The Department will provide the Department of Environmental Protection with its schedule for biennial hospital licensure inspections at a reasonable time in advance of such inspections. It will also be responsible for updating this schedule promptly as required in the event of any changes. The Department will exert every effort to coordinate and cooperate with DER in the exercise of their duties to enforce all applicable environmental, health, sanitation and safety standards under their jurisdiction.

The provisions of this § 101.63 issued under section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P.S. § 448.803).

The provisions of this § 101.63 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial pages (52725) and (37762).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.64 Hospital responsibilities.

A hospital shall comply with all applicable environmental, health, sanitation, and life-safety standards which are not under the direct jurisdiction of the Department. This shall include, but not be limited to, radiologic health, sanitation, food service, pharmacy, electric wiring and life-safety code compliance. When the hospital has been inspected by another regulatory agency, it shall have on the record during the survey by the Department written confirmation of compliance as provided by the rules and regulations of appropriate agencies.

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.65 Notice of biennial survey.

The Department will give reasonable notice to a hospital of its intent to conduct the site visit component of the biennial survey.

The provisions of this § 101.65 issued under section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P.S. § 448.803).

The provisions of this § 101.65 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (37762).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.66 Presurvey preparation.

Prior to a biennial survey site visit of a hospital by the Department, the Department may request from the hospital any documents, records, necessary consents to review the records of the hospital held by other organizations or agencies, or other information necessary for the Department to prepare for the site visit. The hospital shall provide any and all information or consents so requested.

The provisions of this § 101.66 issued under section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P.S. § 448.803).

The provisions of this § 101.66 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (37762).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.67 Access by the Department.

(a) Upon presenting the official Department of Health identification card to the hospital’s chief executive officer or his designee, authorized agents of the Department shall have access to the hospital to determine compliance with this subpart. Such access shall include:

(1) Entry to all hospital premises.

(2) Inspection and examination of all of the facilities, records, documents, and phases of operations, as permitted by law, including those relating to compliance with Chapter 103 (relating to governance and management).

(3) Interviewing of any staff, employes, members of the governing body and patients, subject to subsection (b).

(4) Examination of any patient, with his consent.

(b) The Department will not interview any patient in intensive care or for whom the order of the attending physician specifically limits visitors, without first seeking the consent of the attending physician.

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.68 Site survey coverage.

The Department may survey onsite only those aspects of the hospital as it deems necessary to fully and fairly assess the compliance of the hospital with this subpart.

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.69 Documentation.

The Department will document the extent of the compliance of a hospital with this subpart in at least one of the following ways:

(1) The statement of a responsible, authorized administrator or staff member.

(2) Documentary evidence provided by the facility.

(3) Answers by the hospital to detailed questions provided by the Department concerning the implementation of any provision of this subpart or examples of such implementation which will enable a judgment about compliance to be made.

(4) On-site observation by surveyors.

(5) Interviews with patients, employes or other persons or sources capable of providing reliable information to the Department.

The provisions of this § 101.69 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 101.69 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (37763).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.71 Policy.

After completion of the site visit, the Department will evaluate all relevant information gathered during the survey, formulate its compliance findings and determinations, notify the hospital of its findings and determinations, and order the hospital to correct, within a specified period of time, any deficiencies found.

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.72 Compliance directive.

(a) In the event of noncompliance with any provision of this subpart, the Department will notify the hospital, in writing, of any deficiencies and will direct the officers governing or managing the hospital to take such corrective action as the Department directs or to submit a plan of correction, or to do both, within the time specified by the Department. In its compliance directive and request for plan of correction, the Department will state its findings and the reasons for its determination.

(b) The hospital shall be presumed to be in compliance with any provision of this subpart for which the compliance directive does not cite a deficiency.

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.73 Submission of plan of correction.

Unless Federal regulations require an earlier submission, a plan of correction shall be submitted to the Department within the period specified by the Department. The plan shall be attested to by the signature of the chairman of the governing body or the chief executive officer. The plan of correction shall be submitted to the governing body as a whole for its review at its next regular meeting.

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.74 Content of plan of correction.

A plan of correction shall address all deficiencies cited in the compliance directive of the Department. The plan shall state specifically what corrective action is to be taken, by whom, and when.

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.75 Public inspection of compliance documents.

Copies of compliance directives and plans of correction will be kept readily available by the Department’s Division of Hospitals or its successor in appropriate regional offices for the purpose of public inspection, examination, and duplication at a reasonable cost. Each hospital shall make available for inspection and examination by any person a current copy of these documents provided to it by the Department.

The provisions of this § 101.75 issued under 67 Pa.C.S. § § 6101—6104 and Reorganization Plan No. 2 of 1973 (71 P. S. § 755-2).

The provisions of this § 101.75 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37764).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.81 Unannounced surveys.

Whenever the Department has received any complaint or has other reasonable grounds to believe that a deficiency exists, the Department may without notice to the hospital, investigate, inspect or survey any service, facility, or portion of the hospital to which the alleged deficiency relates.

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.91 Principle.

The Department will issue hospital licenses to qualified facilities. The license will reflect a regular or provisional status of the hospital. The license shall apply only to those facilities designated.

The provisions of this § 101.91 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 808 of the Health Care Facilities Act (35 P. S. § 448.808).

The provisions of this § 101.91 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (52727).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.92 Regular license.

(a) The Department will issue a regular 2-year license to a hospital when that hospital is in full compliance with section 808 of the act (35 P. S. § 448.808) and is in full or substantial compliance with the provisions of this subpart.

(b) As used in subsection (a), ‘‘full compliance’’ means total compliance; as used in subsection (a), ‘‘substantial compliance’’ means:

(1) That any deficiencies are, individually and in combined effect, of a minor nature such that neither the deficiencies nor efforts toward their correction will:

(i) Interfere with or adversely affect normal hospital operations; or

(ii) Adversely affect any patient’s health or safety; and

(2) That the hospital has adopted a plan of correction approved by the Department.

The provisions of this § 101.92 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 808 of the Health Care Facilities Act (35 P. S. § 448.808).

The provisions of this § 101.92 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial pages (52727) to (52728) and (37766).

This section cited in 28 Pa. Code § 101.101 (relating to grounds); 28 Pa. Code § 101.102 (relating to modification of license); and 28 Pa. Code § 101.111 (relating to policy).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.93 Provisional license.

(a) The Department may issue a provisional license, valid for a specified time period of no more than 6 months, when there are numerous deficiencies or a serious specific deficiency in compliance with applicable statutes, ordinances or regulations but when:

(1) The hospital is taking appropriate steps to correct the deficiencies in accordance with a timetable submitted by the hospital and agreed upon by the Department.

(2) There is no pattern of repeat deficiencies over a period of 2 or more years.

(b) A provisional license may be renewed no more than three times at the discretion of the Department.

(c) A provisional license may not be issued to allow services or facilities, or parts of facilities, which are subject to Certificate of Need review, but have not been submitted for such review, to be operated pending completion of Certificate of Need review.

The provisions of this § § 101.93 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 808 of the Health Care Facilities Act (35 P. S. § 448.808).

The provisions of this § 101.93 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (37766).

This section cited in 28 Pa. Code § 101.101 (relating to grounds); and 28 Pa. Code § 101.102 (relating to modification of license).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.101 Grounds.

(a) The Department may revoke or refuse to issue a license for any of the following reasons:

(1) Failure to comply with any compliance directive issued by the Department.

(2) Violation of or noncompliance with this subpart except when the hospital is in full compliance or substantial compliance as defined in § 101.92(b) (relating to regular license) or otherwise meets the conditions set forth in § 101.93 (relating to provisional license).

(3) Failure to correct any deficiency pursuant to a plan of correction, unless the Department approves an extension or modification of the plan of correction.

(4) Gross incompetence, negligence or misconduct in operating the hospital.

(5) Fraud, deceit, misrepresentation or bribery in obtaining or attempting to obtain a license.

(6) Lending, borrowing, or using the license of another hospital.

(7) Knowingly aiding or abetting in any way the improper granting of a license.

(8) Mistreating or abusing individuals cared for by the hospital.

(9) A pattern of continued noncompliance, in disregard of regulations, which is corrected only when actively supervised by the Department.

(b) Failure to obtain a Certificate of Need will necessitate a licensure modification to exclude the service lacking certificate of need approval.

The provisions of this § 101.101 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 101.101 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial pages (37766) to (37767).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.102 Modification of license.

The Department may modify a license by substituting a provisional license for a regular license whenever the Department determines that the hospital is not in full compliance or substantial compliance as defined in § 101.92(b) (relating to regular license) but the hospital otherwise meets the requirements of § 101.93(b) (relating to provisional license).

The provisions of this § 101.102 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 101.102 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (37767).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.103 Notice.

Whenever the Department proposes to revoke, modify or refuse to issue a license or to issue a provisional license, or to suspend admissions or withholds State funds available to the hospital, it will give written notice to the hospital by certified mail.

The provisions of this § 101.103 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 101.103 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (37767).

This section cited in 28 Pa. Code § 101.104 (relating to form of notice); and 28 Pa. Code § 101.121 (relating to demand for hearing).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.104 Form of notice.

A notice under § 101.103 (relating to notice) will conform to 1 Pa. Code § 35.14 (relating to orders to show cause). The order will specify the reasons for the proposed action of the Department and will notify the hospital of its right to a hearing. The order will specify the time within which the request of the hospital for a hearing must be filed with the Department.

The provisions of this § 101.104 issued under sections 2101—3002 of The Administrative Code of 1929 (71 P. S. § § 531—732); Articles IX and X of the Public Welfare Code (62 P. S. § § 901—1059); and Reorganization Plan No. 3 of 1975.

The provisions of this § 101.104 adopted December 9, 1977, 7 Pa.B. 3631.

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.111 Policy.

Whenever any hospital notifies the Department that it has completed a plan of correction and corrected its deficiencies, the Department will conduct a survey to ascertain completion of the plan of correction. Upon finding full or substantial compliance, as defined in § 101.92(b) (relating to regular license), the Department may issue a regular license.

The provisions of this § 101.111 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 101.111 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (37768).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.121 Demand for hearing.

The Department will convene and conduct a hearing for any hospital which requests, in accordance with 1 Pa. Code § 35.37 (relating to answers to orders to show cause) and this chapter, a hearing to contest an order to show cause issued pursuant to § 101.103 (relating to notice).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.122 Conduct of proceedings.

Any administrative hearing held pursuant to this subpart shall be conducted in accordance with 1 Pa. Code Part II (relating to general rules of administrative practice and procedure).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.141 Principle.

The Department will enforce this subpart and its recommendations and directives through all lawful and appropriate means.

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.142 Withhold State funds.

After proper notice and the opportunity for a hearing, the Department may withhold, in whole or in part, any and all State funds available to any hospital which does either:

(1) Fails to comply with a compliance directive without having timely requested a hearing.

(2) Operates without a valid license.

The provisions of this § 101.142 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 101.142 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (37769).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.143 Judicial proceedings and injunctions.

The Department may request the Office of Attorney General to institute appropriate legal proceedings to enforce compliance with this subpart.

The provisions of this § 101.143 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 101.143 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (37769).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.151 Principle.

All hospitals shall comply with the Child Protective Services Law, 23 Pa.C.S. § § 6301—6384, and with any regulations promulgated thereunder by the Department of Public Welfare.

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.161 Principle.

Hospitals shall comply with the Pennsylvania Human Relations Act (43 P. S. § § 951—963) and 16 Pa. Code Part II, Subpart A (relating to Human Relations Commission).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.162 Civil rights compliance.

Civil rights compliance shall be a condition required for the issuance of a license. The Department may make onsite visits at its discretion to verify the civil rights compliance status of the hospital.

The provisions of this § 101.162 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 101.162 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (52730).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.163 Compliance requirements.

(a) Inpatient and outpatient care including all clinic locations, emergency room care and any contracted services for patients shall be provided without regard to race, color, national origin, sex or sexual preference or religion.

(b) All patients shall be assigned to rooms, floors and sections in accordance with their medical needs.

(c) Patients shall not be asked whether they are willing or desire to share a room with a person of another race or religion.

(d) Employes shall be assigned to patient services without regard to the race, color, national origin, or religion of either the patient or employe.

(e) Transfer of patients from rooms assigned or selected, or both, shall not be made for other than valid medical reasons.

(f) At discharge, patients shall be referred only to those skilled nursing care facilities, intermediate care facilities, personal care facilities or foster homes which are not known to the hospital to be in noncompliance with the provisions of the Pennsylvania Human Relations Act (43 P. S. § § 951—963). The hospital shall report immediately to the Compliance Office of the Department all instances of posthospital discriminatory practices experienced by patients referred by the hospital when such practices are brought to the attention of the hospital.

(g) All training programs and opportunities offered by the hospital shall be open to qualified applicants without regard to race, creed, color, national origin, sex, or, in nonsectarian hospitals, religion; and recruitment efforts for these shall include sources having potential racial minority applicants.

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.164 Civil rights compliance records.

The following records shall be maintained to indicate that no person is excluded from participation in, is denied the benefits of, or is otherwise subjected to discrimination in the provision of any care or services on the ground of race, creed, color, sex, sexual preference, national origin or religion.

(1) A signed and dated copy of the policies of the hospital pertaining to the admission of patients and visitors. The date the policies were adopted shall also be indicated. The policies shall set forth in clear terms nondiscriminatory practices with regard to race, creed, color, religion, national origin, sex or sexual preference.

(2) Copies of signed and dated notification forms by which doctors and other persons who normally refer to admit patients to the hospitals have been informed of the nondiscriminatory admission policy of the hospital.

(3) A copy of the date, notification, and description of the continuing method used to inform employes of the nondiscriminatory policies.

(4) Evidence that nondiscriminatory practices of the facility have been publicized in the community by one of the following methods: newspaper, radio, television, brochure, yellow pages in the telephone book, patient handbooks and so on.

(5) Records, by race, showing the utilization of inpatient rooms; intensive care and other units; outpatient clinics; emergency rooms; and referrals to nursing homes or other posthospital care facilities, homes, or agencies and showing the participation in training programs for such periods of time as may be required by the Department to determine compliance with the Pennsylvania Human Relations Act (43 P. S. § § 951—963).

(6) Written personnel policies giving evidence that employment practices of the hospital are in conformity with the Pennsylvania Human Relations Act (43 P. S. § § 951—963). These policies shall be made available to all employes and shall be discussed with each new employe.

(7) The stated ethical policy of the hospital, as defined in 16 Pa. Code § 51.2 (relating to definitions) with regard to abortion or sterilization if the hospital has adopted such a policy pursuant to 16 Pa. Code § 51.31 (relating to adoption and substance of a stated ethical policy) and any written objections to participating in such procedures submitted by any employe or staff member pursuant to 16 Pa. Code § 51.41 (relating to written objection to performance, participation in or cooperation in abortion or sterilization procedures).

(8) Such other records or reports as may be required by the Department, from time to time, to determine compliance with the Pennsylvania Human Relations Act (43 P. S. § § 951—963). This includes the competion of the Department’s Civil Rights Compliance Form.

The provisions of this § 101.164 issued under 67 Pa.C.S. § § 6101—6104; and Reorganization Plan No. 2 of 1973 (71 P. S. § 755-2).

The provisions of this § 101.164 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial pages (37770) to (37771).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.165 Ethnic language barriers.

When it is substantiated that the regular patient population of the hospital contains a foreign language speaking population for whom the language barrier constitutes a service disadvantage, the hospital should do all of the following:

(1) Have a roster of bilingual personnel or volunteers, or both.

(2) Post bilingual signs and have other printed materials, such as hospital handbooks, medical care instructions and follow-up care, readily available.

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.172 Patient limits.

The number of patients admitted to any area of the hospital shall not exceed the number for which the area is designed, equipped, and staffed except in cases of emergency, and then only in accordance with the emergency or disaster plan of the hospital.

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.181 Principle.

License fees will be charged and collected in accordance with section 807 of the act (35 P. S. § 448.807).

The provisions of this § 101.181 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 101.181 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (52733).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.191 Multiple-clinical facilities.

A general or special hospital or medical center may operate any number of separate or distinct clinical facilities under its ownership and direct management. Such facilities may be structurally integrated or may be physically located elsewhere. The Department will rule on all requests for single licensing of multiple-clinical facilities according to pre-established criteria which are available from the Department. All such patient care facilities except physicians’ offices shall be subject to appropriate onsite inspection and survey to determine whether there is compliance with applicable provisions of this subpart.

The provisions of this § 101.191 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 101.191 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (52733).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.192 Owners or controlling persons.

A hospital shall provide the Department with a written list of the names and addresses of all persons having a 5.0% or more ownership or controlling interest in the hospital. As used in this section, ‘‘person’’ means any natural person, partnership, or corporate entity, including any public agency or religious, fraternal or philanthropic organization.

The provisions of this § 101.192 issued under 67 Pa.C.S. § § 6101—6104 (Repealed); and Reorganization Plan No. 2 of 1973 (71 P. S. § 755-2) (Renumbered).

The provisions of this § 101.192 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37773).

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.193 Incorporated hospitals.

If a hospital is incorporated, it shall provide the Department, upon request, with a written list of the names and addresses of the hospital or parent corporation’s officers, directors, and principal stockholders, either beneficial or of record.

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.194 Nonprofit corporation hospital.

Every hospital which is organized as a nonprofit corporation shall file with the Department a copy of its charter and articles of incorporation certified from the public record. It shall be the responsibility of the hospital to promptly submit to the Department a copy of any amendments or changes to the original charter.

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

28 Pa. Code § 101.196 Notice of closure.

A hospital shall give written notice of an intent to close to the Department, not later than 90 days prior to the anticipated date of closing.

History

Authority: The provisions of this § 101.
Source: The provisions of this § 101.

Chapter 105 Admission and Discharge

28 Pa. Code § 105.1 Principle.

The hospital shall have written policies for the admission, discharge, and proper referral of all patients who present themselves for care. Criteria should specify additional approaches to assure appropriate utilization of hospital resources such as preadmission testing, ambulatory care programs and short-term procedure units.

History

Authority: The provisions of this § 105.
Source: The provisions of this § 105.

28 Pa. Code § 105.11 Access.

(a) No person seeking necessary medical care from the hospital shall be denied such care for reasons not based on sound medical practice or the hospital’s charter and, particularly, no such person shall be denied such care on account of race, creed, color, religion, sex or sexual preference, in accordance with the provisions of the Pennsylvania Human Relations Act (43 P.S. § § 951—963).

(b) When the hospital does not provide the services required by a patient or a person seeking necessary medical care, an appropriate referral shall be made. No hospital shall be required to make any referral which is contrary to its stated ethical policy promulgated in accordance with 16 Pa. Code § 51.31 (relating to adoption and substance of a stated ethical policy).

(d) Those facilities having an obligation under 42 U.S.C.A. § 291 shall comply with the provisions of that Act as it relates to free and low-cost care.

History

Authority: The provisions of this § 105.
Source: The provisions of this § 105.

28 Pa. Code § 105.12 Admission criteria.

The governing body, with the advice of and in conjunction with the medical staff, shall establish medical criteria for admissions to ensure provision of care based on medical necessity and appropriateness.

This section cited in 28 Pa. Code § 141.23 (relating to medical appraisal of dental patients); and 28 Pa. Code § 143.4 (relating to medical appraisal of a podiatric patient).

History

Authority: The provisions of this § 105.
Source: The provisions of this § 105.

28 Pa. Code § 105.13 Alternate admissions arrangements.

When, according to established criteria and the opinion of the attending physician, a patient requires inpatient care but, for any reason, cannot be admitted to the hospital, the hospital or attending physician, or both, should assist the patient in making arrangements for care in an alternate facility so as not to jeopardize the health and safety of the patient.

This section cited in 28 Pa. Code § 141.23 (relating to medical appraisal of dental patients); and 28 Pa. Code § 143.4 (relating to medical appraisal of a podiatric patient).

History

Authority: The provisions of this § 105.
Source: The provisions of this § 105.

28 Pa. Code § 105.14 Admission diagnosis.

Each patient who is admitted shall be given a provisional diagnosis, entered on the clinical record, at the time of admission.

This section cited in 28 Pa. Code § 141.23 (relating to medical appraisal of dental patients); and 28 Pa. Code § 143.4 (relating to medical appraisal of a podiatric patient).

History

Authority: The provisions of this § 105.
Source: The provisions of this § 105.

28 Pa. Code § 105.15 Patient identification.

At the time of admission or as soon as possible thereafter, each patient shall be fitted with an identification band or other visible means of identification.

History

Authority: The provisions of this § 105.
Source: The provisions of this § 105.

28 Pa. Code § 105.22 Discharge planning.

(a) Discharge planning shall be an integral part of the hospitalization of each patient and shall commence as soon as possible after admission. When the hospital determines no discharge planning is necessary in a particular case, that conclusion shall be noted on the medical record of the patient.

(b) The hospital shall have written policies governing discharge planning. These shall include but need not be limited to the following:

(1) Appropriate referral and transfer plans.

(2) Methods to facilitate the provision of follow-up care.

(3) Information to be given to the patient or his family or other persons involved in caring for the patient on matters such as the patient’s condition; his health care needs; the amount of activity he should engage in; any necessary medical regimens including drugs, diet, or other forms of therapy; sources of additional help from other agencies; and procedures to follow in case of complications. This information should be provided by the attending physician.

(4) Procedures for assisting the patient and his family in gaining information regarding financial assistance in paying bills incurred as a result of the hospitalization. The procedures shall specify how the patient is to be informed where relevant information can be obtained, how relevant hospital information is to be made available in a timely and useful manner, and how the hospital will affirmatively inquire into the eligibility of the patient for assistance from the various Federal and State government programs, for example, Medicare, Medicaid, Hill-Burton.

History

Authority: The provisions of this § 105.
Source: The provisions of this § 105.

28 Pa. Code § 105.23 Transfer agreements.

(a) Any hospital which does not provide extended care, subacute care, long-term care, or intermediate care shall maintain, to the extent possible, written agreements with institutions offering these kinds of care. Such agreements shall provide for the prompt transfer and admission of patients who no longer require the services of the hospital but do require one of the aforementioned kinds of institutional care.

(b) The hospital shall have written policies, adopted by the governing body, prohibiting transfer agreements which violate the provisions of § 103.9 (relating to conflicts of interest) or which could jeopardize the health of patients.

History

Authority: The provisions of this § 105.
Source: The provisions of this § 105.

28 Pa. Code § 105.24 Discharge by transfer.

A patient shall not be transferred to another medical care facility unless prior arrangements for admission have been made. Clinical records of sufficient content to insure continuity of care shall accompany the patient.

History

Authority: The provisions of this § 105.
Source: The provisions of this § 105.

28 Pa. Code § 105.25 Discharge of minor or incompetent patient.

Any individual who cannot legally consent to his own care shall be discharged only to the custody of parents, legal guardian, person standing in loco parentis, or another responsible party unless otherwise directed by the parent or guardian or court of competent jurisdiction. If the parent or guardian directs that discharge be made otherwise, he shall so state in writing, and the statement shall become a part of the permanent medical record of the patient.

The provisions of this § 105.25 issued under 67 Pa.C.S. § § 6101—6104; and Reorganization Plan No. 2 of 1973 (71 P. S. § 755-2).

The provisions of this § 105.25 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37791).

History

Authority: The provisions of this § 105.
Source: The provisions of this § 105.

Chapter 107 Medical Staff

28 Pa. Code § 107.1 Principle.

There shall be an organized medical staff which is accountable to the governing body and which has responsibility for the quality of all medical care provided to patients and for the ethical conduct and professional practice of its members.

History

Authority: The provisions of this § 107.
Source: The provisions of this § 107.

28 Pa. Code § 107.2 Medical staff membership.

The medical staff shall be limited to physicians and dentists who have made application in accordance with the bylaws, rules, and regulations of the medical staff and with the bylaws of the hospital. Each member of the medical staff shall be qualified for membership and the exercise of clinical privileges granted to him. The medical staff must define in bylaws the requirements for admission to staff membership and for the delineation and retention of clinical privileges. The governing body of the hospital, after considering the recommendations of the medical staff, may grant clinical privileges to other qualified, licensed practitioners in accordance with their training, experience, and demonstrated competence and judgment. Members of the medical staff and those granted clinical privileges shall currently hold licenses to practice in this Commonwealth.

History

Authority: The provisions of this § 107.
Source: The provisions of this § 107.

28 Pa. Code § 107.3 Requirements for membership and privileges.

(a) In order to receive favorable recommendation for appointment or reappointment, members of the medical staff must always act in a manner consistent with the highest ethical standards and levels of professional competence.

(b) Privileges granted shall be commensurate with an individual’s qualifications, experience, and present capabilities.

(c) No applicant shall be denied medical staff privileges on the basis of sex, race, creed, color, or national origin or on the basis of any other criterion lacking professional or ethical justification, including association with a prepaid group practice.

History

Authority: The provisions of this § 107.
Source: The provisions of this § 107.

28 Pa. Code § 107.4 Medical staff status.

(a) Every hospital shall have an active medical staff to deliver the preponderance of medical services within the hospital. The active medical staff shall be responsible for its own organization and administration and should perform all significant duties pertaining thereto. Every member of the active medical staff shall be eligible to vote at staff meetings and to hold office.

(b) In addition to the active medical staff, the hospital may provide for additional kinds of medical staff privileges as delineated in subsection (c). The existence of additional staff categories shall in no way modify the privileges, duties, and responsibilities of the active medical staff.

(1) Associate medical staff. There may be an associate medical staff consisting of individuals who are being considered for advancement to the medical staff. Members of the associate medical staff shall be appointed and assigned to departments or services in the same manner as are members of the active medical staff. Although they may not hold office, they may serve on some medical staff hospital committees. The active medical staff should determine the extent of voting privileges to be granted to members of the associate medical staff.

(2) Courtesy medical staff. There may be a courtesy medical staff consisting of those medical practitioners eligible for staff membership who are given privileges to admit an occasional patient to the hospital. Courtesy staff members may neither vote nor hold office. Because admission of patients to the hospital is an exercise of a privilege and, therefore, is accompanied by a responsibility, admission of more than an occasional patient should require the practitioner to seek membership on the active medical staff.

(3) Temporary medical staff privileges. Temporary clinical privileges at the time of emergency or locum tenens may be granted to a medical practitioner for a limited and stated period on the recommendation of the chief of the applicable department/service or the president of the staff and with the concurrence of the chief executive officer.

(4) Consulting medical staff. There may be a consulting medical staff consisting of medical practitioners of recognized professional ability who are not members of another category of the medical staff and who have signified willingness to accept appointment to the consulting staff. Members of the consulting staff may neither vote nor hold office.

(5) Honorary medical staff. There may be an honorary medical staff consisting of former staff members, retired or emeritus, and of other practitioners of outstanding reputation whom the medical staff desires to honor. Those who are members of the honorary medical staff exclusively may neither vote nor hold office.

(d) Applicants approved for membership on the active, associate, or courtesy staff shall serve an initial provisional staff appointment. During this appointment, they must be assigned to departments services where their clinical competence and their ethical and moral conduct may be observed by a designated member of the active medical staff until such time as the probationary requirements established by the medical staff have been fulfilled.

History

Authority: The provisions of this § 107.
Source: The provisions of this § 107.

28 Pa. Code § 107.5 Membership appointment and reappointment.

(a) The governing body shall affirm or refuse the appointment of any physician or dentist to the medical staff or the granting of clinical privileges to any practitioner after considering the recommendation of the active medical staff in accordance with the procedure established pursuant to subsection (b).

(b) Formal application for membership and for granting of clinical privileges shall follow established procedures set forth in the bylaws, rules and regulations of the medical staff. These procedures shall provide the following:

(1) A written record of the application, which shall include the scope of privileges sought and granted.

(2) A review, summarized on record with appropriate documentation, of the qualifications of the applicant.

(3) A reasoned statement, in writing, by the medical staff recommending or declining to recommend the applicant.

(4) Written notice to the applicant of the recommendation of the medical staff, including notice of an applicant’s right to a hearing and reexamination before the medical staff or the governing body, or both.

(5) A review by a joint committee of the active medical staff and the governing body in cases where the governing body does not concur in the medical staff’s recommendation regarding the granting or refusing of clinical privileges. Such review shall occur prior to the rendering of a final decision by the governing body.

(c) Reappointment shall be required of every member of the medical staff at regular intervals no longer than every 2 years.

(d) No appointment or reappointment to the medical staff shall be denied on the basis of sex, race, creed, color or National origin.

The provisions of this § 107.5 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 107.5 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (52759).

History

Authority: The provisions of this § 107.
Source: The provisions of this § 107.

28 Pa. Code § 107.11 Principle.

The medical staff shall develop and adopt, subject to the approval of the governing body, a set of bylaws, rules and regulations.

History

Authority: The provisions of this § 107.
Source: The provisions of this § 107.

28 Pa. Code § 107.12 Content of bylaws, rules and regulations.

The medical staff bylaws, rules and regulations shall provide for at least the following:

(1) Organizational structure. The organizational structure of the medical staff, consistent with § § 107.21—107.26 (relating to organization of the medical staff) shall be delineated.

(2) Staff privileges. Qualifications for staff membership shall be specified, as shall procedures for admission, retention, assignment and reduction or withdrawal of privileges. This delineation of privileges shall also address specifically the privileges of house staff and house staff officers.

(3) Credentials review. The bylaws shall establish procedures and standards whereby staff credentials will be reviewed.

(4) Appeals. The bylaws shall provide for the establishment of fair hearing and appellate review mechanisms, which will be available if requested by the practitioner in connection with medical staff recommendations for denial of staff appointments, as well as the denial of reappointments, or the curtailment, suspension or revocation of privileges. It is recognized that the mechanism for individuals applying for initial medical staff appointments or privileges may differ from that which is applicable to medical staff members.

(5) Nonphysician clinical privileges and duties. Clinical privileges and duties of specified professional personnel, as defined in paragraph (14), as well as responsibilities of the physician members of the medical staff in relation to specified professional personnel, shall be delineated and approved by the medical staff.

(6) Ethics. The bylaws shall require each member of the medical staff and applicant for staff membership to state in writing that:

(i) He may not rebate a portion of a fee or accept other inducements in exchange for a patient referral.

(ii) He may not deceive a patient as to the identity of an operating surgeon, or another medical practitioner providing treatment or services.

(iii) He may not delegate the responsibility for diagnosis or care of hospitalized patients to another medical practitioner unless he believes the practitioner to be qualified to undertake this responsibility.

(7) Officer selection. Methods for the selection of officers and department/service chairmen shall be provided.

(8) Officer and service chairman responsibilities. Duties and responsibilities of the medical staff officers and clinical department/service chairmen shall be stated.

(9) Standing committees. Composition and functions of standing committees shall be specified as required by the complexity of the hospital.

(10) Committee meetings. Requirements regarding the frequency of and attendance at general and departmental meetings of the medical staff shall be established.

(11) Delineation of hospital staff responsibilities. The bylaws shall specify who is authorized to evaluate the significance of medical histories, to authenticate medical histories, to perform and record physical examinations and to prescribe treatment. The authorizations shall be given only to those with appropriate licenses or clinical privileges, or both. Specific attention shall be given to the clinical responsibilities and authority of house-staff officers and other physicians in training.

(12) Medical records. Requirements shall be established regarding completion of medical records, including a system for disciplinary actions for those who do not complete records in a timely manner.

(13) Liaison with governing body. A mechanism shall be provided by which the medical staff shall consult with and report to the governing body. Because the governing body of the hospital, acting through the chief executive officer, has the overall responsibility for the conduct of the hospital and because the medical staff has the overall responsibility for the provision of medical care to patients, there shall be full communication between the two bodies. Both shall be adequately informed regarding hospital activities. Further, representatives of the medical staff shall participate in hospital deliberations which affect the discharge of medical staff responsibilities.

(14) Specified professional personnel. Specified professional personnel are individuals who are duly licensed practitioners, members of the house staff, or persons otherwise qualified to render direct medical care under the supervision of a member of the medical staff and who are capable of effectively communicating with patients, the medical staff and hospital personnel. The bylaws shall state the rules and regulations, qualifications, status, clinical duties and responsibilities of specified professional personnel whose services require that they be processed through usual medical staff channels. The training, experience and demonstrated current competence of specified professional personnel shall be sufficient to permit their performance of the following functions:

(i) The exercise of judgment within their areas of competence; provided that a member of the medical staff shall have the ultimate responsibility for patient care.

(ii) Direct participation in the management of patients under the supervision or direction of a member of the medical staff.

(iii) The writing of orders and the recording of reports and progress notes in medical records of patients, within the limits established by the medical staff and consistent with the provisions of the Medical Practice Act of 1974 (63 P. S. § § 421.1—421.18) (Repealed).

(15) Acceptance of medical staff bylaws. Mechanisms shall be provided whereby there is evidence that each medical staff member has read and understands the bylaws and agrees to abide by the current medical staff bylaws and rules and regulations and by the hospital bylaws. As evidence of having read and understood the bylaws, each member of the medical staff should sign, on application to the medical staff and as the bylaws are amended, an agreement to abide by the current medical staff bylaws and rules and regulations and hospital bylaws.

(16) Consultations. Consultations, when requested by staff physicians, should be provided where possible by Board Certified or Board Eligible physicians for the particular specialty required.

The provisions of this § 107.12 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 107.12 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761; amended December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial pages (52760) and (52762).

Determination of the appropriate method of judicial review of a hospital’s revocation of a physician’s staff privileges should be determined on basis of procedural safeguards and there is no distinction between public, private and quasi-public hospitals. Allison v. Centre Community Hospital, 604 A.2d 294 (Pa. Cmwlth. 1992).

This section cited in 28 Pa. Code § 107.12a (relating to specified professional personnel—statement of policy); 28 Pa. Code § 107.61 (relating to written orders); and 28 Pa. Code § 117.43 (relating to medical records).

History

Authority: The provisions of this § 107.
Source: The provisions of this § 107.

28 Pa. Code § 107.12a Specified professional personnel—statement of policy.

(a) Scope. This section applies to hospitals that use ‘‘specified professional personnel’’ to provide direct medical care in accordance with § 107.12(14) (relating to content of bylaws, rules and regulations).

(b) Purpose. This section clarifies the Department’s regulations as they affect the use of certified registered nurse practitioners (CRNPs), physician assistants (PAs) and certified nurse midwives (CNMs) in hospitals.

(1) Section 107.12(14) permits ‘‘specified professional personnel,’’ including persons qualified to render direct medical care under the supervision of a member of the medical staff, to perform certain functions, including direct participation in the management of patients under the supervision or direction of a member of the medical staff and the writing of orders within the limits established by the medical staff.

(2) Sections 107.61, 107.62 and 107.64 (relating to written orders; oral orders; and administration of drugs) and other sections of the hospital regulations limit the performance of certain functions including the writing or countersigning of orders to practitioners, defined as licensed physicians, dentists or podiatrists. This definition appears to render § 107.12(14) ineffective.

(3) Commonwealth statutes and regulations defining CRNP, PA and CNM scope of practice permit those personnel to issue written and oral medical orders, take oral orders and otherwise render medical care and manage patients consistent with § 107.12(14).

(d) Policy regarding specified professional personnel. The Department will permit CRNPs, PAs and CNMs to function in hospitals as ‘‘specified professional personnel’’ under § 107.12, notwithstanding apparently conflicting provisions elsewhere in the regulations, in accordance with the following policy:

(1) The medical staff bylaws shall set forth the rules and regulations, qualifications, status, clinical duties and responsibilities of specified professional personnel, including CRNPs, PAs and CNMs. (§ 107.12(14)). When appropriate, the medical staff bylaws may incorporate by reference applicable rules and regulations, policies and procedures or hospital bylaws related to the foregoing. The medical staff bylaws, directly or by reference, shall also delineate the clinical privileges and duties of those specified professional personnel as well as the responsibilities of the physician members of the medical staff in relation to those specified professional personnel. (§ 107.12(5)). Finally, the bylaws, directly or by reference, shall specify who is authorized to evaluate the significance of medical histories, to authenticate medical histories, to perform and record physical examinations and to provide treatment. (§ 107.12(11)).

(2) Upon incorporation of the provisions in paragraph (1) as they pertain to CRNPs, PAs and CNMs into the medical staff bylaws, CRNPs, PAs and CNMs are permitted to perform the following functions in accordance with § 107.12:

(i) Exercise of judgment within their area of competence provided that a physician member of the medical staff has the ultimate responsibility for patient care.

(A) Some scope of practice rules mandate the development of an agreement in writing between the physician and the CRNP, PA or CNM that must address certain aspects of the relationship appropriate to the practice setting.

(B) Some agreements must be filed with the applicable State board, and some must be approved by the applicable State Board. (See 49 Pa. Code Chapter 18, Subchapters A and D (relating to licensure and regulation of midwife activities; and physician assistants); 49 Pa. Code Chapter 21, Subchapter C (relating to certified registered nurse practitioners); 49 Pa. Code Chapter 25, Subchapter C (relating to physician assistant provisions); section 8.2 of The Professional Nursing Law (63 P. S. § 218.2); sections 13 and 35 of the Medical Practice Act of 1985 (63 P. S. § § 422.13 and 422.35); and section 10 of the Osteopathic Medical Practice Act (63 P. S. § 271.10)).

(C) The agreement must contain the provisions required by regulation or statute, and satisfactorily address physician availability appropriate to the provision of quality care in an acute care facility.

(D) In the case of multiple supervising physicians, one agreement may be used as long as each physician is named in and signs the agreement and other applicable requirements of the State boards are met.

(E) The facility must maintain a copy of each written agreement, with evidence of filing with the applicable State board, if the filing is required by the Board, and approval, if the approval is required by the Board, for verification by the Department of compliance with regulations and statutes governing scope of practice.

(ii) Direct participation in the management of patients under the supervision or direction of a licensed physician who is a member of the medical staff. Scope of practice rules require that the physician with whom the CRNP, PA or CNM has an agreement shall be onsite or readily available for consultation by telephone, radio, or telecommunications. Under certain circumstances described in the rules, a physician shall be physically present to direct the PA.

(iii) Writing of orders and recording of reports and progress notes in medical records of patients, within the limits established by the medical staff. Scope of practice limitations are contained in the Medical Practice Act of 1985 (63 P. S. § § 422.1—422.45), section 10 of the Osteopathic Medical Practice Act and The Professional Nursing Law (63 P. S. § § 211—225.5) and regulations promulgated thereunder in 49 Pa. Code Chapters 18, 21 and 25 (relating to State Board of Medicine—practitioners other than medical doctors; State Board of Nursing; and State Board of Osteopathic Medicine).

(3) As required by 49 Pa. Code § 21.291 (relating to reserved), the hospital shall establish a committee in each area of practice whose function is to establish standard policies and procedures, in writing, pertaining to the scope and circumstances of practice of CRNPs in the medical management of the patient. Under this section, the committee serves as an advisory and interpretive body to the various staff of the hospital, and includes equal representation from the medical staff, the nursing staff and nursing administration.

History

Authority: The provisions of this § 107.
Source: The provisions of this § 107.

28 Pa. Code § 107.21 Principle.

The medical staff shall be organized to accomplish its required functions. It shall provide for the election or appointment of its officers. The complexity of the medical staff organization shall be commensurate with the size of the hospital and the scope of the activities of the medical staff.

This section cited in 28 Pa. Code § 107.12 (relating to content of bylaws, rules and regulations).

History

Authority: The provisions of this § 107.
Source: The provisions of this § 107.

28 Pa. Code § 107.22 Departments.

Departmentalization should occur when the medical staff duties and functions become too complex to be handled by the staff as a whole.

This section cited in 28 Pa. Code § 107.12 (relating to content of bylaws, rules and regulations).

History

Authority: The provisions of this § 107.
Source: The provisions of this § 107.

28 Pa. Code § 107.23 Clinical department chairmen.

Each clinical department chairperson in a departmentalized hospital shall be responsible for departmental implementation of actions taken by the medical staff. He must maintain continuing surveillance of the professional performance of all members of the medical staff with privileges in his department and must report regularly thereon to the medical staff. A clinical department chairman should be certified by the appropriate Board, be eligible for Board certification, or have successfully completed an approved residency training program in the clinical field of which he is chairman.

This section cited in 28 Pa. Code § 107.12 (relating to content of bylaws, rules and regulations).

History

Authority: The provisions of this § 107.
Source: The provisions of this § 107.

28 Pa. Code § 107.24 Medical staff officers.

There shall be such officers of the medical staff organization as will provide effective control of its affairs and ensure proper discharge of the responsibility for the quality of medical care delegated to the medical staff by the governing body.

This section cited in 28 Pa. Code § 107.12 (relating to content of bylaws, rules and regulations).

History

Authority: The provisions of this § 107.
Source: The provisions of this § 107.

28 Pa. Code § 107.25 Medical staff executive committee.

(a) In a departmentalized hospital, there shall be an executive committee, or its equivalent, which represents the medical staff, which has responsibility for the effectiveness of all medical activities of the staff, and which acts for the medical staff.

(b) The executive committee, or its equivalent, shall:

(1) receive and act upon the reports of other medical staff committees;

(2) consider and recommend action to the chief executive officer on all matters of a medical administrative nature;

(3) implement the policies of the medical staff;

(4) make recommendations to the governing body and chief executive officer concerning hospital operations, problems, and procedures.

(5) take reasonable steps to ensure ethical professional conduct on the part of all members of the medical staff, and initiate such prescribed disciplinary measures as are indicated;

(6) be held accountable to the governing body, as representative of the medical staff, for the medical care rendered to the patients of the hospital;

(7) ensure that the medical staff is kept abreast of the approved accreditation program and informed of the accreditation status of the hospital;

(8) meet as necessary, but at least ten times a year, and maintain a per- manent record of each meeting and of any actions taken. The record of each executive committee meeting shall be submitted in full or in summary form to the governing body prior to the next meeting of the governing body; and

(9) fulfill such other responsibilities as are assigned to it by the medical staff bylaws.

This section cited in 28 Pa. Code § 107.12 (relating to content of bylaws, rules and regulations).

History

Authority: The provisions of this § 107.
Source: The provisions of this § 107.

28 Pa. Code § 107.26 Additional committees.

(a) There shall be such additional committees as are necessary to organize and conduct the operations of the medical staff. All rules and proceedings of any additional committees shall be permanently recorded and kept available for inspections by members of the medical staff and the governing body.

(b) The following additional committees are mandatory:

(1) A credentials committee which shall make recommendations for staff appointments and reappointments, promotions, demotions, and clinical privileges. The credentials committee shall be advisory and investigative and shall report to the executive committee of the medical staff.

(2) A tissue committee, which shall review and evaluate surgery performed in the hospital when there is a disagreement among the preoperative, post-operative, and pathological diagnoses, or where a question of the acceptability of the procedure undertaken has been raised. The tissue committee shall meet at least once monthly, and its reports should be made available to the medical care evaluation committee.

(3) A medical records committee or its equivalent, which shall supervise the maintenance of medical records at the required standard of completeness. The medical records committee shall recommend for discipline any member of the medical staff whose medical records practices fail to conform with necessary record keeping requirements. The medical records committee shall have at least four meetings annually.

(4) A medical care evaluation committee.

(5) A pharmacy-therapeutics committee in accordance with § 113.5 (relating to pharmacy and therapeutics committee).

(6) A radiation safety committee.

(7) A bylaws committee.

(8) Such other committees as the medical staff deems appropriate.

(c) Committees may be labeled other than in subsection (b), and functions of committees may be combined, provided that all functions are appropriately performed.

The provisions of this § 107.26 issued under 67 Pa.C.S. § § 6101—6104; and Reorganization Plan No. 2 of 1973 (71 P. S. § 755-2).

The provisions of this § 107.26 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial pages (37801) and (37802).

This section cited in 28 Pa. Code § 107.12 (relating to content of bylaws, rules and regulations); and 28 Pa. Code § 115.34 (relating to medical records review).

History

Authority: The provisions of this § 107.
Source: The provisions of this § 107.

28 Pa. Code § 107.31 Medical staff meetings.

There shall be regular medical staff and departmental meetings for the purpose of reviewing the performance of the medical staff, departments/services and reports and recommendations of medical staff and multi-disciplinary committees.

History

Authority: The provisions of this § 107.
Source: The provisions of this § 107.

28 Pa. Code § 107.32 Meetings and attendance.

Where the medical staff is departmentalized, the frequency of general staff meetings shall be determined by the medical staff and clearly stated in the medical staff bylaws and rules and regulations. Departmental meetings should be held monthly. When the medical staff is not departmentalized, medical staff meetings shall be conducted at least ten times annually, at monthly intervals. There shall be at least an annual meeting of the medical staff at which officers and committee chairmen make such reports as may be desirable and at which officers are elected for the ensuing year.

History

Authority: The provisions of this § 107.
Source: The provisions of this § 107.

28 Pa. Code § 107.33 Minutes.

Minutes shall be taken at each meeting and retained in accordance with the policy of the hospital. These minutes shall adequately reflect the transactions, conclusions and recommendations of the meetings.

The provisions of this § 107.33 issued under 67 Pa.C.S. § § 6101—6104; and Reorganization Plan No. 2 of 1973 (71 P. S. § 755-2).

The provisions of this § 107.33 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37803).

History

Authority: The provisions of this § 107.
Source: The provisions of this § 107.

28 Pa. Code § 107.41 Continuing education.

The medical staff shall require a continuing program of professional education for medical staff members, or require its members to give evidence of participation in such a program.

History

Authority: The provisions of this § 107.
Source: The provisions of this § 107.

28 Pa. Code § 107.51 Medical staff responsibilities.

(a) In order for the medical staff to take reasonable steps to ensure clinical practice of the highest quality, each staff member should endeavor to:

(1) Provide his patients with the best quality of care consistent with the circumstances of each case.

(2) Conduct his professional activities in accordance with the bylaws, rules and regulations of the medical staff.

(3) Assist in the promotion and maintenance of high quality care through the analysis, review, and evaluation of the clinical practice which exists within the hospital.

(b) The medical staff shall have in effect a system to review medical services rendered, to assure their quality, and to provide an educational process for medical staff members. There shall be written procedures and policies governing the process and frequency of review.

History

Authority: The provisions of this § 107.
Source: The provisions of this § 107.

28 Pa. Code § 107.52 Criteria.

The medical staff shall establish criteria for the evaluation of medical care.

History

Authority: The provisions of this § 107.
Source: The provisions of this § 107.

28 Pa. Code § 107.53 Utilization review.

The hospital shall have a written plan for utilization review approved by the medical staff, administration, and governing body which generates reports adequate enough to permit identification of patient care problems. The plan shall establish a system to use this data to document appropriate utilization which shall include at least the following:

(1) A description of the method for evaluating the appropriateness and medical necessity of admissions, continued stays, and supportive services as well as delays in the provision of supportive services.

(2) The procedures for conducting concurrent review, including the time period within which the review is to be initiated following admission and the length of stay norms and percentiles to be used in assigning continued stay review dates. Records of the findings shall be maintained and reported, according to established mechanisms, to the executive committee of the medical staff and to the governing body.

The provisions of this § 107.53 issued under 67 Pa.C.S. § § 6101—6104; and Reorganization Plan No. 2 of 1973 (71 P. S. § 755-2).

The provisions of this § 107.53 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37804).

History

Authority: The provisions of this § 107.
Source: The provisions of this § 107.

28 Pa. Code § 107.54 Medical audit.

(a) Medical audit shall include periodic review, on a sample or other basis, of the care rendered to patients in every medical department of the hospital. The audit shall cover admission, length of stay and professional services furnished.

(b) The medical audit process should include both practitioners and allied health professionals from the hospital staff and should be interdisciplinary in nature.

(c) Minutes shall be taken at all medical audit committee meetings, and these minutes made available to the medical staff on a regular basis in accordance with established policy. These minutes shall be retained on file for no less than two years.

The provisions of this § 107.54 issued under 67 Pa.C.S. § § 6101—6104; and Reorganization Plan No. 2 of 1973 (71 P. S. § 755-2).

The provisions of this § 107.54 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37804).

History

Authority: The provisions of this § 107.
Source: The provisions of this § 107.

28 Pa. Code § 107.61 Written orders.

Medication or treatment shall be administered only upon written and signed orders of a practitioner acting within the scope of his license and qualified according to medical staff bylaws and § 107.12(k) (relating to content of bylaws, rules and regulations) except as provided in § § 107.62, 107.64 and 107.65 (relating to oral orders; administration of drugs; and automatic stop drug orders). The date that the order was written shall be included on all written orders.

The provisions of this § 107.61 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 107.61 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (52769).

This section cited in 28 Pa. Code § 107.12a (relating to specified professional personnel—statement of policy); 28 Pa. Code § 109.23 (relating to written nursing care policies and procedures); 28 Pa. Code § 109.61 (relating to medication or treatment); and 28 Pa. Code § 115.33 (relating to entries).

History

Authority: The provisions of this § 107.
Source: The provisions of this § 107.

28 Pa. Code § 107.62 Oral orders.

(a) Oral orders for medication or treatment shall be accepted only under urgent circumstances when it is impractical for the orders to be given in written manner by the responsible practitioner. Oral orders shall be taken only by personnel qualified according to medical staff bylaws who shall transcribe the orders in the proper place in the medical record of the patient. The order shall include the date, time, and full signature of the person taking the order and shall be countersigned by a practitioner within 24 hours. If the practitioner is not the attending physician, he must be authorized by the attending physician and must be knowledgeable about the patient’s condition.

(b) The medical staff bylaws shall specify personnel who are qualified to accept oral orders and shall specify that acceptance of orders is limited to personnel listed in this subsection, with restrictions as noted:

(1) A practitioner.

(2) A professional nurse.

(3) A licensed practical nurse.

(4) A pharmacist who may transcribe oral orders pertaining to drugs.

(5) A physical therapist who may transcribe oral orders pertaining to physical therapy regimens.

(6) A respiratory therapist who may transcribe oral orders pertaining to respiratory therapy treatments.

(7) A paramedic practicing under § 117.30 (relating to emergency paramedic services).

The provisions of this § 107.62 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

March 27, 1985, 15 Pa.B. 250. Immediately preceding text appears at serial pages (77251) to (77252).

This section cited in 28 Pa. Code § 107.12a (relating to specified professional personnel—statement of policy); 28 Pa. Code § 107.61 (relating to written orders); 28 Pa. Code § 109.23 (relating to written nursing care policies and procedures); 28 Pa. Code § 109.61 (relating to medication or treatment); 28 Pa. Code § 113.23 (relating to records); 28 Pa. Code § 115.33 (relating to entries); and 28 Pa. Code § 117.41 (relating to emergency patient care).

History

Authority: The provisions of this § 107.
Source: The provisions of this § 107.

28 Pa. Code § 107.64 Administration of drugs.

Drugs shall be administered only upon the proper order of a practitioner acting within the scope of his license and authorized according to medical staff bylaws, rules and regulations. Drugs shall be administered directly by a practitioner qualified according to medical staff bylaws, rules and regulations or by a professional nurse or by a licensed practical nurse with pharmacy training. Graduate practical nurses, graduate nurses, and students in approved schools of nursing may be authorized to administer drugs, but only under the supervision of a registered professional nurse or a physician under 49 Pa. Code § 21.14 (relating to administration of drugs). A paramedic may be permitted to administer drugs only under § 117.30 (relating to emergency paramedic services) and Chapter 2, Subchapter A (relating to emergency medical technicians). Further policies on the administration of drugs shall be established by the medical staff in conjunction with the pharmacy committee.

The provisions of this § 107.64 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 107.64 amended January 25, 1985, effective March 27, 1985, 15 Pa.B. 250. Immediately preceding text appears at serial pages (77251) to (77252).

History

Authority: The provisions of this § 107.
Source: The provisions of this § 107.

28 Pa. Code § 107.65 Automatic stop drug orders.

The medical staff shall establish a written policy pursuant to § 113.26 (relating to administration of drugs) for all dangerous medications not specifically prescribed as to time or number of doses to be automatically stopped after a reasonable time limit. The prescriber shall be notified according to hospital policies and procedures within 48 hours before an order is automatically stopped.

This section cited in 28 Pa. Code § 107.61 (relating to written orders); 28 Pa. Code § 109.23 (relating to written nursing care policies and procedures); 28 Pa. Code § 109.61 (relating to medication or treatment); 28 Pa. Code § 113.26 (relating to administration of drugs); and 28 Pa. Code § 115.33 (relating to entries).

History

Authority: The provisions of this § 107.
Source: The provisions of this § 107.

Chapter 109 Nursing Services

28 Pa. Code § 109.1 Principle.

The hospital shall maintain a nursing staff to provide nursing care for the needs of the patients and a nursing staff organization to be responsible to the chief executive officer or chief operating officer of the hospital for the performance of its members.

The provisions of this § 109.1 issued under 67 Pa.C.S. § § 6101—6104; and Reorganization Plan No. 2 of 1973 (71 P.S. § 755-2).

The provisions of this § 109.1 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37809).

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.2 Director of nursing services.

(a) The nursing service shall be under the direction of a registered professional nurse who should be qualified in the field of administration and who has the ability to organize, coordinate and evaluate the service.

(b) The director of nursing services shall be employed on a full-time basis and shall be responsible to the chief executive officer or his designee for developing and implementing policies and procedures of the service.

(c) The director shall make the recommendations on the selection and promotion of nursing personnel based on established job descriptions and individual qualifications and capabilities.

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.3 Assistants to director of nursing services.

There shall be assistants to the director for evening and night services and, when necessary, for day services, which assistants are registered professional nurses and are qualified, by experience and otherwise, for the responsibilities delegated to them.

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.4 Professional nursing staff.

A sufficient number of registered professional nurses shall be on duty at all times to plan, assign, supervise, and evaluate nursing care as well as to give patients such nursing care as requires the judgment and specialized skills of a registered nurse. A graduate nurse, or graduate practical nurse, providing care shall be under the supervision of a registered nurse.

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.5 Auxiliary nursing staff.

Licensed practical nurses and other nursing personnel shall be qualified by training, education, experience, and demonstrated abilities to give nursing care that does not require the skill and judgment of a registered or professional nurse. Auxiliary nursing personnel shall be supervised by a professional nurse.

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.6 Staffing schedules.

(a) There shall be staffing schedules reflecting actual nursing personnel required for the hospital and for each patient unit, including but not limited to the surgical and obstetrical suites, the outpatient unit, special care units, and the emergency service unit. Staffing patterns should reflect consideration of nursing goals, standards of nursing practice, and the needs of the patients.

(b) Staffing schedules shall accomplish the following:

(1) Staffing patterns which reflect the quality and quantity of various categories of nursing personnel necessary to carry out the nursing care program.

(2) Assignment of personnel in a manner which minimizes the risk or cross-infections.

(3) The patient care assignment is commensurate with the qualifications of each nursing staff member, the identified nursing needs of the patient, and the prescribed medical regimen.

(c) Schedules which contain an indication of personnel attendance by date, service unit, and time of actual attendance shall be kept on file for a minimum of one year.

The provisions of this § 109.6 issued under 67 Pa.C.S. § § 6101—6104; and Reorganization Plan No. 2 of 1973 (71 P. S. § 755-2).

The provisions of this § 109.6 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37810).

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.7 Nursing staff qualifications.

Persons employed and classified as registered professional nurses or licensed practical nurses shall be licensed to practice in this Commonwealth. There shall be a procedure to verify the licensure status of all such nurses. A licensed practical nurse in charge of a patient unit must have satisfactorily completed a course in practical nursing which meets the curricula standards prescribed and approved by the State Board of Nurse Examiners.

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.11 Contents and function.

(a) A written organizational plan of nursing services shall be an integral part of the overall hospital organizational plan and shall be available to all nursing personnel.

(b) The nursing service organizational plan shall:

(1) indicate the lines of communication within and between nursing services and other departments;

(2) define the relationship of nursing services to other services and departments of the hospital, both administrative and professional; and

(3) include a written statement which defines the role and responsibility of both the nursing service and the education program if the hospital provides clinical facilities for the education and training of nursing students.

The provisions of this § 109.11 issued under 67 Pa.C.S. § § 6101—6104; and Reorganization Plan No. 2 of 1973 (71 P. S. § 755-2).

The provisions of this § 109.11 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial pages (37810) to (37811).

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.12 Role in hospital planning.

Any planning, decision making, and formulation of policies that affects the operation of the nursing service, the nursing care of patients, or the environment of patients should include nursing service representatives, and their recommendations should be considered.

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.13 Job descriptions.

Job descriptions shall be written for each position classification in nursing services and shall delineate the functions, responsibilities, and desired qualification of each classification. Copies of job descriptions shall be available to nursing personnel.

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.14 Nursing committees.

Nursing committees should be formally organized within the nursing department to facilitate the establishment and attainment of the goals and objectives of the nursing service. The purpose and function of each standing committee shall be defined in the nursing service organizational plan.

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.21 Principle.

Written nursing care and administrative policies and procedures shall be developed to provide the nursing staff with methods of meeting its responsibilities and achieving goals.

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.22 Nursing service goals.

Nursing service goals shall be identified and made available to all nursing personnel.

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.23 Written nursing care policies and procedures.

(a) Written administrative and nursing care policies shall be reviewed at least annually and revised as necessary. They shall be dated to indicate the time of the most recent review.

(b) Nursing care policies and procedures shall be consistent with professionally recognized standards of nursing practice and shall be in accordance with The Professional Nursing Law (63 P. S. § § 211—225) and regulations promulgated by the State Board of Nurse Examiners. These policies shall include procedures for the following:

(1) Noting diagnostic and therapeutic orders.

(2) Assigning the nursing care of patients.

(3) Infection control.

(4) Patient safety.

(5) Implementing orders for medication or treatment, consistent with § § 107.61—107.65 (relating to medical orders).

(c) Written copies of policies shall be available to the nursing staff in every nursing care unit and service area, as well as to other services and departments of the hospital.

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.24 Specialized nursing services.

(a) If specialized nursing services are provided for separate medical departments, those services shall be subject to the policies and procedures established pursuant to this chapter.

(b) Some of the departments which may utilize special nursing services are the following:

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.31 Principle.

There shall be evidence that the nursing service provides safe, efficient, and therapeutically effective nursing care through the planning of the care of each inpatient and the effective implementation of nursing care plans. In any case where it is determined that a nursing care plan is not necessary, that decision shall be documented in the medical record.

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.32 Coordination.

The nursing care plan for each patient shall be coordinated with his medical plan of care.

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.33 Contents.

Each nursing care plan should, at minimum, indicate:

(1) what nursing care is needed;

(2) how it can best be accomplished;

(3) what methods and approaches are believed likely to be most successful; and

(4) what modifications are necessary to ensure the best results.

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.34 Administration.

Each nursing care plan shall be initiated upon the admission of the patient to the hospital and should include a discharge plan.

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.35 Distribution.

The nursing care plans should be available to all nursing personnel and should be reviewed and revised as necessary.

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.36 Nursing notes.

Nursing records and reports which reflect the progress of each patient and the nursing care planned shall be maintained. They shall be pertinent, accurate, and concise so that they contribute to the continuity of patient care. Nursing records and reports shall become part of each patient’s medical record.

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.37 Unusual incidents.

A procedure shall be established to investigate any unusual incidents which occur at any time during any nursing shift. The procedure shall include the making and disposition of incident reports. Notation of incidents having a direct medical effect on a specific patient shall be entered in the medical record of that patient. Each report shall be analyzed and summarized, and corrective action shall be taken if necessary. Summarized reports shall be available to the Department.

This section cited in 28 Pa. Code § 115.33 (relating to entries).

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.41 Principle.

Meetings of the nursing staff shall be held at least six times per year in order to discuss ways of improving nursing care and nursing service problems and policies. Meetings may be organized by clinical department or service, by categories of nursing staff, or by the staff as a whole, consistent with the organizational plan of nursing staff.

The provisions of this § 109.41 issued under 67 Pa.C.S. § § 6101—6104; and Reorganization Plan No. 2 of 1973 (71 P. S. § 755-2).

The provisions of this § 109.41 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37814).

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.51 Principle.

There shall be continuing education programs and educational opportunities for nursing personnel.

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.52 Orientation and continuing education.

(a) The director of nursing services or his designee shall design and implement an education program to orient new employes and to keep the nursing staff up-to-date on new and expanding programs, techniques, equipment, and concepts of care. The program shall be planned, scheduled, documented by a written outline of its contents, and evaluated at least annually.

(b) The scope and duration of the education program shall be such as to effectively train new and existing personnel. An orientation program shall be provided for each new nursing service employe.

(c) The education program may be conducted using resources internal or external to the hospital. Teaching material and suitable reference shall be supplied as needed for each nursing unit and special care area.

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.61 Medication or treatment.

Medication or treatment shall be administered only upon written and signed orders of a practitioner and in accordance with the provisions of § § 107.61—107.65 (relating to medical orders).

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.62 Administration of drugs.

(a) The individual preparing a dose of medication for administration shall also administer it, except as provided by subsections (b) and (c).

(b) A pharmacist may prepare intravenous solutions with additives, dilute dried or concentrated injectables, or prepare unit dose medications for administration by an appropriately licensed individual.

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.63 Self-administered drugs.

Self-administration of drugs by patients may be permitted as prescribed in writing by the attending practitioner.

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.64 Patients’ own drugs.

If patients bring their own drugs to the hospital, these drugs shall not be administered unless the attending practitioner has written an order for their administration. If the drugs are not to be used, they shall be packaged, sealed, and returned to the patient for removal from the hospital. If such removal is not feasible, the drugs shall be stored and returned to the patient at the time of discharge. The patient shall be cautioned concerning outdated or distressed drugs. Controlled substances as listed in the schedule of controlled substances pursuant to section 4 of the act of April 14, 1972 (P. L. 233, No. 64) (35 P. S. § 780-104) known as The Controlled Substances, Drug Device and Cosmetic Act shall not be returned to the patient without approval of the attending practitioner.

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.65 Recording of drugs administered.

(a) Each dose of drug shall be recorded in the medical record of the patient and properly signed after the drugs have been administered.

(b) Any medication error or apparent drug reaction shall be reported immediately to the practitioner who ordered the drug. Any entry of the medication given in error or the apparent drug reaction, or both, shall be properly recorded in the medical record of the patient. Any adverse drug reaction shall be immediately noted on the medical record of the patient in the most conspicuous manner possible, in order to notify everyone treating the patient throughout the duration of his hospitalization of his drug sensitivity and thereby prevent a recurrence of adverse reaction. Notification of all drug sensitivities, including any apparent adverse reaction, shall be sent to the physician and to the director of pharmaceutical services. Records of drug sensitivities shall be retained in accordance with § 113.23(e) (relating to records).

This section cited in 28 Pa. Code § 113.23 (relating to records).

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.66 Blood transfusions and intravenous medications.

When blood transfusions and intravenous medications are administered by nurses, they shall be administered only by professional nurses who have been specially trained for this duty under the Professional Nursing Law (63 P. S. § § 211—225) and 49 Pa. Code Chapter 21 (relating to State Board of Nursing). Paramedics may be authorized to administer intravenous medications only under § 117.30 (relating to emergency paramedic services) and Chapter 2, Subchapter A (relating to emergency medical technicians).

The provisions of this § 109.66 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 109.66 amended January 25, 1985, effective March 27, 1985, 15 Pa.B. 250. Immediately preceding text appears at serial pages (52782) to (52783).

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.67 Disposable syringes and needles.

Disposable syringes and needles shall be maintained in hospital-approved locations which provide adequate security, and access shall be available only to authorized personnel. Provision shall be made for disposable syringes and needles to be destroyed or otherwise rendered unusable and inaccessible immediately following their use.

The provisions of this § 109.67 issued under 67 Pa.C.S. § § 6101—6104; and Reorganization Plan No. 2 of 1973 (71 P. S. § 755-2).

The provisions of this § 109.67 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37817).

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

28 Pa. Code § 109.68 Emergency drug cart or kit.

An emergency drug cart or kit shall be available, maintained, and used in accordance with § 113.27 (relating to emergency pharmaceutical services).

History

Authority: The provisions of this § 109.
Source: The provisions of this § 109.

Chapter 111 Dietetic Services

28 Pa. Code § 111.1 Principle.

There shall be an organized dietetic service which shall effectively apply the principles of the science of nutrition to the nutritional care of patients and the preparation of palatable and appropriate food.

History

Authority: The provisions of this § 111.
Source: The provisions of this § 111.

28 Pa. Code § 111.2 Organization and staffing.

The service shall be under the full-time direction of a person who is trained and experienced in food services administration and dietary management. If the director of the services is not the qualified dietitian, there should be an effective method of communication and a close working relationship between the director and dietitian.

History

Authority: The provisions of this § 111.
Source: The provisions of this § 111.

28 Pa. Code § 111.3 Dietitian.

(a) The dietary services shall have at least one qualified dietitian, either full-time, part-time, or as consultant. The resume of the dietitian shall be included in the personnel files. The dietitian shall have training and experience in nutrition, therapeutic diets, and nutritional food service management.

(b) If a consultant dietitian is used, there shall be a written contract which shall clearly define the responsibilities and frequency of visits of the consultant dietitian. This contract, together with the dietitian’s regular reports or running log of services performed, shall be available for review by the surveyors of the Department. The consultant dietician shall provide a minimum of four hours service per week.

History

Authority: The provisions of this § 111.
Source: The provisions of this § 111.

28 Pa. Code § 111.4 Staffing pattern.

The number of personnel assigned to the dietary department shall be adequate to perform effectively all functions related to food service to meet the needs of patients. Supervisors of appropriate ability shall be assigned in such numbers as to provide a satisfactory span of control as well as to provide coverage for all hours of department operation.

History

Authority: The provisions of this § 111.
Source: The provisions of this § 111.

28 Pa. Code § 111.5 Patient nutritional care.

The administration of the nutritional aspects of patient care shall be directed by a qualified dietitian or by other appropriate persons such as dietetic technicians or dietetic assistants who are supervised by the dietitian. Observations and information pertinent to special dietetic treatment shall be recorded in the medical record of the patient and discussed with the patient and his physician, if appropriate.

History

Authority: The provisions of this § 111.
Source: The provisions of this § 111.

28 Pa. Code § 111.6 Menus.

All master menus shall be approved, dated and signed by the dietitian.

The provisions of this § 111.6 issued under 67 Pa.C.S. § § 6101—6104; and Reorganization Plan No. 2 of 1973 (71 P.S. § 755-2).

The provisions of this § 111.6 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37819).

History

Authority: The provisions of this § 111.
Source: The provisions of this § 111.

28 Pa. Code § 111.7 Commercial food service.

A hospital which has a contract with an outside food management service shall require as a part of the contract that the company maintain at least the standards outlined in this chapter for the service. The contract shall be available for review by the surveyors.

History

Authority: The provisions of this § 111.
Source: The provisions of this § 111.

28 Pa. Code § 111.11 Principle.

The dietetic service shall have adequate space, equipment and supplies to perform the efficient, safe and sanitary operation of all functions assigned to it.

History

Authority: The provisions of this § 111.
Source: The provisions of this § 111.

28 Pa. Code § 111.12 Equipment.

The type, size and layout of equipment shall provide for ease of cleaning, optimal workflow and efficient food production to meet the scope and complexity of the regular and therapeutic diet requirements of the patients. Equipment and work areas shall be clean and orderly. Effective procedures for cleaning all equipment and work areas shall be followed consistently to safeguard the health of the patient.

History

Authority: The provisions of this § 111.
Source: The provisions of this § 111.

28 Pa. Code § 111.13 Handwashing facilities.

Handwashing facilities, with hot and cold running water, liquid soap or individual soap leaves and towels shall be available for use by food handlers.

History

Authority: The provisions of this § 111.
Source: The provisions of this § 111.

28 Pa. Code § 111.14 Dry storage.

Dry or staple food items shall be stored in accordance with standard dry food storage techniques:

(1) Shelves shall be at a height above the floor as to facilitate cleaning, or the shelves shall be of solid construction and flush to the floor so as to eliminate the need for cleaning under them.

(2) The room provided for storage of dry or staple food items shall be ventilated and may not be subject to sewage or waste water back-flow.

(3) The food products shall be protected from contamination by condensation, leakage, mopping, insects, rodents or vermin.

History

Authority: The provisions of this § 111.
Source: The provisions of this § 111.

28 Pa. Code § 111.15 Storage of perishable food.

Perishable foods shall be refrigerated at the appropriate temperature and in an orderly and sanitary manner as provided in regulations of the Department of Environmental Resources, set forth in 7 Pa. Code § § 78.21—78.24, 78.31 and 78.32 (Reserved). Foods being displayed or transported shall be protected from contamination and held at proper temperatures in clean containers, cabinets or serving carts.

History

Authority: The provisions of this § 111.
Source: The provisions of this § 111.

28 Pa. Code § 111.16 Refuse.

Leakproof, nonabsorbent containers with close-fitting covers shall be used for the disposal of garbage and kitchen refuse. Garbage and kitchen refuse shall be removed from the dietetic department in a manner which does not permit transmission of disease or create a nuisance or a breeding place for flies, insects or rodents. Garbage containers shall be thoroughly cleaned inside and out, each time emptied. Places in which refuse is stored shall be tightly sealed and leak-proof.

History

Authority: The provisions of this § 111.
Source: The provisions of this § 111.

28 Pa. Code § 111.21 Principle.

There shall be written policies and procedures to govern all dietetic service activities. These policies should be developed by the dietetic service in cooperation with personnel from other departments or services which are involved with dietetic service, and they shall be reviewed at least once every 2 years, revised as necessary, and dated to indicate the time of last review.

History

Authority: The provisions of this § 111.
Source: The provisions of this § 111.

28 Pa. Code § 111.22 Food storage.

There shall be written policies and procedures for food storage, preparation and service.

History

Authority: The provisions of this § 111.
Source: The provisions of this § 111.

28 Pa. Code § 111.23 Job description.

Job descriptions shall be written for all classifications of dietetic services personnel. They shall be made available to dietetic services personnel.

History

Authority: The provisions of this § 111.
Source: The provisions of this § 111.

28 Pa. Code § 111.24 Education programs.

Education programs, including orientation, on-the-job training, in-service education, and continuing education programs shall be offered to dietetic services personnel. The programs shall include instruction in personal hygiene; in the proper inspection, handling, preparation, and serving of food; and in the proper cleaning and the safe operation of equipment. Current reference materials should be conveniently located, accessible, and available.

History

Authority: The provisions of this § 111.
Source: The provisions of this § 111.

28 Pa. Code § 111.25 Infection control.

There shall be procedures to control employes with infections and open lesions. Routine health examinations and infection control procedures shall meet at least the standards set forth in 7 Pa. Code § § 78.41—78.43 (Reserved). A dietician, dietetic technician, or dietetic assistant shall serve on any appropriate hospital infection control committees. These committees may be combined, and dietetic services infection control activities may be included among the responsibilities of the committee established pursuant to § 147.21 (relating to infection control).

History

Authority: The provisions of this § 111.
Source: The provisions of this § 111.

28 Pa. Code § 111.26 Dishwashing.

(a) Dishwashing procedures and techniques shall be well developed, understood, and carried out. Dishwashing procedures shall be at least those set forth in 7 Pa. Code § § 78.61—78.65 (Reserved).

(b) There shall be periodic checks at established intervals of:

(1) washing, rinsing, and sanitizing temperatures and cleanliness of machines and jets; and

(2) thermostatic controls.

History

Authority: The provisions of this § 111.
Source: The provisions of this § 111.

28 Pa. Code § 111.27 Nutritional aspects of patient care.

(a) The administration of the nutritional aspects of patient care shall be under the direction of a qualified dietitian.

(b) Therapeutic diets, when appropriate, shall be prescribed in written or- ders on the medical record by the physician and shall be instructive, accurate and as complete as possible.

(c) The dietitian shall have available an up-to-date manual of regimens for therapeutic diets, approved jointly by the dietetic and medical staff, which shall be available to dietetic supervisory personnel. There shall be a standardized recipe file.

(d) Patients’ nutrition needs shall be met in accordance with the current Recommended Dietary Allowance of the Food and Nutrition Board, National Research Council, or shall be in accordance with physician’s orders.

(e) The dietitian shall be responsible for the development of a nutritional care plan in compliance with physician’s orders to meet the needs of the patient for the maintenance of health, prevention of disease, and treatment through diet modification and normal nutritional counseling. The nutritional care plan shall be integrated into the total care plan of the patient and shall be included on his discharge plan and in transfer orders to any nursing facility or home health agency to the extent necessary for continuity of care.

(f) The director of dietetic services should attend and participate in meetings of heads of departments and function as an integral member of the hospital staff.

(g) The director of dietetic services should have regularly scheduled conferences with the chief executive officer or his designee, to keep him informed, to seek his counsel, and to present program plans for mutual consideration and solution.

(h) Conferences should be held regularly within the dietary services department at all levels of responsibility, to disseminate information, interpret policy, solve problems, and develop procedures and program plans.

History

Authority: The provisions of this § 111.
Source: The provisions of this § 111.

Chapter 115 Medical Record Services

28 Pa. Code § 115.1 Principle.

The hospital shall maintain facilities and services adequate to provide medical records which are accurately documented and readily accessible to authorized persons requiring such access and which can be readily used for retrieving and compiling information.

History

Authority: The provisions of this § 115.
Source: The provisions of this § 115.

28 Pa. Code § 115.2 Organization and staffing.

A hospital shall have a medical record service. It shall be directed, staffed and equipped to ensure the accurate processing, indexing and filing of all medical records.

History

Authority: The provisions of this § 115.
Source: The provisions of this § 115.

28 Pa. Code § 115.3 Director.

(a) The medical records service shall be under the direction and supervision of a certified medical records practitioner. If no certified person is available on a full-time basis, a certified person shall be employed on a part-time or consulting basis.

(b) The director of the medical record service should advise, administer, supervise, and perform work involved in the development, analysis, maintenance and use of medical records and reports.

(c) When the director is employed on a part-time or consulting basis, he shall organize the department, train the regular personnel, and make periodic visits to the hospital to evaluate the records and the operation of the service. A written contract specifying his duties and responsibilities shall be kept on file and made available for inspection by the Department’s surveyor.

The provisions of this § 115.3 issued under section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P.S. § 448.803).

The provisions of this § 115.3 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (52797).

History

Authority: The provisions of this § 115.
Source: The provisions of this § 115.

28 Pa. Code § 115.4 Medical record personnel.

At least one full-time or part-time employe shall provide regular medical service. Other personnel shall be employed as needed to effectively perform the functions assigned to the medical record department.

The provisions of this § 115.4 issued under 67 Pa.C.S. § § 6101—6104 (Repealed); and Reorganization Plan No. 2 of 1973 (71 P.S. § 755-2) (Renumbered).

The provisions of this § 115.4 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37833).

History

Authority: The provisions of this § 115.
Source: The provisions of this § 115.

28 Pa. Code § 115.5 Education programs.

The hospital shall provide orientation, on-the-job training, and regular in-service, either hospital-based or outside the hospital, education programs for medical records personnel. Employes should be encouraged to participate in job-related workshops, institutes or correspondence education courses available outside the hospital.

History

Authority: The provisions of this § 115.
Source: The provisions of this § 115.

28 Pa. Code § 115.6 Job descriptions.

There shall be written job descriptions for all medical records personnel which are made available to them.

History

Authority: The provisions of this § 115.
Source: The provisions of this § 115.

28 Pa. Code § 115.11 Principle.

The medical record service shall be properly equipped to enable its personnel to function in an effective manner and to maintain medical records so that they are readily accessible and secure from unauthorized use.

History

Authority: The provisions of this § 115.
Source: The provisions of this § 115.

28 Pa. Code § 115.21 Identification and filing of medical records.

The medical record service shall maintain a system of identification and filing to facilitate the prompt location of the medical record of a patient.

History

Authority: The provisions of this § 115.
Source: The provisions of this § 115.

28 Pa. Code § 115.22 Storage of medical records.

Medical records shall be stored in such a manner as to provide protection from loss, damage and unauthorized access.

History

Authority: The provisions of this § 115.
Source: The provisions of this § 115.

28 Pa. Code § 115.23 Preservation of medical records.

(a) Medical records, whether original, reproductions or microfilm, shall be kept on file for a minimum of 7 years following the discharge of a patient.

(b) If the patient is a minor, records shall be kept on file until his majority, and then for 7 years or as long as the records of adult patients are maintained.

(c) If a hospital discontinues operation, it shall make known to the Department where its records are stored. Records are to be stored in a facility offering retrieval services for at least 5 years after the closure date. Prior to destruction, public notice shall be made to permit former patients or their representatives to claim their own records. Public notice shall be in at least two forms, legal notice and display advertisement in a newspaper of general circulation.

The provisions of this § 115.23 issued under 67 Pa.C.S. § § 6101—6104; and Reorganization Plan No. 2 of 1973 (71 P. S. § 755-2).

The provisions of this § 115.23 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37834).

This section cited in 28 Pa. Code § 139.28 (relating to patient medical records).

History

Authority: The provisions of this § 115.
Source: The provisions of this § 115.

28 Pa. Code § 115.24 Microfilming medical records.

Medical records may be microfilmed immediately after completion. Microfilming may be done on or off the premises. If done off the premises, the hospital shall take precautions to assure the confidentiality and safekeeping of the records. The original of microfilmed medical records shall not be destroyed until the medical records department has had an opportunity to review the processed film for content.

The provisions of this § 115.24 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 115.24 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (55622).

History

Authority: The provisions of this § 115.
Source: The provisions of this § 115.

28 Pa. Code § 115.25 Infant footprints.

The imprint of infant footprints shall be retained. Microfilm records are acceptable to meet this requirement.

History

Authority: The provisions of this § 115.
Source: The provisions of this § 115.

28 Pa. Code § 115.26 Automation of medical records.

Nothing in this subpart shall be construed to prohibit the use of automation in the medical records service, provided that all provisions in this chapter are met and the information is readily available for use in patient care. Innovations in medical record formats, compilation and data retrieval are specifically encouraged.

History

Authority: The provisions of this § 115.
Source: The provisions of this § 115.

28 Pa. Code § 115.27 Confidentiality of medical records.

All records shall be treated as confidential. Only authorized personnel shall have access to the records. The written authorization of the patient shall be presented and then maintained in the original record as authority for release of medical information outside the hospital.

Assertion of Confidentiality Privilege

Since a hospital owes a duty to limit access to the medical records of its patients, it is proper to consider a claim of physician-patient privilege by a hospital when its medical records are subpoenaed, even though such right or privilege is ordinarily properly asserted only by the patient. In re June 1979 Allegheny County Investigating Grand Jury, 415 A.2d 73 (Pa. 1980).

Evidence Not Excluded

Blood alcohol test results which were reported to a police officer were not suppressed under the exclusionary rule in that the patient’s rights were violated by the nurse who volunteered the information as a private individual, not the police officer. Commonwealth v. Ellis, 608 A.2d 1090 (Pa. Super. 1992); appeal denied 620 A.2d 489 (Pa. 1993).

This section cited in 28 Pa. Code § 115.28 (relating to ownership).

History

Authority: The provisions of this § 115.
Source: The provisions of this § 115.

28 Pa. Code § 115.28 Ownership.

Medical records are the property of the hospital, and they shall not be removed from the hospital premises, except for court purposes. Copies may be made available for authorized appropriate purposes such as insurance claims, and physician review, consistent with § 115.27 (relating to confidentiality of medical records).

Subpoena

The provisions of this section do not cover a situation where a subpoena has been issued for medical records where there is no case yet before a court, so the records obtained under such a subpoena were suppressed. Commonwealth v. Jolly, 486 A.2d 515 (Pa. Super. 1984).

Since medical records are the property of the hospital, not each individual patient, and are to be removed from hospital premises only for court purposes, a subpoena for the production of such records was properly served on the hospital. In re June 1979 Allegheny County Investigating Grand Jury, 415 A.2d 73 (Pa. 1980).

History

Authority: The provisions of this § 115.
Source: The provisions of this § 115.

28 Pa. Code § 115.29 Patient access.

Patients or patient designees shall be given access to or a copy of their medical records, or both, in accordance with § 103.22(b)(15) (relating to implementation). Upon the death of a patient, the hospital shall provide, upon request, to the executor of the decedent’s estate or, in the absence of an executor, the next of kin responsible for the disposition of the remains, access to all medical records of the deceased patient. The patient or the patient’s next of kin may be charged for the cost of reproducing the copies; however, the charges shall be reasonably related to the cost of making the copy.

The provisions of this § 115.29 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 115.29 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (55623).

Health Care Facilities Act

Inmate who avers right to copies of his medical records at cost reasonably related to cost of making copies pursuant to regulation that pertains to patient access to medical records and to health care facilities as defined in the Health Care Facilities Act failed to state a claim because inmate does not allege he is a patient as defined by the Act or that Department of Corrections operates a health care facility within the meaning of the Act. Richardson v. Beard, 942 A.2d 911, 914-915 (Pa. Cmwlth. 2008)

Illustrative Cases

Requiring a patient to sign a release of liability in exchange for medical records violated the public policy of freely accessible records underlying this section. Soxman v. Goodge, 539 A.2d 826 (Pa. Super. 1988).

Subpoena

Standing

The plaintiff-clients, whose attorneys purchased photocopies of the clients’ hospital records for the purpose of prosecuting their clients’ personal injury and medical malpractice claims, did not have standing to bring a treble-damages claim because they are not ‘‘direct purchasers,’’ as required by Illinois Brick Co. v. Illinois, 431 U. S. 720, 52 L. Ed. 2d 707, 97 S. Ct. 2061 (1977). However, these clients are not barred from seeking injunctive relief under section 16 of the Clayton Act. McCarthy v. Recordex Service, 80 F.3d 842 (3d Cir. 1996), cert. denied, 136 L.Ed. 2d 42 (U. S. 1996).

History

Authority: The provisions of this § 115.
Source: The provisions of this § 115.

28 Pa. Code § 115.31 Patient medical records.

(a) An adequate medical record shall be maintained for every inpatient, outpatient and patient treated or examined in the emergency unit. This record shall contain data from all episodes of care and treatment of the patient whether services were performed on an inpatient basis, on an outpatient basis, or in the emergency unit. The unit record system should be used whenever feasible. When it is not feasible or appropriate to combine all inpatient, outpatient and emergency records of an individual patient into a unitary record, a system shall be established to:

(1) Assemble, when necessary, all divergently located record components when an inpatient is admitted to the hospital or appears for a prescheduled outpatient appointment.

(2) Require placing copies of pertinent portions of an inpatient’s medical record, such as the discharge resume, the operative note and the pathology report, in the outpatient or combined outpatient/emergency unit record file.

(b) A patient’s medical records shall be complete, readily accessible and available to the professional staff concerned with the care and treatment of the patient.

The provisions of this § 115.31 issued under 67 Pa.C.S. § § 6101—6104; and Reorganization Plan No. 2 of 1973 (71 P. S. § 755-2).

The provisions of this § 115.31 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37836).

This section cited in 28 Pa. Code § 117.43 (relating to medical records); 28 Pa. Code § 119.24 (relating to patient medical records); 28 Pa. Code § 135.13 (relating to patient’s medical record; preoperative procedures); and 49 Pa. Code § 16.95 (relating to medical records).

History

Authority: The provisions of this § 115.
Source: The provisions of this § 115.

28 Pa. Code § 115.32 Contents.

(a) The medical record shall contain sufficient information to identify the patient clearly, to justify the diagnosis and treatment, and to document the results accurately.

(b) If a member of the hospital’s medical staff has performed a physical examination consistent with the medical staff bylaws within 30 days prior to a patient’s admission to the hospital, a reasonably durable, legible copy of the record of this examination may be used in lieu of an admission history and report of physical examination. An interval admission note shall, however, be recorded, including any additions to the history and any subsequent changes in the physical findings.

(c) If the patient was admitted to another hospital within 30 days prior to his admission, the medical staff or attending physician shall determine whether to record its own complete history and physical examination. The hospital shall, with the written authorization of the patient, request the records of the previous admission from the other hospital as soon as possible.

(d) A medical record shall include notes by authorized house staff members and individuals who have been granted clinical privileges, consultation reports, nurses’ notes and entries by specified professional personnel.

(e) A medical record shall include the findings and results of any pathological or clinical laboratory examinations, radiology examinations, medical and surgical treatment, and other diagnostic or therapeutic procedures.

(f) A medical record shall include a provisional diagnoses; primary and secondary final diagnoses, the latter if necessary; a clinical resume; and, where appropriate, necropsy reports.

The provisions of this § 115.32 issued under 67 Pa.C.S. § § 6101—6104; and Reorganization Plan No. 2 of 1973 (71 P. S. § 755-2).

The provisions of this § 115.32 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37837).

This section cited in 28 Pa. Code § 119.24 (relating to patient medical records); 28 Pa. Code § 135.13 (relating to patient’s medical record; preoperative procedures); 28 Pa. Code § 710.23 (relating to patient records); 28 Pa. Code § 711.43 (relating to client records); 28 Pa. Code § 711.53 (relating to client records); 28 Pa. Code § 711.62 (relating to client records); 28 Pa. Code § 711.72 (relating to client records); 28 Pa. Code § 711.83 (relating to client records); 28 Pa. Code § 711.93 (relating to client records); and 49 Pa. Code § 16.95 (relating to medical records).

History

Authority: The provisions of this § 115.
Source: The provisions of this § 115.

28 Pa. Code § 115.33 Entries.

(a) All significant clinical information pertaining to a patient shall be incorporated in the patient’s medical record.

(b) Entries in the record shall be dated and authenticated by the person making the entry.

(c) Symbols and abbreviations may be used only when they have been approved by the medical staff and when there exists a legend to explain them.

(d) Oral orders shall include the date and signature of the person recording them. They shall be given and authenticated in accordance with the provisions of § 107.62 (relating to oral orders). All other orders shall be recorded in accordance with the provisions in § § 107.61 and 107.62—107.65 (relating to medical orders).

(e) A single signature on the face sheet of a record shall not suffice to authenticate the entire record. Each entry shall be individually authenticated.

(f) Notation of unusual incidents shall be entered in accordance with the provisions of § 109.37 (relating to unusual incidents) and Chapter 151 (relating to fire, safety and disaster services).

(g) Records of patients discharged shall be completed within 30 days following discharge.

The provisions of this § 115.33 issued under 67 Pa.C.S. § § 6101—6104; and Reorganization Plan No. 2 of 1973 (71 P. S. § 755-2).

The provisions of this § 115.33 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37838).

This section cited in 28 Pa. Code § 119.24 (relating to patient medical records); 28 Pa. Code § 135.13 (relating to patient’s medical record; preoperative procedures); and 49 Pa. Code § 16.95 (relating to medical records).

History

Authority: The provisions of this § 115.
Source: The provisions of this § 115.

28 Pa. Code § 115.34 Medical records review.

(a) Medical records shall be reviewed periodically in accordance with medical staff bylaws, rules and regulations by the medical records committee, or its equivalent, established under § 107.26(b)(4) (relating to additional committees).

(b) The medical records committee:

(1) Shall review records for completeness and shall establish requirements regarding completion of medical records, including a system for disciplinary actions for those who do not complete records in a timely manner.

(2) Shall make recommendations to the medical staff, regarding any changes in the format of the records.

(3) Should review the medical records to ensure that the recorded clinical information is sufficient for the purpose of medical care evaluation.

This section cited in 28 Pa. Code § 119.24 (relating to patient medical records); and 49 Pa. Code § 16.95 (relating to medical records).

History

Authority: The provisions of this § 115.
Source: The provisions of this § 115.

Chapter 117 Emergency Services

28 Pa. Code § 117.1 Provision of services.

(a) Regardless of the scope of services offered, every hospital shall institute essential life-saving measures and provide emergency procedures that will minimize aggravation of the condition of the patient during transportation when referral is indicated. In accordance with the principle that an individual confronting an emergency should not bear the responsibility of choosing the proper emergency service, every hospital shall provide and maintain equipment necessary to institute essential life-saving measures.

(b) Where there is an emergency service, it shall provide prompt examination or treatment, or both, to all persons who come or are brought into the hospital in need of treatment, irrespective of ability to pay. The treatment shall be of the highest type consistent with the facilities available and with the standards established in the medical community of which the hospital is a part.

(c) Where emergency services are provided indirectly, through a contract between the hospital and other organizations or individuals or through alternative, innovative, organizational approaches, these services should meet the principles and standards set forth in this chapter.

(d) Where emergency services are provided indirectly, as set forth in subsection (c), the name of the organization and individuals responsible for the operation of the emergency services shall be posted conspicuously to so inform patients.

History

Authority: The provisions of this § 117.
Source: The provisions of this § 117.

28 Pa. Code § 117.11 Emergency services plan.

A comprehensive written plan for emergency care, based on community need and on the capability of the hospital, shall exist within every hospital.

This section cited in 28 Pa. Code § 141.25 (relating to emergency dental services); and 28 Pa. Code § 1021.104 (relating to responsibilities of regional EMS councils).

History

Authority: The provisions of this § 117.
Source: The provisions of this § 117.

28 Pa. Code § 117.12 Procedures.

Every hospital shall have established procedures whereby the ill or injured person can be assessed and either treated, referred to an appropriate facility or discharged, as indicated.

This section cited in 28 Pa. Code § 141.25 (relating to emergency dental services).

History

Authority: The provisions of this § 117.
Source: The provisions of this § 117.

28 Pa. Code § 117.13 Scope of services.

Three levels of care are acceptable, but the scope of services chosen shall be consistent with the scope of other services provided by the hospital.

(1) Hospitals that offer a broad range of services shall provide effective care for any type of patient requiring emergency services.

(2) Hospitals which offer a partial range of services and which are therefore capable of operating only a limited emergency service shall arrange for the transfer or referral of patients for whom they cannot render proper care to other institutions.

(3) Hospitals offering the most limited range of services may elect to refer all emergency patients after institution of essential life-saving measures.

This section cited in 28 Pa. Code § 117.51 (relating to scope); 28 Pa. Code § 117.58 (relating to exemption for hospitals providing limited emergency services); and 28 Pa. Code § 141.25 (relating to emergency dental services).

History

Authority: The provisions of this § 117.
Source: The provisions of this § 117.

28 Pa. Code § 117.14 Required minimal services.

(a) During the rendering of emergency care, no patient may be transferred if the hospital where he was initially seen has means for appropriate care of his emergency medical problem, unless the patient or his family requests a transfer.

(b) Examination or treatment, or both by nonphysician members of the medical staff shall be provided in accordance with medical staff bylaws.

(c) When emergency services are provided, the hospital and medical staff are responsible for insuring that emergency patient care meets the general standards of care which prevail in other areas of the hospital. Services shall be available 24 hours a day, and medical staff coverage shall be adequate to ensure that an applicant for treatment will be seen within a period of time which is reasonable in light of the severity of his illness or injury.

(d) No patient may be transferred until the receiving institution has consented to accept him.

(e) The individual arranging for the transfer of a patient shall record on a form to accompany the patient all pertinent medical and social information. This information shall include copies of reports from diagnostic procedures performed, if available.

(f) Every patient seeking medical care from the emergency service who is not in need of emergency services or for whom services cannot be provided by the hospital from which he has sought treatment shall be given information on how to obtain appropriate medical care.

The provisions of this § 117.14 issued under 67 Pa.C.S. § § 6101—6104 (Repealed); and Reorganization Plan No. 2 of 1973 (71 P. S. § 755-2) (Renumbered).

The provisions of this § 117.14 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37842).

This section cited in 28 Pa. Code § 141.25 (relating to emergency dental services).

History

Authority: The provisions of this § 117.
Source: The provisions of this § 117.

28 Pa. Code § 117.15 Community-based plan.

(a) Every hospital, its governing board, its chief administrative officer and its medical staff shall promote and assist other local agencies to develop a written community-based emergency plan.

(b) The plan must:

(1) Be developed with community participation and be coordinated with the local emergency health services council, where one exists.

(2) Indicate where cooperative arrangements, if any, have been made with other local hospitals to coordinate emergency services, especially when the hospital offers a very limited range of emergency services.

(3) Indicate what arrangements with other local hospitals, agencies or municipal services have been made for transportation in receiving and referring emergency cases and for communication among relevant institutions and services.

(4) State specifically what services are available and what administrative procedures shall be followed for prompt, medically appropriate treatment of patients whose emergency conditions:

(i) Are psychiatrically related.

(ii) Involve the use of drugs or alcohol.

(iii) Arise from an alleged criminal act, including specific procedures in the case of an alleged sexual assault.

(iv) Arise from a motor vehicle accident.

(v) Involve radioactive contamination.

The provisions of this § 117.15 amended under sections 102, 201(12), 801.1 and 803(2) of the Health Care Facilities Act (35 P. S. § § 448.102, 448.201(12), 448.801a and 448.803(2)); and under section 2102(a) and (g) of The Administrative Code of 1929 (71 P. S. § 532(a) and (g)).

The provisions of this § 117.15 amended January 25, 2008, effective January 26, 2008, 38 Pa.B. 573. Immediately preceding text appears at serial page (240218).

This section cited in 28 Pa. Code § 141.25 (relating to emergency dental services).

History

Authority: The provisions of this § 117.
Source: The provisions of this § 117.

28 Pa. Code § 117.21 Staffing and organization.

Where there is an emergency service, regardless of its scope, it shall be well organized, properly directed and integrated with other departments of the hospital. Staffing shall be related to the scope and nature of the needs anticipated and the services offered.

History

Authority: The provisions of this § 117.
Source: The provisions of this § 117.

28 Pa. Code § 117.22 Organizational plan.

An organizational plan shall be developed which identifies the emergency service, its place in the overall hospital organizational plan and its current relationship to other community emergency services including municipal services such as fire and police and other services such as the American Red Cross.

History

Authority: The provisions of this § 117.
Source: The provisions of this § 117.

28 Pa. Code § 117.23 Departmental structure.

When warranted by its activities and its degree of complexity, the emergency service should be organized as a department.

History

Authority: The provisions of this § 117.
Source: The provisions of this § 117.

28 Pa. Code § 117.24 Director.

The governing body shall adopt a written statement defining the qualifications, duties and authority of the director of emergency services.

History

Authority: The provisions of this § 117.
Source: The provisions of this § 117.

28 Pa. Code § 117.25 Emergency medical services.

(a) Emergency medical services shall be directed and supervised by a physician with training and experience in emergency care, including cardiopulmonary resuscitation. The physician director is responsible for implementing emergency services policies and for overall coordination of emergency medical services provided.

(b) In the absence of a single physician, direction of emergency medical services may be provided through a multi-disciplinary medical staff committee. The chairman of this committee shall serve as director of emergency medical services.

History

Authority: The provisions of this § 117.
Source: The provisions of this § 117.

28 Pa. Code § 117.26 Physician on-call schedule for basic and general emergency service.

(a) A roster of on-call physicians including name and telephone number shall be posted in the emergency service area.

(b) Acceptable methods of providing medical coverage for the emergency service include the following:

(1) Use of house staff under adequate medical staff supervision.

(2) Rotating panels of staff physicians.

(3) Contractors whose members may or may not be members of the medical staff.

(4) Physician hospital employes.

History

Authority: The provisions of this § 117.
Source: The provisions of this § 117.

28 Pa. Code § 117.27 Specialists and consultants.

Additional members of the medical staff shall be on call for consultation and for unusual contingencies. Services of specialists should be prearranged.

History

Authority: The provisions of this § 117.
Source: The provisions of this § 117.

28 Pa. Code § 117.28 Emergency nursing services.

The emergency nursing service shall be directed and supervised by a professional registered nurse qualified by training and experience in emergency nursing care, including cardiopulmonary resuscitation. There shall be at least one registered professional nurse with the skills on each tour of duty.

History

Authority: The provisions of this § 117.
Source: The provisions of this § 117.

28 Pa. Code § 117.29 Training and education.

Physicians, nurses and specified professional personnel who provide emergency services shall have cardiopulmonary resuscitation training. The hospital shall provide emergency care conferences as part of its education program. Ambulance personnel, emergency service personnel and medical staff who are hospital employes shall be encouraged to participate in the conferences.

History

Authority: The provisions of this § 117.
Source: The provisions of this § 117.

28 Pa. Code § 117.30 Emergency paramedic services.

In hospitals, where paramedics are employed by the hospital for treatment of patients in the emergency service area:

(1) The primary responsibility of the paramedic is to respond to emergency situations outside the hospital. Paramedics cannot be utilized as an integral part of the hospital emergency service area staff, that is, as a replacement for licensed health professionals. Paramedics may only be utilized to support and assist licensed health professionals in the care of patients in emergency situations meeting the requirements of paragraph (4).

(2) Paramedics may function in hospitals as paramedics only when the hospitals provide advanced life support services, when the paramedics are employed by an advanced life support service, or when the paramedics are functioning under paragraph (6).

(3) Paramedics may not function as paramedics, except in extraordinary life threatening situations, in an area of the hospital other than the emergency service area except for training and continuing education purposes under paragraph (6).

(4) A paramedic may function as a paramedic only in an emergency situation. In these situations, a paramedic may practice the skills for which the paramedic is certified to perform. The paramedic may only practice as a paramedic in the hospital emergency service area, when under the direct supervision of a physician, who shall be physically present in the emergency service area. An emergency situation is a situation for which an absence of intervention within hours will result in loss of life or significant impairment of body function.

(5) The paramedic’s scope of practice shall be in accordance with the limitations imposed by the act of November 30, 1976 (P. L. 1205, No. 264) (35 P. S. § § 6801—6805) (Repealed) and Chapter 2, Subchapter A (Reserved).

(6) Paramedic students enrolled in a training program approved by the Department, or paramedics enrolled in a continuing education program, may function in a hospital under the direct supervision of licensed or certified personnel, operating within their legal scopes of practice, who have been assigned responsibility for specific components of the training programs. The Department may approve training programs for paramedic students in hospitals without advanced life support units. A continuing education program shall consist of a written program of instruction, designed to enhance the paramedics’ skills in accordance with standards mandated by the applicable regional Emergency Health Services Council.

The provisions of this § 117.30 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 117.30 adopted January 25, 1985, effective March 27, 1985, 15 Pa.B. 250.

The section cited in 28 Pa. Code § 107.62 (relating to oral orders); 28 Pa. Code § 107.64 (relating to administration of drugs); and 28 Pa. Code § 109.66 (relating to blood transfusions and intravenous medications).

History

Authority: The provisions of this § 117.
Source: The provisions of this § 117.

28 Pa. Code § 117.31 Principle.

Facilities for the emergency service shall be such as to ensure effective patient care.

History

Authority: The provisions of this § 117.
Source: The provisions of this § 117.

28 Pa. Code § 117.32 Location.

The emergency service area shall be located near an outside entrance to the hospital and shall be easily accessible from within the hospital.

History

Authority: The provisions of this § 117.
Source: The provisions of this § 117.

28 Pa. Code § 117.33 Instruments and supplies.

(a) Instruments and supplies used in the emergency service shall be of the same quality as those used throughout the hospital.

(b) Suction and oxygen equipment and cardiopulmonary resuscitation units shall be available and ready for use.

(c) Standard drugs, parenteral fluids, plasma substitutes and surgical supplies shall be on hand for immediate use in treating life-threatening conditions.

(d) Resuscitation equipment shall be available in sizes suitable for adults, children and infants. As used in this section, ‘‘resuscitation equipment’’ shall include equipment used for tracheal intubation, tracheotomy, ventilating bronchoscopy, intra-pleural decompression and intravenous fluid administration.

(e) Equipment which is mechanical or electrical, or both, shall be checked periodically to ensure its operational safety and effectiveness. Records of the checks shall be maintained until the next inspection of the equipment by the appropriate regulatory agency.

History

Authority: The provisions of this § 117.
Source: The provisions of this § 117.

28 Pa. Code § 117.41 Emergency patient care.

(a) Emergency patient care shall be guided by written policies and procedures which delineate the proper administrative and medical procedures and methods to be followed in providing emergency care. These policies and procedures shall be clear and explicit; approved by the medical staff and hospital governing body; reviewed annually; revised as necessary; and dated to indicate the date of the latest review or revision, or both.

(b) Policies and procedures for emergency patient care should, at a minimum, do the following:

(1) Provide for the admission of a patient if, in the judgment of the physician, admission is warranted.

(2) Provide for the referral and placement of patients whose needs cannot be met by the hospital.

(3) Establish procedures to minimize the possibility of cross-infection and contamination.

(4) Provide for the discharge of patients only upon written orders of a physician. Telephone discharge orders may be accepted in accordance with § 107.62 (relating to oral orders).

(5) Specify explicitly the location and mode of storage of medications, supplies and special equipment.

(6) Establish methods for 24-hour-a-day procurement of equipment and drugs.

(7) Establish procedures for notification of the personal physician of the patient and the transmission of relevant reports to the physician.

(8) Establish procedures on disclosure of patient information. Policies on confidentiality of emergency room records must be the same as those which apply to other hospital medical records. The identity and the general condition of the patient may be released to the public after the next of kin have been notified.

(9) Plan for communication with police, local or State health or welfare authorities as appropriate, regarding accident victims and patients whose condition or its cause is reportable, for example, persons having contagious diseases or victims of suspected criminal acts such as sexual assault or gunshot wounds, see 18 Pa.C.S. § 5106 (relating to failure to report injuries by firearm or criminal act), and child abuse, see 23 Pa.C.S. Chapter 63 (relating to Child Protective Services).

(10) Instruct personnel in special procedures for handling persons who are mentally ill, under the influence of drugs or alcohol, victims of suspected criminal acts or contaminated by radioactive material or who otherwise require special care or have other conditions requiring special instructions.

(11) Instruct personnel how to deal with patients who are dead on arrival.

(12) Provide for a review by the appropriate committee of the medical staff of each death occurring on the emergency service or, if there is no service, of each death occurring during the performance of essential life-saving measures prior to transfer to another facility.

(13) Explain the role of the emergency service in the hospital’s disaster plan established in accordance with Chapter 151 (relating to fire, safety and disaster services).

(14) Delineate medical staff obligations for emergency patient care.

(15) Specify which procedures may not be performed in the emergency area.

(16) Provide for appropriate utilization of any beds used for observation.

(17) Establish procedures to be used when the patient is required to return to the hospital for treatment, for example, when treatment is impossible to arrange otherwise.

(18) Establish procedures for early transfer of severely ill or injured patients to special treatment areas within the hospital, such as the surgical suite, the intensive care unit or the cardiac care unit.

(19) Delineate instructions to be given to a patient or the patient’s family, or both, or others as appropriate regarding follow-up care.

(20) Make available to the emergency service current toxicological reference material along with the telephone numbers of the regional poison control center.

(21) Provide for the ready availability of reference materials and charts relating to the initial treatment of burns, cardiopulmonary resuscitation and tetanus immunization.

(22) Provide for effective coordination with outpatient services, where these services are provided.

(23) Establish procedures to clearly inform patients of emergency service billing policies, including prominent display of that information in the emergency service area. This information must indicate whether patients are to be billed separately for physicians’ services and other emergency services. Those hospitals having an obligation under section 2 of the Hospital Survey and Construction (Hill-Burton) Act (42 U.S.C.A. § § 291—291o), shall comply with the provisions of that act as it relates to free and low-cost care.

The provisions of this § 117.41 issued under 67 Pa.C.S. § § 6101—6104 (Repealed); and Reorganization Plan No. 2 of 1973 (71 P. S. § 755-2) (Renumbered); amended under sections 102, 201(12), 801.1 and 803(2) of the Health Care Facilities Act (35 P. S. § § 448.102, 448.201(12), 448,801a and 448.803(2)); and under section 2102(a) and (g) of The Administrative Code of 1929 (71 P. S. § 532(a) and (g)).

The provisions of this § 117.41 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761; amended January 25, 2008, effective January 26, 2008, 38 Pa.B. 573. Immediately preceding text appears at serial pages (240222) to (240224).

History

Authority: The provisions of this § 117.
Source: The provisions of this § 117.

28 Pa. Code § 117.42 Control register.

The emergency service shall maintain a control register for reference. The register shall contain, at a minimum the name, date and time of arrival of each patient. The name of those dead on arrival shall be entered in the register. The control register shall indicate whether the patient has ever been a patient at the hospital, in order to facilitate coordination of patient medical records. Unless and until a permanent record number can be assigned to the records of a new patient, the control register shall contain, for each patient, a record number which shall also appear on all records pertinent to the care rendered that patient by the emergency services. These records shall be retained for at least 3 years.

History

Authority: The provisions of this § 117.
Source: The provisions of this § 117.

28 Pa. Code § 117.43 Medical records.

(a) A medical record shall be kept for every patient receiving emergency service, and it shall become an official hospital record.

(b) The medical record shall include:

(1) Patient identification data.

(2) Time of arrival.

(3) By whom transported.

(4) Pertinent history of injury or illness.

(5) Clinical, laboratory and roentgenologic findings.

(6) Diagnosis.

(7) Treatment given.

(8) Condition at time of discharge.

(9) Final disposition, including instructions given for necessary follow-up.

(d) A review of emergency service medical records shall be conducted regularly to evaluate the quality of emergency medical care. Special attention shall be given to the records of patients dying within 24 hours of admission to the emergency service.

(e) Nonphysicians may write in patient medical records in accordance with § 107.12 (relating to content of bylaws, rules and regulations).

(f) Medical records of emergency services patients shall be made part of any other patient medical record maintained in accordance with § 115.31 (relating to patient medical records).

The provisions of this § 117.43 issued under 67 Pa.C.S. § § 6101—6104 (Repealed); and Reorganization Plan No. 2 of 1973 (71 P. S. § 755-2) (Renumbered).

The provisions of this § 117.43 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37849).

History

Authority: The provisions of this § 117.
Source: The provisions of this § 117.

28 Pa. Code § 117.51 Scope.

Except as otherwise provided by § § 117.57 and 117.58 (relating to religious and moral exemptions; and exemption for hospitals providing limited emergency services), a hospital shall provide sexual assault emergency services to a sexual assault victim in accordance with this section and § § 117.52—117.58 (relating to sexual assault victim emergency services).

(1) A hospital that does not provide emergency contraception under the exemption in § 117.57 shall comply with the notification and transport provisions of that section.

(2) A hospital that provides the most limited range of services and elects to refer all emergency patients after institution of essential life-saving measures in accordance with § 117.13(3) (relating to scope of services), and elects not to provide any sexual assault emergency services under § 117.58, shall comply with the notification and transfer provisions of that section.

The provisions of this § 117.51 adopted under sections 102, 201(12), 801.1 and 803(2) of the Health Care Facilities Act (35 P. S. § § 448.102, 448.201(12), 448.801a and 448.803(2)); and under section 2102(a) and (g) of The Administrative Code of 1929 (71 P. S. § 532(a) and (g)).

The provisions of this § 117.51 adopted January 25, 2008, effective January 26, 2008, 38 Pa.B. 573.

This section cited in 28 Pa. Code § 117.58 (relating to exemption for hospitals providing limited emergency services).

History

Authority: The provisions of this § 117.
Source: The provisions of this § 117.

28 Pa. Code § 117.52 Minimum requirements for sexual assault emergency services.

(a) Promptly upon a sexual assault victim presenting to a hospital that provides sexual assault emergency services, or as immediately thereafter as medically appropriate depending on the condition of the victim, the hospital shall, at a minimum and in addition to any other services required by the condition of the victim, provide, with the consent of the victim, the following:

(1) Medical examinations and laboratory or diagnostic tests required to ensure the health, safety and welfare of the victim, or which may be used as evidence in a criminal proceeding against a person accused of the sexual assault, or both. A hospital shall utilize a rape kit that complies with the minimum standard requirements developed by the Department or that is otherwise approved by the Department under the Sexual Assault Testing and Evidence Collection Act (35 P. S. § § 10172.1—10172.4). The Department will publish a notice of minimum standard requirements for rape kits or approved rape kits in the Pennsylvania Bulletin.

(2) Oral and written information concerning the possibility of a sexually transmitted disease and pregnancy resulting from the sexual assault.

(3) Oral and written information concerning accepted medical procedures, medication and possible contraindications of the medication available for the prevention or treatment of infection or disease resulting from the sexual assault.

(4) Medication as deemed appropriate by the attending physician, including HIV and sexually transmitted disease prophylaxis.

(5) Tests and examinations as medically indicated to determine the presence or absence of a sexually transmitted disease.

(6) Oral and written instructions advising of the need for additional blood tests at time periods after the sexual assault as medically indicated to determine the presence or absence of a sexually transmitted disease.

(7) Information on the availability of a rape crisis center or sexual assault counselor and the telephone number of a local rape crisis center or sexual assault counselor. The hospital shall promptly contact the local rape crisis center or sexual assault counselor at the request of the victim.

(8) The opportunity for the victim to consult with the rape crisis center or sexual assault counselor in person and in private while at the hospital.

(9) Emergency contraception under § 117.53 (relating to emergency contraception) for a female sexual assault victim.

(b) A hospital shall maintain records of the results of all examinations, tests and services provided to a sexual assault victim in accordance with Chapter 115 (relating to medical record services) and other applicable laws and regulations, and make those records available to law enforcement officials upon the request and with the consent of the sexual assault victim.

The provisions of this § 117.52 amended under sections 102, 201(12), 801.1 and 803(2) of the Health Care Facilities Act (35 P. S. § § 448.102, 448.201(12), 448.801a and 448.803(2)); and under section 2102(a) and (g) of The Administrative Code of 1929 (71 P. S. § 532(a) and (g)).

The provisions of this § 117.52 adopted January 25, 2008, effective January 26, 2008, 38 Pa.B. 573.

This section cited in 28 Pa. Code § 117.51 (relating to scope); 28 Pa. Code § 117.53 (relating to emergency contraception); and 28 Pa. Code § 117.58 (relating to exemption for hospitals providing limited emergency services).

History

Authority: The provisions of this § 117.
Source: The provisions of this § 117.

28 Pa. Code § 117.53 Emergency contraception.

A hospital shall provide the following services to a female sexual assault victim in addition to the minimum requirements set forth in § 117.52 (relating to minimum requirements for sexual assault emergency services):

(1) Provide the victim with written informational materials regarding emergency contraception prepared under § 117.55 (relating to emergency contraception informational materials).

(2) Objectively and orally inform the victim of the availability of emergency contraception, its use, risks and efficacy.

(3) Offer emergency contraception to the victim and provide emergency contraception onsite upon the victim’s request, unless medically contraindicated or unless the hospital claims an exemption in accordance with § 117.57 (relating to religious and moral exemptions).

The provisions of this § 117.53 amended under sections 102, 201(12), 801.1 and 803(2) of the Health Care Facilities Act (35 P. S. § § 448.102, 448.201(12), 448.801a and 448.803(2)); and under section 2102(a) and (g) of The Administrative Code of 1929 (71 P. S. § 532(a) and (g)).

The provisions of this § 117.53 adopted January 25, 2008, effective January 26, 2008, 38 Pa.B. 573.

This section cited in 28 Pa. Code § 117.51 (relating to scope); 28 Pa. Code § 117.52 (relating to minimum requirements for sexual assault emergency services) 28 Pa. Code § 117.57 (relating to religious and moral exemptions); and 28 Pa. Code § 117.58 (relating to hospitals providing limited emergency services).

History

Authority: The provisions of this § 117.
Source: The provisions of this § 117.

28 Pa. Code § 117.54 Prevention of sexually transmitted diseases.

(a) A hospital shall provide a sexual assault victim with an assessment of the victim’s risk for contracting a sexually transmitted disease, hepatitis and HIV.

(b) The hospital shall base the risk assessment upon the following considerations:

(1) Available information regarding the assault as well as the subsequent findings from medical examinations and tests that may be conducted.

(2) Established standards of risk assessment, including consideration of recommendations made by the United States Department of Health and Human Services Centers for Disease Control and Prevention.

(c) In addition to the assessment required in subsection (a), a hospital shall advise a sexual assault victim of sexually transmissible diseases, hepatitis and HIV, for which postexposure prophylaxis exists, and for which deferral of treatment would either significantly reduce treatment efficacy or would pose a substantial risk to the individual’s health.

(d) Upon the victim’s consent, the hospital shall provide the victim with an initial dosage of up to 72 hours of postexposure prophylactic treatment for sexually transmissible diseases, hepatitis and HIV, and provide the victim with information and prescriptions necessary to obtain the remainder of the treatment regimen. A hospital will not be required to comply with this subsection when risk evaluation, adopted by the United States Department of Health and Human Services Centers for Disease Control and Prevention, clearly recommends against the application of postexposure prophylaxis.

The provisions of this § 117.54 amended under sections 102, 201(12), 801.1 and 803(2) of the Health Care Facilities Act (35 P. S. § § 448.102, 448.201(12), 448.801a and 448.803(2)); and under section 2102(a) and (g) of The Administrative Code of 1929 (71 P. S. § 532(a) and (g)).

The provisions of this § 117.54 adopted January 25, 2008, effective January 26, 2008, 38 Pa.B. 573.

This section cited in 28 Pa. Code § 117.51 (relating to scope); and 28 Pa. Code § 117.58 (relating to exemption for hospitals providing limited emergency services).

History

Authority: The provisions of this § 117.
Source: The provisions of this § 117.

28 Pa. Code § 117.55 Emergency contraception informational materials.

(a) A hospital that provides sexual assault emergency services shall ensure that each member of the hospital personnel that provides the services is furnished with written informational materials about emergency contraception developed by the Department under this section.

(b) The Department will prepare the written emergency contraception informational materials and make them available to hospitals in electronic format.

The provisions of this § 117.55 amended under sections 102, 201(12), 801.1 and 803(2) of the Health Care Facilities Act (35 P. S. § § 448.102, 448.201(12), 448.801a and 448.803(2)); and under section 2102(a) and (g) of The Administrative Code of 1929 (71 P. S. § 532(a) and (g)).

The provisions of this § 117.55 adopted January 25, 2008, effective January 26,2008, 38 Pa.B. 573.

This section cited in 28 Pa. Code § 117.51 (relating to scope); and 28 Pa. Code § 117.58 (relating to exemption for hospitals providing limited emergency services).

History

Authority: The provisions of this § 117.
Source: The provisions of this § 117.

28 Pa. Code § 117.56 Information regarding payment for sexual assault emergency services.

A hospital shall inform a sexual assault victim receiving sexual assault emergency services at the hospital of the availability of known financial resources for services provided to the victim due to the sexual assault, including payments by the victim’s medical insurer, if applicable, the Victim’s Compensation Assistance Program administered by the Pennsylvania Commission on Crime and Delinquency, government programs, public assistance programs and programs administered by the hospital. The hospital shall provide the victim any information required to secure the services, including copies of itemized bills and medical records.

The provisions of this § 117.56 amended under sections 102, 201(12), 801.1 and 803(2) of the Health Care Facilities Act (35 P. S. § § 448.102, 448.201(12), 448.801a and 448.803(2)); and under section 2102(a) and (g) of The Administrative Code of 1929 (71 P. S. § 532(a) and (g)).

The provisions of this § 117.56 adopted January 25, 2008, effective January 26, 2008, 38 Pa.B. 573.

This section cited in 28 Pa. Code § 117.51 (relating to scope); and 28 Pa. Code § 117.58 (relating to exemption for hospitals providing limited emergency services).

History

Authority: The provisions of this § 117.
Source: The provisions of this § 117.

28 Pa. Code § 117.57 Religious and moral exemptions.

In accordance with section 902(a) of the act (35 P. S. § 448.902(a)), a hospital is not required to comply with § 117.53(3) (relating to emergency contraception) if compliance would be contrary to the stated religious or moral beliefs of the hospital. If the hospital does not provide emergency contraception under this religious and moral exemption, the hospital shall do the following:

(1) Notify the Department within 30 days of the hospital’s decision not to provide emergency contraception.

(i) The hospital shall address and send the written notice to the Division of Acute and Ambulatory Care.

(ii) The Department will annually publish a list of hospitals in the Pennsylvania Bulletin that have chosen not to provide emergency contraception under this section.

(2) Notify the law enforcement agencies that may transport or refer a sexual assault victim to the hospital that the hospital has elected not to provide emergency contraception. The written notice to law enforcement agencies shall be sent no later than 30 days after the hospital’s decision not to provide those services.

(3) Notify the ambulance and emergency medical care and transport services that may transport or refer a sexual assault victim to the hospital that the hospital has elected not to provide emergency contraception. The written notice to ambulance and emergency medical transport and care services shall be sent no later than 30 days after the hospital’s decision not to provide those services.

(4) Provide individual oral and written notice to the sexual assault victim that emergency contraception is not provided at the hospital due to the stated religious or moral beliefs of the hospital.

(5) Provide oral and written notice to the victim of the hospital’s obligation to arrange for transportation for the victim in accordance with paragraph (6). Notice shall also be prominently displayed in the hospital’s emergency service area.

(6) Upon request of the victim, arrange for immediate transportation for the victim, at no cost to the victim, to the closest hospital where a victim could obtain emergency contraception. If the victim’s medical condition does not require further inpatient hospital services, the hospital may arrange to transport the victim to a rural health clinic, Federally-qualified health center, pharmacy or other similar location where a victim could obtain emergency contraception.

The provisions of this § 117.57 amended under sections 102, 201(12), 801.1 and 803(2) of the Health Care Facilities Act (35 P. S. § § 448.102, 448.201(12), 448.801a and 448.803(2)); and under section 2102(a) and (g) of The Administrative Code of 1929 (71 P. S. § 532(a) and (g)).

The provisions of this § 117.57 adopted January 25, 2008, effective January 26, 2008, 38 Pa.B. 573.

This section cited in 28 Pa. Code § 117.51 (relating to scope); and 28 Pa. Code § 117.53 (relating to emergency contraception).

History

Authority: The provisions of this § 117.
Source: The provisions of this § 117.

28 Pa. Code § 117.58 Exemption for hospitals providing limited emergency services.

A hospital offering the most limited range of services and that elects to refer all emergency patients after institution of essential life-saving measures under § 117.13(3) (relating to scope of services) may elect not to provide any sexual assault emergency services. If a hospital otherwise governed by this subpart elects not to provide any sexual assault emergency services under this section, the hospital shall:

(1) Notify the Department within 30 days of the hospital’s decision not to provide any sexual assault emergency services.

(i) The hospital shall address and send the written notice to the Division of Acute and Ambulatory Care.

(ii) The Department will annually publish a list of hospitals in the Pennsylvania Bulletin that have chosen not to provide any sexual assault emergency services.

(2) Notify the law enforcement agencies that may transport or refer a sexual assault victim to the hospital that the hospital has elected not to provide any sexual assault emergency services. The written notice to law enforcement agencies shall be sent no later than 30 days after the hospital’s decision not to provide those services.

(3) Notify the ambulance and emergency medical care and transport services that may transport or refer a sexual assault victim to the hospital that the hospital has elected not to provide any sexual assault emergency services. The written notice to ambulance and emergency medical transport and care services shall be sent no later than 30 days after the hospital’s decision not to provide those services.

(4) Provide individual oral and written notice to the sexual assault victim that sexual assault emergency services are not provided at the hospital.

(5) Provide oral and written notice to the victim of the hospital’s obligation to arrange for a transfer of the victim in accordance with paragraph (6). Notice shall also be prominently displayed in the hospital’s emergency service area.

(6) Upon request of the victim, arrange for the immediate transfer of the victim to the closest hospital that provides sexual assault emergency services under § § 117.51—117.56.

The provisions of this § 117.58 amended under sections 102, 201(12), 801.1 and 803(2) of the Health Care Facilities Act (35 P. S. § § 448.102, 448.201(12), 448.801a and 448.803(2)); and under section 2102(a) and (g) of The Administrative Code of 1929 (71 P. S. § 532(a) and (g)).

The provisions of this § 117.58 adopted January 25, 2008, effective January 26, 2008, 38 Pa.B. 573.

This section cited in 28 Pa. Code § 117.51 (relating to scope).

History

Authority: The provisions of this § 117.
Source: The provisions of this § 117.

Chapter 121 Social Work Services

28 Pa. Code § 121.1 Principle.

Social work services shall be available to patients accepted for care as well as to their families in order to promote adequate social functioning and to encourage full and appropriate utilization of hospital resources.

The provisions of this § 121.1 issued under 67 Pa.C.S. § § 6101—6104; and Reorganization Plan No. 2 of 1973 (71 P.S. § 755-2).

The provisions of this § 121.1 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37859).

History

Authority: The provisions of this § 121.
Source: The provisions of this § 121.

28 Pa. Code § 121.2 Organization and staffing.

Every hospital shall have a well-defined plan for providing social work services to patients with social problems. The method for providing social work services shall be clearly defined and shall provide for supervision of the delivery of such services by a qualified social worker or by an equally qualified consultant.

History

Authority: The provisions of this § 121.
Source: The provisions of this § 121.

28 Pa. Code § 121.3 Organization plan.

The chief executive officer, or his designee, shall provide an organizational plan to identify the social service department or other program for providing social services and to specify the place of the department in the overall hospital organizational structure. The scope of social work services provided shall depend upon the size and complexity of the services of the hospital.

History

Authority: The provisions of this § 121.
Source: The provisions of this § 121.

28 Pa. Code § 121.11 Principle.

The method for providing social work services shall be clearly stated, and there shall be written policies and procedures which the chief executive officer or the governing body shall review, revise as necessary, and date to include the time of last review.

History

Authority: The provisions of this § 121.
Source: The provisions of this § 121.

28 Pa. Code § 121.12 Referral.

Patients or families, or both, with social problems not appropriate to be dealt with by hospital social work services should be referred to local community agencies.

History

Authority: The provisions of this § 121.
Source: The provisions of this § 121.

28 Pa. Code § 121.13 Plans.

Plans for patients requiring social work services shall be established with primary emphasis placed on helping patients to fully utilize preadmission, inpatient, outpatient, extended care, and home health services. Social work services shall be provided on an interdisciplinary basis.

History

Authority: The provisions of this § 121.
Source: The provisions of this § 121.

28 Pa. Code § 121.14 Coordination of social services.

Social work staff should assist in the coordination of hospital services, community programs, and appropriate educational and orientation programs for hospital personnel.

History

Authority: The provisions of this § 121.
Source: The provisions of this § 121.

28 Pa. Code § 121.16 Patient medical records.

Social work services delivered shall be recorded in the medical record of the patient.

History

Authority: The provisions of this § 121.
Source: The provisions of this § 121.

28 Pa. Code § 121.21 Administration.

Where social work services are organized on a department basis, the director of the department shall have full responsibility for the administration of the social work programs and activities of the department. The department shall be integrated with other departments of the hospital, and its members shall participate in periodic inter-departmental meetings.

History

Authority: The provisions of this § 121.
Source: The provisions of this § 121.

28 Pa. Code § 121.22 Director.

The director of the social work department shall be responsible for planning, organization, implementation, and management of the fiscal and personnel resources of the social work department and should be a member of appropriate hospital committees.

History

Authority: The provisions of this § 121.
Source: The provisions of this § 121.

28 Pa. Code § 121.23 Staffing.

The staff of the social work department, when provided, should include graduate social workers or undergraduate social workers, or both, and supportive personnel in sufficient numbers to meet patient needs and perform the functions of the department effectively.

History

Authority: The provisions of this § 121.
Source: The provisions of this § 121.

Chapter 125 Laboratory Services

28 Pa. Code § 125.1 Clinical and anatomical pathology services.

Clinical and anatomical pathology and consultation services shall be available to meet the needs of patients. Laboratory services shall be provided in compliance with the Clinical Laboratory Act (35 P.S. § § 2151—2165) and all regulations promulgated pursuant thereto except § § 5.91—5.94 (Reserved). The current permit shall be displayed.

History

Authority: The provisions of this § 125.
Source: The provisions of this § 125.

28 Pa. Code § 125.2 Blood transfusion.

The hospital shall be capable of providing blood transfusions to meet the needs of patients. Where there is a blood transfusion service, it shall be directed by a pathologist or physician qualified in immunohematology and knowledgeable about the principles of hematherapy and blood banking. This service shall be provided in compliance with the Pennsylvania Blood Bank Act (35 P.S. § § 6501—6523) and with Chapter 30 (relating to blood banks). The current license issued shall be displayed in accordance with section 12 of the act (35 P.S. § 6512).

History

Authority: The provisions of this § 125.
Source: The provisions of this § 125.

28 Pa. Code § 125.11 Facilities and services.

Each hospital shall make provisions for necropsy service either onsite or through effective agreements with other facilities capable for providing the ser-vices. Each necropsy shall be performed by a pathologist or a physician who is qualified in anatomic pathology.

History

Authority: The provisions of this § 125.
Source: The provisions of this § 125.

28 Pa. Code § 125.12 Procedures.

Each procedure and the record of it shall be sufficiently thorough and detailed to meet the needs of the medical staff. The gross and microscopic reports shall be made part of the completed medical record of the patient.

The provisions of this § 125.12 issued under 67 Pa.C.S. § § 6101—6104; and Reorganization Plan No. 2 of 1973 (71 P.S. § 755-2).

The provisions of this § 125.12 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37870).

History

Authority: The provisions of this § 125.
Source: The provisions of this § 125.

28 Pa. Code § 125.13 Storage of the remains of deceased patients.

If the hospital does not have morgue services on the premises, provisions shall be made to retain a deceased patient no longer than necessary in a room which is not otherwise occupied and which is properly ventilated to the outdoors.

History

Authority: The provisions of this § 125.
Source: The provisions of this § 125.

28 Pa. Code § 125.14 Removal of a dead body from patient unit to morgue.

(a) The remains of a deceased patient shall not be removed to a morgue or storage area until a physician has conducted an examination, has pronounced death, and has authenticated the time and provisional diagnosis or final cause of death in the patient’s medical records.

(b) The remains of deceased patients shall be prepared for removal from clinical areas in accordance with hospital procedures. Terminal disinfection of the remains of persons who died of a reportable contagious disease shall be in accordance with the applicable instructions in § 27.60 (relating to disease control measures).

(c) Bodies of patients who have died of any reportable communicable disease specified in § 27.203 (relating to preparation for burial or transportation of deceased human bodies) shall bear appropriate warning labels.

(d) Radiological cadavers shall bear proper warning labels and be handled according to applicable standards of the Department of Environmental Protection and the United States Nuclear Regulatory Commission.

History

Authority: The provisions of this § 125.
Source: The provisions of this § 125.

28 Pa. Code § 125.15 Disposition of a deceased patient. FACILITIES;Pt.;IV

The remains of any deceased patient, including a fetal death, as defined in 35 P.S. § 450.105, or a neonatal death shall not be subjected to disposition until death has been officially pronounced by a physician.

The provisions of this § 125.15 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 480.803).

The provisions of this § 125.15 adopted December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (52839).

History

Authority: The provisions of this § 125.
Source: The provisions of this § 125.

28 Pa. Code § 125.16 Personnel safety.

All areas where hospital personnel must work with dead bodies shall be properly ventilated. Plumbing, maintenance, and housekeeping should be planned to minimize health hazards both to personnel working in the areas and to other hospital personnel, patients, and visitors.

The provisions of this § 125.16 adopted December 3, 1982, effective December 4, 1982, 13 Pa.B. 833.

History

Authority: The provisions of this § 125.
Source: The provisions of this § 125.

Chapter 127 Radiology Services

28 Pa. Code § 127.1 Principle.

Radiologic consultation and services shall be regularly and conveniently available to meet the needs of patients.

History

Authority: The provisions of this § 127.
Source: The provisions of this § 127.

28 Pa. Code § 127.2 Organization and staffing.

The hospital shall provide radiographic and fluoroscopic diagnostic services adequate to meet the needs of patients.

History

Authority: The provisions of this § 127.
Source: The provisions of this § 127.

28 Pa. Code § 127.3 Director.

The director of radiology services shall be a member of the medical staff and should be certified by the American Board of Radiology or an equivalent Board, be eligible for Board certification, or have successfully completed an approved residency training program in radiology.

History

Authority: The provisions of this § 127.
Source: The provisions of this § 127.

28 Pa. Code § 127.4 Radiotherapy procedures.

(a) Radiotherapy services provided in the hospital shall be operated safely and effectively. Provisions shall be made for safe storage and use of radium and other radioactive sources. The services of a radiation physicist or of a competently trained dosimetrist shall be available, as needed, for consultation, for supervision of radiation safety procedures, and for participation in educational programs. Radiologic technologists and other personnel shall be available to meet patient needs.

(b) When the facility does not provide certain service, such as radiotherapy or special diagnostic procedures, the director shall participate in recommending one or more sources to be approved by the medical staff.

History

Authority: The provisions of this § 127.
Source: The provisions of this § 127.

28 Pa. Code § 127.5 Radiology service personnel.

There shall be at least one radiologic technician registered or eligible for registration by the American Registry of Radiologic Technologists on duty or available when needed. Work assignments shall be in accordance with written job descriptions and employe qualifications.

History

Authority: The provisions of this § 127.
Source: The provisions of this § 127.

28 Pa. Code § 127.6 Education programs.

Radiology service personnel should have the opportunity to further their knowledge and skills through hospital based educational opportunities, such as on-the-job training and in-service education programs, or through attendance at workshops and institutes held outside the hospital.

History

Authority: The provisions of this § 127.
Source: The provisions of this § 127.

28 Pa. Code § 127.11 Principle.

Radiology services shall have adequate space and facilities to safely meet the diagnostic and therapeutic needs of the patients, and shall be in compliance with 25 Pa. Code § § 221.1—235.15 (relating to radiological health).

History

Authority: The provisions of this § 127.
Source: The provisions of this § 127.

28 Pa. Code § 127.21 Equipment operation.

The hospital shall ensure that all radiographic equipment is operated at all times by competent personnel under physician supervision and trained in the use of radiographic equipment and in safety precautions. Nonportable equipment shall be operated only in properly shielded spaces. Caution shall be exercised in using portable equipment to protect employes, patients, and other persons from exposure to radiation.

History

Authority: The provisions of this § 127.
Source: The provisions of this § 127.

28 Pa. Code § 127.22 Radiation safety inspection.

Radiation safety inspections are made by the Department of Environmental Protection on a scheduled basis.

History

Authority: The provisions of this § 127.
Source: The provisions of this § 127.

28 Pa. Code § 127.23 Safety precautions.

Proper safety precautions shall be maintained against fire and explosion and electrical and mechanical hazards.

History

Authority: The provisions of this § 127.
Source: The provisions of this § 127.

28 Pa. Code § 127.24 Personnel monitoring.

The exposure of radiology service personnel shall be periodically monitored by means of film badges or other similar personnel monitoring devices. A record of the annual accumulation shall be maintained as part of the personnel file of the employe, and a copy given to the employe upon termination. The employe shall have access to these records during time of employment.

The provisions of this § 127.24 issued under section 2103 of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 127.24 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (52842).

History

Authority: The provisions of this § 127.
Source: The provisions of this § 127.

28 Pa. Code § 127.25 Instruction in safety procedures.

All radiology service personnel shall be instructed in safety precautions and in procedures for dealing with emergency radiation hazards.

History

Authority: The provisions of this § 127.
Source: The provisions of this § 127.

28 Pa. Code § 127.26 Patient safety.

To assure that patients are not subjected to unnecessary amounts of radiation, the director shall establish a procedure to review cases where a radiographic photograph has to be retaken due to the first such photograph not being of usable quality.

History

Authority: The provisions of this § 127.
Source: The provisions of this § 127.

28 Pa. Code § 127.31 Policies and procedures.

(a) Policies and procedures shall be developed by the director of radiology services in cooperation with the hospital administrative staff, medical staff, nursing service, and other departments or services as necessary. These shall be reviewed annually by the director of radiology services, revised as necessary, and dated to indicate the time of the last review.

(b) Procedures shall be developed to guide radiology personnel in performing their duties and also to guide persons involved in preparing patients for radiologic services. Procedures shall include radiology examinations in areas other than the radiology department, the administration of diagnostic agents by paramedical personnel, and the care of patients having special need, including those who are critically ill and those needing isolation precautions.

History

Authority: The provisions of this § 127.
Source: The provisions of this § 127.

28 Pa. Code § 127.32 Written orders.

Diagnostic radiology services shall be performed only upon the written order of a member of the medical staff, or house staff, or a physician who has been granted clinical privileges. Orders for radiology services shall, in all other respects, conform to the regulations generally applicable to written orders or the exceptions thereto. Any request for radiology services should contain a concise statement as to the reason for the request.

History

Authority: The provisions of this § 127.
Source: The provisions of this § 127.

28 Pa. Code § 127.33 Authority to use radium.

The therapeutic use of radium or other sealed radioactive sources in the hospital shall be limited to physicians who have been granted this privilege by the governing body at the recommendation of the medical staff after consultation with and consideration of the recommendations of the radiologist or of a radiation safety committee, or both. Only persons who have had suitable training and experience as determined by the director of radiology services or radiation safety committee shall be permitted to handle radioactive material. A license from the Department of Environmental Protection or the United States Nuclear Regulatory Commission authorizing the use of radioactive materials shall be required.

History

Authority: The provisions of this § 127.
Source: The provisions of this § 127.

28 Pa. Code § 127.34 Storage and handling of radioactive material.

Rules shall be established by the director of radiology services or the radiation safety committee, or both, as to the use, removal, handling and storage of the radium element, its disintegration products, and other radioactive elements.

History

Authority: The provisions of this § 127.
Source: The provisions of this § 127.

28 Pa. Code § 127.35 Patient care records.

Authenticated reports of radiology interpretations and of consultation, therapy, and radiotherapy summaries shall be part of the patient’s medical record and shall conform to the requirements of Chapter 115 (relating to medical records).

History

Authority: The provisions of this § 127.
Source: The provisions of this § 127.

Chapter 129 Nuclear Medicine Services

28 Pa. Code § 129.1 Principle.

Nuclear medicine and consultation services should be conveniently available to meet the needs of the patients.

History

Authority: The provisions of this § 129.
Source: The provisions of this § 129.

28 Pa. Code § 129.2 Organizational options.

When these services are obtained outside the hospital for hospitalized patients, the providers of such services must be approved by the medical staff and must have a current permit from the Department of Environmental Protection.

The provisions of this § 129.2 issued under 67 Pa.C.S. § § 6101—6104; and Reorganization Plan No. 2 of 1973 (71 P.S. § 755-2).

The provisions of this § 129.2 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial pages (37876) and (37877).

History

Authority: The provisions of this § 129.
Source: The provisions of this § 129.

28 Pa. Code § 129.3 Organization and staffing.

The system for providing nuclear medicine services shall be clearly defined by the chief executive officer or the governing body.

The provisions of this § 129.3 issued under 67 Pa.C.S. § § 6101—6104; and Reorganization Plan No. 2 of 1973 (71 P.S. § 755-2).

The provisions of this § 129.3 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37877).

History

Authority: The provisions of this § 129.
Source: The provisions of this § 129.

28 Pa. Code § 129.4 Director.

Direction of nuclear medicine services shall be provided by a member of the medical staff who is certified by the American Board of Nuclear Medicine or an equivalent Board who is eligible for Board certification, or who has successfully completed an approved residency in nuclear medicine or equivalent training. The director may be available full time or part time, depending on the size and complexity of the service. The director shall ensure that proper radiation safety principles and practices are observed.

History

Authority: The provisions of this § 129.
Source: The provisions of this § 129.

28 Pa. Code § 129.5 Consultation by physicist.

The services of a radiation physicist or other physical scientist shall be available, as needed.

History

Authority: The provisions of this § 129.
Source: The provisions of this § 129.

28 Pa. Code § 129.6 Education program for nuclear medicine personnel.

Nuclear medicine personnel should have the opportunity to further their knowledge and skills through on-the-job training, in-service education programs, and attendance at workshops and institutes held outside the hospital.

History

Authority: The provisions of this § 129.
Source: The provisions of this § 129.

28 Pa. Code § 129.11 Principle.

Nuclear medicine services, when provided within the hospital, shall have adequate space and facilities to meet, with safety, the diagnostic and therapeutic needs of the patients.

History

Authority: The provisions of this § 129.
Source: The provisions of this § 129.

28 Pa. Code § 129.12 Space requirements.

Space and facilities for the nuclear medicine service should include those necessary for the reception, examination, and diagnostic study of patients, as well as for related clerical work and conferences.

History

Authority: The provisions of this § 129.
Source: The provisions of this § 129.

28 Pa. Code § 129.13 Storage and disposal studies.

Facilities shall be provided for the safe preparation, transportation, storage, and disposal of radioactive materials so that radiation levels meet the regulations of the Department of Environmental Protection and the United States Nuclear Regulatory Commission.

History

Authority: The provisions of this § 129.
Source: The provisions of this § 129.

28 Pa. Code § 129.14 Equipment.

The type, quantity and quality of equipment for the nuclear medicine service shall be adequate to conduct reliable diagnostic studies and therapy. Standards having equivalent energy radiations of the radionuclides used in patient studies shall be utilized for routine calibration and be readily available.

History

Authority: The provisions of this § 129.
Source: The provisions of this § 129.

28 Pa. Code § 129.21 Policies and procedures.

There shall be written policies and procedures for the nuclear medicine services. They shall be reviewed annually, revised as necessary, and dated to indicate the date of last review.

History

Authority: The provisions of this § 129.
Source: The provisions of this § 129.

28 Pa. Code § 129.22 Standardized diagnostic studies.

The director of nuclear services shall establish procedures to guide personnel in the standardized performance of diagnostic studies and to ensure that the identity, strength, and integrity of radio-pharmaceutical agents are maintained.

History

Authority: The provisions of this § 129.
Source: The provisions of this § 129.

28 Pa. Code § 129.23 Radiation safety committee.

(a) A radiation safety committee shall be established in hospitals providing nuclear medicine services. At least one member of this committee shall be a physician experienced in the safe handling of radioisotopes, in the measurement of radioactivity, and in determining radioisotope dosage for various patient studies and treatments. Representatives of various fields of specialization should be included on the committee, as determined by the nature of the program conducted in the hospital.

(b) The radiation safety committee shall be responsible for all of the following:

(1) Reviewing all proposals for diagnostic and therapeutic uses for radionuclides.

(2) Recommending to the medical staff medical practitioners having suitable training and experience to perform nuclear medicine procedures.

(3) Developing rules governing the use, removal, handling and storage of radioactive materials used in nuclear medicine procedures.

(4) Recommending corrective and appropriate disciplinary action where there is a failure to observe safety rules and procedures.

History

Authority: The provisions of this § 129.
Source: The provisions of this § 129.

28 Pa. Code § 129.24 Written orders.

Nuclear medicine therapeutic and diagnostic services, when provided within the hospital, shall be performed only upon written request of the responsible physician or member of the house staff and shall be subject to the regulations otherwise governing written medical orders or exceptions thereto.

History

Authority: The provisions of this § 129.
Source: The provisions of this § 129.

28 Pa. Code § 129.31 Principle.

There shall be quality control procedures governing nuclear medicine services that ensure diagnostic reliability and patient safety.

History

Authority: The provisions of this § 129.
Source: The provisions of this § 129.

28 Pa. Code § 129.32 Radioisotopes.

All radioisotopes shall be prepared, stored, and periodically checked to ensure accuracy, patient safety and precision of results. All radioisotopes shall be labeled to indicate identity, date of preparation and concentration assay.

History

Authority: The provisions of this § 129.
Source: The provisions of this § 129.

28 Pa. Code § 129.33 Instrument calibration procedures.

Instrument calibration procedures designed to affirm proper performance shall be conducted periodically as required by the nature of the instrument. The results of these calibration procedures shall be recorded as provided in § 129.35 (relating to instrument log book).

History

Authority: The provisions of this § 129.
Source: The provisions of this § 129.

28 Pa. Code § 129.34 Radionuclides and radiopharmaceutical records.

The following records shall be maintained for radionuclides and radiopharmaceuticals:

(1) Dates, amounts and methods of receipt and disposal.

(2) Supplier and lot number.

(3) The use, date, amount and identity of any recipient, where applicable.

History

Authority: The provisions of this § 129.
Source: The provisions of this § 129.

28 Pa. Code § 129.35 Instrument log books.

Instrument log books shall be maintained for the life of each instrument with at least the following information:

(1) Calibration records of equipment and monitors showing dates, names of technologists and sources of reference standards.

(2) Maintenance and repair records showing dates and source of service.

This section cited in 28 Pa. Code § 129.33 (relating to instrument calibration procedures).

History

Authority: The provisions of this § 129.
Source: The provisions of this § 129.

28 Pa. Code § 129.36 Personnel monitoring.

The radiation exposure of nuclear medicine employes shall be monitored by means of film badges or other similar personnel monitoring devices. A record of the annual accumulation shall be maintained as part of the personnel file of the employe, and a copy given to the employe upon termination. The employe shall have access to these records during time of employment.

The provisions of this § 129.36 issued under section 2021(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 129.36 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (52850).

History

Authority: The provisions of this § 129.
Source: The provisions of this § 129.

28 Pa. Code § 129.37 Patient records.

Reports of nuclear medicine interpretations, consultations, and therapy shall be included in each patient’s medical record. Duplicate reports shall be kept on file in the nuclear medicine department. The patient’s medical record should show the identity, date and amount of radiopharmaceutical used, as well as any specific patient preparation performed. These records shall conform in other respects, with Chapter 115 (relating to medical records).

History

Authority: The provisions of this § 129.
Source: The provisions of this § 129.

28 Pa. Code § 129.38 Compliance with other law.

All applicable provisions of the Department of Environmental Protection and the United States Nuclear Regulatory Commission shall be complied with. A copy of the most recent inspection and approval letter by the Department of Environmental Protection shall be available for review by survey team members.

History

Authority: The provisions of this § 129.
Source: The provisions of this § 129.

Chapter 131 Rehabilitation Services

28 Pa. Code § 131.1 Principle.

Rehabilitation services shall be available to meet the needs of the patients. These may include physical medicine, physical therapy, occupational therapy and other related programs.

28 Pa. Code § 131.2 Organization and staffing.

Organized rehabilitation services within the hospital shall be provided by a qualified staff of adequate size to meet patient needs and under qualified medical direction.

28 Pa. Code § 131.3 Director.

A hospital which provides rehabilitation services shall organize those services under the direction and supervision of: a phychiatrist who is a member of the medical staff; a physician who is a member of the medical staff and who, on the basis of training and experience, is knowledgeable in physical medicine; or a medical staff committee whose chairman directs the program with committee guidance.

28 Pa. Code § 131.4 Personnel.

Rehabilitation programs such as physical therapy and occupational therapy shall be under the direction of persons licensed or registered in their respective fields and employed either full time or part time to implement the programs and carry out treatments as ordered by the medical staff. Designated procedures may be performed insofar as is consistent with law by supportive personnel who have completed an organized training or on-the-job training program to qualify them for the performance of their duties.

28 Pa. Code § 131.5 Nursing services.

(a) Restorative nursing services shall be coordinated with rehabilitation programs.

(b) If specialized nursing services are provided, they shall be governed by Chapter 109 (relating to nursing services) and by the following provisions:

(1) Restorative nursing services shall be under the direction and supervision of a registered nurse qualified by training and experience in rehabilitation and restorative nursing.

(2) There shall be an active restorative nursing care program to carry out, between visits of the physical therapist, those procedures which are consistent with the qualifications of the restorative nursing staff.

(3) Restorative nursing care shall include the following measures, among others:

(i) Maintaining good body alignment.

(ii) Proper positioning of bedfast patients.

(iii) Keeping patients active.

(iv) Helping patients stay out of bed in accordance with prescribed orders.

(v) Developing independence in activities of daily living.

28 Pa. Code § 131.6 Organizational plan.

Rehabilitation services and other physical restorative and maintenance programs shall be identified in a current written organizational plan which defines the responsibility, authority, and relationship of all personnel within each service and program.

28 Pa. Code § 131.7 Services provided outside the hospital.

When rehabilitation services required by an inpatient are not provided within the hospital, such services must be arranged for, upon prescription by a practitioner from appropriate community resources. These services must be in accordance with standards outlined in this chapter.

28 Pa. Code § 131.11 Principle.

When rehabilitation services are provided within the hospital, there shall be adequate space, facilities, and equipment to fulfill the professional, educational, and administrative needs of the services. Each rehabilitation service area should be easily accessible to patients by means of transportation ordinarily available to patients requiring rehabilitation services. Equipment shall be provided to meet the needs of patients served, shall be calibrated according to the directions of the manufacturer, and shall be serviced periodically as part of a preventive maintenance program. Records of equipment servicing shall be maintained and retained for the life of the equipment.

28 Pa. Code § 131.21 Policies and procedures.

Policies and procedures for rehabilitation services shall be developed by the director of rehabilitation or by the designated medical staff committee in cooperation with representatives from the medical staff, the administration, the nursing service and other appropriate services. Policies and procedures shall be reviewed periodically, revised if necessary, and dated to indicate the time of the last review.

28 Pa. Code § 131.22 Treatment orders.

Rehabilitation treatment shall be initiated only upon the written prescription of the responsible physician.

28 Pa. Code § 131.23 Plan of care.

There shall be a current written plan of care for each patient receiving treatment, based on the direction of the attending physician and on the rehabilitation potential of the patient. The plan of care shall state the needs and limitations of the patient as well as the goals of the treatment program for that patient. Because the patient should be an active participant in his treatment program, the prescribing physician or the person providing the service, or both, should discuss the treatment goals and the capabilities of the rehabilitative service with the patient or his family, or both. The prescribing physician, or the person providing the service, or both, should participate in planning for the discharge and followup care of the patient, whenever indicated. The patient or his family, or both, should receive the written instructions that are necessary for the appropriate aftercare of the patient.

28 Pa. Code § 131.24 Patients’ medical records.

Inpatient rehabilitation therapy orders, procedures and treatments shall be recorded in the patient’s medical record, in accordance with Chapter 115 (relating to medical record services). The responsible therapist shall make notations in the patient’s chart which reflect repeated evaluations of the patient’s progress. Records shall be reviewed by the medical staff at prescribed intervals to evaluate the service and to ascertain means of improving the quality of patient care.

Chapter 133 Special Care Units

28 Pa. Code § 133.1 Principle.

Special care units, as appropriate for the hospital, shall be developed for patients who require extraordinary care.

The provisions of this § 133.1 adopted December 9, 1977, effective December 10, 1977, 7 Pa.B. 3631.

History

Authority: The provisions of this § 133.
Source: The provisions of this Chapter 133 adopted December 9, 1977, effective December 10, 1977, 7 Pa.

28 Pa. Code § 133.2 Types of special care units.

A special care unit of a hospital is an area set aside for the treatment of patients who require extraordinary care on a concentrated and continuous basis. There are two kinds of special care units as follows:

(1) Multipurpose for the intensive treatment of critically ill patients with a wide variety of diagnoses.

(2) Specific purpose for the continuous care of patients in special diagnostic categories. These categories include but are not limited to:

(i) Burn.

(ii) Coronary care.

(iii) Neonatal care.

(iv) Postobstetric and post operative recovery care.

(v) Pulmonary care.

(vi) Renal dialysis.

(vii) Surgical, including trauma, intensive care units.

The provisions of this § 133.2 adopted December 9, 1977, effective December 10, 1977, 7 Pa.B. 3631.

History

Authority: The provisions of this § 133.
Source: The provisions of this Chapter 133 adopted December 9, 1977, effective December 10, 1977, 7 Pa.

28 Pa. Code § 133.4 Organization and staffing.

Special care units shall be organized so as to function effectively and shall be integrated with other departments or services of the hospital.

The provisions of this § 133.4 adopted December 9, 1977, effective December 10, 1977, 7 Pa.B. 3631.

History

Authority: The provisions of this § 133.
Source: The provisions of this Chapter 133 adopted December 9, 1977, effective December 10, 1977, 7 Pa.

28 Pa. Code § 133.5 Director.

(a) Special care units shall be under the direction of a physician who has a special interest in and, preferably, additional experience in providing the type of care supplied by the special care unit. If an experienced physician is not available, direction of the unit may be provided by a medical staff committee.

(b) The special care unit director or committee shall be responsible for the establishment and implementation of written policies governing the following:

(1) Proper utilization of the service.

(2) Staff participation in appropriate training programs for safe and effective use of diagnostic and therapeutic equipment, for cardiopulmonary resuscitation and for other aspects of intensive care.

(3) Supervision of the collection and analysis of clinical data needed for the retrospective evaluation of care provided in the unit.

History

Authority: The provisions of this § 133.
Source: The provisions of this Chapter 133 adopted December 9, 1977, effective December 10, 1977, 7 Pa.

28 Pa. Code § 133.6 Special care unit nursing service.

(a) When a special care unit is occupied, specialized nursing services shall be provided to ensure medically appropriate and effective patient care.

(b) Nursing services shall be provided in accordance with Chapter 109 (relating to nursing services), as well as the following:

(1) At no time may the occupied unit be without a registered professional nurse. Other registered nurses and health care personnel may serve as assistant or backup personnel under the direct supervision of a qualified special care unit nurse.

(2) When a special care unit is occupied, the professional nurse on each tour of duty shall be responsible for the nursing care in the unit. The nurse so assigned shall be qualified by training and experience and shall have demonstrated appropriate competence.

The provisions of this § 133.6 adopted December 9, 1977, effective December 10, 1977, 7 Pa.B. 3631.

History

Authority: The provisions of this § 133.
Source: The provisions of this Chapter 133 adopted December 9, 1977, effective December 10, 1977, 7 Pa.

28 Pa. Code § 133.11 Principle.

A continuing education program developed especially for the personnel of the special care unit shall be provided in order to enable the personnel to maintain and improve their skills, as well as to learn new techniques. The program may be inside or outside the hospital.

The provisions of this § 133.11 issued under 67 Pa.C.S. § § 6101—6104.

The provisions of this § 133.11 adopted December 9, 1977, effective December 10, 1977, 7 Pa.B. 3631; amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37888).

History

Authority: The provisions of this § 133.
Source: The provisions of this Chapter 133 adopted December 9, 1977, effective December 10, 1977, 7 Pa.

28 Pa. Code § 133.12 Special requirements.

(a) Special care unit personnel shall be prepared for their responsibilities through appropriate training and educational programs. Each staff member shall have completed an education course specifically oriented to his level of participation in the care of patients who require extraordinary care.

(b) The educational programs should prepare special care unit personnel to:

(1) Recognize, interpret and record appropriate signs and symptoms in the critically ill patients.

(2) Initiate cardiopulmonary resuscitation.

(3) Administer electrolytes and fluids parenterally.

(4) Use equipment in the unit safely and effectively.

(5) Perform specialized nursing procedures peculiar to the needs of patients in the unit.

(6) Prevent contamination and cross-infection.

(7) Exercise appropriate safety precautions in the use of electrical or electronic equipment.

(8) Recognize and attend to the psychological and social needs of the patients and their families.

The provisions of this § 133.12 adopted December 9, 1977, effective December 10, 1977, 7 Pa.B. 3631.

History

Authority: The provisions of this § 133.
Source: The provisions of this Chapter 133 adopted December 9, 1977, effective December 10, 1977, 7 Pa.

28 Pa. Code § 133.21 Facilities.

Facilities provided for special care units shall be specifically designed and equipped for the type of special care to be provided.

The provisions of this § 133.21 adopted December 9, 1977, effective December 10, 1977, 7 Pa.B. 3631.

History

Authority: The provisions of this § 133.
Source: The provisions of this Chapter 133 adopted December 9, 1977, effective December 10, 1977, 7 Pa.

28 Pa. Code § 133.22 Equipment.

(a) The type and quality of equipment provided in a special care unit shall depend upon the needs of the patient treated.

(b) There shall be a written preventive maintenance program which includes techniques for cleaning and for contamination control as well as for the scheduled periodic testing of equipment with records kept of the results of such testing.

(c) Special safety precautions related to proper grounding, current leakage and device safety shall be observed when electronic devices are used. Potential electrical hazards must be recognized and guarded against in instances where electrically operated beds are used. Documentation of safety testing shall be retained for the life of the equipment.

The provisions of this § 133.22 adopted December 9, 1977, effective December 10, 1977, 7 Pa.B. 3631.

History

Authority: The provisions of this § 133.
Source: The provisions of this Chapter 133 adopted December 9, 1977, effective December 10, 1977, 7 Pa.

28 Pa. Code § 133.31 Policies and procedures.

(a) Because of the intensity of care given within the special care unit and of the critical nature of the illnesses of patients cared for in it, written policies and procedures additional to basic hospital policies shall be developed to guide personnel in the management of the unique situations which may occur within the unit. These policies and procedures shall be developed by the medical staff, the nursing staff, other appropriate hospital departments and services and the chief executive officer and shall be approved by the appropriate committee of the medical staff. They shall be reviewed and revised as necessary.

(b) Policies and procedures established in accordance with subsection (a) of this section should give special attention to the following:

(1) Functions and authority of the unit director, with special emphasis on the working relationships that exist between the attending physicians and the director.

(2) Admission and discharge criteria, including priority determinations.

(3) Staff responsibility for special procedures and specifications as to which procedures are to be done, by whom, under what circumstances, and under what degree of supervision. Special procedures, as used in this paragraph, may include cardiopulmonary resuscitation, tracheotomy, ordering of medications, administration of parenteral fluids and other medications, and obtaining of blood and other laboratory specimens.

(4) The assignment of responsibility for a preventive and corrective maintenance program, including procedures to follow in the event of breakdown of essential equipment.

(5) The use and location of special equipment and supplies.

(6) Respiratory care, including assisted ventilation and humidification.

(7) Infection control and isolation procedures.

(8) Procedures for priority orders for laboratory tests.

(9) Standing orders, if any.

(10) Regulations governing visitors and traffic control.

The provisions of this § 133.31 issued under 67 Pa.C.S. § § 6101—6104.

The provisions of this § 133.31 adopted December 9, 1977, effective December 10, 1977, 7 Pa.B. 3631; amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37889).

History

Authority: The provisions of this § 133.
Source: The provisions of this Chapter 133 adopted December 9, 1977, effective December 10, 1977, 7 Pa.

Chapter 135 Surgical Services

28 Pa. Code § 135.1 Principle.

When a hospital provides surgical services, they shall be provided in a manner sufficient to meet the medical needs of the patients.

The provisions of this § 135.1 adopted December 9, 1977, effective December 10, 1977, 7 Pa.B. 3631.

History

Authority: The provisions of this § 135.
Source: The provisions of this Chapter 135 adopted December 9, 1977, effective December 10, 1977, 7 Pa.

28 Pa. Code § 135.2 Director of surgical services.

The director of the surgical services shall be a member of the medical staff who is certified by the American Board of Surgery or an equivalent board or who is eligible for Board certification or has successfully completed an approved residency training program in surgery.

The provisions of this § 135.2 adopted December 9, 1977, effective December 10, 1977, 7 Pa.B. 3631.

History

Authority: The provisions of this § 135.
Source: The provisions of this Chapter 135 adopted December 9, 1977, effective December 10, 1977, 7 Pa.

28 Pa. Code § 135.3 Surgical staff.

A roster of physicians, dentists and podiatrists with a delineation of the surgical privileges of each shall be maintained in the surgical suite and available to the surgical nurse supervisor.

The provisions of this § 135.3 adopted December 9, 1977, effective December 10, 1977, 7 Pa.B. 3631.

History

Authority: The provisions of this § 135.
Source: The provisions of this Chapter 135 adopted December 9, 1977, effective December 10, 1977, 7 Pa.

28 Pa. Code § 135.4 Operating room register.

An operating room register shall be provided and maintained on a current basis. The operating room log or register shall contain date of the operation, name and number of patient, names of surgeons and surgical assistants, names of anesthetists, type of anesthesia given, pre- and postoperative diagnosis, type of surgical procedure, and the presence or absence of complications in surgery. This information may also be maintained in an accession file of copies of the operating room record.

The provisions of this § 135.4 adopted December 9, 1977, effective December 10, 1977, 7 Pa.B. 3631.

History

Authority: The provisions of this § 135.
Source: The provisions of this Chapter 135 adopted December 9, 1977, effective December 10, 1977, 7 Pa.

28 Pa. Code § 135.5 Surgical emergency care.

There shall be an on-call schedule of physicians established and posted at each patient unit or other area where surgical patients are admitted or the communications center of the hospital to ensure that there is 24-hour emergency care or postoperative followup care, or both, available.

The provisions of this § 135.5 adopted December 9, 1977, effective December 10, 1977, 7 Pa.B. 3631.

History

Authority: The provisions of this § 135.
Source: The provisions of this Chapter 135 adopted December 9, 1977, effective December 10, 1977, 7 Pa.

28 Pa. Code § 135.11 Policies and procedures.

(a) The surgical division of the medical staff, shall develop written policies and procedures for surgical services. These policies shall be made available to the medical staff and surgical nursing personnel.

(b) The policies and procedures of the surgical services shall establish:

(1) Appointment procedures which will fairly evaluate the quality and competence of each surgeon seeking appointment to the surgical staff.

(2) Reappointment procedures which provide for the periodic reappraisal of the qualifications and competence of each surgeon.

(3) Criteria to determine what circumstances require an assistant present at surgery and to determine whether the assistant should be a physician, a professional, or nonprofessional personnel.

(4) Surgical specimens that are exempt from pathological review in § 135.15 (relating to surgical specimens).

The provisions of this § 135.11 amended under sections 801.1 and 803 of the Health Care Facilities Act (35 P. S. § § 448.801a and 448.803).

The provisions of this § 135.11 adopted December 9, 1977, effective December 10, 1977, 7 Pa.B. 3631; amended June 9, 1989, effective June 10, 1989, 19 Pa.B. 2445. Immediately preceding text appears at serial pages (77284) to (77285).

History

Authority: The provisions of this § 135.
Source: The provisions of this Chapter 135 adopted December 9, 1977, effective December 10, 1977, 7 Pa.

28 Pa. Code § 135.12 Preoperative and postoperative records.

The medical staff shall establish procedures to ensure that preoperative and postoperative medical records are completed in a timely and accurate manner.

The provisions of this § 135.12 adopted December 9, 1977, effective December 10, 1977, 7 Pa.B. 3631.

History

Authority: The provisions of this § 135.
Source: The provisions of this Chapter 135 adopted December 9, 1977, effective December 10, 1977, 7 Pa.

28 Pa. Code § 135.13 Patient’s medical record; preoperative procedures.

(a) The record of surgery shall be maintained in accordance with § § 115.31—115.33 (relating to patient medical records; contents; and entries).

(b) After the patient has been placed on the operating table, it is the responsibility of the primary operating surgeon and the person administering anesthesia to properly identify the patient and to document this identification in the patient’s medical record. This procedure shall be set forth in written policies designating the mechanism to be used to identify each surgical patient.

(c) Procedures shall be established to ensure that, except in emergencies, at least the following data are recorded in the medical record of the patient prior to surgery:

(1) Verification of identity of patient.

(2) Medical history and supplemental information regarding drug sensitivities and other pertinent facts.

(3) General physical examination, details of significant abnormalities, and evaluation of the capacity of the patient to withstand anesthesia and surgery.

(4) Provisional diagnosis.

(5) Laboratory test results.

(6) Consultation reports.

(7) Signed informed consent obtained by the surgeon.

(8) X-ray reports.

(9) Dental X-ray reports if applicable.

The provisions of this § 135.13 amended under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilties Act (35 P. S. § 448.803).

The provisions of this § 135.13 adopted December 9, 1977, effective December 10, 1977, 7 Pa.B. 3631; amended December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial pages (52862) to (52863).

History

Authority: The provisions of this § 135.
Source: The provisions of this Chapter 135 adopted December 9, 1977, effective December 10, 1977, 7 Pa.

28 Pa. Code § 135.14 Recovery room nursing.

Responsibilities of nursing personnel in the surgical recovery room shall be established.

The provisions of this § 135.14 adopted December 9, 1977, effective December 10, 1977, 7 Pa.B. 3631.

History

Authority: The provisions of this § 135.
Source: The provisions of this Chapter 135 adopted December 9, 1977, effective December 10, 1977, 7 Pa.

28 Pa. Code § 135.15 Surgical specimens.

Tissues or exudates removed during a surgical procedure shall be properly labeled and sent to the laboratory for examination by the pathologist, who shall determine the extent of examination necessary for diagnosis except as provided in this section. The specimen shall be accompanied by pertinent clinical information, including its source and the preoperative and postoperative surgical diagnosis. A hospital may elect not to send the following categories of specimens to the laboratory for pathologic examination, as set forth in its written policies and procedures:

(1) Specimens that by nature or condition do not permit fruitful examination, such as a cataract, orthopedic appliance, calculi, foreign body or a portion of rib removed only to enhance operative exposure.

(2) Therapeutic radioactive sources, the removal of which shall be guided by radiation safety requirements.

(3) Traumatically injured members that have been amputated and for which examination for either medical or legal reasons is not deemed necessary.

(4) Specimens known to rarely, if ever, show pathological change, and removal of which is highly visible postoperatively, such as the foreskin from the circumcision of a newborn infant.

(5) Placentas that are grossly normal and have been removed in the course of operative and nonoperative obstetrics.

(6) Teeth, if the number, including fragments, is recorded in the medical record.

The provisions of this § 135.15 amended under sections 801.1 and 803 of the Health Care Facilities Act (35 P. S. § § 448.801a and 448.803).

The provisions of this § 135.15 adopted December 9, 1977, effective December 10, 1977, 7 Pa.B. 3631; amended June 9, 1989, effective June 10, 1989, 19 Pa.B. 2445. Immediately preceding text appears at serial page (77286).

This section cited in 28 Pa. Code § 135.11 (relating to policies and procedures).

History

Authority: The provisions of this § 135.
Source: The provisions of this Chapter 135 adopted December 9, 1977, effective December 10, 1977, 7 Pa.

28 Pa. Code § 135.16 Surgical procedures and consent.

A competent adult may authorize any surgical procedure to be performed upon his body, and the consent of no other person is required.

The provisions of this § 135.16 adopted December 9, 1977, effective December 10, 1977, 7 Pa.B. 3631.

History

Authority: The provisions of this § 135.
Source: The provisions of this Chapter 135 adopted December 9, 1977, effective December 10, 1977, 7 Pa.

28 Pa. Code § 135.21 Surgical suite nursing administration.

Surgical suite nursing service shall be under the direction and supervision of a professional registered nurse who is qualified by training and experience in operating room management and techniques.

The provisions of this § 135.21 adopted December 9, 1977, effective December 10, 1977, 7 Pa.B. 3631.

History

Authority: The provisions of this § 135.
Source: The provisions of this Chapter 135 adopted December 9, 1977, effective December 10, 1977, 7 Pa.

28 Pa. Code § 135.22 Professional and nonprofessional surgical suite nursing personnel.

When surgical services are provided, professional or nonprofessional personnel, or both, who are trained and experienced in postoperative care shall be provided on a 24-hour basis.

The provisions of this § 135.22 adopted December 9, 1977, effective December 10, 1977, 7 Pa.B. 3631.

History

Authority: The provisions of this § 135.
Source: The provisions of this Chapter 135 adopted December 9, 1977, effective December 10, 1977, 7 Pa.

28 Pa. Code § 135.23 Surgical recovery room nursing personnel.

At least one professional registered nurse shall be on duty in the recovery room whenever the room is occupied. Additional personnel shall be provided to meet the needs of each patient.

The provisions of this § 135.23 adopted December 9, 1977, effective December 10, 1977, 7 Pa.B. 3631.

History

Authority: The provisions of this § 135.
Source: The provisions of this Chapter 135 adopted December 9, 1977, effective December 10, 1977, 7 Pa.

28 Pa. Code § 135.24 Surgical nursing service.

If surgical nursing is a distinct and separate service, the following conditions shall be met, in addition to those governing nursing services generally:

(1) The surgical nursing service shall be under the direction and supervision of a professional registered nurse who is qualified by training and experience in the field of surgical nursing.

(2) A patient care unit with patients requiring skilled nursing care shall have professional registered nurse supervision on each tour of duty, and the skilled care shall be administered by professional registered nurses.

(3) A patient care unit with patients requiring moderate or minimal nursing care, or both, shall have supervision by either a professional registered nurse or a licensed practical nurse on each tour of duty. If the person so assigned is a licensed practical nurse, he shall work under the direction and supervision of a professional registered nurse.

The provisions of this § 135.24 adopted December 9, 1977, effective December 10, 1977, 7 Pa.B. 3631.

History

Authority: The provisions of this § 135.
Source: The provisions of this Chapter 135 adopted December 9, 1977, effective December 10, 1977, 7 Pa.

Chapter 136 Open Heart Surgical Services

28 Pa. Code § 136.1 Principle.

Adult open heart surgical services and pediatric open and closed heart surgical services shall be performed only in hospitals and shall be performed in accordance with accepted and prevailing standards of medical practice.

History

Authority: The provisions of this Chapter 136 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 136 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 136.2 Definitions.

The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise: Board certified—A physician licensed to practice medicine in this Commonwealth who has successfully passed an examination and has maintained certification in the relevant medical specialty or subspecialty area, or both, recognized by one of the following groups:

(i) The American Board of Medical Specialties.

(ii) The American Osteopathic Association.

(iii) The foreign equivalent of either group listed in subparagraph (i) or (ii). CABG—Coronary artery bypass graft—A type of open heart procedure wherein a section of a blood vessel is taken from another part of the body to create an alternative path for blood to flow around a narrow or blocked portion of a coronary artery. Cardiac intensive care service—Service provided to an open heart surgery patient immediately after surgery. This service is provided in a specially equipped area in a facility wherein the highest level of medical care is available. This area shall be equipped to provide invasive monitoring, including arterial pressure, Swan-Ganz catheters and intra-aortic balloon pumps. Cardiac surgical service—Those personnel involved in the preparation, operation and postoperative care of patients receiving cardiac surgery. Onsite—In the physical structure at which open heart surgical services are being offered or in an adjoining structure. Open heart surgery—A surgical procedure to repair acquired or congenital diseases of the heart. The procedure shall do one of the following:

(i) Include the use of an extracorporeal pump oxygenator (heart lung machine) to perform the functions of the circulatory system during the surgery.

(ii) Employ minimally invasive procedures, which do not routinely involve the use of the extracorporeal pump oxygenator to perform the same types of surgical procedures, although its presence is required because, in a certain number of cases, this approach may have to be abandoned in favor of the other method. Open heart surgery program—A service established by a hospital to evaluate, operate on and provide postoperative care to individuals with cardiovascular illness who require surgical intervention. Adult open heart surgery programs may perform any open or closed heart surgery not defined as pediatric heart surgery. Operating room—The room wherein the open heart surgery is performed. Pediatric heart surgery—Includes both open heart and closed heart procedures for patients under 18 years of age except for those whose physical development, in the judgment of the patient’s physician, allows the patient to receive treatment safely and appropriately in hospitals which do not have a pediatric heart program. Preboard certification status—A physician licensed to practice medicine in this Commonwealth who has completed the requirements necessary to take a certification examination offered by a medical specialty board recognized by the American Board of Medical Specialties, the American Osteopathic Association or the foreign equivalent of either group, and who has been eligible to take the examination for no longer than 3 years. Surgical suite—That area of the hospital wherein the patient is brought for open heart surgery and which is dedicated to the preparation of the surgical team and the patient for open heart surgery and to the actual performance of that surgery. Twenty-four hours per day—Refers to the availability or onsite presence of specific personnel, support services or equipment on a 24-hour-per-day, 7-days-a-week basis.

History

Authority: The provisions of this Chapter 136 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 136 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 136.11 Director.

(a) The Director of the open heart surgery program shall be a Board certified thoracic surgeon. The director of a pediatric heart surgery program shall be a Board certified pediatric and thoracic surgeon.

(b) An interim director may be appointed during the period of time between the departure of the prior director and the selection of a new director. The interim director shall be a physician who is able to demonstrate qualifications acceptable to the medical staff of the hospital and to the Department. The hospital shall apply to the Department for an exception under the procedures in § § 51.31—51.34. If the exception is granted, the Department will specify the maximum period of time for which the interim director shall be appointed.

History

Authority: The provisions of this Chapter 136 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 136 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 136.12 Medical staff.

Supporting medical staff of the service shall include:

(1) Thoracic surgeons who are either Board certified or who have attained preboard certification status. There shall be a sufficient number of surgeons within the service to allow for 24-hour-per-day continuous coverage. In a pediatric service, the medical staff shall include pediatric and thoracic surgeons who are either Board certified or who have attained preboard certification status.

(2) A Board certified medical cardiologist with subspecialty certification in cardiovascular disease or who has demonstrated competence as determined by peer review. A pediatric open heart surgery program shall include a board certified pediatric cardiologist.

(3) A cardiac catheterization team with interventional ability on call 24 hours per day.

(4) A Board certified anesthesiologist experienced in open heart anesthesia. There shall be a sufficient number of anesthesiologists within the service for 24 hour per day continuous coverage. The anesthesiologists in a service performing pediatric surgery shall have experience in pediatric anesthesia.

(5) A physician who is Board certified in anatomic and clinical pathology.

History

Authority: The provisions of this Chapter 136 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 136 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 136.13 Nursing staff; other health care personnel.

(a) Nursing personnel shall include nurses with specialized education which includes theory, advanced technical skills, and supervised experience in a surgical intensive care unit or in a postoperative cardiovascular unit before assuming primary responsibility for the nursing care of open heart patients.

(b) There shall be nursing service goals and objectives, standards of nursing practice, procedure manuals and written job descriptions for each level of personnel which shall include the following:

(1) A means for assessing the nursing care needs of the patients and determining adequate staffing to meet those needs.

(2) Staffing patterns that are adequate to meet the nursing goals, standards of practice and the needs of the patients.

(3) An adequate number of licensed and unlicensed assistive personnel to assure that staffing levels meet the total nursing needs of the patient.

(4) Nursing personnel assigned to duties consistent with their training, experience and scope of practice, when applicable.

(c) Surgical suite nursing services shall be under the direction and supervision of a registered professional nurse with specific education and experience in dealing with cardiovascular patients.

(d) In addition to the requirements for the nursing staff in subsections (a)—(c), there shall be service goals and objectives, standards of patient care, procedure manuals and written job descriptions for each level of other health care personnel which includes the following:

(1) A means for assessing the needs of patients and determining adequate staffing to meet those needs.

(2) Staffing patterns that are adequate to meet patient care goals, standards of practice and needs of patients.

(3) An adequate number of licensed and unlicensed health care personnel to assure that staffing levels meet the total needs of patients.

(4) Health care personnel in the open heart surgical services program shall be assigned to duties consistent with their training, experience and scope of practice where applicable.

History

Authority: The provisions of this Chapter 136 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 136 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 136.14 Support team in the operating room.

(a) The operating room support team shall include:

(1) A circulating registered professional nurse and additional nursing personnel as required.

(2) A perfusionist. Each open heart procedure shall have a designated perfusionist in attendance. This individual shall meet the requirements for Board certification as established by the American Board of Cardiovascular Perfusion. If the perfusionist is not Board certified, all duties shall be performed under the supervision of a certified perfusionist, cardiologist or cardiac surgeon, until the perfusionist obtains Board certification. This certification shall be obtained within 2 years of the commencement of the perfusionist’s employment at the hospital. The perfusionist’s duties shall include the operation of the extracorporeal pump oxygenator (heart-lung machine) in accordance with the requirements of the hospital. The perfusionist shall have immediate access to hospital and surgeon specific procedure manuals for the conduct of cardiopulmonary bypass during all open heart procedures.

(b) There shall be a sufficient number of extracorporeal pump oxygenators and perfusionists to allow 24-hour-per-day coverage.

History

Authority: The provisions of this Chapter 136 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 136 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 136.15 Other support services.

(a) Supportive services within the hospital shall include the following, which shall be provided 24 hours per day and shall be either available or onsite, as noted:

(1) Medicine (cardiology onsite; availability of nuclear cardiology; hematology; pulmonary; nephrology; neurology; and infectious disease).

(2) Anesthesiology—available.

(3) Clinical laboratory services, onsite for blood banking, hematology, blood chemistry and urinalysis. These services shall be under the same direct management and quality assurance programs as the main hospital laboratories.

(4) Diagnostic radiology, including bedside X-rays—onsite.

(5) Cardiac catheterization and interventional angiography laboratory—onsite.

(6) Respiratory care services—available.

(7) Cardiac intensive care service—onsite.

(8) Inpatient service for continuing care after transfer from the intensive care unit.

(9) An advanced cardiac life support certified physician—onsite.

(10) Cardiographic laboratory, including continuous electrocardiogram monitoring—available.

(11) Echocardiography service (this may or may not be a part of the cardiographic laboratory)—available.

(12) Installation of pacemakers—available.

(13) Organized and designated cardiopulmonary resuscitation team—onsite.

(14) Bioengineering service—available.

(15) Peripheral vascular surgery and a noninvasive vascular laboratory—available.

(16) Acute inpatient dialysis—available.

(b) An operating room shall be specifically equipped for cardiac surgery, and the room and support facilities shall be of adequate size, as per Inter-society Commission on Heart Disease requirements or American College of Cardiology/American Hospital Association Guidelines.

History

Authority: The provisions of this Chapter 136 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 136 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 136.16 Rapid mobilization.

(a) An open heart surgery program shall have the capability for rapid mobilization of the cardiac surgical service and support team members for emergency procedures, 24 hours per day.

(b) There shall be an on-call schedule of physicians established and posted at each patient unit and other areas where cardiac surgical patients are admitted and at the communications center of the hospital to ensure that there is 24-hour-per-day emergency care and peri-operative care available.

History

Authority: The provisions of this Chapter 136 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 136 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 136.17 Observation of patients.

A cardiac surgical care service shall include the capability of visual observation of all patients.

History

Authority: The provisions of this Chapter 136 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 136 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 136.18 Postoperative care.

(a) An intensive surgical care service shall be available immediately after surgery to provide invasive monitoring, including Swan-Ganz catheter, arterial pressure and intra-aortic balloon pumps.

(b) The cardiac surgical service shall be responsible for postoperative care and involved in discharge planning of patients.

History

Authority: The provisions of this Chapter 136 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 136 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 136.19 Education and training.

The staff of the open heart surgical program shall engage in the following activities:

(1) Ongoing programs of continuing education in cardiovascular care.

(2) Provision of training and consultation services with other providers of cardiovascular care and others.

(3) Patient and family education.

History

Authority: The provisions of this Chapter 136 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 136 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 136.20 Pediatric heart surgery—supplementary criteria.

(a) A hospital which provides pediatric heart surgery shall meet the standards in this chapter for a cardiovascular surgery program for adults.

(b) In addition, the following criteria shall be met by a pediatric heart surgery program:

(1) The facility shall be capable of providing definitive diagnostic and therapeutic services for children with all types of cardiovascular disease.

(2) A diagnostic laboratory with radiographic and cardiac catheterization equipment generally similar to that for adults. Bi-plane cineangiography shall be readily available 24 hours per day, and laboratories (both catheterization and general chemical) shall be equipped for small volume samples.

(3) Surgical equipment appropriate for newborns, infants and children.

(4) Intensive care facilities for newborns (as defined by current American Academy of Pediatrics/American College of Obstetrics and Gynecology Guidelines for Perinatal Care), infants and children.

(5) All staff responsible for care of the pediatric patient shall have experience and training in pediatrics including both physiological and psychosocial needs of the patient.

History

Authority: The provisions of this Chapter 136 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 136 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 136.21 Quality management and improvement.

(a) A hospital performing open heart surgery shall maintain patient data on the following:

(1) Mortality/morbidity.

(2) Infections and complications.

(3) Patient risk factors.

(4) Volume of procedures performed.

(b) The hospital shall provide this information to the Department on a quarterly basis, on a form prescribed by the Department. This data shall be integrated into the hospital’s quality assurance program and used to ensure necessary corrections to improve outcomes.

(c) In lieu of the information listed under subsection (a), a hospital may submit information provided by its thoracic surgeons to the Risk Stratification Program of the Society of Thoracic Surgeons.

(d) The Department will review the information submitted by the hospital and other relevant information which is available to assess the qualitative performance of the hospital’s open heart surgery program.

(e) If the Department’s review of this information raises concerns with the quality of care in an open heart surgery program, the Department will undertake a review of that program to determine if these concerns are valid. The hospital shall cooperate with the Department in this review.

History

Authority: The provisions of this Chapter 136 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 136 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

Chapter 137 Obstetrical Services

28 Pa. Code § 137.1 Principle.

Where a hospital provides obstetrical services, they shall be provided in a manner sufficient to meet the medical needs of the patients.

History

Authority: The provisions of this § 137.
Source: The provisions of this § 137.

28 Pa. Code § 137.2 Organization and staffing.

The obstetrics service shall be organized in a manner that will ensure appropriate, effective care of maternity patients.

History

Authority: The provisions of this § 137.
Source: The provisions of this § 137.

28 Pa. Code § 137.3 Director.

(a) The director of the obstetrical services must be a member of the medical staff who is certified by the American Board of Obstetrics and Gynecology or an equivalent Board or who is eligible for Board certification or has successfully completed an approved residency training program in obstetrics-gynecology. The director of the obstetrical service, in cooperation with a committee of staff physicians, nurses, administrators, and other relevant personnel, shall establish policies for the proper conduct of the service.

(b) A designated physician who is experienced in the practice of obstetrics shall be on call at all times for consultation and obstetrical emergencies.

(c) A designated physician who is experienced in the practice of anesthesiology shall be on call at all times for consultation and anesthesia emergencies.

History

Authority: The provisions of this § 137.
Source: The provisions of this § 137.

28 Pa. Code § 137.4 Obstetrical nursing service.

(a) Obstetrical nursing services shall be provided in accordance with Chapter 109 (relating to nursing services) in addition to this section.

(b) The obstetrical nursing service shall be under the direction and supervision of a professional registered nurse who is qualified by training and experience in obstetrics and care of the newborn.

(c) There shall be at least one professional nurse on each tour of duty and other nursing personnel as needed. A professional nurse shall be available to supervise persons monitoring all occupied labor rooms.

(d) Recovery rooms, when occupied, shall have continuous coverage by nursing personnel qualified by training and experience in postobstetrical care.

History

Authority: The provisions of this § 137.
Source: The provisions of this § 137.

28 Pa. Code § 137.11 Facilities and equipment.

The obstetrics service shall be contained within a unit that shall include a labor and delivery unit and maternity unit, all of which shall be located and arranged to preclude unrelated traffic through the suite. Clean gynecological patients may be housed on the obstetrical unit.

The provisions of this § 137.11 issued under 67 Pa.C.S. § § 6101—6104; and Reorganization Plan No. 2 of 1973 (71 P.S. § 755-2).

The provisions of this § 137.11 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37896).

History

Authority: The provisions of this § 137.
Source: The provisions of this § 137.

28 Pa. Code § 137.12 Delivery suite.

(a) Each delivery room shall be maintained and supplied as a separate unit which contains the equipment and supplies necessary for normal delivery, including examination and care of infants, and for the immediate management of complications in mother and infant. The obstetrical delivery suite shall be in an area which does not have traffic-bearing corridors to other parts of the hospital and which is physically separated from other departments.

(b) Each delivery room shall be equipped for administration of inhalation and regional anesthesia.

(d) Caesarean sections may be performed in an operating room on the surgical service or in an operating room within the labor and delivery unit. At least one delivery room should be equipped for the performance of emergency Caesarean sections.

(e) Each delivery room shall have an emergency call or intercommunication system.

(f) Oxygen and suction equipment which can be accurately regulated shall be available for both mother and infant in each delivery room.

(g) Equipment for examination, identification and care of infants shall be readily available to each delivery room.

(h) The delivery room and equipment shall be cleaned after each patient’s delivery is completed.

(i) A movable heated bassinet, transport incubator, or similar device should be made available to transport an infant from the delivery room. Oxygen shall be available for use during transit in cases of neonatal distress. Elevators, when used to transport infants from the delivery room shall be kept free of other passengers. The medical record of the infant shall accompany him to the nursery.

(j) Scrub sinks, equipped with elbow, knee or foot controls; hot and cold running water with mixer; and hand scrubbing accessories shall be available adjacent to or within all delivery rooms.

History

Authority: The provisions of this § 137.
Source: The provisions of this § 137.

28 Pa. Code § 137.13 Labor rooms.

The labor and delivery unit shall be considered a semirestricted area. The hospital shall establish and post appropriate restrictions to limit entry into this unit to authorized persons only. There shall be at least one labor room, properly equipped, for each delivery room. It shall provide privacy and be convenient to the delivery room. In an emergency, a properly equipped labor room may be used as a delivery room. The number of beds in a labor room or other rooms used for this purpose shall not exceed two. Beds used by patients in labor shall be equipped with protective sides.

The provisions of this § 137.13 issued under 67 Pa.C.S. § § 6101—6104; and Reorganization Plan No. 2 of 1973 (71 P. S. § 755-2).

The provisions of this § 137.13 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37897).

History

Authority: The provisions of this § 137.
Source: The provisions of this § 137.

28 Pa. Code § 137.21 Policies and procedures.

(a) Written policies and procedures for obstetrical services shall be maintained and made available to medical and nursing staff members. They shall be reviewed by the medical staff, revised as necessary, and dated to indicate the time of last review.

(b) Obstetrical services policies and procedures shall include:

(1) A current roster of physicians with a delineation of their obstetrical privileges which shall be properly maintained and made available to nursing personnel.

(2) An on-call schedule established to ensure that a physician with obstetrical privileges is readily available at all hours.

(3) Provisions to ensure that spontaneous deliveries of patients in the final stages of labor shall not be delayed.

(4) Policies for intervention where patients demonstrate evidence of maternal, fetal, or neonatal distress.

(5) Criteria established by the medical staff to govern the administration of oxytocic agents, when used for induction or stimulation of labor. These criteria shall include a requirement for the immediate presence of a physician.

(6) A program to prevent isoimmunization of RH-negative mothers.

(7) A program for immediate blood transfusion services, as necessary.

(8) Procedures in accordance with Chapters 27 and 29 (relating to communicable and noncommunicable diseases; and miscellaneous health provisions) governing the reporting of metabolic diseases in the newborn and screening for phenylketonuria. All hospitals with obstetrical services must comply with the act of September 9, 1965 (P. L. 497, No. 251) (35 P. S. § 621) which provides for the testing of all newborns for phenylketonuria.

(9) Clean gynecology patients may be housed on maternity units at the discretion of the chief of service. A maternity patient shall not be denied a bed because of the presence of gynecological patients.

(10) Policies for visitors.

(11) Policies and procedures governing the presence of fathers or other supportive persons in the delivery room, if the hospital allows this practice.

(12) Policies and procedures for the care and treatments of drug-dependent newborns.

History

Authority: The provisions of this § 137.
Source: The provisions of this § 137.

28 Pa. Code § 137.22 Infection control.

(a) The hospital shall designate a committee which shall formulate specific policies for prevention, reporting, and control of infections on the obstetrical service. These policies shall be in written form, readily available to all appropriate personnel, and reviewed at least once every year for possible revision. One member of the committee or other individual shall be delegated to receive reports of infections and to assist in interpretation and implementation of established policies.

(b) The policies established in accordance with subsection (a) shall provide at a minimum:

(1) that, if a patient is admitted to the labor and delivery area with suspected or confirmed transmissible infection, isolation precautions or other appropriate precautions shall be instituted and followed.

(2) written policies governing the use of delivery rooms by patients with diagnosed or suspected infection and establishing techniques for cleaning delivery rooms following use by such patients. If a regular delivery room is used for such a patient, it shall be thoroughly cleaned following use in accordance with hospital policies and in a manner adequate to control the contamination.

History

Authority: The provisions of this § 137.
Source: The provisions of this § 137.

28 Pa. Code § 137.23 Labor room procedures.

(a) Medical and licensed nursing staff shall be present in the labor and delivery unit in sufficient numbers for the proper observation and care of patients in labor whenever a labor room is occupied.

(b) The director of obstetrical services or the appropriate medical staff committee shall establish written policies, which shall be available in the labor and delivery unit, concerning the use of oxytocic drugs during each of the three stages of labor.

(c) The director of obstetrical services or the appropriate medical staff committee shall establish written policies, which shall be available on the labor and delivery unit, regarding the use and administration of anesthetics, sedatives, analgesics, and other drugs.

History

Authority: The provisions of this § 137.
Source: The provisions of this § 137.

28 Pa. Code § 137.24 Delivery room procedures.

(a) Every patient in a delivery room shall be under the immediate care of a physician, house staff, registered nurse, licensed practical nurse or licensed midwife at all times.

(b) Aseptic surgical techniques shall be used in all delivery rooms.

(c) Each obstetric patient shall be kept under close observation by competent professional personnel during the period of recovery after delivery, whether in the delivery room or in a recovery area until she is transferred to the maternity unit.

(d) All persons present in a delivery room in which explosive anesthetics are stored or in use shall observe necessary precautions against explosion and electric shock hazards and shall wear appropriate antistatic apparel and non-conductive footwear.

(e) Identification shall be attached to the mother and newborn infant before they are removed from the delivery room. Reference should be made to the act of April 20, 1925 (P. L. 358) (35 P. S. § § 351—353).

(f) The eyes of newborn infants shall have instilled medication under § 27.98 (relating to prophylactic treatment of newborns) by the physician or his designee as soon as the condition of the infant permits. Procedures for prophylaxis shall be in accordance with § 27.98 (relating to prophylactic treatment of newborns).

The provisions of this § 137.24 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); section 16 of the Disease Prevention and Control Law of 1955 (35 P. S. § 521.16); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 137.24 amended May 4, 1984, effective May 5, 1984, 14 Pa.B. 1553. Immediately preceding text appears at serial page (77289).

History

Authority: The provisions of this § 137.
Source: The provisions of this § 137.

28 Pa. Code § 137.25 Radiologic examination.

The medical staff shall establish written policies for the performance of diagnostic radiologic examinations of known or suspected pregnant patients,for the purpose of control of excessive radiation to fetus and mother. These policies shall be available to all appropriate personnel and shall be reviewed by the medical staff at least once annually for possible revision. A written request for a diagnostic radiologic examination of a female patient of childbearing age shall be marked in such a way as to clearly indicate to the person taking the roentgenogram the date of the patient’s last menstrual period or the fact that the patient may be pregnant.

The provisions of this § 137.25 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 137.25 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial pages (52870) to (52871).

History

Authority: The provisions of this § 137.
Source: The provisions of this § 137.

28 Pa. Code § 137.26 Adoption procedures.

(a) A hospital providing maternity care shall provide a list, upon request, of available counselors and counseling services, compiled by the court, to maternity patients who are known to be considering relinquishment or termination of parental rights.

(b) Medical history information shall, where practicable, be delivered by the attending physician or other designated person to the intermediary, who shall deliver the information to the adopting parents or their physician. In cases where there is no intermediary, medical history information shall be delivered directly to the adopting parents or their physician. Medical history information shall be construed to be the adoptee’s complete medical records as well as other information concerning an adoptee or an adoptee’s natural family which are relevant to the adoptee’s present or future health care or medical treatment.

(c) In all cases, medical history information shall be edited before delivery so as to remove contents which would identify the adoptee’s natural family.

The provisions of this § 137.26 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and the Adoption Act, 23 Pa.C.S. § 2909.

The provisions of this § 137.26 adopted November 2, 1984, effective November 3, 1984, 14 Pa.B. 3961.

History

Authority: The provisions of this § 137.
Source: The provisions of this § 137.

28 Pa. Code § 137.32 Director of combined obstetrical-gynecological services.

If the services are combined, the director shall be a member of the medical staff who is certified by the American Board of Obstetrics and Gynecology or an equivalent board or who is eligible for such certification or has successfully completed an approved residency in Obstetrics and Gynecology.

History

Authority: The provisions of this § 137.
Source: The provisions of this § 137.

28 Pa. Code § 137.33 Obstetrical-gynecological nursing service.

(a) Obstetrical-gynecological nursing service shall be under the direction and supervision of a professional registered nurse who is experienced in maternity-gynecological and newborn nursing. Professional registered nurse supervision shall be provided on each tour of duty.

(b) A separate nursing staff shall be provided for the nursery.

(d) Bedside nursing care for obstetrical or gynecological patients, or both, may be provided by the same nursing staff.

History

Authority: The provisions of this § 137.
Source: The provisions of this § 137.

28 Pa. Code § 137.34 Policies and procedures.

(a) Written policies and procedures for the combined obstetrical and gynecological services shall be available to the medical and nursing staff.

(b) Policies shall state the type of patients admitted, retained and transferred. They shall also include the following:

(1) A current roster of physicians, with a delineation of their obstetrical-gynecological responsibilities, which shall be properly maintained and made available to nursing personnel.

(2) An on-call roster, to ensure that a physician with obstetrical-gynecological privileges is readily available at all hours.

(3) A provision that no maternity patient shall be denied a bed because of the presence of gynecological patients. If necessary, gynecological patients shall be transferred to other areas of the hospital.

(4) A requirement for isolation in a separate room of any patient with an infection or condition inimical to the safety and welfare of other patients.

History

Authority: The provisions of this § 137.
Source: The provisions of this § 137.

Chapter 138 Cardiac Catheterization Services

28 Pa. Code § 138.1 Principle.

Cardiac catheterizations shall be performed only in hospitals and shall be performed in accordance with accepted and prevailing standards of medical practice.

History

Authority: The provisions of this Chapter 138 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 138 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 138.2 Definitions.

(i) The American Board of Medical Specialties.

(ii) The American Osteopathic Association.

(iii) The foreign equivalent of either group listed in subparagraph (i) or (ii). Cardiac catheterization—A procedure used to diagnose and treat various cardiac and circulatory diseases that involves inserting a thin, pliable catheter, which is viewable by X-ray, into a major blood vessel of the arm or leg, and manipulating the tip of the catheter through veins or arteries to the heart. Cardiac catheterization area—That portion of the hospital dedicated to the performance of cardiac catheterizations, including the cardiac catheterization laboratory where the invasive procedures are performed by the physician, and preoperative and postoperative recovery units used for treatment of the cardiac catheterization patient. Electrophysiology study (EPS)—diagnostic—The use of blood vessel access to position electrode catheters in various intra cardiac locations with the help of fluoroscopy for the purpose of recording the timing of electrical events to assess the location and direction of impulse propagation. The term includes procedures designed to induce ventricular or supraventricular tachycardia and activation sequence mapping of cardiac tachyarrhythmias. Electrophysiology study (EPS)—therapeutic—EPS used as or in combination with a therapeutic procedure, which includes electrode catheter ablative procedures and implantation of antitachyarrhythmia devices and implantable cardiovertor defibrillators. High-risk cardiac catheterization—Cardiac catheterization which presents a high risk of significant cardiac complication. The term includes diagnostic cardiac catheterization procedures that present a high risk of significant cardiac complication, PTCA, pediatric cardiac catheterization and therapeutic electrophysiology except for the implantation of routine permanent pacemakers. Low-risk cardiac catheterization—Cardiac catheterization which is not high-risk cardiac catheterization. Onsite—In the physical structure at which cardiac catheterization services are being offered or in an adjoining structure. PTCA—Percutaneous transluminal coronary angioplasty—A procedure which uses a balloon catheter, plaque removing device, laser device or mechanical stent to re-open collapsed, blocked or partially blocked arteries. Pediatric cardiac catheterization—The performance of cardiac catheterization on a person who is under 18 years of age except for those patients whose physical development, in the judgment of the patient’s physician, allows the patient to receive treatment safely and appropriately in hospitals that do not have pediatric cardiac catheterization programs. Preboard certification status—A physician licensed to practice medicine in this Commonwealth who has completed the requirements necessary to take a certification examination offered by a medical specialty board recognized by the American Board of Medical Specialties, the American Osteopathic Association, or the foreign equivalent of either group, and who has been eligible to take the examination for no longer than 3 years. Twenty-four hours per day—Refers to the availability or onsite presence of specific personnel, support services or equipment on a 24-hour-per-day, 7-days-a-week basis.

History

Authority: The provisions of this Chapter 138 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 138 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 138.11 Director.

(a) The director of the cardiac catheterization service shall be Board certified in cardiology or pediatric cardiology, as appropriate.

(b) An interim director may be appointed during the period of time between the departure of the prior director and the selection of a new director. The interim director shall be a physician who is able to demonstrate qualifications acceptable to the medical staff of the hospital and to the Department. The hospital shall apply to the Department for an exception under the procedures in § § 51.31—51.34 (relating to exceptions). If the exception is granted, the Department will specify the maximum period of time for which the interim director shall be appointed.

History

Authority: The provisions of this Chapter 138 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 138 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 138.12 Medical staff.

(a) There shall be at least two physicians staffing the cardiac catheterization laboratory to perform angiographies.

(b) These physicians shall be either Board certified or shall have attained preboard certification status is cardiovascular diseases with specialized training in invasive procedures.

History

Authority: The provisions of this Chapter 138 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 138 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 138.13 Nursing staff; other health care personnel.

(a) There shall be at least one registered nurse assigned to provide nursing care for patients in the cardiac catheterization area at all times who shall have intensive care or coronary care experience and knowledge of cardiovascular medications, and experience with cardiac catheterization patients. In pediatric units, this nurse shall also have experience in pediatric cardiac surgery units.

(b) There shall be nursing service goals and objectives, standards of nursing practice, procedure manuals and written job descriptions for each level of personnel which shall include the following:

(1) A means for assessing the nursing care needs of the patients and determining adequate staffing to meet those needs.

(2) Staffing patterns that are adequate to meet the nursing goals, standards of practice and the needs of the patients.

(3) An adequate number of licensed and unlicensed assistive personnel to assure that staffing levels meet the total nursing needs of the patient.

(4) Nursing personnel assigned to duties consistent with their training, experience and scope of practice, where applicable.

(c) In addition to the requirements for the nursing staff in subsections (a) and (b), there shall be service goals and objectives, standards of patient care, procedure manuals and written job descriptions for each level of other health care personnel which includes the following:

(1) A means for assessing the needs of patients and determining adequate staffing to meet those needs.

(2) Staffing patterns that are adequate to meet patient care goals, standards of practice and needs of patients.

(3) An adequate number of licensed and unlicensed health care personnel to assure that staffing levels meet the total needs of patients.

(4) Catheterization laboratory health care personnel shall be assigned to duties consistent with their training, experience and scope of practice when applicable.

(d) The patient’s preoperative and postoperative care in the cardiac catheterization area shall be provided by a registered nurse and other nursing staff as required to meet patient care needs. Either nursing personnel or other health care personnel with appropriate education, training and experience shall assist the physician in the performance of the cardiac catheterization procedures in the cardiac catheterization laboratory.

History

Authority: The provisions of this Chapter 138 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 138 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 138.14 Programs and services.

(a) To perform cardiac catheterizations a hospital shall be an acute care facility that:

(1) Has inpatient medical and surgical services onsite.

(2) Has a coronary care unit onsite with 24-hour per day monitoring capability.

(3) Has a peripheral vascular surgical program available.

(4) Provides noninvasive cardiac diagnostic modalities including exercise and pharmacologic stress testing, echo cardiography and nuclear cardiology.

(5) Has a setting in which ambulatory cardiac catheterization patients can be observed for 4 to 6 hours after the procedure.

(6) Has adequate physician coverage to manage postprocedure complications.

(b) Outpatient diagnostic cardiac catheterization services shall be performed if care is exercised in selecting only appropriate low risk patients as defined in this chapter.

(c) To allow for continuity of care, mobile cardiac catheterization laboratories may be utilized onsite at a hospital which is already providing cardiac catheterization services while the existing, fixed cardiac catheterization laboratory is being renovated or its equipment upgraded.

History

Authority: The provisions of this Chapter 138 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 138 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 138.15 High-risk cardiac catheterizations.

A hospital may perform high-risk cardiac catheterizations only if it has an open heart surgical program onsite.

History

Authority: The provisions of this Chapter 138 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 138 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 138.16 Transfer agreements for low-risk cardiac catheterization hospitals.

(a) A hospital that does not have an open heart surgical program onsite may perform low-risk cardiac catheterizations if the hospital has protocols for distinguishing between low and high-risk cardiac catheterization patients and a formal written agreement with at least one hospital that does have an open heart surgical program onsite, which agreement includes the following:

(1) Protocols addressing indications, contraindications and other criteria for the emergency transfer of patients in a timely manner.

(2) Assurance of transfer of patients to an open heart surgery program and initiation of open heart surgery in a timely manner.

(3) Provision for semiannual data exchange on performance between the hospitals party to the agreement.

(4) Specification of mechanisms for continued substantive communication between the hospitals party to the agreement, and between their sending and receiving physicians.

(b) The agreement shall remain continuously in effect and be reviewed at least annually.

History

Authority: The provisions of this Chapter 138 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 138 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 138.17 PTCA.

(a) In a hospital in which elective PTCA is performed, each physician performing PTCAs shall be either Board certified or shall have attained preboard certification status in cardiovascular diseases with specialized and appropriate training in interventional cardiology procedures.

(b) A rigorous mechanism for valid peer review shall be established and ongoing in a hospital offering PTCA services.

(c) If a hospital that does not have an open heart surgery program onsite performs an emergent PTCA, the hospital shall report the circumstances to the Department in writing within 72 hours.

History

Authority: The provisions of this Chapter 138 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 138 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 138.18 EPS studies.

(a) In a hospital in which EPS is performed, each physician performing EPS shall be either Board certified or shall have attained preboard certification status in cardiovascular diseases and shall also be either Board certified or have attained preboard certification status in clinical cardiac electrophysiology.

(b) Therapeutic electrophysiology, including ablation and the implantation of automatic implantable cardiovertor defibrillators shall be performed in a hospital with an open heart surgery program, and not in another facility. Implantation of routine permanent pacemakers may be performed in hospitals that do not have an open heart surgery program onsite. Pediatric diagnostic electrophysiology procedures also shall only be performed at a hospital with onsite pediatric cardiovascular surgery.

History

Authority: The provisions of this Chapter 138 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 138 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 138.19 Pediatric cardiac catheterizations.

A hospital may perform pediatric cardiac catheterizations only if:

(1) It has a pediatric heart surgical program onsite.

(2) The physicians and other staff who participate in the pediatric cardiac catheterizations are trained and experienced in the care of the pediatric cardiac patient.

(3) The equipment used for pediatric cardiac catheterizations is appropriate to meet the needs of the pediatric patient. Bi-plane cineangiography shall be readily available 24 hours per day, and laboratories (both catheterization and general chemical) shall be equipped for small volume samples.

History

Authority: The provisions of this Chapter 138 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 138 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 138.20 Quality management and improvement.

(a) A hospital providing cardiac catheterization services shall maintain patient data on the following:

(1) Mortality/morbidity.

(2) Infections and complications.

(3) Patient risk factors.

(4) Volume of procedures performed (including separate volumes for diagnostic visualizations, PTCA and electrophysiology procedures).

(b) The hospital shall provide this information to the Department through the Pennsylvania Cardiac Catheterization Report. This data shall be integrated into the hospital’s quality assurance program and used to ensure necessary corrections to improve outcomes.

(c) The Department will review the information submitted by the hospital and other relevant information which is available to assess the qualitative performance of the hospital’s cardiac catheterization program.

(d) If the Department’s review of this information raises concerns with the quality of care in a cardiac catheterization program, the Department will undertake a review of that program to determine if these concerns are valid. The hospital shall cooperate with the Department in this review.

History

Authority: The provisions of this Chapter 138 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 138 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

Chapter 139 Neonatal Services

28 Pa. Code § 139.1 Principle.

When a hospital provides neonatal services, they shall be provided in a manner that meets the medical needs of the neonates.

History

Authority: The provisions of this Chapter 139 amended under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 139 amended June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 139.2 Scope.

This chapter applies to hospitals which provide obstetrical or neonatal infant care, or both. The Department recognizes the following levels of neonatal care:

(1) Level I: (Normal Neonatal).

(2) Level II: (Neonatal Intermediate/Intensive Care).

(3) Level III: (Neonatal Intensive Care).

History

Authority: The provisions of this Chapter 139 amended under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 139 amended June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 139.2a Definitions.

The following words and terms, when used in this chapter have the following meaning, unless the context clearly indicates otherwise:

Board certified—A physician licensed to practice medicine in this Commonwealth who has successfully passed an examination and has maintained certification in the relevant medical specialty area or subspecialty area, or both, recognized by one of the following groups:

(i) The American Board of Medical Specialties.

(ii) The American Osteopathic Association.

(iii) The foreign equivalent of either group listed in subparagraph (i) or (ii).

Guidelines—The term refers to the current Guidelines for Perinatal Care issued by the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists.

NICU—Neonatal intensive care unit—The term refers to a unit which is specifically equipped and staffed for the care and treatment of high-risk infants and those infants otherwise in need of intensive care.

Neonate—Patients treated in neonatal care units. The term is synonymous with baby or infant.

Preboard certification status—A physician licensed to practice medicine in this Commonwealth who has completed the requirements necessary to take a certification examination offered by a medical specialty board recognized by the American Board of Medical Specialties, the American Osteopathic Association, or the foreign equivalent of either group, and who has been eligible to take the examination for no longer than 3 years.

History

Authority: The provisions of this Chapter 139 amended under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 139 amended June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 139.3 Director.

(a) A member of the medical staff shall be appointed director of neonatal services. The director shall be certified by the American Board of Pediatrics or an equivalent board.

(b) An interim director may be appointed during the period of time between the departure of the prior director and the selection of a new director. The interim director shall be a physician who is able to demonstrate qualifications acceptable to the medical staff of the hospital and to the Department. The hospital shall apply to the Department for an exception under the procedures in § § 51.31—51.34 (relating to exceptions). If the exception is granted, the Department will specify the maximum period of time for which the interim director shall be appointed.

History

Authority: The provisions of this Chapter 139 amended under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 139 amended June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 139.4 Nursing services; other health care personnel.

(a) Neonatal nursing services shall be provided in accordance with Chapter 109 (relating to nursing services) and this section.

(b) A registered professional nurse, especially trained and experienced in the care of normal and high-risk infants, shall be responsible for the neonatal care unit at all times when the unit is occupied. No neonate may be left unattended.

(c) Licensed nursing personnel shall be assigned to duties consistent with their legal scope of practice. Unlicensed assistive personnel shall be assigned duties consistent with standardized training and competency evaluation.

(d) Staffing shall be adequate to meet nursing care goals, standards of nursing practice and nursing care needs of patients. The appropriate number of staff necessary to accomplish these goals, standards and needs shall be established in the written policies of the neonatal service and shall be consistent with the Guidelines.

(e) In addition to the requirements for the nursing staff in subsections (a)—(d), there shall be service goals and objectives, standards of patient care, procedure manuals and written job descriptions for each level of other health care personnel which includes the following:

(1) A means for assessing the needs of patients and determining adequate staffing to meet those needs.

(2) Staffing patterns that are adequate to meet patient care goals, standards of practice and needs of patients.

(3) An adequate number of licensed and unlicensed health care personnel to assure that staffing levels meet the total needs of patients.

(4) Health care personnel in neonatal services shall be assigned to duties consistent with their training, experience and scope of practice when applicable.

History

Authority: The provisions of this Chapter 139 amended under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 139 amended June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 139.11 Facilities and equipment.

The maternity and neonatal services shall be separate and apart from other hospital services and especially from potential sources of infection. Access to each neonatal care unit shall be controlled to insure security and safety of all infants.

The provisions of this § 139.11 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 139.11 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (52874).

History

Authority: The provisions of this Chapter 139 amended under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 139 amended June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 139.12 Neonatal care units.

(a) Hospitals with maternity services shall provide neonatal care units with areas for neonate recovery, observation and isolation and provisions or arrangements for the care of high-risk infants in a neonatal intensive care unit either at the facility of birth or at a transfer site. Space allocation and total number of bassinets shall be consistent with the Guidelines.

(b) There should be an isolation area for the reception and care of infants exposed to potential sources of infection and infants suspected of or having a communicable disease. Infants may be housed and nursed in the isolation area pending diagnosis, disposition or completion of treatment. This isolation area should be served by nursing personnel and shall meet the standards established in the Guidelines for this type of care.

(c) A neonatal intensive care unit is one which is specifically equipped and staffed for the care and treatment of high-risk infants and those otherwise in need of intensive care. The neonatal intensive care unit shall meet the standards established in the Guidelines for this type of care. If such a service is not provided at the facility of birth, arrangements shall be made with an existing neonatal intensive care unit in the area of appropriate referral. The judgment of the attending physician and the policies of the hospital’s neonatal services department shall determine the need for consultation with and referral to the hospital with an existing neonatal intensive care unit. The term ‘‘high risk infant’’ means any infant who, on the basis of socioeconomic, genetic or patho-physiologic history prior to delivery or on the basis of findings in the neonate period, manifests or is likely to manifest persistent and significant signs of distress. This may include:

(1) An infant with a birth weight below 2,000 grams or of less than 34 weeks gestation and any other low birth weight or premature infant who shows any abnormal signs.

(2) An infant showing persistent and significant signs of illness. This includes those with respiratory distress, congenital anomalies, tumors, jaundice, seizures, infections, metabolic distress or other conditions which pose an immediate threat to neonatal survival.

(3) An infant with serious feeding difficulties, excessive lethargy or instability of body temperature.

(4) An infant whose mother is drug addicted or habituated, diabetic, toxemic, isoimmunized, or having any other illness or condition which may affect the fetus.

(5) An infant requiring major surgical procedures.

The provisions of this § 139.12 issued under 67 Pa.C.S. § § 6101—6104; and Reorganization Plan No. 2 of 1973 (71 P. S. § 755-2).

The provisions of this § 139.12 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37905).

History

Authority: The provisions of this Chapter 139 amended under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 139 amended June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 139.13 Equipment and supplies.

(a) Required equipment and supplies shall be in accordance with this section, the Guidelines for Design and Construction of Hospital and Health Care Facilities issued by the American Institute of Architects and with written policies of the neonatal service which shall be consistent with the Guidelines.

(b) An individual bassinet and equipment for the exclusive use of the infant to whom it is assigned shall be provided for each infant. All necessary supplies shall be stored in covered containers to permit individualized infant care and minimize risk of infection.

(c) Each neonatal care unit shall have its own sink with hot and cold running water equipped with foot, knee or elbow control so that hand contact with the sink is avoided. A sufficient supply of an antiseptic cleansing agent and disposable towels shall be readily available. Where paper towels are used, a dispenser shall be provided.

(d) Neonatal intensive care units shall be equipped with all equipment and supplies required for other neonatal care units.

History

Authority: The provisions of this Chapter 139 amended under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 139 amended June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 139.14 Oxygen control.

Oxygen shall be administered only with proper apparatus for its safe administration and control of concentration. Concentration of oxygen should not exceed a safe level commensurate with current concepts of oxygen therapy as recommended by the Guidelines.

History

Authority: The provisions of this Chapter 139 amended under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 139 amended June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 139.15 Temperature control.

A stable year-round temperature and humidity shall be maintained in all neonatal care units in accordance with written neonatal service policies consistent with the Guidelines.

History

Authority: The provisions of this Chapter 139 amended under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 139 amended June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 139.16 Housekeeping and maintenance.

The neonatal care unit shall be maintained in a clean and sanitary manner at all times. An environmental services room shall be provided for the exclusive use of the neonatal unit and shall be directly accessible from the unit.

History

Authority: The provisions of this Chapter 139 amended under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 139 amended June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 139.17 Neonatal intensive care units (Levels II and III).

In addition to the general requirements for the equipment of neonatal care units, the following provisions shall be required for all new construction, renovation or expansion of neonatal intensive care units and shall be available to all present neonatal intensive care units:

(1) The construction and arrangement of the neonatal intensive care unit shall permit personnel to observe the infants and have immediate access to them. Total neonatal care unit space, exclusive of anteroom, shall provide adequate floor space consistent with the Guidelines.

(2) Each infant requiring heat or air control, or both, shall have a separate incubator or other warming device and an individual environment with individualized heat, oxygen, suction and air turnover controls, as appropriate. Any infant whose condition permits may be placed in a bassinet.

(3) At least one oxygen outlet shall be provided for each patient station. Suction apparatus shall be easily available for each infant. A source of medically pure compressed air shall be available.

(4) A double-grounded electrical outlet shall be provided for each incubator or radiant warmer. Sufficient extra outlets should be provided for other electronic patient care equipment. Some electrical outlets in the unit shall be on the emergency electrical circuit of the hospital and shall be so marked.

(5) Resuscitation equipment shall be available within the neonatal intensive care unit. An effective method for preventing heat loss by the infant shall be available while the infant is undergoing any treatment.

(6) Air within neonatal intensive care units may not be recirculated and shall be frequently turned over each hour.

History

Authority: The provisions of this Chapter 139 amended under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 139 amended June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 139.21 Policies and procedures.

The director of neonatal services shall be responsible for developing written policies and procedures for the provision of medical services within the neonatal care unit which shall be available to the medical and nursing staff. The policies and procedures shall be reviewed by the director once a year and revised as necessary, and dated to indicate the time of last review. They shall provide specifications to conform to § § 139.22—139.29.

History

Authority: The provisions of this Chapter 139 amended under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 139 amended June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 139.22 Physicians’ services.

(a) There shall be a physician available at all times. This physician shall be either certified by the American Board of Pediatrics or an equivalent board, have attained preboard certification status, or have successfully completed an approved residency in pediatrics.

(b) All infants shall have a complete physical examination at or near the time of delivery consistent with the recommendations contained in the Guidelines and the results of the examinations shall be recorded in the infant’s medical record.

(d) Every infant shall be examined by the attending physician or his authorized delegate within 1 day prior to discharge, and the findings recorded shall be in the infant’s medical record.

(e) There shall be a method for the proper identification of each infant and mother or other responsible person at the time of discharge from the hospital. Infants discharged or transferred to another neonatal care unit or hospital shall be carefully identified.

This section cited in 28 Pa. Code § 139.21 (relating to policies and procedures).

History

Authority: The provisions of this Chapter 139 amended under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 139 amended June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 139.23 Delivery suite services.

(a) Delivery suite facilities shall include a neonatal recovery area specifically equipped for evaluation and treatment of the infant immediately after birth. An area of the delivery room set aside for infant care is acceptable.

(b) The director of obstetrics and the director of neonatal services shall formulate policies and procedures for delivery room care of infants. These policies and procedures shall be written and shall include provisions for:

(1) Notification of the physician in charge of the infant and the nurse responsible for the provision of nursing services in the neonatal care unit when the delivery of a potentially high-risk infant is expected.

(2) Continuity of care for all infants and especially for high-risk infants to be initiated in the delivery area, with constant observation of neonates for distress.

(3) The umbilical cord to be clamped or tied in accordance with standard medical practice.

(4) The collection of sample of cord blood and performance of laboratory studies for blood type, Rh and Coombs Test on every infant born to an Rh negative mother or having a family history of blood incompatibility.

(5) Infant identification, by an accepted duplicate system, for both mother and infant to be carried out in the delivery room and checked by the nurse or physician and, if possible, by the mother.

(6) Prophylaxis with medication under § 27.98 (relating to prophylactic treatment of neonates), to be carried out as soon as the condition of the infant permits.

(7) Every neonate to be examined at the time of delivery and the following noted on his medical record:

(i) Condition at birth including Apgar score or its equivalent.

(ii) Time of sustained respirations.

(iii) Physical abnormalities or pathological states.

(iv) Evidence of distress.

(8) A carefully planned procedure to be instituted for the transportation of infants to the neonatal care unit from the delivery room to insure maximum protection of the infant. Transfer of distressed infants to the unit shall be done in a manner that minimizes heat loss and to insure adequate oxygenation.

(9) The record of the infant to accompany the infant from the place of delivery to the neonatal care unit and be immediately available to unit personnel. This record shall include information concerning prenatal history, course of labor, delivery, drug administration to mother and infant, Apgar score, relevant conditions of the mother, procedures performed on the infant in the delivery room, complications of any type, and other facts and observations.

The provisions of this § 139.23 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); section 16 of the Disease Prevention and Control Law of 1955 (35 P. S. § 521.16); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 139.23 amended May 4, 1984, effective May 5, 1984, 14 Pa.B. 1553. Immediately preceding text appears at serial pages (37907) to (37909).

This section cited in 28 Pa. Code § 139.21 (relating to policies and procedures).

History

Authority: The provisions of this Chapter 139 amended under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 139 amended June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 139.24 Neonatal intensive care units (Levels II and III).

(a) In hospitals with neonatal intensive care units, the director of the neonatal services shall develop written policies and procedures regarding admission of infants to neonatal intensive care units.

(b) Policies for neonatal intensive care units shall include:

(1) Requirements, in accordance with the Guidelines, for staffing of neonatal intensive care units. In addition, these units shall be staffed on every shift by at least one registered professional nurse who has special training, experience and interest in infants requiring special care and who is assigned no other responsibilities.

(2) A requirement that a pediatrician designated by the director of the neonatal services shall be on call 24 hours a day.

(3) A provision that private physicians or specialists may care for their patients in neonatal intensive care units. However, the final authority for policy in neonatal intensive care units shall reside with the director of neonatal services.

(4) A requirement that ancillary personnel employed to meet the needs of infants shall have appropriate, specified skills and training.

(5) Provisions for physicians, nurses and social service staff to assist parents of special care infants to become acquainted with their infant and any problems during the infant’s hospitalization.

(6) A definite written policy, developed by the director of neonatal services, which provides for the unique problems involved in the total care of infants in neonatal intensive care units to be met, by making arrangements with the hospital nursing and social service departments and community health and social agencies, and by specifying what provisions will be made for continuing care, follow-up and home assistance.

This section cited in 28 Pa. Code § 139.21 (relating to policies and procedures).

History

Authority: The provisions of this Chapter 139 amended under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 139 amended June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 139.25 Control of infection.

(a) The director of neonatal services through the hospital’s infection control program shall establish procedures for the control of infection, governing matters such as appropriate attire, isolation and cleaning of equipment in the neonatal care unit. Infection control procedures for neonatal services may be included among the responsibilities of the committee established under other licensure regulations. These procedures shall be written, reviewed at least annually and dated to indicate the date of last review.

(b) Infection control procedures shall do the following:

(1) Prohibit common or group carriers from transporting infants to their mothers.

(2) Require and specify procedures for scrupulous hand cleansing by all neonatal care unit personnel and visitors before and after each infant contact.

This section cited in 28 Pa. Code § 139.21 (relating to policies and procedures).

History

Authority: The provisions of this Chapter 139 amended under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 139 amended June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 139.26 Care given by parents.

(a) The obstetrical and neonatal care departments of any hospital which provides rooming-in services shall have written policies governing the services. These procedures shall be designed to prevent cross contamination.

(b) When rooming in is provided, it shall be under professional nurse supervision.

(c) ‘‘Rooming-in services,’’ as used in this section, shall include any of a variety of arrangements which allows the mother and her infant to be cared for together in a setting that gives the mother access to her infant during all or a substantial part of the day and which allows the father to have extensive contact with the mother and the infant during their hospital stay.

(d) Whether or not a hospital provides rooming-in services, it shall provide new parents with orientation, instructions, and demonstration in neonatal care and hygiene.

This section cited in 28 Pa. Code § 139.21 (relating to policies and procedures).

History

Authority: The provisions of this Chapter 139 amended under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 139 amended June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 139.27 Laboratory services and radiological services.

(a) Laboratory services shall be available on a 24-hour-a-day, 7-day-a-week basis for, at a minimum, hemoglobin; hematocrit; Coombs test; blood type; Rh type; urinalysis; bacteriologic cultures; spinal fluid analysis; and microchemical determinations for bilirubin, blood glucose, sodium, potassium, chloride and total protein.

(b) Radiological equipment and services shall be available on a 24-hour-a-day, seven-day-a-week basis.

(d) A hospital in which a neonatal intensive care unit is located shall have a licensed blood bank, available or on call to the unit on a 24-hour-a-day, 7-day-a-week basis.

This section cited in 28 Pa. Code § 139.21 (relating to policies and procedures).

History

Authority: The provisions of this Chapter 139 amended under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 139 amended June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 139.28 Patient medical records.

Patient medical records shall be maintained in accordance with Chapter 115 (relating to medical records services). The following information shall also be included in the neonatal record if the entire maternal records are not maintained as the neonatal records in § 115.23(b) (relating to preservation of medical records):

(1) Obstetrical history of mother’s previous pregnancies.

(2) Description of complications of pregnancy or delivery.

(3) List of complicating maternal disease.

(4) Drugs taken by the mother during pregnancy, labor and delivery.

(5) Duration of ruptured membranes.

(6) Maternal antenatal blood serology, rubella titer, blood typing, Rh factors, and, when indicated, a Coombs test for maternal antibodies.

(7) Complete description of progress of labor including reasons for induction and operative procedures, if any, signed by the attending physician or an authorized delegate.

(8) Anesthesia, analgesia and medications given to mother and infant.

(9) Condition of infant at birth, including the 1-and 5-minute Apgar Score or its equivalent, resuscitation, time of sustained respirations, details of physical abnormalities, pathological states observed and treatments given before transfer to the neonatal care unit.

(10) Abnormalities of the placenta and cord vessels.

(11) Date and hour of birth, birth weight and length, and period of gestation.

(12) A written verification of eye prophylaxis.

(13) Report of initial physical examination, including abnormalities, signed by the attending physician or an authorized delegate.

(14) Discharge physical examination, including head circumference and body length, unless previously done; recommendations; and signature of attending physician or a delegate.

(15) A listing of all diagnoses since birth, including discharge diagnosis.

(16) Specific follow-up plans for care of infant.

The provisions of this § 139.28 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 139.28 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (37911).

This section cited in 28 Pa. Code § 139.21 (relating to policies and procedures).

History

Authority: The provisions of this Chapter 139 amended under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 139 amended June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 139.29 Infant nursing records.

Upon admission to a neonatal care unit, nurses shall initiate and maintain records on all infants as to weight, type and volume of feedings; time of first voiding; time of passage of first stool; number, color and consistency of stools; and temperature. If abnormalities are suspected or recognized, nurses shall also make notations on respiratory rate, dyspnea, color, cyanosis, jaundice, pallor, lethargy, twitching, motor activity, skin and buttocks, vomiting, condition of the eyes and umbilical cord, and other relevant factors as indicated and warranted by the condition of the infant. Treatments, medication and special procedures ordered by a physician should also be recorded with time, date and the name and title of the individual who administers them.

This section cited in 28 Pa. Code § 139.21 (relating to policies and procedures).

History

Authority: The provisions of this Chapter 139 amended under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 139 amended June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 139.31 Policies and procedures.

Written policies and procedures for infant feeding shall be established and shall be available to the medical and nursing staffs.

History

Authority: The provisions of this Chapter 139 amended under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 139 amended June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 139.32 Commercial formula.

Precautions shall be taken to prevent the contamination and expiration of commercial formulas.

History

Authority: The provisions of this Chapter 139 amended under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 139 amended June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 139.33 Formula preparation.

(a) A registered professional nurse or dietitian shall be in charge of formula preparation.

(b) Formula shall be individually bottled and sterilized by pressure method 230�DF. for 25 minutes, with the following exceptions:

(1) If hermetically sealed commercial formula products are used and the hospital’s method of dispensing the formula has been approved by the Department.

(2) Special mixtures which cannot be subjected to terminal heating shall be prepared by aseptic technique.

(d) Bacteriologic examinations of the equipment used, and analysis of techniques shall be done at least once each month. Plate counts on random sample of 24-hour milk mixtures shall not exceed 25 organisms per milliliter. Results of the bacteriologic tests shall be recorded and maintained on file.

History

Authority: The provisions of this Chapter 139 amended under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 139 amended June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 139.34 Breastfeeding.

Management of breastfeeding mothers and infants shall be consistent with the Guidelines.

History

Authority: The provisions of this Chapter 139 amended under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 139 amended June 5, 1998, effective June 6, 1998, 28 Pa.

Chapter 141 Dental Services

28 Pa. Code § 141.1 Principle.

When a hospital provides dental services, the services shall be an integral part of comprehensive health care and should be readily available to meet the needs of patients, in accordance with accepted ethical and professional practices.

History

Authority: The provisions of this § 141.
Source: The provisions of this § 141.

28 Pa. Code § 141.2 Dental director.

In hospitals that provide dental services, there shall be a director of dental services who is a dentist qualified to assume professional, organizational and administrative responsibility, and who serves either full-time or part-time as the activity of the services requires.

History

Authority: The provisions of this § 141.
Source: The provisions of this § 141.

28 Pa. Code § 141.3 Organization and staffing.

The dental service shall be staffed by a sufficient number of competent personnel, in keeping with the size and scope of dental services of the hospital.

History

Authority: The provisions of this § 141.
Source: The provisions of this § 141.

28 Pa. Code § 141.4 Special area of dental practices.

In hospitals where dental services are confined largely to one of the special areas of dental practice, the dental services organizational plan may be limited to a section of the department of surgery co-equal with other surgical specialities.

History

Authority: The provisions of this § 141.
Source: The provisions of this § 141.

28 Pa. Code § 141.5 Staffing.

Each dentist member of the medical staff shall be qualified for membership and for the exercise of the clinical privileges granted to him, in accordance with the medical staff bylaws. The dental service shall be organized to include dentist members of the medical staff. If qualified dental hygienists, dental assistants, or dental laboratory technicians are employed, they shall be recommended by and be under the supervision of the director of dental services.

This section cited in 28 Pa. Code § 141.23 (relating to medical appraisal of dental patients).

History

Authority: The provisions of this § 141.
Source: The provisions of this § 141.

28 Pa. Code § 141.6 Scope of services.

(a) If the hospital provides dental services, the dental director shall develop, where appropriate, a comprehensive oral health plan.

(b) The oral health plan should encompass at least the following:

(1) Provision for consultation and treatment in accordance with local needs.

(2) Provision for emergency services.

(3) Provision for oral hygiene, preventative dentistry and pain control.

(4) Provision for coordination of oral health services, facilities and procedures with other services of the hospital.

(5) Provision for a continuing program of professional education.

(6) Provision for audit and utilization review of health care in a manner consistent with policies of the medical staff.

History

Authority: The provisions of this § 141.
Source: The provisions of this § 141.

28 Pa. Code § 141.11 Facilities and equipment.

Facilities and supplies for the dental service shall be such as to foster effective and timely patient care. The dental service area shall have adequate space to facilitate effective care of dental patients. Equipment, instruments and supplies in the dental service shall be of the same high quality as is required by generally accepted standards of dental practice.

History

Authority: The provisions of this § 141.
Source: The provisions of this § 141.

28 Pa. Code § 141.12 Availability of beds.

Hospital beds shall be available to the dental service in the same manner as they are to other services of the hospital.

History

Authority: The provisions of this § 141.
Source: The provisions of this § 141.

28 Pa. Code § 141.21 Policies and procedures.

Policies and procedures for dental services shall be written and shall be available to medical staff members and nursing personnel.

History

Authority: The provisions of this § 141.
Source: The provisions of this § 141.

28 Pa. Code § 141.22 Medical supervision of dental patients.

A physician member of the medical staff shall be responsible for the care of any medical problem which may be present or suspected or which may arise during the hospitalization of a dental patient. The dentist shall be responsible for requesting consultation with physician members of the medical staff when medical complications are present or develop during hospitalization of a dental patient.

History

Authority: The provisions of this § 141.
Source: The provisions of this § 141.

28 Pa. Code § 141.23 Medical appraisal of dental patients.

A patient admitted for dental services shall receive the same basic admission appraisal by a physician member of the medical staff or appropriate house staff as patients admitted for other service in accordance with § § 105.12—105.14 (relating to admission criteria; alternate admissions arrangements; and admission diagnosis). However, oral surgeons who admit patients without known medical problems may perform a complete admission history and physical examination and assess the medical risks of the procedure on the patient if they are qualified to do so. The hospital, if it chooses to permit oral surgeons to perform these services, shall evaluate the qualifications of each oral surgeon as set forth in § 141.5 (relating to staffing).

The provisions of this § 141.23 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 141.23 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (37916).

History

Authority: The provisions of this § 141.
Source: The provisions of this § 141.

28 Pa. Code § 141.24 Dental surgical procedures.

The scope and extent of surgical procedures which each dentist may perform shall be specifically defined and recommended by the medical staff in the same manner as all other surgical procedures.

History

Authority: The provisions of this § 141.
Source: The provisions of this § 141.

28 Pa. Code § 141.25 Emergency dental services.

A well organized plan for emergency dental care shall be an integral part of the emergency plan of the hospital as required in § § 117.11—117.15 (relating to emergency services planning). When the medical staff includes sufficient dentists, the emergency service of the hospital must have a policy whereby emergencies involving the oral cavity and associated structures are assessed by a dentist member of the medical staff.

History

Authority: The provisions of this § 141.
Source: The provisions of this § 141.

28 Pa. Code § 141.26 Patient dental records.

A record of any dental services provided for an inpatient, outpatient or emergency patient shall be made a part of the patient’s medical record. Completion of dental records shall be in accordance with Chapter 115 (relating to medical record services).

This section cited in 49 Pa. Code § 33.209 (relating to preparing, maintaining and retaining patient records).

History

Authority: The provisions of this § 141.
Source: The provisions of this § 141.

Chapter 143 Podiatry Services

28 Pa. Code § 143.1 Principle.

Where a hospital provides podiatry services, they shall be an integral part of comprehensive health care and shall be readily available to meet the needs of patients, in accordance with accepted professional and ethical practices.

28 Pa. Code § 143.2 Podiatry director.

When podiatry services are available, they shall be directed and (with the exception of surgery) supervised, by a podiatrist qualified by training and ex- perience and currently licensed to practice in this Commonwealth.

28 Pa. Code § 143.3 Podiatry surgical procedures.

The scope and extent of surgical procedures which each podiatrist may perform shall be specifically defined and recommended in the same manner as all other surgical privileges and shall be made known to the surgical suite nursing supervisor and personnel. Surgical procedures performed by podiatrists shall be under the supervision of the chief of surgery.

28 Pa. Code § 143.4 Medical appraisal of a podiatric patient.

A patient admitted for podiatric services shall receive the same basic admission appraisal by a physician member of the medical staff or appropriate house-staff as patients admitted for other services in accordance with § § 105.12—105.14 (relating to admission criteria and diagnosis; alternate admissions arrangements; and admission diagnosis).

28 Pa. Code § 143.5 Medical supervision of podiatric patients.

A podiatrist with clinical privileges, may, with the concurrence of any physician member of the medical staff, initiate procedures for admitting a patient. This concurring physician shall assume responsibility for the nonpodiatrical medical care of the patient throughout the hospital stay, including the medical history and physical examination and any medical problem which may be present or which may arise during the hospitalization.

28 Pa. Code § 143.6 Podiatry policies and procedures.

Policies and procedures for podiatry services shall be written and shall be available to medical staff members, podiatrists granted clinical privileges, and nursing personnel.

28 Pa. Code § 143.7 Medical orders and patient records.

The podiatrist may write medical orders within the scope of his license and the medical staff bylaws, rules and regulations. He shall be responsible for the podiatry history and podiatry physical examination and all elements of the patient’s medical record relating to podiatric care.

Chapter 145 Professional Library Services

28 Pa. Code § 145.1 Principle.

Library services shall be made available in the hospital to the medical and hospital staff. There shall be books, periodicals, and other materials appropriate to meet their needs.

History

Authority: The provisions of this § 145.
Source: The provisions of this § 145.

28 Pa. Code § 145.3 Librarian.

(a) Hospitals providing extensive library services should have the services of at least one full-time librarian.

(b) When there is no full-time librarian, a suitably trained person should be available to provide library services.

(c) The librarian or person designated in charge of library services shall be a member of the library committee if there is one.

The provisions of this § 145.3 issued under 67 Pa.C.S. § § 6101—6104; and Reorganization Plan No. 2 of 1973 (71 P.S. § 755-2).

The provisions of this § 145.3 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37920).

History

Authority: The provisions of this § 145.
Source: The provisions of this § 145.

28 Pa. Code § 145.4 Services.

The professional library services of the hospital should include:

(1) The ability to suggest references and sources of information, as well as the ability to find facts within a reasonable period of time.

(2) The ability to respond to a reasonable request, either to produce published matter from the library’s own collection or to acquire it from source libraries.

(3) The ability to provide audio-visual material and equipment.

History

Authority: The provisions of this § 145.
Source: The provisions of this § 145.

28 Pa. Code § 145.5 Materials.

Commonly used current reference material shall be provided in the hospital. These shall include Index Medicus or an abridged Index Medicus and other pertinent indices, basic books, and journals in the fields in which the hospital provides services, as well as books in basic sciences such as anatomy, physiology, pathology, biochemistry, and pharmacology.

History

Authority: The provisions of this § 145.
Source: The provisions of this § 145.

28 Pa. Code § 145.6 Procedures.

The librarian or library committee shall develop procedures governing the circulation of library materials, including accurate control of loans and the handling of photo-reproduction requests. Although a priority system of library privileges may be established, the professional library services shall be avail- able to all hospital staff and employes, regardless of position.

The provisions of this § 145.6 issued under 67 Pa.C.S. § § 6101—6104; and Reorganization Plan No. 2 of 1973 (71 P.S. § 755-2).

The provisions of this § 145.6 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37921).

History

Authority: The provisions of this § 145.
Source: The provisions of this § 145.

28 Pa. Code § 145.7 Catalogue.

A cross-reference catalogue of the book holdings of the library should be maintained to provide access at least by subject and author. A complete record of all other holdings should be maintained.

History

Authority: The provisions of this § 145.
Source: The provisions of this § 145.

28 Pa. Code § 145.8 Facilities.

Each hospital should provide a professional library-reading room.

History

Authority: The provisions of this § 145.
Source: The provisions of this § 145.

Chapter 146 Infection Control

28 Pa. Code § 146.1 Principle.

(a) A multidisciplinary committee made up of representatives of the medical staff, the administration, the microbiology laboratory, and the nursing service shall establish effective measures for the control and prevention of infections.

(b) The multidisciplinary committee described in subsection (a) shall do the following:

(1) Develop written standards for hospital sanitation and medical asepsis. Copies of the standards shall be made available to all appropriate personnel. Adequate standards should comply with those described in Infection Control in the Hospital, published by The American Hospital Association, Chicago, Illinois.

(2) Develop isolation procedures.

(3) Develop, evaluate, and revise on a continuing basis the procedures and techniques for meeting established sanitation and asepsis standards.

(4) Develop a practical system to report, evaluate, and keep records of infections which originate in the hospital among patients and personnel to trace the sources of infection, and to identify epidemic situations.

(5) Review periodically the use of antibiotics as they relate to patient care within the hospital.

(6) Provide assistance in the development of the employe health program of the hospital.

(7) Submit a copy of pertinent findings and recommendations to the chief executive officer, the director of nursing service, and other appropriate personnel.

(8) Maintain written minutes of meetings.

Adoption of Standards

This regulation only referenced the standard for intravenous catheter sites, and did not require its adoption. The regulation merely states that whatever standards a hospital’s infection committee chooses to adopt should be in line with Infection Control. This regulation did not require the hospital to follow in lock step with the 48-hour rule, so its decision to adopt a 72-hour rule was not necessarily negligent. Therefore, the hospital’s failure to move the patient’s heparin lock after 48-hours did not constitute negligence per se. Edwards v. Brandywine Hospital, 652 A.2d 1382 (Pa. Super. 1995).

History

Authority: The provisions of this Chapter 146 issued under section 2102(q) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 146 adopted December 3, 1982, effective December 4, 1982, 12 Pa.

28 Pa. Code § 146.2 Isolation procedures.

The multidisciplinary infection control committee, in cooperation with other appropriate personnel, shall establish procedures for the physical separation of all isolation patients. Isolation facilities shall be equipped in such a way as to enable good medical and nursing isolation techniques to be practiced and shall include handwashing facilities. Isolation of patients with communicable diseases shall be in accordance with Chapter 27, Subchapter E (relating to procedure for treating each reportable disease).

History

Authority: The provisions of this Chapter 146 issued under section 2102(q) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 146 adopted December 3, 1982, effective December 4, 1982, 12 Pa.

Chapter 147 Environmental Services

28 Pa. Code § 147.1 Principle.

A clean, safe environment shall be provided and maintained within the hospital in accordance with standards specified by the Department of Environmental Protection in 25 Pa. Code Chapter 173 (Reserved) in addition to the provisions of this subpart.

28 Pa. Code § 147.2 Maintenance of safety and sanitation.

The hospital shall be equipped, operated, and maintained so as to sustain its safe and sanitary characteristics and to minimize all health hazards in the hospital, for the protection of both patients and employes.

28 Pa. Code § 147.11 Principle.

Housekeeping, laundry and maintenance functions shall be effectively organized, directed and staffed by qualified personnel.

28 Pa. Code § 147.12 Organization.

Each department or service shall have a current written organization plan. Each such plan shall indicate all categories of personnel employed in the department, and shall clearly define the lines of communication.

28 Pa. Code § 147.13 Directors.

(a) Each environmental service or department shall be supervised by a director who shall be qualified for the position by education, training, or experience. Directors shall develop departmental policies and procedures, train and supervise personnel, schedule and assign responsibilities and maintain communication with other department heads in the hospital. Directors of environmental services shall be responsible to the chief executive officer of the hospital or his designee.

(b) Each department providing environmental services shall have written policies and procedures and shall make them available to environmental services personnel.

28 Pa. Code § 147.14 Personnel, environmental services.

Sufficient personnel shall be employed to fulfill the needs of each department or service. Supervisory personnel shall be employed to ensure the effective implementation of departmental goals and objectives.

28 Pa. Code § 147.15 Education programs.

An initial orientation and continuing in-service education program should be provided for all environmental services employes. Personnel assigned to environmental duties in special areas, such as the surgical suite, obstetrical units, emergency service, special care units and inhalation therapy units shall receive additional training in the execution of procedures unique to these departments.

28 Pa. Code § 147.16 Reference material.

Current reference manuals, pamphlets, journals and books, as well as information and scientific data from manufacturers concerning their products should be available to environmental service employes for reference and guidance.

The provisions of these § § 147.21—147.22 reserved December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial pages (37925) to (37926).

28 Pa. Code § 147.31 Procedures.

A manual shall be established setting forth policy and procedure for use, cleaning, and care of equipment; for establishment of cleaning schedules; for cleaning methods; and for proper use of cleaning supplies.

28 Pa. Code § 147.32 Rodent and insect control.

The hospital shall have a program for the prevention and eradication of rodents, pests and insects.

28 Pa. Code § 147.33 Housekeeping and rubbish carts.

Housekeeping carts and carts used to transport rubbish shall not be stored on any patient unit unless enclosed storage space is provided for that purpose.

28 Pa. Code § 147.34 Storage areas.

Storage areas shall be kept uncluttered. The lower shelves in storage areas shall be so constructed as to allow access for cleaning beneath them.

28 Pa. Code § 147.41 Policies and procedure.

Written policies and procedures for the maintenance of the physical plant and equipment shall be available to all employes. Written procedures shall be readily available for employes to follow in the event of a breakdown in mechanical systems or utilities.

28 Pa. Code § 147.42 Mechanical systems.

Mechanical systems throughout the hospital shall be maintained in accordance with a written preventive maintenance program.

28 Pa. Code § 147.43 Ventilation system.

The ventilation system shall be inspected and maintained in accordance with the written maintenance schedule to ensure that a properly conditioned air supply meeting minimum filtration, humidity and temperature requirements is provided in critical areas, such as the surgical and delivery suites, emergency operating rooms, nurseries, recovery and isolation units.

This section cited in 28 Pa. Code § 119.43 (relating to basic facilities for outpatient surgery).

28 Pa. Code § 147.51 Principle.

The hospital shall establish and maintain an organized laundry service with equipment on the premises or through a shared or commercial service or through both a shared and a commercial service.

This section cited in 28 Pa. Code § 147.55 (relating to off-premises laundry service).

28 Pa. Code § 147.52 Clean linen.

Clean linens shall be available to meet the daily and emergency needs of the hospital. Clean linen shall be handled and stored in such a way as to minimize contamination from surface contact or airborne deposits.

This section cited in 28 Pa. Code § 147.55 (relating to off-premises laundry service).

28 Pa. Code § 147.53 Soiled linen.

Soiled linen shall be collected and stored in such a manner as to avoid microbial dissemination into the environment. Soiled linen shall be kept segregated from clean linen at all times. Soiled linen from isolation areas shall be identified and separately bagged. Precautions shall be taken in the subsequent processing of soiled linen from isolation areas to prevent microbial dissemination and infection.

This section cited in 28 Pa. Code § 147.55 (relating to off-premises laundry service).

28 Pa. Code § 147.54 Laundry facilities.

The laundry areas shall be planned, equipped, and ventilated in such a way as to prevent the dissemination of contaminents. Laundry facilities, when located in the hospital, shall be separated from the clean linen processing area, patient rooms, food preparation and food storage areas, and areas used to store clean materials and equipment.

This section cited in 28 Pa. Code § 147.55 (relating to off-premises laundry service).

28 Pa. Code § 147.55 Off-premises laundry service.

Hospitals using off-premises or commercial linen processing shall require the agency providing the service to maintain at least the standards outlined in § § 47.51—147.55 (relating to laundry service) and the contract shall so state. The off-premises laundry service must ensure that clean linen is completely packaged and is protected from contamination upon delivery to the hospital.

This section cited in 28 Pa. Code § 147.55 (relating to off-premises laundry service).

28 Pa. Code § 147.61 Source water.

Water shall be obtained from a municipal or a private water system approved by the Department of Environmental Protection and in compliance with applicable Federal, State and local regulations.

28 Pa. Code § 147.62 Emergency water supply.

Provisions shall be made for an emergency supply of water when the usual source of water is neither usable nor available.

28 Pa. Code § 147.71 Liquid waste.

Building sewers shall be approved by the Department of Environmental Protection and in compliance with local regulations.

28 Pa. Code § 147.72 Garbage disposal.

Garbage unless disposed through garbage grinders, shall be stored in tight, nonabsorbent, and readily cleanable containers with tight-fitting lids and should be stored in a refrigerated room which is easily cleanable and free of odors. Garbage shall be removed from the premises as frequently as necessary to prevent nuisance and shall be disposed of in a manner consistent with Federal, State and local regulations, codes and ordinances.

28 Pa. Code § 147.73 Refuse disposal.

Refuse shall be stored in covered trash containers prior to removal. Combustible refuse may be burned on the premises in a suitable incinerator, provided this method of disposal is approved by the Department of Environmental Protection and appropriate local regulatory agencies.

28 Pa. Code § 147.74 Bacteriological and pathological wastes.

Pathological and bacteriological wastes, surgical and obstetrical wastes, contaminated wastes and similar materials shall be incinerated on the premises or disposed of by a method approved by the Department of Environmental Protection and in compliance with local regulations.

28 Pa. Code § 147.75 Incinerators.

Incineration facilities shall be approved by the Department of Environmental Protection.

28 Pa. Code § 147.81 Lighting.

Glare-free, artificial lighting shall be provided in all areas of the hospital. Minimum intensity requirement for artificial light in various occupied places, corridors, stairways, and so forth shall meet the standards as specified by the levels listed by Public Health Service Publication. Hospital Electrical Facilities, 930D-16 (Revision January 1969).

28 Pa. Code § 147.82 Sterilization control.

There shall be written policies establishing a method of control to assure sterilization of supplies and water, and requiring sterile supplies to be reprocessed at specified intervals.

Chapter 149 Central Supply Services

28 Pa. Code § 149.1 Principle

Central supply service functions shall be effectively organized, directed and staffed by qualified personnel.

28 Pa. Code § 149.2 Director.

The person in charge of central supply services shall be qualified by education, training, or experience in the intended purposes of this department. He shall participate in the development of the departmental policies, procedures, and training programs, shall supervise, schedule and assign responsibilities to personnel, and shall maintain communication with other department heads in the hospital.

28 Pa. Code § 149.3 Facilities.

The hospital shall have a central supply service physically separated from other areas. Central supply service shall be provided with facilities to process, sterilize, store, and dispense supplies and equipment.

28 Pa. Code § 149.11 Availability of supplies and equipment.

The hospital shall have an effective written plan for the availability of all necessary materials, equipment and supplies.

28 Pa. Code § 149.12 Handling of equipment.

All hospital employes using sterile supplies shall be advised of sterilization controls, rotation schedules for stored equipment, appropriate and proper use of all sterile equipment, and methods for handling and returning contaminated materials.

28 Pa. Code § 149.13 Prevention of transmission of pathogens.

There shall be written policies and procedures to prevent indirect and direct transmission of pathogens or other toxic substances with materials issued from the central supply service.

28 Pa. Code § 149.14 Central supply service education program.

Although initial orientation of employes in the central supply service should be sufficient to enable them to carry out the tasks outlined in their job descriptions, they should have further on-the-job training and continuing education in the areas of asepsis and other pertinent topics applicable to the services rendered by the service.

28 Pa. Code § 149.15 Reference material.

Current reference manuals, pamphlets, journals, and books, as well as information and scientific data from manufacturers concerning their products and equipment, should be made available for reference and guidance of central supply service personnel and potential users of the equipment and supplies.

Chapter 151 Fire, Safety and Disaster Services

28 Pa. Code § 151.1 Principle.

The hospital shall have an organized fire, safety and disaster program under the direction and supervision of one or more persons qualified to implement the program.

History

Authority: The provisions of this § 151.
Source: The provisions of this § 151.

28 Pa. Code § 151.2 Policies and procedures.

Written policies and procedures for use in preventing and responding to fire and disaster shall be available to all personnel.

History

Authority: The provisions of this § 151.
Source: The provisions of this § 151.

28 Pa. Code § 151.11 Fire fighting service.

The chief executive officer, or his designee, shall establish a workable plan with the nearest fire department for fire fighting service. The hospital shall provide the fire department with a current floor plan of the building showing the location of fire fighting equipment, exits, patient rooms, storage places of flammable and explosive gases, and other information as the fire department requires or as may be necessary.

History

Authority: The provisions of this § 151.
Source: The provisions of this § 151.

28 Pa. Code § 151.12 Fire warning and safety systems.

Every building should have an automatic and manually activated fire alarm system installed to transmit an alarm automatically to the fire department by the most direct and reliable method approved by local regulations.

History

Authority: The provisions of this § 151.
Source: The provisions of this § 151.

28 Pa. Code § 151.13 Testing fire warning systems.

Fire safety systems, including automatic fire extinguishing systems, automatic and manual alarms, stand-pipes, and hose reels shall be of an approved type. They shall be kept in good operating condition and inspected by qualified hospital personnel at least every 3 months. Records of these inspections shall be kept on file for 2 years.

History

Authority: The provisions of this § 151.
Source: The provisions of this § 151.

28 Pa. Code § 151.14 Internal disaster and fire plans.

The hospital shall have an internal disaster and fire plan incorporating evacuation procedures. These plans shall be made available to all personnel and posted throughout the hospital. These plans should be developed in accordance with the American Hospital Association’s guidelines for disaster planning.

History

Authority: The provisions of this § 151.
Source: The provisions of this § 151.

28 Pa. Code § 151.15 Safety education program.

All employes shall participate in the safety program in the duties delegated to them and be instructed in the operation of the fire warning system, the proper use of fire fighting equipment, and the procedure to follow in event that electric power is impaired.

History

Authority: The provisions of this § 151.
Source: The provisions of this § 151.

28 Pa. Code § 151.21 Fire drills.

(a) Fire, internal disaster and evacuation drills shall be held at least quarterly for each shift of hospital personnel and under varied conditions.

(b) These drills shall be planned and implemented so as to:

(1) Ensure that all personnel on all tours of duty are trained to perform assigned duties.

(2) Ensure that all personnel on all tours of duty are familiar with the use and operation of the fire-fighting equipment in the hospital.

(3) Enable the chief executive officer to evaluate the effectiveness of the plan.

History

Authority: The provisions of this § 151.
Source: The provisions of this § 151.

28 Pa. Code § 151.22 Fire drill supervised by the local fire department.

At least one hospital fire drill each year should be supervised by the local fire department.

History

Authority: The provisions of this § 151.
Source: The provisions of this § 151.

28 Pa. Code § 151.23 Record of fire drills.

A written report and evaluation of all drills conducted since the last survey shall be kept on file.

History

Authority: The provisions of this § 151.
Source: The provisions of this § 151.

28 Pa. Code § 151.24 Evacuation of patients.

The actual evacuation of patients to safe areas during a drill is optional.

History

Authority: The provisions of this § 151.
Source: The provisions of this § 151.

28 Pa. Code § 151.31 Written external disaster plan.

(a) Each hospital shall have written plans, based on its capabilities, for the proper and timely care of casualties arising from external disasters. These plans should be developed in accordance with the disaster planning guidelines published by the American Hospital Association. The disaster plan should be developed in conjunction with other emergency facilities in the community so that adequate logistical provisions are made for the expansion of the activities of the hospital in coordination with the activities of other facilities.

(b) The disaster plan should make provision for the following:

(1) The availability of basic utilities and supplies, including gas, water, food and essential medical and supportive materials.

(2) An efficient system of notifying and assigning personnel.

(3) Unified medical command.

(4) Conversion of all usable space into clearly defined areas for efficient triage and for patient observation and for immediate care.

(5) Prompt transfer of casualties, when necessary, after preliminary medical or surgical services have been rendered, to the facility most appropriate for administering definitive care.

(6) A special disaster medical record which shall accompany the casualty patient as he is moved.

(7) The prompt and orderly discharge or transfer of patients already in the hospital who can be safely moved without jeopardy.

(8) Maintaining security to keep unauthorized persons out of the triage area.

(9) Preestablishment of a public information center and assignment of public relations liaison duties to a qualified individual. Advance arrangements should be made with communications media to provide for organized dissemination of information in the event of a disaster.

History

Authority: The provisions of this § 151.
Source: The provisions of this § 151.

28 Pa. Code § 151.32 Rehearsed disaster plan.

The external disaster plan shall be rehearsed at least twice a year, preferably as part of a coordinated drill in which other community emergency service agencies participate. The drills shall involve professional, administrative, nursing and other hospital personnel. Actual evacuation of patients during drills is optional. A written report and evaluation of all drills must be maintained for at least 2 years.

History

Authority: The provisions of this § 151.
Source: The provisions of this § 151.

28 Pa. Code § 151.41 Emergency power.

The emergency electric power source and associated equipment shall be regularly inspected, tested and maintained in accordance with current NFPA Standards. A written record shall be maintained of inspection, performance, exercising period and repairs of emergency power equipment.

History

Authority: The provisions of this § 151.
Source: The provisions of this § 151.

28 Pa. Code § 151.42 Fire inspection.

The hospital shall request an annual inspection by its local fire department.

History

Authority: The provisions of this § 151.
Source: The provisions of this § 151.

28 Pa. Code § 151.43 Smoking.

(a) The governing body shall adopt written rules governing smoking within the hospital which shall be made known to hospital personnel, to patients and to the public.

(b) These rules shall include at least the following:

(1) Smoking shall be prohibited in any room, ward or compartment where flammable liquid, combustible gas, or oxygen is being used or stored and in any other hazardous area of the hospital. The areas shall be posted with ‘‘NO SMOKING’’ signs.

(2) Patients classified as not mentally or physically responsible for their actions shall be prohibited from smoking unless constant supervision is provided.

History

Authority: The provisions of this § 151.
Source: The provisions of this § 151.

28 Pa. Code § 151.44 Hazardous areas.

Special safety procedures, including use of special facilities and equipment, shall be provided for areas of the hospital which present an unusual hazard to patients and personnel. Exposed heating pipes and radiators in patient rooms and within reach shall be covered.

History

Authority: The provisions of this § 151.
Source: The provisions of this § 151.

28 Pa. Code § 151.45 Electrical safety.

All appliances, instruments and installations shall be tested before use to determine compliance with grounding, current leakage and other device safety requirements to ensure protection of patients and employes. A program of routine maintenance shall be effectively enforced to ensure that all electrical receptacles and plugs, wires and connectors are safe. If an appliance requiring three-wire circuitry for grounding is attached to a two-wire outlet, the adaptor plug pigtail shall be attached to a ground.

History

Authority: The provisions of this § 151.
Source: The provisions of this § 151.

28 Pa. Code § 151.46 General safety precautions.

The following safety precautions shall be met:

(1) Doorways, corridors and stairwells shall be free of obstructions and properly lighted.

(2) Doors into patient rooms shall not be locked when the patient is alone in the room.

(3) Exit doors shall never be locked from the inside.

(4) Doors opening to shafts shall be equipped with self-closing devices and positive latches.

(5) Wastebaskets, cubicle curtains, window shades and drapes shall be rendered flame retardant.

(6) Call bells in the shower, tub room or water closet shall be easily accessible to patients while using these facilities.

The provisions of this § 151.46 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 151.46 amended through December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129. Immediately preceding text appears at serial page (52884).

History

Authority: The provisions of this § 151.
Source: The provisions of this § 151.

28 Pa. Code § 151.47 Safety devices.

The following safety devices shall be provided:

(1) Grab bars within reaching distance on at least one side of toilets, bathtubs and showers used by patients.

(2) Bedside rails on both sides of a bed for use when the condition of the patient warrants.

History

Authority: The provisions of this § 151.
Source: The provisions of this § 151.

28 Pa. Code § 151.48 Report of emergencies causing interruption of service.

(a) The chief executive officer or his designee shall make a report of any emergency, such as a strike, fire or natural disaster, which significantly interrupts or alters hospital services and threatens the health and safety of patients and which requires one of the following:

(1) The services of a fire department.

(2) The evacuation of any patient.

(3) The use of nonmedical emergency equipment.

(b) The report made under subsection (a) shall be submitted to the Director of the Division of Hospitals of the Department as soon as possible and shall include the following information:

(1) Time, date, cause, location, and nature of emergency.

(2) Number of patients evacuated.

(3) Loss of life and name of any deceased patient.

(4) Name of any patients sent to other facilities and name of the facilities.

(5) Any assistance required from the Health Department to protect the health and safety of the patients.

(c) Oral reports shall be followed by a complete written report verifying the information listed in this section. The written report shall be dated and shall be authenticated by the chief executive officer or his designee.

The provisions of this § 151.48 issued under 67 Pa.C.S. § § 6101—6104; and Reorganization Plan No. 2 of 1973 (71 P. S. § 755-2).

The provisions of this § 151.48 amended September 19, 1980, effective September 20, 1980, 10 Pa.B. 3761. Immediately preceding text appears at serial page (37939).

History

Authority: The provisions of this § 151.
Source: The provisions of this § 151.

Chapter 153 Initial Construction and Continuing Operating Standards

28 Pa. Code § 153.1 Minimum standards.

(a) Hospital construction shall be in accordance with the standards set forth in the latest edition of the Department of Health and Human Services handbook, Minimum Requirements of Construction and Equipment for Hospital and Medical Facilities, DHHS Publication No. (HRA) 14500 Regulations, published under Title VI of the Public Health Service Act (42 U.S.C. § § 291—291 o-1) and referred to as ‘‘HHS Requirements,’’ except as modified in this chapter.

(b) Hospitals previously in compliance with prior editions of Department of Health and Human Services handbook, Minimum Requirements of Construction and Equipment for Hospital and Medical Facilities, DHHS Publication No. (HRA) 14500 Regulations, will be deemed in compliance with any subsequent regulations with the exception of any new renovations or construction, which shall meet the current edition.

(c) A hospital shall meet the edition of the National Fire Protection Association 101, Life Safety Code and all applicable appendices which are currently enforced by the Federal government. Hosptals previously in compliance with prior editions of the Life Safety Code will be deemed in compliance with any subsequent codes with the exception of any new renovation or construction, which shall meet the current edition.

The provisions of this § 153.1 issued under 67 Pa.C.S. § § 6101—6104; and Reorganization Plan No. 2 of 1973 (71 P.S. § 755-2).

The provisions of this § 153.1 amended through January 20, 1984, effective January 21, 1984, 14 Pa.B. 215. Immediately preceding text appears at serial pages (77321) to (77322).

History

Authority: The provisions of this § 153.
Source: The provisions of this § 153.

28 Pa. Code § 153.2 Modifications.

(a) The prescribed standards shall be sections 1 through 7 and sections 9 through 15 of the HHS Requirements except as stated in this section.

(b) The following changes shall be made:

(1) Page iii, under ‘‘Foreword’’: Delete the fourth paragraph.

(2) Pages iv and v: Delete ‘‘Major Additions and Revisions’’ and the 17 items thereunder.

(3) Delete the last sentence in section 1.1.D.

(4) Delete item 2 in section 1.3.

(5) Delete the last two sentences in section 4.3.

(6) Add to section 5.1: ‘‘Marked-up, approved final drawings (or duplicates thereof) showing as-built conditions will be acceptable to this Department. This does not prevent the owner from requiring a redrafted set of as-built drawing as part of the construction contract, if he desires a more formal document.’’

(7) Change section 6.2 as follows:

(i) Add between listing for Standard No. N.F.P.A. 56A and listing for Standard No. 56F the following:

‘‘National Fire Protection Association (N.F.P.A.) Standard No. 56C (Laboratories in Health Related Institutions) sections 7.11F, 7.30D(2)(1).’’

(ii) Change reference to ‘‘Standard No. 101 (1973)’’ to read ‘‘the edition of the National Fire Protection Association 101, Life Safety Code and all applicable appendices which are currently enforced by the Federal government.’’

(8) Add a new section 7.11F, to read as follows:

‘‘Where laboratory facilities are located within the hospital, they shall comply with the requirements of N.F.P.A. 56C.’’

(9) Add, as a new first sentence to section 7.30D(2)(1):

‘‘Laboratories shall comply with N.F.P.A. 56C in addition to the following general and special requirements.’’

‘‘The plans and specifications for construction shall indicate the information for each of the three submission stages as follows:

‘‘(1) First stage—Program and schematics.

‘‘(i) Program or narrative description.

‘‘(A) List in outline form the rooms or spaces to be included in each department, explaining the functions or services to be provided in each, indicating the approximate size, the number of personnel, and the kind of equipment or furniture it will contain. Note any special or unusual services or equipment to be included in the facility.

“(B) For inpatient facilities, submit a schedule showing total number of beds, type of rooms (such as single and two-bed rooms), and distribution of services (such as medicine and surgery).

‘‘(C) Give an outline of construction materials.

‘‘(ii) Schematic plans.

‘‘(A) Single line drawings of each floor shall show the relationship of the various departments or services to each other and the room arrangement in each department. The name of each room shall be noted. The proposed roads and walks, service and entrance courts, parking, and orientation may be shown on either a small plot plan or the first-floor plan. A simple vertical space diagram shall be submitted at this state.

‘‘(B) If the project is an addition or is otherwise related to existing buildings on the site, the plans shall show the facilities and general arrangement of those buildings.

‘‘(2) Second stage—Preliminaries.

‘‘(i) Plans. Preliminary sketch plans shall include the following:

‘‘(A) Architectural.

‘‘(I) Plans of basement, floors, and roof showing space assignment, sizes, and outline of fixed and movable equipment.

‘‘(II) All elevations and typical sections.

‘‘(III) Plot plan showing roads, parking, and sidewalks.

‘‘(IV) Areas and bed capacities by floors.

‘‘(B) Mechanical.

‘‘(I) Single line layouts of all duct and piping systems.

‘‘(II) Riser diagrams for multi-story construction.

‘‘(III) Scale layout of boilers and major associated equipment and central heating, cooling, and ventilating units.

‘‘(C) Electrical.

‘‘(I) Plans showing space assignment, sizes and outline of fixed equipment, such as transformers, main switch and switchboards, and generator sets.

‘‘(II) Simple riser diagram for multi-story building construction, showing arrangement of feeders, subfeeders, bus work, load centers, and branch circuit panels.

‘‘(ii) Outline specifications.

‘‘(A) General description of the construction, including interior finishes, types and locations of acoustical material, and special floor covering.

‘‘(B) Description of the airconditioning, heating, and ventilation systems and their controls; duct and piping systems and dietary, laundry, sterilizing, and other special equipment.

‘‘(C) General description of electrical service including voltage, number of feeders, and whether feeders are overhead or underground.

‘‘(3) Third stage—contract documents.

‘‘(i) Working drawings. Working drawings shall be complete and adequate bid contract, and construction purposes. Drawings shall be prepared for each of the following branches of the work; architectural, structural, mechanical, and electrical. They shall include the following:

‘‘(A) Architectural drawings.

‘‘(I) Approach plan showing all new topography, newly established levels and grades, existing structures, on the site, if any, new buildings and structures; roadways, walks, and the extent of the areas to be seeded. All structures and improvements which are to be removed under the construction contract shall be shown. A print of the site survey drawing shall be included with the working drawings for the information of bidders only. However, the survey drawing need not be made part of the contract documents.

‘‘(II) Plan of each basement, floor, and roof.

‘‘(III) Elevations of each facade.

‘‘(IV) Sections through the building.

‘‘(V) Required scale and full-size details.

‘‘(VI) Schedule of doors and finishes.

‘‘(VII) Location of all fixed equipment. Layout of typical and special rooms indicating all fixed equipment and major items of movable equipment. Equipment not included in the contract shall be so indicated.

‘‘(VIII) Details of construction, size and type of equipment, length and route of travel, machine and control spaces necessary, and utility requirements for:

‘‘conveyors—gravity and power driven; cranes, dumbwaiters—electric, hand, hydraulic; elevators—freight, passenger, patient; hoists—electric, hand, hydraulic, pneumatic; loading dock devices; material handling systems; pneumatic tube systems; and stairs, moving.

‘‘(B) Structural-drawings.

‘‘(I) Plans for foundations, floors, roofs, and all intermediate levels with sizes, sections, and the relative location of the various structural members.

‘‘(II) Schedule of beams, girders, and columns.

‘‘(III) Dimensions of special openings and pipe sleeves.

‘‘(IV) Dimensions between floor levels, column centers, and offsets.

‘‘(V) Details of all special connections, assemblies, and expansion joints.

‘‘(VI) For special structures, a stress sheet showing outline of the structure; all load assumptions; stresses and bending moments separately for each kind of loading; maximum stress or bending, or both, for which each member is designed, when not readily apparent from stresses, and bending moments for each kind of loading; and horizontal and vertical reactions at column bases.

‘‘(C) Mechanical drawings.

‘‘(I) Heating, steam piping, and air-conditioning systems, including:

‘‘radiators and steam heated equipment such as sterilizers, warmers, and steam tables, heating and steam mains and branches with pipe sizes; diagram of heating and steam risers with pipe sizes; sizes, types, and heating, surfaces of boilers, furnaces, with stokers, and oil burners, if any; pumps, tanks, boiler breeching and piping and boiler room accessories; air-conditioning systems with required equipment, water and refrigerant piping, and ducts; supply return and exhaust ventilating systems with steam connections and piping; and air quantities for all room supply return and exhaust ventilating duct openings.

‘‘(II) Plumbing, drainage, and standpipe systems, including:

‘‘Size and elevation of street sewer, house sewer, house drains, street water main, and water service into the building; location and size of soil, waste, and vent stacks with connections to house drains, clean-outs, fixtures, and equipment; size and location of hot, cold, and circulating mains, branches, and risers from the service entrance, and tanks; riser diagram of all plumbing stacks with vents, water risers, and fixture connections; gas, oxygen, and special connections; standpipe and sprinkler systems; and all fixtures and equipment that require water and drain connections.

‘‘(D) Electrical drawings.

‘‘(I) Electric service entrance with switches and feeders to the public service feeders, characteristics of the light and power current, transformers and their connections if located in the building.

‘‘(II) Location of main switchboard, power panels, light panels, and equipment. Diagram of feeders and conduits with schedule of feeder breakers or switches.

‘‘(III) Light outlets, receptacles switches power outlets, and circuits.

‘‘(IV) Telephone layout showing service entrance, telephone switchboard, strip boxes, telephone outlets, and branch conduits.

‘‘(V) Nurses’ call systems with outlets for beds, duty stations, door signal lights, annunciators, and wiring diagrams.

‘‘(VI) Fire alarm system with stations, signal devices, control board, and wiring diagrams.

‘‘(VII) Emergency electrical system with outlets, transfer switch, sources of supply, feeders, and circuits.

‘‘(VIII) All other electrically operated systems and equipment.

‘‘(ii) Specifications. Specifications shall supplement the drawings to fully describe the types, sizes, capacities, workmanship, finishes, and other characteristics of all materials and equipment and shall include the following:

‘‘(A) Cover or title sheet.

‘‘(B) Index.

‘‘(C) Sections describing materials and workmanship in detail for each class of work.

‘‘(D) The following statement with respect to access to the work:

‘‘Representatives of the State agency will have access at all reasonable times to work whenever it is in preparation or progress, and the contractor shall provide proper facilities for such access and inspection.’’

‘‘(4) One copy of the narrative description and one copy of the schematic drawings shall be provided as the first stage submission.

‘‘(5) Three copies each of the plans and specifications shall be provided for both the second and third stage submissions.

‘‘(6) When, after review of the third stage documents by the Department, they are found to comply with the provisions of this section, one set of the final plans will be stamped as approved and returned to the owner. This approval is valid for a period of 18 months. If construction is not started within this 18 month period, a new submission of construction documents is required.’’

The provisions of this § 153.2 issued under 67 Pa.C.S. § § 6101—6104; and Reorganization Plan No. 2 of 1973 (71 P. S. § 755-2).

The provisions of this § 153.2 amended through January 20, 1984, effective January 21, 1984, 14 Pa.B. 215. Immediately preceding text appears at serial pages (77322) and (78038) to (78041).

History

Authority: The provisions of this § 153.
Source: The provisions of this § 153.

28 Pa. Code § 153.3 Applications.

This chapter is not retroactive to the existing facilities except as directed by the Department where the health or safety of patients may be adversely affected.

History

Authority: The provisions of this § 153.
Source: The provisions of this § 153.

28 Pa. Code § 153.4 Approval of plans.

For practical reasons, construction drawings should not be submitted for final approval to the Division of Safety Inspection until a Certificate of Need has been obtained where necessary. Final approval of construction drawings by the Division of Safety Inspection is not to be construed as a Certificate of Need approval.

The provisions of this § 153.4 issued under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)); and section 803 of the Health Care Facilities Act (35 P. S. § 448.803).

The provisions of this § 153.4 adopted December 3, 1982, effective December 4, 1982, 12 Pa.B. 4129.

History

Authority: The provisions of this § 153.
Source: The provisions of this § 153.

Chapter 155 Psychiatric Services

28 Pa. Code § 155.1 Principle.

When a hospital provides psychiatric services, they shall be provided in a manner sufficient to meet the psychiatric needs of the patients. The hospital shall meet the requirements of the Mental Health Procedures Act of 1976 (50 P.S. § § 7101—7503). Inpatient psychiatric services shall be coordinated with psychiatric clinic and partial hospitalization program as appropriate.

History

Authority: The provisions of this Chapter 155 issued under section 2102(g) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 155 adopted December 3, 1982, effective December 4, 1982, 12 Pa.

28 Pa. Code § 155.2 Organization options.

Psychiatric services may be provided in an identified psychiatric unit or in beds dispersed throughout the hospital.

History

Authority: The provisions of this Chapter 155 issued under section 2102(g) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 155 adopted December 3, 1982, effective December 4, 1982, 12 Pa.

28 Pa. Code § 155.3 Director of psychiatric services.

The director of the psychiatric service shall be a member of the medical staff who is certified by the American Board of Psychiatry and Neurology or an equivalent board or who is eligible for board certification or who has successfully completed an approved residency training program in psychiatry.

History

Authority: The provisions of this Chapter 155 issued under section 2102(g) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 155 adopted December 3, 1982, effective December 4, 1982, 12 Pa.

28 Pa. Code § 155.4 Organization and staffing.

Organized psychiatric services within the hospital shall be provided by a qualified staff of adequate size to meet patient needs and under qualified psychiatric direction.

History

Authority: The provisions of this Chapter 155 issued under section 2102(g) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 155 adopted December 3, 1982, effective December 4, 1982, 12 Pa.

28 Pa. Code § 155.5 Personnel.

Psychiatric services such as nursing, psychology, social services, and adjunctive therapies shall be under the direction of persons licensed or registered in their respective fields and employed either full time or part time to implement the patient’s individualized treatment plan. Designated treatment components may be performed insofar as is consistent with law by supportive personnel who have completed an organized training or an on-the-job training program to qualify them for the performance of their duties.

History

Authority: The provisions of this Chapter 155 issued under section 2102(g) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 155 adopted December 3, 1982, effective December 4, 1982, 12 Pa.

28 Pa. Code § 155.6 Nursing services.

(a) Nursing services shall be provided in accordance with Chapter 109 (relating to nursing services) and the provisions of this section.

(b) Psychiatric nursing services shall be under the direction and supervision of a registered nurse qualified by training or experience in psychiatric nursing.

(d) Sufficient number of nursing personnel shall be on duty at all times to provide adequate psychiatric treatment consistent with the individualized treatment plans.

History

Authority: The provisions of this Chapter 155 issued under section 2102(g) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 155 adopted December 3, 1982, effective December 4, 1982, 12 Pa.

28 Pa. Code § 155.7 Therapeutic environment.

(a) There shall be adequate space, facilities, and equipment to meet the needs of the patients for privacy and for group interaction.

(b) Where a quiet room is used, facilities shall provide for the safety and visibility of the patient.

History

Authority: The provisions of this Chapter 155 issued under section 2102(g) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 155 adopted December 3, 1982, effective December 4, 1982, 12 Pa.

28 Pa. Code § 155.8 Policies and procedures.

(a) Written policies and procedures for the psychiatric service shall be developed and revised annually.

(b) Each patient shall have an individualized treatment plan based on the assessment of clinical needs.

(d) Inpatient treatment and aftercare plans shall be developed consistent with patient needs.

(e) In addition to the hospital’s Patients Bill of Rights, the psychiatric service shall conform to the Bill of Rights as described in the Mental Health Procedures Act of 1976 (50 P.S. § § 7101—7503).

(f) Admissions and commitments to the psychiatric service shall be consistent with the provisions of the Mental Health Procedures Act.

(g) Written policies and procedures governing the use of seclusion and restraints shall be developed and revised annually.

(h) Confidentiality shall be assured to each patient receiving treatment.

History

Authority: The provisions of this Chapter 155 issued under section 2102(g) of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 155 adopted December 3, 1982, effective December 4, 1982, 12 Pa.

Chapter 158 Vital Organ Transplantation Services

28 Pa. Code § 158.1 Principle.

Transplantation services shall be performed only in hospitals and shall be performed in accordance with accepted and prevailing standards of medical practice.

This section cited in 28 Pa. Code § 158.31 (relating to kidney transplantation program); 28 Pa. Code § 158.32 (relating to heart transplantation program); 28 Pa. Code § 158.33 (relating to liver transplantation program); 28 Pa. Code § 158.35 (relating to pancreas transplantation programs); and 28 Pa. Code § 158.37 (relating to pediatric transplantation programs).

History

Authority: The provisions of this Chapter 158 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 158 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 158.2 Definitions.

The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise: Board certified—A physician licensed to practice medicine in this Commonwealth who has successfully passed an examination and has maintained certification in the relevant medical specialty area or subspecialty area, or both, recognized by one of the following groups:

(i) The American Board of Medical Specialties.

(ii) The American Osteopathic Association.

(iii) The foreign equivalent of either group listed in subparagraph (i) or (ii). Onsite—In the physical structure at which vital organ transplantation services are being offered or in an adjoining structure. Organ Procurement and Transplantation Network—A private nonprofit entity created under 42 U.S.C.A. § 274 to coordinate organ procurement and allocation for transplants in the United States and whose duties include the establishment of membership and medical criteria for institutions that perform vital organ transplants. Pediatric transplantation program—Describes that program where vital organ transplantation services are provided to all patients under 18 years of age, except for those whose physical development precludes them from being handled as a pediatric patient when receiving transplantations. Preboard certification status—A physician licensed to practice medicine in this Commonwealth who has completed the requirements necessary to take a certification examination offered by a medical specialty board recognized by the American Board of Medical Specialities, the American Osteopathic Association, or the foreign equivalent of either group and who has been eligible to take the examination for no longer than 3 years. Transplantation center—The entire unit of a hospital which is devoted to the provision of vital organ transplantation services. Within a transplantation center, separate programs shall be established for each type of vital organ transplanted. Transplantation program—The offering of a surgical service which involves the transfer of a vital organ from one individual to another. Each type of organ transplantation constitutes a separate transplantation program.

History

Authority: The provisions of this Chapter 158 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 158 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 158.3 Scope.

(a) When a hospital provides transplantation services, it shall make a sufficient commitment of resources and planning to all transplantation services which it provides. This commitment shall be demonstrated as follows:

(1) Commitment of the hospital to the transplantation service shall be present at all levels and broadly evident throughout the facility. This requires a major commitment of resources. These shall include many other departments, as well as the principal sponsoring departments.

(2) The hospital shall have both the expertise and the commitment for participation in medical, surgical and other relevant areas. The hospital shall identify individuals in these areas to achieve an identifiable and stable transplant team.

(3) The component teams shall be integrated into a comprehensive team with clearly defined leadership and corresponding responsibility.

(4) The hospital shall have active medical and surgical programs in the specific areas in which transplantation services are offered.

(5) The commitment to medical staff shall include the elements in § 158.13 (relating to medical staff).

(6) The nursing service shall identify a team trained not only in the support of the patient, but also in the special problems of managing immunosuppressed patients.

(7) Adequate social services resources shall be available.

(8) Mechanisms shall be in place for managing the transplantation program which assures that:

(i) Patient selection criteria are consistent with those set forth in the hospital’s written patient selection criteria.

(ii) The hospital is responsible for the ethical and medical considerations involved in the patient selection process and application of patient selection criteria.

(9) Adequate plans exist for organ procurement which meet legal and ethical criteria.

(b) Each transplantation program shall be a participating member of the Organ Procurement and Transplantation Network and shall comply with its standards, guidelines and bylaws.

This section cited in 28 Pa. Code § 158.31 (relating to kidney transplantation program); 28 Pa. Code § 158.33 (relating to liver transplantation program); 28 Pa. Code § 158.35 (relating to pancreas transplantation programs); and 28 Pa. Code § 158.37 (relating to pediatric transplantation programs).

History

Authority: The provisions of this Chapter 158 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 158 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 158.11 Medical director.

(a) The medical director of the transplantation center shall be an active member of the medical staff who is a qualified transplantation surgeon or transplantation physician and who is either certified by the American Board of Surgery or the American Board of Internal Medicine or an equivalent Board.

(b) An interim director may be appointed during the period of time between the departure of the prior director and the selection of a new director. The interim director shall be a physician who is able to demonstrate qualifications acceptable to the medical staff of the hospital and to the Department. The hospital shall apply to the Department for an exception under the procedures in § § 51.31—51.34 (relating to exceptions). If the exception is granted, the Department will specify the maximum period of time for which the interim director shall be appointed.

This section cited in 28 Pa. Code § 158.31 (relating to kidney transplantation program); 28 Pa. Code § 158.33 (relating to liver transplantation program); 28 Pa. Code § 158.34 (relating to lung and heart/lung transplantation programs); 28 Pa. Code § 158.35 (relating to pancreas transplantation programs); and 28 Pa. Code § 158.37 (relating to pediatric transplantation programs).

History

Authority: The provisions of this Chapter 158 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 158 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 158.12 Transplantation coordinator.

Each transplantation center shall have onsite on a full time basis at least one transplantation coordinator. Transplantation coordinators shall be certified by the American Board of Transplant Coordinators within 2 years of obtaining this position.

History

Authority: The provisions of this Chapter 158 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 158 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 158.13 Medical staff.

(a) Each transplantation program shall have at least one transplantation surgeon and one transplantation physician who are either Board certified or who have attained preboard certification status, members of the hospital’s active medical staff and who meet the requirements established by the Organ Procurement and Transplantation Network to serve in that capacity.

(b) Each transplantation center shall have supporting medical staff to provide necessary services to transplant patients. Required medical staff shall be available at all times and shall include the following:

(1) Nephrology services comprised of at least one nephrologist who is either Board certified or who has attained preboard certification status in nephrology with the American Board of Internal Medicine or an equivalent Board. The nephrologist may also serve as the transplant physician.

(2) Pathology services with a pathologist who is either certified or who has attained preboard certification status with the American Board of Clinical Pathology or an equivalent Board. The pathology service shall be available for studying and reporting promptly the pathological responses to transplantation.

(3) Anesthesiology services with an anesthesiologist who is either certified or who has attained preboard certification status with the American Board of Anesthesiology or an equivalent Board. Anesthesiology shall identify a team for transplantation that is trained in transplant surgery and is available at all times.

(4) Radiology services with a radiologist who is certified by the American Board of Radiology or an equivalent Board. A radiologist shall have 1 year of training or 2 years experience in imaging techniques used in transplantation of the applicable organ and shall be available at all times.

(5) An internist who is certified in infectious diseases by the American Board of Internal Medicine or an equivalent Board and who shall be readily available to transplant patients. The internist shall have both the professional skills and the laboratory resources needed to discover, identify and manage the complications from organisms encountered in transplant patients.

(6) Psychiatric services with a psychiatrist who is either currently certified or who has attained preboard certification status in psychiatry with the American Board of Psychiatry and Neurology or an equivalent Board. The psychiatrist shall be available to meet the psychiatric needs of transplant patients.

This section cited in 28 Pa. Code § 158.3 (relating to scope); 28 Pa. Code § 158.31 (relating to kidney transplantation program); 28 Pa. Code § 158.33 (relating to liver transplantation program); 28 Pa. Code § 158.34 (relating to lung and heart/lung transplantation programs); 28 Pa. Code § 158.35 (relating to pancreas transplantation programs); and 28 Pa. Code § 158.37 (relating to pediatric transplantation programs).

History

Authority: The provisions of this Chapter 158 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 158 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 158.14 Nursing staff; other health care personnel.

(a) Nursing personnel shall include nurses with specialized education which includes theory, advanced technical skills and supervised experience in a surgical intensive care unit or in a postoperative transplantation unit before assuming primary responsibility for the nursing care of transplantation patients.

(b) There shall be nursing service goals and objectives, standards of nursing practice, procedure manuals and written job descriptions for each level of personnel which shall include the following:

(1) A means for assessing the nursing care needs of the patients and determining adequate staffing to meet those needs.

(2) Staffing patterns that are adequate to meet the nursing goals, standards of practice and the needs of the patients.

(3) An adequate number of licensed and unlicensed assistive personnel to assure that staffing levels meet the total nursing needs of the patient.

(4) Nursing personnel assigned to duties consistent with their training, experience and scope of practice, when applicable.

(c) Surgical suite nursing services shall be under the direction and supervision of a registered professional nurse with specific education and experience in dealing with transplantation patients.

(1) A means for assessing the needs of patients and determining adequate staffing to meet those needs.

(2) Staffing patterns that are adequate to meet patient care goals, standards of practice and needs of patients.

(3) An adequate number of licensed and unlicensed health care personnel to assure that staffing levels meet the total needs of patients.

(4) Health care personnel in the transplantation program shall be assigned to duties consistent with their training, experience and scope of practice when applicable.

History

Authority: The provisions of this Chapter 158 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 158 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 158.15 Laboratories.

(a) The transplantation center shall maintain, or by agreement have access to, a tissue typing laboratory with appropriate space and resources to perform required histocompatibility testing and cross matches.

(b) The transplantation center shall maintain, or by agreement have access to, laboratory facilities capable of performing virology, cytology, clinical chemistry, microbiology and monitoring of immunosuppressive drugs.

(c) The transplantation center shall have blood bank support with the capacity to supply blood components for the number of transplants that are projected, the ability to irradiate blood components and the availability of a blood separator and central blood repository.

History

Authority: The provisions of this Chapter 158 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 158 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 158.16 Support services.

(a) The transplantation center shall maintain, or by agreement have access to, a rehabilitation center which can provide physical rehabilitation, psychological services and vocational and occupational therapy.

(b) The transplantation center shall maintain, or by agreement have access to, the social support services necessary for the care of transplant recipients and for the assistance to families coping with the transplant experience.

(c) The transplantation center shall maintain a service for counseling recipients which is directed to their particular needs and problems. Additionally, as appropriate, the transplantation service shall provide counseling to donors and to their relatives.

(d) The transplantation center shall maintain the following facilities:

(1) Adequately equipped operating rooms.

(2) Adequate equipment and supplies.

(3) Intensive care facilities capable of maintaining transplant patients.

(4) Facilities for acute hemodialysis.

History

Authority: The provisions of this Chapter 158 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 158 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 158.17 Selection criteria.

(a) The transplantation program shall have written procedures for selecting transplantation candidates and distributing organs in a fair and equitable manner. Selection criteria shall comply with the National Organ Procurement and Transplantation Network organ allocation priorities and shall be based on objective medical criteria and time on a waiting list.

(b) The transplantation program shall have written policies in place to assure that:

(1) Patient selection decisions are consistent with criteria set forth in the written patient selection criteria.

(2) The transplantation program is responsible for ethical and medical considerations in the patient selection process.

History

Authority: The provisions of this Chapter 158 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 158 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 158.18 Referrals, hours of operation.

(a) The transplantation center shall accept referrals from all physicians.

(b) Transplantation services shall be accessible 24- hours-a-day, 7-days-a-week.

History

Authority: The provisions of this Chapter 158 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 158 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 158.19 Volume of procedures.

(a) Each transplantation program shall perform an adequate number of procedures to maximize quality.

(b) Each transplantation program shall meet the expected survival rate as set forth by the Organ Procurement and Transplantation Network in its bylaws. Those programs whose actual survival rates fall below their expected survival rates will be reviewed by the Department to determine if this deviation can be accounted for by patient mix or some other unique clinical aspect of the transplantation program.

(c) If the transplantation program is unable to provide an explanation for its failure to meet the expected survival rate, the Department will undertake a review of that program to determine if it is in compliance with the criteria in this chapter. The hospital shall cooperate with the Department in this review.

History

Authority: The provisions of this Chapter 158 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 158 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 158.20 Post-transplantation care.

(a) The transplantation center shall maintain a program for continuing patient follow-up care throughout the recipient’s life.

(b) This program shall include the following:

(1) A system for referring physicians that integrates patient referral and continued patient supervision.

(2) The interchange of medical and other information necessary in the care and treatment of patients transferred between physicians responsible for patient care and the transplantation surgery.

(3) The provisions of a discharge plan to the referring physician.

(4) An obligation to follow the patient at appropriate intervals to assess the outcome of the transplant and to provide consultative care as necessary.

History

Authority: The provisions of this Chapter 158 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 158 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 158.31 Kidney transplantation program.

(a) The general standards in § § 158.1—158.19 apply to kidney transplantation programs. Additionally, the criteria contained in this section apply only to kidney transplantation programs.

(b) A kidney transplantation program shall have overall plans and resources to assure a reasonable concentration of experience.

(c) A kidney transplantation program shall participate in and be certified by the Federal ESRD (End Stage Renal Disease) (Medicare) program and as an ESRD center.

(d) A hospital which has a kidney transplantation program shall have a Division of Urology comprised of at least one urologist who is either certified by or who has attained preboard certification status with the American Board of Urology or an equivalent Board. The urologist shall be available to act as a consultant when appropriate for the preoperative, operative and postoperative surgical evaluation and management of transplant patients and living donors.

(e) In addition to dialysis facilities for acute hemodialysis, a kidney transplantation program shall be capable of providing peritoneal dialysis.

This section cited in 28 Pa. Code § 158.37 (relating to pediatric transplantation programs).

History

Authority: The provisions of this Chapter 158 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 158 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 158.32 Heart transplantation program.

(a) The general standards in § § 158.1—158.19 apply to heart transplantation programs. Additionally, the criteria contained in this section apply only to heart transplantation programs.

(b) A heart transplantation program shall have overall plans and resources to assure a reasonable concentration of experience.

(c) A heart transplantation program shall have on staff and available at all times a cardiologist and a pulmonologist both of whom are either certified by or have attained preboard certification status with the respective appropriate American Board or an equivalent Board. Either of these specialists may also serve as the transplant physician.

(d) The hospital shall have a cardiac catheterization service which meets all of the regulatory requirements for this service. The cardiac catheterization laboratory shall be available to perform these procedures on an emergency basis.

(e) The hospital shall have an open heart surgery program and shall meet all of the regulatory requirements for this service.

(f) The hospital shall meet the following conditions:

(1) Possess expertise in other relevant areas including cardiology, cardiovascular surgery and pulmonary diseases.

(2) Identify individuals in these areas to achieve a stable transplant team.

This section cited in 28 Pa. Code § 158.37 (relating to pediatric transplantation programs).

History

Authority: The provisions of this Chapter 158 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 158 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 158.33 Liver transplantation program.

(a) The general standards in § § 158.1—158.19 apply to liver transplantation programs. Additionally, the criteria contained in this section apply only to liver transplantation programs.

(b) A liver transplantation program shall have overall plans and resources to assure a reasonable concentration of experience.

(c) A hospital shall have on staff and available a gastroenterologist who is either certified by or who has attained preboard certification status with the American Board of Gastroenterology or an equivalent Board. The gastroenterologist shall have at least 2 years experience in hepatology. The gastroenterologist may also serve as the transplant physician.

(d) The pathologist shall be specifically trained in liver pathology.

This section cited in 28 Pa. Code § 158.37 (relating to pediatric transplantation programs).

History

Authority: The provisions of this Chapter 158 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 158 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 158.34 Lung and heart/lung transplantation programs.

(a) The general standards in § § 158.11—158.19 apply to lung and heart/lung transplantation programs. Additionally, the criteria contained in this section apply only to lung and heart/lung transplantation programs.

(b) A lung or heart/lung transplantation program shall have overall plans and resources to assure a reasonable concentration of experience.

(c) A lung or heart/lung transplantation program shall have on staff and available a cardiologist and a pulmonologist who are either certified by or who have attained preboard certification status with the respective appropriate American Board or equivalent Board. Either of these specialists may also serve as the transplant physician.

(e) The hospital shall have an open heart surgery program and shall meet all of the regulatory requirements for this service.

This section cited in 28 Pa. Code § 158.37 (relating to pediatric transplantation programs).

History

Authority: The provisions of this Chapter 158 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 158 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 158.35 Pancreas transplantation programs.

(a) The general standards in § § 158.1—158.19 apply to pancreas transplantation programs. Additionally, the criteria contained in this section applies only to pancreas transplantation programs.

(b) A pancreas transplantation program shall have overall plans and resources to assure a reasonable concentration of experience.

(c) A hospital in which a pancreas transplantation program performs combined kidney/pancreas transplants or sequential kidney and pancreas or sequential pancreas and kidney transplants shall have an active kidney transplantation program.

(d) A hospital which has a pancreas transplantation program shall have a division of endocrinology comprised of at least one endocrinologist currently certified by the American Board of Endocrinology or an equivalent Board. If the endocrinologist serves as the transplant physician, then the endocrinologist shall have at least 1 year of training or 2 years experience in the care of transplant patients.

This section cited in 28 Pa. Code § 158.37 (relating to pediatric transplantation programs).

History

Authority: The provisions of this Chapter 158 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 158 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 158.36 Other organs.

A facility proposing to establish a program for transplant of an organ other than kidney, heart, liver, lung, heart/lung or pancreas shall:

(1) Comply with the general criteria contained in this chapter.

(2) Comply with Organ Procurement Transplant Network criteria applicable to the specific organ.

This section cited in 28 Pa. Code § 158.37 (relating to pediatric transplantation programs).

History

Authority: The provisions of this Chapter 158 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 158 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

28 Pa. Code § 158.37 Pediatric transplantation programs.

(a) A transplantation center that provides a transplantation program to pediatric patients shall do the following:

(1) Follow the general criteria for transplantation centers and programs in § § 158.1—158.19.

(2) Follow the supplementary criteria for the applicable organ transplantation program in § § 158.31—158.36.

(3) Follow the criteria in this section in the treatment of pediatric patients.

(b) In those instances where criteria for pediatric transplantation programs differs from supplementary criteria for organ specific transplants, transplantation centers providing services to both adult and to pediatric patients are required to fulfill both the supplementary criteria for the specific organ and the following pediatric transplant criteria. Transplantation centers providing programs exclusively to pediatric patients need only meet the criteria for pediatric transplantation programs.

(c) Those transplantation centers which are exclusively pediatric shall have overall plans and resources to assure a reasonable concentration of experience.

(d) Transplantation centers providing services to pediatric patients shall have on staff and available the following specialists who shall be either certified by or have attained preboard certification status with the appropriate subspecialty board of the American Board of Pediatrics or an equivalent Board:

(1) Pediatric transplantation programs shall have on staff: a pediatric nephrologist, a pediatric infectious disease specialist and a pediatric internist.

(2) Pediatric liver transplantation programs shall have on staff: a pediatric gastroenterologist and a pediatric pulmonologist.

(3) Pediatric heart, lung and combined heart/lung transplantation programs shall have on staff: a pediatric pulmonologist, a pediatric cardiologist and a pediatric cardiac surgeon.

(4) Pediatric pancreas transplantation programs shall have on staff a pediatric endocrinologist.

(e) Transplantation centers providing services to pediatric patients shall have on staff and available the following personnel who are certified or qualified, or both, as follows:

(1) An anesthesiologist who is either certified by or who has attained preboard certification status with the American Board of Anesthesiology or an equivalent Board and has 2 years of experience providing anesthesiology services to pediatric patients.

(2) A dietitian who is registered by the American Dietetic Association or who is a feeding specialist and who has 2 years of experience providing dietetic services to pediatric patients.

(3) A radiologist who is either certified by or who has attained preboard certification status with the American Board of Radiology or an equivalent Board and who has 2 years of experience providing radiology services to pediatric patients.

(4) A physical therapist who has 2 years experience providing services to pediatric patients.

(5) A psychiatrist who is either certified by or who has attained preboard certification status with the American Board of Child Psychiatry or an equivalent Board.

(6) A social worker who has 1 year of experience providing social services to pediatric patients.

(7) A nursing staff that is experienced in providing nursing services to pediatric patients and is of a sufficient complement to meet nursing care goals, standards of nursing practice and nursing care needs of pediatric patients.

(8) An occupational therapist who is registered with the American Occupational Therapy Association and who has 1 year of experience in treating pediatric patients.

(f) A pediatric heart transplantation center shall have cardiac catheterization and open heart surgical services which meet all of the regulatory requirements for pediatric patients.

(g) A pediatric program which provides kidney transplantation services to pediatric patients shall have on staff and available a urologist who is either certified by or who has attained preboard certification status with the American Board of Urology or an equivalent Board and who has 2 years experience providing urology services to pediatric patients.

(h) Transplantation centers that provide transplantation programs to pediatric patients shall have appropriate equipment available to provide the following services to pediatric patients:

(1) Dialysis.

(2) Anesthesia.

(3) Intensive care.

(4) Operating room.

History

Authority: The provisions of this Chapter 158 issued under section 803(2) of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 158 adopted June 5, 1998, effective June 6, 1998, 28 Pa.

Subpart C Long-Term Care Facilities

Chapter 201 Applicability, Definitions, Ownership and General Operation of Long-Term Care Nursing Facilities

28 Pa. Code § 201.1 Applicability.

This subpart applies to long-term care nursing facilities as defined in section 802.1 of the act (35 P.S. § 448.802a).

The provisions of this § 201.1 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 201.1 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended February 11, 1977, effective February 12, 1977, 7 Pa.B. 437; amended April 23, 1982, effective April 24, 1982, 12 Pa.B. 1316; amended January 30, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8043. Immediately preceding text appears at serial page (412134).

History

Authority: The provisions of this § 201.
Source: The provisions of this Chapter 201 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 201.2 Requirements.

(a) The Department incorporates by reference 42 CFR Part 483, Subpart B of the Federal requirements for long-term care facilities, (relating to requirements for long-term care facilities), as licensing regulations for long-term care nursing facilities, with the exception of 42 CFR 483.1 (relating to basis and scope) and the requirements under 42 CFR Part 483 Subpart B for the transmission of data and minimum data set (MDS) reporting to the Centers for Medicare & Medicaid Services (CMS) unless the facility is participating in the Medicare or Medical Assistance Program.

(b) A facility may apply for an exception to the requirements of this subpart under § § 51.31—51.34 (relating to exceptions).

The provisions of this § 201.2 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 201.2 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended July 6, 1979, effective July 7, 1979, 9 Pa.B. 2252; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8043. Immediately preceding text appears at serial pages (412134) and (258313).

History

Authority: The provisions of this § 201.
Source: The provisions of this Chapter 201 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 201.3 Definitions.

The following words and terms, when used in this subpart, have the following meanings, unless the context clearly indicates otherwise: Abuse—As defined in 42 CFR 483.5 (relating to definitions). Act—The Health Care Facilities Act (35 P.S. § § 448.101—448.904b). Administration of medication—The giving of a dose of medication to a resident as a result of an order of a practitioner licensed by the Commonwealth to prescribe medications. Administrator—As defined in 42 CFR 483.70(d)(2) (relating to administration). The administrator shall be currently licensed and registered by the Department of State under the Nursing Home Administrators License Act (63 P.S. § § 1101—1114.2). Authorized person to administer medications—Persons qualified to administer medications in facilities are as follows:

(i) Physicians and dentists who are currently licensed by the Bureau of Professional and Occupational Affairs, Department of State.

(ii) Registered nurses who are currently licensed by the Bureau of Professional and Occupational Affairs, Department of State.

(iii) Practical nurses who have successfully passed the State Board of Nursing examination.

(iv) Practical nurses licensed by waiver in this Commonwealth who have successfully passed the United States Public Health Service Proficiency Examination.

(v) Practical nurses licensed by waiver in this Commonwealth who have successfully passed a medication course approved by the State Board of Nursing.

(vi) Student nurses of approved nursing programs who are functioning under the direct supervision of a member of the school faculty who is present in the facility.

(vii) Recent graduates of approved nursing programs who possess valid temporary practice permits and who are functioning under the direct supervision of a professional nurse who is present in the facility. The permits shall expire if the holders of the permits fail the licensing examinations.

(viii) Physician assistants and registered nurse practitioners who are certified by the Bureau of Professional and Occupational Affairs. Basement—A story or floor level below the main or street floor. If, due to grade differences, there are two levels qualifying as a street floor, a basement is a floor below the lower of the two street floors. CRNP—certified registered nurse practitioner—A registered nurse licensed in this Commonwealth who is certified by the State Board of Nursing and the State Board of Medicine as a CRNP, under The Professional Nursing Law (63 P.S. § § 211—225) and the Medical Practice Act of 1985 (63 P.S. § § 422.1—422.45). Charge nurse—A person designated by the facility who is experienced in nursing service administration and supervision and in areas such as rehabilitative or geriatric nursing or who acquires the preparation through formal staff development programs and who is licensed by the Commonwealth as one of the following:

(i) An RN.

(ii) An RN licensed by another state as an RN and who has applied for endorsement from the State Board of Nursing and has received written notice that the application has been received by the State Board of Nursing. This subparagraph applies for 1 year, or until Commonwealth licensure is completed, whichever period is shorter.

(iii) [Reserved].

(iv) An LPN designated by the facility as a charge nurse on the night tour of duty in a facility with a census of 59 or less in accordance with § 211.12 (relating to nursing services). Clinical laboratory—As defined in 42 U.S.C.A. § 263a(a). Construction, alteration or renovation—The erection, building, remodeling, modernization, improvement, extension or expansion of a facility, or the conversion of a building or portion thereof to a facility. The term does not include part-for-part replacement or regular facility maintenance. Controlled substance—A drug, substance or immediate precursor included in Schedules I—V of the Controlled Substance, Drug, Device and Cosmetic Act (35 P.S. § § 780-101—780-144). Corridor—A passageway, hallway or other common avenue used by residents and personnel to travel between buildings or sections of the same building to reach a common exit or service area. The service area includes, but is not limited to, living room, kitchen, bathroom, therapy rooms and storage areas not immediately adjoining the resident’s sleeping quarters. Department—The Department of Health of the Commonwealth. Director of nursing services—An RN designated by a facility under 42 CFR 483.35(b)(2) (relating to nursing services) and has 1 year of experience or education in nursing service administration and supervision, as well as additional education or experience in areas such as rehabilitative or geriatric nursing, and participates annually in continuing nursing education. Discharge—The movement of a resident from a bed in one certified facility to a bed in another certified facility or other location in the community, when return to the original facility is not expected. Elopement—When a resident leaves the premises or a safe area without authorization. Exit or exitway—A means of egress which is lighted and has three components: an exit access (corridor leading to the exit), an exit (a door) and an exit discharge (door to the street or public way). Exploitation—As defined in 42 CFR 483.5. Facility—A licensed long-term care nursing facility as defined in Chapter 8 of the act (35 P.S. § § 448.801—448.821). Full-time—A minimum of a 35-hour work week. Full compliance—Means total compliance. Health care practitioner—As defined in section 103 of the act (35 P.S. § 448.103). Interdisciplinary team—As defined in 42 CFR 483.21(b)(2)(ii) (relating to comprehensive person-centered care planning). Intimidation—As defined in section 3 of the Older Adults Protective Services Act (35 P.S. § 10225.103). Involuntary seclusion—Separation of a resident from other residents or from the resident’s room or confinement with or without roommates against the resident’s will, or the will of the resident’s representative, excluding emergency or short term monitored separation from other residents for a limited period of time as a therapeutic intervention to reduce agitation until professional staff can develop a plan of care to meet the resident’s needs. LPN—licensed practical nurse—A practical nurse licensed to practice under the Practical Nurse Law (63 P.S. § § 651—667.8) and the regulations of the State Board of Nursing in 49 Pa. Code Chapter 21, Subchapter B (relating to practical nurses). Licensee—The individual, partnership, association or corporate entity including a public agency or religious or fraternal or philanthropic organization authorized to operate a licensed facility. Long-term care ombudsman—An individual at the State or local level who is responsible for carrying out the duties and functions under section 3058g of the State Long-Term Care Ombudsman Program (42 U.S.C.A. § 3058g). Medication—A substance meeting one of the following qualifications:

(i) Is recognized in the official United States pharmacopeia, or official National formulary or a supplement to either of them.

(ii) Is intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals.

(iii) Is other than food and intended to affect the structure or a function of the human body or other animal body.

(iv) Is intended for use as a component of an article specified in subparagraphs (i), (ii) or (iii), but not including devices or their components, parts or accessories. Medication administration—An act in which a single dose of a prescribed medication or biological is given to a resident by an authorized person in accordance with statutes and regulations governing the act. The complete act of administration entails removing an individual dose from a previously dispensed, properly labeled container, verifying it with the physician’s orders, giving the individual dose to the proper resident and promptly recording the time and dose given. Medication dispensing—An act by a practitioner or a person who is licensed in this Commonwealth to dispense medications under the Pharmacy Act (63 P.S. § § 390-1—390-13) entailing the interpretation of an order for a medication or biological and, under that order, the proper selecting, measuring, labeling, packaging and issuance of the medication or biological for a resident or for a service unit of the facility. Mental abuse—Includes humiliation, harassment, threats of punishment or deprivation. Misappropriation of resident property—As defined in 42 CFR 483.5. Mistreatment—As defined in 42 CFR 483.5. NFPA—National Fire Protection Association. Neglect—As defined in 42 CFR 483.5. Non-prescription medication—An over-the-counter medication legally purchased without a prescription. Nurse aide—An individual, as defined in 42 CFR 483.5, providing nursing or nursing-related services to residents in a facility who:

(i) Does not have a license to practice professional or practical nursing in this Commonwealth.

(ii) Does not volunteer services for no pay.

(iii) Has met the requisite training and competency evaluation requirements as defined in 42 CFR 483.35 (relating to nursing services).

(iv) Appears on the Commonwealth’s Nurse Aide Registry.

(v) Has no substantiated findings of abuse, neglect or misappropriation of resident property recorded in the Nurse Aide Registry. Nursing care—A planned program to meet the physical and emotional needs of the resident. The term includes procedures that require nursing skills and techniques applied by properly trained personnel. Nursing service personnel—Registered nurses, licensed practical nurses and nurse aides. Person—As defined in section 103 of the act. Pharmacist—A person licensed by the State Board of Pharmacy to engage in the practice of pharmacy. Pharmacy—A place properly licensed by the State Board of Pharmacy where the practice of pharmacy is conducted. Physical abuse—Includes hitting, slapping, pinching and kicking. The term also includes controlling behavior through corporal punishment. Physician assistant—An individual certified as a physician assistant by the State Board of Medicine under the Medical Practice Act of 1985, or by the State Board of Osteopathic Medical Examiners under the Osteopathic Medical Practice Act (63 P.S. § § 271.1—271.18). Practitioner—A health care practitioner as defined in section 103 of the act. Prescription—A written or verbal order for medications issued by a health care practitioner in the course of professional practice. Qualified dietician—As defined in 42 CFR 483.60(a)(1) (relating to food and nutrition services). Qualified social worker—As defined in 42 CFR 483.70(p). Qualified therapeutic recreation specialist—As defined in 42 CFR 483.24(c) (relating to quality of life). RN—registered nurse—An individual licensed to practice professional nursing under The Professional Nursing Law and the regulations of the State Board of Nursing in 49 Pa. Code Chapter 21, Subchapter A (relating to registered nurses). Resident—A person who is admitted to a licensed long-term care nursing facility for observation, treatment or care for illness, disease, injury or other disability. Resident representative—As defined in 42 CFR 483.5. Restraint—A restraint can be physical or chemical.

(i) A physical restraint includes any manual method, physical or mechanical device, equipment or material that is attached or adjacent to the resident’s body, cannot be removed easily by the resident, and restricts the resident’s freedom of movement or normal access to the resident’s body.

(ii) A chemical restraint includes any medication that is used for discipline or convenience and not required to treat medical symptoms. Serious bodily injury—As defined in section 3 of the Older Adults Protective Services Act. Serious physical injury—As defined in section 3 of the Older Adults Protective Services Act. Sexual abuse—Non-consensual contact of any type with a resident, including sexual harassment, sexual coercion or sexual assault. Substantial compliance—

(i) cited deficiencies are, individually and in combined effect, of a minor nature such that neither the deficiencies nor efforts toward their correction will interfere with or adversely affect normal facility operations or adversely affect any resident’s health or safety; and

(ii) the facility has implemented a plan of correction approved by the Department. Transfer—The movement of a resident from a bed in one certified facility to a bed in another certified facility when the resident expects to return to the original facility. Verbal abuse—Use of oral, written or gestured language that willfully includes disparaging and derogatory terms to residents or their families, or within their hearing distance, regardless of their age, ability to comprehend or disability. Examples of verbal abuse include:

(i) Threats of harm.

(ii) Saying things to frighten a resident, such as telling a resident that the resident will never be able to see the resident’s family again.

The provisions of this § 201.3 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 201.3 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended October 1, 1976, effective October 2, 1976, 6 Pa.B. 2441; amended February 11, 1977, effective February 12, 1977, 7 Pa.B. 437; amended May 6, 1977, effective May 7, 1977, 7 Pa.B. 1236; amended May 26, 1978, effective May 27, 1978, 8 Pa.B. 1466; amended July 6, 1979, effective July 7, 1979, 9 Pa.B. 2252; amended April 23, 1982, effective April 24, 1982, 12 Pa.B. 1316; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; corrected June 19, 1987, 17 Pa.B. 2462; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8043. Immediately preceding text appears at serial pages (258315) to (258322) and (412135).

This section cited in 28 Pa. Code § 211.9 (relating to pharmacy services).

History

Authority: The provisions of this § 201.
Source: The provisions of this Chapter 201 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 201.11 Types of ownership.

The owner of a facility may be an individual, a partnership, an association, a corporation or combination thereof.

The provisions of this § 201.11 amended under section 803 of the Health Care Facilities Act (35 P.S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)).

The provisions of this § 201.11 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial page (202317).

History

Authority: The provisions of this § 201.
Source: The provisions of this Chapter 201 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 201.12 Application for license of a new facility or change in ownership.

(a) [Reserved].

(a.1) A person may not operate or assume ownership of a facility without first obtaining a license from the Department.

(a.2) A prospective licensee of a facility shall obtain an application form from the Division of Nursing Care Facilities, Department of Health.

(b) In addition to the completed application and fee required under section 807 of the act (35 P.S. § 448.807), a prospective licensee of a facility shall submit the following:

(1) The names, addresses, e-mail addresses and phone numbers of any person who meets any of the following:

(i) Has or will have a direct or indirect ownership interest of 5% or more in the facility.

(ii) Holds or will hold the license or ownership interest in the land on which the facility is located or the building in which the facility is located.

(iii) Owns or will own a whole or part interest in any mortgage, deed, trust, note or other long-term liability secured in whole or in part by the equipment used in the facility, the land on which the facility is located or the building in which the facility is located.

(2) If a person identified in paragraph (1) is a nonprofit corporation, a complete list of the names, addresses, e-mail addresses and phone numbers of the officers and directors of the corporation and an exact copy of its charter and articles of incorporation which are on file with the Department of State as well as amendments or changes.

(3) If a person identified in paragraph (1) is a partnership, the names, addresses, e-mail addresses and phone numbers of partners.

(4) The name, address, e-mail address, phone number and license number of the administrator.

(5) The names, addresses, e-mail addresses and phone numbers of any persons who have or will have an interest in the management of the facility.

(6) The names, addresses, e-mail addresses and phone numbers of the facility’s officers and members of the board of directors.

(7) The names, addresses, e-mail addresses and phone numbers of the following:

(i) A parent company.

(ii) A shareholder.

(iii) A related party of the persons identified in paragraphs (1) through (6).

(8) An annual financial report which shall include the following:

(i) Audited financial statements prepared in accordance with generally accepted accounting principles (GAAP). If GAAP requires consolidated financial statements, then consolidated statements shall be provided.

(ii) A visual representation of the current ownership structure, which must include parent companies, shareholders and any related parties of the persons identified in paragraphs (1) through (6).

(iii) A supplemental schedule of annual gross revenues, prepared in accordance with GAAP. The supplemental schedule shall be broken out by payor type.

(9) A list of every licensed long-term care nursing facility in any state, the District of Columbia or territory in which the prospective licensee has or has had a direct or indirect interest of 5% or more in the ownership, management or real property.

(10) The prospective licensee’s licensing and regulatory history in all jurisdictions where the prospective licensee has or has had a direct or indirect ownership interest of 5% or more in a facility.

(11) A detailed summary of adjudicated or settled civil actions or criminal actions filed against the prospective licensee.

(12) A list of any persons, identified in paragraph (1), who have experienced financial distress that resulted in a bankruptcy, receivership, assignment, debt consolidation or restructuring, mortgage foreclosure, corporate integrity agreement, or sale or closure of a long-term care nursing facility, the land it sits on or the building in which it is located.

(13) Identification of whether an immediate family member relationship exists between a prospective licensee, a person under paragraph (1) and a person under paragraph (7).

(14) Additional information the Department may require.

(c) For the purposes of subsection (B), a ‘‘related party’’ is a person that provides a service, facility or supply to a long-term care nursing facility or that is under common ownership or control, as defined in 42 CFR 413.17(b) (relating to cost to related organizations). The term includes the following:

(1) A home office.

(2) A management organization.

(3) An owner of real estate.

(4) An entity that provides staffing, therapy, pharmaceutical, marketing, administrative management, consulting, insurance or similar services.

(5) A provider of supplies and equipment.

(6) A financial advisor or consultant.

(7) A banking or financial entity.

(8) A parent company, holding company or sister organization.

(d) For the purposes of subsection (b), an ‘‘immediate family member’’ includes a spouse, biological parent, biological child, sibling, adopted child, adoptive parent, stepparent, stepchild, stepsibling, father-in-law, mother-in-law, sister-in-law, brother-in-law, son-in-law, daughter-in-law, grandparent or grandchild.

(e) In addition to the information required under subsection (b), a prospective licensee of a facility shall provide all of the following:

(1) A proposed staffing and hiring plan, which shall include the management and oversight staff, the structure of the facility’s governing body and its participants.

(2) A proposed training plan for staff.

(3) A proposed emergency preparedness plan that meets the requirements of 42 CFR 483.73(a) (relating to emergency preparedness).

(4) Proposed standard admissions agreements.

(5) A detailed budget for 3 years of operations, prepared in accordance with GAAP, and evidence of access to sufficient capital needed to operate the facility in accordance with the budget and the facility assessment conducted under 42 CFR 483.70(e) (relating to administration).

(f) A prospective licensee who fails, under this section, to demonstrate capacity to operate a facility, will be given 30 days from the date of the denial of an application to cure the application. A prospective licensee will be permitted one opportunity, under this subsection, in which to cure the application.

The provisions of this § 201.12 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 201.12 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; reserved April 23, 1982, effective April 24, 1982, 12 Pa.B. 1316; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective October 31, 2023, 52 Pa.B. 8163. Immediately preceding text appears at serial pages (412135) to (412136).

This section cited in 28 Pa. Code § 201.12a (relating to notice and opportunity to comment); 28 Pa. Code § 201.12b (relating to evaluation of application for license of a new facility or change in ownership); and 28 Pa. Code § 201.18 (relating to management).

History

Authority: The provisions of this § 201.
Source: The provisions of this Chapter 201 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 201.12a Notice and opportunity to comment.

(a) In addition to the requirements in § 201.12 (relating to application for license of a new facility or change in ownership), a prospective licensee of a new facility shall concurrently provide written notice to the Office of the State Long-Term Care Ombudsman when the prospective licensee submits its application.

(b) In addition to the requirements in § 201.12, a prospective licensee for a change in ownership of a facility shall concurrently provide written notice to all of the following:

(1) Residents of the facility being purchased or acquired, and their resident representatives.

(2) Employees of the facility being purchased or acquired.

(3) The Office of the State Long-Term Care Ombudsman.

(1) The name and address of the facility.

(2) The name and address of the prospective licensee.

(3) The contact information for the State Long-Term Care Ombudsman.

(4) A statement that an application for licensure has been submitted to the Department and more information regarding the application, including the ability to comment, may be found on the Department’s web site.

(d) The Department will post notice of the receipt of an application for license of a new facility or change in ownership and a copy of the completed application form submitted under § 201.12 on the department’s web site and provide a 10-day public comment period.

The provisions of this § 201.12a added under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 201.12a added December 23, 2022, subsections (a)—(c)(3) are effective July 1, 2023, subsections (c)(4) and (d) are effective October 31, 2023, 52 Pa.B. 8163.

History

Authority: The provisions of this § 201.
Source: The provisions of this Chapter 201 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 201.12b Evaluation of application for license of a new facility or change in ownership.

(a) The Department will conduct an evaluation of the application, which will include consideration of the application form and documents submitted under § 201.12 (relating to application for license of a new facility or change in ownership) and comments submitted under § 201.12a(d) (relating to notice and opportunity to comment).

(b) Upon completion of the evaluation conducted under subsection (a), the Department will approve or deny the application and post notice of the approval or denial of the application on the Department’s web site.

(1) The prospective licensee’s past performance related to owning or operating a facility in this Commonwealth or other jurisdictions.

(2) The prospective licensee’s demonstrated financial and organizational capacity and capability to successfully perform the requirements of operating a facility based on the information provided under § 201.12.

(3) The prospective licensee’s demonstrated history and experience with regulatory compliance, including evidence of consistent performance in delivering quality care.

(4) Comments submitted under § 201.12a(d).

The provisions of this § 201.12b added under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 201.12b added December 23, 2022, subsections (a), (d) and (e) are effective July 1, 2023, subsections (b) and (c) are effective October 31, 2023, 52 Pa.B. 8163.

This section cited in 28 Pa. Code § 201.12b (relating to evaluation of application for license of a new facility or change in ownership).

History

Authority: The provisions of this § 201.
Source: The provisions of this Chapter 201 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 201.13 Issuance of license for a new facility or change in ownership.

(a) [Reserved].

(b) A license to operate a facility will be issued when the Department has determined that the necessary requirements for licensure have been met under this part.

(d) The license will be issued to the owner of a facility and will indicate the name and address of the facility, the name and address of the owner of the facility, the number of beds authorized and the date of the valid license.

(e) [Reserved].

(f) [Reserved].

(g) [Reserved].

(h) [Reserved].

(i) [Reserved].

The provisions of this § 201.13 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 201.13 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended February 11, 1977, effective February 12, 1977, 7 Pa.B. 437; amended April 23, 1982, effective April 24, 1982, 12 Pa.B. 1316; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8163. Immediately preceding text appears at serial pages (412136) to (412137) and (336939).

History

Authority: The provisions of this § 201.
Source: The provisions of this Chapter 201 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 201.13a Regular license.

The Department will issue a regular 1-year license when the facility is in full compliance with section 808 of the act (35 P.S. § 448.808) and is in full or substantial compliance with the provisions of this subpart.

The provisions of this § 201.13a added under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 201.13a added December 23, 2022, effective July 1, 2023, 52 Pa.B. 8163.

History

Authority: The provisions of this § 201.
Source: The provisions of this Chapter 201 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 201.13b Provisional license.

(a) Under section 812 of the act (35 P.S. § 448.812), the Department may issue a provisional license if there are numerous deficiencies or a serious specific deficiency and the facility is not in substantial compliance with this subpart and the Department finds that:

(1) The facility is taking appropriate steps to correct the deficiencies in accordance with a timetable submitted by the facility and agreed upon by the Department.

(2) There is no cyclical pattern of deficiencies over a period of 2 or more years.

(b) A provisional license will be issued for a specified time period of no more than 6 months.

(c) Upon a determination of substantial compliance, including the payment of any fines and fees, a regular license will be issued.

The provisions of this § 201.13b added under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 201.13b added December 23, 2022, effective July 1, 2023, 52 Pa.B. 8163.

This section cited in 28 Pa. Code § 201.13c (relating to license renewal).

History

Authority: The provisions of this § 201.
Source: The provisions of this Chapter 201 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 201.13c License renewal.

(a) A facility shall apply to renew its license on a form prescribed by the Department with the fee required under section 807(b) of the act (35 P.S. § 448.807(b)).

(b) In addition to the application form and fee under subsection (a), a facility shall submit an updated annual financial report that meets the requirements set forth in § 201.12(b)(8) (relating to application for license of a new facility or change in ownership).

(c) A facility shall file an application to renew its license and the updated financial report at least 21 days before the expiration of the current license, unless otherwise directed by the Department.

(d) The Department will renew a regular 1-year license under this section if the facility is in full compliance with section 808 of the act (35 P.S. § 448.808) and is in full or substantial compliance with the provisions of this subpart.

(e) A provisional license issued in accordance with section 812 of the act (35 P.S. § 448.812) and § 201.13b (relating to provisional license) may be renewed, no more than three times at the discretion of the Department.

The provisions of this § 201.13c added under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 201.13c added December 23, 2022, subsections (a), (d) and (e) are effective July 1, 2023, subsections (b) and (c) are effective October 31, 2023, 52 Pa.B. 8163.

History

Authority: The provisions of this § 201.
Source: The provisions of this Chapter 201 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 201.14 Responsibility of licensee.

(a) The licensee is responsible for meeting the minimum standards for the operation of a facility as set forth by the Department and by other Federal, State and local agencies responsible for the health and welfare of residents. This includes complying with all applicable Federal and State laws, and rules, regulations and orders issued by the Department and other Federal, State or local agencies.

(b) If services are purchased for the administration or management of the facility, the licensee is responsible for ensuring compliance with all applicable Federal and State laws, and rules, regulations and orders issued by the Department and other Federal, State and local agencies.

(c) The licensee through the administrator shall report as soon as possible, or, at the latest, within 24 hours to the appropriate Division of Nursing Care Facilities field office serious incidents involving residents as set forth in § 51.3 (relating to notification). For purposes of this subpart, references to patients in § 51.3 include references to residents.

(d) [Reserved].

(e) [Reserved].

(f) Upon receipt of a strike notice, the licensee or administrator shall promptly notify the appropriate Division of Nursing Care Facilities field office, and the Office of the State Long-Term Care Ombudsman, and keep the Department apprised of the strike status and the measures being taken to provide resident care during the strike.

(g) A facility owner shall pay in a timely manner bills incurred in the operation of a facility that are not in dispute and that are for services without which the resident’s health and safety are jeopardized.

(h) The facility shall report to the Department census, rate, program occupancy and any other information the Department may request. The Department will provide advance notice of new reporting requirements, except in instances of an emergency.

(i) The facility shall have on file the most recent inspection reports, relating to the health and safety of residents, indicating compliance with applicable Federal, State and local statutes and regulations. Upon request, the facility shall make the most recent report available to interested persons.

(j) The facility shall conduct a facility-wide assessment that meets the requirements of 42 CFR 483.70(e) (relating to administration), as necessary, but at least quarterly.

The provisions of this § 201.14 amended under sections 102, 201(12), 601, 801.1a and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 201.14 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended February 11, 1977, effective February 12, 1977, 7 Pa.B. 437; amended April 23, 1982, effective April 24, 1982, 12 Pa.B. 1316; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8163. Immediately preceding text appears at serial pages (336939) to (336940).

The Commonwealth’s pervasive regulation of the nursing home industry does not preempt a local school district from levying and collecting business privilege taxes from a private, for-profit nursing home. Rose View Manor, Inc. v. Williamsport, 630 A.2d 474 (Pa. Cmwlth. 1993); appeal denied 641 A.2d 591 (Pa. 1994).

History

Authority: The provisions of this § 201.
Source: The provisions of this Chapter 201 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 201.15 Restrictions on license.

(a) [Reserved].

(b) A license becomes automatically void without notice if any of the following conditions exist:

(1) The license term expires unless the term expires due to a departmental delay, a Federal emergency or State disaster emergency.

(2) There is a change in ownership and the Department has not given prior approval.

(3) There is a change in the name of the facility, and the Department has not given prior approval.

(4) There is a change in the location of the facility and the Department has not given prior approval.

The provisions of this § 201.15 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 201.15 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended July 6, 1979, effective July 7, 1979, 9 Pa.B. 2252; amended April 23, 1982, effective April 24, 1982, 12 Pa.B. 1316; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8163. Immediately preceding text appears at serial pages (336940) and (258327).

History

Authority: The provisions of this § 201.
Source: The provisions of this Chapter 201 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 201.15a Enforcement.

Actions the Department may take to enforce compliance with the act and this subpart include but are not limited to the following:

(a) Requiring a plan of correction.

(b) Issuance of a provisional license.

(d) Appointment of a temporary manager.

(e) Limitation or suspension of admissions to the facility.

(f) Assessment of fines or civil monetary penalties.

The provisions of this § 201.15a added under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 201.15a added December 23, 2022, effective July 1, 2023, 52 Pa.B. 8163.

History

Authority: The provisions of this § 201.
Source: The provisions of this Chapter 201 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 201.15b Appeals.

A final order or determination of the Department relating to licensure may be appealed by the provider of services to the Health Policy Board under section 2102(n) of The Administrative Code of 1929 (71 P.S. § 532(n)).

The provisions of this § 201.15b added under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 201.15b added December 23, 2022, effective July 1, 2023, 52 Pa.B. 8163.

History

Authority: The provisions of this § 201.
Source: The provisions of this Chapter 201 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 201.17 Location.

With the approval of the Department, a facility may be located in a building with other providers and share services as follows:

(1) The provider is licensed, as applicable.

(2) The provider operates or provides other health-related services, such as personal care, home health or hospice services.

(3) The shared services may include services such as laundry, pharmacy and meal preparations.

(4) The facility shall be operated as a unit distinct from other health-related services.

The provisions of this § 201.17 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 201.17 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended July 6, 1979, effective July 7, 1979, 9 Pa.B. 2252; amended April 23, 1982, effective April 24, 1982, 12 Pa.B. 1312, 1316; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8163. Immediately preceding text appears at serial page (258327).

History

Authority: The provisions of this § 201.
Source: The provisions of this Chapter 201 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 201.18 Management.

(a) [Reserved].

(b) In addition to the requirements under 42 CFR 483.70(d) (relating to administration), the governing body of a facility shall adopt and enforce rules relative to:

(1) The health care and safety of the residents.

(2) Protection of personal and property rights of the residents, while in the facility, and upon discharge or after death, including the return of any personal property remaining at the facility within 30 days after discharge or death.

(3) The general operation of the facility.

(c) The governing body shall report to the Department within 30 days changes to the information that was submitted with the facility’s application for licensure under § 201.12(b)(1)—(6) (relating to application for license of a new facility or change in ownership).

(d) The governing body shall adopt effective administrative and resident care policies and bylaws governing the operation of the facility in accordance with legal requirements. The administrative and resident care policies and bylaws shall be in writing; shall be dated; and shall be reviewed and revised, in writing, as often as necessary but at least annually. The policies and bylaws shall be available upon request, to residents, resident representatives and for review by members of the public.

(d.1) The administrator appointed by the governing body under 42 CFR 483.70(d)(2) shall be currently licensed and registered in this Commonwealth and shall be employed full-time in facilities that have more than 25 beds. Facilities with 25 beds or less may share an administrator provided that all of the following apply:

(1) The Department is informed of this arrangement.

(2) There is a plan in the event of an emergency when the administrator is not working.

(3) There is a readily available method for residents and resident representatives to contact the administrator should they find it necessary.

(4) The director of nursing services has at a minimum, knowledge and experience of the facility, its policies and procedures and resident needs to compensate for the time the administrator is not in the building.

(5) The sharing of an administrator shall be limited to two facilities.

(d.2) The administrator’s anticipated biweekly work schedule shall be publicly posted in the facility. The anticipated work schedule shall be updated within 24 hours of a change.

(e) In addition to the requirements under 49 Pa. Code § 39.91 (relating to standards of professional practice and professional conduct for nursing home administrators), the administrator’s responsibilities shall include the following:

(1) Enforcing the regulations relative to the level of health care and safety of residents and to the protection of their personal and property rights.

(2) Planning, organizing and directing responsibilities obligated to the administrator by the governing body.

(2.1) Ensuring that a sanitary, orderly and comfortable environment is provided for residents through satisfactory housekeeping in the facility and maintenance of the building and grounds.

(3) Maintaining an ongoing relationship with the governing body, medical and nursing staff and other professional and supervisory staff through meetings and reports, occurring as often as necessary, but at least on a monthly basis.

(4) Studying and acting upon recommendations made by committees.

(5) Appointing, in writing and in concurrence with the governing body, a responsible employee to act on the administrator’s behalf during temporary absences.

(6) Assuring that appropriate and adequate relief personnel are utilized for those necessary positions vacated either on a temporary or permanent basis.

(7) Developing a written plan to assure the continuity of resident care and services in the event of a strike in a unionized facility.

(f) A written record shall be maintained on a current basis for each resident with written receipts for personal possessions received or deposited with the facility. The record shall be available for review by the resident or resident representative upon request.

(g) The governing body shall disclose, upon request, to be made available to the public, the licensee’s current daily reimbursement under Medical Assistance and Medicare as well as the average daily charge to other insured and noninsured private pay residents.

(h) When the facility accepts the responsibility for the resident’s financial affairs, the resident or resident representative shall designate, in writing, the transfer of the responsibility. The facility shall provide cash, if requested, within 1 day of the request or a check, if requested, within 3 days of the request. If a facility utilizes electronic transfers, the facility shall initiate an electronic transfer of funds, if requested, within one day of the request.

The provisions of this § 201.18 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 201.18 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended July 6, 1979, effective July 7, 1979, 9 Pa.B. 2252; amended April 23, 1982, effective April 24, 1982, 12 Pa.B. 1316; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8098. Immediately preceding text appears at serial pages (258327) to (258328) and (336941).

History

Authority: The provisions of this § 201.
Source: The provisions of this Chapter 201 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 201.19 Personnel records.

Personnel records shall be kept current and available for each facility employee and contain all of the following information:

(1) The employee’s job description, educational background and employment history.

(2) Employee performance evaluations, including documentation of any monitoring, performance or disciplinary action related to the employee.

(3) Documentation of credentials, which shall include, at a minimum, current certification, registration or licensure, if applicable, for the position to which the employee is assigned.

(4) A determination by a health care practitioner that the employee, as of the employee’s start date, is free from the communicable diseases or conditions listed in § 27.155 (relating to restrictions on health care practitioners).

(5) Records relating to a medical exam, if required by a facility, or attestation that the employee is able to perform the employee’s job duties.

(6) Documentation of the employee’s orientation to the facility and the employee’s assigned position prior to or within 1 week of the employee’s start date.

(7) Documentation of the employee’s completion of required trainings under this chapter, including documentation of orientation and other trainings.

(8) A copy of the final report received from the Pennsylvania State Police and the Federal Bureau of Investigation, as applicable, in accordance with the Older Adults Protective Services Act (35 P.S. § § 10225.101—10225.5102), the Adult Protective Services Act (35 P.S. § § 10210.101—10210.704) and applicable regulations.

(9) In the event of a conviction prior to or following employment, documentation that the facility determined the employee’s suitability for initial or continued employment in the position to which the employee is assigned. ‘‘Suitability for employment’’ shall include a review of the offense; the length of time since the individual’s conviction; the length of time since incarceration, if any; evidence of rehabilitation; work history; and the employee’s job duties.

(10) The employee’s completed employment application.

The provisions of this § 201.19 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 201.19 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended April 23, 1982, effective April 24, 1982, 12 Pa.B. 1316; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8098. Immediately preceding text appears at serial page (336941).

Personnel Procedures

If the administrator of a county-operated nursing home adopts disciplinary and dismissal procedures and the county commissioners use those procedures to fulfill the requirements of State and Federal agencies and in the orientation of new employes, then the commissioners are estopped from denying the validity of those procedures, even if the administrator acted beyond his authority in adopting them. DeFrank v. County of Greene, 412 A.2d 663 (Pa. Cmwlth. 1980).

History

Authority: The provisions of this § 201.
Source: The provisions of this Chapter 201 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 201.20 Staff development.

(a) There shall be an ongoing coordinated educational program which is planned and conducted for the development and improvement of skills of the facility’s personnel, including, at a minimum, annual in-service training on the topics outlined in 42 CFR 483.95 (relating to training requirements) in addition to the following topics:

(1) Accident prevention.

(2) Restorative nursing techniques.

(3) Emergency preparedness in accordance with 42 CFR 483.73(d) (relating to emergency preparedness).

(4) Fire prevention and safety in accordance with 42 CFR 483.90 (relating to physical environment).

(5) Resident rights, including nondiscrimination and cultural competency.

(6) Training needs identified through a facility assessment.

(b) An employee shall receive appropriate orientation to the facility, its policies and to the position and duties. The orientation shall include training on the prevention, detection and reporting of resident abuse and dementia management and communication skills.

(d) Written records shall be maintained which indicate the content of and attendance at staff development programs.

The provisions of this § 201.20 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 201.20 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended April 23, 1982, effective April 24, 1982, 12 Pa.B. 1316; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8098. Immediately preceding text appears at serial page (336942).

History

Authority: The provisions of this § 201.
Source: The provisions of this Chapter 201 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 201.21 Use of outside resources.

(a) [Reserved].

(b) [Reserved].

(c) In addition to the requirements under 42 CFR 483.70(g) (relating to administration), the responsibilities, functions, objectives and terms of agreements related to outside resources shall be delineated in writing and signed and dated by the parties.

(d) [Reserved].

(e) If a facility acquires employees from outside resources, the facility shall obtain confirmation from the outside resource that the employees are free from the communicable diseases and conditions listed in § 27.155 (relating to restrictions on health care practitioners) and are able to perform their assigned job duties.

The provisions of this § 201.21 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 201.21 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8098. Immediately preceding text appears at serial pages (336942) and (258331).

History

Authority: The provisions of this § 201.
Source: The provisions of this Chapter 201 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 201.22 Prevention, control and surveillance of tuberculosis (TB).

(a) The facility shall have a written TB infection control plan with established protocols which address risk assessment and management, screening and surveillance methods, identification, evaluation, and treatment of residents and employees who have a possible TB infection or active TB.

(b) Recommendations of the Centers for Disease Control and Prevention (CDC), United States Department of Health and Human Services (HHS) shall be followed in screening, testing and surveillance for TB and in treating and managing persons with confirmed or suspected TB.

(d) [Reserved].

(e) [Reserved].

(f) [Reserved].

(g) [Reserved].

(h) [Reserved].

(i) [Reserved].

(j) [Reserved].

(k) [Reserved].

(l) [Reserved].

(m) [Reserved].

(n) [Reserved].

The provisions of this § 201.22 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 201.22 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8163. Immediately preceding text appears at serial pages (258331) to (258332).

History

Authority: The provisions of this § 201.
Source: The provisions of this Chapter 201 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 201.23 Closure of facility.

In addition to the requirements set forth in 42 CFR 483.70(l) and (m) (relating to administration), the following conditions apply to the closure of a long-term care nursing facility:

(a) [Reserved].

(b) [Reserved].

(c.1) The facility shall develop a closure plan that includes all of the following:

(1) The identification of those who will be responsible for the daily operation and management of the facility during the closure process.

(2) The roles and responsibilities, and contact information, for the facility owner and the administrator or any replacement or temporary manager during the closure process.

(3) Assurance that no new residents will be admitted to the facility after the written notice of closure is provided under subsection (c.3).

(4) A plan for identifying and assessing available facilities to which residents can be transferred, taking into consideration each resident’s individual best interests and resident’s goals, preferences and needs regarding services, location and setting. This shall include all of the following:

(i) Interviewing each resident and resident representative, if applicable, to determine each resident’s goals, preferences and needs.

(ii) Offering the opportunity, to each resident and resident representative, if applicable, to obtain information regarding options within the community.

(iii) Providing residents and resident representatives, if applicable, with information or access to information regarding providers and services.

(5) A plan for the communication and transfer of resident information, including of medical records.

(6) Provisions for the ongoing operations and management of the facility, its residents and staff during the closure process, that include all of the following:

(i) Payment of salaries and expenses.

(ii) Continuation of appropriate staffing and resources to meet the needs of the residents, including provision of medications, services, supplies and treatment.

(iii) Ongoing accounting, maintenance and reporting of resident personal funds.

(iv) Labeling, safekeeping and appropriate transfer of each resident’s personal belongings.

(c.2) The facility shall provide the notice of closure and the closure plan developed under subsection (c.1) to the Department for approval at least 75 days prior to the proposed date of closure.

(c.3) At least 60 days before the proposed date of closure, the facility shall provide written notice of the proposed closure to the following:

(1) Residents and their resident representatives, if applicable, in writing or in a language and manner they understand.

(2) Employees of the facility.

(3) The Office of the State Long-Term Care Ombudsman Program.

(4) The Department of Human Services.

(c.4) The written notice provided under subsections (c.2) and (c.3) shall contain all of the following:

(1) The date of the proposed closure.

(2) Contact information for the facility representative delegated to respond to questions about the closure.

(3) Contact information for the Office of the State Long-Term Care Ombudsman Program.

(4) The transfer and relocation plan of residents.

(d) Residents in a facility may not be required to leave the facility prior to 30 days following receipt of a written notice from the licensee of the intent to close the facility, except when the Department determines that removal of the resident at an earlier time is necessary for health and safety.

(e) If an orderly transfer of the residents cannot be safely effected within 30 days, the Department may require the facility to remain open an additional 30 days.

(f) The Department is permitted to monitor the transfer of residents.

(g) The licensee of a facility shall file proof of financial responsibility with the Department to ensure that the facility continues to operate in a satisfactory manner until closure of the facility.

The provisions of this § 201.23 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 201.23 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended May 26, 1978, effective May 27, 1978, 8 Pa.B. 1466; amended July 6, 1979, effective July 7, 1979, 9 Pa.B. 2252; amended April 23, 1982, effective April 24, 1982, 12 Pa.B. 1316; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8065. Immediately preceding text appears at serial page (336943).

This section cited in 28 Pa. Code § 211.5 (relating to medical records).

History

Authority: The provisions of this § 201.
Source: The provisions of this Chapter 201 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 201.24 Admission policy.

(a) The resident is not required to name a resident representative if the resident is capable of managing the resident’s own affairs.

(b) A facility may not obtain from or on behalf of residents a release from liabilities or duties imposed by law or this subpart except as part of formal settlement in litigation.

(c) A facility shall admit only residents whose nursing care and physical needs can be provided by the staff and facility.

(d) A resident with a disease in the communicable stage may not be admitted to the facility unless it is deemed advisable by the attending physician—medical director, if applicable—and administrator and unless the facility has the capability to care for the needs of the resident.

(e) The governing body of a facility shall establish written policies for the admissions process for residents, and through the administrator, shall be responsible for the development of and adherence to procedures implementing the policies. The policies and procedures shall include all of the following:

(1) Introduction of residents to at least one member of the professional nursing staff for the unit where the resident will be living and to direct care staff who have been assigned to care for the resident. Prior to introductions, the professional nursing and direct care staff shall review the orders of the physician or other health care practitioner for the resident’s immediate care.

(2) Orientation of the resident to the facility and location of essential services and key personnel, including the dining room, nurses’ workstations and offices for the facility’s social worker and grievance or complaint officer.

(3) A description of facility routines, including nursing shifts, mealtimes and posting of menus.

(4) Discussion and documentation of the resident’s customary routines and preferences, to be included in the care plan developed for the resident under 42 CFR 483.21 (relating to comprehensive person-centered care planning).

(5) Assistance to the resident in creating a homelike environment and settling and securing personal possessions in the room to which the resident has been assigned.

(f) The coordination of introductions, orientation and discussions, under subsection (e), shall be the responsibility of the facility’s social worker, or a delegee designated by the governing body. The activities included under subsection (e)(1) and (2) shall occur within 2 hours of a resident’s admission. The activities included under subsection (e)(3) and (4) shall occur within 24 hours of a resident’s admission. the activities included under subsection (e)(5) shall occur within 72 hours of a resident’s admission.

The provisions of this § 201.24 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 201.24 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended February 11, 1977, effective February 12, 1977, 7 Pa.B. 437; amended May 26, 1978, effective May 27, 1978, 8 Pa.B. 1466; amended April 23, 1982, effective April 24, 1982, 12 Pa.B. 1316; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8098. Immediately preceding text appears at serial pages (336943) to (336944).

History

Authority: The provisions of this § 201.
Source: The provisions of this Chapter 201 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 201.26 Resident representative.

A resident representative may not be a licensee, owner, operator, members of the governing body, an employee or anyone with a financial interest in the facility unless ordered by a court of competent jurisdiction, except that:

(1) A resident’s family member who is employed in the facility may serve as a resident representative so long as there is no conflict of interest.

(2) A facility may be designated as a representative payee in accordance with Title II or XVI of the Social Security Act (42 U.S.C.A. § § 401—434 and 1381—1385) and applicable regulations.

The provisions of this § 201.26 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 201.26 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8098. Immediately preceding text appears at serial page (336944).

History

Authority: The provisions of this § 201.
Source: The provisions of this Chapter 201 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 201.27 Advertisement of special services.

A facility may not advertise special services offered unless the service is under the direction and supervision of personnel trained or educated in that particular special service, such as, rehabilitation or physical therapy by a registered physical therapist; occupational therapy by a registered occupational therapist; skilled nursing care by registered nurses; special diets by a dietitian; or special foods.

The provisions of this § 201.27 amended under section 803 of the Health Care Facilities Act (35 P. S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

The provisions of this § 201.27 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial page (202331).

History

Authority: The provisions of this § 201.
Source: The provisions of this Chapter 201 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 201.29 Resident rights.

(a) The governing body of the facility shall establish written policies regarding the rights and responsibilities of residents as provided for in 42 CFR 483.10 (relating to resident rights) and this section. Through the administrator, the governing body shall be responsible for development of and adherence to procedures implementing the policies. The written policies shall include a mechanism for the inclusion of residents, or a resident representative, in the development, implementation and review of the policies and procedures regarding the rights and responsibilities of residents.

(b) Policies and procedures regarding rights and responsibilities of residents shall be available to residents and members of the public.

(c) Policies of the facility shall be available to staff, residents, consumer groups and the interested public, including a written outline of the facility’s objectives and a statement of the rights of its residents. The policies shall set forth the rights of the resident and prohibit mistreatment and abuse of the resident.

(c.1) The facility shall post in a conspicuous place near the entrances and on each floor of the facility a notice which sets forth the list of resident rights. The posting of resident rights shall include the rights under subsection (c.3) and 42 CFR 483.10.

(c.2) A facility shall provide personal notice of a resident’s rights in accordance with 42 CFR 483.10(g)(16). A certificate of the provision of personal notice shall be entered in the resident’s medical record.

(c.3) In addition to the resident rights set forth in 42 CFR 483.10, residents have a right to the following:

(1) If changes in charges occur during the resident’s stay, the resident, or resident representative, shall be advised verbally and in writing reasonably in advance of the change. ‘‘Reasonably in advance’’ shall be interpreted to be 30 days prior to the change unless circumstances dictate otherwise. If a facility requires a security deposit, the written procedure or contract that is given to the resident, or resident representative, shall indicate how the deposit will be used and the terms for the return of the deposit. A security deposit is not permitted for a resident receiving medical assistance.

(2) Prior to transfer, the facility shall inform the resident, or the resident representative, as to whether the facility where the resident is being transferred is certified to participate in the Medicare and the Medical Assistance Programs.

(3) Experimental research or treatment in a facility may not be carried out without the approval of the Department, including the Department’s Institutional Review Board, and without the written approval and informed consent of the resident, or resident representative, obtained prior to participation and initiation of the experimental research or treatment. The following apply:

(i) The resident, or resident representative, shall be fully informed of the nature of the experimental research or treatment and the possible consequences, if any, of participation.

(ii) The resident, or resident representative, shall be given the opportunity to refuse to participate both before and during the experimental research or treatment.

(iii) For the purposes of this subsection, ‘‘experimental research’’ means the development, testing and use of a clinical treatment, such as an investigational drug or therapy that has not yet been approved by the United States Food and Drug Administration or medical community as effective and conforming to medical practice.

(4) A resident has the right to care without discrimination based upon race, color, familial status, religious creed, ancestry, age, sex, gender, sexual orientation, gender identity or expression, national origin, ability to pay, handicap or disability, use of guide or support animals because of the blindness, deafness or physical handicap of the resident or because the resident is a handler or trainer of support or guide animals.

(d) [Reserved].

(e) [Reserved].

(f) [Reserved].

(g) [Reserved].

(h) [Reserved].

(i) [Reserved].

(j) [Reserved].

(k) [Reserved].

(l) [Reserved].

(m) [Reserved].

(n) [Reserved].

(o) [Reserved].

The provisions of this § 201.29 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 201.29 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended July 6, 1979, effective July 7, 1979, 9 Pa.B. 2252; amended April 23, 1982, 12 Pa.B. 1316; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; corrected June 19, 1987, 17 Pa.B. 2462; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8098. Immediately preceding text appears at serial pages (258335) to (258336) and (336945).

History

Authority: The provisions of this § 201.
Source: The provisions of this Chapter 201 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 201.31 Transfer agreement.

(a) The facility shall have in effect a transfer agreement with one or more hospitals, located reasonably close by, which provides the basis for effective working arrangements between the two health care facilities. Under the agreement, inpatient hospital care or other hospital services shall be promptly available to the facility’s residents when needed.

(b) A transfer agreement between a hospital and a facility shall be in writing and specifically provide for the exchange of medical and other information necessary to the appropriate care and treatment of the residents to be transferred. The agreement shall further provide for the transfer of residents’ personal effects, particularly money and valuables, as well as the transfer of information related to these items when necessary.

The provisions of this § 201.31 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 201.31 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8098. Immediately preceding text appears at serial pages (336946) and (258339).

History

Authority: The provisions of this § 201.
Source: The provisions of this Chapter 201 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

Chapter 204 Physical Environment and Equipment Standards for Construction, Alteration or Renovation of Long-Term Care Nursing Facilities

28 Pa. Code § 204.1 Application of Guidelines for Design and Construction of Residential Health, Care and Support Facilities.

(a) In addition to the requirements set forth in this chapter, facility construction, alteration or renovation approved on or after July 1, 2023, shall comply with the 2018 edition of the Facility Guidelines Institute Guidelines for Design and Construction of Residential Health, Care, and Support Facilities.

(b) Facility construction, alteration or renovation approved before July 1, 2023, shall comply with the standards set forth in Chapter 205 (relating to physical environment and equipment standards for long-term care nursing facilities construction, alteration or renovation approved before July 1, 2023).

(c) Construction, alteration or renovation shall meet the requirements in effect on the date that the facility’s plans for construction, alteration or renovation are approved by the Department.

History

Authority: The provisions of this Chapter 204 added under sections 102, 201(12), 601, 801.
Source: The provisions of this Chapter 204 added December 23, 2022, effective July 1, 2023, 52 Pa.

28 Pa. Code § 204.2 Building plans.

(a) A licensee or prospective licensee shall submit its plans for construction, alteration or renovation to the department. The Department will post instructions for submissions on its public web site.

(b) A licensee or prospective licensee shall have the opportunity to present and discuss with the Department its purposes and plans concerning the requested changes indicated on architectural plans submitted under § 51.3(d) (relating to notification). If differences occur and cannot be resolved, an administrative hearing may be sought under 1 Pa. Code Part II (relating to General Rules of Administrative Practice and Procedure).

(c) Construction, alteration or renovation approved by the Department shall begin within 2 years of the Department’s approval and shall be completed within 5 years of the Department’s approval.

(d) A facility may seek an extension of the time periods under subsection (c) for beginning or completing an approved construction, alteration or renovation by written request to the Department. The Department may approve an extension for good cause shown.

(e) A facility shall obtain approval from the Department before using an area of the facility for resident care when that area has not been occupied or used by residents for 1 year or more.

History

Authority: The provisions of this Chapter 204 added under sections 102, 201(12), 601, 801.
Source: The provisions of this Chapter 204 added December 23, 2022, effective July 1, 2023, 52 Pa.

28 Pa. Code § 204.3 Buildings and grounds; general.

(a) A building to be used for and by residents shall be located in an area that is geographically and environmentally conducive to the health and safety of residents.

(b) No part of a building may be used for a purpose that interferes with or jeopardizes the health and safety of residents. Special authorization shall be given by the Department’s Division of Nursing Care Facilities if a part of the building is to be used for a purpose other than health care.

(c) Only residents, employees, the licensee, the administrator or members of the administrator’s immediate family may reside in the facility.

(d) Grounds shall be adequate to provide necessary service areas and outdoor areas for residents. A facility may provide rooftop or balcony areas if adequate protective enclosures are provided.

(e) A delivery area, service yard or parking area shall be located so that traffic does not cross an area commonly used by residents.

History

Authority: The provisions of this Chapter 204 added under sections 102, 201(12), 601, 801.
Source: The provisions of this Chapter 204 added December 23, 2022, effective July 1, 2023, 52 Pa.

28 Pa. Code § 204.4 Basement.

(a) A basement may be used for storage, laundry, kitchen, heat, electric and water equipment. Approval from the Department’s Division of Nursing Care Facilities shall be secured before any part of the basement may be used for other purposes, such as physical therapy, central supply and occupational therapy.

(b) A door to a basement may not be located in a resident room.

History

Authority: The provisions of this Chapter 204 added under sections 102, 201(12), 601, 801.
Source: The provisions of this Chapter 204 added December 23, 2022, effective July 1, 2023, 52 Pa.

28 Pa. Code § 204.5 Resident rooms.

(a) A bed for a resident may be placed only in a room approved by the Department as a resident room.

(b) The basement of a facility may not be used for resident rooms.

(c) The maximum number of residents who may be accommodated in a facility shall be indicated on the facility license. The number of resident rooms and the number of beds in a room may not exceed the maximum number approved by the Department.

(d) A resident shall have a choice in the placement of the resident’s bed in the room unless the placement presents a safety hazard.

(e) A bed may not be placed close to a radiator, heat vent, air conditioner, direct glare of natural light or draft unless the resident chooses to do so and the placement does not pose a safety hazard.

(f) A resident shall be provided with a drawer or cabinet in the resident’s room that can be locked.

History

Authority: The provisions of this Chapter 204 added under sections 102, 201(12), 601, 801.
Source: The provisions of this Chapter 204 added December 23, 2022, effective July 1, 2023, 52 Pa.

28 Pa. Code § 204.6 Locks.

A door into a room used by a resident may not be locked from the outside when the resident is in the room.

History

Authority: The provisions of this Chapter 204 added under sections 102, 201(12), 601, 801.
Source: The provisions of this Chapter 204 added December 23, 2022, effective July 1, 2023, 52 Pa.

28 Pa. Code § 204.7 Laundry.

Equipment shall be made available and accessible for residents desiring to do their personal laundry.

History

Authority: The provisions of this Chapter 204 added under sections 102, 201(12), 601, 801.
Source: The provisions of this Chapter 204 added December 23, 2022, effective July 1, 2023, 52 Pa.

28 Pa. Code § 204.8 Utility room.

The facility shall make provisions in each nursing unit for utility rooms. The nursing unit shall have separate soiled and clean workrooms. The rooms may not be more than 120 feet from the most remote room served.

History

Authority: The provisions of this Chapter 204 added under sections 102, 201(12), 601, 801.
Source: The provisions of this Chapter 204 added December 23, 2022, effective July 1, 2023, 52 Pa.

28 Pa. Code § 204.9 Bathing facilities.

(a) A facility shall provide a general bathing area in each nursing unit to serve resident rooms that do not have adjoining bathrooms with a bathtub or shower.

(b) Unless bathing fixtures are located in a separate room, there shall be compartments to permit privacy. Cubicle curtains may provide this privacy.

(c) Each bathing room shall include a toilet and lavatory. If more than one tub or shower is in the bathing room, privacy shall be provided at each bathing facility and at the toilet.

(d) The facility shall have at least one bathtub in each centralized bath area on each floor.

History

Authority: The provisions of this Chapter 204 added under sections 102, 201(12), 601, 801.
Source: The provisions of this Chapter 204 added December 23, 2022, effective July 1, 2023, 52 Pa.

28 Pa. Code § 204.10 Toilet facilities.

Toilets and lavatories, other than resident facilities, shall be provided for visitors in a facility.

History

Authority: The provisions of this Chapter 204 added under sections 102, 201(12), 601, 801.
Source: The provisions of this Chapter 204 added December 23, 2022, effective July 1, 2023, 52 Pa.

28 Pa. Code § 204.11 Equipment for bathrooms.

(a) Grab bars shall be installed as necessary at each tub and shower for safety and convenience. Grab bars, accessories and anchorage shall have sufficient strength to accommodate the residents’ needs.

(b) The general bathroom or shower room used by residents shall have one emergency signal bell located in close proximity to the tub or shower and which registers at the workstation. An emergency signal bell shall also be located at each toilet unless a signal bell can be reached by the resident from both the toilet and tub or shower.

(c) The facility shall make provisions to get residents in and out of bathtubs in a safe way to prevent injury to residents and personnel. The facility shall provide appropriate supervision and assistance to ensure the safety of all residents being bathed.

(d) A dressing area shall be provided immediately adjacent to the shower stall and bathtub. In the dressing area, there shall be provisions for keeping clothes dry while bathing.

(e) The facility shall ensure that water for baths and showers is at a safe and comfortable temperature before the resident is bathed.

History

Authority: The provisions of this Chapter 204 added under sections 102, 201(12), 601, 801.
Source: The provisions of this Chapter 204 added December 23, 2022, effective July 1, 2023, 52 Pa.

28 Pa. Code § 204.12 Toilet room equipment.

Each toilet used by residents shall be provided with handrails or assist bars on each side capable of accommodating the residents’ needs.

History

Authority: The provisions of this Chapter 204 added under sections 102, 201(12), 601, 801.
Source: The provisions of this Chapter 204 added December 23, 2022, effective July 1, 2023, 52 Pa.

28 Pa. Code § 204.13 Linen.

The facility shall have available at all times a quantity of linens essential for proper care and comfort of residents.

History

Authority: The provisions of this Chapter 204 added under sections 102, 201(12), 601, 801.
Source: The provisions of this Chapter 204 added December 23, 2022, effective July 1, 2023, 52 Pa.

28 Pa. Code § 204.14 Supplies.

Adequate supplies shall be available at all times to meet the residents’ needs.

History

Authority: The provisions of this Chapter 204 added under sections 102, 201(12), 601, 801.
Source: The provisions of this Chapter 204 added December 23, 2022, effective July 1, 2023, 52 Pa.

28 Pa. Code § 204.15 Windows.

(a) Each window opening in the exterior walls that are used for ventilation shall be effectively covered by screening.

(b) A room with windows opening onto light or air shafts, or onto an exposure where the distance between the building or an obstruction higher than the windowsill is less than 20 feet, may not be used for resident rooms.

History

Authority: The provisions of this Chapter 204 added under sections 102, 201(12), 601, 801.
Source: The provisions of this Chapter 204 added December 23, 2022, effective July 1, 2023, 52 Pa.

28 Pa. Code § 204.16 Dining.

The dining area shall be a minimum of 15 square feet per bed for the first 100 beds and 13 1/2 square feet per bed for beds over 100. This space is required in addition to the space required for lounge and recreation rooms.

History

Authority: The provisions of this Chapter 204 added under sections 102, 201(12), 601, 801.
Source: The provisions of this Chapter 204 added December 23, 2022, effective July 1, 2023, 52 Pa.

28 Pa. Code § 204.17 Lounge and recreation rooms.

A recreation or lounge room shall be a minimum of 15 square feet of floor space per bed provided for the first 100 beds and 13 1/2 square feet for all beds over 100. A facility shall provide recreation or lounge rooms for residents on each floor.

History

Authority: The provisions of this Chapter 204 added under sections 102, 201(12), 601, 801.
Source: The provisions of this Chapter 204 added December 23, 2022, effective July 1, 2023, 52 Pa.

28 Pa. Code § 204.18 Storage.

General storage space shall be provided for storage of supplies, furniture, equipment, residents’ possessions and the like. Space provided for this purpose shall be commensurate with the needs of the nursing facility but may not be less than 10 square feet per bed.

History

Authority: The provisions of this Chapter 204 added under sections 102, 201(12), 601, 801.
Source: The provisions of this Chapter 204 added December 23, 2022, effective July 1, 2023, 52 Pa.

28 Pa. Code § 204.19 Plumbing, heating, ventilation, air conditioning and electrical.

Building systems, such as plumbing, heating, ventilation, air conditioning and electrical must comply with all State and local codes.

History

Authority: The provisions of this Chapter 204 added under sections 102, 201(12), 601, 801.
Source: The provisions of this Chapter 204 added December 23, 2022, effective July 1, 2023, 52 Pa.

28 Pa. Code § 204.20 Airborne infection isolation room.

A facility shall have at least one airborne infection isolation room for isolating residents as necessary to prevent the spread of airborne infections. An airborne infection isolation room shall be in accordance with the 2018 edition of the Facility Guidelines Institute Guidelines for Design and Construction of Residential Health, Care, and Support Facilities.

History

Authority: The provisions of this Chapter 204 added under sections 102, 201(12), 601, 801.
Source: The provisions of this Chapter 204 added December 23, 2022, effective July 1, 2023, 52 Pa.

Chapter 205 Physical Environment and Equipment Standards for Long-Term Care Nursing Facilities Construction, Alteration or Renovation Approved Before July 1, 2023

28 Pa. Code § 205.1 Location or site.

A building to be used for and by residents shall be located in areas conducive to the health and safety of the residents.

The provisions of this § 205.1 amended under section 803 of the Health Care Facilities Act (35 P.S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)).

The provisions of this § 205.1 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial page (242505).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.2 Grounds.

(a) Grounds shall be adequate to provide necessary service areas and outdoor areas for residents. A facility with site limitations may provide rooftop or balcony areas if adequate protective enclosures are provided.

(b) Delivery areas, service yards or parking area shall be located so that traffic does not cross areas commonly used by residents.

The provisions of this § 205.2 amended under section 803 of the Health Care Facilities Act (35 P.S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)).

The provisions of this § 205.2 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial page (242505).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.6 Function of building.

(a) No part of a building may be used for a purpose which interferes with or jeopardizes the health and safety of residents. Special authorization shall be given by the Department’s Division of Nursing Care Facilities if a part of the building is to be used for a purpose other than health care.

(b) The only persons who may reside in the facility shall be residents, employees, the licensee, the administrator or members of the administrator’s immediate family.

The provisions of this § 205.6 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 205.6 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8065. Immediately preceding text appears at serial pages (258346) to (258347).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.7 Basement or cellar.

Basements or cellars may be used for storage, laundry, kitchen, heat, electric and water equipment. Approval from the Department’s Division of Nursing Care Facilities shall be secured before any area of the basement may be used for other purposes, such as physical therapy, central supply and occupational therapy.

The provisions of this § 205.7 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 205.7 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8065. Immediately preceding text appears at serial page (258347).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.8 Ceiling heights.

Ceiling heights may be 7 feet 6 inches except in boiler rooms where a minimum of 30 inches shall be provided above the main boiler heater and connecting piping. Adequate headroom for convenient maintenance and other proposed operations shall be maintained below the piping.

The provisions of this § 205.8 amended under section 803 of the Health Care Facilities Act (35 P.S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)).

The provisions of this § 205.8 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial page (242508).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.9 Corridors.

(a) Resident corridors shall have a handrail on both sides with a return to the wall at each rail ending. Handrails shall be detailed and finished for safety and shall be free from snagging. Brackets may not impede the continuous progress of hands along the railing.

(b) Corridors shall be lighted adequately during the day and night.

(c) Areas used for corridor traffic may not be considered as areas for dining, storage, diversional or social activities.

The provisions of this § 205.9 issued under section 803 of the Health Care Facilities Act (35 P.S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)).

The provisions of this § 205.9 adopted January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial page (242509).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.10 Doors.

(a) Doors into bathrooms and toilet rooms used by residents shall be at least 36 inches wide, except for an existing facility where the minimum width of toilet room doors is 32 inches.

(b) A door to a resident room shall swing into the room.

(c) A door to a toilet room which swings into the toilet area shall be equipped with special hardware which permits the door to be opened from the outside, and swing out, in case of emergency.

(d) Resident and visitor toilet stall doors shall swing out. Curtains or equivalent shall be considered as meeting this requirement.

(e) A door to a basement or a cellar may not be located in a resident room.

(f) A door opening to the exterior, which may be opened occasionally for ventilation purposes, with the exception of an approved exit door, shall be effectively covered with screening.

The provisions of this § 205.10 issued under section 803 of the Health Care Facilities Act (35 P.S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)).

The provisions of this § 205.10 adopted January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial pages (242509) to (242510).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.12 Elevators.

(a) Elevator service shall be provided for residents when a resident use area is located above or below the first floor or grade level entrance in a building constructed or converted for use after January 1975 as a facility providing either skilled or intermediate care.

(b) The cab platform of an elevator shall measure no less than 5 feet by 7 feet 6 inches. Cab and shaft door may have not less than a 44 inch opening and shall be power operated.

The provisions of this § 205.12 amended under section 803 of the Health Care Facilities Act (35 P.S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)).

The provisions of this § 205.12 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial page (242510).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.13 Floors.

(a) Floors traveled by residents shall be of nonskid material.

(b) Floors in the kitchen, bathroom, toilet rooms, shower rooms, utility rooms, bedpan and hopper rooms shall be of nonskid, nonabsorbent materials and easily cleanable.

The provisions of this § 205.13 amended under section 803 of the Health Care Facilities Act (35 P.S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)).

The provisions of this § 205.13 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended February 11, 1977, effective February 12, 1977, 7 Pa.B. 437; reserved April 23, 1982, effective April 24, 1982, 12 Pa.B. 1316; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial pages (242510) to (242511).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.14 Locks.

Doors into rooms used by residents may not be locked from the outside when the resident is in the room.

The provisions of this § 205.14 amended under section 803 of the Health Care Facilities Act (35 P.S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)).

The provisions of this § 205.14 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial page (242511).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.16 Stairs.

Stairs used by residents shall have no locked gates or free swinging doors obstructing ascent or descent.

The provisions of this § 205.16 amended under section 803 of the Health Care Facilities Act (35 P. S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

The provisions of this § 205.16 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial pages (242511) to (242512).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.17 Stairways.

There shall be indoor stairs and stairways to a basement if the stairs are to be used by personnel of the facility.

The provisions of this § 205.17 amended under section 803 of the Health Care Facilities Act (35 P. S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

The provisions of this § 205.17 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial page (242512).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.19 Windows and windowsills.

(a) Window openings in the exterior walls that are used for ventilation shall be effectively covered by screening.

(b) Rooms with windows opening onto light or air shafts, or onto an exposure where the distance between the building or an obstruction higher than the windowsill is less than 20 feet may not be used for resident bedrooms.

The provisions of this § 205.19 amended under section 803 of the Health Care Facilities Act (35 P.S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)).

The provisions of this § 205.19 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial page (242513).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.20 Resident bedrooms.

(a) A bed for a resident shall be placed only in a bedroom approved by the Department.

(b) The maximum number of residents who may be accommodated in the facility shall be indicated on the license.

(c) The number of resident bedrooms and the number of beds in a room may not exceed the maximum number approved by the Department.

(d) Single bed bedrooms shall provide minimum room area clearance, in addition to the area of closets, vestibule, wardrobes and toilet rooms, of 100 square feet.

(e) Single resident bedrooms in facilities licensed prior to January 1975, shall contain at least 80 square feet of space.

(f) A multibed bedroom shall provide minimum room area clearances, in addition to the area of closets, vestibule, wardrobes and toilet rooms of 80 square feet per bed.

(g) In facilities licensed prior to January 1975, resident multibed bedrooms shall have at least 65 square feet of space per resident.

The provisions of this § 205.20 amended under section 803 of the Health Care Facilities Act (35 P.S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)).

The provisions of this § 205.20 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial pages (242513) to (242515).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.21 Special care room.

(a) Provisions shall be made for isolating a resident as necessary in a single room which is ventilated to the outside.

(b) Provisions shall be available to identify this room with appropriate precautionary signs.

The provisions of this § 205.21 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 205.21 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1,m 2023, 52 Pa.B. 8065. Immediately preceding text appears at serial page (258352).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.22 Placement of beds.

A bed may not be placed in proximity to radiators, heat vents, air conditioners, direct glare of natural light or drafts unless the resident chooses to do so and the placement does not pose a safety hazard.

The provisions of this § 205.22 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 205.22 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8065. Immediately preceding text appears at serial page (258352).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.23 Location of bedrooms.

A resident bedroom shall have adjoining toilet facilities and shall be located conveniently near bathing facilities, except for those facilities licensed prior to January 1975.

The provisions of this § 205.23 amended under section 803 of the Health Care Facilities Act (35 P.S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)).

The provisions of this § 205.23 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial pages (242516) to (242517).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.24 Dining room.

(a) There shall be a minimum dining area of 15 square feet per bed for the first 100 beds and 13 1/2 square feet per bed for beds over 100. This space is required in addition to the space required for lounge and recreation rooms. These areas shall be well lighted and well ventilated.

(b) Tables and space shall be provided to accommodate wheelchairs with trays and other devices.

The provisions of this § 205.24 amended under section 803 of the Health Care Facilities Act (35 P.S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)).

The provisions of this § 205.24 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended April 23, 1982, effective April 24, 1982, 12 Pa.B. 1316; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; corrected June 19, 1987, 17 Pa.B. 2462; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial page (242517).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.25 Kitchen.

(a) There shall be at least one kitchen large enough to meet the needs of the facility.

(b) A service pantry shall be provided for each nursing unit. The pantry shall contain a refrigerator, device for heating food, sink, counter and cabinets. For existing facilities, a service pantry shall be provided for a nursing unit unless the kitchen is sufficiently close for practical needs and has been approved by the Department.

The provisions of this § 205.25 amended under section 803 of the Health Care Facilities Act (35 P.S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)).

The provisions of this § 205.25 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial pages (242517) to (242518).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.26 Laundry.

(a) A laundry room shall be provided in a facility where commercial laundry service is not used for the washing of soiled linens.

(b) The entrance and exit to the laundry room shall be located to prevent the transportation of soiled or clean linens through food preparation, food storage or food serving areas.

(c) The facility shall have a separate room for central storage of soiled linens. The room shall be well ventilated, constructed of materials impervious to odors and moisture and easily cleaned. Soiled linens may not be transported through areas where clean linen is stored.

(d) A facility shall provide a separate room or area for central storage of clean linens and linen carts.

(e) Equipment shall be made available and accessible for residents desiring to do their personal laundry.

The provisions of this § 205.26 amended under section 803 of the Health Care Facilities Act (35 P.S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)).

The provisions of this § 205.26 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; corrected June 19, 1987, 17 Pa.B. 2462; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial pages (242518) to (242519).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.27 Lounge and recreation rooms.

There shall be a minimum of 15 square feet of floor space per bed for recreation or lounge rooms provided for the first 100 beds and 13 1/2 square feet for all beds over 100. There shall be recreation or lounge rooms for residents on each floor.

The provisions of this § 205.27 amended under section 803 of the Health Care Facilities Act (35 P.S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)).

The provisions of this § 205.27 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial page (242519).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.28 Nurses’ station.

(a) A nurses’ station shall be located in each nursing unit, located as centrally as practical within the nursing unit. A common nurses’ station serving more than a single nursing unit may be permitted when the design of the project and method of operation indicate a satisfactory level of service. The size and facilities of the nurses’ station shall be increased appropriate to the number of beds served and additional staffing required.

(b) The nurses’ station may not be more than 120 feet from the most remote resident room served.

(1) A nurses’ call system.

(2) Charting and supplies.

(3) Medication storage and preparation, which may be within the clean workroom, if a self-contained cabinet is provided. The medication storage cabinet shall be locked. Mechanical ventilation shall be provided in this workroom. If a medication cart is used, provisions shall be made to lock the cart or to place the cart when not in use in a safe area that can be locked. The cart may not be stored in the corridor.

(4) A double-locked narcotic compartment within the medication area.

The provisions of this § 205.28 amended under section 803 of the Health Care Facilities Act (35 P.S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)).

The provisions of this § 205.28 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial pages (242519) to (242520).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.31 Storage.

The provisions of this § 205.31 amended under section 803 of the Health Care Facilities Act (35 P.S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)).

The provisions of this § 205.31 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended April 23, 1982, effective April 24, 1982, 12 Pa.B. 1316; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial page (242521).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.32 Janitor closet.

(a) At least one janitor closet shall be provided in a unit. If physical arrangement permits, one janitor’s closet may serve more than one nursing unit or wing.

(b) A separate janitor’s closet is required for the kitchen.

The provisions of this § 205.32 amended under section 803 of the Health Care Facilities Act (35 P.S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)).

The provisions of this § 205.32 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial pages (242521) to (242522).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.33 Utility room.

(a) Provisions shall be made in each nursing unit near the nurses’ station for utility rooms. The area shall have separate soiled and clean workrooms. The rooms may not be more than 120 feet from the most remote room served. If one nursing station services several resident corridors, a soiled utility room shall be on each unit.

(b) Facilities for flushing and rinsing bedpans, such as a spray attachment for the clinical sink or a separate bedpan flusher, shall be provided in the soiled workroom of each nursing unit, unless bedpan flushing devices, together with bedpan lugs on toilets are provided in each resident’s toilet for this purpose.

The provisions of this § 205.33 amended under section 803 of the Health Care Facilities Act (35 P.S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)).

The provisions of this § 205.33 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial page (242522).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.36 Bathing facilities.

(a) The facility shall provide a general bathing area in each nursing unit to serve residents’ bedrooms which do not have adjoining bathrooms with a bathtub or shower.

(b) Bathing fixtures for either the tub or shower shall be provided at a ratio of one fixture per 15 beds or major fraction thereof.

(c) Unless bathing fixtures are located in a separate room, there shall be compartments to permit privacy. Cubicle curtains may provide this privacy.

(d) Each room or compartment shall provide space for the use of bathing fixtures, wheelchairs and dressing. Sufficient space shall be provided for the attendant who may need to assist the resident.

(e) Each bathing room shall include a toilet and lavatory. If more than one tub or shower is in the bathing room, privacy shall be provided at each bathing facility and at the toilet.

(f) Showers designed for wheelchair use may be no less than 4 feet square, shall be without curbs and shall have handrails and curtains.

(g) Water controls for handicapped shower areas shall be located outside the shower stall. Other shower areas may have standard installation of shower controls.

(h) The facility shall have at least one bathtub in each centralized bath area on each floor that is accessible from three sides with a minimum of 3 feet clearance on each side and 4 feet clearance from the foot of the tub to adjacent wall or obstruction.

The provisions of this § 205.36 amended under section 803 of the Health Care Facilities Act (35 P.S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)).

The provisions of this § 205.36 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial pages (242523) to (242524).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.37 Equipment for bathrooms.

(a) Grab bars shall be installed as necessary at each tub and shower for safety and convenience. Grab bars, accessories and anchorage shall have sufficient strength to sustain a weight of 250 pounds for 5 minutes.

(b) The general bathroom or shower room used by residents shall be provided with one emergency signal bell located in close proximity to the tub or shower and which registers at the nursing station. This is in addition to the emergency signal bell located at each toilet unless a single bell can be reached by the resident from both the toilet and tub or shower.

(c) Provisions shall be made available to get residents in and out of bathtubs in a safe way to prevent injury to residents and personnel. The facility shall provide appropriate supervision and assistance to ensure the safety of all residents being bathed.

(d) A dressing area shall be provided immediately adjacent to the shower stall and bathtub. In the dressing area, there shall be provisions for keeping clothes dry while bathing.

(e) The facility shall ensure that water for baths and showers is at a safe and comfortable temperature before the resident is bathed.

The provisions of this § 205.37 amended under section 803 of the Health Care Facilities Act (35 P.S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)).

The provisions of this § 205.37 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial pages (242524) to (242525).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.38 Toilet facilities.

(a) In toilet rooms that adjoin resident bedrooms, there shall be at least one toilet for four residents. This shall be directly accessible from bedrooms without entering the general corridor. In no case may one toilet service more than two bedrooms. The minimum dimension of a resident toilet room containing only a toilet shall be 3 feet by 6 feet.

(b) There may be no less than 3 1/2 feet of space from front of toilet to opposite wall or fixtures.

(d) At least one toilet room shall be provided for toilet training. This room shall be accessible from the nursing corridor and may serve the bathing area. Minimum dimensions for a toilet-training room containing only a toilet shall be 5 feet by 6 feet.

(e) Floors or units with more than eight residents of both sexes shall be provided with separate toilet fixtures in a ratio of 1:4 or major fraction thereof for each sex. In existing facilities, overall toilet fixtures shall be provided in a ratio of 1:8 or major fraction thereof for each bed.

(f) Toilets and lavatories other than resident facilities shall be provided for male and female visitors in facilities.

The provisions of this § 205.38 amended under section 803 of the Health Care Facilities Act (35 P.S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)).

The provisions of this § 205.38 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial page (242525).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.39 Toilet room equipment.

(a) Toilet rooms shall be provided with lavatory, soap or soap dispenser, paper towels, mechanical dryer or other sanitary means of toweling. In toilet rooms adjacent to bedrooms, the lavatory may be omitted if provided in each bedroom.

(b) Toilets used by residents shall be provided with handrails or assist bars on each side capable of sustaining a weight of 250 pounds and an emergency call bell within reaching distance.

The provisions of this § 205.39 amended under section 803 of the Health Care Facilities Act (35 P.S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)).

The provisions of this § 205.39 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial page (242526).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.40 Lavatory facilities.

(a) A floor occupied by residents shall have lavatories in the ratio of 1:4 residents or major fraction thereof. In existing facilities, lavatory fixtures shall be provided in a ratio of 1:8 or major fraction thereof for each bed.

(b) A mirror shall be over each lavatory used by residents.

The provisions of this § 205.40 amended under section 803 of the Health Care Facilities Act (35 P.S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)).

The provisions of this § 205.40 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial page (242526).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.61 Heating requirements for existing construction.

(a) The heating system shall comply with local and State codes. If there is a conflict, the more stringent requirements shall apply.

(b) Exposed heating pipes, hot water pipes or radiators in rooms and areas used by residents or within reach of residents, shall be covered or protected to prevent injury or burns to residents. This includes hot water or steam piping above 125°F.

The provisions of this § 205.61 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 205.61 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8065. Immediately preceding text appears at serial pages (258361) to (258362).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.63 Plumbing and piping systems required for existing construction.

(a) Potable ice may not be manufactured or stored in the soiled utility room.

(b) Water distribution systems shall be designed and arranged to provide potable hot and cold water at hot and cold water outlets at all times. The system pressure shall be sufficient to operate fixture and equipment during maximum demand periods.

(c) Hot water outlets accessible to residents shall be controlled so that the water temperature of the outlets does not exceed 110°F.

The provisions of this § 205.63 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 205.63 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended February 11, 1977, effective February 12, 1977, 7 Pa.B. 437; corrected at 7 Pa.B. 2059; amended April 23, 1982, effective April 24, 1982, 12 Pa.B. 1316; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8065. Immediately preceding text appears at serial pages (258362) to (258363).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.67 Electric requirements for existing construction.

(a) Artificial lighting shall be restricted to electric lighting.

(b) Spaces occupied by people, machinery and equipment within buildings shall have electric lighting which is operational at all times.

(d) Electric lights in rooms used by residents shall be placed or shaded to prevent direct glare to the eyes of residents.

(e) Night lights shall be provided in bedrooms, stairways, corridors, bathrooms and toilet rooms used by residents.

(f) Arrangements to transfer lighting from overhead fixtures to night light fixtures in stairways and corridors shall be designed so that switches can only select between two sets of fixtures and cannot extinguish both sets at the same time.

(g) In addition to night lights, residents’ bedrooms shall have general lighting. The light emitting surfaces of the night light may not be in direct view of a resident in a normal in-bed position.

(h) A reading light shall be provided for each resident.

(i) In each resident room there shall be grounding type receptacles as follows: one duplex receptacle on each side of the head of each bed except for parallel adjacent beds. Only one duplex receptacle is required between beds plus sufficient duplex receptacles to supply portable lights, television and motorized beds, if used, and one duplex receptacle on another wall.

(j) A nurse’s calling station—signal originating device—with cable with push button housing attached or other system approved by the Department shall be provided at each resident bed location so that it is accessible to the resident. Two cables and buttons serving adjacent beds may be served by one station. An emergency calling station within reach of the resident shall be provided at each bathing fixture and toilet unless a single bell can be reached by the resident from both the bathing fixture and the toilet. Cable and push button housing requirement will apply to those facilities constructed after July 1, 1987.

(k) Calls shall register by a signal receiving and indicating device at the nurses’ station, and shall activate a visible signal in the corridor at the resident’s door. In multicorridor nursing units, additional visible signal indicators shall be installed at corridor intersections.

The provisions of this § 205.67 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 205.67 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8065. Immediately preceding text appears at serial page (258366).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.71 Bed and furnishings.

A bed shall be equipped with a firm supporting mattress which is equal to the size of the frame and provides for the comfort and safety of the resident.

The provisions of this § 205.71 amended under section 803 of the Health Care Facilities Act (35 P.S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)).

The provisions of this § 205.71 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended April 23, 1982, effective April 24, 1982, 12 Pa.B. 1316; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial page (242535).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.72 Furniture.

A resident shall be provided with a drawer or cabinet in the resident’s room that can be locked.

The provisions of this § 205.72 amended under section 803 of the Health Care Facilities Act (35 P.S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)).

The provisions of this § 205.72 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial pages (242535) to (242536).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.74 Linen.

The facility shall have available at all times a quantity of linens essential for proper care and comfort of residents.

The provisions of this § 205.74 amended under section 803 of the Health Care Facilities Act (35 P.S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)).

The provisions of this § 205.74 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial page (242537).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.75 Supplies.

Adequate supplies shall be available at all times to meet the residents’ needs.

The provisions of this § 205.75 amended under section 803 of the Health Care Facilities Act (35 P.S. § 448.803); and section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)).

The provisions of this § 205.75 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; corrected June 19, 1987, 17 Pa.B. 2462; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999. Immediately preceding text appears at serial pages (242537) to (242538).

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 205.101 Scope.

This chapter applies to facility construction, alteration or renovation approved by the Department before July 1, 2023.

The provisions of this § 205.101 added under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12). 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)), unless otherwise noted.

The provisions of this § 205.101 added December 23, 2022, effective July 1, 2023, 52 Pa.B. 8065, unless otherwise noted.

History

Authority: The provisions of this § 205.
Source: The provisions of this Chapter 205 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

Chapter 209 Fire Protection and Safety Programs for Long-Term Care Nursing Facilities

28 Pa. Code § 209.3 Smoking.

(a) Policies regarding smoking shall be adopted. The policies shall include provisions for the protection of the rights of smoking and nonsmoking residents. The smoking policies shall be posted in a conspicuous place and in a legible format so that they may be easily read by residents, visitors and staff.

(b) [Reserved].

(d) Smoking by residents in bed is prohibited unless the resident is under direct observation.

(e) [Reserved].

(f) [Reserved].

(g) [Reserved].

The provisions of this § 209.3 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 209.3 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8098. Immediately preceding text appears at serial pages (397589) to (397590).

History

Authority: The provisions of this § 209.
Source: The provisions of this Chapter 209 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

Chapter 211 Program Standards for Long-Term Care Nursing Facilities

28 Pa. Code § 211.1 Reportable diseases.

(a) When a resident develops a reportable disease, the administrator shall report the information to the appropriate health agencies and appropriate Division of Nursing Care Facilities field office. Reportable diseases, infections and conditions are listed in § 27.21a (relating to reporting of cases by health care practitioners and health care facilities).

(b) Cases of scabies or lice or bed bug infestations shall be reported to the appropriate Division of Nursing Care Facilities field office.

(c) Significant nosocomial outbreaks, as determined by the facility’s medical director, Methicillin Resistant Staphylococcus Aureus (MRSA), Vancomycin-Resistant Staphylococcus Aureus (VRSA), Vancomycin-Resistant Enterococci (VRE) and Vancomycin-Resistant Staphylococcus Epidermidis (VRSE) shall be reported to the appropriate Division of Nursing Care Facilities field office.

The provisions of this § 211.1 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)); amended under the Disease Prevention and Control Law of 1955 (35 P.S. § § 521.1—521.21).

The provisions of this § 211.1 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended January 25, 2002, effective January 26, 2002, 32 Pa.B. 491; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8163. Immediately preceding text appears at serial pages (397591) to (397592).

History

Authority: The provisions of this § 211.
Source: The provisions of this Chapter 211 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 211.2 Medical director.

(a) [Reserved].

(b) [Reserved].

(c) In addition to the requirements of 42 CFR 483.70(h) (relating to administration), the medical director of a facility shall be licensed as a physician in this Commonwealth and shall complete at least four hours annually of continuing medical education (CME) pertinent to the field of medical direction or post-acute and long-term care medicine. The medical director may be designated for single or multiple facilities. There shall be a written agreement between the physician and the facility.

(d) The medical director’s responsibilities shall include at least the following:

(1) [Reserved].

(2) [Reserved].

(3) Ensuring the appropriateness and quality of medical care and medically related care.

(4) Assisting in the development of educational programs for facility staff and other professionals.

(5) Working with the facility’s clinical team to provide surveillance and develop policies to prevent the potential infection of residents in accordance with the infection control requirements under 42 CFR 483.80 (relating to infection control).

(6) Cooperating with facility staff to establish policies for assuring that the rights of individuals are respected.

(7) Supporting and promoting person-directed care such as the formation of advance directives, end-of-life care, and provisions that enhance resident decision making, including choice regarding medical care options.

(8) Identifying performance expectations and facilitating feedback to physicians and other health care practitioners regarding their performance and practices.

(9) Discussing and intervening, as appropriate, with a health care practitioner regarding medical care that is inconsistent with current standards of care.

(10) Assisting in developing systems to monitor the performance of health care practitioners, including mechanisms for communicating and resolving issues related to medical care and ensuring that other licensed practitioners who may perform physician-delegated tasks act within their scope of practice.

The provisions of this § 211.2 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 211.2 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8098. Immediately preceding text appears at serial page (397592).

History

Authority: The provisions of this § 211.
Source: The provisions of this Chapter 211 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 211.3 Verbal and telephone orders.

(a) Verbal and telephone orders shall be given to a registered nurse, physician or other individual authorized by appropriate statutes and the State Boards in the Bureau of Professional and Occupational Affairs and shall immediately be recorded on the resident’s clinical record by the person receiving the order. The entry shall be signed and dated by the person receiving the order.

(b) Verbal and telephone orders for care, and treatment shall be dated and countersigned with the original signature of the physician, or physician’s delegee authorized under 42 CFR 483.30(e) (relating to physician services), within 72 hours of receipt of the order.

(c) Verbal and telephone orders for medications shall be dated and countersigned by the prescribing physician, or physician’s delegee authorized under 42 CFR 483.80(e), within 48 hours.

(d) Verbal orders for care, treatment or medication shall be accepted only under circumstances where it is impractical for the orders to be given in a written manner by the physician, or physician’s delegee authorized under 42 CFR 483.30(e). An initial written order as well as a countersignature may be sent by a fax or secure electronic transmission which includes the practitioner’s signature.

(e) The facility shall establish policies identifying the types of situations for which verbal orders may be accepted and the appropriate protocols for the taking and transcribing of verbal orders in these situations, which shall include:

(1) Identification of all treatments or medications which may not be prescribed or dispensed by way of verbal order, but which instead require written orders.

(2) A requirement that all verbal orders be stated clearly, repeated by the issuing physician, or physician’s delegee authorized under 42 CFR 483.30(e), and be read back in their entirety by personnel authorized to take the verbal order.

(3) Identification of all personnel authorized to take and transcribe verbal orders.

(4) The policy on fax or secure electronic transmissions.

The provisions of this § 211.3 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 211.3 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended February 11, 1977, effective February 12, 1977, 7 Pa.B. 437; amended May 26, 1978, effective May 27, 1978, 8 Pa.B. 1466; amended April 23, 1982, effective April 24, 1982, 12 Pa.B. 1316; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8098. Immediately preceding text appears at serial pages (397592) and (329217).

This section cited in 49 Pa. Code § 42.25 (relating to orders).

History

Authority: The provisions of this § 211.
Source: The provisions of this Chapter 211 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 211.4 Procedure in event of death.

(a) Written postmortem procedures shall be available to all personnel.

(b) Documentation shall be on the resident’s clinical record that the next of kin, guardian or resident representative has been notified of the resident’s death. The name of the notified party shall be written on the resident’s clinical record.

The provisions of this § 211.4 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 211.4 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8098. Immediately preceding text appears at serial pages (329217) to (329218).

History

Authority: The provisions of this § 211.
Source: The provisions of this Chapter 211 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 211.5 Medical records.

(a) [Reserved].

(b) Information contained in a resident’s record shall be privileged and confidential. Written consent of the resident or the resident representative is required for release of information, except as follows:

(1) Written consent is not necessary for authorized representatives of the Federal and State government during the conduct of their official duties.

(2) Written consent is not necessary for the release of medical records for treatment purposes in accordance with Federal and State law.

(d) Records of discharged residents shall be completed within 30 days of discharge. Medical information pertaining to a resident’s stay shall be centralized in the resident’s record.

(e) When a facility closes, resident medical records may be transferred with the resident if the resident is transferred to another health care facility. Otherwise, the owners of the facility shall make provisions for the safekeeping and confidentiality of resident medical records and shall provide to the Department, within 30 days of providing notice of closure under § 201.23 (relating to closure of facility), a plan for the storage and retrieval of medical records.

(f) In addition to the items required under 42 CFR 483.70(i)(5) (relating to administration), a resident’s medical record shall include at a minimum:

(i) Physicians’ orders.

(ii) Observation and progress notes.

(iii) Nurses’ notes.

(iv) Medical and nursing history and physical examination reports.

(v) Admission data.

(vi) Hospital diagnoses authentication.

(vii) Report from attending physician or transfer form.

(viii) Diagnostic and therapeutic orders.

(ix) Reports of treatments.

(x) Clinical findings.

(xi) Medication records.

(xii) Discharge summary, including final diagnosis and prognosis or cause of death.

(g) [Reserved].

(h) [Reserved].

(i) The facility shall assign overall supervisory responsibility for the medical record service to a medical records practitioner. Consultative services may be utilized; however, the facility shall employ sufficient personnel competent to carry out the functions of the medical record service.

The provisions of this § 211.5 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 211.5 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8098. Immediately preceding text appears at serial pages (329218) and (352793).

Alteration of medical records during the course of a licensure survey in order to produce the appearance of compliance with regulations constitutes fraud and deceit justifying the Department of Health to refuse to renew a nursing home license. Colonial Gardens Nursing Home, Inc. v. Department of Health, 382 A.2d 1273 (Pa. Cmwlth. 1978).

History

Authority: The provisions of this § 211.
Source: The provisions of this Chapter 211 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 211.6 Dietary services.

(a) Menus shall be planned and posted in the facility or distributed to residents at least 2 weeks in advance. Records of menus of foods actually served shall be retained for 30 days. When changes in the menu are necessary, substitutions shall provide equal nutritive value.

(b) [Reserved].

(d) [Reserved].

(e) [Reserved].

(f) Dietary personnel shall practice hygienic food handling techniques. Employees shall wear clean outer garments, maintain a high degree of personal cleanliness and conform to hygienic practices while on duty. Employees shall wash their hands thoroughly with soap and water before starting work, after visiting the toilet room and as often as necessary to remove soil and contamination.

The provisions of this § 211.6 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 211.6 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended April 23, 1982, effective April 24, 1982, 12 Pa.B. 1316; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8098. Immediately preceding text appears at serial pages (352793) to (352794).

Although hygienic food handling and general dietary supervision are required by Health Care Facilities Act regulations, alleged wrong doing of skilled nursing facility that led to resident’s death by salmonella poisoning did not involve ‘‘furnishing of medical services’’ as contemplated by the Act’s definition of ‘‘professional liability’’ and therefore, was outside coverage by the Medical Professional Liability Catastrophe Loss Fund. Stenton Hall v. Medical Liability Loss Fund, 829 A.2d 377, 384 (Pa. Cmwlth. 2003); appeal denied 857 A.2d 681 (Pa. 2004).

History

Authority: The provisions of this § 211.
Source: The provisions of this Chapter 211 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 211.7 Physician assistants and certified registered nurse practitioners.

(a) [Reserved].

(b) If the facility utilizes the services of physician assistants or certified registered nurse practitioners, the following apply:

(1) [Reserved].

(2) There shall be a list posted at each workstation of the names of the supervising physician and the persons, and titles, whom they supervise.

(3) A copy of the supervising physician’s registration from the State Board of Medicine or State Board of Osteopathic Medicine and the physician assistant’s or certified registered nurse practitioner’s certificate shall be available in the facility.

(4) A notice plainly visible to residents shall be posted in prominent places in the institution explaining the meaning of the terms ‘‘physician assistant’’ and ‘‘certified registered nurse practitioner.’’

(d) [Reserved].

(e) [Reserved].

The provisions of this § 211.7 amended under sections 102, 210(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601 and 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 211.7 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended April 23, 1982, effective April 24, 1982, 12 Pa.B. 1316; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended October 1, 2010, effective October 2, 2010, 40 Pa.B. 5578; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8098. Immediately preceding text appears at serial pages (352794) to (352795).

History

Authority: The provisions of this § 211.
Source: The provisions of this Chapter 211 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 211.8 Use of restraints.

(a) [Reserved].

(b) [Reserved].

(c.1) If restraints are used, a facility shall use the least restrictive method for the least amount of time to safely and adequately respond to individual resident needs in accordance with the resident’s comprehensive assessment and comprehensive care plan. The following shall apply:

(1) When a recurring restraint is ordered, the facility shall document the need for the restraint and the personnel responsible for performing the intervention on each shift.

(2) A facility shall document the type of restraint and each time a restraint is used or removed.

(3) In determining the least restrictive method for the least amount of time, the following minimums apply:

(i) Physical restraints shall be removed at least 10 minutes out of every 2 hours during normal waking hours to allow the resident an opportunity to move and exercise.

(ii) During normal waking hours, the resident’s position shall be changed at least every 2 hours.

(d) An order from a physician, or physician’s delegee authorized under 42 CFR 483.30(e) (relating to physician services), shall be required for a restraint.

(e) The physician, or physician’s delegee authorized under 42 CFR 483.30(e), shall document the reason for the initial restraint order and shall review the continued need for the use of the restraint order by evaluating the resident. If the order is to be continued, the order shall be renewed by the physician, or physician’s delegee authorized under 42 CFR 483.30(e), in accordance with the resident’s total program of care.

(f) Every 30 days, or sooner if necessary, the interdisciplinary team shall review and reevaluate the use of all restraints ordered by a physician or physician’s delegee authorized under 42 CFR 483.30(e).

The provisions of this § 211.8 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 211.8 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8098. Immediately preceding text appears at serial page (352795).

History

Authority: The provisions of this § 211.
Source: The provisions of this Chapter 211 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 211.9 Pharmacy services.

(a) Facility policies shall ensure that:

(1) Facility staff involved in the administration of resident care shall be knowledgeable of the policies and procedures regarding pharmacy services including medication administration.

(2) [Reserved].

(b) Facility policies shall ensure that medications are administered by authorized persons as indicated in § 201.3 (relating to definitions).

(c) Medications and biologicals shall be administered by the same licensed person who prepared the dose for administration and shall be given as soon as possible after the dose is prepared.

(d) Medications, both prescription and non-prescription, shall be administered under the orders of the attending physician, or the physician’s delegee authorized under 42 CFR 483.30(e) (relating to physician services).

(e) [Reserved].

(f) Residents shall be permitted to purchase prescribed medications from the pharmacy of their choice. If the resident does not use the pharmacy that usually services the facility, the resident is responsible for securing the medications and for assuring that applicable pharmacy regulations and facility policies are met. The facility:

(1) Shall notify the resident or the resident representative, at admission and as necessary throughout the resident’s stay in the facility, of the right to purchase medications from a pharmacy of the resident’s choice as well as the resident’s and pharmacy’s responsibility to comply with the facility’s policies and Federal and State laws regarding packaging and labeling requirements.

(2) Shall have procedures for receipt of medications from outside pharmacies including requirements for ensuring accuracy and accountability. Procedures shall include the review of medications for labeling requirements, dosage and instructions for use by licensed individuals who are authorized to administer medications.

(3) Shall ensure that the pharmacist or pharmacy consultant will receive a monthly resident medication profile from the selected pharmacy provider.

(4) Shall have a policy regarding the procurement of medications in urgent situations. Facilities may order a 7-day supply from a contract pharmacy if the resident’s selected pharmacy is not able to comply with these provisions.

(g) [Reserved].

(h) [Reserved].

(i) [Reserved].

(j) [Reserved].

(j.1) The facility shall have written policies and procedures for the disposition of medications that address all of the following:

(1) Timely and safe identification and removal of medications for disposition.

(2) Identification of storage methods for medications awaiting final disposition.

(3) Control and accountability of medications awaiting final disposition consistent with standards of practice.

(4) Documentation of actual disposition of medications to include the name of the individual disposing of the medication, the name of the resident, the name of the medication, the strength of the medication, the prescription number if applicable, the quantity of medication and the date of disposition.

(5) A method of disposition to prevent diversion or accidental exposure consistent with applicable Federal and State requirements, local ordinances and standards of practice.

(k) The oversight of pharmaceutical services shall be the responsibility of the quality assurance committee. Arrangements shall be made for the pharmacist responsible for the adequacy and accuracy of the services to have committee input. The quality assurance committee, with input from the pharmacist, shall develop written policies and procedures for drug therapy, distribution, administration, control, accountability and use.

(l) A facility shall have at least one emergency medication kit that is readily available to staff. The kit used in the facility shall be governed by the following:

(1) The facility shall have written policies and procedures pertaining to the use, content, storage, security, refill of and inventory tracking for the kits.

(2) The quantity and categories of medications and equipment in the kits shall be based on the immediate needs of the facility and criteria for the contents of the emergency medication kits shall be reviewed not less than annually.

(3) The emergency medication kits shall be under the control of a practitioner authorized to dispense or prescribe medications under the Pharmacy Act (63 P.S. § § 390-1—390-13).

(4) [Reserved].

The provisions of this § 211.9 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 211.9 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended April 23, 1982, effective April 24, 1982, 12 Pa.B. 1316; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8098. Immediately preceding text appears at serial pages (352795) to (352796) and (287199).

History

Authority: The provisions of this § 211.
Source: The provisions of this Chapter 211 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 211.10 Resident care policies.

(a) Resident care policies shall be available to admitting physicians, sponsoring agencies, residents and the public and shall reflect an awareness of, and provision for, meeting the total medical, nursing, mental and psychosocial needs of residents.

(b) The policies shall be reviewed at least annually and updated as necessary.

(c) The policies shall be designed and implemented to ensure that each resident receives treatments, medications, diets and rehabilitative nursing care as prescribed.

(d) The policies shall be designed and implemented to ensure that the resident receives proper care to prevent pressure sores and deformities; that the resident is kept comfortable, clean and well-groomed; that the resident is protected from accident, injury and infection; and that the resident is encouraged, assisted and trained in self-care and group activities.

The provisions of this § 211.10 amended under sections 102, 201(12), 601, 801.1 and 803 of Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 211.10 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8098. Immediately preceding text appears at serial pages (287199) to (287200).

Transfer

The transfer of a nursing home patient from an immediate care facility to a domiciliary care facility was proper as the decision to transfer was based on documentation in the clinical record which included the attending physician’s statement and consideration was given to the patient’s mental and psychological well being as well. Grkman v. Department of Public Welfare, 637 A.2d 761 (Pa. Cmwlth. 1994).

History

Authority: The provisions of this § 211.
Source: The provisions of this Chapter 211 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 211.12 Nursing services.

(a) [Reserved].

(b) There shall be a full-time director of nursing services who shall be a qualified licensed registered nurse.

(c) The director of nursing services shall have, in writing, administrative authority, responsibility and accountability for the functions and activities of the nursing services personnel and shall serve only one facility in this capacity.

(d) The director of nursing services shall be responsible for:

(1) Standards of accepted nursing practice.

(2) Nursing policy and procedure manuals.

(3) Methods for coordination of nursing services with other resident services.

(4) Recommendations for the number and levels of nursing services personnel to be employed.

(5) General supervision, guidance and assistance for a resident in implementing the resident’s personal health program to assure that preventive measures, treatments, medications, diet and other health services prescribed are properly carried out and recorded.

(e) The facility shall designate a charge nurse who is responsible for overseeing total nursing activities within the facility on each tour of duty each day of the week.

(f) [Reserved].

(f.1) In addition to the director of nursing services, a facility shall provide all of the following:

(1) Nursing services personnel on each resident floor.

(2) Effective July 1, 2023, a minimum of 1 nurse aide per 12 residents during the day, 1 nurse aide per 12 residents during the evening, and 1 nurse aide per 20 residents overnight.

(3) Effective July 1, 2024, a minimum of 1 nurse aide per 10 residents during the day, 1 nurse aide per 11 residents during the evening, and 1 nurse aide per 15 residents overnight.

(4) Effective July 1, 2023, a minimum of 1 LPN per 25 residents during the day, 1 LPN per 30 residents during the evening, and 1 LPN per 40 residents overnight.

(5) Effective July 1, 2023, a minimum of 1 RN per 250 residents during all shifts.

(f.2) To meet the requirements of subsections (f.1)(2) through (5):

(1) A facility may substitute an LPN or RN for a nurse aide but may not substitute a nurse aide for an LPN or RN.

(2) A facility may substitute an RN for an LPN.

(3)(i) A facility may not substitute an LPN for an RN except as provided under subparagraph (ii).

(ii) A facility with a census of 59 or under may substitute an LPN for an RN on the overnight shift only if an RN is on call and located within a 30-minute drive of the facility.

(g) [Reserved].

(h) [Reserved].

(i) A minimum number of general nursing care hours shall be provided for each 24-hour period as follows:

(1) Effective July 1, 2023, the total number of hours of general nursing care provided in each 24-hour period shall, when totaled for the entire facility, be a minimum of 2.87 hours of direct resident care for each resident.

(2) Effective July 1, 2024, the total number of hours of general nursing care provided in each 24-hour period shall, when totaled for the entire facility, be a minimum of 3.2 hours of direct resident care for each resident.

(i.1) Only direct resident care provided by nursing services personnel may be counted towards the total number of hours of general nursing care required under subsection (i).

(j) [Reserved].

(k) [Reserved].

(l) [Reserved].

The provisions of this § 211.12 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 211.12 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, except subsections (e) and (f) effective July 1, 1988, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, subsections (a)—(f.1)(2), (4) and (5), (f.2)—(i)(1) and (i.1)—(1) are effective July 1, 2023, subsections (f.1)(3) and (i)(2) are effective July 1, 2024, 52 Pa.B. 8098. Immediately preceding text appears at serial pages (287201) to (287202).

This section cited in 28 Pa. Code § 201.3 (relating to definitions).

History

Authority: The provisions of this § 211.
Source: The provisions of this Chapter 211 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 211.15 Dental services.

In addition to the requirements in 42 CFR 483.55 (relating to dental services), a facility shall make provisions to assure that resident dentures are retained by the resident. Dentures shall be marked for each resident.

The provisions of this § 211.15 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 211.15 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8098. Immediately preceding text appears at serial pages (287202) to (287203).

History

Authority: The provisions of this § 211.
Source: The provisions of this Chapter 211 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 211.16 Social services.

(a) A facility shall employ a qualified social worker on a full-time basis except:

(1) A facility with 26 to 59 beds may employ a part-time qualified social worker if the facility assessment indicates that a full-time qualified social worker is not needed.

(2) A facility with 25 beds or less may either employ a part-time qualified social worker or share the services of a qualified social worker with another facility.

(b) [Reserved].

The provisions of this § 211.16 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 211.16 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 31, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8098. Immediately preceding text appears at serial page (287203).

History

Authority: The provisions of this § 211.
Source: The provisions of this Chapter 211 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

28 Pa. Code § 211.17 Pet therapy.

If pet therapy is utilized, a facility shall have written policies and procedures to ensure all of the following:

(1) Animals are not permitted in the kitchen or other food service areas, dining rooms when meals are being served, utility rooms and rooms of residents who do not want animals in their rooms.

(2) Careful selection of types of animals is made so the animals are not harmful or annoying to residents.

(3) The number and types of pets are restricted according to the layout of the building, type of residents, staff and animals.

(4) Animals are carefully selected to meet the needs of the residents involved in the pet therapy program.

(5) [Reserved].

(5.1) Animals are up to date on vaccinations, are in good health and do not pose a risk to the health and safety of residents.

(6) Animals and places where they reside or visit are kept clean and sanitary.

(7) Infection prevention and control measures, such as hand hygiene, are followed by residents and personnel when handling animals.

The provisions of this § 211.17 amended under sections 102, 201(12), 601, 801.1 and 803 of the Health Care Facilities Act (35 P.S. § § 448.102, 448.201(12), 448.601, 448.801a and 448.803); and section 2102(a) and (g) of The Administrative Code of 1929 (71 P.S. § 532(a) and (g)).

The provisions of this § 211.17 adopted August 29, 1975, effective September 1, 1975, 5 Pa.B. 2233; amended January 30, 1987, effective July 1, 1987, 17 Pa.B. 514; amended July 23, 1999, effective July 24, 1999, 29 Pa.B. 3999; amended December 23, 2022, effective July 1, 2023, 52 Pa.B. 8098. Immediately preceding text appears at serial pages (287203) to (287204).

History

Authority: The provisions of this § 211.
Source: The provisions of this Chapter 211 adopted August 29, 1975, effective September 1, 1975, 5 Pa.

Subpart D Health Planning

Chapter 301 Limitation on Federal Participation for Capital Expenditures

28 Pa. Code § 301.1 Applicability.

This chapter is applicable to reviews of proposed capital expenditures by covered health care facilities conducted by the Department of Health under an agreement with the United States Department of Health and Human Services and implementing Federal regulations, 42 CFR 100.101—100.109 (relating to cost containment and quality control). The agreement is authorized by section 1122 of the Social Security Act (42 U.S.C.A. § 1320a-1); section 2102(a) and (g) of The Administrative Code of 1929 (71 P. S. § 532(a) and (g)) and Act 56-A of 1978 as it relates to the Health Department. The purpose of the program is to assure that Federal and State funds appropriated under Titles V, XVIII and XIX of the act (42 U.S.C.A. § § 701—709, 1395—1395zz and 1396—1396ff) and sections 441.1—472 of the Public Welfare Code (62 P. S. § § 441.1—472) are not used to support unnecessary capital expenditures made by or on behalf of health care facilities or health maintenance organizations which are reimbursed under any of those provisions.

History

Authority: The provisions of this § 301.
Source: The provisions of this Chapter 301 adopted October 26, 1979, effective October 27, 1979, 9 Pa.

28 Pa. Code § 301.2 Definitions.

The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise: Act—The Social Security Act, 42 U.S.C.A. § § 201—7706. Applicant—A person proposing a capital expenditure. Designated planning agency or DPA or Department—The Department of Health. HHS—The United States Department of Health and Human Services. Health care facility—The term includes hospitals, psychiatric hospitals, tuberculosis hospitals, skilled nursing facilities, kidney disease treatment centers, including freestanding hemodialysis units, intermediate care facilities and ambulatory surgical facilities, but does not include Christian Science sanatoriums operated, or listed and certified, by the First Church of Christ, Scientist, Boston, Massachusetts. For purposes of this definition:

(i) Hospital. An institution which is primarily engaged in providing to inpatients, by or under supervision of physicians, diagnostic services and therapeutic services for medical diagnosis, treatment and care of injured, disabled or sick persons, or rehabilitation services for the rehabilitation of injured, disabled or sick persons. The term does not include psychiatric and tuberculosis hospitals.

(ii) Psychiatric hospital. An institution which is primarily engaged in providing to inpatients, by or under the supervision of a physician psychiatric services for the diagnosis and treatment of mentally ill persons.

(iii) Tuberculosis hospital. An institution which is primarily engaged in providing to inpatients, by or under the supervision of a physician, medical services for the diagnosis and treatment of tuberculosis.

(iv) Skilled nursing facility. An institution or a distinct part of an institution which is primarily engaged in providing to inpatients skilled nursing care and related services for patients who require medical or nursing care, or rehabilitation services for the rehabilitation of injured, disabled or sick persons.

(v) Intermediate care facility. An institution which provides, on a regular basis, health-related care and services to individuals who do not require the degree of care and treatment which a hospital or skilled nursing facility is designed to provide, but who because of their mental or physical condition require health-related care and services (above the level of room and board).

(vi) Ambulatory surgical facility. A facility, not a part of a hospital, which provides surgical treatment to patients not requiring hospitalization. The term does not include the offices of private physicians or dentists, whether for individual or group practice. Health maintenance organization—A public or private organization, organized under the laws of a state, which:

(i) Provides or otherwise makes available to enrolled participants health care services, including at least the following basic health care services: Usual physician services, hospitalization, laboratory, X-ray, emergency and preventive services and out-of-area coverage.

(ii) Is compensated, except for co-payments, for the provision of the basic health care services listed in subparagraph (i) of this definition to enrolled participants on a predetermined periodic rate basis.

(iii) Provides physicians’ services primarily directly through physicians who are either employes or partners of the organization or through contracts or other arrangements with individual physicians or one or more groups of physicians organized on a group practice or individual practice basis. Health systems agency or HSA—An entity performing regional health planning and regulatory functions and duly designated by the Secretary of HHS under provisions of the Public Health Service Act (42 U.S.C.A. § § 201—300cc-15). Person—An individual, a trust or estate, partnership, a corporation, including associations, joint-stock companies and insurance companies, the Commonwealth, or a political subdivision or instrumentality, including a municipal corporation, of the Commonwealth.

The provisions of this § 301.2 amended through October 26, 1979, effective October 27, 1979, 9 Pa.B. 4164.

History

Authority: The provisions of this § 301.
Source: The provisions of this Chapter 301 adopted October 26, 1979, effective October 27, 1979, 9 Pa.

28 Pa. Code § 301.3 Expenditures covered.

(a) A capital expenditure proposed by or on behalf of a health care facility or health maintenance organization, the obligation for which is incurred by or on behalf of a health care facility or health maintenance organization after March 31, 1973, shall be subject to this chapter; provided, that in the case of a health care facility providing health care services as of December 18, 1970, which on such date was committed to a formal plan of expansion or replacement, this chapter does not apply with respect to such expenditures as may be made or such obligations as may be incurred for capital items included in such plan where preliminary expenditures toward the plan of expansion or replacement including payments for studies, surveys, designs, plans, working drawings, specifications, and site acquisition essential to the acquisition, improvement, expansion or replacement of the health care facility or equipment concerned, of $100,000 or more, had been made during the 3-year period ended December 17, 1970.

(b) For purposes of this chapter, a ‘‘capital expenditure’’ is an expenditure, including a force account expenditure, that is, an expenditure for a construction project undertaken by the facility as its own contractor which under generally accepted accounting principles is not properly chargeable as an expense of operation and maintenance and which exceeds $100,000, changes the bed capacity of the facility with respect to which such expenditure is made, or substantially changes the services of the facility with respect to which such expenditure is made.

(c) For purposes of subsection (b), the cost of studies, surveys, designs, plans, working drawings, specifications and other activities essential to the acquisition, improvement, expansion or replacement of the plant and equipment with respect to which the expenditure is made shall be included in determining whether such expenditure exceeds $100,000.

(d) For purposes of subsection (b), where the estimated cost of a proposed project, including cost escalation factors appropriate to the area in which the project is located, is, within 60 days of the date on which the obligation for the expenditure is incurred, certified by a licensed architect or engineer to be $100,000 or less, the expenditure may be deemed not to exceed $100,000 regardless of the actual cost of such project; provided, that in a case where the actual cost of the project exceeds $100,000, the health care facility or health maintenance organization on whose behalf the expenditure is made shall provide written notification of the cost to the designated planning agency not more than 30 days after the date on which the expenditure is incurred. The notification shall include a copy of the certified estimate.

(e) For purposes of subsection (b), a capital expenditure which changes the bed capacity of a facility means a capital expenditure which results in any increase or decrease in licensed capacity.

(f) For purposes of subsection (b), a capital expenditure which substantially changes the services of a facility means a capital expenditure which results in the addition of a clinically related, that is, diagnostic, curative, or rehabilitative service not previously provided in the facility or in the termination of such a service which had previously been provided in the facility.

(g) A change in a proposed capital expenditure which itself meets the criteria set forth in subsection (b) shall, for purposes of this chapter, be deemed a capital expenditure; provided, that an increase or decrease in the cost of a proposed capital expenditure which increase or decrease is not related to a change in bed capacity or a substantial change in services and does not increase the cost of the project more than 20%, may, at the option of the designated planning agency, be exempt from review under this chapter.

(h) When a person obtains, under lease or comparable arrangement or through donation a facility or part thereof or equipment for a facility the expenditure for which would have been considered a capital expenditure and subject to exclusion from reimbursement under this chapter if the person had acquired it by purchase, the acquisition shall be deemed a capital expenditure by or on behalf of the facility and the designated planning agency shall recommend that the Secretary of HHS:

(1) In the case of a lease or comparable arrangement, in computing the person’s rental expense, in determining the Federal payments to be made under Titles V, XVIII and XIX of the act (42 U.S.C.A. § § 701—709, 1395—1395zz and 1396—1396ff) with respect to services furnished in the facility, deduct the amount which in his judgment is a reasonable equivalent of the amount that would have been excluded if the person had acquired the facility or equipment by purchase.

(2) In the case of a lease or comparable arrangement, in computing the person’s return on equity capital, deduct an amount deposited under the terms of the lease or comparable arrangement.

(3) In the case of a donation which is carried by the person as a capital asset, exclude from reimbursement for services provided under Titles V, XVIII and XIX of the act (42 U.S.C.A. § § 701—709, 1395—1395zz and 1396—1396ff) an amount claimed for depreciation on the facility or equipment, and other costs related to its acquisition.

(i) An obligation for a capital expenditure shall be deemed to have been incurred by or on behalf of a health care facility or health maintenance organization:

(1) When an enforceable contract is entered into by the facility or organization or by a person proposing the capital expenditure on behalf of the facility or organization for the construction, acquisition, lease or financing, of a capital asset; to be enforceable a construction contract shall obligate a party to cause the capital asset to be constructed, require the commencement of construction by a date specified in the contract but no later than 6 months after the close of the period for incurring an obligation, and provide for appropriate liquidated damages in the event of default by the facility or organization.

(2) Upon the formal internal commitment of funds by a facility or organization for a force account expenditure which constitutes a capital expenditure.

(3) In the case of donated property, as described in subsection (h) of this section the date on which the gift is completed in accordance with Commonwealth law.

(4) In any event, if construction when applicable has not commenced within 2 years from the date on which the applicant received a recommended approval from the Department, an obligation incurred under this subsection shall expire and shall result in a termination of the obligation and of the recommended Commonwealth approval.

(j) A determination by the designated planning agency that a proposed expenditure is not a capital expenditure within the meaning of section 1122 of the act (42 U.S.C.A. § 1320a-1) and this chapter or that it falls within the exemption described in this section or that it is otherwise not subject to review under section 1122 of the act (42 U.S.C.A. § 1320a-1) shall be binding upon the Secretary of HHS. A determination by the designated planning agency that a proposed expenditure is a capital expenditure subject to review under section 1122 of the act and this chapter may be appealed, by the applicant, to the Secretary of HHS. The appeal may be made at any time, in such form and manner as the Secretary of HHS may prescribe.

(k) During the pendency of the appeal, the running of all time periods specified in § 301.6 (relating to procedures for agency review) shall be suspended, except that nothing in this subsection shall affect the requirement that written notice of the intention to make a capital expenditure subject to this chapter shall be received by the designated planning agency not less than 60 days prior to the date on which the expenditure is incurred.

History

Authority: The provisions of this § 301.
Source: The provisions of this Chapter 301 adopted October 26, 1979, effective October 27, 1979, 9 Pa.

28 Pa. Code § 301.4 Designation; review of proposed capital expenditures.

The Commonwealth has signed an agreement with the Secretary of HHS to designate the Department of Health as the designated planning agency which will submit to the Secretary of HHS, together with the supporting materials as the Secretary of HHS may require, the following information:

(1) With respect to each capital expenditure proposed by or on behalf of a health care facility or health maintenance organization in the Commonwealth, the findings of the designated planning agency as to whether the following has occurred:

(i) The designated planning agency had been given notice of the proposed capital expenditure at least 60 days prior to obligation for the expenditure.

(ii) The expenditure is or is not consistent with the standards, criteria or plans developed under the Public Health Service Act (42 U.C.S.A. § § 201—300cc-15) or the Mental Retardation Facilities and Community Mental Health Centers Construction Act of 1963, Pub. L. No. 88-64, 77 Stat. 282, to meet the need for adequate health care facilities in the area covered by the plans so developed.

(iii) In reaching the findings, the designated planning agency shall consult with and take into consideration the findings and recommendations of the appropriate health systems agency.

(iv) When the designated planning agency finds that the expenditure is not consistent with the standards, criteria or plans, it shall submit to the Secretary of HHS the findings and recommendations of all other agencies with which it has consulted.

(2) With respect to each proposed capital expenditure which is found by the designated planning agency to be not consistent with the standards, criteria or plans described in paragraph (1), its recommendation as to whether the Secretary of HHS should either:

(i) Exclude, in determining the Federal payments to be made under Titles V, XVIII and XIX of the act (42 U.S.C.A. § § 701—709, 1395—1395zz and 1396—1396ff) with respect to services furnished in the health care facility or health maintenance organization for which the capital expenditure is made, expenses related to the capital expenditure, in accordance with section 1122(d)(1) of the act (42 U.S.C.A. § 1320a-1).

(ii) Not exclude expenses, on the ground that the facility or organization has demonstrated proof of capability to provide comprehensive health care services efficiently, effectively and economically, and that an exclusion would discourage the operation or expansion of the facility or organization, or of any facility of the organization.

(3) With respect to each proposed capital expenditure which is found by an agency described in paragraph (1)(ii) to be not consistent with the standards, criteria or plans described in paragraph (1) within the field of responsibilities of the other agency, the findings and recommendations of the other agency.

(4) With respect to each proposed capital expenditure as to which the designated planning agency reaches a finding contrary to that reached by the health systems agency a statement of the reasons for a contrary finding.

This section cited in 28 Pa. Code § 301.7 (relating to fair hearing); 28 Pa. Code § 301.8 (relating to criteria for agency review); 28 Pa. Code § 301.9 (relating to determination by the Secretary of HHS); and 28 Pa. Code § 301.10 (relating to continuing effect of determinations).

History

Authority: The provisions of this § 301.
Source: The provisions of this Chapter 301 adopted October 26, 1979, effective October 27, 1979, 9 Pa.

28 Pa. Code § 301.5 Advisory body.

The Statewide Health Coordinating Council, constituted under section 1524 the act (42 U.S.C.A. § 300m-3), shall serve as the advisory body to the designated planning agency.

History

Authority: The provisions of this § 301.
Source: The provisions of this Chapter 301 adopted October 26, 1979, effective October 27, 1979, 9 Pa.

28 Pa. Code § 301.6 Procedures for agency review.

(a) Procedures for notification and review of proposed capital expenditures shall include the following:

(1) A health care facility or health maintenance organization proposing to make a capital expenditure subject to this chapter shall provide written notice of its intent to make such capital expenditure to the designated planning agency not less than 60 days prior to the date on which the obligation is expected to be incurred. The designated planning agency shall forward the letter of intent to the appropriate health systems agency.

(2) The notice shall be submitted on an application form provided by the designated planning agency and shall contain the information as may be required by the application and the health systems agency to meet the needs of all the agencies whose respective fields of responsibility cover the proposed expenditure. The designated planning agency shall promptly publicize its receipt of the notice through local newspapers and public information channels.

(3) If the application under this subsection is found by the health systems agency to be incomplete, the agency shall notify the person proposing the capital expenditure within 15 days of its receipt of the incomplete application, advising the person of the additional information required. Where the timely notification of incompleteness is provided, the period within which the designated planning agency is required to notify the person proposing the expenditure that the expenditure is not approved, shall run from the date of receipt by the health systems agency of an application containing the additional information.

(4) The health systems agency shall complete its review of an application for a capital expenditure and send its findings and recommendation to the designated planning agency no later than 70 days after receipt of a complete application.

(5) When an applicant makes a substantial change in its project during review by the designated planning agency, the applicant shall withdraw the application and resubmit it for a full review under paragraph (1). When a substantial change is made by the applicant during review by the health systems agency, the same procedure shall apply unless waived by the health systems agency. A ‘‘substantial change,’’ for purposes of this paragraph, shall mean any alteration to a project which changes the site; changes the project cost in excess of 20% or a limit established by the health systems agency, whichever is smaller; changes the number of beds by 5% or five beds, whichever is smaller; or substantially changes the services provided by the health care facility.

(6) The designated planning agency shall within 90 days after the receipt of a complete application unless the applicant agrees to a longer period, provide written notification to the applicant of its decision to recommend approval or disapproval of a project to the Secretary of HHS or of its decision not to review a project.

(7) A health systems agency may, with the approval of the designated planning agency, give a nonsubstantive review, that is, less than a full review, to a proposed capital expenditure. Factors which will be considered in determining when to permit a nonsubstantive review include a project cost of less than $100,000; replacement of plant or equipment as a result of a natural disaster, fire, equipment failure or similar occurrence requiring immediate replacement in order to maintain continuity of operation; or alteration strictly for remedying Life Safety Code deficiencies, supported by an inspection report from the appropriate agency, when the need is apparent.

(8) The failure of the designated planning agency to provide notification within the time limitations set forth in this section shall have the effect of a recommendation of approval to the Secretary of HHS.

(9) When the designated planning agency notifies an applicant of its intention to recommend disapproval of the proposed expenditure to the Secretary of HHS, it shall include the reasons therefor and a summary of the findings and recommendations of the other agencies with which such agency has consulted and shall provide an opportunity for a fair hearing with respect to the findings and recommendations of the designated planning agency at the request of the applicant.

(10) Copies of the findings and recommendations of the designated planning agency shall also be sent to the other agencies consulted, and shall be publicized through local newspapers and public information channels.

(b) A person proposing a capital expenditure may withdraw his previously filed application without prejudice by filing simultaneous written notification of the withdrawal with the health systems agency and the designated planning agency at any time prior to his receipt of notice from the designated planning agency of its intention to make a recommendation to the Secretary of HHS.

This section cited in 28 Pa. Code § 301.3 (relating to expenditures covered); 28 Pa. Code § 301.9 (relating to determination by the Secretary of HHS); 28 Pa. Code § 301.10 (relating to continuing effect of determinations); and 28 Pa. Code § 301.11 (relating to phase-out of health facilities review program).

History

Authority: The provisions of this § 301.
Source: The provisions of this Chapter 301 adopted October 26, 1979, effective October 27, 1979, 9 Pa.

28 Pa. Code § 301.7 Fair hearing.

The designated planning agency will grant to an applicant an opportunity for a fair hearing with respect to the findings and recommendations of the designated planning agency. The procedures for a fair hearing shall be as follows:

(1) Request for hearing. Requests for hearing shall conform with the following:

(i) Requests for hearing shall be made in writing to the designated planning agency within 30 days after the applicant receives notice of the designated planning agency’s findings and recommendations. The request for hearing shall be in the form of a pleading. It shall indicate which of the issues specified in this subsection the applicant wishes to raise and shall set forth the facts and the law upon which the applicant relies. A mere general assertion that the capital expenditure is consistent with standards, criteria or plans or that the designated planning agency committed prejudicial error, or the like, will not be considered as complying with this subsection. The Hearing Officer may strike a portion of a request for hearing which does not comply with this subsection, or, in the alternative, may permit the applicant to make its request more specific. In the latter event, the hearing shall be commenced within 30 days of the filing of the amended request for hearing.

(ii) Subparagraph (i) supplements 1 Pa. Code § 35.17 (relating to petitions generally).

(2) Commencement and procedure. Commencement and procedure shall conform with the following:

(i) The hearing shall be commenced within 30 days after receipt of the request described in subsection (c)(1) (or later, at the option of the person requesting the hearing), and shall be conducted in accordance with the regulations contained in this subsection and 1 Pa. Code Part II (relating to general rules of administrative practice and procedure); provided that, whenever the general rules of administrative practice and procedure are inconsistent with this subsection, the latter shall control.

(ii) The following provisions of the general rules of administrative practice and procedure are inapplicable to hearings held under this subsection: 1 Pa. Code § § 35.190, 35.201—35.203, 35.211—35.214, 35.221, 35.225, 35.226, 35.231—35.233, 35.241 and 35.251 (relating to appeals to agency head from rulings of presiding officers; certification of record without proposed report; proceedings in which proposed reports are prepared; unavailability of presiding officer; exception to proposed reports; briefs and argument in absence of proposed report; decisions; reopening of record; application for rehearing or reconsideration; and reports of compliance).

(3) Hearing officer. Hearing officers shall conform with the following:

(i) Hearings shall be conducted by an agency or person, other than the designated planning agency, as the Governor designates for that purpose; provided, that no agency which or person who has taken part in a prior consideration of or action upon the proposed capital expenditure may conduct the hearing.

(ii) Subparagraph (i) supersedes 1 Pa. Code § 35.123 (relating to conduct of hearings).

(4) Open to the public. The hearing shall be open to the public and shall be publicized through local newspapers and public information channels.

(5) Testimony from the public. Testimony from the public shall conform with the following:

(i) The person proposing the capital expenditure, the other agency described § 301.4(i)(iii) (relating to designation; review of proposed capital expenditures) and other interested parties, including members of the public and representatives of consumers of health services, shall be permitted to give testimony and present arguments at the hearing without formally intervening. Reference should be made to 1 Pa. Code § § 35.27—35.32 (relating to intervention). The testimony and arguments shall be presented after the testimony of the designated planning agency, the applicant, and any intervening parties has been heard but may be presented, at the discretion of the Hearing Officer, at any other convenient time. When the testimony is presented, parties may cross-examine the witness.

(ii) Subparagraph (i) supplements 1 Pa. Code § § 35.27—35.32 and 35.125(b) (relating to order of procedure).

(6) Scope of the fair hearing. The scope of the fair hearing shall be as follows:

(i) Hearings shall be limited to the following issues the applicant raises:

(A) Whether the findings and recommendations of the designated planning agency are supported by substantial evidence.

(B) Whether there was a violation of the constitutional or statutory rights of the applicant or a prejudicial procedural error in the review of the proposed capital expenditure.

(ii) The following issues may not be considered at a hearing:

(A) The correctness, adequacy or appropriateness of the standards, criteria or plans against which the proposed expenditure was measured.

(B) Whether the proposed expenditure is subject to review by the designated planning agency.

(ii) Subparagraphs (i) and (ii) supplements 1 Pa. Code § 35.162 (relating to reception and ruling on evidence).

(7) Burden of going forward; burden of proof. Procedures shall be as follows:

(i) Unless the Hearing Officer, for good cause, orders otherwise, the designated planning agency will proceed first with its case, followed by the applicant’s case; nevertheless, the burden of proof shall be on the applicant, and the findings and recommendations of the designated planning agency shall be sustained unless unsupported by substantial evidence or unless the applicant establishes that it was the victim of a violation of law or a prejudicial procedural error.

(ii) Subparagraph (i) supersedes 1 Pa. Code § 35.125(a) (relating to order of procedure).

(8) Record from below. Records shall conform with the following:

(i) The Hearing Officer shall admit, if offered, the following documents as constituting the record of the designated planning agency’s decision:

(A) The complete application for the proposed capital expenditure.

(B) The standards, criteria or plans against which the proposed expenditure was measured by the designated planning agency and by any agency consulted by the designated planning agency.

(C) The findings and recommendations of the designated planning agency and of any agency consulted by the designated planning agency.

(D) Minutes, transcripts or other records of a public hearing or public meeting held by the designated planning agency or an agency consulted by the designated planning agency at which hearing or meeting the proposed expenditure was considered.

(E) Other documentary evidence considered by the designated planning agency, or an agency consulted by the designated planning agency, in making its findings and recommendations.

(ii) Paragraph (8) shall not be construed so as to deprive a party of the opportunity to offer additional documentary or oral evidence relevant to an issue raised in the hearing.

(iii) Subparagraph (ii) supplements 1 Pa. Code § § 35.125(d) and 35.162.

(9) Record of the fair hearing. A record of the proceedings shall be kept in accordance with the requirements of applicable State law and copies of the record together with copies of documents received in evidence, shall be available to the public for inspection and copying: provided, that a person who requests copies of the material may be required to bear the costs thereof.

(10) Conclusion of the hearing. Conclusion of the hearing shall conform with the following:

(i) Hearings shall conclude on the last day fixed by the Hearing Officer for the submission of a brief. The Hearing Officer shall notify all parties, in writing or on the record, of the day on which the hearing will conclude and of any changes thereto.

(ii) Subparagraph (i) supplements 1 Pa. Code § 35.191 (relating to proceedings in which briefs are to be filed).

(11) Notification of decision. As soon as practicable, but not more than 45 days after the conclusion of a hearing, the Hearing Officer shall notify the person who requested the hearing, the designated planning agency, the other agencies described in § 301.4(1)(iii) who participated in the hearing, and other interested parties at the discretion of the Hearing Officer of his decision and the reasons therefor. The decision shall be publicized through local newspapers and public information channels. In the event that the Hearing Officer fails to provide notice as required in this section within 45 days after the conclusion of a hearing, the failure to provide notice shall have the effect of a recommendation of approval to the Secretary of HHS.

(12) Disposition of the record. Disposition of the record shall conform with the following:

(i) After rendering his decision, the Hearing Officer shall transmit the record of the hearing to the designated planning agency.

(ii) The provisions of subparagraph (i) supplement the provisions of 1 Pa. Code § 35.133 (relating to copies of transcripts).

(13) Role of the fair hearing decision. A decision of a Hearing Officer arrived at in accordance with this subsection shall, to the extent that it reverses or revises the findings or recommendations of the designated planning agency, supersede the findings and recommendations of the designated planning agency; provided, that where judicial review of the decision is obtained, the final decision of the reviewing court to the extent that it modifies the findings and recommendation of the designated planning agency, shall to such extent supersede the findings and recommendation of the designated planning agency.

(14) Further action. To the extent that any decision of a Hearing Officer under this subsection requires that the designated planning agency take further action, the action shall be completed by the date the Hearing Officer specifies. Failure by the designated planning agency to complete the action by the date shall have the effect of a recommendation of approval of the proposed capital expenditure.

History

Authority: The provisions of this § 301.
Source: The provisions of this Chapter 301 adopted October 26, 1979, effective October 27, 1979, 9 Pa.

28 Pa. Code § 301.8 Criteria for agency review.

The criteria under which the designated planning agency and the other agency described in § 301.4(1)(iii) (relating to designation; review of proposed capital expenditures) evaluates proposals for capital expenditures for purposes of this chapter to determine their conformance with the applicable standards, criteria and plans referred to in § 301.4(1)(ii)—(iv) includes the following:

(1) Whether the proposed project is needed or projected as necessary to meet the needs in the community in terms of health services required; provided, that projects for highly specialized services, such as open-heart surgery, renal transplantation or radiation therapy, which will draw from patient population outside the community in which the project is situated will receive appropriate consideration.

(2) Whether the proposed project can be adequately staffed and operated when completed.

(3) Whether the proposed capital expenditure is economically feasible and can be accommodated in the patient charge structure of the health care facility or health maintenance organization without unreasonable increases.

(4) Whether the project will foster cost containment or improved quality of care through improved efficiency and productivity, including promotion of cost-effective factors such as ambulatory care, preventive health care services, home health care and design and construction economies, or through increased competition between different health services delivery systems.

History

Authority: The provisions of this § 301.
Source: The provisions of this Chapter 301 adopted October 26, 1979, effective October 27, 1979, 9 Pa.

28 Pa. Code § 301.9 Determination by the Secretary of HHS.

(a) This section issued by the Department of Health imposes no legal obligation on the Secretary of HHS. It restates the Federal regulation found at 42 CFR 100.108 (relating to determination by the Secretary). Reference should be made to the Federal regulation.

(b) Except as provided in subsection (c), if the Secretary of HHS determines that the designated planning agency has not been given timely notice of intention to make a capital expenditure in accordance with § 301.6 (relating to procedures for agency review) or that the designated planning agency has, in accordance with the requirements of section 1122 of the act (42 U.S.C.A. § 1320a-1) and this chapter, submitted to the Secretary of HHS its findings that the expenditure is not consistent with the standards, criteria or plans described in § 301.4(2) (relating to designation; review of proposed capital expenditures) then for a period the Secretary of HHS deems necessary to effectuate the purpose of section 1122 of the act, the Secretary of HHS will, in determining the Federal payments to be made under Titles V, XVIII and XIX of the act (42 U.S.C.A. § § 701—709, 1395—1395zz and 1396—1396ff) to the health care facility or health maintenance organization, exclude expenses related to the capital expenditure.

(c) Notwithstanding the provisions of subsection (b), if the Secretary of HHS, after submitting the matters involved to the National Advisory Health Council on Comprehensive Health Planning Programs and after taking into consideration the recommendations of the designated planning agency and the other agency described in § 301.4 (2)(i) with respect to the expenditure, determines that an exclusion of expenses related to a capital expenditure of a health care facility or health maintenance organization would discourage the operation or expansion of the facility or organization or of any facility of the organization which has demonstrated to his satisfaction proof of capability to provide comprehensive health care services efficiently, effectively and economically or would otherwise be inconsistent with the effective organization and delivery of health services or the effective administration of Titles V, XVIII or XIX of the act (42 U.S.C.A. § § 701—709, 1395—1395zz and 1396—1396ff), the Secretary of HHS will include the expenses in Federal payments under such titles.

(d) Upon making a determination under this section, the Secretary of HHS will promptly notify the person proposing a capital expenditure, the designated planning agency and the other agency described in § 301.4 (2)(i) with which the designated planning agency has consulted of the determination and the basis for the determination.

(e) A person dissatisfied with a determination by the Secretary of HHS under section 1122 of the act or this chapter with respect to a particular capital expenditure may, within 6 months following the date of the determination, request the Secretary of HHS to reconsider the determination.

(1) The request for reconsideration shall be in writing, shall be addressed to the Secretary of HHS or to an officer or employe of HHS to whom the Secretary of HHS has delegated responsibility to receive requests, and shall set forth the grounds based upon the record of the proceedings and issues of law upon which reconsideration is requested.

(2) Reconsideration will be based upon the record of the proceedings, which shall consist of the findings; the recommendation and supporting materials submitted to the Secretary of HHS by the designated planning agency, including the findings and recommendations of other agencies, which relate to the findings and recommendations involved; the record of the hearing provided by the designated planning agency, if any, and of judicial proceedings; the materials submitted in connection with the request; and the comments as the Secretary of HHS may request from the designated planning agency.

(3) Notice of a reconsidered determination under this subsection shall be sent to the designated planning agency and the person requesting such reconsideration.

(f) A determination by the Secretary of HHS is, under section 1122 of the act (42 U.S.C.A. § 1320a-1), not subject to administrative or judicial review.

The provisions of this § 301.9 amended through October 26, 1979, effective October 27, 1979, 9 Pa.B. 4164.

History

Authority: The provisions of this § 301.
Source: The provisions of this Chapter 301 adopted October 26, 1979, effective October 27, 1979, 9 Pa.

28 Pa. Code § 301.10 Continuing effect of determinations.

(a) Except in the case of a long-term construction plan of the type described in subsection (b), where the designated planning agency has found that a proposed capital expenditure is in conformity with the standards, criteria and plans described in § 301.4(a)(2) (relating to designation; review of proposed capital expenditures), the obligation for capital expenditure shall be incurred not more than 1 year following the date of the finding; provided, that the designated planning agency may, under a showing of good cause by the person proposing the expenditure, extend the period during which the obligation shall be incurred for up to an additional 6 months from the expiration date of the original approval. The health systems agency shall contact the applicant no later than 10 months after the designated planning agency approval to notify the person of the expiration date and of the procedure for requesting a 6-month extension for good cause. If no obligation is incurred within the period or, if incurred, the facility or organization has not started construction or purchased the equipment for which the approval was granted, within 6 months following the expiration date for incurring an obligation, the approval of the designated planning agency shall, for purposes of this chapter, be deemed to be terminated upon the expiration of the applicable period. When a project approval is terminated for failure to incur an obligation or to start construction or purchase equipment in a timely manner, the designated planning agency will notify the applicant in writing of the termination.

(b) In the case of a plan for capital expenditures proposed by or on behalf of a health care facility or health maintenance organization under which a series of obligations for capital expenditures for discrete components of the plan is to be incurred over a period longer than 1 year, the designated planning agency may review and approve or disapprove, for purposes of this chapter, those of capital expenditures which it estimates will be incurred within 3 years following the date of approval or disapproval.

(1) In any case in which the Secretary of HHS has determined under a finding by the designated planning agency that a proposed capital expenditure is not in conformity with the standards, criteria or plans described in § 301.4(a)(2), that expenses related to the capital expenditure will not be included in determining Federal payments under Titles V, XVIII and XIX of the act (42 U.S.C.A. § § 701—709, 1395—1395zz and 1396—1396ff), the health care facility or health maintenance organization to whom the payments are made shall be entitled, upon its request to the designated planning agency in such form and manner and supported by information as the agency may require, to a reconsideration by the designated planning agency of the finding:

(i) Whenever there is a substantial change in existing or proposed health facilities or services of the type proposed in the area served by the facility or organization.

(ii) Upon a substantial change in the need for facilities or services of the type proposed in the area served by the facility or organization as reflected in the standards, criteria or plans referred to in § 301.4(a)(2).

(iii) At any time following the expiration of 3 years from the date of the finding of the designated planning agency or of its last reconsideration of a finding under this subsection, whichever is later.

(2) Reconsideration shall be dealt with as follows:

(i) If, upon reconsideration of its finding under this subsection and after consulting with and taking into consideration the findings and recommendations of the other agency described in § 301.4(a)(2)(i) the designated planning agency finds that the facilities or services provided by the capital expenditure are in conformity with the standards, criteria and plans described in § 301.4(a)(2) it shall promptly so notify the Secretary of HHS and the person submitting the request.

(ii) If the designated planning agency, upon reconsideration, reaffirms its previous finding, the procedure set forth in § 301.6 (relating to procedures for agency review) and fair hearings following an initial determination shall be followed.

(3) Upon notification by a designated planning agency of a revised finding in accordance with paragraph (2), the Secretary of HHS will include (42 U.S.C.A. § § 701—709, 1395—1395zz and 1396—1396ff), in determining future payments under Titles V, XVIII and XIX of the act, expenses related to the capital expenditure. The expenses will be included for periods following the date of notification only and amounts previously excluded may not be taken into account in determining Federal payments under Titles V, XVIII and XIX of the act.

History

Authority: The provisions of this § 301.
Source: The provisions of this Chapter 301 adopted October 26, 1979, effective October 27, 1979, 9 Pa.

28 Pa. Code § 301.11 Phase-out of health facilities review program.

(a) No letter of intent required by § 301.6(a)(1) (relating to procedures for agency review) will be accepted after July 31, 1980.

(b) No ‘‘Health Facilities Section 1122 Project Form’’ required by § 301.6(a)(2) will be accepted after September 30, 1980. No ‘‘Health Facilities Section 1122 Project Form’’ will be accepted unless a letter of intent related to that project has been submitted prior to July 31, 1980.

(c) Forms required to be filed under § 301.6 will be reviewed for completeness in accordance with the procedures established in that section by December 1, 1980. In the event an application is found to be incomplete; required information shall be submitted by December 1, 1980, or the applications will be deemed to be abandoned and no further review will occur. The Department may grant an appropriate extension if unique circumstances require it, but in no event will the extension exceed 3 months.

The provisions of this § 301.11 issued under section 2102(a) and (g) of The Administrative Code of 1929 (71 P. S. § 532(a) and (g)); and section 904 of the Health Care Facilities Act (35 P. S. § 448.904).

The provisions of this § 301.11 adopted October 24, 1980, effective October 25, 1980, 10 Pa.B. 4213.

History

Authority: The provisions of this § 301.
Source: The provisions of this Chapter 301 adopted October 26, 1979, effective October 27, 1979, 9 Pa.

Chapter 401 Certificate of Need Program

28 Pa. Code § 401.1 Applicability.

The provisions of this chapter shall be applicable to persons who propose to undertake to offer, develop, construct or otherwise establish, or to undertake to establish, within the Commonwealth a new institutional health service.

History

Authority: The provisions of this Chapter 401 issued under the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 401 adopted July 25, 1980, effective August 1, 1980, 10 Pa.

28 Pa. Code § 401.2 Definitions.

The following words or terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise: Act—The Health Care Facilities Act (35 P. S. § § 448.101—448.904). Administrative review—An expedited review conducted solely by the Department. Affected person—A person whose proposal is being reviewed for purposes of certificate of need, the health systems agency for the health service area in which the proposed new institutional health service is to be offered or developed, health systems agencies serving contiguous health service areas, health care facilities and health maintenance organizations located in the health service area which provide institutional health services, and those members of the public who are to be served by the proposed new institutional health services and those agencies, if any, which establish rates for health care facilities and health maintenance organizations located in the health systems area in which the proposed new institutional health service is to be offered or developed. Ambulatory surgical facility—A facility not located upon the premises of a hospital which provides outpatient surgery to patients who do not require overnight hospitalization but who do require medical supervision following the procedure. An ambulatory surgical facility does not include individual or group practice offices of private physicians or dentists, unless such offices have a distinct part used solely for outpatient surgical treatment on a regular and organized basis. Annual implementation plan—The latest annual statement of objectives of the health systems agency to achieve the goals of the health systems plan, including the priorities established among the objectives. Association with—Acting as a director, officer or employe of an organization at the present time or within the last 12 months. Bed capacity—The total number of licensed or approved beds which are set up and staffed and licensed or approved beds which are out of service. Out of service beds include the following:

(i) Beds which are set up but not staffed due to seasonal fluctuations in demand or construction or renovation of the facility.

(ii) Beds which are not being utilized because of the conversion of a multibed room to a single bed room. Business days—Days when the Department is open and staffed for regular business. Certificate of Need—A certificate issued by the Department under this chapter, including those issued as an amendment to an existing Certificate of Need. Council—The Statewide Health Coordinating Council established under the National Health Planning and Resources Development Act of 1974 (42 U.S.C.A. § § 300k—300n-6). Department—The Department of Health of the Commonwealth. Develop—When used in connection with health services or facilities, means to undertake those activities which on their completion will result in the offering of a new health service or the incurring of a financial obligation in relation to the offering of such a service. Health care facility—General or special hospitals, including tuberculosis and psychiatric hospitals, rehabilitation facilities, skilled nursing facilities, intermediate care facilities, kidney disease treatment centers including free-standing dialysis units and ambulatory surgical facilities. The term includes both profit and nonprofit facilities including those operated by an agency of State or local government. Health care facilities does not include the following:

(i) An office used exclusively for a private or group practice by physicians or dentists does not constitute a health care facility unless the office is located within a health care facility or the services of the practice are offered by or through a health care facility.

(ii) A program which renders treatment or care for drug or alcohol abuse or dependence does not constitute a health care facility unless the office is located within a health care facility or the service is offered in, by or through a health care facility.

(iii) A facility providing treatment solely on the basis of prayer or spiritual means in accordance with the tenets of a religious denomination or church does not constitute a health facility.

(iv) A facility providing health care services exclusively to persons in a religious profession who are members of the religious denomination or church which operate the facility does not constitute a health care facility.

(v) A freestanding home health care agency. Health maintenance organization (HMO)—An organization defined as a health maintenance organization by 42 U.S.C.A. § 300n (8) or by the Health Maintenance Organization Act (40 P. S. § § 1551—1567). Health service area—The area served by a health systems agency designated under the National Health Planning and Resources Development Act of 1974 (42 U.S.C.A. § § 300k—300n-6). Health services—Clinically related, that is, diagnostic, treatment or rehabilitative services, including alcohol, drug abuse and mental health services. Health Systems Agency (HSA)—An entity which has been conditionally or fully designated under the National Health Planning and Resources Development Act of 1974 (42 U.S.C.A. § § 300k—300n-6). Health Systems Plan (HSP)—The latest HSA Board approved statement of health service area goals and strategies for achieving the goals. Hearing Board—The State Health Facility Hearing Board created in the Office of General Counsel under the provisions of the act. HHS—The United States Department of Health and Human Services. Home health care—The provision of nursing and other therapeutic services to disabled, injured or sick persons in their place of residence and other health related services provided to protect and maintain persons in their own home. Hospital—An institution licensed or approved by the Department as a hospital. Intermediate care facility—A facility or part of a facility in which professionally supervised nursing care and related medical or other health services are provided for a period exceeding 24 hours for two or more individuals who do not require the degree of care and treatment which a hospital or skilled nursing facility is designed to provide, but who because of age, illness, disease, injury, convalescence or mental or physical infirmity, need medical or other health services. Intermediate care facilities exclusively for mentally retarded persons are considered intermediate care facilities for the purpose of the act. Kidney disease treatment facility—A facility, including a free-standing dialysis unit, providing treatment to persons with end-stage renal or other kidney disease. For purposes of the act, dialysis stations will be treated as licensed/approved beds. Major medical equipment—edical equipment which is used for the provision of medical and other health services and which costs in excess of the minimum expenditure threshold for major medical equipment established by Federal statute or regulations except major medical equipment acquired by or on behalf of a clinical laboratory to provide clinical laboratory services if the clinical laboratory is independent of a physician’s office and a hospital and it has been determined under the Medicare program to meet the applicable requirements of the Social Security Act (42 U.S.C.A. § § 300v—300y-11). In determining whether medical equipment has a value in excess of the threshold, the value of studies, surveys, designs, plans, working drawings, specifications and other activities essential to the acquisition of the equipment shall be included. National Health Planning and Resources Development Act of 1974—42 U.S.C.A. § § 300k—300n-6. Nonsubstantive review—A review which is less comprehensive than a full review but maintains all statutory procedures including third party rights, and an HSA recommendation. Projects may receive a nonsubstantive review as determined by the Department after consultation with the HSA. Projects eligible for a nonsubstantive review should not involve a capital expenditure greater than $2 million and include, but are not limited to, the following:

(i) Change of 10 beds or 10% of capacity or less, whichever is less, if the change conforms to the Health Systems Plan. This subparagraph applies to bed changes to approved projects and to cases in which facilities have already exercised the 10 bed/10% option during a 2-year period.

(ii) Replacement of equipment not involving a substantial change in functional capacity or capability.

(iii) Projects identified as needed in the Health Systems Plan or State Health Plan.

(iv) Renovations necessary to meet code requirements which do not expand the capacity of the facility.

(v) Repairs or reconstruction in cases of emergencies.

(vi) Addition of a new health service if the annual operating expense is less than $500,000.

(vii) Nonclinical projects, such as parking, energy, medical office buildings, and telephone.

(viii) Refinancing.

Due to the relatively insignificant consequences of some of the changes that would require a nonsubstantive review, an administrative review can be substituted if the HSA and the Department agree that only an administrative review is necessary. The Department will render its decision on the project within 30 business days of receipt of the required information. Offer—ake provision for providing in a regular manner and on an organized basis specified health services. Organization—A nonprofit corporation or other corporation, partnership, association or other organization. Person—A natural person, corporation including associations, joint stock companies and insurance companies, partnerships, trusts, estates, associations, the Commonwealth, and any local governmental unit, authority and agency thereof. The term includes all entities owning or operating a health care facility or health maintenance organization. Persons directly affected—A person whose proposal for certificate of need is being reviewed, members of the public who are to be served by the proposed new institutional health services, health care facilities and health maintenance organizations located in the health service area in which the service is proposed to be offered or developed which provide services similar to the proposed services under review, and health care facilities and health maintenance organizations which prior to receipt by the agency of the proposal being reviewed have formally indicated an intention to provide such similar service in the future and those agencies, if any, which establish rates for health care facilities and health maintenance organizations located in the health systems area in which the proposed new institutional health service is to be offered or developed. Policy board—The Health Care Policy Board created in the Department under the act. Predevelopment costs—Expenditures for preparation of architectural designs, working drawings, plans and specifications, and any other preparation directed toward planning, developing, or offering a new institutional health service. Project—A proposal by a person to offer, develop, construct, or otherwise establish or undertake to establish a new institutional health service as defined in § 401.3 (relating to new institutional health services). Public Health Service Act—42 U.S.C.A. § § 201—300z-10. Public hearing—A meeting open to the public where any person has an opportunity to present testimony held without imposition of fee. Rehabilitation facilities—An inpatient facility which is operated for the primary purpose of assisting in the rehabilitation of disabled persons through an integrated program of medical and other services which are provided under competent professional supervision. These facilities are comprehensive physical rehabilitation facilities. They do not include freestanding treatment facilities for drugs or alcohol or both. Retroactive review—A review which is conducted after a person has undertaken a reviewable activity without a certificate of need. The reviews are procedurally identical to a regular review specified in this chapter. Such persons are subject to penalties as specified in the act. Secretary—The Secretary of the Department. Skilled nursing facility—A facility or part of a facility in which professionally supervised nursing care and related medical or other health services are provided for a period exceeding 24 hours for two or more individuals who are not in need of hospitalization and who are not relatives of the nursing home administrator, but who because of age, illness, disease, injury, convalescence, or physical or mental infirmity, need such care. State Health Plan (SHP)—A statement of goals for the State health care system based on the Health Systems Plans for the State and approved by the Statewide Health Coordinating Council and the Governor prepared triennially, reviewed annually and revised as necessary. It describes the institutional health services needed to provide for the well-being of persons receiving care within the State, the number and type of resources, including facilities, personnel, major medical equipment, and other resources, including financial resources, required to meet the goals of the plan, states the extent to which existing health care facilities are in need of modernization, conversion to other uses, or closure and the extent to which new health care facilities need to be constructed or acquired. Statewide Health Coordinating Council—The Council established in compliance with Title XV of the Public Health Service Act. Substantial implementation of a project—The completion of the following requirements relative to but not limited to the following types of projects. All of the requirements listed in this paragraph must be completed within 1 year after issuance of the certificate or within 18 months after issuance of the certificate if an extension has been granted.

(i) New construction or renovation projects. New construction or renovation projects shall conform to all of the following:

(A) The title or long-term lease to the appropriate site has been acquired.

(B) The appropriate State agency has approved the complete set of schematic drawings for the project.

(C) A financial commitment has been obtained for at least 60% of the total approved capital expenditure. The commitment may be any combination of funds, such as the applicant’s own funds, grants, gifts, or an enforceable offer and acceptance from a financial institution to provide adequate capital financing for the project.

(D) An enforceable construction contract has been entered into causing the commencement of construction no later than 24 months after issuance of a certificate. Failure to commence construction within this time period shall be considered an abandonment of the project, and the certificate issued shall be withdrawn. Erection of the foundation shall constitute commencement of construction.

(ii) Acquisition of equipment. The equipment must either be purchased; the lease agreement must be entered into by the proponent; or if acquired by a comparable arrangement, the health care facility or health maintenance organization must have possession of the equipment.

(iii) Addition of a new service. A written statement must be submitted to the Department verifying that the service is in operation.

(iv) Donated property. In the case of donated property, the date on which title to the donated property is transferred in accordance with applicable State statute. Third-party payor—A person who makes payments on behalf of patients under compulsion of law or contract who does not supply care or services as a health care provider or who is engaged in issuing any policy or contract of individual or group health insurance or hospital or medical service benefits, but shall not include the Federal, State, or any local government unit, authority or agency thereof or a health maintenance organization.

The provisions of this § 401.2 issued section 2102(a) and (g) of The Administrative Code of 1929 (71 P. S. § 532 (a) and (g)); and section 201(14) of the Health Care Facilities Act (35 P. S. § 448.201(14)).

The provisions of this § 401.2 amended April 13, 1984, effective April 14, 1984, 14 Pa.B. 1294. Immediately preceding text appears at serial pages (55635) to (55637), and (52906) to (52910).

This section cited in 28 Pa. Code § 401.5 (relating to Certificate of Need); 28 Pa. Code § 401.6 (relating to certificate of need—statement of policy); and 55 Pa. Code § 1187.113a (relating to nursing facility replacement beds—statement of policy).

History

Authority: The provisions of this Chapter 401 issued under the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 401 adopted July 25, 1980, effective August 1, 1980, 10 Pa.

28 Pa. Code § 401.3 New institutional health services.

(a) No person shall offer, develop, construct or otherwise establish or undertake to establish within the State a new institutional health service without first obtaining a certificate of need from the Department.

(b) A new institutional health service shall mean the following:

(1) The construction, development or other establishment of a health care facility or health maintenance organization.

(2) An expenditure by or on behalf of a health care facility or Health Maintenance Organization (HMO) in excess of the minimum capital expenditure threshold established by Federal law or regulation which, under generally accepted accounting principles, consistently applied is a capital expenditure. For the purpose of this subsection, any expenditure which is not properly chargeable under generally accepted accounting principles as an expense of operation and maintenance shall be deemed a capital expenditure. An acquisition of a building, property, or equipment by or on behalf of a health care facility or a HMO under lease or comparable arrangement, or through donation, which would have required review if the acquisition had been by purchase, shall be deemed a capital expenditure subject to review.

(3) An expenditure by or on behalf of a health care facility or a health maintenance organization in excess of the minimum capital expenditure threshold established by Federal law or regulation made in preparation for the offering or development of a new institutional health service and any binding arrangement or commitment by either of them for financing the offering or development of the new institutional health service.

(4) Expenditures for the acquisition of an existing health care facility or health maintenance organization shall not be subject to review if notice has been provided to the Department under subsection (c), and the Department finds within 30 days of receipt of the notice that the services or bed capacity of the facility to be acquired will not be changed in being acquired within 1 year from the date of the change of ownership. This does not prohibit facilities from increasing, redistributing, or relocating beds by 10 beds or 10%, whichever is less, of the bed capacity as allowed by paragraph (6).

(5) The acquisition of major medical equipment not owned by or located in a health care facility if the equipment will be used to provide service for inpatients of a health care facility, or if notice has not been provided to the Department under subsection (c).

(6) The obligation of any capital expenditure by or on behalf of a health care facility which results in the addition of a health service not provided in or through the facility in the previous 12 months or which increases the total number of beds, or redistributes beds among various categories other than levels of care in a nursing home, or relocates such beds from one physical facility or site to another, by more than 10 beds or 10% of total bed capacity, whichever is less, over a 2-year period. For purposes of this paragraph, categories of beds in a hospital are those categories of beds established and defined in the instructions and definitions of the Department’s Annual Hospital Questionnaire. Although dialysis stations are not defined as beds in the annual hospital questionnaire, facilities with dialysis stations may increase the number of stations in accordance with this subsection, except that the 10 beds or 10% rule will apply to the number of dialysis stations only. The total bed capacity of the hospital if the dialysis unit is located in a hospital, is separate and distinct from dialysis stations. The 2-year periods shall begin on the date of licensure. Increases not added during a 2-year period cannot be accumulated and carried over to another period, nor will a change in ownership allow increases of more than 10 beds or 10% of total capacity in a 2-year period.

(7) The addition of a health service which is offered in or through a health care facility having an annual operating expense in excess of the minimum operating expense threshold established by Federal law or regulation and which was not offered on a regular basis in or through the health care facility within the 12-month period prior to the time such services would be offered. A health service shall be considered to be offered by or through a health care facility or a health maintenance organization if the service is offered or made available on a regular basis to inpatients or outpatients of a health care facility.

(c) Before any person enters into a contractual arrangement to acquire major medical equipment which will not be owned by or located in health care facility or before any person acquires an existing health care facility, the person shall notify the Department of his intent to acquire such equipment or existing health care facility.

(1) The notice shall be in writing and shall be made at least 30 days before contractual arrangements are entered into to acquire the major medical equipment or the existing health care facility.

(2) In the case of the intended acquisition of major medical equipment, the notice shall contain information regarding the use that will be made of the equipment. In the case of the intended acquisition of an existing health care facility, the notice shall contain information with regard to the services to be offered in the facility and its bed capacity.

(3) Within 30 days after the receipt of the notice, the Department will inform the person providing the notice whether or not the proposed acquisition of either the major medical equipment or the existing health care facility is a new institutional health service. If the Department determines that the acquisition will be a new institutional health service, the acquisition shall be subject to this chapter.

(4) A decision of the Department that an acquisition requires a certificate of need may be appealed to the Hearing Board.

The provisions of this § 401.3 issued under section 2102(a) and (g) of The Administrative Code of 1929 (71 P. S. § 532(a) and (g)); and section 201(14) of the Health Care Facilities Act (35 P. S. § 448.201(14)).

The provisions of this § 401.3 amended April 13, 1984, effective April 14, 1984, 14 Pa.B. 1294. Immediately preceding text appears at serial pages (52910) to (52911).

History

Authority: The provisions of this Chapter 401 issued under the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 401 adopted July 25, 1980, effective August 1, 1980, 10 Pa.

28 Pa. Code § 401.4 Criteria for certificate of need review.

(a) The following criteria, and standards applicable to each criterion, shall be used to review each application for a certificate of need. A certificate of need shall be recommended, approved and issued when the application substantially meets the following criteria provided that each decision, except in circumstances which pose a threat to public health, shall be consistent with the State Health Plan (SHP):

(1) Whether the relationship of the application to the applicable Health Systems Plan (HSP) and annual implementation plan has been considered.

(2) Whether the services are compatible with the long-range development plan of the applicant.

(3) Whether there is a need by the population served or to be served by the services or facility. Particular consideration shall be given to whether the proposed new institutional health service meets or contributes to the health related needs of members of medically underserved groups.

(4) Whether there is any appropriate, less costly or more effective alternative method of providing the services available.

(5) Whether the service or facility is economically feasible, considering anticipated volume of care, the capability of the service or facility and the availability of reasonable financing.

(6) Whether the proposed service or facility is financially feasible both on an intermediate and long term basis, and whether the impact on the cost of and charges for providing services by the applicant is appropriate.

(7) Whether the proposed service or facility is compatible with the existing health care system in the area. Consideration shall be given to efficiency and appropriateness of the existing services and facilities similar to those proposed.

(8) Whether the service or facility is justified by community need and within the financial capabilities of the institution both on an intermediate and long term basis and whether it will have an inappropriate, adverse impact on the overall cost of providing health services in the area.

(9) Whether there are available resources, including health manpower, management personnel and funds for capital and operating needs to the applicant for the provision of the services proposed to be provided, and whether there is a greater need for alternative uses for such resources for the provision of other health services. The effect on the clinical needs of health professional training programs in the medical service area, the extent to which health professional schools in the medical service area will have access to the services for training purposes and the extent to which the proposed service will be accessible to all the residents of the area to be served by such services shall also be considered in determining resources.

(10) Whether the proposed service or facility will have available to it appropriate ancillary and support services and an appropriate organizational relationship to such services.

(11) Whether the proposed services are consistent with the special needs and circumstances of those entities which provide services or resources both within and without the health service area in which the proposed services are to be located, including medical and other health professional schools, multidisciplinary clinics and specialty centers.

(12) Whether the proposed services are not incompatible with any biomedical or behavioral research projects designed for national need for which local conditions offer special advantages.

(13) Consideration of the need and availability in the community for services and facilities for allopathic and osteopathic physicians and their patients; and the religious orientation of the facility and the religious needs of the community to be served. This paragraph is not intended to create duplicative systems of care.

(14) Whether competitive factors relating to the supply of the health services being reviewed have been considered. Particular attention shall be given to the existence and capacity of market conditions, current or potential, in advancing the purposes of quality assurance, cost containment, and responsiveness to consumer preference. Particular attention shall also be given to the existence and capacity of utilization review programs and other public and private cost control measures to give effect to consumer preferences and to establish appropriate incentives for capital allocations.

(15) Whether consideration has been given to improvements or innovations in the financing and delivery of health services which would foster competition and serve to promote quality assurance, cost effectiveness, and responsiveness to consumer preferences.

(16) Whether, in the case of existing services for facilities, the quality of care provided by services or facilities in the past have been considered.

(17) Whether the special circumstances of applications with respect to the need for conserving energy have been considered.

(b) [Reserved].

(d) If the application is for a proposed service or facility which includes a construction project, a certificate of need shall be recommended, approved, and issued when the provisions of subsection (a) are satisfied and the following occur:

(1) The costs and methods of the proposed construction including the costs and methods of providing energy are appropriate.

(2) The impact of the costs of providing health services by the applicant resulting from the construction is found to be appropriate and the impact on the costs and charges to the public of providing health services by other persons is found to be not inappropriate.

(e) Whenever new institutional health services for inpatients are proposed, a finding will be made in writing by the Department:

(1) That the capital and operating costs, efficiency and appropriateness of the proposed new service and its potential impact on patient charges has been considered.

(2) That less costly alternatives which are more efficient and more appropriate to the inpatient service are not available and the development of the alternatives has been studied and found not practicable.

(3) That existing inpatient facilities providing inpatient services similar to those proposed are being used in an appropriate and efficient manner.

(4) That in the case of new construction, alternatives to new construction such as modernization or sharing arrangements have been considered and have been implemented to the maximum extent practicable.

(5) That patients will experience serious problems in terms of cost, availability, accessibility or such other problems as may be identified in the applicable HSP or SHP in obtaining inpatient care of the type proposed if the proposed new services is not approved.

(f) With respect to any application regarding the offering, developing, constructing, or otherwise establishing of a health maintenance organization, all of the criteria applicable in subsection (a) shall apply unless the proposed entity is found to meet the requirements for exemption contained in 42 U.S.C.A. § 300m-6(a)(5) and (b)(1) and regulations adopted thereto.

(g) Notwithstanding subsections (a), (d) and (e), the following types of applications for certificates of need shall be approved unless the Department finds that the project in question is not needed or that it is not consistent with the SHP. Applications described in the following paragraphs will be approved only to the extent necessary to remedy the deficiencies they address:

(1) Application for a project which is necessary to eliminate or prevent imminent safety hazards as defined by the Life Safety Code or other appropriate codes or regulations.

(2) Application for a project which is necessary to comply with State licensure standards.

(3) Application for a project which is necessary to comply with accreditation standards, compliance with which is required to receive reimbursement or payments under Title XVIII or XIX of the Social Security Act (42 U.S.C.A. § § 300v—300y-11).

The provisions of this § 401.4 issued under section 2102(a) and (g) of The Administrative Code of 1929 (71 P. S. § 532(a) and (g)); and section 201(14) of the Health Care Facilities Act (35 P. S. § 448.201(14)).

The provisions of this § 401.4 amended April 13, 1984, effective April 14, 1984, 14 Pa.B. 1294. Immediately preceding text appears at serial pages (52911) to (52913).

The Department acted within its discretionary authority by accepting evidence as to the projected percentage of Medicare patients and the extent of the applicant’s contribution to medically undeserved groups. Morrisons Cove Home v. Department of Health, 593 A.2d 925 (Pa. Cmwlth. 1991); appeal denied 602 A.2d 863 (Pa. 1992).

This section cited in 28 Pa. Code § 401.5 (relating to Certificate of Need); and 28 Pa. Code § 401.7 (relating to simultaneous and comparative review).

History

Authority: The provisions of this Chapter 401 issued under the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 401 adopted July 25, 1980, effective August 1, 1980, 10 Pa.

28 Pa. Code § 401.5 Certificate of Need.

(a) Letter of intent.

(1) As early as possible, any person desiring to obtain a certificate of need shall submit a letter of intent to the Division of Need Review of the Department and to the Health Systems Agency (HSA) responsible for reviewing applications in the health service area where the proposed project will be located. A letter of intent shall contain at least the following information:

(i) The name and address of the applicant.

(ii) The name and location of the project.

(iii) The reason the project is needed.

(iv) The type of capital expenditure, acquisition, health service, or change in bed capacity involved in the project.

(v) The expected date of project commencement and completion.

(vi) The estimated cost and anticipated source of project financing.

(2) The Department, after consultation with the HSA, will determine whether the project is subject to review and notify the applicant within 30 days of receipt of the letter of intent. Only projects for which letters of nonreviewability are issued will be considered not subject to review. A determination by the Department that a project is subject to review may be appealed to the Hearing Board, under 37 Pa. Code Chapter 197 (relating to practice and procedure). An application may be submitted and reviewed during an appeal to the Hearing Board.

(3) If the project has been inactive for more than 1 year the project proposed by the applicant shall be considered withdrawn.

(b) Application.

(1) An applicant for a certificate of need may obtain the necessary application forms from the local HSA. Applications to obtain or amend a certificate of need shall be submitted simultaneously to the Department and the HSA responsible for reviewing applications in the health service area where the proposed project will be located. The HSA shall advise the applicant as to the number of copies of the application the agency will require to conduct a review.

(2) Applications for a certificate of need shall contain all data and information required by the Department and the HSA. The following information shall be submitted in a format published by the Department:

(i) General.

(A) Identifying information.

(B) Type of ownership.

(D) Type of application.

(E) Anticipated proposal schedule.

(ii) Synopsis of proposal.

(iii) Proposal planning process.

(A) Description of annual institutional planning process.

(B) Results of planning with other organizations.

(iv) Specific description of proposal.

(A) Service, building, equipment and bed changes.

(B) Personnel requirements.

(D) Projected costs.

(E) Anticipated financing.

(v) Need for proposal.

(A) Compatibility with institutional long range plan.

(B) Consistency of proposal objectives with the following:

(I) Goals, objectives and recommended actions in the health systems plan and annual implementation plan.

(II) Goals, objectives, and recommended actions in the State health plan.

(I) Criteria in the health systems plan.

(II) Criteria in the State health plan.

(III) Other relevant criteria developed by professional organizations, if available.

(D) Documentation of alternatives studied and found not practicable.

(I) More efficient use of existing services or facilities, or both.

(II) Implementation of modernization or sharing arrangements to the maximum extent feasible.

(vi) Economic feasibility of proposal.

(A) Documentation of financial feasibility.

(I) Past historical financial data.

(II) Pro Forma statements: status quo; proposal; alternatives.

(III) Financing arrangements and assumptions.

(B) Evaluation of economic feasibility.

(I) Adequate volume of care projected.

(II) Availability of financing.

(III) No inappropriate adverse impact on overall areawide cost of providing services.

(IV) No appropriate, less costly or more effective alternative methods of providing the services available.

(vii) When the HSA, with concurrence of the Department, has adopted additional information requirements, the information requirements shall be published by the HSA in a format approved by the Department, and incorporated into the application. The applicant shall submit this information within the format published by the HSA.

(3) The application for a certificate of need shall specify the time the applicant will need to make the service or equipment available or to complete the project, and a timetable to substantially implement the approved project. The timetable to substantially implement the project must conform with the timetable established at subsection (m).

(4) The appropriate HSA and the Department will review each certificate of need application for completeness. If it is determined that the application is incomplete, the reviewing agency shall send notice to the applicant within 20 business days of the receipt of the application and shall advise such persons in writing of the additional information required to complete the application. Upon receipt of the additional information, the reviewing agency shall determine if the application is complete and send notice within 15 business days of the receipt of same. The application and additional information must be sent to both the Department and the HSA. The time frames for review of the application or additional information will not begin until both the Department and HSA have received the information. If the Department and HSA receive information on different dates, the time frame begins on the later of the two dates. An applicant shall only be required to provide information under paragraph (2).

(5) Any conflicts regarding the completeness of an application will be resolved by the Department. An applicant may notify the Department at any time while an application is under consideration for completeness by an HSA, and request in writing a determination by the Department as to whether the application is complete. The request must indicate the reasons why the HSA determined the application incomplete, and the reasons why the applicant believes the information is contained in the application or in the additional information provided. The Department will notify the applicant of its determination within 14 business days. If the Department determines the application is complete, the HSA shall review the application.

(6) An applicant may, 60 days or more after filing an application, request in writing that the review begin. Requests shall be mailed to the HSA and the Department by certified mail, return receipt requested. Upon receipt of such a request the HSA shall notify the applicant and the Department in writing that the review process will begin on the date of notification in accordance with subsection (d)(1) and shall include at least the same information as required in subsection (c)(3). All subsequent requirements pertinent to a complete application shall apply.

(1) After the HSA determines that an application is complete in accordance with subsection (b)(3) or upon expiration of the time to determine that an application is complete, whichever comes first, the HSA shall send a written notice to the applicant stating that the application is deemed complete and that the review process will begin on the date of notification in accordance with subsection (d)(1).

(2) [Reserved].

(3) The HSA shall notify all affected persons of a complete certificate of need application by publishing a notice in at least one newspaper of general circulation serving the locality in which the proposed service or facility will be developed. The notice shall contain the name and address of the applicant, a brief description and an estimate of the cost of the project, the schedule for review by the agency, the date by which a public hearing must be requested, and the manner in which notice will be given if a public hearing is to be held. If this notice states the date and location of the public hearing, it shall satisfy the requirement for public notice of the HSAs. The Department will publish a similar notice in the Pennsylvania Bulletin.

(4) The HSA shall also provide written notice of a completed certificate of need application to HSAs serving contiguous health service areas, any health care facilities and health maintenance organizations located in the health service area which provide institutional health services, appropriate third party payors, and public agencies. The written notice shall contain the same information as required in paragraph (3) and may be satisfied if published as part of a newsletter.

(d) HSA period for review.

(1) The date of notification begins the time period in which the HSA must complete the review of an application for a certificate of need. The date of notification is the date the HSA publishes a notice in accordance with subsection (c)(3). The HSA shall send the applicant the required notice that the review process will begin and publish such notice within 30 days after either the application is deemed complete in accordance with subsection (b)(4) or after receipt of the applicant’s request that review begin in accordance with subsection (b)(6), whichever date first occurs.

(2) The HSA shall have 60 days from the date of notification to complete its review of the application.

(3) The HSA with concurrence of the Department may extend the time for review beyond 60 days from the date of notification only if the applicant agrees in writing to a specific extension of time for the review by the HSA. Any agreed extension of time must indicate the date upon which the running of the 60 day period stops and begins, and the date upon which the 60 day period expires. Copies of agreed extensions must be submitted to the Department. If there are not agreed extensions in writing, the 60 day period shall not be considered extended, and will expire on the 60th day from the date of notification.

(4) [Reserved].

(5) The HSA, with concurrence from the Department, may establish review cycles for the review of applications. There shall be at least six review cycles per year—one every other month. During a review cycle, all completed applications pertaining to similar types of services, facilities or equipment shall be considered in relation to each other.

(e) Public hearing and objection procedures.

(1) A public hearing shall be conducted by the appropriate HSA if any affected person or any appropriate third-party payor submits a written request for a hearing to the HSA within 15 days from the notice published under subsection (c)(3). Timely notification within the 15 day period shall be determined by the postmark. The HSA may require a public hearing during the course of its review of any application for a certificate of need.

(2) Any person directly affected may file an objection to an application within 15 days from the publication of notice in accordance with subsection (c)(3). The date of filing will be determined by the postmark. Such an objection must be filed with the appropriate HSA and set forth specifically the reasons such objection is filed. Persons filing objections shall be parties to the proceeding unless and until such objections are withdrawn. Any person, other than the applicant, or the HSA, who appeals the decision of the Department subsection (j)(1) must have become a party to the proceedings by having filed an objection with the appropriate HSA.

(3) Notice of a public hearing on a certificate of need application shall be published by the HSA in a newspaper of general circulation serving the locality in which the proposed service or facility would be developed. The HSA shall notify affected persons of the hearing at least 14 days prior to the hearing. This requirement may be satisfied as part of subsection (c)(3).

(4) [Reserved].

(5) Each HSA shall adopt and publish specific procedures for conducting public hearings on certificate of need applications. The procedures must be approved by the Department and shall conform to the following:

(i) The applicant and any person shall be afforded the opportunity to submit testimony, oral or written arguments, and relevant evidence at the hearing. Such persons should request the opportunity to testify by notifying the HSA prior to the hearing date or may register to testify at the hearing. Any person shall have the right to be represented by counsel. Any person directly affected may conduct reasonable questioning of persons who make relevant factual allegations. A record of the hearing shall be maintained. A transcript of this record shall be made upon request of a party to the proceedings and at the expense of the requesting party.

(ii) The time allocated to persons wishing to present testimony may be limited under the hearing procedures adopted and published by the HSA governing body.

(iii) The public shall be notified as soon as possible regarding any changes in the scheduled date of a public hearing or any changes in the applications to be heard therein.

(f) HSA review and recommendations.

(1) A HSA may, with the approval of the Department, give a nonsubstantive review to a proposed new institutional health service. See § 401.2 (relating to definitions) for definitions of nonsubstantive reviews.

(2) HSAs, in formulating recommendations to the Department on a certificate of need application, shall make their findings regarding the criteria set forth in § 401.4 (relating to criteria for Certificate of Need review) under procedures established by the Department.

(3) The HSA shall concurrently send the applicant notification of the findings and recommendations it submits to the Department. The findings shall be submitted to the Department in such form as the Department requires.

(4) The HSA shall submit its findings and recommendations to the Department within the time period allotted in subsection (d)(2) and (3).

(g) Department review and findings.

(1) The Department will consider the timely filed findings and recommendations of the HSA, any information accompanying the application or presented on behalf of the application, any duly promulgated criteria and standards adopted by the Department, and the criteria listed in § 401.4.

(2) If there has been no provision for a public hearing before the HSA, the Department will comply with the requirements of subsection (e).

(3) The Department will approve or disapprove the application within 30 days from the date that the HSA’s recommendation is received.

(4) If the Department determines that an application cannot be adequately reviewed within the time periods stated in paragraph (3), it will notify the applicant indicating the reasons why, and request the applicant to agree to an extension of the review period.

(5) If a decision is not made within the required time period, the applicant may bring an action in the Commonwealth Court to require the Department to approve or disapprove the application. If an order is issued by the Court, the Department will promptly, and in accordance with the order, issue its decision. If the decision is adverse to the applicant, the applicant may appeal to the Hearing Board.

(6) Decisions of the Department will be based solely on the record. There shall be no ex parte contacts.

(i) For purposes of this section, an ex parte contact is a contact between an applicant for a certificate of need, any person acting on behalf of the applicant, or any person opposed to the issuance of a certificate, and any person in the Department who exercises any responsibility respecting the application after the commencement of the public hearing on the applicant’s application and before a decision is made with respect to it. A status report shall not be considered an ex parte contact. A contact which is recorded as part of the official application file in accordance with paragraphs (ii) and (iv) shall not be considered an ex parte contact.

(A) For the purpose of this subsection, a person acting on behalf of the applicant for, or holder of, a certificate of need is any person, including an HSA, who favors the issuance of a certificate of need.

(B) For the purpose of this subsection, a person in the Department who exercises any responsibility respecting the application includes any Departmental employe involved in a given review, from the initial reviewer up to and including the Secretary.

(C) For the purpose of this section, status reports are any communications which do not go to the substance of a certificate of need review. They are routine statements of the progress of the review of an application for a certificate of need.

(ii) When the Department receives a written communication from a person who supports or opposes the granting of a certificate of need, the communication shall be made a part of the official project file regarding the issuance of the certificate of need. Any person may review the official project file during the normal business hours of the Department. Any affected person may receive a copy of written communications which have been made part of the official project file by contacting the Division of Need Review. Requests will be considered to be requests for status reports as defined in clause (C).

(iii) When the Department receives a communication either in person or by telephone from a person who supports or opposes the granting of a certificate of need, a summary of the communication will be made part of the file.

(iv) When the Department holds a meeting with an applicant or a person opposing or supporting the issuance of a certificate of need, parties to the proceeding will be notified, in advance of the time and place of the meeting. A summary of the meeting will be made part of the project file.

(7) When the Department approves an application, the certificate of need shall specify the maximum amount of capital expenditures which may be obligated under the certificate.

(8) Certificates of need shall be granted or refused. They shall not be conditioned upon the applicant changing other aspects of its facilities or services or requiring the applicant to meet other specified requirements and no such obligation shall be imposed in granting or refusing approval.

(9) The Department may grant a certificate of need which permits expenditures only for predevelopment of the new institutional health service with respect to which such predevelopment costs are incurred.

(10) When the Department makes a decision regarding the proposed new institutional health service which is inconsistent with the recommendation made with respect thereto by a HSA, or with the applicable health systems plan, or annual implementation plan, the Department will submit to the HSA and all parties to the proceeding a written detailed statement which describes why it has made findings that are inconsistent with the findings of the HSA, the health systems plan or the annual implementation plan.

(11) The Department will make written findings which state the basis for any final decision made by the Department. The findings shall be sent to the applicant, the HSA, and all parties to the proceedings as soon as reasonably possible following its decision, but no later than 10 business days after its decision, and it shall be made available to others upon request.

(12) A person proposing a new institutional health service may withdraw a previously filed application without prejudice by filing written notice of the withdrawal with both the HSA and the Department at any time prior to final approval or disapproval of the required certificate of need.

(13) An applicant may modify a proposal at any time during the review period. When an applicant desires to modify a proposal, the applicant shall submit in writing a detailed statement of the desired changes and an explanation to justify each change to the HSA and the Department. The HSA shall review the proposed changes to determine if a substantial modification to the original application would occur. If it is determined that a substantial modification would occur, the proposed change will be submitted to the HSA for review and a recommendation on the proposed change returned to the Department within 60 days. The Department will approve or disapprove the application within 30 days from the date the HSA recommendation is received. For the purposes of this paragraph, a substantial modification occurs when one of the following occurs:

(i) The proposed bed complement is increased.

(ii) The total costs are increased by more than 20% or $2 million, whichever is less.

(iii) A proposed service is added or deleted.

(iv) The Department and HSA determine there is a significant change in site.

(h) Emergency certificates.

(1) The application and review process may be suspended, with the concurrence of the HSA and the Department, for a project limited to a replacement of plant and equipment as a result of natural disaster, fire, unforeseen equipment failure or similar occurrence, which endangers the health and safety of patients. Within 5 days of the occurrence, written notification shall be given to the Department and the local HSA.

(2) If the Department suspends the review process, an emergency certificate of need shall be issued subject to any restrictions imposed by the Department. Within 30 days of the issuance of the emergency certificate, the health care provider shall file an application for review of the plant and equipment replaced as a result of the emergency. This application shall be reviewed under the HSA’s nonsubstantive review procedures.

(i) Reconsideration of Department decision.

(1) Any person may, for good cause shown, request, in writing, a public hearing for the purpose of reconsideration of a decision of the Department within 10 days of the decision of the Department. If such hearing is granted, the Department will set forth the cause for the hearing and the issues to be considered at such hearing. The hearing shall be held no sooner than 6 days and no later than 14 days after a request is made, and may be limited to the issues submitted for reconsideration. Notification of such a public hearing shall be sent at least 5 days prior to the date of the hearing, to the person requesting the hearing, the person proposing the new institutional health service, the HSA for the health service area in which the new institutional health service is proposed to be offered or developed, and shall be sent to others upon request. Within 14 days of the conclusion of the hearing, a summary of the oral testimony shall be made of the hearing, and copies thereof supplied at cost to the person proposing the new institutional health service, the appropriate HSA and any parties to the proceeding, and shall be made available by the Department to others upon request.The Department will affirm or reverse its decision and submit the same to the parties, the person requesting the hearing, and the HSA within 14 days of the conclusion of such hearing. Any change in the decision shall be supported by the reasons therefore.

(2) Where reconsideration hearings are held on more than 2 days, consecutive days of hearings and intervening weekends and holidays shall be excluded in calculating the time permitted for the Department to conduct its review and if briefs are to be filed, 10 days subsequent to the adjournment of the hearing shall also be excluded.

(3) Good cause shall be deemed to have been shown if one of the following occurs:

(i) There is significant, relevant information not previously considered.

(ii) There is significant change in factors or circumstances relied on in making the decision.

(iii) There has been material failure to comply with the procedural requirements of this chapter.

(iv) The Department determines that there is good cause shown for some other reason.

(4) If good cause under paragraph (3)(i) and (ii) is found by the Department, a reconsideration hearing will be conducted under section 704(b) and (c) of the act (35 P. S. § 448.704(b) and (c)).

(j) Appeals.

(1) Decisions of the Department on an application for a certificate of need or amendment thereto may be appealed within 30 days by any party or HSA who is involved in the proceeding. The appeal to the Hearing Board shall be commenced within 30 days of receipt of the appeal request and shall be limited to issues raised by the appellant in the specification of objections to the decisions of the Department. Those issues shall be restricted to whether the findings and recommendations of the Department are supported by substantial evidence, and must have been raised or brought to the attention of the HSA or the Department during the course of the review.

(2) The Board shall entertain no evidence that the Hearing Board is satisfied the appellant was able, by the exercise of reasonable diligence, to have submitted before the HSA and the Department.

(k) Cost increases to certificates.

(1) A certificate of need shall state the maximum amount of expenditures which may be obligated under it. Applicants proceeding with an approved project may not exceed this level of expenditures except under the following procedures:

(i) When the applicant proposes an expenditure greater than that stated on the certificate, the applicant shall notify the Division of Need Review in writing. The applicant may not proceed with the proposed changes until the appropriate Departmental approvals have been granted. The written notice shall include at least all of the following:

(A) The name and address of the applicant.

(B) The name and location of the project.

(D) The primary reasons for the cost increase.

(E) The anticipated source of financing for the cost increase.

(ii) Within 20 days of receipt of the information set forth in subparagraph (i), the Department, after consultation with the HSA, will notify the applicant of the type of review which will be conducted.

(A) A cost increase which exceeds 20% of the originally approved amount shall receive a full review as specified in subparagraph (iii).

(B) A cost increase which is less than or equal to 20% of the originally approved amount may receive a nonsubstantive review.

(iii) For purposes of this subsection, a full review shall be limited to the criteria specified in section 707(a)(4)—(6), and (8), (b)(1) and (2) and (c)(1) and (5) of the act (35 P. S. § 448.707(a)(4)—(6), and (8), (b)(1) and (2) and (c)(1) and (5)).

(iv) Due to the relatively insignificant consequences of some of the changes that would require a nonsubstantive review, an administrative review can be substituted if the HSA and the Department agree that only an administrative review is necessary. The Department will render its decision on the project within 30 business days of receipt of the required information.

(v) The procedures set forth in this section shall also apply to approvals under 42 U.S.C.A. § 1320a-1 and projects covered under section 901 of the act (35 P. S. § 448.901).

(l) Changes to certificate of need.

(1) When an applicant proposes a change to an approved certificate of need, the applicant shall notify the Division of Need Review in writing. The applicant may not proceed with the proposed changes until the appropriate Departmental approvals have been granted. The written notice shall include at least the following:

(i) Name and address of the applicant.

(ii) Name and location of the project.

(iii) The change and reason for the change.

(2) Within 20 days of receipt of the information in paragraph (1)(i), the Department, after consultation with the HSA, will notify the applicant of the type of certificate of need review which will be conducted.

(3) Substantial changes which require a full review include, but are not limited to, the following:

(i) A significant change in site as determined by the Department and the HSA.

(ii) The addition or deletion of a health service.

(iii) A change in an application line item by 20%. Line item is defined as single cost categories as listed in the financial section of the certificate of need application. If the overall cost increase does not meet the full review criteria under paragraph (1)(ii)(A) the Department after consultation with the HSA may elect to do a nonsubstantive review.

(iv) A change of greater than 10 beds or 10%, whichever is less, of affected beds in the application.

(v) A 20% change in renovation or construction square footage. Square footage is defined as allocations as listed in the space exhibit of the certificate of need application.

(4) Changes which do not meet the thresholds set forth in this subsection may receive a nonsubstantive review. A change of less than 10 beds or 10%, whichever is less, is not reviewable if the project has been substantially implemented.

(5) Due to the relatively insignificant consequences of some of the changes that would require a nonsubstantive review, an administrative review can be substituted if the HSA and the Department agree that only an administrative review is necessary. The Department will render its decision on the project within 30 business days of receipt of the required information.

(6) This subsection shall also apply to approvals under 42 U.S.C.A. § 1320a-1 and projects covered under section 901 of the act (35 P. S. § 448.901).

(m) Withdrawal of certificates.

(1) A certificate of need shall remain in effect, providing the facilities and services authorized are in use. In the absence of substantial implementation of an approved project for which a certificate of need was issued, the certificate shall be withdrawn 1 year after issuance, unless the Department extends the time for a definite period, not to exceed 6 months. Notification of a request for an extension shall be made in writing to the Department and appropriate HSA and should be made at least 60 days prior to the expiration of the certificate. Only one such extension may be granted for a project. For projects which are approved to be carried out in phases estimated to require no more than 3 years, the certificate of need shall remain in effect after the first phase is implemented but no longer than 3 years unless the project is substantially implemented. All phased construction must commence within 5 years of approval. All phased construction time frames must be approved as part of the review process.

(2) When it comes to the attention of the Department that the time period in which to substantially implement the project has passed without the project being substantially implemented, the Department will send a notice to the holder of the certificate advising that the certificate shall be withdrawn for failure to implement the project in a timely manner.

(i) A notice of the withdrawal shall be sent to all affected persons, published in a newspaper of general circulation in the area to be served by the project, and published in the Pennsylvania Bulletin. The notice shall state the reasons for the withdrawal, and the date by which any affected person may request a hearing on the withdrawal. Objections or comments on the withdrawal may be filed by any persons directly affected.

(ii) If a hearing is requested, the Department will forward the request to the appropriate HSA to hold a hearing in accordance with the procedures established by the HSA for public hearings. Notice of the hearing shall be given in writing to all affected persons, and through a newspaper of general circulation for all others.

(iii) A record of the hearing shall be maintained and forwarded to the Department along with a recommendation by the HSA as to whether the certificate should be withdrawn.

(iv) The Department will consider the recommendation of the HSA, the record of the hearing, and any other pertinent information and render a final decision on the withdrawal within 30 days of receipt of the HSA recommendation.

(3) Substantial implementation of a project occurs when the following requirements are completed relative to, but not limited to, the following types of projects. All of the requirements listed in this paragraph must be completed within 1 year after issuance of the certificate or within 18 months after issuance of the certificate if an extension has been granted.

(i) New construction or renovation projects shall include the following:

(A) The title or long-term lease to the appropriate site has been acquired.

(B) The appropriate State agency has approved the complete set of schematic drawings for the project.

(C) A financial commitment has been obtained, for at least 60% of the total approved capital expenditure. The commitment may be any combination of funds such as the applicant’s own funds, grants, gifts, or an enforceable offer and acceptance from a financial institution to provide adequate capital financing for the project.

(D) An enforceable construction contract has been entered into causing the commencement of construction no later than 24 months after issuance of a certificate. Failure to commence construction within this time period shall be considered an abandonment of the project and the certificate issued shall be withdrawn. Erection of the foundation shall constitute commencement of construction.

(ii) Acquisition of equipment. The equipment must either be purchased; the lease agreement must be entered into by the proponent; or if acquired by a comparable arrangement the health care facility or health maintenance organization must have possession of the equipment.

(iii) Addition of new service. A written statement must be submitted to the Department verifying that the service is in operation.

(iv) Donated property. In the case of donated property, the date on which title to the donated property is transferred in accordance with applicable State statutes.

(n) Reporting requirements.

(1) During the course of review, the HSA and the Department will, upon request of any person, set forth the status and any findings then made or any other appropriate information regarding an application before them. Other appropriate information includes information regarding the conducting of public hearings, the review cycle, or other information to which the public has access under this chapter.

(2) Each HSA shall prepare and publish, at least annually, reports of certificate of need reviews, including a statement of findings and decisions made in the course of each review since the last report.

(3) The Department will prepare and publish, at least annually, reports of the reviews being conducted, including a statement concerning the status of each review, and of the reviews completed by the agency since the publication of the last report and a general statement of the findings and decisions made in the course of review.

(4) Persons subject to review under this chapter shall submit periodic progress reports to the HSA and the Department pertaining to the development of projects which have received certificate of need approval. The reports must detail the progress toward the substantial implementation of projects as defined in subsection (m). The time period for submission of the progress reports is the end of the 10th month following certificate of need approval, although in the case of an extension, an additional report is required by the end of the 18th month following project approval.

(5) For information purposes only, at least 30 days prior to termination or substantial reduction of a service or a permanent decrease in the bed complement, a health care provider shall notify in writing the HSA and the Department of its intended action. However, if any such change should involve a capital expenditure in excess of the minimum threshold for review of capital expenditures, as established by Federal law or regulation, the health care provider shall be required to obtain a certificate of need in accordance with this section.

(o) Penalties. Penalties shall be imposed in accordance with the act.

The provisions of this § 401.5 issued under section 2102 (a) and (g) of The Administrative Code of 1929 (71 P. S. § 532 (a) and (g)); and section 201(14) of the Health Care Facilities Act (35 P. S. § 448.201(14)).

The provisions of this § 401.5 amended April 13, 1984, effective April 14, 1984, 14 Pa.B. 1294. Immediately preceding text appears at serial pages (52913) to (52925).

The Department is not required to apply a ‘‘regional approach’’ when deciding whether to grant a certificate of need application for a freestanding ambulatory surgical facility. Jeannette District Memorial Hospital v. Department of Health, 595 A.2d 677 (Pa. Cmwlth. 1991).

The Department’s internal preliminary inquiry of a proposed out-patient therapy program for cancer patients did not confer standing upon the competitors of the center to challenge the Department’s ‘‘non-reviewability’’ determination that the out-patient program was not required to file an application for a Certificate of Need, because the Health Care Facilities Act (35 P. S. § § 448.801a—448.820), and the Department’s regulations did not require notice of preliminary inquiry to be given to competitors. Powers v. Department of Health, 550 A.2d 857 (Pa. Cmwlth. 1988); appeal denied 574 A.2d 75 (Pa. 1989).

Transfer of rights to provide scanner services did not constitute a change in conditions which required written notice to the Department as such written approval is only necessary when a change of costs or conditions in the original Certificate of Need proposal is sought. Laurel Mobile Health Services, Ltd. v. Department of Health, 550 A.2d 616 (Pa. Cmwlth. 1988).

This section cited in 28 Pa. Code § 401.7 (relating to simultaneous and comparative review); 55 Pa. Code § 1163.453 (relating to allowable and nonallowable costs); 55 Pa. Code § 1181.65 (relating to cost-finding); 55 Pa. Code § 1181.259 (relating to depreciation allowance); and 55 Pa. Code § 1181.260 (relating to interest allowance).

History

Authority: The provisions of this Chapter 401 issued under the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 401 adopted July 25, 1980, effective August 1, 1980, 10 Pa.

28 Pa. Code § 401.6 Certificate of Need—statement of policy.

(a) Statewide goals.

(1) Sufficient ambulatory surgery capacity shall be available and accessible in this Commonwealth to meet local community needs.

(2) Ambulatory surgery shall be promoted throughout this Commonwealth whenever it represents a cost effective alternative to inpatient surgery.

(3) Until 50% of total surgical procedures in an HSA region—or whatever alternative percentage is consistent with local health systems plans adopted by the Health Systems Agency and approved by the Statewide Health Coordinating Council are performed on an ambulatory basis, as indicated hereafter, no application for CDN approval of an ambulatory surgical facility or service shall be considered by the Department as in appropriately increasing total community health care costs, provided the project represents the least costly and most effective method of providing services and meets the guidelines set forth in this section.

(b) Definitions. The following words and terms, when used in this section, have the following meanings, unless the context clearly indicates otherwise: (1) Ambulatory surgical facility—A facility not located upon the premises of a hospital which provides outpatient surgical treatment. The term does not include individual or group practice offices or private physicians or dentists, unless the offices have a distinct part used solely for outpatient surgical treatment on a regular and organized basis. See § 401.2 (relating to definitions). (2) Ambulatory surgical service—The provision of outpatient surgical treatment in a health care facility. (3) Independent ambulatory surgical facility—An ambulatory surgical facility whose majority or controlling interest is not owned or controlled by a hospital, group of hospitals or by corporations owning or controlling hospitals. A hospital or a corporation owning or controlling a hospital desiring to establish an ambulatory surgical facility well outside its current service area shall be considered an independent ambulatory surgical facility for review purposes in the new service area. (4) Outpatient surgical treatment—Surgical treatment to patients who do not require hospitalization, but who require constant medical supervision following the surgical procedure performed. See § 401.2.

(1) The need for an increase in ambulatory surgical services exists if less than 50% of total surgical procedures in an HSA region or whatever alternative percentage is consistent with local health systems plans are performed on an ambulatory basis. The volume of surgical procedures performed in a physician’s office—that is, not a health care facility—shall be excluded.

(2) Additional capacity for ambulatory surgery is needed if each HSA and the Department determine that existing providers of surgery in subregional markets are not making a good faith effort to perform 50% of total surgeries, or whatever alternative percentage is consistent with local health systems plans, on an ambulatory basis.

(3) Once the 50% ambulatory surgical target is met, no additional ambulatory surgery proposals will be considered needed except those which:

(i) Are generated by a facility at full capacity and with a need to expand in order to meet demand.

(ii) Seek to serve underserved populations.

(iii) Are necessary to provide new technology/procedures.

(4) The review of individual ambulatory surgical projects will be based upon a comparative analysis. Comparative analysis of competing proposals will be based upon the criteria for review of CON applications as set forth in the act and this title.

(5) In the interest of fair competition, equal consideration will be given to the following:

(i) Hospitals with no current excess capacity, that is, current operating rooms are utilized for both inpatient and outpatient surgery more than 80% of the time based upon 8 hours per day, 5 days per week.

(ii) Hospitals with excess capacity, but willing to reduce capacity by closing at least one existing operating room for every new ambulatory surgical operating room approved. The closure shall be considered a part of the CON application, and an increase in operating rooms after the implementation of the project shall be considered a change in the scope of the project, and is, therefore subject to CON review.

(iii) Independent freestanding ambulatory surgical facilities.

(6) Hospitals with current excess operating room capacity unwilling to commit to a reduction in inpatient operating rooms will be reviewed on their own merits, but will be given lesser priority than those proposals listed in this section.

(7) Optional preferences—the Department will give additional priority to applications meeting one or more of subparagraphs (i)—(iv). Subparagraphs (i) and (ii) will be used to establish priorities among hospital sponsored or related projects only. The terms shall be considered a part of the CON application and a change shall be considered reviewable.

(i) A proposal which reduces current inpatient operating room capacity by a greater amount than the number of new surgical operating rooms requested.

(ii) A proposal which, in addition to reducing operating rooms, reduces setup and staffed inpatient acute care beds.

(iii) A proposal in which an applicant is willing to guarantee its charges by procedure for at least a 2-year period following initial operation of the approved project. In order to qualify for this preference, the applicant shall include within its application, evidence of binding contractual relationships with major third-party payors guaranteeing charges for the required 2-year period.

(iv) A proposal in which the applicant agrees not to change ownership any sooner than 2 years after the project becomes operational. The ability and expertise of an owner is a critical factor in the issuance of a CON for the development of an ambulatory surgical facility. Thus, all applicants given preference under this subparagraph should be advised that changes in ownership would be considered a substantial change and therefore may be subject to CON review.

(d) Economic and financial feasibility.

(1) Proposals to increase ambulatory surgical capacity shall be financially feasible, considering the anticipated volume of care, the reasonableness of service changes and the availability of appropriate financing.

(2) Careful consideration should be given to each project’s allocation of costs between a parent corporation and a proposed ambulatory surgical facility to ensure that there is no hidden or unfair subsidization by the parent corporation to make the project appear less costly than it may actually be.

(e) Quality of care. Each ambulatory surgery project shall meet the licensure requirements of this title.

(f) Access to care. Each ambulatory surgery project shall demonstrate in its application a commitment to serve a fair share of medically underserved patients in its community.

(g) Project review. Projects for ambulatory surgical services and facilities shall be reviewed on a batching basis. The effective date for implementation of batching will be the date on which the Department publishes a notice of proposed rulemaking in the Pennsylvania Bulletin on batching.

(h) Research and data. The Department and the HSAs will collect current information on ambulatory surgical utilization and costs. The Department will require each applicant to report on a timely basis to the Department and the HSAs information on utilization and charges that the Department determines necessary to assure the provisions of this section are implemented.

The provisions of this § 401.6 adopted March 22, 1985, effective March 23, 1985, 15 Pa.B. 1079.

Economic and Financial Feasibility

The Department need not apply a regional approach when considering an application for a Certificate of Need to operate a freestanding ambulatory surgery center nor must the Department compare the applicant’s charges to more than other service provider. Jeannettee District Memorial Hospital v. Department of Health, 595 A.2d 677 (Pa. Cmwlth. 1991).

The CON Memorandum 85-15, published in 15 Pa.B. 1079, March 23, 1985, and now found in this section, was an interim interpretive policy dealing with the State Health Plan, within the Department’s expertise and was therefore beyond the scope of the Regulatory Review Act. Grandview Surgical Center, Inc. v. Holy Spirit Hospital of the Sisters of Christian Charity, 533 A.2d 796 (Pa. Cmwlth. 1987).

It was improper for the Board to emphasize statistics of one health care provider as opposed to a regional approach in analyzing investment and utilization patterns. Grandview Surgical Center, Inc. v. Holy Spirit Hospital of the Sisters of Christian Charity, 533 A.2d 796 (Pa. Cmwlth. 1987).

‘‘Cost-effectiveness’’ is an appropriate factor for the Board to consider in a decision. Grandview Surgical Center, Inc. v. Holy Spirit Hospital of the Sisters of Christian Charity, 533 A.2d 796 (Pa. Cmwlth. 1987); appeal denied 546 A.2d 623 (Pa. 1988).

History

Authority: The provisions of this Chapter 401 issued under the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 401 adopted July 25, 1980, effective August 1, 1980, 10 Pa.

28 Pa. Code § 401.7 Simultaneous and comparative review.

(a) The following categories of projects will receive simultaneous and comparative review:

(1) Alcohol and other drug treatment and rehabilitation.

(2) Ambulatory surgical services.

(3) Cardiac catheterization.

(4) Cardiac surgery.

(5) Comprehensive medical rehabilitation.

(6) Lithotripters.

(7) Magnetic resonance imaging devices.

(8) Psychiatric services.

(9) Renal dialysis units.

(10) Skilled nursing and intermediate care services.

(b) The Department, after consultation with the HSAs, will establish a schedule for simultaneous and comparative review of the categories of projects identified in this section. The time between the beginning of a period and the beginning of the next succeeding period for submission of applications for a category may not exceed 4 months. This schedule will be submitted for publication as a notice in the Pennsylvania Bulletin.

(c) Simultaneous and comparative reviews will follow the procedures in § 401.4 (relating to criteria for Certificate of Need review), with the following modifications:

(1) To qualify for simultaneous and comparative review, an application shall be submitted to the HSA and the Department under § 401.5 (relating to certificate of need) within 5 days of the scheduled beginning date for receipt of applications. An application submitted after the 5th day of the beginning date will be returned to the applicant for resubmission during a subsequent simultaneous and comparative review period.

(2) An applicant may withdraw an application from a simultaneous and comparative review period by requesting in writing the withdrawal of the application from consideration.

(3) An applicant may request postponement of review until a subsequent simultaneous and comparative review period.

(4) An applicant’s request for an extension will be considered a request for postponement of review until a subsequent simultaneous and comparative review period.

(5) An applicant’s request for a substantial modification will be considered a request for postponement of review until a subsequent simultaneous and comparative review period.

(6) The HSA and the Department will determine if an application is complete and notify the applicant of its findings by the 15th day of the simultaneous and comparative review period. In determining if an application is complete, the HSA and the Department will examine the application to determine if requested information has been provided. An application which is still incomplete on the 30th day of a review period will be returned to the applicant for resubmission during a subsequent simultaneous and comparative review period.

(7) The HSA shall publish a notice, in at least one newspaper of general circulation serving the localities in which the projects will be developed, within 30 days following the beginning of the simultaneous and comparative review period.

(i) The notice shall contain the following information:

(A) Names and addresses of the applicants.

(B) A brief description and an estimate of the cost of the projects.

(D) Notification that the applications are complete.

(E) Notification that the review of the completed applications is beginning.

(F) Notification of the date a public hearing will be held.

(G) Notification of the deadline for submission of objections to the applications and the deadline for submission of intention to attend or testify at the public hearing.

(ii) The Department will provide notice as set forth in this paragraph if one of the following applies:

(A) There is no HSA functioning in an applicant’s regional area.

(B) More than one HSA is involved in the review of applications in a particular project category and the Department has determined that one hearing is preferable to a hearing in each regional area.

(8) No additional information will be accepted by the Department after the applications have been deemed complete, except during the public hearing.

The provisions of this § 401.7 issued under section 702 of the Health Care Facilities Act (35 P. S. § 448.702(j)).

The provisions of this § 401.7 adopted January 9, 1987, effective January 10, 1987, 17 Pa.B. 182.

History

Authority: The provisions of this Chapter 401 issued under the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 401 adopted July 25, 1980, effective August 1, 1980, 10 Pa.

28 Pa. Code § 401.11 Magnetic resonance Certificate of Need—statement of policy.

(a) Status and trends. Magnetic resonance (MR) is a category of service that uses the magnetic spin property of certain atomic nuclei to visualize and analyze tissue. Diagnostic techniques include both MR imaging and spectroscopy.

(1) MR imaging has proven to be a useful tool in the diagnosis of the following:

(i) Brain, brain stem, spinal cord disorders and demylenating diseases.

(ii) Diffuse or infiltrating diseases of the liver and kidney.

(iii) Early changes in ischemia and infarction of heart tissue.

(2) Ovarian and uterine tissue can be imaged well through MR. Also, the process can be used to evaluate growth and development of a fetus.

(3) MR spectroscopy has potential application for in vivo analysis of biochemical processes in healthy and diseased tissue. Potential applications include the following:

(i) Determination of early chemical changes in evolving cerebral or myocardial infarctions.

(ii) Determination of the chemical nature and specific diagnosis of tumors throughout the body.

(iii) Analysis of chemical parameters and changes in metabolic diseases of the liver and kidney.

(iv) In vivo analysis of early changes in multiple sclerosis.

(v) In vivo analysis of dementia-producing disorders such as Alzheimer’s disease.

(4) The Federal Food and Drug Administration (FDA) has approved MR imaging devices produced by certain manufacturers.

(5) On July 1, 1985, Blue Cross of Western Pennsylvania began coverage for all MR imaging scans performed on FDA-approved equipment provided that a certificate of need has been issued or a project has been deemed nonreviewable. Pennsylvania Blue Shield followed suit in October 1985. In November 1985, The Health Care Finance Administration announced that Medicare will provide reimbursement for MR imaging procedures for a limited number of diagnoses. As of April 1987, third party payers were not reimbursing facilities for spectroscopic services which are regarded as experimental.

(6) MR devices are available with one of three broad categories of magnets. Each type of magnet can be obtained in a variety of field strengths up to 2.5 Telsa. Higher field strength becomes important in MR spectroscopy. The three categories of magnets are:

(i) Resistive.

(ii) Permanent.

(iii) Superconductive.

(7) A recent development is the mobile MR unit. Equipment manufacturers predict that up to 40% of their market will be mobile units.

(8) A type of movable unit is the transportable and relocatable system. These are larger than mobile units and are not intended to be moved more than several times per year.

(9) Tables 1 and 2 show the estimated range of purchase and installation costs, and annual operating costs, respectively, as compiled by the American Hospital Association (AHA). Mobile systems will have the following additional costs:

(i) For the trailer—$500,000.

(ii) For the tractor—$50,000 to $125,000.

(10) Although MR imaging has distinct advantages over the less expensive computerized axial tomography (CAT) scan, there are important limitations. Seriously ill patients in monitored beds cannot be imaged because the presence of strong magnetic fields will affect electronic monitoring devices. Also, MR is contraindicated for patients with intravenous (IV) needles and ferrous metal implants. The AHA projects that across all disease categories, MR imaging will replace only about 34% of all CAT scans.

(11) Table 4, set forth in subsection (c), shows the present distribution of certificate of need approved MR devices in this Commonwealth.

(b) Policy. The following criteria will be used in reviewing certificate of need proposals related to magnetic resonance:

(1) The formula set forth in subsection (c) will be used in certificate of need reviews for MR imaging project proposals.

(2) To the extent feasible, and consistent with other criteria, MR devices should be dispersed throughout a region. Magnetic resonance imaging (MRI) services should be located so that 90% of the population of the region is within 1 hour travel time to a service.

(3) Applicants shall establish and document a policy that MR services will be provided regardless of a patient’s ability to pay.

(4) Shared arrangements may be any of the following:

(i) Reciprocal agreements among hospitals with CAT and MRI capability.

(ii) Reciprocal agreements involving use of a device located at a free-standing imaging center.

(iii) Reciprocal agreements involving use of a mobile or a transportable/relocatable unit.

(5) The Department will deem the needs of the population to be best served by hospitals proposing shared arrangements with other health care facilities.

(6) The Department will deem a shared arrangement to be economically more feasible than a single facility use proposal. When comparing two or more shared arrangement proposals, the Department will evaluate the following:

(i) The respective capabilities of the project applicants and associated facilities of each.

(ii) The anticipated volume of care of each.

(iii) The availability of reasonable start-up capital of each.

(iv) Projected marginal revenues of each.

(v) Projected marginal costs, variable costs and fixed costs of each.

(7) An applicant facility shall establish and document a policy that the hospitals in a region to be served by an MR unit will have equal access to the unit. Equal access will be characterized by the following:

(i) A scheduling priority based on patient need. Documented urgent or emergent cases will be given priority access.

(ii) A nondiscriminatory charge schedule.

(iii) Interhospital transport services with appropriate medical supervision established either directly by the applicant or through a mutually agreed upon arrangement with the referring facility.

(8) Charges for MRI services should be reasonably related to service cost. Charges should not exceed the median charge of Commonwealth providers of comparable MRI services by more than 20% without reasonable justification.

(9) Facilities providing MR services shall have a utilization review program that includes MR examinations.

(10) Hospitals offering MR shall be able to directly provide related diagnostic modalities such as the following:

(i) CAT full-body scanning.

(ii) Ultrasound.

(iii) Radionuclide scanning.

(iv) Conventional X-ray, including, but not limited to, arteriography.

(11) A board-certified or board-qualified physician trained in MRI shall be responsible for the operation of the MR facility and interpretation of the MR data. This work shall be the full-time activity of that physician or other physicians delegated by that physician if they have been trained in MRI.

(12) Medical physicist involvement is necessary for quality assurance, computer maintenance and training of staff in magnetic field theory and related issues.

(13) The MR program staff shall include the specialty of radiology and subspecialists appropriate to the applications intended, including experience in computed tomography or nuclear medicine.

(14) Facilities proposing to provide MR services shall also directly provide a variety of medical subspecialty services which include, but are not limited to, oncology, neurology, internal medicine, pathology and radiology.

(15) At least one staff person trained in cardio-pulmonary resuscitation (CPR) shall be on duty in the unit at all times.

(16) The facility shall have a program on image quality control of MR services and a program to calibrate and maintain its diagnostic equipment.

(17) The MR unit shall meet the standards recommended by the FDA.

(18) The area housing the MR unit shall be constructed in accordance with standards established by the manufacturer and Federal or State standards, or both, as may be developed.

(1) Several methodologies for projection of MRI utilization have been studied.

(i) The methodology used in New York State assumes a ratio of one MR unit per three fully utilized CAT scanners. New York considers 3,000 images per year as full utilization of an MR unit.

(ii) Massachusetts uses the AHA utilization model, at least in part.

(iii) Illinois will approve an MR unit at a hospital which does 4,500 CAT scans per year or more.

(iv) The Health Systems Agency of Southwestern Pennsylvania uses the methodology developed by the AHA.

(v) The AHA methodology is based on the opinions of an expert panel of physicians. The panel determined the percent of patients within discrete ICD-9-CM categories who would require MRI.

(2) The Department adopts the AHA methodology, as set forth in the AHA Hospital Technology Series, Vol. 11, No. 8, ‘‘NMR—Nuclear Magnetic Resonance Guideline Report’’ of 1983, to predict the number of initial and followup scans. The Statewide results of this methodology are given in Table 3.

(3) Throughput is the number of patients imaged per year. The Health Systems Agency of Southwestern Pennsylvania estimated that a unit is capable of 2,000 procedures per year. By the end of 1986, the 14 test sites in New York State were achieving an average throughput of 2,500 patients per year. Full utilization in New York State is 3,000. A radiological team headed by W. G. Bradley reports in ‘‘MR Installation, 18 Months Clinical Experience’’ that patient throughput at the MR operated by the 625-bed Huntington Medical Research Institute averages more than 12 patients per day with as many as 18 patients per day often being examined. By reaching reasonable throughput, the Huntington Institute has been able to keep average MR charges at about 25% higher than CAT. Twelve patients per day yields a total annual throughput of 3,000 patients.

(4) The following formula is used to predict the number of MRI devices needed in Pennsylvania.

(5) The Department of Health adopts 2,500 patients per year as a reasonable throughput for a single unit. Therefore, using the formula in paragraph (4), approximately 107 MR units will be adequate to meet the needs of patients in this Commonwealth.

(6) Table 4 shows the projected need for MR units by health service area. Rounding of fractional units next higher integer results in a total State need of 110 units.

The provisions of this § 401.11 adopted July 10, 1987, effective July 11, 1987, 17 Pa.B. 2946; amended August 5, 1988, effective August 6, 1988, 18 Pa.B. 3467; amended December 8, 1989, effective December 19, 1989, 19 Pa.B. 5222. Immediately preceding text appears at serial pages (127049) to (127052) and (129161) to (129163).

History

Authority: The provisions of this Chapter 401 issued under the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 401 adopted July 25, 1980, effective August 1, 1980, 10 Pa.

28 Pa. Code § 401.12 Reviewable clinically related health services—statement of policy.

(a) Section 701(d) of the act (35 P. S. § 448.701(d)), as amended by the act of December 18, 1992 (P. L.

History

Authority: The provisions of this Chapter 401 issued under the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 401 adopted July 25, 1980, effective August 1, 1980, 10 Pa.

28 Pa. Code § 401.13 Examination of Certificate of Need files—statement of policy.

(a) By prior written request and arrangement only, Certificate of Need (CON) applications and materials will normally be available for examination by the public on Tuesdays, Thursdays and Fridays which are official Commonwealth State government business days from 9 a.m. to 12 p.m. and from 1 p.m. to 4 p.m. in Room 1027, Health and Welfare Building, Commonwealth and Forster Streets, Harrisburg, Pennsylvania. Parties requesting examination of materials shall make requests in writing by designating the name, address and telephone number of the requesting party, project name and description or CON number or both, and the calendar date on which the party would like the materials to be made available for review. Parties shall make sure that written requests reach the Department at least 2 full business days prior to the calendar date requested for review. Requesting parties will be notified by the Division of Need Review staff by telephone of the date on which materials are available. Requesting parties that walk in without prior contact with the Division of Need Review will be given a date for examination of requested documents within 2 full business days, upon providing the information required by this subsection.

(b) CON records maintained by the Central Office in Harrisburg may be reviewed and copied only at the Division of Need Review Office.

(c) CON records will be made available for review by the Division of Need Review staff in the Division conference area only.

(d) A fee of 50¢ per page for all pages copied will be invoiced payable to the Department of Health by check or money order; however, there will be a minimum copy charge of $5. The requesting party or their representatives are responsible to make the copies, using the copy machine in the Division of Need Review Office.

The provisions of this § 401.13 adopted December 21, 1990, effective December 22, 1990, 20 Pa.B. 6301.

History

Authority: The provisions of this Chapter 401 issued under the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 401 adopted July 25, 1980, effective August 1, 1980, 10 Pa.

28 Pa. Code § 401.14 Letters of intent and filing fees—statement of policy.

(a) A person intending to offer, develop, construct, renovate, expand or otherwise establish or undertake to establish either a clinically related health service that is included in the Department’s list of reviewable clinically related health services in § 401.12 (relating to addition of a health service subject to Certificate of Need review—statement of policy), or a health care facility as defined in section 103 of the act (35 P. S. § 448.103) shall at the earliest possible time in their planning submit a signed letter of intent to the Department.

(b) Letters of intent shall contain the following information:

(1) The name and address of the applicant.

(2) The name and address of the contact person for the project.

(3) The proposed name and location of the project.

(4) A brief description of the proposed project, including the amount of capital expenditure, the type of health service being proposed or a change in bed capacity involved in the proposed project.

(5) The expected date of project commencement and completion.

(6) The expected capital expenditure, including capital leases or donations as defined in § 401.15 (relating to Certificate of Need application procedures and filing fees—statement of policy), and anticipated source of project financing.

(7) A statement certifying that the data, information and statements are factual to the best of the applicant’s knowledge, information and belief.

(c) Every person who submits to the Department a letter of intent shall file a nonrefundable fee of $150 in the form of a certified check made payable to the ‘‘Commonwealth of Pennsylvania.’’ The required fee for a letter of intent is due upon filing of the letter of intent. The letter of intent will not be considered until the fee is received.

(d) Within 30 days of receipt of a letter of intent, the Department will assign a project number, determine reviewability of the proposal and notify the applicant if a Certificate of Need is required. If a Certificate of Need is required, the Department will mail to the applicant an application form and appropriate instructions for completion of the application.

(e) Even if the required letter of intent fee is received, the elements of subsection (b) shall be addressed before the time period in subsection (d) commences.

(f) The Department will withdraw from further consideration a letter of intent if a Certificate of Need application is not filed within 1 year of the date of determination of reviewability.

(g) The Department will not accept a facsimile of a letter of intent electronically transmitted to the Department.

The provisions of this § 401.14 adopted February 19, 1993, effective February 20, 1993, 23 Pa.B. 843.

History

Authority: The provisions of this Chapter 401 issued under the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 401 adopted July 25, 1980, effective August 1, 1980, 10 Pa.

28 Pa. Code § 401.15 Certificate of Need application procedures and filing fees.

(a) An application for a Certificate of Need shall be submitted to the Department on application forms provided by the Department. An applicant shall submit an original and one copy of the completed application to the Department of Health, Division of Need Review, and one copy of the completed application to the appropriate district office of the Department. The copy supplied to the district office is for public review, and copies of the application to persons other than the Department shall be supplied by the applicant in accordance with subsection (o).

(b) An application for a Certificate of Need will be accepted by the Department only on the first 5 business days of each month. Applications received after the fifth day will be returned to the applicant.

(c) Every person who submits to the Department an application for a Certificate of Need shall also file a nonrefundable fee as follows:

(1) For each Certificate of Need application, filed under section 702(b) of the act (35 P. S. § 448.702(b)), $500 plus $3 per $1,000 of proposed capital expenditure. The maximum application fee may not exceed $20,000 for a single proposal.

(2) The letter of intent fee shall be deducted from the required total application fee.

(d) The following formula shall be used in calculation of the required Certificate of Need application fee:

(g) The required fee for a Certificate of Need application, less previously paid letter of intent fee, is due upon filing of the application.

(h) An application shall be mailed to the Division of Need Review, Pennsylvania Department of Health, 1027 Health and Welfare Building, 7th and Forster Streets, Harrisburg, Pennsylvania 17120, accompanied by a certified check made payable to the ‘‘Commonwealth of Pennsylvania’’ in the correct amount of the fee. An application submitted without the correct fee in the form of a certified check will be returned immediately to the applicant. The Department will not begin a preliminary assessment of an application until the appropriate fee is paid in full as determined by the Department.

(i) Consistent with generally accepted accounting principles, a capital lease is a capital expenditure for purposes of Certificates of Need. A lease will be determined to be a capital lease if one or more of the following conditions applies:

(1) Ownership of the leased asset will be conveyed to the lessee at the end of the lease period.

(2) The lease gives the lessee the option to purchase the leased asset at less than fair market value at some point either during the lease period or at the end of the lease period.

(3) The period of the lease is 75% or more of the expected useful life of the leased asset.

(4) The present value of the minimum lease payments is 90% or more of the fair market value of the leased asset.

(j) Acquisition of a donated capital asset will be considered a capital expenditure for purposes of Certificates of Need. Valuation of donated capital assets will be the higher of historic cost or current market value, consistent with generally accepted accounting principles.

(k) Upon receipt of an application for a Certificate of Need and appropriate filing fee, the Department will conduct its preliminary assessment within 60 days, and determine whether additional information is required. If additional information is required, the Department will send notice to the applicant, stating what additional information is required. Upon receipt of the additional information, the Department will complete its preliminary assessment within 45 days of receipt of the same. Timely notice of the beginning of review of the application by the Department will be published after preliminary assessment of the application is completed by the Department.

(l) The Department retains the right to use an expedited review process.

(m) After 1 year from the date of the Department’s request for additional information, the Department will withdraw from further consideration a Certificate of Need application for which questions were asked, but no responsive answers have been received.

(n) The ‘‘date of notification’’ begins the 90-day time period in which the Department must complete review of the application. The date of notification shall be the date the Department sends notice to the applicant, or publishes a notice of the beginning of a review in the Pennsylvania Bulletin or in a newspaper of general circulation, whichever is latest.

(o) Interested persons may request a public meeting within 15 days of publication of the notice. A request for a public meeting shall be in writing and set forth specifically the reasons a public meeting is being requested. The applicant is required to provide a copy of the application to interested persons making a request for the application. The applicant may charge the interested person the reasonable cost of making the copy.

(p) A cost increase or a change in scope of a previously approved Certificate of Need will be regarded as a new proposal subject to application fees. The fee shall be $500, plus $3 per $1,000 for a proposed capital expenditure over the approved capital expenditure. The total amount of additional fee may not be more than $20,000. Modifications which result in additional capital costs to a proposal during the review process will be subject to additional fees payable at the time of submission of the modification to the Department.

The provisions of this § 401.15 adopted February 19, 1993, effective February 20, 1993, 23 Pa.B. 843.

This section cited in 28 Pa. Code § 401.14 (relating to letters of intent and filing fees—statement of policy).

History

Authority: The provisions of this Chapter 401 issued under the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 401 adopted July 25, 1980, effective August 1, 1980, 10 Pa.

28 Pa. Code § 401.16 Positron Emission Tomography (PET) services; interim criteria for Certificate of Need (CON) review—statement of policy.

(a) Acquisition of a PET scanner is subject to review under section 701 of the act (35 P. S. § 448.701).

(b) Certificate of Need review for proposed PET scanners will be conducted using the need methodology in subsection (c), and the review criteria in subsection (h).

(d) The incidence rate for open heart surgery is derived from the formula found at Chapter 26 of the SHP as amended July 16, 1991.

(e) Incidence rates for percutaneous transluminal coronary angioplasty (PTCA), epilepsy, brain tumor and dementia are derived from a methodology developed by the American Hospital Association. This methodology determined which ICD-9 diagnostic codes involve conditions which might require a PET scan, the percentage of patients with the condition who would receive a scan and the average number of scans each patient would be likely to receive. Incidence data are based on 1989 hospital discharge data reported to the National Center for Health Statistics.

(f) The optimal use rate, expressed as number of scans per unit, is taken from a number of studies as well as from literature supplied to the Department by manufacturers of PET scan devices. This material supports a rate range of six to ten scans per device per day. A midpoint of eight scans per device per day is adopted, and results in a total annual use rate of 2,000 scans per device per year.

(g) Application of the formula in subsection (c) projects the following need by health planning area through the year 1995.

(h) The Department will use the following review criteria in addition to the need projections in subsection (g) to determine the need for a PET service:

(1) A site where PET services are proposed to be offered shall be a site where the following clinical services also are currently offered:

(i) An open heart surgery program that is approved by the Department and where an average of at least 700 open heart cases per year during the most recent 3-year period were performed. In the interest of geographic distribution of PET services, the Department may waive this requirement in its consideration of an application from a hospital where at least 450 open heart cases per year were performed during the most recent 3-year period, if no other hospital in the same health planning area met the 700 case standard. The Department may also waive this requirement in its consideration of an application from a medical college.

(ii) A therapeutic cardiac catheterization service that is approved by the Department and that includes a PTCA program.

(iii) A full range of full-time, onsite related diagnostic modalities including conventional x-ray, full-body computed tomography, ultrasound, magnetic resonance imaging and other radio-nuclide scanning.

(2) The Department will consider applications for shared PET services. The standards in paragraph (1) shall be met by each hospital participating in the shared PET service.

(3) Hospitals in a region served by one or more PET scanners will have equal access to at least one of the units. Equal access will be characterized by the following:

(i) A scheduling priority based on patient need.

(ii) Services provided to patients from referring hospitals will be charged for the PET services at the same rate as patients in the hospital housing the PET scanner.

(iii) Transportation services with appropriate supervision established either directly through the sponsor or through a mutually agreed upon arrangement with the referral facilities.

(4) The equipment shall be certified for clinical use by the Federal Food and Drug Administration (FDA). The facility shall also present evidence of approval by the FDA of its New Drug Application (NDA) for the production of radiopharmaceuticals as part of the CON application.

(5) A PET service shall be under the medical direction of a physician who is board certified in nuclear medicine or nuclear radiology, or trained and licensed in nuclear cardiology and has additional documented experience and training in PET technology, including radiochemistry. The physician shall be licensed by the Nuclear Regulatory Commission to possess radiopharmaceuticals and perform diagnostic procedures employing radiopharmaceuticals in human beings.

(6) Additional staff for a PET service shall include at a minimum the following staff as appropriate:

(i) A radiochemist trained at the master’s or Ph.D. level in radiochemistry or radiopharmacy who also has a background in PET physics or radiochemistry and experience in radiopharmaceutical production.

(ii) A nuclear medicine technologist with training onsite or offsite in cyclotron operation and radiopharmaceutical production, and who will work under direction and supervision of the medical director.

(iii) Two radiological technologists with documented training in radiology, nuclear medicine or MRI/CT scanning and who are able to provide support in the areas of PET imaging systems operation, patient preparation for PET studies and image analysis and processing.

(7) The PET service should be available for operation at least 8 hours per day, 5 days per week. Evening and weekend hours are encouraged as an aid to accessibility.

(8) It is the policy of the Department to encourage efficient use of expensive technology through sharing of cyclotron facilities.

(9) Proposals to convert an existing research scanner to clinical use will be subject to CON review.

(10) Additional scanners in a health planning area beyond the need projected in subsection (g) will not be approved until previously approved PET scanners in the health planning area are operating at an average of 2,000 scans per year.

(i) This section shall serve as an interim policy until replaced with standards and criteria in the State Health Services Plan.

The provisions of this § 401.16 adopted May 21, 1993, effective May 22, 1993, 23 Pa.B. 2449.

History

Authority: The provisions of this Chapter 401 issued under the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 401 adopted July 25, 1980, effective August 1, 1980, 10 Pa.

28 Pa. Code § 401.17 Prohibited communications with the Department—statement of policy.

(a) After the conclusion of a public meeting on a Certificate of Need application held under section 704(b) of the act (35 P. S. § 448.104(b)), there may be no ex parte contacts with the Department.

(b) For purposes of this section, an ex parte contact is communication between the following individuals and any member of the Department exercising any responsibility for the applicant:

(1) The applicant for a Certificate of Need.

(2) A person acting on behalf of the applicant.

(3) A person who supports or opposes the granting of a Certificate of Need.

(c) The Department will not accept telephone calls from any of the individuals listed in subsection (b)(1)—(3) after the public meeting, unless that call consists only of a request for a status report. A ‘‘status report’’ consists of a statement of the progress of the review of a Certificate of Need application. Communication regarding the substantive elements of a Certificate of Need application is not a status report.

(d) At the conclusion of the public meeting, the meeting officer will announce a schedule during which communications and responses to those communications will be received by the Department and the date upon which the record will be closed. After the public meeting, the Department will not accept written communications from the individuals listed in subsection (b)(1)—(3), unless the document indicates that copies have been sent to those persons who attended the public meeting. If no notation is made on the document, it will be returned by the Department to the sender and will not be considered by the Department in its review of the project nor will it become part of the official file.

(e) If a public meeting is not held, there may be no ex parte contacts with the Department after the time has expired for interested persons to request a public meeting as set forth in section 704(b) of the act. After that date, the individuals listed in subsection (b)(1)—(3) may not contact the Department, except for requests for a status report.

The provisions of this § 401.17 adopted December 2, 1994, effective December 3, 1994, 24 Pa.B. 5993.

History

Authority: The provisions of this Chapter 401 issued under the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 401 adopted July 25, 1980, effective August 1, 1980, 10 Pa.

28 Pa. Code § 401.18 Hospital-based skilled nursing facilities—statement of policy.

(a) The Department will apply the relevant criteria contained in Chapter 14 of the State Health Services Plan (SHSP) in the review of Certificate of Need applications to establish hospital-based skilled nursing facilities.

(b) The criteria to be applied will include the long-term care bed need projections contained in Appendix 14-A to Chapter 14 of the SHSP and any updated revisions to that Appendix. If a proposed hospital-based skilled nursing facility is located in a county for which the number of licensed or approved long-term care beds equals or exceeds the projected bed need, the Department will consider approval of the application only if the applicant is able to demonstrate that the approval is otherwise justified under the criteria contained in Chapter 14 of the SHSP.

(c) This section applies to Certificate of Need applications for which a completion of preliminary assessment has not been published in the Pennsylvania Bulletin.

(d) This section will remain in effect unless it is superseded by specific criteria in the SHSP addressing the issue of bed need projections for hospital-based skilled nursing facilities.

The provisions of this § 401.18 adopted November 4, 1994, effective November 5, 1994, 24 Pa.B. 5563.

History

Authority: The provisions of this Chapter 401 issued under the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 401 adopted July 25, 1980, effective August 1, 1980, 10 Pa.

Subpart E Birth Centers

Chapter 501 Birth Centers

28 Pa. Code § 501.1 Legal base.

(a) This subpart is promulgated by the Department under the powers granted and the duties mandated by Chapter 8 of the Health Care Facilities Act (35 P. S. § § 448.801a—448.820), and by section 2102(a) and (g) of The Administrative Code of 1929 (71 P. S. § 532(a) and (g)).

(b) The Department has the power and its duty is to promulgate, after consultation with the Health Care Policy Board, the rules and regulations necessary to carry out Chapter 8 of the Health Care Facilities Act and to assure that the act is enforced.

(c) The purpose of this chapter is to protect and promote the public health and welfare through the establishment and enforcement of regulations setting minimum standards in the construction, maintenance, and operation of health care facilities. The standards are intended by the Department to assure safe, adequate, and efficient facilities and services, and to promote the health, safety, and adequate care of the patients or residents of the facilities. It is also the purpose of this chapter to assure quality health care through appropriate and nonduplicative review and inspection, with regard to the protection of the health and rights of privacy of patients and without unreasonably interfering with the operation of the health care facility.

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.2 Affected health care facilities.

(a) This subpart shall apply to birth centers, profit or nonprofit, operated within this Commonwealth.

(b) Existing facilities or sections of facilities, which were being used as birth centers prior to June 26, 1985, shall be required to meet the same standards as facilities or sections constructed, converted or remodeled after June 26, 1985, unless an exception is granted by the Department under § 501.6 (relating to exceptions).

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.3 Reports/contact person.

(a) The facility shall report regularly to the Department, on forms issued by the Department, statistical information that the Department may request and shall comply with the requirements for recordkeeping in § 28.41 (relating to recordkeeping requirements).

(b) Data that could lead to the disclosure of the identity of individuals involved will be considered confidential and may not be released without prior authorization of the legal parent, guardian or newborn infant upon obtaining the age of 18.

(c) Questions concerning reports required should be addressed to Director, Division of Primary Care and Home Health Services, Department of Health, Post Office Box 90, Harrisburg, Pennsylvania 17108.

The provisions of this § 501.3 amended under section 16(a) of the Disease Control and Prevention Act of 1955 (35 P. S. § 521.16(a)); sections 2102(g) and 2111(b) of The Administrative Code of 1929 (71 P. S. § § 532(g) and 541(b)); and sections 3 and 5 of the Newborn Child Testing Act (35 P. S. § § 623 and 625).

The provisions of this § 501.3 amended May 17, 2002, effective May 18, 2002, 32 Pa.B. 2435. Immediately preceding text appears at serial page (245707).

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.4 Regulations.

(a) A current copy of this subpart shall be maintained at the facility at all times.

(b) Facilities licensed under this subpart shall comply with environmental, health, sanitation and professional licensure standards which are required by Federal, State and local authorities. This shall include, but not be limited to, standards promulgated by the State Boards of Medicine, Nursing and Pharmacy (49 Pa. Code Chapters 16—18, 21 and 27), and the Department of Environmental Resources (25 Pa. Code Chapters 221—235 (relating to radiological health)). Facilities shall also comply with Chapter 1 (relating to administration of vital records), Chapter 5 (relating to clinical laboratories) and Chapter 27 (relating to communicable and noncommunicable diseases).

(c) If there is a difference in applicable State or local statutes, the standards established under State statute shall apply for the purposes of compliance with this subpart.

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.5 Inspections.

All areas of the facility shall be subject to inspection, at reasonable times, by authorized representatives of the Department. Inspections may be scheduled in advance or be unannounced.

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.6 Exceptions.

(a) The Department may, within its discretion and for good reason, grant an exception to the standards when the policy objective of those standards is met in existing facilities. The request for an exception shall be made in writing by the facility.

(b) Exceptions will be granted to the standards for physical plant and environment only if the facility is unable to comply because of structural features, which preclude modification, and if the rights, privacy, health and safety of the patients are not jeopardized.

This section cited in 28 Pa. Code § 501.2 (relating to affected health care facilities); and 28 Pa. Code § 501.81 (relating to safety from fire).

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.7 Definitions.

The following words and terms, when used in this subpart, have the following meanings, unless the context clearly indicates otherwise: Basement—A story or floor level below the main or street floor. Where due to grade differences, there are two levels each qualifying as a street floor, a basement is a floor level below the lower of the two street floors. Basements may not be counted in determining the height of a building in stories. Bathing facility—A bathtub or shower, or both. Birth center—A facility not part of a hospital which provides maternity care to childbearing families not requiring hospitalization. A birth center provides a home-like atmosphere for maternity care, including prenatal labor delivery and postpartum care related to medically uncomplicated pregnancies. Birthing room—A room designed, equipped, and arranged to provide for the care of a woman and newborn, and which includes accommodations for support persons during the process of vaginal childbirth, including the three stages of labor and recovery of a woman and newborn. Department—The Department of Health of the Commonwealth. Grade—The average elevation of the ground, paved or unpaved, adjoining a building or structure, at the center of each exterior wall. Hazardous area—Areas of structures, buildings or parts thereof, used for purposes that involve highly combustible, highly flammable, or explosive products or materials which are likely to burn with extreme rapidity, or which may produce poisonous fumes or gases, including highly toxic, or noxious alkalies, acids, or other liquids or chemicals, which involve flame, fume, explosive, poisonous, or irritant hazards; also uses that cause division of material into fine particles or dust subject to explosion or spontaneous combustion, and uses that constitute a high hazard because of the form, character, or volume of the material used. Licensed practical nurse—A practical nurse who holds a current and valid license to practice in this Commonwealth, under the Practical Nurse Law (63 P. S. § § 651—667). Low risk individual—A woman experiencing normal, uncomplicated prenatal course as determined by adequate prenatal care and prospects for a normal, uncomplicated, birth as defined by reasonably and currently accepted criteria of maternal and fetal health. Midwife—A certified midwife holding a valid and current license to practice midwifery in this Commonwealth, under the act of April 4, 1929 (P. L. 160, No. 155) (63 P. S. § § 171—176). Minor alterations—Structural or functional changes which do not affect the use of a room or an area. New construction—Construction started after June 26, 1985, for use as a birth center, including:

(i) New buildings.

(ii) Additions to existing buildings.

(iii) Alterations, other than minor alterations. Owner—The individual, partnership, association, or corporation which is authorized to operate a facility for licensure by the Department. Physician—A Doctor of Medicine or a Doctor of Osteopathy, who holds a current and valid license to practice in this Commonwealth. Registered nurse—A nurse licensed to practice in this Commonwealth under The Professional Nursing Law (63 P. S. § § 211—225). Support person—The individual selected or chosen by a patient to provide emotional support and to assist her during the process of labor and childbirth.

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.11 General.

(a) The owner of a birth center may be an individual, partnership, association, corporation, or a combination thereof. The following applies to facilities according to the mode of ownership:

(1) Individual ownership. A complete list of names and addresses of the persons in charge shall be submitted with the application. When death occurs to a person who was a sole owner of the facility, the executor or administrator of the estate may apply for, and the Department may, after review, grant a license for the facility.

(2) Partnerships. A complete list of names and addresses of the persons in charge and all partners responsible for the management of the facility shall be submitted with the application. When a license is issued to a partnership and one or more of the partners dies, the executor or administrator of the deceased’s estate, together with the surviving partner, if any, may apply for a license. After review, the Department may grant the license.

(3) Association or corporation. A complete list of names and addresses of the officers, directors, principal stockholders, either beneficial or of record, of the corporate owner and of the parent corporation, if applicable, and of the persons in charge who are responsible for the management of the facility, shall be submitted with the application.

(b) The Department shall be notified, in writing, within 30 days whenever a change in the partners, officers, directors, principal stockholders, or persons in charge of a facility owned by a partnership or corporation has taken place.

(c) The facility shall identify each person who has a direct or indirect ownership interest of 5.0% or more in the birth center.

(d) The Department shall be notified, in writing, at least 90 days before change in ownership or the form of ownership or name of the facility takes place. The license is transferrable upon approval by the Department.

(e) A physically noncontiguous branch of the birth center shall meet all requirements for licensure and shall be independently licensed.

This section cited in 28 Pa. Code § 501.32 (relating to governing body).

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.12 Profit or nonprofit status.

A facility may be operated as a profit-making enterprise or on a nonprofit basis.

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.21 Licensure process.

(a) An application for license to operate a birth center shall be made under section 807 of the Health Care Facilities Act (35 P. S. § 448.807).

(b) The application form for a license to operate a birth center shall be obtained from the Department of Health, Division of Primary Care and Home Health Services, P.O. Box 90, Harrisburg, Pennsylvania 17108.

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.22 Issuance of license.

(a) The Department will grant a regular license to operate a birth center after a survey conducted by the Department indicates that the applicant is in substantial compliance with this subpart. The survey shall include an onsite inspection and a review of written approvals by regulatory agencies responsible for building, electric, fire, and environmental safety. New construction, alterations, or renovations that provide space for patient services or rooms shall not be used or occupied until authorization for the occupancy has been received by the birth center from the Department.

(b) A regular license issued by the Department shall expire 1 year from the date of issue. A regular license is issued when, in the judgment of the Department, there is substantial compliance with all applicable regulations.

(c) A provisional license is issued when there are multiple minor deficiencies or a serious specific deficiency, which indicates that the facility is not in compliance with applicable statutes, ordinances, or rules, and the Department finds all of the following:

(1) The applicant is taking appropriate steps to correct the deficiencies in accordance with a timetable submitted by the applicant and agreed upon by the Department.

(2) There is no pattern of deficiencies over a period of 2 or more years.

(3) There is no danger to the health or safety of the patients of the facility or newborn infants.

(d) The Department may issue a provisional license for a specific period of not more than 6 months. A provisional license may be renewed no more than three times.

(e) The current license shall be posted in a conspicuous place in the birth center.

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.23 Responsibility of facility owners.

(a) The owner shall be responsible for meeting the minimum standards for the operation of a birth center, as set forth by the Department, and by other State and local agencies responsible for the health, welfare, and safety of the patients therein.

(b) When services for the administration or management of the facility are purchased, the owner shall be responsible for insuring compliance with this title, as well as those of other appropriate agencies.

(c) The owner, or person in charge, shall immediately report, by telephone to the Department and by a written follow-up report as soon as possible, any catastrophic incident, such as fire or flood, or any incident which may cause interruption or cessation of the delivery of services, or another interruption of services which would affect the health and safety of either the patient or newborn infant.

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.24 Restrictions on a license.

The Department may refuse to renew a license, or may suspend, revoke, or limit a license of a birth center or may suspend admissions for any of the following reasons:

(1) A serious violation of this subpart, or of the Health Care Facilities Act (35 P. S. § § 448.101—448.904), or of other statutes, which seriously threatens the health, safety, and welfare of patients.

(2) Failure of an owner to submit a reasonable timetable for correction of deficiencies.

(3) The existence of a cyclical pattern of deficiencies that extends over a period of 2 or more years.

(4) Failure, by the holder of a provisional license, to correct deficiencies in accordance with a timetable submitted by the applicant and agreed upon by the Department.

(5) Fraud or deceit in obtaining, or attempting to obtain, a license.

(6) Lending, borrowing, or using the license of another, or in knowingly aiding or abetting the improper granting of a license.

(7) Incompetence, negligence, or misconduct in operating the birth center or in providing services to individuals.

(8) Mistreating or abusing individuals cared for by the birth center.

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.31 General.

(a) The birth center shall develop a written table of organization, which shall be available at the birth center at all times.

(b) The table of organization shall identify a governing body, which has full authority and responsibility for the operation of the birth center.

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.32 Governing body.

The governing body shall be responsible for all of the following:

(1) Developing, adopting and enforcing rules and regulations relative to:

(i) The assurance of a safe and professionally acceptable level of comprehensive care at the birth center.

(ii) Protection of personal and property rights of the patient, newborn infant, and support persons.

(iii) The general operation of the birth center.

(2) Providing ownership information as stated in § 501.11 (relating to general).

(3) Appointing a full time person in charge, who has authority and responsibility for the operation of the birth center at all times. Qualifications, authority, responsibilities, and duties of the person in charge shall be defined in a written statement adopted by the governing body.

(4) Adopting effective policies and bylaws governing operation of the facility in accordance with legal requirements. The policies and bylaws shall be in writing, dated and available for public review. These shall include, but not be limited to, policies and procedures which assure that there shall be:

(i) Obstetric, pediatric, and midwifery services available on a 24-hour basis, 7 days a week, and shall include obstetric and pediatric consultative services, transportation in case of emergency, and provision for referral to outside resources.

(ii) Written birth center policies developed by the Physician Director of Medical Affairs and Director of Midwifery Services readily available to all staff. All staff members shall be oriented to existing policies and procedures. There shall be prompt notification to all staff of changes in policy or procedures.

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.41 Personnel policies.

(a) Personnel policies shall be reviewed, revised, and approved by the governing body periodically, but no less often than once every 2 years.

(b) An individual personnel record shall be maintained for each person employed by the birth center which shall include, but not be limited to, the following:

(1) A current job description for each person, which is reviewed and revised as needed.

(2) Evidence of a pre-employment examination, which shall include the results of a rubella antibody titer, a tuberculin skin test, and, if indicated, a chest x-ray.

(3) Evidence of the education, training, and experience of the individual, in addition to a copy of the current appropriate license or certification credentials, or both.

(4) Records which reflect the orientation, in-service, and out-service educational program of the birth center.

(d) New employes shall be oriented to their specific job description, facility personnel policies, philosophy, and emergency procedures during the first week of employment.

(e) Staffing schedules, time-worked schedules, on-call, and payroll records shall be retained and available in the facility at all times. All records must be maintained for 1 year.

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.42 Use of outside resources.

If the facility does not employ a qualified professional for a specific service to be provided by the birth center, the governing body shall make arrangements and approve each written policy and procedure for services provided by the use of outside resources.

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.43 Agreements.

The governing body, through the person in charge of the birth center, shall assume full responsibility for the initiation and maintenance of current contracts or agreements.

This section cited in 28 Pa. Code § 501.75 (relating to laboratory services).

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.44 Transfer agreement with physicians.

(a) The birth center shall have a written transfer agreement with physicians who have admitting privileges to a hospital obstetric/newborn service for the mother and infant when complications or emergencies arise.

(b) The terms of the transfer agreement shall include, but not be limited to, the following:

(1) That the medical necessity for transfer is based upon criteria developed by Director of Midwifery Services and Physician Director of Medical Affairs. The criteria shall be reviewed, revised, and approved annually by the governing body.

(2) In the case of a newborn infant transfer, that a transfer incubator must be available.

(3) That a complete health record, relating to the mother or newborn infant, shall be provided at the time of the transfer to the support person, or authorized individual, for hospital use.

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.45 Emergency transportation agreement.

(a) The birth center shall have a written agreement for emergency transportation of the mother or newborn infant which includes, but is not limited to, the following:

(1) That the transportation service shall provide the birth center information relative to the service’s emergency medical service certification status.

(2) The types of services that are to be provided.

(b) The birth center shall insure that an alternative service, in the area, with equivalent services, is available in the event that the primary transportation service is unable to accept a call.

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.46 Patient’s rights.

(a) The birth center shall have written policies and procedures to assure the individual mother the right to dignity, privacy, and safety and shall include, but not be limited to, the items listed in subsection (b). The policies and procedures shall be developed by the Physician Director of Medical Affairs and Director of Midwifery Services and approved by the governing body. The policies shall be reviewed, revised, and approved anually by the governing body.

(b) It is the right of every mother, or support person, to expect and receive:

(1) Good quality care and high professional standards that are continually maintained and reviewed.

(2) Answers to questions, regarding services and treatment, and the names and functions of the staff person providing services.

(3) Confidentiality, anonymity, and privacy.

(4) Respectful and dignified treatment at all times.

(5) Information regarding cost and counseling on the availability of known financial resources to the service being rendered.

(6) Disclosure and discussion of the nature, purposes, expected effects, and results of the medical treatment under consideration, prior to signing an informed consent.

(7) Control over the release of her health record information. Except in an emergency, a written release, signed by the mother, shall be required, prior to the release of health record information, except as otherwise provided by law or third party contractual arrangements.

(8) Availability of, or actual contact with, a physician, midwife, or registered nurse on a 24 hour per day, 7 day per week basis, as established by the written policies of the birth center.

(9) The right to refuse treatment, at any time, after treatment has begun.

(10) Full information on the medical consequences of refusal of treatment.

(11) A copy of the center’s rules that apply to conduct as a mother, spouse, and support person.

(12) A written set of the rights guaranteed by this subpart and by the birth center.

(13) Treatment without discrimination based upon race, color, religion, sex, sexual preference, national origin, or source of payment.

(14) The right to review, or obtain, a copy of the mother’s medical records.

(15) The right to expect emergency procedures to be implemented without unnecessary delay.

(16) Full information of the mother’s and newborn infant’s continuing health care requirements, following discharge and the means for meeting them.

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.47 Patient education.

The birth center shall have a written plan for patient education, which is consistent with current professional standards.

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.48 Birth center policies and procedures.

(a) The birth center policies and procedures shall include but not be limited to the following:

(1) A philosophy of care for the birth center.

(2) Standards, policies and procedures for providing safe and appropriate plans of care to meet the needs of each mother, her family, and her newborn infant. These shall be in keeping with current professional standards for uncomplicated pregnancy, intrapartal care, postpartal care, and newborn care and shall include the following:

(i) Written criteria for the admission of only uncomplicated pregnancies into the birth center system of care.

(ii) Written screening, protocol, and health records which identify high risk and potentially high risk individuals, which shall exclude them from birth center care.

(iii) Written protocols for referral of high risk pregnant women and newborns to appropriate providers of obstetrical and newborn care.

(iv) Program to prevent isoimmunization of Rh-negative mothers and neonatal disease due to Rh incompatibilities.

(b) Policies and procedures shall be consistent with the current professional standards of the American College of Nurse Midwives, the American College of Obstetricians and Gynecologists, and the American Academy of Pediatrics, and shall be approved by the Director of Midwifery Services and the Physician Director of Medical Affairs. A support person for each mother shall be required.

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.49 Newborn infant care policies and procedures.

The newborn infant care policies, protocols and procedures shall include the following:

(1) Resuscitation equipment for newborn infant care management of short-term assisted ventilation shall include bag and mask or bag and endotracheal tube, with oxygen supply available.

(2) Medication approved by the Department in § 27.98 (relating to prophylactic treatment of newborns), shall be instilled in the eyes of the newborn infant according to statute. If the parent or guardian of the newborn child objects on the ground that the prophylactic treatment conflicts with the parent’s religious beliefs or practices, prophylactic treatment will be withheld, and an entry in the child’s record indicating the reason for withholding treatment shall be made and signed by the Physician Director of Medical Affairs and the parent or guardian of the newborn infant.

(3) Before discharge from the center, the newborn infant shall be examined by a midwife or a physician, and the results shall be entered in the health record. An infant with identified abnormalities shall be referred for appropriate follow-up, in accordance with the birth center policies.

(4) The birth center shall explain to the mother the purpose and nature of the screening tests for diseases of the newborn, required by Chapter 28 (relating to screening and follow-up for diseases of the newborn), give her an informational pamphlet provided by the Department, inform her of her right to refuse the tests because of religious beliefs or practices, and see that the recorded written objection is entered into the medical record of the newborn child and signed by the parent or guardian, if screening is refused.

(5) The birth center shall comply with the requirements for specimen collection, testing and follow-up in § § 28.21—21.28 (relating to specimen collection and followup).

(6) Policies and other criteria, which govern discharge of newborn infants, shall be in accordance with birth center policies.

(7) The birth center shall communicate with the pediatric care provider and transfer birth and newborn records to the pediatric care provider.

(8) The birth center shall provide a list of available counselors and counseling services, compiled under 23 Pa.C.S. § 2505 (relating to counseling), to mothers who are known to be considering relinquishing or termination of parental rights under 23 Pa.C.S. § § 2101—2909 (relating to the Adoption Act).

The provisions of this § 501.49 amended under section 16(a) of the Disease Control and Prevention Act of 1955 (35 P. S. § 521.16(a)); sections 2102(g) and 2111(b) of The Administrative Code of 1929 (71 P. S. § § 532(g) and 541(b)); and sections 3 and 5 of the Newborn Child Testing Act (35 P. S. § § 623 and 625).

The provisions of this § 501.49 amended May 17, 2002, effective May 18, 2002, 32 Pa.B. 2435. Immediately preceding text appears at serial pages (245716) to (245717).

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.61 General.

(a) The birth center, in establishing its policy and procedures for a system of health record keeping, shall take into consideration professional standards and practices appropriate to primary care of the patient and newborn infant as established by the American College of Obstetricians and Gynecologists, 600 Maryland Avenue, SW, Suite 300 East, Washington, DC 20024; American College of Nurse-Midwives, 1522 K Street, N.W., Suite 1120, Washington, DC 20005; American Academy of Pediatrics, P.O. Box 1034, 1801 Hinman Avenue, Evanston, Illinois 60204; and other professional standards and practices approved by the Department. The policy and procedures shall be approved by the governing body, at the recommendation of the Physician Director of Medical Affairs, and by the Director of Midwifery Services.

(b) An individual shall be designated who shall have the responsibility for maintaining health record files and developing statistical reports.

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.62 Health record transfer, retention and confidentiality.

(a) In the event a referral or transfer to another level of care provider is needed during pregnancy, delivery or post-delivery period, the patient’s record, or a complete copy of the record, shall accompany the mother or newborn infant at the time of transfer.

(b) The birth center shall comply with the act of April 29, 1925 (P. L. 358, No. 209) (35 P. S. § § 351 and 352), regarding footprinting and infant identification.

(c) Health records shall be retained by the birth center for the mother and newborn infant, as recommended by the Department for outpatient facilities, as follows:

(1) The mother’s entire record shall be retained for 7 years after discharge and date of last entry.

(2) The newborn infant’s entire record shall be retained for 7 years after the child reaches 18 years of age.

(3) Health records shall be stored to provide protection from loss, damage, or unauthorized access.

(4) A written authorization for release of health record information, outside the birth center, shall be signed by the mother, prior to the release of health record information.

(5) In the event of a request for newborn infant health record information, authorization shall be signed by the legal parent or guardian except that, if the newborn infant has reached 18 years of age, or is otherwise legally emancipated, the written authorization shall be granted by the person.

(d) In the case of newborn adoptions, medical history information shall be delivered by the attending physician, or other designated person, to the intermediary, who shall deliver the information to the adopting parents or their physician. In cases where there is no intermediary, medical history information shall be delivered directly to the adopting parents or their physician.

(e) In cases of newborn adoption, medical history information shall be edited before a copy is transferred so as to remove contents which would identify the adoptee’s natural family.

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.63 Birth certificate.

A certificate of birth shall be filed for each birth, within 10 days of the birth, with the local registrar of vital statistics, in the district where the birth occurs, under Chapter 1 (relating to administration of vital records).

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.71 Midwifery services.

Midwifery services provided at the birth center shall be in compliance with applicable Federal, State and local statutes, and shall include, but not be limited to, the following:

(1) Midwifery services shall be under the supervision of the Director of Midwifery Services.

(2) Each midwife shall be licensed to practice midwifery in this Commonwealth. The license shall be current and displayed in the birth center.

(3) Midwifery services at the birth center shall be provided within the scope of written medical and midwifery protocols, approved by the Director of Midwifery Services and the Physician Director of Medical Affairs. These shall be reviewed, revised, signed and dated by both, on an annual basis.

(4) Policies, procedures and service delivery protocols, shall be developed to assure comprehensive quality care for the patient and newborn infant.

(5) Inservice training for professional staff shall be provided on a regular basis. The training shall include the areas of medication, patient education, as well as normal patterns and complications of pregnancy.

(6) Adequate health supervision of mother and newborn at the time of referral or discharge from the birth center services shall be provided.

(7) A certified midwife or physician shall be physically present, at all times, when a mother is laboring in the birth center.

This section cited in 28 Pa. Code § 501.74 (relating to pharmaceutical services).

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.72 Birth center services.

(a) There shall be a Physician Director of Medical Affairs who is a licensed physician.

(b) A Physician Director of Medical Affairs, who is not certified as an obstetrician or pediatrician, shall have developed consultant services in these specialties for the birth center by contractual arrangement.

(1) Immediate availability of physician services through direct communication, by radio, telephone or telecommunications.

(2) An agreement with a Board certified obstetrician and Board certified pediatrician, including arrangements for hospital admission of mother and newborn infant, in order to ensure effective care in life threatening situations.

(3) Review, by the Physician Director of Medical Affairs and Director of Midwifery Services on a semiannual basis, of records of mothers and newborn infants discharged or transferred from the birth center during that 6 month period.

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.73 Nursing services.

(a) Nursing services at the birth center shall be under the supervision of the Director of Midwifery Services.

(b) Nursing staff shall be provided with orientation and in-service training on a regular basis by the Physician Director of Medical Affairs and Director of Midwifery Services. Opportunities for out-service training shall be offered to licensed and professional staff members.

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.74 Pharmaceutical services.

(a) There shall be a listing of all drugs and biologicals, including intravenous solutions, which are to be retained for emergency use in the birth center, which is consistent with the midwifery and medical protocols as required in § 501.71(3) (relating to midwifery services). The listing shall be developed and approved by the Physician Director of Medical Affairs. The listing shall include the identity of birth center staff who are authorized to administer the drugs, biologicals, or intravenous solutions. The purchase and use of drugs shall be done under the direction of the Physician Director of Medical Affairs or supervising physician.

(b) If a drug, biological, or intravenous solution is obtained on an emergency basis, it shall only be done upon an order, written or oral, by a physician, and it must be noted in the current list.

(c) Drugs and biologicals must be secured in an appropriate cabinet, or when refrigeration is necessary, must be stored in a separate refrigerator located in a controlled area for staff use only or in a locked stationary container, if stored in a refrigerator to which the public has access.

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.75 Laboratory services.

(a) The birth center shall provide laboratory services directly or by arrangement with a licensed provider.

(b) If the service is provided directly, the facility must be licensed and approved by the Department to perform the necessary tests under the Clinical Laboratory Act (35 P. S. § § 2151—2165) and Chapter 5 (relating to clinical laboratories).

(c) If the service is provided by arrangement, the written agreement shall meet the requirements of § 501.43 (relating to agreements) and shall be available for review.

(d) If services are provided by arrangement with, or referral to, an outside provider of services, the original copy of the signed and dated report shall become a part of the mother’s permanent record.

(e) Tests completed at the birth center shall be entered, dated, and signed in the mother’s record by the individual who performed the test. Abnormal test findings shall be promptly referred to the consulting physician.

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.81 Safety from fire.

(a) Birth centers are classified as C-1 modified occupancy and must comply with the following:

(1) Buildings of one story in height may be constructed of fire resistive, noncombustible, ordinary, or wood frame construction as defined in National Fire Prevention Association, 1961 Edition, Standard Types of Building Construction.

(2) Buildings of two stories or more in height shall be constructed of fire resistive or noncombustible construction as defined in National Fire Prevention Association, 1961 Edition, Standard Types of Building Construction.

(3) Means of egress requirements shall comply with the following:

(i) Each floor or fire section of the building shall have at least two means of egress, remotely located from each other.

(A) At least one means of egress shall be a stairway directly to grade, door directly to grade, horizontal exit, or ramp directly to grade.

(B) The other means of egress shall be a fire escape or outside stair if two means of egress are not provided in accordance with clause (A).

(ii) Width of stairways, fire escapes, and ramps.

(A) Stairs shall have a minimum width of 30 inches. Winders in stairs are not acceptable.

(B) Fire escapes shall have a minimum width of 24 inches. Fire escapes shall be constructed of steel.

(D) Handrails shall be provided. Handrails may protrude into the stairs, but not more than 3 inches on either side.

(iii) Travel distance.

(A) The travel distance between a room door, required as exit access, and an exit may not exceed 100 feet.

(B) The travel distance between a point in a room and an exit may not exceed 150 feet.

(iv) Illumination of means of egress.

(A) Each facility shall provide illumination of the means of egress.

(B) The floors of the means of egress shall be illuminated at all points, including angles and intersections of corridors and passageways, stairways, landings of stairs, and exit doors to values of not less than one footcandle measured at the floor.

(4) Interior finish on walls, floors, and ceilings throughout shall be Class C, 200 flame spread rating or less.

(5) Operable residential type smoke detectors shall be installed in all rooms, corridors, and means of egress. The number of detectors shall be determined by the manufacturer’s specifications on coverage.

(6) Occupancy shall comply with the following:

(i) Birthing rooms shall be limited to the lowest level with direct grade access, unless an exception is granted by the Department under § 501.6 (relating to exceptions). Basement occupancy by patients shall be prohibited.

(ii) Examination rooms are permitted above the first floor.

(7) Rooms or spaces, including repair shops, used for storage of combustible supplies and equipment in quantities deemed hazardous by the Department shall comply with the following:

(i) One-hour separation from all adjacent areas.

(ii) Automatic sprinkler system water source, which can be from the domestic water system. Installation and maintenance shall comply with National Fire Prevention Association 13 and 13A.

(8) All types of occupancies, which are not classified as C-1 modified, shall be separated by a 2-hour fire wall from the birth center.

(9) Fire extinguishers shall comply with the following:

(i) Portable fire extinguishers shall be provided. At least two extinguishers shall be provided per floor with a travel distance of 50 feet maximum to each extinguisher.

(ii) Fire extinguishers shall be the ABC type.

(iii) Maintenance shall be yearly.

(b) Prior to construction, birth centers shall submit plans for review by the Department, using the procedures set forth in 34 Pa. Code § 49.3 (relating to submission of plans). A certificate of occupancy will be issued, in accordance with those procedures, when it is determined by the Department that the birth center is in compliance with subsection (a).

(c) All necessary accommodations shall be made to meet the needs of persons with semi-ambulatory disabilities, sight and hearing disabilities, and disabilities in coordination, and to meet the requirements of 45 CFR § 84.23 (relating to new construction), concerning design, construction, and alteration of facilities. Conformity with the American National Standards Specifications for Making Buildings and Facilities Accessible to, and Usable by, the Physically Handicapped, published by the American National Standards Institute, Inc. (ANSI A117.1 1961 (R 1971), constitutes compliance with this subsection.

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.82 Physical environment.

(a) At a minimum, each birth room shall have a toilet and sink with hot and cold running water in the room or convenient access to it. The bathroom shall not be shared by more than two patients, support persons, and family. Toilet facilities for staff members shall be separate from birth room toilet facilities.

(b) If a kitchen is available for birth room occupants and their family members or support persons, the kitchen shall be maintained in a safe and sanitary manner and should contain a refrigerator, sink, stove, and oven.

(c) The birth center shall adequately meet the comfort and privacy needs of the laboring woman and her family or support persons through the provision of:

(1) Comfortable chairs for laboring.

(2) An interview room with facilities for assured privacy.

(3) Consultation and examining rooms to meet the needs of the patient, consultant, and family.

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.83 Infection control.

The birth center shall develop infection control policies and procedures to minimize and control possibilities of infection, which shall include, but not be limited to, the following:

(1) Handwashing techniques for adequate protection of the mother or newborn infant from infection and other contamination.

(2) Contagious disease control measures for staff personnel, carrier or suspected carrier, spouse, or support persons.

(3) Sterilization methods and procedures.

(4) Infection control measures, including birth room cleaning policies and birth room waste disposal policies and procedures.

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.84 Disposal of placenta.

Pathological and bacteriological waste, surgical and obstetrical wastes, contaminated wastes, and similar materials shall be incinerated on the premises or disposed of by a method approved by the Department of Environmental Resources and in compliance with local regulations.

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

28 Pa. Code § 501.85 Water supply.

If the water supply is from an individual well source, a water sample testing report shall be obtained annually from a testing laboratory, and a report of the findings shall be made available to the Department.

History

Authority: The provisions of this § 501.
Source: The provisions of this § 501.

Subpart F Ambulatory Surgical Facilities

Chapter 551 General Information

28 Pa. Code § 551.1 Legal base.

(a) This subpart is promulgated by the Department under Chapter 8 of the act (35 P. S. § § 448.801—448.820), and section 2102(a) and (g) of The Administrative Code of 1929 (71 P. S. § 532(a) and (g)).

(b) The Department has the duty to promulgate regulations necessary to implement Chapter 8 of the act and to assure that its regulations and the act are enforced.

(c) The purpose of this subpart is to protect and promote the public health and welfare through the establishment and enforcement of regulations setting minimum standards in the construction, maintenance and operation of ASFs. The standards are intended to assure safe, adequate and efficient facilities and services, and to promote the health, safety and adequate care of the patients of the facilities. It is also the purpose of this subpart to assure quality health care through appropriate and nonduplicative review and inspection, with regard to the protection of the health and rights of privacy of the patients and without unreasonably interfering with the operation of the ambulatory surgical facility.

The provisions of this § 551.1 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial pages (251633) to (251634).

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 551.2 Affected institutions.

(a) This subpart applies to ASFs, profit or nonprofit, operated within this Commonwealth. Only those facilities which are licensed under this subpart shall provide ambulatory surgery in this Commonwealth, except as provided in Class A facilities.

(b) This subpart does not apply to outpatient surgery performed at licensed hospitals, or to dentists’ or oral surgeons’ offices except to the extent the offices seek licensure as ASFs.

The provisions of this § 551.2 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (251634).

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 551.3 Definitions.

The following words and terms, when used in this subpart, have the following meanings, unless the context clearly indicates otherwise: ASF—Ambulatory surgical facility—

(i) A facility or portion thereof not located upon the premises of a hospital which provides specialty or multispecialty outpatient surgical treatment.

(ii) This does not include individual or group practice offices of private physicians or dentists, unless the offices have a distinct part used solely for outpatient surgical treatment on a regular and organized basis. For the purposes of this provision, outpatient surgical treatment means treatment to patients who do not require hospitalization, but who require constant medical supervision following the surgical procedure performed. Act—The Health Care Facilities Act (35 P. S. § § 448.101—448.904). Ambulatory surgery—Surgery which is performed:

(i) On an outpatient basis in a facility which is not located in a hospital.

(ii) On patients who do not require hospitalization but who do require constant medical supervision following the surgical procedure performed and whose total length of stay does not exceed the standards in this subpart. Anesthesia—The use of pharmaceutical agents to induce the loss of sensation. For the purpose of this chapter, the term applies when any patient, in any setting receives, for any purpose, by any route, one of the following:

(i) General, spinal or other regional anesthesia.

(ii) Sedation (with or without analgesia), for which there is a reasonable expectation that, in the manner used, will result in the loss of protective reflexes for a significant percentage of a group of patients. Anesthesiologist—A physician licensed by the State Board of Medicine under the Medical Practice Act of 1985 (63 P. S. § § 422.1—422.45) who has completed an accredited residency training program in anesthesia. Anesthetist—A generic term used to identify anesthesiologists, nurse anesthetists or dentist anesthetists. Authenticate—To verify authorship for example by written signature, identifiable initials or computer key. Authorized person to administer drugs and medications—In an ASF, the term includes the following:

(i) Persons who are currently licensed or certified by the Bureau of Professional and Occupational Affairs, Department of State, and whose scope of practice includes the administration of drugs.

(ii) Registered nurses who are currently licensed by the Bureau of Professional and Occupational Affairs, Department of State.

(iii) Practical nurses who have successfully passed the State Board of Nursing examination.

(iv) Practical nurses licensed by waiver in this Commonwealth who have successfully passed the United States Public Health Service Proficiency Examination.

(v) Practical nurses licensed by waiver in this Commonwealth who have successfully passed a medication course approved by the State Board of Nursing.

(vi) Student nurses of approved nursing programs who are functioning under the direct supervision of a member of the school faculty who is present in the facility.

(vii) Recent graduates of approved nursing programs who are functioning under the direct supervision of a professional nurse who is present in the facility and who possesses valid temporary practice permits. The permits shall expire if the holders of the permits fail the licensing examinations.

(viii) Physician assistants and registered nurse practitioners who are certified by the Bureau of Professional and Occupational Affairs. Board certified—A physician licensed to practice medicine or osteopathic medicine in this Commonwealth who has successfully passed an examination and has maintained certification in the relevant specialty or subspecialty area, or both, recognized by one of the following groups:

(i) The American Board of Medical Specialties.

(ii) The American Osteopathic Association.

(iii) The foreign equivalent of either group listed in subparagraph (i) or (ii). Classification levels—ASFs shall be classified as follows:

(i) Class A—A private or group practice office of practitioners where procedures performed are limited to those requiring administration of either local or topical anesthesia, or no anesthesia at all and during which reflexes are not obtunded.

(ii) Class B—A single-specialty or multiple-specialty facility with a distinct part used solely for ambulatory surgical treatments involving administration of sedation analgesia or dissociative drugs wherein reflexes may be obtunded; and where patients are limited to Physical Status (PS) PS-I or PS-II patients, unless the patient’s PS status would not be adversely affected or sought to be remedied by the surgery. A Class B ASF may be a distinct part of a private or group practice medical or dental office so long as the requirements of this subpart are met.

(iii) Class C—A single-specialty or multiple-specialty facility used exclusively for the purpose of providing ambulatory surgical treatments which involve the use of a spectrum of anesthetic agents, up to and including general anesthesia and where patients are limited to physical status (PS) PS-1, PS-2 or PS-3 patients. Classification system—A process used to identify three levels of ASFs (A, B and C) based on the procedure, patient status and anesthesia used. Clinical privileges—Permission to independently render medical care in the ASF which is granted by the governing body under § 553.4(c) and (d) (relating to other functions). Compliance directive—A directive issued by the Department, citing deficiencies which have come to the attention of the Department through the survey process, or by onsite inspection and directing the ASF to take corrective action as the Department directs or to submit a plan of correction. Deficiency—A condition which exists contrary to, in violation of, or in noncompliance with this subpart. Dentist—A person licensed by the State Board of Dentistry under The Dental Law (63 P. S. § § 120—130b). Dentist anesthetist—A person licensed by the State Board of Dentistry who has met the requirements for providing anesthesia care services in accordance with the regulations of that Board. Department—The Department of Health of the Commonwealth. Distinct part—An area which is part of a practitioner’s office which is physically identifiable and where surgery is performed on a regular and organized basis. Drug administration—An act in which a single dose of an identified drug is given to a patient. Drug dispensing—The issuance of one or more doses of a prescribed medication under § § 25.41—25.101. Facilities—Buildings, equipment and supplies necessary for implementation of ASF services. Governing body—The individuals, group or entity that has ultimate authority and responsibility for establishing policy, maintaining quality patient care and providing for organizational management and planning. Graduate nurse—A graduate of an approved program of professional nursing practicing the profession under The Professional Nursing Law (63 P. S. § § 221—225). Licensed practical nurse—A person licensed to practice practical nursing under The Practical Nurse Law (63 P. S. § § 651—667). Medical—Pertaining to the practice of medicine, osteopathy, podiatry or dentistry. Medical staff—The organized group of practitioners who has been appointed by the governing body of the ASF to function under § § 555.1—555.3 (relating to principle; medical staff membership; and requirements for membership and privileges). NFPA—The National Fire Protection Association. New construction—New buildings, additions to existing buildings, conversion of existing buildings or portions thereof or portions of buildings undergoing alterations other than repair. Nurse anesthetist—A registered nurse licensed by the State Board of Nursing providing anesthesia care in accordance with the requirements of the regulations of that Board. Nurse practitioner—A person who has been certified by the State Board of Nursing and the State Board of Medicine to perform acts of medical diagnosis or prescription of medical, therapeutic or corrective measure in collaboration with and under the direction of a physician licensed to practice medicine in this Commonwealth, under the Medical Practice Act of 1985 and The Professional Nursing Law. Nursing services—Patient care aspects of nursing that are performed by registered nurses or by licensed practical nurses and ancillary nursing personnel under the direct supervision of a registered nurse. Organized—Administratively and functionally structured to include the following:

(i) Governing body.

(ii) Medical staff.

(iii) Quality assurance.

(iv) Nursing services.

(v) Pharmacy services.

(vi) Medical record services.

(vii) Laboratory and radiology services.

(viii) Environmental services.

(ix) Fire and safety services. Outpatient surgical treatment—Surgical procedures performed upon patients who do not require hospitalization but who require constant medical supervision following the surgical procedure performed. Person in charge—The individual appointed by the governing body to act in its behalf in the overall management of the ASF. Pharmacist—A person licensed to engage in the practice of pharmacy in this Commonwealth under The Pharmacy Act (63 P. S. § § 390.1—390.13). Pharmacy—A place where the practice of pharmacy is conducted under The Pharmacy Act. Physical status classifications—The evaluation of the patient’s overall health as it would influence the conduct and outcome of anesthesia or surgery, or both. Physical status shall be defined within one of five assigned classes which are:

(i) Class 1 patients have no organic, physiologic, biochemical, metabolic or psychiatric disturbance. The operation to be performed is for a local pathologic process and has no systemic effect.

(ii) Class 2 patients have a systemic disturbance which may be of a mild to moderate degree but which is either controlled or has not changed in its severity for some time.

(iii) Class 3 patients suffer from significant systemic disturbance, although the degree to which it limits the patient’s functioning or causes disability may not be quantifiable.

(iv) Class 4 patients suffer from severe systemic diseases that are already life-threatening and may or may not be correctable by surgery.

(v) Class 5 patients are moribund and not expected to survive without surgery. Physician—A doctor of medicine or osteopathy who holds a current and valid license to practice in this Commonwealth. Physician assistant—A person who has been certified by the State Board of Medicine or the State Board of Osteopathic Medical Examiners to assist a physician or group of physicians under The Medical Practice Act of 1985 or The Osteopathic Medical Practice Act (63 P. S. § § 271.1—271.18). Podiatrist—A person licensed by the State Board of Podiatry Examiners to practice podiatry under The Podiatry Act of 1956 (63 P. S. § § 42.1—42.21a). Practitioner—A licensed physician, dentist or podiatrist. Preboard certification status—A physician licensed to practice medicine or osteopathic medicine in this Commonwealth who has completed the requirements necessary to take a certification examination offered by a specialty board recognized by the American Board of Medical Specialties, the American Osteopathic Association or the foreign equivalent of either group, and who has been eligible to take the examination for no longer than 3 years. Premises of a hospital—Buildings, equipment and supplies licensed as a hospital to provide inpatient and outpatient services. Professional nurse/registered nurse—A person licensed to practice professional nursing under The Professional Nursing Law. Provider—An individual; a trust or estate; a partnership; a corporation including associations, joint stock companies, health maintenance organizations, professional health service plan corporations and insurance companies; the Commonwealth or a political subdivision or instrumentality thereof, including a municipal corporation or authority that operates an ambulatory surgical facility; and any other legal entity that operates an ambulatory surgical facility. Secretary—The Secretary of the Department. Surgery—The branch of medicine that diagnoses and treats diseases, disorders, malformations and injuries wholly or partially by operative procedures. Survey—The process of evaluation or reevaluation of the compliance of an ASF with this subpart.

The provisions of this § 551.3 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial pages (251634) to (251637).

This section cited in 28 Pa. Code § 555.32 (relating to administration of anesthesia).

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 551.21 Criteria for ambulatory surgery.

(a) Ambulatory surgical procedures are limited to those that do not exceed:

(1) A total of 4 hours of operating time.

(2) A total of 4 hours directly supervised recovery.

(b) The time limits in subsection (a) may be exceeded only if the patient’s condition demands care or recovery beyond the 4-hour limit and the need for the additional time could not have been anticipated prior to surgery.

(1) Local or regional anesthesia.

(2) General anesthesia of 4 hours or less duration.

(d) Surgical procedures may not be of a type that:

(1) Are associated with the risk of extensive blood loss.

(2) Require major or prolonged invasion of body cavities.

(3) Directly involve major blood vessels.

(4) Are emergency or life threatening in nature, unless no hospital is available for the procedure and the need for the surgery could not have been anticipated.

(e) In obtaining informed consent, the practitioner performing the surgery is responsible for disclosure of:

(1) The risks, benefits and alternatives associated with the anesthesia which will be administered.

(2) The risks, benefits and alternatives associated with the procedure which will be performed.

(3) The comparative risks, benefits and alternatives associated with performing the procedure in the ASF instead of in a hospital.

(f) The Department may issue interpretations of this subpart, which apply to the question of whether the performance of certain surgical procedures will require licensure as an ASF.

(g) Interpretations issued under this section do not constitute an exercise of delegated legislative power by the Department and will expressly be subject to modification by the Department in an adjudicative proceeding based upon the particular facts and circumstances relevant to a proceeding. Interpretations are not intended to be legally enforceable against a person by the Department. In issuing an adjudication, the Department may consider, but is not bound by, interpretations.

(h) Interpretations adopted by the Department under this section will be reviewed for form and legality under the Commonwealth Attorneys Act (71 P.S. § § 732.101—732-506) and, upon approval, will be submitted to the Legislative Reference Bureau for recommended publication in the Pennsylvania Bulletin and Pennsylvania Code as a statement of policy of the Department as a part of this subpart.

(Editor’s Note: Under section 2 of the act of July 11, 2022 (P.L. 1575, No. 87), effective September 9, 2022, the provisions of § 551.21 are abrogated insofar as they are inconsistent with section 822 of the Health Care Facilities Act (35 P.S. § 448.822).)

The provisions of this § 551.21 abrogated in part under section 2 of the act of July 11, 2022 (P.L. 1575, No. 87).

The provisions of this § 551.21 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583; abrogated in part July 11, 2022 (P.L. 1575, No. 87), effective September 9, 2022. Immediately preceding text appears at serial pages (412139) to (412140).

This section cited in 28 Pa. Code § 551.22 (relating to criteria for performance of ambulatory surgery on pediatric patients).

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 551.22 Criteria for performance of ambulatory surgery on pediatric patients.

In addition to the criteria in § 551.21 (relating to criteria for ambulatory surgery), the following criteria apply to the performance of ambulatory surgery on children under 18 years of age:

(1) A child under 6 months of age may not be treated in an ASF.

(2) The medical record shall include documentation that the child’s primary care provider was notified by the surgeon in advance of the performance of a procedure in an ASF and that an opinion was sought from the primary care provider regarding the appropriateness of the use of the facility for the proposed procedure. When an opinion from the child’s primary care provider is not obtainable, the medical record shall include documentation which explains why an opinion could not be obtained.

(3) Surgical procedures on persons older than 6 months and younger than 18 years of age shall be performed only under the following conditions:

(i) Anesthesia services shall be provided by an anesthesiologist who is a graduate of an anesthesiology residency program accredited by the accreditation council for graduate medical education or its equivalent, or by a certified registered nurse anesthetist trained in pediatric anesthesia, either of whom shall have documented demonstrated historical and continuous competence in the care of these patients.

(ii) The practitioner performing the surgery shall be either board certified by or have obtained preboard certification status with the American Board of Medical Specialties, the American Osteopathic Board of Surgery, the American Board of Podiatric Surgery or the American Board of Oral and Maxillofacial Surgery.

(4) A medical professional who has successfully completed a course in advanced pediatric life support offered by the American Academy of Pediatrics and either the American College of Emergency Physicians or the American Heart Association shall be present in the facility.

The provisions of this § 551.22 adopted October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583.

This section cited in 28 Pa. Code § 553.3 (relating to governing body responsibilities).

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 551.31 Licensure.

(a) A Class A ASF shall meet the following criteria:

(1) A license is not required for the operation of a Class A ASF. The facility shall be accredited by the Accreditation Association for Ambulatory Health Care, the Joint Commission on the Accreditation of Health Care Organizations, the American Association for the Accreditation of Ambulatory Surgical Facilities or another Nationally recognized accrediting agency acknowledged by the Medicare Program in order to be identified as providing ambulatory surgery.

(2) A Class A ASF shall register with the Department and shall forward a copy of its accreditation survery to the Department.

(3) The Class A registration form shall request the following information, which shall also be provided to the Department by the Class A ASF on an annual basis.

(i) A list of operative procedures proposed to be performed at the facility and the ages of the patients to be served.

(ii) The type of anesthetic proposed to be used for each operative procedure.

(iii) The facility’s current accreditation survey and the designation of accreditation status by the Nationally recognized accrediting agency.

(iv) Other information the Department deems pertinent to registration requirements.

(b) A license shall be obtained to operate a freestanding Class B or Class C ASF.

(d) An applicant for a license to operate an ASF shall request licensure by the Department by means of written communication which sets forth:

(1) A list of operative procedures proposed to be performed at the facility and the ages of the patients to be served.

(2) The highest level of anesthetic proposed to be used for each proposed operative procedure.

(3) The highest PS patient level proposed to receive ambulatory surgery at the facility.

(4) A statement from the applicant which may be accompanied by a written opinion from a Nationally recognized accrediting body stating the most appropriate facility Class (B or C).

(e) If a facility desires to change its classification level from a Class B enterprise to a Class C enterprise, the facility shall request and obtain a license prior to providing services to ASF Class III or PS-III patients.

(f) The Department may enter and inspect an ASF (Class A, B or C), at any time, announced or unannounced, to investigate any complaints. The Department may mandate closure of an ASF that the Department determines is providing substandard care or for any other lawful reason.

The provisions of this § 551.31 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (251638).

This section cited in 28 Pa. Code § 551.53 (relating to presurvey preparation).

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 551.33 Survey.

The Department will conduct a survey to insure that the applicant is in compliance with this subpart. The survey will include an onsite inspection and review of written approvals submitted to the Department by regulatory agencies responsible for building, electric, fire and environmental safety. The Department may designate Nationally recognized accrediting agencies whose standards are at least as stringent as the Department’s to perform some or all aspects of licensure surveys.

The provisions of this § 551.33 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (251639).

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 551.34 Licensure process.

(a) An application for the appropriate license to operate an ASF shall be made in accordance with section 807 of the act (35 P. S. § 448.807).

(b) The application form for a license to operate an ASF shall be obtained from the Department of Health, Division of Acute and Ambulatory Care Facilities, Post Office Box 90, Harrisburg, Pennsylvania 17108.

(d) Applications or renewal forms shall be accompanied by a fee of $250.

The provisions of this § 551.34 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (251639).

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 551.41 Policy.

The Department will issue a license valid for 1 year to an ASF which is in compliance with this subpart.

The provisions of this § 551.41 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (251639).

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 551.43 Void license.

(a) The license of an ASF becomes automatically void when one of the following occurs:

(1) The license term of 1 year expires.

(2) The ASF substantially changes its name or location, in which case a new license will be automatically issued upon application by an ASF if the ASF is otherwise in compliance with this subpart.

(b) If the ASF locates or relocates services at a site other than the current site or a site contiguous thereto, the ASF shall notify the Department 30 days prior to the change so that the Department may determine if a new license is necessary.

The provisions of this § 551.43 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial pages (251639) to (251640).

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 551.44 Display of license.

The current license shall be displayed in a public and conspicuous place in the ASF.

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 551.45 Licensure information/application.

Information regarding licensure shall be completed annually on forms supplied by the Department. Both the Annual ASF Questionnaire and the Application for Licensure and other data requested by the Department shall be completed each year.

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 551.51 Policy.

Representatives of the Department will annually conduct a survey of every ASF required to be licensed.

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 551.52 ASF responsibilities.

An ASF shall comply with applicable standards which are required by Federal, State and local authorities. This includes, but is not limited to, standards at 49 Pa. Code Chapters 17, 21 and 27 (relating to State Board of Medicine—medical doctors; State Board of Nursing; and State Board of Pharmacy) in addition to standards related to radiologic health, sanitation, food service, electric wiring and life safety code compliance. When the ASF has been inspected by another regulatory agency, it shall have available during the survey by the Department written confirmation of compliance as required by the other regulatory agency.

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 551.53 Presurvey preparation.

Prior to an annual survey site visit of an ASF by the Department, the Department may request from the ASF documents or records of the ASF, or other information necessary for the Department to prepare for the site visit. The ASF shall provide the information requested, including a declarative statement that sets forth the information requested in § 551.31 (relating to licensure) as follows:

(1) A list of operative procedures proposed to be performed at the facility.

(2) The highest level of anesthetic proposed to be used for each proposed operative procedure.

(3) The highest PS patient level proposed to receive outpatient surgical treatments at the facility.

The provisions of this § 551.53 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (251640).

This section cited in 28 Pa. Code § 553.4 (relating to other functions).

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 551.54 Access by the Department.

Upon presenting the official Department identification card to the ASF’s person in charge, authorized agents of the Department will have access to the ASF to determine compliance with this subpart. The access shall include:

(1) Entry to the entire ASF premises.

(2) Inspection and examination of the facilities, records, documents and phases of operations, including those relating to compliance with Chapter 553 (relating to ownership, governance and management).

(3) Interviews of staff, employes, members of the governing body and patients.

(4) Examination of a patient, with the patient’s consent.

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 551.55 Site survey coverage.

The Department will survey on-site those aspects of the ASF as it deems necessary to fully and fairly assess the compliance of the ASF with this subpart.

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 551.56 Documentation.

The Department will document the extent of an ASF’s compliance with this subpart in at least one of the following ways:

(1) The statement of a person in charge or staff member.

(2) Documentary evidence provided by the facility.

(3) Answers by the ASF to detailed questions provided by the Department concerning the implementation of this subpart or examples of the implementation which will enable a judgment about compliance to be made.

(4) On-site observation by surveyors.

(5) Interviews with patients, employes or other persons or sources capable of providing reliable information to the Department.

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 551.61 Policy.

After completion of the site visit, the Department will evaluate relevant information gathered during the survey, formulate its compliance findings and determinations, and order the ASF to correct, within a specified period of time, deficiencies found.

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 551.62 Compliance directive.

(a) If there is noncompliance with this subpart, the Department will notify the ASF in writing of deficiencies and will direct the officers governing or managing the ASF to take corrective action as the Department directs or to submit a plan of correction, or to do both, within the time specified by the Department. In its compliance directive and request for plan of correction, the Department will state its findings and the reasons for its determination.

(b) The ASF shall be presumed to be in compliance with provisions of this subpart for which the compliance directive does not cite a deficiency.

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 551.63 Submission of plan of correction.

A plan of correction shall be submitted to the Department within 30 days of receipt of written notification by the Department. The plan shall be attested to by the signature of the chairman of the governing body or the person in charge. The plan of correction shall be submitted to the governing body as a whole for its review at its regular meeting.

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 551.64 Content of plan of correction.

A plan of correction shall address deficiencies cited in the compliance directive of the Department. The plan shall state specifically what corrective action is to be taken, by whom and when.

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 551.65 Public inspection of compliance documents.

Copies of compliance directives and plans of correction will be kept readily available by the Department in appropriate regional offices for the purpose of public inspection, examination and duplication at a reasonable cost. An ASF shall make available a current copy of these documents for inspection and examination.

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 551.71 Unannounced surveys.

Whenever the Department has received a complaint or has other reasonable grounds to believe that a deficiency exists, the Department may without notice to the ASF investigate, inspect or survey the facility, or portion of the ASF to which the alleged deficiency relates.

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 551.81 Principle.

The Department will issue an ASF license to a facility which complies with this subpart. The license will reflect the regular, provisional or limited status and the classification assigned to the ASF. The license applies only to the designated facility.

The provisions of this § 551.81 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (251642).

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 551.82 Regular license.

(a) The Department will issue a regular license to an ASF when that ASF is in compliance with section 808 of the act (35 P. S. § 448.808) and is in full or substantial compliance with this subpart.

(b) As used in subsection (a) ‘‘substantial compliance’’ means:

(1) Deficiencies are, individually and in combined effect, of a minor nature so that neither the deficiencies nor efforts toward their correction will do one of the following:

(i) Interfere with or adversely affect normal ASF operations.

(ii) Adversely affect a patient’s health or safety.

(iii) Exceed the assigned classification of the ASF.

(2) The ASF has adopted a plan of correction approved by the Department.

The provisions of this § 551.82 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial pages (251642) to (251643).

This section cited in 28 Pa. Code § 551.91 (relating to grounds); 28 Pa. Code § 551.92 (relating to modification of license); and 28 Pa. Code § 551.101 (relating to policy).

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 551.83 Provisional license.

(a) The Department may issue a provisional license if:

(1) There are numerous deficiencies or a serious specific deficiency in compliance with applicable statutes, ordinances or regulations.

(2) The ASF is taking appropriate steps to correct the deficiencies in accordance with a plan of correction submitted by the ASF and agreed upon by the Department.

(3) There is no cyclical pattern of deficiencies over a period of 2 or more years. A cyclical pattern is one where an ASF is alternately in and out of substantial or full compliance, which is corrected only when actively supervised by the Department.

(b) A provisional license is valid for a specific time period of no more than 6 months.

The provisions of this § 551.83 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (251643).

This section cited in 28 Pa. Code § 551.91 (relating to grounds); and 28 Pa. Code § 551.92 (relating to modification of license).

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 551.91 Grounds.

(a) The Department may refuse to issue a license for one or more of the following reasons:

(1) The health care provider is not a responsible person.

(2) The place to be used as an ASF is not adequately constructed, equipped, maintained and operated to safely and efficiently render the services offered.

(3) The ASF does not provide safe and efficient services which are adequate for the care, treatment and comfort of the patients or residents of the facility.

(4) There is not substantial compliance with this subpart.

(b) The Department may refuse to renew a license, or may suspend or revoke or limit a license for all or a portion of an ASF, or for a particular service offered by an ASF, or may suspend admissions for any of the following reasons:

(1) Serious violation of or noncompliance with the act or with this subpart except when the ASF is in compliance or substantial compliance as defined in § 551.82 (relating to regular license) or otherwise meets the conditions in § 551.83 (relating to provisional license). A serious violation is one which poses a significant threat to the health of a patient.

(2) Failure to submit a plan of correction when required to do so, or failure, by the holder of a provisional license, to correct a deficiency under a plan of correction, unless the Department approves an extension or modification of the plan of correction.

(3) Incompetence, negligence or misconduct in operating the ASF, or in providing services to patients.

(4) Fraud or deceit in obtaining or attempting to obtain a license.

(5) Lending, borrowing or using the license of another ASF.

(6) Knowingly aiding or abetting the improper granting of a license.

(7) Mistreating or abusing individuals cared for by the ASF.

(8) The existence of a cyclical pattern of deficiencies over a period of 2 or more years. A cyclical pattern means an ASF is alternately in and out of full or substantial compliance, which is corrected only when actively supervised by the Department.

(9) Serious violation of the laws relating to Medical Assistance or Medicare reimbursement.

(10) Providing services exceeding the scope of the classification assigned in the license.

The provisions of this § 551.91 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial pages (251643) to (251644).

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 551.92 Modification of license.

The Department may modify a license by substituting a provisional license for a regular license if the Department determines that the ASF is not in compliance or substantial compliance as defined in § 551.82 (relating to regular license) but the ASF otherwise meets the requirements of § 551.83 (relating to provisional license).

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 551.93 Notice.

(a) If the Department proposes to revoke, modify, limit or refuse to issue or renew a license or to issue a provisional license, or to suspend admissions or to levy a civil penalty against the ASF, it will give written notice to the ASF by certified mail.

(b) Written notice will specify the reasons for the proposed action of the Department and will notify the ASF of its right to a hearing. The order will specify the time within which a request of the ASF for a hearing shall be filed with the Health Policy Board.

The provisions of this § 551.93 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (251644).

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 551.101 Policy.

If an ASF notifies the Department that it has completed a plan of correction and corrected its deficiencies, the Department will conduct a survey to ascertain completion of the plan of correction. Upon finding full or substantial compliance, as defined in § 551.82(b) (relating to a regular license), the Department will issue a regular license.

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 551.111 Hearings relating to licensure.

Hearings relating to licensure, including the issuance of a provisional license, or the suspension of admissions, will be conducted by the Health Policy Board, under 37 Pa. Code Chapter 197 (relating to practice and procedure).

The provisions of this § 551.111 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (251645).

History

Authority: The provisions of this Chapter 551 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 551 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

Chapter 553 Ownership, Governance and Management

28 Pa. Code § 553.1 Principle.

There shall be an organized governing body or designated person vested with ownership who shall assume the full legal authority and responsibility for the conduct of the ASF.

History

Authority: The provisions of this Chapter 553 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 553 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 553.2 Ownership.

(a) The owner of the ASF may be an individual, partnership, association, a corporation or a combination thereof.

(b) A complete list of the names and addresses of owners, directors, officers and managers shall be submitted with the application.

(c) Owners shall be considered any person who has a direct or indirect equity interest in the facility of 5% or more, including shareholders and partners.

(d) A physically noncontiguous branch of the ASF shall meet the requirements for licensure and shall be independently licensed.

The provisions of this § 553.2 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (247506).

History

Authority: The provisions of this Chapter 553 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 553 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 553.3 Governing body responsibilities.

Governing body responsibilities include:

(1) Conforming to applicable Federal, State and local law.

(2) Determining the goals and objectives of the ASF.

(3) Assuring that facilities and personnel are adequate and appropriate to carry out the goals and objectives.

(4) Establishing an organizational structure and specifying functional relationships among the various components of the ASF.

(5) Adopting bylaws or similar rules and regulations for the orderly development and management of the ASF, which:

(i) Describe the authority delegated to the person in charge and to the medical staff.

(ii) Require the governing body to review and approve the bylaws, or similar rules and regulations, of the medical staff.

(6) Adopting policies or procedures necessary for the orderly conduct of the ASF.

(7) Assuring that the quality of care is evaluated and that identified problems are appropriately addressed.

(8) Establishing personnel policies and practices which adequately support sound patient care to include the following:

(i) Require the employment of personnel with qualifications commensurate with a job’s responsibilities and authority, including appropriate licensure and certification.

(ii) Applicants for positions requiring a licensed person shall be hired only after obtaining verification of their licenses, records of education and written references.

(iii) Personnel records shall include current information relative to periodic work performance evaluations.

(iv) Compliance with Occupational Safety and Health Administration (OSHA) Universal Precautions for prevention of transmission of diseases.

(v) Written job descriptions shall exist for each type of job in the ASF.

(vi) Compliance with Federal and State regulations including, The Americans with Disabilities Act of 1990 (42 U.S.C.A. § § 12101—12213), civil rights and OSHA regulations.

(9) Reviewing legal and ethical matters concerning the ASF including the reports and disposition of unusual incidents.

(10) Maintaining effective communication throughout the ASF.

(11) Establishing a system of financial management and accountability that includes an audit appropriate for the ASF.

(12) Establishing a procedure for implementing, disseminating and enforcing a patient’s bill of rights in compliance with § 553.13 (relating to procedures for distribution).

(13) Approving major contracts or arrangements affecting the medical care provided under its auspices, including those concerning:

(i) The employment for contractual arrangements with practitioners and others providing direct patient care.

(ii) The provision of all treatment related services including, radiology, medical laboratory, pathology, anesthesia and pharmaceutical services.

(iii) The provision of care by other health care organizations.

(iv) The provision of education to students and postgraduate trainees.

(14) Formulating long-range plans in accordance with the goals and objectives of the ASF.

(15) Operating the ASF without limitation because of age, race, creed, color, sex, national origin, religion, handicap or disability.

(16) Assuring that at least one medical professional in the facility when patients are present is currently and on an ongoing basis certified in advanced cardiac life support, or its successor. If a pediatric patient is present in the facility, the certification of the medical professional shall be in advanced pediatric life support as defined in § 551.22(4) (relating to criteria for performance of ambulatory surgery on pediatric patients).

The provisions of this § 553.3 adopted January 23, 1987, effective March 25, 1987, 17 Pa.B. 376; amended July 21, 1989, effective July 22, 1989, 19 Pa.B. 3105; amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial pages (247506) to (247508).

History

Authority: The provisions of this Chapter 553 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 553 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 553.4 Other functions.

(a) The governing body shall meet at least annually and keep minutes or other records necessary for the orderly conduct of the ASF.

(b) If the governing body elects, appoints or employs officers and administrators to carry out its directives, the authority, responsibility and functions of the positions shall be defined.

(c) If the governing body is comprised of two or more members, and if the majority of those members are practitioners, the governing body, either directly or by delegation, shall make—based on evidence of the education, training and current competence—initial appointments, reappointments and assignment or curtailment of clinical privileges of the practitioners.

(d) If the governing body is comprised of only one member, or if a majority of the members of the governing body are not practitioners, the ASF bylaws or similar rules and regulations shall specify a procedure for establishing medical review by practitioners for the purpose of recommending to the governing body for its approval based on evidence of the education, training and current competence—initial appointments, reappointments and assignment or curtailment of clinical privileges of the practitioners.

(e) If students and postgraduate trainees are present in the facility, their role and functions shall be defined.

(f) The governing body shall ensure that personnel are provided with continuing education which is relevant to their responsibilities within the organization.

(g) The governing body shall ensure that the licensee provides to the Department, the documents under § 551.53 (relating to presurvey preparation).

(h) The governing body shall appoint a medical director who shall be board certified by an American Board of Medical Specialties recognized board or the dental, podiatric or osteopathic equivalent. The governing body may appoint an interim director during the period of time between the departure of a director and the selection of a new director.

(1) The interim director shall be a physician who is able to demonstrate qualifications acceptable to the medical staff of the ASF and to the Department.

(2) If the interim director is not board certified, the Department will specify the maximum period of time for which the interim director may serve.

The provisions of this § 553.4 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (247508).

This section cited in 28 Pa. Code § 551.3 (relating to definitions).

History

Authority: The provisions of this Chapter 553 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 553 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 553.11 Purpose.

The purpose of § § 553.11—553.13 (relating to patient’s bill of rights) is to promote the interests and well-being of the patients of ambulatory surgical facilities subject to this subpart even in those instances where the interests of the patients may be in opposition to the interests of the ASF. It is the policy of the Department that the interests of patients be protected by a patient’s bill of rights. Nothing in § § 553.11—553.13 is intended to serve as evidence of a standard of reasonable conduct for the purpose of determining civil liability between providers and consumers of health services. The ASF has the right to expect the patient to fulfill patient responsibilities as may be stated in the ASF’s rules affecting patient care and conduct.

History

Authority: The provisions of this Chapter 553 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 553 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 553.12 Implementation.

(a) The ASF governing body shall establish a patient’s bill of rights not less in substance and coverage than the minimal patient’s bill of rights provided by subsection (b).

(b) The following are minimal provisions for the patient’s bill of rights:

(1) A patient has the right to respectful care given by competent personnel.

(2) A patient has the right, upon request, to be given the name of his attending practitioner, the names of all other practitioners directly participating in his care and the names and functions of other health care persons having direct contact with the patient.

(3) A patient has the right to consideration of privacy concerning his own medical care program. Case discussion, consultation, examination and treatment are considered confidential and shall be conducted discreetly.

(4) A patient has the right to have records pertaining to his medical care treated as confidential except as otherwise provided by law or third party contractual arrangements.

(5) A patient has the right to know what ASF rules and regulations apply to his conduct as a patient.

(6) The patient has the right to expect emergency procedures to be implemented without unnecessary delay.

(7) The patient has the right to good quality care and high professional standards that are continually maintained and reviewed.

(8) The patient has the right to full information in layman’s terms, concerning diagnosis, treatment and prognosis, including information about alternative treatments and possible complications. When it is not medically advisable to give the information to the patient, the information shall be given on his behalf to the responsible person.

(9) Except for emergencies, the practitioner shall obtain the necessary informed consent prior to the start of a procedure. Informed consent is defined in section 103 of the Health Care Services Malpractice Act (40 P. S. § 1301.103).

(10) A patient or, if the patient is unable to give informed consent, a responsible person, has the right to be advised when a practitioner is considering the patient as a part of a medical care research program or donor program, and the patient, or responsible person, shall give informed consent prior to actual participation in the program. A patient, or responsible person, may refuse to continue in a program to which he has previously given informed consent.

(11) A patient has the right to refuse drugs or procedures, to the extent permitted by statute, and a practitioner shall inform the patient of the medical consequences of the patient’s refusal of drugs or procedures.

(12) A patient has the right to medical and nursing services without discrimination based upon age, race, color, religion, sex, national origin, handicap, disability or source of payment.

(13) The patient who does not speak English shall have access, where possible, to an interpreter.

(14) The ASF shall provide the patient, or patient designee, upon request, access to the information contained in his medical records, unless access is specifically restricted by the attending practitioner for medical reasons.

(15) The patient has the right to expect good management techniques to be implemented within the ASF. These techniques shall make effective use of the time of the patient and avoid the personal discomfort of the patient.

(16) When an emergency occurs and a patient is transferred to another facility, the responsible person shall be notified. The institution to which the patient is to be transferred shall be notified prior to the patient’s transfer.

(17) The patient has the right to examine and receive a detailed explanation of his bill.

(18) A patient has the right to expect that the ASF will provide information for continuing health care requirements following discharge and the means for meeting them.

(19) A patient has the right to be informed of his rights at the time of admission.

This section cited in 28 Pa. Code § 553.11 (relating to purpose).

History

Authority: The provisions of this Chapter 553 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 553 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 553.13 Procedures for distribution.

The ASF shall develop procedures to inform each patient of his rights. Copies of the ASF’s patient’s bill of rights shall be made generally available through one of the following ways:

(1) Prominent displays in appropriate locations in addition to copies available upon request.

(2) Provision of a copy to each patient or responsible party upon admission.

This section cited in 28 Pa. Code § 553.3 (relating to governing body responsibilities); and 28 Pa. Code § 553.11 (relating to purpose).

History

Authority: The provisions of this Chapter 553 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 553 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 553.21 Principle.

(a) The ASF shall have written policies for the admission, discharge, transfer and proper referral of patients.

(b) The ASF may not provide beds or other accommodations for an overnight stay of patients.

(c) A patient shall be discharged in a conscious and coherent condition and able to maintain vital life functions or shall be transferred to a hospital.

(d) A patient shall be discharged only with appropriate discharge instructions under § 555.24 (relating to postoperative care).

The provisions of this § 553.21 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (247511).

History

Authority: The provisions of this Chapter 553 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 553 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 553.22 Admission criteria.

The governing body, with the advice of and in conjunction with the medical staff, shall establish medical criteria for admissions under § 555.22(a) (relating to preoperative care). Medical criteria shall be congruent with the assigned ASF class level stated on the facility license.

The provisions of this § 553.22 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (247511).

History

Authority: The provisions of this Chapter 553 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 553 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 553.23 Discharge by transfer.

A patient may not be transferred to another medical facility unless prior arrangements for admission have been made. Clinical records of sufficient content to insure continuity of care shall accompany the patient.

History

Authority: The provisions of this Chapter 553 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 553 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 553.24 Discharge of a minor or incompetent patient.

An individual who cannot legally consent to his own care shall be discharged only to the custody of parents, legal guardian, person standing in loco parentis or another responsible party unless otherwise directed by the parent or guardian or court of competent jurisdiction. If the parent or guardian directs that discharge be made otherwise, he shall so state in writing, and the statement shall become a part of the permanent medical record of the patient.

History

Authority: The provisions of this Chapter 553 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 553 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 553.25 Discharge criteria.

A patient may only be discharged from an ASF if the following physical status criteria are met:

(1) Vital signs. Blood pressure, heart rate, temperature and respiratory rate are within the normal range for the patient’s age or at preoperative levels for that patient.

(2) Activity. The patient has regained preoperative mobility without assistance or syncope, or function at the patient’s usual level considering limitations imposed by the surgical procedure.

(3) Mental status. The patient is awake, alert or functions at the patient’s preoperative mental status.

(4) Pain. The patient’s pain can be effectively controlled with medication.

(5) Bleeding. Bleeding is controlled and consistent with that expected from the surgical procedure.

(6) Nausea/vomiting. Minimal nausea or vomiting is controlled and consistent with that expected from the surgical procedure.

The provisions of this § 553.25 adopted October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583.

History

Authority: The provisions of this Chapter 553 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 553 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 553.31 Administrative responsibilities.

(a) A full time person in charge shall be appointed who has authority and responsibility for the operation of the ASF at all times. Qualifications, authority, responsibilities and duties of the person in charge shall be defined in a written statement adopted by the governing body.

(b) Administrative policies, procedures and controls shall be established, documented and implemented to assure the orderly and efficient management of the ASF.

The provisions of this § 553.31 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial pages (247511) to (247512).

History

Authority: The provisions of this Chapter 553 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 553 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

Chapter 555 Medical Staff

28 Pa. Code § 555.1 Principle.

There shall be an organized medical staff which is accountable to the governing body and which has responsibility for the quality of medical care provided to patients and for the ethical conduct and professional practice of its members and other practitioners who have been granted clinical privileges in the ASF.

This section cited in 28 Pa. Code § 551.3 (relating to definitions).

History

Authority: The provisions of this Chapter 555 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 555 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 555.2 Medical staff membership.

A member of the medical staff shall be qualified for membership and the exercise of clinical privileges granted to him. The governing body of the ASF, after considering the recommendations of the medical staff, may grant clinical privileges to qualified, licensed practitioners in accordance with their training, experience and demonstrated competence and judgment. Members of the medical staff and others granted clinical privileges shall currently hold licenses to practice in this Commonwealth.

This section cited in 28 Pa. Code § 551.3 (relating to definitions).

History

Authority: The provisions of this Chapter 555 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 555 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 555.3 Requirements for membership and privileges.

(a) To receive favorable recommendation for appointment, or reappointment, members of the medical staff shall always act in a manner consistent with the highest ethical standards and levels of professional competence.

(b) Privileges granted shall reflect the results of peer review or utilization review programs, or both, specific to ambulatory surgery.

(d) Granting of clinical privileges shall follow established policies and procedures in the bylaws or similar rules and regulations. The procedures shall provide the following:

(1) A written record of the application, which includes the scope of privileges sought and granted. The delineation ‘‘clinical privileges’’ shall address the administration of anesthesia.

(2) A review, summarized on record with appropriate documentation, of the qualifications of the applicant.

(e) Reappraisal and reappointment shall be required of every member of the medical staff at regular intervals no longer than every 2 years.

(f) The governing body shall request and consider reports from the National Practitioner Data Bank on each practitioner who requests privileges.

The provisions of this § 555.3 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256562).

This section cited in 28 Pa. Code § 551.3 (relating to definitions).

History

Authority: The provisions of this Chapter 555 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 555 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 555.4 Clinical activities and duties of physician assistants and certified registered nurse practitioners.

(a) If the ASF assigns patient care responsibilities to physician assistants and nurse practitioners, the medical staff shall have established policies and procedures approved by the governing body, for overseeing and evaluating their clinical activities. The training, experience and demonstrated current competence of physician assistants and nurse practitioners shall be commensurate with their duties and responsibilities.

(b) Physician assistants shall perform within the limits established by the medical staff and consistent with the Medical Practice Act of 1985 (63 P. S. § § 422.1—422.45) and the Osteopathic Medical Practice Act (63 P. S. § § 261—271). Certified registered nurse practitioners shall perform within the limits established by the medical staff and consistent with the Professional Nursing Law (63 P. S. § § 211—225.5) and the joint regulations of the State Boards of Medicine and Nursing.

The provisions of this § 555.4 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256563).

History

Authority: The provisions of this Chapter 555 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 555 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 555.11 Written orders.

(a) Medication or treatment shall be administered by authorized persons to administer drugs and medications only upon written and signed orders of a practitioner acting within the scope of the practitioner’s license.

(b) Physician assistants and certified registered nurse practitioners may write orders for medication or treatment in accordance with their legally authorized scope of practice and policies and procedures of the ASF.

The provisions of this § 555.11 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256563).

History

Authority: The provisions of this Chapter 555 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 555 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 555.12 Oral orders.

Oral orders for medication or treatment shall be accepted only under urgent circumstances when it is impractical for the orders to be given in written manner by the responsible practitioner. Oral orders shall be administered in accordance with § 555.13 (relating to administration of drugs) only by personnel qualified by their professional license or certification issued by the Commonwealth and according to medical staff bylaws or rules, who shall document the orders in the proper place in the medical record of the patient. The order shall include the date, time and full signature of the person taking the order and shall be countersigned by a practitioner within 48 hours of the order. If the practitioner is not the attending physician, the practitioner shall be authorized by the attending physician and shall be knowledgeable about the patient’s condition. Countersignatures may be received by facsimile transmission.

The provisions of this § 555.12 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256563).

History

Authority: The provisions of this Chapter 555 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 555 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 555.13 Administration of drugs.

Drugs shall be administered only upon the proper order of a practitioner acting within the scope of the practitioner’s license and authorized according to medical staff bylaws, rules and regulations. Drugs shall be administered directly by a practitioner qualified according to medical staff bylaws, rules and regulations or by a professional nurse or by a licensed practical nurse with pharmacy training. Physician assistants and certified registered nurse practitioners shall be permitted to administer drugs within their authorized scope of practice. Further policies on the administration of drugs shall be established by the medical staff in conjunction with pharmaceutical services or personnel.

The provisions of this § 555.13 adopted October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583.

History

Authority: The provisions of this Chapter 555 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 555 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 555.21 Surgical procedures.

Procedures performed in the ASF are limited to procedures that are approved by the governing body, upon the recommendation of the medical staff and congruent with ASF classification as stated on its ASF license.

The provisions of this § 555.21 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256563).

History

Authority: The provisions of this Chapter 555 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 555 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 555.22 Preoperative care.

(a) Pertinent medical histories and physical examinations, and supplemental information regarding drug sensitivities shall be documented the day of surgery or one of the following:

(1) If medical evaluation, examination and referral are made from a private practitioner’s office, hospital or clinic, pertinent records thereof shall be available and made part of the patient’s clinical record at the time the patient is registered and admitted to the ASF. This information is considered valid only if the evaluation was performed no more than 30 days prior to date of surgery.

(2) A practitioner shall examine the patient immediately before surgery to evaluate the risk of anesthesia and of the procedure to be performed. The information shall be clearly documented in the medical record.

(b) A written statement indicating informed consent, obtained by the practitioner, and signed by the patient, or responsible person, for the performance of the specific procedures shall be procured and made part of the patient’s clinical record. It shall contain a statement which evidences the appropriateness of the proposed surgery, as well as any alternative treatments discussed with the patient. It shall also identify any practitioner who will participate in the surgery.

(c) Written instructions for preoperative procedures, which have been approved by the medical staff, shall be given to the patient or responsible person, and shall include:

(1) Applicable restrictions upon food and drink before surgery.

(2) Special preparations to be made by the patient.

(3) The required proximity of the patient to the ASF for a specific time following surgery, if applicable.

(4) An understanding that the patient may require admission to the hospital in the event of medical need.

(5) Upon discharge of a patient who has received sedation or general anesthesia, a responsible person shall be available to escort the patient home. With respect to patients who receive local or regional anesthesia, a medical decision shall be made regarding whether these patients require a responsible person to escort them home.

(d) Preoperative diagnostic studies, if performed, shall be evaluated, annotated, signed and entered into the patient’s medical record before surgery.

(e) Prior to the administration of anesthesia, it is the responsibility of the primary operating surgeon and the person administering anesthesia to properly identify the patient and the procedure to be performed and to document this identification in the patient’s medical record. This procedure shall be in written policies designating the mechanism to be used to identify each surgical patient.

The provisions of this § 555.22 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial pages (256563) to (256564).

This section cited in 28 Pa. Code § 553.22 (relating to admission criteria); and 28 Pa. Code § 555.24 (relating to post-operative care).

History

Authority: The provisions of this Chapter 555 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 555 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 555.23 Operative care.

(a) Approved surgical procedures shall be performed only by a qualified physician, dentist or podiatrist within the limits of the practitioner’s defined specific practice privileges. Physician assistants and certified registered nurse practitioners may be permitted to assist in the performance of surgical procedures in accordance with their legally authorized scope of practice and the policies and procedures of the ASF.

(b) Tissues and exudates removed during a surgical procedure shall be properly labeled and sent to a laboratory for examination by a pathologist. The specimen shall be accompanied by pertinent clinical information, including its source and the preoperative and postoperative surgical diagnosis. The pathologist’s signed report of the examination shall be made a part of the patient’s medical record. Certain tissues and exudates may be exempt from laboratory examination. The exemptions shall be those that are consistent with current medical practices and are in writing and approved by the governing body.

(c) An ASF shall be prepared to initiate immediate onsite resuscitation or other appropriate response to an emergency which may be associated with procedures performed there.

(d) The ASF shall have an effective procedure for the immediate transfer to a hospital of patients requiring emergency medical care beyond the capabilities of the ASF.

(e) The ASF shall have a written transfer agreement with a hospital which has emergency and surgical services available, or physicians performing surgery in the ASF shall have admitting privileges at a hospital in close proximity to the ASF, to which patients may be transferred.

(f) There shall be a written agreement in effect with an ambulance service staffed by certified EMT personnel, for the safe transfer of a patient to a hospital in an emergency situation, or as the need arises.

The provisions of this § 555.23 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial pages (256564) to (256565).

History

Authority: The provisions of this Chapter 555 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 555 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 555.24 Postoperative care.

(a) The findings and techniques of an operation shall be accurately and completely written or dictated immediately after the procedure by the practitioner medical staff member who performed the operation. If a physician assistant or certified registered nurse practitioner performed part of the operation, the findings and techniques of the procedure shall be accurately recorded and the report shall be countersigned by the medical staff member. This description shall become a part of the patient’s medical record.

(b) A patient who has received anesthesia shall be observed in the facility by a registered nurse, physician assistant or a practitioner for a period of time which is sufficient to ensure that no immediate postoperative complications are present.

(c) Patients in whom a complication is known or suspected to have occurred during or after the performance of a surgical procedure shall be informed of the condition and arrangements made for treatment of the complication. In the event of admission to an inpatient facility, a summary of care given in the ASF concerning the suspected complication shall accompany the patient.

(d) A medical professional certified in advanced cardiac life support shall be present until patients operated on that day have been discharged from the facility. If a patient receives general anesthesia, regional anesthesia or IV sedation, an anesthetist shall remain present until that patient has been discharged from the facility.

(e) Patients shall be discharged in the company of a responsible person, if one is deemed to be necessary under § 555.22(c)(5) (relating to preoperative care).

(f) Protocols approved by the medical staff shall be established for instructing patients in self-care after surgery including written instructions which, at a minimum, include the following:

(1) The symptoms of complications associated with procedures performed.

(2) An explanation of prescribed drug regime including directions for use of medications.

(3) The limitations and restrictions on activities of the patient, if necessary.

(4) A specific telephone number to be used by the patient, if a complication or question arises.

(5) A date for follow-up or return visit after the performance of the surgical procedure.

(6) Instructions on the care of dressing and wounds.

(7) Instructions on dietary limitations.

(g) Patients shall be discharged only on the written signed order of a practitioner.

The provisions of this § 555.24 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256565).

This section cited in 28 Pa. Code § 553.21 (relating to principle).

History

Authority: The provisions of this Chapter 555 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 555 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 555.31 Principle.

(a) Anesthesia services provided in the facility are limited to those techniques that are approved by the governing body upon the recommendation of qualified medical staff. They shall be limited to those techniques appropriate to the assigned classification per ASF license.

(b) The governing body shall define the degree of supervision required and the scope of responsibilities delegated to anesthesiologists, certified registered nurse anesthetists and dentist anesthetists, as well as the corresponding responsibilities of supervising physicians.

The provisions of this § 555.31 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256566).

History

Authority: The provisions of this Chapter 555 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 555 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 555.32 Administration of anesthesia.

(a) Anesthetics shall be administered by anesthesiologists and certified registered nurse anesthetists and dentist anesthetists, or practitioners as defined in § 551.3 (relating to definitions).

(b) If a nonphysician administers the anesthesia, the anesthetist shall be under the overall direction of an anesthesiologist or a physician or dentist who is present in the ASF.

(c) The Director of Anesthesia Services shall be responsible for designating the physician or dentist who will be responsible for the overall direction of the anesthetist.

The provisions of this § 555.32 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256566).

History

Authority: The provisions of this Chapter 555 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 555 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 555.33 Anesthesia policies and procedures.

(a) In ASFs where an anesthesiologist is present, the anesthesiologist shall be designated the Director of Anesthesia Services and shall be responsible for directing the anesthesia services and establishing the general policies and procedures for the administration of anesthesia in the ASF which shall be approved by the governing body.

(b) In ASFs where there is no anesthesiologist, the governing body shall designate a physician or dentist to function as the Director of Anesthesia Services, who shall be responsible for directing the anesthesia services and establishing the general policies and procedures for the administration of anesthesia in the ASF which shall be approved by the governing body.

(1) Education, training and supervision of personnel.

(2) Responsibilities of nonphysician anesthetists.

(3) Responsibilities of supervising physicians or dentists.

(d) Anesthesia procedures shall provide at least the following:

(1) A patient requiring anesthesia shall have a pre-anesthesia evaluation by a practitioner, with appropriate documentation of pertinent information regarding the choice of anesthesia.

(2) A review and documentation shall be made of the condition of the patient immediately prior to induction of anesthesia, including pertinent laboratory findings, time of administration and dosage of preanesthesia medications.

(3) Prior to beginning the administration of anesthesia, the anesthetist shall check equipment to be used in administration of anesthetic agents. An anesthetic gas machine in anesthetising areas shall have a pin-index safety system.

(4) Following the procedure for which anesthesia was administered, the anesthetist shall remain with the patient as long as necessary to insure safe transport to the recovery area and shall advise personnel responsible for postanesthetic care of the condition of the patient.

(5) A patient receiving anesthesia shall have an anesthetic record maintained. This shall include a record of vital signs and all events taking place during the induction of, maintenance of and emergence from anesthesia, including the dosage and duration of anesthetic agents, other drugs and intravenous fluids.

(6) Intraoperative physiologic monitoring shall include the following at a minimum:

(i) The use of oxygen saturation by pulse oximetry.

(ii) The use of End Tidal CO2 monitoring during endotracheal anesthesia.

(iii) The use of EKG monitoring.

(iv) The use of blood pressure monitoring.

(7) A patient may not receive general anesthesia unless one or more additional health care professionals besides the one performing the surgery, are present, one of whom is trained in the administration of anesthesia.

(8) Before discharge from the ASF, a patient shall be evaluated for proper anesthesia recovery by an anesthetist, the operating room surgeon, anesthesiologist or dentist. Depending on the type of anesthesia and length of surgery, the postoperative check shall include at least the following:

(i) Level of activity.

(ii) Respirations.

(iii) Blood pressure.

(iv) Level of consciousness.

(v) Oxygen saturation by pulse oximetry.

The provisions of this § 555.33 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial pages (256566) to (256567).

History

Authority: The provisions of this Chapter 555 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 555 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 555.34 Development and review of safety regulations.

Regulations governing procedures to assure the safety of anesthetics and other medical gases shall be developed, approved and reviewed by appropriate representatives of the medical staff and of the governing body.

History

Authority: The provisions of this Chapter 555 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 555 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 555.35 Safety regulations.

(a) Appropriate precautions shall be taken to ensure the safe administration of anesthetic and other medical gas agents, in accordance with the latest edition of NFPA Code 56G, and other applicable NFPA Codes as required.

(b) The machines used for anesthesia shall have at least one annual function testing by technicians with appropriate training and a log of this testing and outcomes shall be maintained.

The provisions of this § 555.35 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256567).

History

Authority: The provisions of this Chapter 555 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 555 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

Chapter 557 Quality Assurance and Improvement

28 Pa. Code § 557.1 Policy.

The ASF, with active participation of the medical and nursing staff, shall conduct an ongoing quality assurance and improvement program designed to objectively and systematically monitor and evaluate the quality and appropriateness of patient care, pursue opportunities to improve patient care and resolve identified problems.

The provisions of this § 557.1 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256569).

History

Authority: The provisions of this Chapter 557 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 557 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 557.2 Plan.

(a) The ASF shall have a written plan for the quality assurance and improvement program that describes the program’s objectives, organization, scope and mechanisms for overseeing the effectiveness of monitoring, evaluation and problem solving activities.

(b) The written plan shall be endorsed by the governing body and the medical director who are responsible for establishment and direction of the program and which indicates the staff person responsible for implementation of the program.

(c) The plan shall emphasize the ongoing nature of the quality assurance program and the comprehensiveness of the scope of the program which shall include monitoring and evaluation of the following:

(1) Medical staff functions including:

(i) Peer-based review of clinical performance of individuals with clinical privileges.

(ii) Surgical case and tissue review.

(2) Anesthesia services.

(3) Nursing services.

(4) Pharmaceutical services.

(5) Pathology and radiology services.

(6) Infection control procedures.

(7) Procedures performed in the ASF and their necessity.

(8) Reports of accidents, injuries and safety hazards.

(d) The plan shall include participation of practitioners and other health care personnel.

The provisions of this § 557.2 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256569).

History

Authority: The provisions of this Chapter 557 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 557 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 557.3 Quality Assurance and Improvement Program.

(a) The quality assurance program shall include monitoring and evaluation of data collected, based on defined criteria that reflect current knowledge and clinical experience and relate to the care provided by the service. Sources of data include the medical records, incident reports, infection control records and patient complaints. The medical record shall contain sufficient data to support the diagnosis and determine that the procedures are appropriate to the diagnosis. Facilities that treat pediatric patients shall segregate data regarding these patients.

(b) The quality assurance program shall provide for the identification of problems and actions taken—through the monitoring and evaluation process—which improve the quality of patient care.

(d) Measures shall be implemented to resolve important problems or concerns identified. The results of these corrective measures shall be monitored to assure that the problem has been satisfactorily resolved. Measures which may be taken include:

(1) Changes in policies and procedures.

(2) Staffing and assignment changes.

(3) Appropriate education and training.

(4) Adjustments in clinical privileges.

(5) Changes in equipment or physical plant.

(e) The program shall include a mechanism to assure that activities are documented and reports of the quality assurance activities are brought to the attention of the governing body. There shall be a periodic reappraisal of the program.

(f) The quality assurance program shall include the establishment of a quality assurance committee.

The provisions of this § 557.3 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256570).

History

Authority: The provisions of this Chapter 557 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 557 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 557.4 Quality Assurance and Improvement Committee.

(a) The Committee shall consist of the following:

(1) A practitioner who is not an owner.

(2) A representative of administration.

(3) A registered nurse.

(4) Other health care personnel, as appropriate.

(b) Committee functions shall include:

(1) Evaluating data submitted as part of the quality assurance program.

(2) Reviewing credentials.

(3) Reviewing tissue examination reports.

(4) Reviewing infection control program.

(5) Reviewing the standards of practice in all specific areas of the ASF.

(1) Reports made to the governing body.

(2) Minutes of committee meetings including date, time, persons attending, description and results of cases reviewed and recommendations made by the committee.

(3) Corrective actions taken including appropriate orientation, training or education programs necessary to correct deficiencies which are uncovered as a result of the quality assurance program.

The provisions of this § 557.4 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial pages (256570) to (256571).

History

Authority: The provisions of this Chapter 557 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 557 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

Chapter 559 Nursing Services

28 Pa. Code § 559.1 Nursing department.

The ASF shall have an organized nursing department under the supervision of a registered nurse who has responsibility and accountability for nursing services.

History

Authority: The provisions of this Chapter 559 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 559 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 559.2 Director of nursing.

The director of nursing shall be currently licensed as a registered nurse in this Commonwealth and be responsible and accountable to the person in charge of the ASF for:

(1) Delivery of nursing services to patients.

(2) Development and maintenance of nursing service goals and objectives, standards of nursing practice, nursing policy and procedure manuals and written job descriptions for each level of personnel.

(3) Coordination of nursing services with other patient services.

(4) Establishment of a means of assessing the nursing care needs of patients and staffing to meet those needs.

(5) Staff development.

The provisions of this § 559.2 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256573).

History

Authority: The provisions of this Chapter 559 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 559 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 559.3 Nursing personnel.

(a) An adequate number of licensed and assistive personnel shall be on duty to assure that staffing levels meet the total nursing needs of patients based on the number of patients in the facility and their individual nursing care needs. Class B and Class C ASFS which provide surgical services to pediatric patients shall have nursing staff with documented experience in the postoperative care of these patients.

(b) At least one registered nurse shall be in attendance during the hours patients are present. Nursing personnel shall be assigned to duties consistent with their education, training and experience.

(c) Registered professional nurses or licensed practical nurses practicing at an ASF shall be licensed to practice in this Commonwealth. There shall be a procedure to verify the licensure status of the nurses.

The provisions of this § 559.3 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial pages (256573) to (256574).

History

Authority: The provisions of this Chapter 559 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 559 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 559.4 Staffing schedules.

(a) There shall be staffing schedules reflecting actual nursing personnel required for the ASF. Staffing patterns should reflect consideration of nursing goals, standards of nursing practice and the needs of the patients.

(b) Schedules which contain an indication of personnel attendance by date, and time of actual attendance shall be kept on file for a minimum of 1 year.

History

Authority: The provisions of this Chapter 559 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 559 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 559.5 Nursing notes.

Nursing notes shall be pertinent, accurate and concise so that they contribute to the continuity of patient care. Nursing records and reports shall become part of the patient’s medical record.

History

Authority: The provisions of this Chapter 559 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 559 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

Chapter 561 Pharmaceutical Services

28 Pa. Code § 561.1 Drugs and biologicals.

The ASF shall provide drugs and biologicals in a safe and effective manner to meet the needs of the patients and to adequately support the organization’s clinical capabilities commensurate with their license classification, in accordance with accepted ethical and professional practice and applicable State and Federal law, including the Pharmacy Act (63 P. S. § § 390.1—390.13), 49 Pa. Code Chapter 27 (relating to State Board of Pharmacy), The Controlled Substance, Drug, Device and Cosmetic Act (35 P. S. § § 780-101—780-144) and Chapter 25 (relating to controlled substances, drugs, devices and cosmetics).

The provisions of this § 561.1 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256575).

History

Authority: The provisions of this Chapter 561 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 561 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 561.2 Pharmaceutical service.

(a) Pharmaceutical services shall be supervised by a physician or dentist who is qualified to assume professional, organization and administrative responsibility for the quality of services rendered. Practitioners may dispense drugs only to the patients who are in their care.

(b) A pharmacy owned and operated by the ASF shall be supervised by a licensed pharmacist.

(c) Contracted pharmaceutical services shall be provided in accordance with the same ethical and professional practices and legal requirements that would be required if these services are provided directly by the organization.

The provisions of this § 561.2 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256576).

History

Authority: The provisions of this Chapter 561 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 561 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 561.11 Principle.

The ASF shall provide equipment and supplies for the pharmaceutical service to implement its professional and administrative functions and to ensure patient safety through the proper storage and dispensing of drugs. Facilities shall be provided for the storage, safeguarding, preparation and dispensing of drugs.

History

Authority: The provisions of this Chapter 561 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 561 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 561.12 Supplies.

The pharmacist or practitioner in charge of the pharmaceutical service shall maintain a supply of drugs and devices adequate to meet the needs of the patients. Pharmacy supplies shall conform to 49 Pa. Code § 27.14 (relating to supplies).

History

Authority: The provisions of this Chapter 561 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 561 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 561.13 Storage.

The area in the ASF where drugs are stored shall be periodically checked by the responsible pharmacist or practitioner and proper logs maintained.

The provisions of this § 561.13 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256576).

History

Authority: The provisions of this Chapter 561 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 561 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 561.14 Space.

There shall be adequate space provided for pharmaceutical operations, and the storage of drugs at a satisfactory location provided with proper lighting. Ventilation and temperature controls shall be in accordance with 49 Pa. Code § § 27.15 and 27.16 (relating to sanitary standards; and construction requirements).

History

Authority: The provisions of this Chapter 561 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 561 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 561.15 Locked storage.

Special locked storage space shall be provided to meet requirements for storage of controlled substances, alcohol and other prescribed drugs as set forth in Chapter 25 (relating to controlled substances, drugs, devices and cosmetics) and 49 Pa. Code § § 27.16(b)(4) and 27.17 (relating to construction requirements; and security for Schedule II controlled substances).

History

Authority: The provisions of this Chapter 561 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 561 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 561.21 Principle.

The scope of the pharmaceutical service shall be consistent with the medication needs of the patients and congruent with the license classification of the ASF. The pharmaceutical policies shall include a program for the control and accountability of drug products throughout the ASF. If drugs are used for an experimental purpose, the use thereof shall be approved by an Institutional Review Board (IRB) or an IRB shall waive review and proper consent for use shall be obtained.

The provisions of this § 561.21 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256577).

History

Authority: The provisions of this Chapter 561 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 561 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 561.22 Records.

(a) Drug transactions of the pharmaceutical service shall be recorded, and those records shall be correlated with other ASF records. Records and security shall be maintained to assure the control and safe dispensing of drugs and compliance with Federal and Commonwealth statutes.

(b) Drugs ordered and administered to patients shall be documented in the medical record of the patient.

(c) Oral orders for drugs for immediate administration shall be followed by a written order, signed by the prescribing practitioner, prior to the discharge of the patient.

(d) Adverse drug reactions and drug sensitivities shall be recorded in the patient’s medical record and copies maintained for review by the quality assurance committee.

History

Authority: The provisions of this Chapter 561 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 561 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 561.23 Use of controlled substances and other drugs.

There shall be policies and procedures developed and approved by the medical staff which establish controls governing the use of controlled substances and other drugs, including sedatives, anticoagulants, antibiotics, oxytoxics and corticosteroids. Policies shall be established regarding written orders for appropriate dosage of all drugs.

The provisions of this § 561.23 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256577).

History

Authority: The provisions of this Chapter 561 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 561 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 561.24 Emergency pharmaceutical services.

Provision shall be made for emergency pharmaceutical services. Emergency drugs shall be kept readily available and under the control of either the pharmacist or the practitioner in charge of pharmaceutical services.

History

Authority: The provisions of this Chapter 561 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 561 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 561.25 Distressed drugs, devices and cosmetics.

Drugs, devices and cosmetics which are outdated, visibly deteriorated, unlabeled or inadequately labeled, recalled, discontinued or obsolete shall be identified by the licensed pharmacist or responsible practitioner and shall be disposed of in compliance with applicable Commonwealth and Federal regulations.

History

Authority: The provisions of this Chapter 561 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 561 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 561.26 Mishandling of drugs.

If there is reason to suspect mishandling of scheduled or controlled drugs, the person in charge of the ASF shall contact the Bureau of Drug Control of the Office of Attorney General or State or local police.

History

Authority: The provisions of this Chapter 561 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 561 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

Chapter 563 Medical Records

28 Pa. Code § 563.1 Principle.

The ASF shall maintain complete, comprehensive and accurate medical records for every patient to ensure adequate patient care.

History

Authority: The provisions of this Chapter 563 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 563.2 Organization and staffing.

(a) The ASF shall have a medical record service. It shall be directed, staffed and equipped to ensure the accurate processing, indexing and filing of medical records.

(b) At least one full-time or part-time employe shall provide regular medical record service.

History

Authority: The provisions of this Chapter 563 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 563.3 Facilities.

History

Authority: The provisions of this Chapter 563 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 563.4 Identification and filing of medical records.

The medical record service shall maintain a system of identification and filing to facilitate the prompt location of the medical record of a patient.

History

Authority: The provisions of this Chapter 563 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 563.5 Storage of medical records.

Medical records shall be stored to provide protection from loss, damage or unauthorized access.

History

Authority: The provisions of this Chapter 563 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 563.6 Preservation of medical records.

(a) The facility shall have a written policy regarding the retention of records. Medical records whether original, reproductions or microfilm, shall be kept on file for a minimum of 7 years following the discharge of a patient.

(b) If the patient is a minor, records shall be kept on file until his majority, and then, for 7 years or as long as the records of adult patients are maintained.

(c) If an ASF discontinues operation, it shall make known to the Department where its records are stored. Records are to be stored in a facility offering retrieval services for at least 5 years after the closure date. Prior to destruction, public notice shall be made to permit former patients or their representatives to claim their own records. Public notice shall be in at least two forms, legal notice and display advertisement in a local newspaper of general circulation.

History

Authority: The provisions of this Chapter 563 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 563.7 Microfilming medical records.

Medical records may be microfilmed at any time including immediately after completion. Microfilming may be done on or off the premises. If done off the premises, the ASF shall take precautions to assure the confidentiality and safekeeping of the records. The original of microfilmed medical records may not be destroyed until the medical records service has had an opportunity to review the processed film for content.

History

Authority: The provisions of this Chapter 563 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 563.8 Automation or computerization of medical records.

Nothing in this subpart prohibits the use of automation or computerization in the medical records service, if the provisions in this chapter are met and the information is readily available for use in patient care. Innovations in medical record formats, compilation and data retrieval are specifically encouraged.

The provisions of this § 563.8 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256580).

History

Authority: The provisions of this Chapter 563 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 563.9 Confidentiality of medical records.

Records shall be treated as confidential. Only authorized personnel shall have access to the records. The written authorization of the patient shall be presented and then maintained in the original record as authority for release of medical information outside the ASF.

History

Authority: The provisions of this Chapter 563 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 563.10 Ownership.

There shall be written policies and procedures which specify who has access to medical records, under what conditions records may be removed from the ASF, and under what conditions medical record information may be released. Medical records are the property of the ASF, and they may not be removed from the premises except for court purposes. Copies may be made available for authorized appropriate purposes, such as insurance claims and practitioner review.

History

Authority: The provisions of this Chapter 563 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 563.11 Patient access.

Patients or patient designees shall be given access to or a copy of their medical records, or both. The patient or the patient’s designee may be charged for the cost of reproducing the copies; however, the charges shall be reasonably related to the cost of making the copy.

History

Authority: The provisions of this Chapter 563 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 563.12 Form and content of record.

The ASF shall maintain a separate medical record for each patient. Every record shall be accurate, legible and promptly completed. Patient medical records shall be constructed to stand alone and be easily identified as ASF records. Medical records shall include at least the following:

(1) Patient identification.

(2) Pertinent medical history and results of physical examination.

(3) Preoperative diagnostic studies—entered before surgery—if performed.

(4) The presence or absence of allergies and untoward drug reactions recorded in a prominent and uniform location in all patient charts on a current basis.

(5) Documentation of properly executed, informed patient consent.

(6) Entries related to anesthesia administration.

(7) Findings and techniques of the operation, including a pathologist report on tissue removed during surgery.

(8) Notes by authorized staff members and individuals who have been granted clinical privileges, nurses’ notes and entries by other professional personnel.

(9) Written and verbal disposition recommendations and instructions given to the patient.

(10) Significant medical advice given to a patient by telephone.

(11) Discharge summary including discharge diagnosis.

The provisions of this § 563.12 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256581).

This section cited in 28 Pa. Code § 563.13 (relating to entries).

History

Authority: The provisions of this Chapter 563 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 563.13 Entries.

(a) Entries in the record shall be dated and authenticated by the person making the entry.

(b) Symbols and abbreviations may be used only when they have been approved by the medical staff and when a legend exists to explain them.

(c) A single signature on the fact sheet of a record does not suffice to authenticate the entire record. Each entry shall be individually authenticated.

(d) Notation of unusual incidents shall be entered in the medical record.

(e) Necessary documentation on the patient’s medical record as specified in § 563.12 (relating to form and content of record) shall be completed in a timely manner not to exceed 30 days.

The provisions of this § 563.13 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256581).

History

Authority: The provisions of this Chapter 563 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter adopted January 23, 1987, effective March 25, 1987, 17 Pa.

Chapter 565 Laboratory and Radiology Services

28 Pa. Code § 565.1 Principle.

The ASF shall have procedures for obtaining routine and emergency laboratory services to meet the needs of patients.

History

Authority: The provisions of this Chapter 565 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 565 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 565.2 Laboratory service policy.

Laboratory services shall be provided under The Clinical Laboratory Act (35 P. S. § § 2151—2165) and Chapter 5 (relating to clinical laboratories).

History

Authority: The provisions of this Chapter 565 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 565 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 565.3 Functions.

Laboratory functions shall include:

(1) Performing tests in a timely manner.

(2) Distributing test results within 24 hours after completion of a test and maintaining a copy of the results in the laboratory.

History

Authority: The provisions of this Chapter 565 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 565 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 565.4 Records.

Dated reports of services performed shall be made a part of the patient’s medical record.

History

Authority: The provisions of this Chapter 565 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 565 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 565.11 Principle.

Radiology services provided or made available shall meet the needs of the patients and shall be provided in accordance with ethical and professional standards of the American Society of Radiologic Technologists and the American College of Radiology.

History

Authority: The provisions of this Chapter 565 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 565 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 565.12 Radiology service policy.

(a) The service shall be provided by contract or directly by the ASF.

(b) Applicable provisions of the Department of Environmental Protection regulations in 25 Pa. Code Chapters 221—233 and 25 Pa. Code § § 235.1 and 235.11—235.15, and the United States Nuclear Regulatory Commission regulations in 10 CFR Chapter I (relating to Nuclear Regulatory Commission) shall be met by the ASF or its contracted radiology service.

The provisions of this § 565.12 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256584).

History

Authority: The provisions of this Chapter 565 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 565 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 565.13 Organization and staffing.

(a) Radiology services provided by the ASF shall be directed by a person who is qualified to assume professional, organizational and administrative responsibility for the quality of services rendered.

(b) Sufficient adequately trained, certified and experienced personnel shall be available to supervise and conduct the work of the radiology services.

The provisions of this § 565.13 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256584).

History

Authority: The provisions of this Chapter 565 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 565 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 565.14 Policies.

(a) Policies shall address the quality aspects of radiology services including, but not limited to:

(1) Performing radiology services only upon the written order of a practitioner, which shall be accompanied by a concise statement of the reason for the examination.

(2) Limiting the use of radioactive sources to qualified persons in the organization who have been granted privileges for the use on the basis of their training, experience and current competence.

(3) Storing and retaining of films.

(b) Policies shall address the safety aspects of radiology services including, but not limited to:

(1) Regulation of the use, removal, handling and storage of radioactive material.

(2) Precautions against electrical, mechanical and radiation hazards.

(3) Proper shielding where radiation sources are used.

(4) Wearing of acceptable monitoring devices by personnel who might be exposed to radiation in an area with a radiation hazard.

(5) Maintenance of radiation exposure records on personnel.

(6) Instructions to personnel in safety precautions and in dealing with emergency radiation hazards.

(7) Periodic evaluation by qualified personnel of radiation sources and of safety measures followed, including calibration of equipment in compliance with Federal and Commonwealth statutes and regulations and local ordinances.

History

Authority: The provisions of this Chapter 565 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 565 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 565.15 Records.

Authenticated, dated reports of services performed shall be made a part of the patient’s medical record, in a timely manner not to exceed 30 days.

The provisions of this § 565.15 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256585).

History

Authority: The provisions of this Chapter 565 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 565 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 565.16 Facilities.

If radiology services are provided by the ASF, adequate space, equipment and supplies shall be provided to perform the volume of work with optimal accuracy, precision, efficiency and safety.

History

Authority: The provisions of this Chapter 565 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 565 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

Chapter 567 Environmental Services

28 Pa. Code § 567.1 Principle.

The ASF shall have a sanitary environment, properly constructed, equipped and maintained to protect surgical patients and ASF personnel from cross-infection and to protect the health and safety of patients.

The provisions of this § 567.1 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256588).

History

Authority: The provisions of this Chapter 567 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 567 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 567.2 Committee responsibilities.

The quality assurance committee shall be responsible for:

(1) The prevention, control and investigation of infection in the ASF and for assuring the effectiveness of current procedural techniques in all departments.

(2) The designation of one full-time or one part-time employe responsible for developing and monitoring the infection control program including, but not limited to:

(i) Written standards for ASF sanitation and asepsis.

(ii) Procedures and techniques for meeting established sanitation and asepsis standards.

(iii) Isolation procedures.

(iv) Maintaining records of infections which originate in the ASF among patients and personnel to trace the sources of infection and to identify epidemic situations.

(v) Providing assistance in the development of the employe health program of the ASF.

(vi) Submitting a copy of pertinent findings and recommendations to the committee.

History

Authority: The provisions of this Chapter 567 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 567 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 567.3 Policies and procedures.

(a) Only authorized persons, who are properly attired, shall be allowed in the surgical area.

(b) Current written policies and procedures to assure definite and valid infection control shall include the following:

(1) Medical asepsis.

(2) Surgical asepsis.

(3) Sterilization and disinfection, including suitable equipment for routine and rapid sterilization.

(4) Sterilized materials are packaged, labeled and dated in a consistent manner.

(5) Housekeeping.

(6) Cleaning of surgical suites prior to each operation.

(7) Clean and soiled linen and utility rooms.

(8) Linen.

(9) Traffic flow patterns.

(10) Isolation protocols.

(11) Staff health status requirements.

(12) Infection control in-service education for personnel.

(13) Recording and reporting of potential infection.

(14) Bacteriological testing of potential infections, recording results and reporting to the quality assurance committee.

(15) Admission criteria for patients with specific or suspected infections.

(16) Patient postdischarge investigation.

(17) Reporting of communicable diseases as required by § 27.2 (relating to specific identified reportable diseases, infections and conditions).

The provisions of this § 567.3 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial pages (256588) to (256589).

History

Authority: The provisions of this Chapter 567 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 567 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 567.11 Operating suite equipment.

The operating suite shall be adequately equipped with age appropriate equipment for the types of procedures to be performed and the recovery area shall be adequately equipped for the proper care of postanesthesia recovery of surgical patients. All equipment and supplies shall be age and size appropriate for the patients treated. The following equipment shall be available in the operating suite and recovery area.

(1) Suitable surgical instruments customarily available for the planned surgical procedure.

(2) Emergency call system.

(3) Airways, breathing bag and device for the provision of positive pressure rescue breathing.

(4) Cardio-pulmonary drugs and intubation equipment.

(5) Cardiac monitor and defibrillator.

(6) Resuscitator including oxygen and suction equipment.

(7) Tracheostomy and necessary pulmonary reexpansion supplies.

The provisions of this § 567.11 adopted January 23, 1987, effective March 25, 1987, 17 Pa.B. 376; amended July 21, 1989, effective July 22, 1989, 19 Pa.B. 3105; amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256589).

History

Authority: The provisions of this Chapter 567 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 567 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 567.21 Principle.

An adequate supply of clean linen, sterile linen and disposable materials shall be maintained.

History

Authority: The provisions of this Chapter 567 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 567 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 567.22 Linen service policy.

The ASF shall require the agency providing the linen service to maintain at least the standards outlined in this chapter, and the contract shall so state. The off-premises laundry service shall ensure that clean linen is completely packaged and is protected from contamination upon delivery to the ASF.

History

Authority: The provisions of this Chapter 567 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 567 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 567.23 Clean linen.

Clean linen shall be available to meet the daily and emergency needs of the ASF. Clean linen shall be handled and stored to minimize contamination from surface contact or airborne deposits.

History

Authority: The provisions of this Chapter 567 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 567 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 567.24 Soiled linen.

Soiled linen shall be collected and stored to avoid microbial dissemination into the environment. Soiled linen shall be kept segregated from clean linen. Soiled linen from isolation areas shall be identified and separately bagged. Precautions shall be taken in the subsequent processing of soiled linen from isolation areas to prevent microbial dissemination and infection.

History

Authority: The provisions of this Chapter 567 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 567 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 567.31 Principle.

The facility, the premises and equipment shall be kept clean and free of vermin, insects, rodents and litter.

History

Authority: The provisions of this Chapter 567 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 567 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 567.32 Policies and procedures.

Procedures shall be developed for cleaning and care of equipment, for establishment of cleaning schedules, for cleaning methods and for proper use of cleaning supplies and disposal of waste. Suitable equipment shall be provided to facilitate cleaning.

The provisions of this § 567.32 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256590).

History

Authority: The provisions of this Chapter 567 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 567 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 567.33 Waste disposal.

(a) Garbage shall be stored in tight, nonabsorbent and readily cleanable containers with tight-fitting lids. Garbage shall be removed from the premises as frequently as necessary to prevent nuisance and shall be disposed of in a manner consistent with Federal and Commonwealth regulations and local codes and ordinances.

(b) Refuse shall be stored in covered trash containers prior to removal.

(c) Pathological, bacteriological, surgical, gynecological and contaminated waste and similar materials shall be disposed of by a method approved by the Department of Environmental Resources under 25 Pa. Code Chapter 75 (relating to solid waste management) and in compliance with local ordinances.

History

Authority: The provisions of this Chapter 567 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 567 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 567.41 Principle.

The ASF shall be equipped, operated and maintained to sustain its safe and sanitary characteristics and to minimize health hazards in the ASF for the protection of patients and employes.

History

Authority: The provisions of this Chapter 567 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 567 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 567.42 Policies and procedures.

(a) A schedule of preventive maintenance shall be developed for the physical plant, biomedical and other equipment.

(b) Written procedures shall be readily available for employes to follow in the event of a breakdown in equipment, mechanical systems or utilities.

History

Authority: The provisions of this Chapter 567 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 567 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 567.43 Ventilation system.

The ventilation system shall be inspected and maintained in accordance with the written maintenance schedule to ensure that a properly conditioned air supply meeting minimum filtration, humidity and temperature requirements is provided in critical areas such as the surgical and recovery suites under Chapter 571 (relating to construction standards).

History

Authority: The provisions of this Chapter 567 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 567 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 567.51 Water supply.

(a) Water shall be obtained from a municipal or private water system approved by the Department of Environmental Resources and in compliance with applicable Federal and Commonwealth regulations and local ordinances.

(b) Provisions shall be made for an emergency supply of water when the usual source of water is neither usable nor available.

History

Authority: The provisions of this Chapter 567 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 567 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 567.52 Lighting.

Glare-free artificial lighting shall be provided in all areas of the ASF. For current recommendations of lighting levels for ASFs, see the latest edition of the IES, (Illuminating Engineering Society), Lighting Handbook, Application Volume or Lighting for Health Care Facilities. Both documents are published by the IES of North America, 345 East 47th Street, New York, New York 10017.

History

Authority: The provisions of this Chapter 567 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 567 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 567.53 Sterilization control.

There shall be written policies to establish the following:

(1) A method of control to assure sterilization of supplies and water.

(2) Processing of sterile supplies at specified intervals.

(3) Use of disposable equipment.

History

Authority: The provisions of this Chapter 567 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 567 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

Chapter 569 Fire and Safety Services

28 Pa. Code § 569.1 Principle.

The ASF shall have an organized fire, safety and disaster program under the direction and supervision of one or more persons qualified to implement the program.

History

Authority: The provisions of this Chapter 569 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 569 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 569.2 Fire safety standards.

(a) An ASF shall meet the applicable edition of National Fire Protection Association 101 Life Safety Code, which is currently adopted by the Department.

(b) An ASF previously in compliance with prior editions of the Life Safety Code, is deemed in compliance with subsequent Life Safety Codes, except renovation or new construction shall meet the current edition adopted by the Department.

The provisions of this § 569.2 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256594).

This section cited in 28 Pa. Code § 571.2 (relating to modifications to HHS requirements).

History

Authority: The provisions of this Chapter 569 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 569 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 569.3 Policies and procedures.

Written policies and procedures for use in preventing and responding to fire and disaster shall be available to personnel.

History

Authority: The provisions of this Chapter 569 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 569 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 569.11 Firefighting service.

The person in charge of the ASF shall establish a workable plan with the nearest fire department for fire- fighting service. The ASF shall provide the fire department with a current floor plan of the building showing the location of firefighting equipment, exits, patient rooms, storage places of flammable and information that the fire department requires or as may be necessary.

The provisions of this § 569.11 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256594).

History

Authority: The provisions of this Chapter 569 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 569 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 569.12 Fire warning and safety systems.

An ASF shall have an automatic and manually activated fire alarm system installed to transmit an alarm automatically to the fire department by the most direct and reliable method approved by local ordinances.

History

Authority: The provisions of this Chapter 569 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 569 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 569.13 Testing fire warning systems.

Fire safety systems, including automatic fire extinguishing systems, automatic and manual alarms, stand-pipes and hose reels shall be of an approved type. They shall be kept in good operating condition and inspected by qualified ASF personnel at least every 3 months. Records of the inspections shall be kept on file for the licensure period.

History

Authority: The provisions of this Chapter 569 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 569 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 569.14 Internal disaster and fire plans.

The ASF shall have an internal disaster and fire plan incorporating evacuation procedures and the safety of both closed records and the records of those patients being evacuated. These plans shall be made available to personnel and evacuation diagrams shall be posted throughout the ASF.

History

Authority: The provisions of this Chapter 569 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 569 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 569.15 Safety education program.

Employes shall participate in the safety program and perform the duties delegated to them and be instructed in the operation of the fire warning system, the proper use of fire fighting equipment and the procedure to follow if electric power is impaired.

History

Authority: The provisions of this Chapter 569 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 569 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 569.21 Fire drills.

(a) Fire, internal disaster and evacuation drills shall be held at least quarterly for ASF personnel and under varied conditions.

(b) The CEO shall:

(1) Ensure that all personnel are trained to perform assigned duties.

(2) Ensure that all personnel are familiar with the use and operation of the firefighting equipment in the ASF.

(3) Enable the chief executive officer to evaluate the effectiveness of the plan.

(d) The actual evacuation of patients to safe areas during a drill is optional.

The provisions of this § 569.21 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256595).

History

Authority: The provisions of this Chapter 569 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 569 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 569.31 Emergency power.

History

Authority: The provisions of this Chapter 569 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 569 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 569.32 Fire inspection.

The ASF shall request an annual inspection by its local fire department.

History

Authority: The provisions of this Chapter 569 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 569 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 569.33 Smoking.

Smoking is not permitted in an ASF.

The provisions of this § 569.33 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256596).

History

Authority: The provisions of this Chapter 569 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 569 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 569.34 Electrical safety.

Appliances, instruments and installations shall be tested before use to determine compliance with grounding, current leakage and other device safety requirements to ensure protection of patients and employes. A program of routine maintenance shall be effectively enforced to ensure that electrical receptacles and plugs, wires and connectors are safe. If an appliance requiring three-wire circuitry for grounding is attached to a two-wire outlet, the adaptor plug pigtail shall be attached to a ground.

History

Authority: The provisions of this Chapter 569 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 569 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 569.35 General safety precautions.

The following safety precautions shall be met:

(1) Doorways, corridors and stairwells shall be properly lighted and free of obstructions.

(2) Doors into patient rooms may not be locked.

(3) Exit doors may not be locked from the inside while patients are in the ASF.

(4) Doors opening to shafts shall be equipped with self-closing devices and positive latches.

(5) Wastebaskets, cubicle curtains, window shades and drapes shall be rendered flame retardant.

(6) Call bells in the shower, tub room or water closet shall be easily accessible to patients.

(7) Only nonflammable agents may be present in a surgical suite.

The provisions of this § 569.35 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256596).

History

Authority: The provisions of this Chapter 569 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 569 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 569.36 Safety devices.

The following safety devices shall be provided:

(1) Grab bars within reaching distance on at least one side of toilets, bathtubs and showers used by patients.

(2) Bedside rails on both sides of a bed for use when the condition of the patient warrants.

History

Authority: The provisions of this Chapter 569 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 569 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 569.37 Report of emergencies causing interruption of service.

(a) The person in charge of the ASF shall make a report of any emergency, such as a strike, fire or natural disaster which significantly interrupts or alters ASF services and threatens the health and safety of patients, and which requires one of the following:

(1) The services of a fire department.

(2) The evacuation of a patient.

(3) The use of nonmedical emergency equipment.

(b) The report made under subsection (a) shall be submitted to the Director of the Division of Hospitals of the Department as soon as possible, and shall include the following information:

(1) Time, date, cause, location and nature of emergency.

(2) Number of patients evacuated.

(3) Loss of life and name of a deceased patient.

(4) Names of patients sent to other facilities and names of the facilities.

(5) Assistance required from the Health Department to protect the health and safety of the patients.

(c) Oral reports shall be followed by a complete written report verifying the information in subsection (b). The written report shall be dated and shall be authenticated by the person in charge.

History

Authority: The provisions of this Chapter 569 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 569 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

Chapter 571 Construction Standards

28 Pa. Code § 571.1 Minimum standards.

ASF construction shall be in accordance with the latest edition of the ‘‘Guidelines for Design and Construction of Hospital and Health Care Facilities,’’ as published by the American Institute of Architects/Academy of Architecture for Health including those guidelines established for various outpatient facilities. In the alternative, a facility shall meet the construction guidelines for specified types of surgical procedures as listed in Appendix A (relating to alternative construction guidelines). Where renovation or replacement work is performed within an existing facility, all new work or additions shall comply with the requirements for new construction.

The provisions of this § 571.1 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256599).

History

Authority: The provisions of this Chapter 571 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 571 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 571.2 Modifications to HHS requirements.

(a) Life Safety Code means the standard as defined in § 569.2 (relating to fire safety standards).

(b) Adequate storage areas shall be provided to meet the needs of the facility.

(d) In multistory buildings, where the ASF may be provided on floors other than at grade level, at least one hospital type elevator shall be provided.

(e) Elevators shall conform to ‘‘HHS Requirements’’ and the latest edition of the ‘‘American National Standard Safety Code for Elevators, Dumbwaiters, Escalators and Moving Stairs.’’

(f) The Americans with Disabilities Act of 1990 (ADA) (42 U.S.C.A. § § 12101—12213).

The provisions of this § 571.2 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256600).

History

Authority: The provisions of this Chapter 571 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 571 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 571.11 Principle.

Plans and specifications shall be submitted to the Division of Safety Inspection of the Department for approval prior to construction of an ASF, in accordance with § 51.5 (relating to building occupancy). Submission shall be in three stages.

The provisions of this § 571.11 amended October 22, 1999, effective November 22, 1999, 29 Pa.B. 5583. Immediately preceding text appears at serial page (256600).

History

Authority: The provisions of this Chapter 571 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 571 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

28 Pa. Code § 571.12 Submission stages.

(a) First stage. One copy of the narrative description and one copy of the schematic drawings shall be provided.

(1) Program narrative.

(i) List in outline form the rooms or spaces to be included in each department, explaining the functions or services to be provided in each, indicating the approximate size, the number of personnel and the kind of equipment or furniture it will contain. Note special or unusual services or equipment to be included in the facility.

(ii) Give an outline of construction materials.

(2) Schematic plans.

(i) Single line drawings of each floor shall show the relationship of the various departments or services to each other and the room arrangement in each department. The name of each room shall be noted. The proposed roads and walks, service and entrance courts, parking and orientation may be shown on either a small plot plan or the first floor plan. A simple vertical space diagram shall be submitted at this stage.

(ii) If the project is an addition or is otherwise related to existing buildings on the site, the plans shall show the facilities and general arrangement of those buildings.

(b) Second stage. Two copies of the preliminary plans shall be provided.

(1) Architectural.

(i) One-eighth inch scale floor plans of basement, floors and roof showing space assignment, sizes and outline of fixed and movable equipment.

(ii) Elevations and typical wall sections.

(iii) Plot plan showing roads, parking and sidewalks.

(2) Mechanical.

(i) Single line layouts of duct and piping systems which include air rates for determining pressure relationships.

(ii) Riser diagrams for multi-story construction.

(3) Electrical.

(i) Plans showing space assignment, sizes and outline of fixed equipment, such as transformers, main switch and switchboards and generator sets.

(ii) Simple riser diagram for multi-story building construction showing arrangement of feeders, subfeeders, bus work, load centers and branch circuit panels.

(c) Third stage—contract documents. Four sets of drawings shall be provided, complete and adequate for bid contract and construction purposes. Drawings shall be prepared for each of the following branches of work: architectural, structural, mechanical and electrical.

(1) Drawings may be no less than 1/8 inch scale and show indications of fixed and movable equipment.

(2) If necessary, 1/4 inch scale drawing shall be included.

(3) Fire-rated assemblies, such as U.L., Factory Mutual and the like—shall be included on the drawings.

(4) Specifications shall supplement the drawings to fully describe the types, sizes, capacities, workmanship, finishes and other characteristics of materials and equipment.

History

Authority: The provisions of this Chapter 571 issued under Chapter 8 of the Health Care Facilities Act (35 P.
Source: The provisions of this Chapter 571 adopted January 23, 1987, effective March 25, 1987, 17 Pa.

Subpart G Home Health Care Agencies

Chapter 601 Home Health Care Agencies

28 Pa. Code § 601.1 Legal base.

(a) This subpart is promulgated by the Department under the powers granted and the duties mandated by Chapter 8 of the act (35 P.S. § § 448.801a—448.820).

(b) The Department has the power and its duty is to promulgate, after consultation with the Health Care Policy Board, the regulations necessary to implement the provisions and purpose of Chapter 8 of the act (35 P.S. § § 448.801a—448.820) and to assure that its regulations and the act are enforced.

(c) The purpose of this subpart is to protect and promote the public health and welfare through the establishment and enforcement of regulations setting minimum standards in the construction, maintenance and operation of home health care agencies. The standards are intended by the Department to assure safe, adequate and efficient home health care agencies and services, and to promote the health, safety and adequate care of the patients of the home health care agencies. It is also the purpose of this subpart to assure quality health care through appropriate and nonduplicative review and inspection with regard to the protection of the health and rights of privacy of patients and without unreasonably interfering with the operation of the home health care agency.

History

Source: The provisions of this § 601.

28 Pa. Code § 601.2 Affected home health care agencies.

(a) This subpart applies to home health care agencies, profit or nonprofit, operated in this Commonwealth, as defined in this subpart.

(b) Existing home health care agencies which were home health care agencies prior to April 23, 1987 shall be required to meet the same standards as home health care agencies created after April 23, 1987 unless an exception is granted by the Department under § 601.5 (relating to exceptions).

(c) A home health care agency certified to participate in the Medicare program shall be deemed to comply with and satisfy this subpart upon compliance with § 601.11(a)—(c) (relating to licensure process).

History

Source: The provisions of this § 601.

28 Pa. Code § 601.3 Requirements for home health care agencies.

(a) A current copy of this subpart shall be maintained at the home health care agency.

(b) Home health care agencies licensed under this subpart shall comply with applicable environmental, health, sanitation and professional licensure standards which are required by Federal, State and local authorities. This includes, but is not limited to, standards promulgated by the State Boards of Medicine, Nursing, Pharmacy, Physical Therapy Examiners—49 Pa. Code Chapters 16—18, 21, 27 and 40—and the Occupational Therapy Practice Act (63 P. S. § § 1501—1519). Home health care agencies shall also comply with Chapter 27 (relating to communicable and noncommunicable diseases) and Chapter 25 (relating to controlled substances, drugs, devices and cosmetics).

(c) If there is a difference in applicable State or local standards, the standards established under State statutes apply for the purpose of compliance with this subpart.

History

Source: The provisions of this § 601.

28 Pa. Code § 601.4 Inspections.

The home health care agency shall be subject to inspection at any time by authorized representatives of the Department. Inspections may be scheduled in advance or be unannounced.

History

Source: The provisions of this § 601.

28 Pa. Code § 601.5 Exceptions.

The Department may grant an exception to the standards and this subpart when the policy objective of the standards and this subpart is met in existing home health care agencies. The exception shall be requested in writing and be made by the home health care agency. The reason for granting the exceptions and the time period for the exceptions shall be made in writing by the Department, and incorporated as part of the permanent record of the home health care agency maintained on file in the Department.

This section cited in 28 Pa. Code § 601.2 (relating to affected home health care agencies).

History

Source: The provisions of this § 601.

28 Pa. Code § 601.6 Definitions.

The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise: Act—The Health Care Facilities Act (35 P. S. § § 448.101—448.904). Administrator—A person who performs the functions as outlined in § 601.21(d) (relating to organization, services and administration) and is one of the following:

(i) A licensed physician.

(ii) A registered nurse.

(iii) Has training and experience in health service administration and at least 1 year of supervisory or administrative experience in home health care or related health programs. Agency—An administrative unit that is responsible financially and legally. Bylaws—A set of rules adopted by a home health care agency for governing the agency’s operation. Branch office—A location or site from which a home health care agency provides services within a portion of the total geographic area served by the parent agency. The term includes an office that is part of the home health care agency and is sufficiently accessible to share administration, supervision and services in a manner that renders it unnecessary for the branch independently to meet the requirements of this subpart as a home health care agency. Clinical note—A dated written notation by a member of the health team, of a single contact with a patient, containing a description of signs and symptoms, treatment or drug given, the patient’s reaction and changes in physical or emotional condition. Department—The Department of Health of the Commonwealth. Health team—Persons associated with the agency and assigned to a particular patient to provide services. Home health aide—A nonprofessional person who has completed a minimum of 60 hours of classroom instruction prior to or during the first 3 months of employment. The term includes aides who are carefully trained in methods of assisting patients to achieve maximum self-reliance, principles of nutrition and meal preparation, the aging process and emotional problems of illness, changes in patient’s condition that should be reported, work of the agency and the health team, ethics, confidentiality and record keeping. Home health care agency—An organization or part thereof staffed and equipped to provide skilled nursing and at least one therapeutic service—physical therapy, occupational therapy, speech pathology, medical social services or home health aides—to disabled, aged, injured or sick persons on a part-time or intermittent basis in their place of residence. The term includes an agency that also provides other health-related services to protect and maintain persons in their own homes. Licensed practical nurse—A practical nurse who holds a current and valid license to practice in this Commonwealth under the Practical Nurse Law (63 P. S. § § 651—667). Occupational therapist—A person who is currently licensed as an occupational therapist in this Commonwealth under the Occupational Therapy Act (63 P. S. § § 1501—1519). Occupational therapy assistant—A person who is currently licensed as an occupational therapy assistant in this Commonwealth under the Occupational Therapy Practice Act (63 P. S. § § 1501—1519). Parent home health care agency—The agency that develops and maintains administrative control of subunits or branch offices. The term includes a subdivision which has subunits or branches. Part-time intermittent service—Services which are provided for less than 8 hours a day or less than 40 hours a week. Pharmacist—A person who is currently licensed as a pharmacist in this Commonwealth under the Pharmacy Act (63 P. S. § § 390-1—390-13). Physical therapist—A person who is currently licensed as a physical therapist in this Commonwealth under the Physical Therapy Practice Act (63 P. S. § § 1301—1312). Physical therapist assistant—A person who is currently registered as a physical therapist assistant in this Commonwealth under the Physical Therapy Practice Act (63 P. S. § § 1301—1312). Physician—A Doctor of Medicine or Doctor of Osteopathy who holds a current and valid license to practice in this Commonwealth. Primary home health care agency—The agency that is responsible for the service rendered to patients and for implementation of the plan of treatment. Progress note—A dated, written notation by a member of the health team summarizing facts about care and the patient’s response during a given period of time. Registered nurse—A person licensed to practice professional nursing under The Professional Nursing Law (63 P. S. § § 211—225). Secretary—The Secretary of the Department. Skilled nursing service—High intensity comprehensive, planned service provided with maximum efficiency by a registered professional nurse in instances where judgment is required, or by a licensed practical nurse under the supervision of a registered nurse. Social work assistant—A person who has a baccalaureate degree in social work, psychology, sociology or other field related to social work, or 2 years of social work experience in a health care setting. Social worker—A person who has a master’s degree from a school of social work accredited by the Council on Social Work Education, and has 1 year of social work experience in a health care setting. Speech pathologist/audiologist—A person who meets one of the following:

(i) The education and experience requirements for a Certificate of Clinical Competence in the appropriate area—speech pathology or audiology—granted by the American Speech and Hearing Association.

(ii) The educational requirements for certification and is in the process of accumulating the supervised experience required for certification. Subdivision—A component of a multi-function health agency, such as the home care department of a hospital or the nursing division of a health department, which independently meets the requirements of this subpart for home health care agencies. Subunit—A semi-autonomous organization, which serves patients in a geographic area different from that of the parent agency. Summary report—A compilation of the pertinent factors from the clinical notes and progress notes regarding a patient, which is submitted as to the patient’s physician.

History

Source: The provisions of this § 601.

28 Pa. Code § 601.7 Ownership.

(a) The owner of a home health care agency may be an individual, partnership, association, corporation or a combination thereof. The following apply to home health care agencies according to the mode of ownership:

(1) Individual ownership. A complete list of names and addresses of the owners of the home health care agency shall be submitted with the application. When death occurs to a person who was a sole owner of a home health care agency, the executor or administrator of the estate may apply for, and the Department may, after review, transfer a license for the home health care agency.

(2) Partnerships. A complete list of names and addresses of the owners of the home health care agency, general partners and partners responsible for the management of the home health care agency shall be submitted with the application. When a license is issued to a partnership and one or more of the partners dies, the executor or administrator of the deceased’s estate, together with the surviving partners may apply for a license. After review, the Department may transfer the license.

(b) The Department shall be notified in writing within 30 days whenever a change in the partners, officers, directors, principal stockholders or persons in charge of a home health care agency owned by a partnership or corporation has taken place.

History

Source: The provisions of this § 601.

28 Pa. Code § 601.11 Licensure process.

(a) The application form for a license to operate a home health care agency shall be obtained from the Pennsylvania Department of Health, Division of Primary Care and Home Health Services, Post Office Box 90, Harrisburg, Pennsylvania 17108.

(b) Application or renewal forms shall be accompanied by a fee of $50.

(c) The home health care agency shall report yearly to the Department, on forms issued by the Department, statistical information the Department may request.

(d) Home health care agencies certified as providers by the Department to the Federal government for purposes of the Medicare program shall be deemed to comply with this subpart upon compliance with subsections (a)—(c).

This section cited in 28 Pa. Code § 601.2 (relating to affected home health care agencies).

History

Source: The provisions of this § 601.

28 Pa. Code § 601.12 Issuance of license.

(a) The Department will issue a regular license to operate a home health care agency after a survey conducted by the Department indicates that the applicant is in substantial compliance with this subpart. The survey may include an onsite inspection.

(b) A regular license issued by the Department shall expire 1 year from the date of issue.

(c) A provisional license may be issued when there are numerous deficiencies or a serious specific deficiency, which has a substantial impact on governance and management or services, which indicates that the home health care agency is not in compliance with applicable statutes, ordinances or this title, and the Department finds that:

(1) The applicant is taking appropriate steps to correct the deficiencies in accordance with a timetable submitted by the applicant and agreed upon by the Department.

(2) There is no pattern of deficiencies over a period of 2 or more years.

(3) There is no danger to the health or safety of the patients of the home health care agency.

(d) The Department may issue a provisional license for a specific period of not more than 6 months. A provisional license may be renewed three times.

(e) The current license shall be posted in a conspicuous place in the home health care agency.

History

Source: The provisions of this § 601.

28 Pa. Code § 601.13 Responsibility of home health care agency owners.

(a) The owner shall be responsible for meeting the minimum standards for operation of a home health care agency as set forth by the Department and by other State and local agencies responsible for the health, welfare and safety of the patients.

(b) When services for the administration or management of the home health care agency or for the provision of patient care are purchased, the owner shall be responsible for insuring compliance with this title and regulations of other appropriate agencies.

(c) The owner, administrator or designee shall immediately report, by telephone to the Department and by a written follow-up report as soon as possible, a catastrophic incident, such as a fire or flood, or an incident which may cause interruption or cessation of the delivery of services, or another interruption of home health care agency services which would affect the health and safety of the patients.

History

Source: The provisions of this § 601.

28 Pa. Code § 601.14 Reasons for revocation or nonrenewal of license.

(a) Departmental refusals. The Department may refuse to renew a license, may suspend, revoke or limit a license of a home health care agency or may suspend admissions for any of the following reasons:

(1) A serious violation of this subpart, the act or of other statutes and regulations, which seriously threatens the health, safety and welfare of patients.

(2) Failure of an owner to submit a reasonable timetable for correction of deficiencies.

(3) The existence of a pattern of cyclical deficiencies which extends over a period of 2 or more years.

(4) Failure, by the holder of a provisional license, to correct deficiences in accordance with a timetable submitted by the applicant and agreed upon by the Department.

(5) Fraud or deceit in obtaining or attempting to obtain a license.

(6) Lending, borrowing or using the license of another, or knowingly aiding or abetting the improper granting of a license.

(7) Incompetence, negligence or misconduct in operating the home health care agency or in providing services to individuals.

(8) Mistreating or abusing individuals cared for by the home health care agency.

(9) Serious violation of the statutes relating to Medical Assistance or Medicare reimbursement.

(b) Notice. Whenever the Department proposes to revoke a license, refuse to issue a license, issue a provisional license or suspend admissions, it will give written notice to the home health care agency by certified mail.

(c) Form of notice. Notice under subsection (b) will conform to 1 Pa. Code § 35.14 (relating to orders to show cause). The order will specify the reasons for the proposed action of the Department and will notify the home health care agency of its right to a hearing before the State Health Facility Hearing Board. The order will specify the time within which the request of the home health care agency shall be filed with the Board.

(d) Correction of deficiency. Whenever a home health care agency notifies the Department that it has completed a plan of correction and corrected its deficiencies, the Department will conduct a survey to ascertain completion of the plan of correction. Upon finding full or substantial compliance, the Department will issue a regular license.

(e) Appeal. A final order or determination by the Department relating to licensure may be appealed to the State Health Facility Hearing Board under section 805 of the act (35 P. S. § 448.805). Administrative proceedings will be conducted under the State Health Facility Hearing Board rules of practice and procedure at 37 Pa. Code Chapter 197 (relating to practice and procedure).

(f) Practice and procedure. Subsection (c) supplements 1 Pa. Code § 35.14.

History

Source: The provisions of this § 601.

28 Pa. Code § 601.21 Organization, services and administration.

(a) Writing requirements. Organization, services provided, administrative control and lines of authority for the delegation of responsibility to the patient care level shall be clearly set forth in writing and shall be readily identifiable. Administrative and supervisory functions may not be delegated to another agency or organization and services not provided directly shall be monitored and controlled by the primary agency, including services provided through subunits of the parent agency. If an agency has subunits, appropriate administrative records shall be maintained for each subunit. The subunit, by virtue of the lack of accessibility between it and the parent agency, is judged incapable of sharing administration, supervision and services on a daily basis with the parent agency and shall independently meet this subpart.

(b) Services provided. Part-time or intermittent skilled nursing services and at least one other therapeutic service—physical therapy, occupational therapy, speech pathology, medical social services or home health aides—shall be made available on a visiting basis, in a place of residence used as a patient’s home. A home health care agency shall provide at least one of the qualifying services directly through agency employes, but may provide, by written contract, the second qualifying service and additional services under arrangements with another agency or organization.

(c) Governing body. A governing body or designated persons so functioning shall assume full legal authority and responsibility for the operation of the agency. The governing body shall appoint a qualified administrator, arrange for professional advice—see § 601.22 (relating to agency evaluation and review)—adopt and periodically review written bylaws, and oversee the management and fiscal affairs of the agency.

(d) Administrator. The administrator, who may also be the supervising physician or registered nurse—see subsection (e)—shall organize and direct the agency’s ongoing functions; maintain ongoing liaison among the governing body, the group of professional personnel and the staff, employ qualified personnel and ensure adequate staff education and evaluations; ensure the accuracy of public information materials and activities; and implement an effective budgeting and accounting system. A qualified person shall be authorized in writing to act in the absence of the administrator.

(e) Supervising physician or registered nurse. The skilled nursing and other therapeutic services provided shall be under the supervision and direction of a physician or a registered nurse with at least 1 year of nursing experience. This person, or a similarly qualified alternate, shall be available at all times during the operating hours and participate in activities relevant to the professional services provided, including the development of qualifications and assignments of personnel.

(f) Personnel policies. Personnel practices shall be supported by appropriate, written personnel policies. Personnel records shall include job descriptions, qualifications, licensure, performance evaluations, health examinations and documentation of orientation provided. Records shall be kept current.

(g) Civil rights. Home health care agencies shall comply with the Pennsylvania Human Relations Act (43 P. S. § § 951—963) and 16 Pa. Code Part II, Subpart A (relating to the Human Relations Commission).

(h) Coordination of patient services. Personnel providing services shall maintain liaison to assure their efforts effectively complement one another and support the objectives outlined in the plan of treatment. The clinical record or minutes of case conferences shall establish that effective interchange, reporting and coordinated patient evaluation does occur. A written summary report for each patient shall be sent to the attending physician at least every 60 days.

(i) Institutional planning. The home health care agency, under the direction of the governing body, and in conjunction with representatives of the administrative and health professional staff, shall prepare an overall plan and budget.

This section cited in 28 Pa. Code § 601.6 (relating to definitions).

History

Source: The provisions of this § 601.

28 Pa. Code § 601.22 Agency evaluation and review.

(a) Annual policy review. Professional personnel, which include at least one physician and one registered nurse with appropriate representation from other professional disciplines, shall establish and annually review the agency’s policies governing scope of services offered, admission and discharge policies, medical supervision and plans of treatment, emergency scope of services offered, medical care, clinical records, personnel qualifications and program evaluation.

(b) Advisory and evaluation function. The group of professional personnel shall meet at least annually to advise the agency on professional issues, to participate in the evaluation of the agency’s program and to assist the agency in maintaining liaison with other health care providers in the community and in its community information program. Its meetings shall be documented by dated minutes.

(c) Annual program evaluation. The home health care agency shall have written policies requiring an overall evaluation of the agency’s total program at least once a year by the group of professional personnel or a committee of this group, home health care agency staff and consumers; or by professional people outside the agency working in conjunction with consumers. The evaluation shall consist of an overall policy and administrative review and a clinical record review. The evaluation shall assess the extent to which the agency’s program is appropriate, adequate, effective and efficient. Results of the evaluation shall be reported to and acted upon by those responsible for the operation of the agency and shall be maintained separately as administrative records. As a part of the evaluation process, the policies and administrative practices of the agency shall be reviewed to determine the extent to which they promote patient care that is appropriate, adequate, effective and efficient. Mechanisms shall be established in writing for the collection of pertinent data to assist in evaluation. The data to be considered may include, but are not limited to: Number of patients receiving each service offered, number of patient visits, reasons for discharge, breakdown by diagnosis, sources of referral, number of patients not accepted with reasons and total staff days for each service offered.

(d) Clinical record review. At least quarterly, appropriate health professionals, representing at least the scope of the program, shall review a sample of both active and closed clinical records to assure that established policies are followed in providing services—direct services as well as services under arrangement. There shall be a continuing review of clinical records for each 60-day period that a patient receives home health care services to determine adequacy of the plan of treatment and appropriateness of continuation of care.

This section cited in 28 Pa. Code § 601.21 (relating to organization, services and administration).

History

Source: The provisions of this § 601.

28 Pa. Code § 601.31 Acceptance of patients, plan of treatment and medical supervision.

(a) Patient acceptance. Patients shall be accepted for treatment on the basis of a reasonable expectation that the patient’s medical, nursing and social needs can be met adequately by the agency in the patient’s place of residence. Patient care shall follow a written plan of treatment established and periodically reviewed by the attending physician, and patient care shall continue under the supervision of the attending physician.

(b) Plan of treatment. The plan of treatment shall be developed in consultation with the agency staff and shall cover pertinent diagnoses, including mental status, types of services and equipment required, frequency of visits, prognosis, rehabilitation potential, functional limitations, activities permitted, nutritional requirements, medications and treatments, safety measures to protect against injury, instructions for timely discharge or referral and other appropriate items. If an attending physician refers a patient under a plan of treatment which cannot be completed until after an evaluation visit, the attending physician shall be consulted to approve additions or modifications to the original plan. Orders for therapy services shall include the specific procedures and modalities to be used and the amount, frequency and duration of the procedures and modalities. The therapist and other agency personnel shall participate in developing the plan of treatment.

(c) Periodic review of plan of treatment. The total plan of treatment shall be reviewed by the attending physician and home health care agency personnel as often as the severity of the patient’s condition requires, but at least once every 60 days. Agency professional staff shall promptly alert the physician to changes that suggest a need to alter the plan of treatment.

(d) Conformance with physician’s orders. Prescriptions and nonprescription (over-the-counter) drugs, devices, medications and treatments, shall be administered by agency staff in accordance with the written orders of the physician. Prescription drugs and devices shall be prescribed by a licensed physician. Only licensed pharmacists shall dispense drugs and devices. Licensed physicians may dispense drugs and devices to the patients who are in their care. The licensed nurse or other individual, who is authorized by appropriate statutes and the State Boards in the Bureau of Professional and Occupational Affairs, shall immediately record and sign oral orders and obtain the physician’s countersignature within 7 days. Agency staff shall check medicines a patient may be taking to identify possibly ineffective drug therapy or adverse reactions, significant side effects, drug allergies, and contraindicated medication, and shall promptly report problems to the physician.

The provisions of this § 601.31 corrected February 13, 1987, effective April 23, 1987, 17 Pa.B. 718. Immediately preceding text appears at serial pages (113300) to (113301).

This section cited in 28 Pa. Code § 601.36 (relating to clinical records); and 49 Pa. Code § 42.25 (relating to orders).

History

Source: The provisions of this § 601.

28 Pa. Code § 601.32 Skilled nursing service.

(a) Supervision. The home health care agency shall provide skilled nursing services by or under the supervision of a registered nurse and in accordance with the plan of treatment.

(b) Duties of the registered nurse. The registered nurse shall make the initial evaluation visit, regularly reevaluate the patient’s nursing needs, initiate the plan of treatment and necessary revisions, provide services requiring substantial specialized nursing skill, intitiate appropriate preventive and rehabilitative nursing procedures, prepare clinical and progress notes, coordinate services, inform the physician and other personnel of changes in the patient’s condition and needs, counsel the patient and family in meeting nursing and related needs, participate in inservice programs and supervise and teach other nursing personnel.

(c) Duties of the licensed practical nurse. The licensed practical nurse shall provide services in accordance with agency policies, prepare clinical and progress notes, assist the physician or registered nurse in performing specialized procedures, prepare equipment and materials for treatments observing aseptic technique as required and assist the patient in learning appropriate self-care techniques.

History

Source: The provisions of this § 601.

28 Pa. Code § 601.33 Therapy services.

(a) Qualified therapists. Therapy services offered by the home health care agency directly or under arrangement shall be given by a qualified therapist or by a qualified therapist assistant under the supervision of a qualified therapist in accordance with the plan of treatment. The qualified therapist shall assist the physician in evaluating level of function, help develop the plan of treatment—revising as necessary—prepared clinical and progress notes, advise and consult with the family and other agency personnel and participate in inservice programs.

(b) Supervision of occupational therapy assistant. Services provided by a qualified occupational therapy assistant may be furnished under the supervision of a qualified occupational therapist.

(c) Supervision of speech therapy services. Speech therapy services shall be provided only by or under supervision of a qualified speech pathologist or audiologist.

History

Source: The provisions of this § 601.

28 Pa. Code § 601.34 Medical and social services.

Medical social services, when provided, shall be given by a qualified social worker or by a qualified social work assistant under the supervision of a qualified social worker, and in accordance with the plan of treatment. The social worker shall assist the physician and other team members in understanding the significant social and emotional factors related to the health problems, participate in the development of the plan of treatment, prepare clinical and progress notes, work with the family, utilize appropriate community resources, participate in discharge planning and inservice programs and act as a consultant to other agency personnel.

History

Source: The provisions of this § 601.

28 Pa. Code § 601.35 Home health aide services.

(a) Selection of aides. Home health aides shall be selected on the basis of such factors as a sympathetic attitude toward the care of the sick, ability to carry out directions, maturity and ability to deal effectively with the demands of the job. Aides shall be carefully trained in methods of assisting patients to achieve maximum self-reliance, principles of nutrition and meal preparation, the aging process and emotional problems of illness, procedures for maintaining a clean, healthful and pleasant environment, changes in patient’s condition that should be reported, work of the agency and the health team, ethics, confidentiality and recordkeeping. They shall be closely supervised to assure their competence in providing care.

(b) Assignment and duties of the home health aide. The home health aide shall be assigned to a particular patient by a registered nurse. Written instructions for patient care shall be prepared by a registered nurse or therapist as appropriate. Duties shall include the performance of simple procedures as an extension of therapy services, personal care, ambulation and exercise, household services essential to health care at home, assistance with medications that are ordinarily self-administered, reporting changes in the patient’s conditions and needs and completing appropriate records.

(c) Supervision. The registered nurse, or appropriate professional staff member, if other services are provided, shall make a supervisory visit to the patient’s residence at least every 2 weeks, either when the aide is present to observe and assist, or when the aide is absent, to assess relationships and determine whether goals are being met.

History

Source: The provisions of this § 601.

28 Pa. Code § 601.36 Clinical records.

(a) Maintenance and content of records. A clinical record containing pertinent past and current findings in accordance with accepted professional standards shall be maintained for every patient receiving home health care services. In addition to the plan of treatment—see § 601.31(b) (relating to acceptance of patients, plan of treatment and medical supervision)—the record shall contain appropriate identifying information; name of physician; drug and dietary treatment; activity orders; signed and dated clinical and progress notes by the individual who delivered the service—clinical notes are written the day service is rendered and incorporated into the clinical record no less often than weekly; copies of summary reports sent to the physician; and a discharge summary.

(b) Retention of records. Clinical records shall be retained for 7 years after discharge of the patient. Policies shall provide for retention even if the home health care agency discontinues operations. If the patient is transferred to another home health care agency, a copy of the record or abstract shall accompany the patient.

(c) Protection of records. Information contained in the patient’s record shall be privileged and confidential. Clinical record information shall be safeguarded against loss or unauthorized use. Written procedures shall govern use and removal of records and conditions for release of information. The patient’s written consent shall be required for release of information outside the home health care agency, except as otherwise provided by law or third-party contractual arrangements.

History

Source: The provisions of this § 601.

Subpart H Home Care Agencies and Home Care Registries

Chapter 611 Home Care Agencies and Home Care Registries

28 Pa. Code § 611.1 Legal base.

(a) This chapter is promulgated by the Department under the powers granted and the duties mandated under sections 803 and 809.1 of the act (35 P.S. § § 448.803 and 448.804a).

(b) The Department has the power and its duty is to promulgate the regulations necessary to implement the provisions of Chapter 8 of the act (35 P.S. § § 448.801a—448.820) and to assure that its regulations and the act are enforced.

(c) The purpose of this chapter is to protect and promote the public health and welfare through the establishment and enforcement of regulations setting minimum standards for the operation of home care agencies and home care registries. The standards are intended by the Department to assure safe, adequate and efficient home care agencies and home care registries, and to promote the health, safety and adequate care of the consumers of services provided by home care agencies and home care registries.

28 Pa. Code § 611.2 License required.

(a) Except as set forth in subsection (c), no entity or organization may operate, maintain, or hold itself out as operating or maintaining a home care agency or home care registry without first having obtained a license from the Department in accordance with this chapter. Each physical location of the home care agency or home care registry must be separately licensed. The Department will conduct an inspection prior to issuing an initial license or a license renewal.

(b) The license will specify whether the entity is licensed as a home care agency, a home care registry, or both, the term of the license, and any conditions or limitations imposed on the license.

(c) An entity operating a home care agency or home care registry, or both, as of December 12, 2009, may continue to operate after December 12, 2009, provided it submits an application for a license to the Department in accordance with instructions published in the Pennsylvania Bulletin and posted on the Department’s web site by February 10, 2010. An entity that has submitted an application for licensure in accordance with the requirements of this subsection may continue to operate the home care agency or home care registry until a date that the Department may refuse the application for licensure. If the Department grants the application for licensure, the home care agency or home care registry may continue operation of the agency or registry in accordance with this chapter.

(d) The applicant shall obtain the application for a license to operate a home care agency or home care registry from the Department of Health, Division of Home Health.

(e) The applicant shall submit an application or renewal form to the Department with the fee of $100. The applicant shall submit a renewal form at least 60 days prior to the expiration date on the license. There will be no rebate, refund, or prorating of the application fee. The applicant shall complete a separate application and pay a separate application fee for each separately licensed home care agency or home care registry that it intends to operate.

(f) The applicant shall specify on its application the type of facility for which it is seeking a license.

28 Pa. Code § 611.3 Affected home care agencies and home care registries.

(a) This chapter applies to home care agencies, home care registries and to entities that meet both definitions, profit or nonprofit, operated in this Commonwealth, as defined in this chapter. This chapter does not apply to a home health care agency, a durable medical equipment provider, a volunteer provider, or an organization or business entity designated under section 3504 of the Internal Revenue Code (26 U.S.C.A. § 3504) regarding acts to be performed by agents and either IRS revenue procedure 70-6 or IRS revenue procedure 80-4, that provides financial management services or supports coordination services, or both, to consumers of home and community-based services through Medicaid Waiver or other publicly funded programs.

(b) Existing home care agencies and home care registries which were home care agencies or home care registries prior to December 12, 2009, shall be required to meet the same standards as home care agencies and home care registries created after December 12, 2009.

28 Pa. Code § 611.4 Requirements for home care agencies and home care registries.

(a) A current copy of this chapter shall be maintained at the home care agency or home care registry.

(b) Chapter 51 (relating to general information), applicable to all entities licensed as health care facitilies under the act, applies to home care agencies and home care registries licensed under this chapter.

(c) Home care agencies and home care registries licensed under this chapter shall comply with applicable environmental, health, sanitation and professional licensure standards which are required by Federal, State and local authorities.

(d) If there is a difference in applicable State or local standards, the standards established under State statutes apply for the purpose of compliance with this chapter.

28 Pa. Code § 611.5 Definitions.

The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise: Act—The Health Care Facilities Act (35 P. S. § § 448.101—448.904b). ChildLine—An organizational unit of the Department of Public Welfare which operates a State-wide toll-free system for receiving reports of suspected child abuse established under 23 Pa.C.S. 6332 (relating to establishment of Statewide toll-free telephone number), refers the reports for investigation and maintains the reports in the appropriate file. ChildLine verification—Confirmation regarding whether an applicant for employment or referral by a home care agency or home care registry is named in the Department of Public Welfare’s Statewide Central Register as the perpetrator of a founded or indicated report of child abuse (as defined in 55 Pa. Code § 3490.4 (relating to definitions)). Companionship services—Socialization, support and assistance with instrumental activities of daily living. Consumer—An individual to whom services are provided. Consumer control—Control and direction by the consumer in identifying, exercising choice of, and managing home care services in accordance with the consumer’s needs and personal preferences. Criminal history report—A State Police criminal history record or a Department of Aging letter of determination of eligibility for hire or roster based on a review of a Federal criminal history record. Department—The Department of Health of the Commonwealth. Department of Aging letter of determination—A written decision supplied by the Department of Aging regarding whether, based on the criminal history report from the Federal Bureau of Investigation, the applicant for employment by a home care agency or referral by a home care registry may be employed or rostered. Direct care worker—The individual employed by a home care agency or referred by a home care registry to provide home care services to a consumer. Direct consumer contact—Face-to-face interaction with the consumer in the consumer’s place of residence or other independent living environment. Financial management services—One or more of the following services:

(i) Managing payroll including Federal, State and local employment taxes for direct care workers recruited and retained by the consumer.

(ii) Processing the payment of workers’ compensation, health and other insurance benefits for the direct care worker.

(iii) Assisting consumers in calculating and managing individual budgets for Medicaid Waiver and other publicly funded home and community based services.

(iv) Monitoring the consumer’s spending of public funds and any underage or overage in accordance with the consumer’s approved budget.

(v) Collecting, processing and maintaining time sheets for direct care workers.

(vi) Providing training to consumers related to employer-related tasks (for example, recruiting, hiring, training, managing and discharging direct care workers and managing payroll and bill paying). Home care agency—An organization that supplies, arranges or schedules employees to provide home care services, as directed by the consumer or the consumer’s representative, in the consumer’s place of residence or other independent living environment for which the organization receives a fee, consideration or compensation of any kind. Home care registry—An organization or business entity or part of an organization or business entity that supplies, arranges or refers independent contractors to provide home care services, as directed by the consumer or the consumer’s representative, in the consumer’s place of residence or other independent living environment for which the registry receives a fee, consideration or compensation of any kind. Home care services—The term encompasses the following activities:

(i) Personal care.

(ii) Assistance with instrumental activities of daily living.

(iii) Companionship services.

(iv) Respite care.

(v) Specialized care. Independent living philosophy—A system of beliefs, concepts and attitudes that emphasize self-direction, control, peer support and community integration for individuals with disabilities. Inspection—A scheduled or unscheduled examination or assessment of a home care agency or home care registry during regular business hours, to determine compliance with requirements for licensure using one or more of the following means: inspection of records, interviews with office staff, consumers and direct care workers, and observation of the provision of services to consumers who have consented in advance to observation. Instrumental activities of daily living—As defined in section 802a of the act (35 P.S. § 448.802a). Nurse—A registered nurse or a licensed practical nurse. Personal care—The term includes, but is not limited to, assistance with self-administered medications, feeding, oral, skin and mouth care, shaving, assistance with ambulation, bathing, hair care and grooming, dressing, toileting and transfer activities. Respite care—Personal care and assistance with instrumental activities of daily living provided on a short term basis because of the absence or need for relief for those persons normally providing the services. Roster—To place an individual on a list of individuals eligible to be referred by a home care registry to provide home care services to an individual in the individual’s place of residence or other independent living environment; or the list of individuals eligible to be referred by a home care registry to provide home care services to an individual in the individual’s place of residence or other independent living environment. Specialized care—Nonskilled services unique to the consumer’s care needs that facilitate the consumer’s health, safety and welfare, and ability to live independently. Statewide central register—A register of child abuse established in the Department of Public Welfare, which consists of founded and indicated reports of child abuse. Supports coordination services—Services to consumers of home and community-based services through Medicaid Waiver or other publicly funded programs including intake services, needs assessment, and advocacy to ensure coordination of medical, social, educational and other services and maximum consumer independence.

28 Pa. Code § 611.51 Hiring or rostering of direct care workers.

(a) Hiring or rostering prerequisites. Prior to hiring or rostering a direct care worker, the home care agency or home care registry shall:

(1) Conduct a face-to-face interview with the individual.

(Editor’s Note: Under section 2 of the act of October 16, 2024 (P.L. 977, No. 96) (act), § 611.51(a)(1) is abrogated to the extent of any inconsistency with the act.)

(2) Obtain at least two satisfactory references for the individual. A satisfactory reference is a positive, verifiable reference, either verbal or written, from a former employer or other person not related to the individual that affirms the ability of the individual to provide home care services.

(3) Require the individual to submit a criminal history report, in accordance with § 611.52 (relating to criminal background checks), and a ChildLine verification, if applicable, in accordance with the requirements of § 611.53 (relating to child abuse clearance).

(b) Direct care worker files. Files for direct care workers employed or rostered must include documentation of the date of the face-to-face interview with the individual and of references obtained. Direct care worker files must also include other information as required under § 611.52, § 611.53, and if applicable, § § 611.54, 611.55 and 611.56 (relating to provisional hiring; competency requirements; and health screening).

The provisions of § 611.51(a)(1) abrogated in part under section 2 of the act of October 16, 2024 (P.L. 977, No. 96).

The provisions of § 611.51(a)(1) abrogated in part October 16, 2024 (P.L. 977, No. 96). Immediately preceding text appears at serial page (346486).

28 Pa. Code § 611.52 Criminal background checks.

(a) General rule. The home care agency or home care registry shall require each applicant for employment or referral as a direct care worker to submit a criminal history report obtained at the time of application or within 1 year immediately preceding the date of application. An applicant for employment as a member of the office staff for the home care agency or home care registry and the owner or owners of the home care agency or home care registry also are required to obtain a criminal history report in accordance with requirements contained in this section.

(b) State Police criminal history record. If the individual required to submit or obtain a criminal history report has been a resident of this Commonwealth for 2 years preceding the date of the request for a criminal history report, the individual shall request a State Police criminal history record.

(c) Federal criminal history record. If the individual required to submit or obtain a criminal history report has not been a resident of this Commonwealth for the 2 years immediately preceding the date of the the request for a criminal history report, the individual shall obtain a Federal criminal history record and a letter of determination from the Department of Aging, based on the individual’s Federal criminal history record, in accordance with 6 Pa. Code § 15.144(b) (relating to procedure).

(d) Proof of residency. The home care agency or home care registry may request an individual required to submit or obtain a criminal history record to furnish proof of residency through submission of any one of the following documents:

(1) Motor vehicle records, such as a valid driver’s license or a State-issued identification.

(2) Housing records, such as mortgage records or rent receipts.

(3) Public utility records and receipts, such as electric bills.

(4) Local tax records.

(5) A completed and signed, Federal, State or local income tax return with the applicant’s name and address preprinted on it.

(6) Employment records, including records of unemployment compensation.

(e) Prohibition. The home care agency or home care registry may not hire, roster or retain an individual if the State Police criminal history record reveals a prohibited conviction listed in 6 Pa. Code § 15.143 (relating to facility responsibilities), or if the Department of Aging letter of determination states that the individual is not eligible for hire or roster.

(f) Records maintained. The home care agency or home care registry shall maintain files for direct care workers and members of the office staff which include copies of State Police criminal history records or Department of Aging letters of determination regarding Federal criminal history records. The files shall be available for Department inspection. The agency or registry shall maintain copies of the criminal history report for the agency or registry owners, which shall be available for Department inspection.

(g) Confidentiality. The home care agency or home care registry shall keep the information obtained from State Police criminal history records and Department of Aging letters of determination regarding Federal criminal history records confidential and use it solely to determine an applicant’s eligibility to be hired, rostered or retained.

(h) Opportunity to appeal. If the decision not to hire, roster or retain an individual is based in whole or in part on State Police criminal history records, Department of Aging letters of determination regarding Federal criminal history records, or both, the home care agency or home care registry shall provide an affected individual with information on how to appeal to the sources of criminal history records if the individual believes the records are in error.

(i) Exceptions. A direct care worker who has complied with this section and who transfers to another agency or registry owned and operated by same entity is not required to obtain another criminal history report. A direct care worker employed or rostered by an entity that undergoes a change of ownership is not required to obtain another criminal history report to submit to the new owner.

(j) Individuals currently employed or rostered. A direct care worker and each member of the agency or registry office staff who is employed by or rostered by a home care agency or home care registry as of December 12, 2009, shall obtain and submit a State Police criminal history record or Department of Aging letter of determination, as applicable, to the home care agency or home care registry by April 12, 2010. This subsection does not apply if the home care agency or home care registry obtained a criminal history report meeting the requirements of this subsection when the direct care worker or office staff member was hired or rostered and a copy of the report is included in the individual’s file.

This section cited in 28 Pa. Code § 611.51 (relating to hiring or rostering of direct care workers); and 28 Pa. Code § 611.54 (relating to provisional hiring).

28 Pa. Code § 611.53 Child abuse clearance.

(a) General rule. A home care agency or home care registry that serves persons under 18 years of age shall require each applicant for employment or referral as a direct care worker, each applicant for employment as a member of the agency or registry office staff to request a ChildLine verification regarding whether the applicant is named in the Statewide Central Register as the perpetrator of a founded or indicated report of child abuse as defined in 55 Pa. Code § 3490.4 (relating to definitions).

(b) Prohibition. A home care agency or home care registry may not employ, roster or retain an individual where ChildLine has verified that the individual is named in the Statewide Central Register as the perpetrator of a founded or indicated report of child abuse.

(c) Records maintained. The files maintained by the home care agency or home care registry for each individual employed or rostered and for each member of the office staff must include copies of the ChildLine verification. The agency or registry shall maintain copies of the ChildLine verification for the agency or registry owners, which shall be available for Department inspection.

(d) Individuals currently employed or rostered. A person who is employed by or rostered by the home care agency or home care registry, including each member of the agency or registry office staff, as of December 12, 2009, shall obtain and submit a ChildLine verification to the home care agency or home care registry by April 12, 2010. This subsection does not apply if the home care agency or home care registry obtained a ChildLine verification when the individual was hired or rostered and a copy of the verification is included in the individual’s file.

This section cited in 28 Pa. Code § 611.51 (relating to hiring or rostering of direct care workers); and 28 Pa. Code § 611.54 (relating to provisional hiring).

28 Pa. Code § 611.54 Provisional hiring.

(a) General rule. The home care agency or home care registry may hire an applicant for employment or referral on a provisional basis, pending receipt of a criminal history report or a ChildLine verification, as applicable, if the following conditions are met:

(1) The applicant shall have applied for a criminal history report and ChildLine verification, as applicable, and provided the home care agency or home care registry with a copy of the completed request forms.

(2) The home care agency or home care registry shall have no knowledge about the applicant that would disqualify the applicant under 18 Pa.C.S. § 4911 (relating to tampering with public record information).

(3) The applicant shall swear or affirm in writing that the applicant is not disqualified from employment or referral under this chapter.

(4) The home care agency or home care registry may not assign or refer the provisionally hired applicant until that person has met the requirements of § 611.55 (relating to competency requirements).

(5) The home care agency or home care registry shall monitor the provisionally hired applicant awaiting a criminal background check through random, direct observation and consumer feedback. The results of monitoring shall be documented in the individual’s file.

(6) The home care agency or home care registry shall directly supervise, or assign another direct care worker to accompany, a provisionally hired applicant awaiting a child abuse clearance who will provide home care services to a consumer less than 18 years of age.

(7) The period of provisional hire of an individual who is and has been, for a period of 2 years or more, a resident of this Commonwealth, may not exceed 30 days. The period of provisional hire of an individual who has not been a resident of this Commonwealth for 2 years or more may not exceed 90 days.

(b) Termination. If the information obtained from the criminal history report or ChildLine verification, or both, reveals that the individual is disqualified from employment or referral under § 611.52 (relating to criminal background checks) or under § 611.53 (relating to child abuse clearance), the individual shall be terminated by the home care agency or removed from the home care registry’s roster immediately. If the individual fails to provide the ChildLine verification or criminal history report, or both, within the time period permitted for provisional hire, the individual shall be terminated by the home care agency or removed from the home care registry’s roster immediately.

This section cited in 28 Pa. Code § 611.51 (relating to hiring or rostering of direct care workers).

28 Pa. Code § 611.55 Competency requirements.

(a) Prior to assigning or referring a direct care worker to provide services to a consumer, the home care agency or home care registry shall ensure that the direct care worker has done one of the following:

(1) Obtained a valid nurse’s license in this Commonwealth.

(2) Demonstrated competency by passing a competency examination developed by the home care agency or home care registry which meets the requirements of subsections (b) and (c).

(3) Successfully completed one of the following:

(i) A training program developed by a home care agency, home care registry, or other entity which meets the requirements of subsections (b) and (c).

(ii) A home health aide training program meeting the requirements of 42 CFR 484.36 (relating to the conditions of participation; home health aide services).

(iii) The nurse aid certification and training program sponsored by the Department of Education and located at www.pde.state.pa.us.

(iv) A training program meeting the training standards imposed on the agency or registry by virtue of the agency’s or registry’s participation as a provider in a Medicaid Waiver or other publicly funded program providing home and community based services to qualifying consumers.

(v) Another program identified by the Department by subsequent publication in the Pennsylvania Bulletin or on the Department’s web site.

(b) A competency examination or training program developed by an agency or registry for a direct care worker must address, at a minimum, the following subject areas:

(1) Confidentiality.

(2) Consumer control and the independent living philosophy.

(3) Instrumental activities of daily living.

(4) Recognizing changes in the consumer that need to be addressed.

(5) Basic infection control.

(6) Universal precautions.

(7) Handling of emergencies.

(8) Documentation.

(9) Recognizing and reporting abuse or neglect.

(10) Dealing with difficult behaviors.

(c) A competency examination or training program developed by an agency or registry for a direct care worker who will provide personal care must address the following additional subject areas:

(1) Bathing, shaving, grooming and dressing.

(2) Hair, skin and mouth care.

(3) Assistance with ambulation and transferring.

(4) Meal preparation and feeding.

(5) Toileting.

(6) Assistance with self-administered medications.

(d) The home care agency or home care registry shall include documentation of the direct care worker’s satisfactory completion of competency requirements in the direct care worker’s file. If the direct care worker has a nurse’s license or other licensure or certification as a health professional, the individual’s file shall include a copy of the current license or certification. Documentation of satisfactory completion of competency requirements is transferable from one home care agency or registry to another home care agency or registry, provided the break in the individual’s employment or roster status does not exceed 12 months.

(e) The home care agency or home care registry also shall include documentation in the direct care worker’s file that the agency or registry has reviewed the individual’s competency to perform assigned duties through direct observation, testing, training, consumer feedback or other method approved by the Department or through a combination of methods. The competency review must occur at least once per year after initial competency is established, and more frequently when discipline or other sanction, including, for example, a verbal warning or suspension, is imposed because of a quality of care infraction.

(f) A direct care worker employed by a home care agency or rostered by the home care registry on December 12, 2009, shall achieve compliance with the competency requirements imposed by this chapter by December 12, 2011.

This section cited in 28 Pa. Code § 611.51 (relating to hiring or rostering of direct care workers); and 28 Pa. Code § 611.54 (relating to provisional hiring).

28 Pa. Code § 611.56 Health screening.

(a) A home care agency or home care registry shall insure that each direct care worker and other office staff or contractors with direct consumer contact, prior to consumer contact, provide documentation that the individual has been screened for and is free from active mycobacterium tuberculosis. The screening shall be conducted in accordance with CDC guidelines for preventing the transmission of mycobacterium tuberculosis in health care settings. The documentation must indicate the date of the screening which may not be more than 1 year prior to the individual’s start date.

(b) A home care agency or home care registry shall require each direct care worker, and other office staff or contractors with direct consumer contact, to update the documentation required under subsection (a) at least every 12 months and provide the documentation to the agency or registry. The 12 months must run from the date of the last evaluation. The documentation required under subsection (a) shall be included in the individual’s file.

(c) A direct care worker employed by a home care agency or rostered by the home care registry on December 12, 2009, shall achieve compliance with the health evaluation requirements imposed by this chapter by June 10, 2010.

This section cited in 28 Pa. Code § 611.51 (relating to hiring or rostering of direct care workers).

28 Pa. Code § 611.57 Consumer protections.

(a) Consumer rights. The consumer of home care services provided by a home care agency or through a home care registry shall have the following rights:

(1) To be involved in the service planning process and to receive services with reasonable accommodation of individual needs and preferences, except where the health and safety of the direct care worker is at risk.

(2) To receive at least 10 calendar days advance written notice of the intent of the home care agency or home care registry to terminate services. Less than 10 days advance written notice may be provided in the event the consumer has failed to pay for services, despite notice, and the consumer is more than 14 days in arrears, or if the health and welfare of the direct care worker is at risk.

(b) Prohibitions. No individual as a result of the individual’s affiliation with a home care agency or home care registry may assume power of attorney or guardianship over a consumer utilizing the services of that home care agency or home care registry. The home care agency or home care registry may not require a consumer to endorse checks over to the home care agency or home care registry.

(c) Information to be provided. Prior to the commencement of services, the home care agency or home care registry shall provide to the consumer, the consumer’s legal representative or responsible family member an information packet containing the following information in a form that is easily read and understood:

(1) A listing of the available home care services that will be provided to the consumer by the direct care worker and the identity of the direct care worker who will provide the services.

(2) The hours when those services will be provided.

(3) Fees and total costs for those services on an hourly or weekly basis.

(4) Who to contact at the Department for information about licensure requirements for a home care agency or home care registry and for compliance information about a particular home care agency or home care registry.

(5) The Department’s complaint Hot Line (1-866-826-3644) and the telephone number of the Ombudsman Program located with the local Area Agency on Aging (AAA).

(6) The hiring and competency requirements applicable to direct care workers employed by the home care agency or referred by the home care registry.

(7) A disclosure, in a format to be published by the Department in the Pennsylvania Bulletin by February 10, 2010, addressing the employee or independent contractor status of the direct care worker providing services to the consumer, and the resultant respective tax and insurance obligations and other responsibilities of the consumer and the home care agency or home care registry.

(d) Documentation. The home care agency or home care registry shall maintain documentation on file at the agency or registry of compliance with the requirements of this section which shall be available for Department inspection.

Part V Department of Drug and Alcohol Programs

Chapter 704 Staffing Requirements for Drug and Alcohol Treatment Activities

28 Pa. Code § 704.1 Scope.

This chapter applies to staff persons employed by drug and alcohol treatment facilities which are licensed or approved under Chapters 709, 710 and 711 (relating to standards for licensure of freestanding treatment activities; drug and alcohol services; and standards for certification of treatment activities which are a part of a health care facility) with the exception of staff persons employed in intake, evaluation and referral facilities as delineated in Chapter 709, Subchapter D (relating to standards for intake, evaluation and referral activities) and Chapter 711, Subchapter C (relating to standards for intake evaluation and referral activities). Staff persons shall possess the qualifications set forth in this chapter and shall also participate in training as required in this chapter.

History

Authority: The provisions of this Chapter 704 issued under Articles IX and X of the Public Welfare Code (62 P.
Source: The provisions of this Chapter 704 adopted February 2, 1996, effective March 4, 1996, 26 Pa.

28 Pa. Code § 704.2 Compliance plan.

(a) The project’s governing body shall approve a written compliance plan to insure that the staff persons affected by this chapter meet the appropriate educational and experiential qualifications and receive training as stipulated in this chapter.

(b) The plan documenting the qualifications and training of staff shall be presented to Department licensing representatives at the time of the project’s site visit.

History

Authority: The provisions of this Chapter 704 issued under Articles IX and X of the Public Welfare Code (62 P.
Source: The provisions of this Chapter 704 adopted February 2, 1996, effective March 4, 1996, 26 Pa.

28 Pa. Code § 704.3 General requirements for projects.

(a) The project shall develop a written policy to address relapse of recovering clinical personnel. The project’s policy shall also address the discipline of nonrecovering employes who abuse alcohol and other drugs.

(b) The project shall develop a policy that addresses the recruitment and hiring of staff persons who are appropriate to the population to be served. Every effort shall be made to hire staff persons representative of that population.

(c) Clerical and other support staff shall be employed in sufficient numbers to insure efficient and safe operation of all of the services provided by the project.

(d) Inpatient nonhospital facilities except for transitional living facilities and licensed facilities providing halfway house services shall have awake staff coverage 24 hours a day. Halfway houses shall have at least one staff person on the premises at all times.

History

Authority: The provisions of this Chapter 704 issued under Articles IX and X of the Public Welfare Code (62 P.
Source: The provisions of this Chapter 704 adopted February 2, 1996, effective March 4, 1996, 26 Pa.

28 Pa. Code § 704.4 Compliance with staff qualifications.

(a) This chapter applies to project directors, facility directors, clinical supervisors, counselors and counselor assistants hired or promoted on or after March 4, 1996.

(b) Project directors and facility directors who were hired prior to March 4, 1996, need not comply with the specific qualifications listed in § 704.5 (relating to qualifications for the positions of project director and facility director). They shall comply with § § 704.11(a)—(f) and 704.12 (relating to staff development program; and full-time equivalent (FTE) maximum client/staff and client/counselor ratios).

(c) A facility director who transfers to the same position in another facility operated by the same project after March 4, 1996, need not meet the qualifications set forth in § 704.5(c).

(d) A project director who accepts a position as a project director in a different project after March 4, 1996, shall comply with § 704.5(c).

(e) Persons employed as clinical supervisors and counselors who were hired or promoted prior to March 4, 1996, who do not meet the appropriate staff qualifications shall show evidence that they are working toward full compliance. They shall be in full compliance with this chapter by March 6, 2000. Upon completion of course work, transcripts and other forms of documentation shall be placed in the individual’s personnel file. A licensing representative will check progress at the time of the project site visit.

History

Authority: The provisions of this Chapter 704 issued under Articles IX and X of the Public Welfare Code (62 P.
Source: The provisions of this Chapter 704 adopted February 2, 1996, effective March 4, 1996, 26 Pa.

28 Pa. Code § 704.5 Qualifications for the positions of project director and facility director.

(a) A drug and alcohol treatment project shall have a project director responsible for the overall management of the project and staff and each drug and alcohol treatment facility shall have a facility director responsible for the overall management of the facility and staff unless the project has but one facility.

(b) If the facility does not have a clinical supervisor on staff, clinical responsibilities shall be addressed in one of the following ways:

(1) A facility director who has direct responsibility for clinical services shall meet the qualifications in at least one of the paragraphs of § 704.7(b) (relating to qualifications for the position of counselor).

(2) If the facility director does not meet counselor qualifications and the facility employs less than eight counselors, a lead counselor or part-time clinical supervisor shall be appointed.

(c) The project director and the facility director shall meet the qualifications in at least one of the following paragraphs:

(1) A Master’s Degree or above from an accredited college with a major in medicine, chemical dependency, psychology, social work, counseling, nursing (with a specialty in nursing/health administration, nursing/counseling education or a clinical specialty in the human services), public administration, business management or other related field and 2 years of experience in a human service agency, preferably in a drug and alcohol setting, which includes supervision of others, direct service and program planning.

(2) A Bachelor’s Degree from an accredited college with a major in chemical dependency, psychology, social work, counseling, nursing (with a specialty in nursing/health administration, nursing/counseling education or a clinical specialty in the human services), public administration, business management or other related field and 3 years of experience in a human service agency, preferably in a drug and alcohol setting, which includes supervision of others, direct service and program planning.

(3) An Associate Degree from an accredited college with a major in chemical dependency, psychology, social work, counseling, nursing (with a specialty in nursing/health administration, nursing/counseling education or a clinical specialty in the human services), public administration, business management or other related field and 4 years of experience in a human service agency, preferably in a drug and alcohol setting, which includes supervision of others, direct service and program planning.

This section cited in 28 Pa. Code § 704.4 (relating to compliance with staff qualifications).

History

Authority: The provisions of this Chapter 704 issued under Articles IX and X of the Public Welfare Code (62 P.
Source: The provisions of this Chapter 704 adopted February 2, 1996, effective March 4, 1996, 26 Pa.

28 Pa. Code § 704.6 Qualifications for the position of clinical supervisor.

(a) A drug and alcohol treatment project shall have a full-time clinical supervisor for every eight full-time counselors or counselor assistants, or both.

(b) A clinical supervisor shall meet at least one of the following groups of qualifications:

(1) A Master’s Degree or above from an accredited college with a major in medicine, chemical dependency, psychology, social work, counseling, nursing (with a clinical specialty in administration or the human services) or other related field and 2 years of clinical experience in a health or human service agency which includes 1 year of working directly with the chemically dependent.

(2) A Bachelor’s Degree from an accredited college with a major in chemical dependency, psychology, social work, counseling, nursing (with a clinical specialty in administration or the human services) or other related field and 3 years of clinical experience in a health or human service agency which includes 1 year of working directly with the chemically dependent person.

(3) An Associate Degree from an accredited college with a major in chemical dependency, psychology, social work, counseling, nursing (with a clinical specialty in administration or the human services) or other related field and 4 years of clinical experience in a health or human service agency which includes 1 year of working directly with the chemically dependent person.

(4) Full certification as an addictions counselor by a statewide certification body which is a member of a National certification body or certification by another state government’s substance abuse counseling certification board and 3 years of clinical experience in a health or human service agency which includes 1 year of working directly with the chemically dependent person. The individual shall also complete a Department approved core curriculum training which includes a component on clinical supervision skills.

(c) Clinical supervisors and lead counselors who have not functioned for 2 years as supervisors in the provision of clinical services shall complete a core curriculum in clinical supervision. Training not provided by the Department shall receive prior approval from the Department.

(d) If a clinical supervisor or lead counselor has less than 2 years of clinical experience working directly with the chemically dependent person, 6 of the training hours required in § 704.11(e)(2) and (f)(2) (relating to staff development program) during the first year of employment shall be in diseases of addiction.

(e) Clinical supervisors are required to participate in documented monthly meetings with their supervisors to discuss their duties and performance for the first 6 months of employment in that position. Frequency of meetings thereafter shall be based upon the clinical supervisor’s skill level.

This section cited in 28 Pa. Code § 704.9 (relating to supervision of counselor assistant).

History

Authority: The provisions of this Chapter 704 issued under Articles IX and X of the Public Welfare Code (62 P.
Source: The provisions of this Chapter 704 adopted February 2, 1996, effective March 4, 1996, 26 Pa.

28 Pa. Code § 704.7 Qualifications for the position of counselor.

(a) Drug and alcohol treatment projects shall be staffed by counselors proportionate to the staff/client and counselor/client ratios listed in § 704.12 (relating to full-time equivalent (FTE) maximum client/staff and client/counselor ratios).

(b) Each counselor shall meet at least one of the following groups of qualifications:

(1) Current licensure in this Commonwealth as a physician.

(2) A Master’s Degree or above from an accredited college with a major in chemical dependency, psychology, social work, counseling, nursing (with a clinical specialty in the human services) or other related field which includes a practicum in a health or human service agency, preferably in a drug and alcohol setting. If the practicum did not take place in a drug and alcohol setting, the individual’s written training plan shall specifically address a plan to achieve counseling competency in chemical dependency issues.

(3) A Bachelor’s Degree from an accredited college with a major in chemical dependency, psychology, social work, counseling, nursing (with a clinical specialty in the human services) or other related field and 1 year of clinical experience (a minimum of 1,820 hours) in a health or human service agency, preferably in a drug and alcohol setting. If a person’s experience did not take place in a drug and alcohol setting, the individual’s written training plan shall specifically address a plan to achieve counseling competency in chemical dependency issues.

(4) An Associate Degree from an accredited college with a major in chemical dependency, psychology, social work, counseling, nursing (with a clinical specialty in the human services) or other related field and 2 years of clinical experience (a minimum of 3,640 hours) in a health or human service agency, preferably in a drug and alcohol setting. If a person’s experience was not in a drug and alcohol setting, the individual’s written training plan shall specifically address a plan to achieve counseling competency in chemical dependency issues.

(5) Current licensure in this Commonwealth as a registered nurse and a degree from an accredited school of nursing and 1 year of counseling experience (a minimum of 1,820 hours) in a health or human service agency, preferably in a drug and alcohol setting. If a person’s experience was not in a drug and alcohol setting, the individual’s written training plan shall specifically address a plan to achieve counseling competency in chemical dependency issues.

(6) Full certification as an addictions counselor by a statewide certification body which is a member of a National certification body or certification by another state government’s substance abuse counseling certification board.

This section cited in 28 Pa. Code § 704.5 (relating to qualifications for the positions of project director and facility director); 28 Pa. Code § 704.9 (relating to supervision of counselor assistant); and 28 Pa. Code § 704.10 (relating to promotion of counselor assistant).

History

Authority: The provisions of this Chapter 704 issued under Articles IX and X of the Public Welfare Code (62 P.
Source: The provisions of this Chapter 704 adopted February 2, 1996, effective March 4, 1996, 26 Pa.

28 Pa. Code § 704.8 Qualifications for the position of counselor assistant.

(a) A person who does not meet the educational and experiential qualifications for the position of counselor may be employed as a counselor assistant if the requirements of at least one of the following paragraphs are met. However, a project may not hire more than one counselor assistant for each employe who meets the requirements of clinical supervisor or counselor.

(1) A Master’s Degree in a human service area.

(2) A Bachelor’s Degree in a human service area.

(3) Licensure in this Commonwealth as a registered nurse.

(4) An Associate’s Degree in a human service area.

(5) A high school diploma or General Education Development (GED) equivalent.

(b) A counselor assistant shall also complete the training requirements in § 704.11 (relating to staff development program).

(c) In addition to training, assignment of a full caseload shall be contingent upon the supervisor’s positive assessment of the counselor assistant’s individual skill level.

This section cited in 28 Pa. Code § 704.9 (relating to supervision of counselor assistant).

History

Authority: The provisions of this Chapter 704 issued under Articles IX and X of the Public Welfare Code (62 P.
Source: The provisions of this Chapter 704 adopted February 2, 1996, effective March 4, 1996, 26 Pa.

28 Pa. Code § 704.9 Supervision of counselor assistant.

(a) Supervision. A counselor assistant shall be supervised by a full-time clinical supervisor or counselor who meets the qualifications in § 704.6 or § 704.7 (relating to qualifications for the position of clinical supervisor; and qualifications for the position of counselor).

(b) Performance evaluation. The counselor assistant shall be given a written semiannual performance evaluation based upon measurable performance standards. If the individual does not meet the standards at the time of evaluation, the counselor assistant shall remain in this status until the supervised period set forth in subsection (c) is completed and a satisfactory rating is received from the counselor assistant’s supervisor.

(1) A counselor assistant with a Master’s Degree as set forth in § 704.8(a)(1) (relating to qualifications for the position of counselor assistant) may counsel clients only under the close supervision of a trained counselor or clinical supervisor for at least the first 3 months of employment.

(2) A counselor assistant with a Bachelor’s Degree as set forth in § 704.8(a)(2) may counsel clients only under the close supervision of a trained counselor or clinical supervisor for at least the first 6 months of employment.

(3) A registered nurse as set forth in § 704.8(a)(3) may counsel clients only under the close supervision of a trained counselor or clinical supervisor for at least the first 6 months of employment.

(4) A counselor assistant with an Associate Degree as set forth in § 704.8(a)(4) may counsel clients only under the close supervision of a trained counselor or clinical supervisor for at least the first 9 months of employment.

(5) A counselor assistant with a high school diploma or GED equivalent as set forth in § 704.8(a)(5) may counsel clients only under the direct observation of a trained counselor or clinical supervisor for the first 3 months of employment. For the next 9 months, the counselor assistant may counsel clients only under the close supervision of a lead counselor or a clinical supervisor.

History

Authority: The provisions of this Chapter 704 issued under Articles IX and X of the Public Welfare Code (62 P.
Source: The provisions of this Chapter 704 adopted February 2, 1996, effective March 4, 1996, 26 Pa.

28 Pa. Code § 704.10 Promotion of counselor assistant.

(a) A counselor assistant who satisfactorily completes one of the sets of qualifications in § 704.7 (relating to qualifications for the position of counselor) may be promoted to the position of counselor.

(b) A counselor assistant shall document to the facility director that he is working toward counselor status. This information shall be documented upon completion of each calendar year.

(c) A counselor assistant shall meet the requirements for counselor within 5 years of employment. A counselor assistant who has accumulated less than 7,500 hours of employment during the first 5 years of employment will have 2 additional years to meet the requirements for counselor.

(d) A counselor assistant who cannot meet the time requirements in subsection (c) may submit to the Department a written petition requesting an exception. The petition shall describe the circumstances that make compliance with subsection (c) impracticable and shall be approved by both the clinical supervisor or lead counselor and the project director. Granting of the petition will be within the discretion of the Department.

History

Authority: The provisions of this Chapter 704 issued under Articles IX and X of the Public Welfare Code (62 P.
Source: The provisions of this Chapter 704 adopted February 2, 1996, effective March 4, 1996, 26 Pa.

28 Pa. Code § 704.11 Staff development program.

(a) Components. The project director shall develop a comprehensive staff development program for agency personnel including policies and procedures for the program indicating who is responsible and the time frames for completion of the following components:

(1) An assessment of staff training needs.

(2) An overall plan for addressing these needs.

(3) A mechanism to collect feedback on completed training.

(4) An annual evaluation of the overall training plan.

(b) Individual training plan.

(1) A written individual training plan for each employe, appropriate to that employe’s skill level, shall be developed annually with input from both the employe and the supervisor.

(2) This plan shall be based upon an employe’s previous education, experience, current job functions and job performance.

(3) Each individual employe shall complete the minimum training hours as listed in subsections (d)—(g). The subject areas in subsections (d)—(g), with the exception of subsection (g), are suggested training areas. They are not mandates. Subject selections shall be based upon needs delineated in the individual’s training plan.

(1) Staff persons and volunteers shall receive a minimum of 6 hours of HIV/AIDS and at least 4 hours of tuberculosis, sexually transmitted diseases and other health related topics training using a Department approved curriculum. Counselors and counselor assistants shall complete the training within the first year of employment. All other staff shall complete the training within the first 2 years of employment.

(2) CPR certification and first aid training shall be provided to a sufficient number of staff persons, so that at least one person trained in these skills is onsite during the project’s hours of operation.

(3) At least one-half of all training in this section shall be provided by trainers not directly employed by the project unless the project employs staff persons specifically to provide training for its organization and staff.

(4) An individual who holds more than one position in a facility shall meet the training requirement hours set forth for the individual’s primary position. Subject areas shall be selected according to the individual’s training plan. Primary position is defined as that position for which an individual was hired.

(d) Training requirements for project directors and facility directors.

(1) Subject areas for training shall be selected according to the training plan for each individual.

(2) A project director and facility director shall complete at least 12 clock hours of training annually in areas such as:

(i) Fiscal policy.

(ii) Administration.

(iii) Program planning.

(iv) Quality assurance.

(v) Grantsmanship.

(vi) Program licensure.

(vii) Personnel management.

(viii) Confidentiality.

(ix) Ethics.

(x) Substance abuse trends.

(xi) Developmental psychology.

(xii) Interaction of addiction and mental illness.

(xiii) Cultural awareness.

(xiv) Sexual harassment.

(xv) Relapse prevention.

(xvi) Disease of addiction.

(xvii) Principles of Alcoholics Anonymous and Narcotics Anonymous.

(e) Training requirements for clinical supervisors.

(1) Subject areas for training shall be selected according to the training plan for each individual.

(2) Each clinical supervisor shall complete at least 12 clock hours of training annually in areas such as:

(i) Supervision and evaluation.

(ii) Counseling techniques.

(iii) Substance abuse trends and treatment methodologies in the field of addiction.

(iv) Confidentiality.

(v) Codependency/Adult Children of Alcoholics (ACOA) issues.

(vi) Ethics.

(vii) Interaction of addiction and mental illness.

(viii) Cultural awareness.

(ix) Sexual harassment.

(x) Developmental psychology.

(xi) Relapse prevention.

(xii) Disease of addiction.

(xiii) Principles of Alcoholics Anonymous and Narcotics Anonymous.

(f) Training requirements for counselors.

(1) Subject areas for training shall be selected according to the training plan for each individual.

(2) Each counselor shall complete at least 25 clock hours of training annually in areas such as:

(i) Client recordkeeping.

(ii) Confidentiality.

(iii) Pharmacology.

(iv) Treatment planning.

(v) Counseling techniques.

(vi) Drug and alcohol assessment.

(vii) Codependency.

(viii) Adult Children of Alcoholics (ACOA) issues.

(ix) Disease of addiction.

(x) Aftercare planning.

(xi) Principles of Alcoholics Anonymous and Narcotics Anonymous.

(xii) Ethics.

(xiii) Substance abuse trends.

(xiv) Interaction of addiction and mental illness.

(xv) Cultural awareness.

(xvi) Sexual harassment.

(xvii) Developmental psychology.

(xviii) Relapse prevention.

(3) If a counselor has been designated as lead counselor supervising other counselors, the training shall include courses appropriate to the functions of this position and a Department approved core curriculum or comparable training in supervision.

(g) Training requirements for counselor assistants.

(1) Each counselor assistant shall complete at least 40 clock hours of training the first year and 30 clock hours annually thereafter in areas such as:

(i) Pharmacology.

(ii) Confidentiality.

(iii) Client recordkeeping.

(iv) Drug and alcohol assessment.

(v) Basic counseling.

(vi) Treatment planning.

(vii) The disease of addiction.

(viii) Principles of Alcoholics Anonymous and Narcotics Anonymous.

(ix) Ethics.

(x) Substance abuse trends.

(xi) Interaction of addiction and mental illness.

(xii) Cultural awareness.

(xiii) Sexual harassment.

(xiv) Developmental psychology.

(xv) Relapse prevention.

(h) Training hours. Training hours are not cumulative from one personnel classification to another.

This section cited in 28 Pa. Code § 704.4 (relating to compliance with staff qualifications); 28 Pa. Code § 704.6 (relating to qualifications for the position of clinical supervisor); and 28 Pa. Code § 704.8 (relating to qualifications for the position of counselor assistant).

History

Authority: The provisions of this Chapter 704 issued under Articles IX and X of the Public Welfare Code (62 P.
Source: The provisions of this Chapter 704 adopted February 2, 1996, effective March 4, 1996, 26 Pa.

28 Pa. Code § 704.12 Full-time equivalent (FTE) maximum client/staff and client/counselor ratios.

(a) General requirements. Projects shall be required to comply with the client/staff and client/counselor ratios in paragraphs (1)—(6) during primary care hours. These ratios refer to the total number of clients being treated including clients with diagnoses other than drug and alcohol addiction served in other facets of the project. Family units may be counted as one client.

(1) Inpatient nonhospital detoxification (residential detoxification).

(i) There shall be one FTE primary care staff person available for every seven clients during primary care hours.

(ii) There shall be a physician on call at all times.

(2) Inpatient hospital detoxification. There shall be one FTE primary care staff person available for every five clients during primary care hours.

(3) Inpatient nonhospital treatment and rehabilitation (residential treatment and rehabilitation).

(i) Projects serving adult clients shall have one FTE counselor for every eight clients.

(ii) Projects serving adolescent clients shall have one FTE counselor for every six clients.

(4) Inpatient hospital treatment and rehabilitation (general, psychiatric or speciality hospital).

(i) Projects serving adult clients shall have one FTE counselor for every seven clients.

(ii) Projects serving adolescent clients shall have one counselor for every five clients.

(5) Partial hospitalization. Partial hospitalization programs shall have a minimum of one FTE counselor who provides direct counseling services to every ten clients.

(6) Outpatients. FTE counselor caseload for counseling in outpatient programs may not exceed 35 active clients.

(b) Counselor assistants. Counselor assistants may be included in determining FTE ratios when the counselor assistant is eligible for a caseload.

(d) Exceptions. A project director may submit to the Department a written petition requesting an exception to the client/staff and client/counselor ratios in this section. The petition shall describe how the characteristics of the program and its client mix support the request for the exception and shall be approved by the governing body. Granting the petition shall be at the discretion of the Department. Long-term residential facilities and halfway houses which include a client’s participation in schooling or employment as part of a treatment day are examples when requests for exceptions will be considered.

Applicability

Since the Public Welfare Code expressly excludes any drug and alcohol treatment facilities operated by the State and Federal governments from the scope of the applicability of Article IX and X, the staffing and licensing requirements set forth in Chapters 704 and 709 and promulgated thereunder are inapplicable to the programs operated at State correctional institutions. McGill v. Department of Health, et al., 758 A.2d 268 (Pa. Cmwlth. 2000).

This section cited in 28 Pa. Code § 704.4 (relating to compliance with staff qualifications); and 28 Pa. Code § 704.7 (relating to qualifications for the position of counselor).

History

Authority: The provisions of this Chapter 704 issued under Articles IX and X of the Public Welfare Code (62 P.
Source: The provisions of this Chapter 704 adopted February 2, 1996, effective March 4, 1996, 26 Pa.

Chapter 710 Drug and Alcohol Services

28 Pa. Code § 710.1 Principle.

When a hospital provides inpatient drug and alcohol detoxification services or inpatient drug and alcohol detoxification and treatment and rehabilitation services, it shall provide the services in a manner sufficient to meet the medical and psychological needs of the patients.

History

Authority: The provisions of this Chapter 157 issued under Articles IX and X of the Public Welfare Code (62 P.
Source: The provisions of this Chapter 157 adopted October 18, 1985, effective November 18, 1985, 15 Pa.

28 Pa. Code § 710.2 Definitions.

The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise: Aftercare plan—A plan for patients to follow after they leave formal treatment. It is the patient’s individual plan for the future, including an identification of the patient’s personal goals and objectives. Detoxification—The process whereby a drug or alcohol intoxicated or dependent patient is assisted through the period of time necessary to eliminate, by metabolic or other means, the presence of the intoxicating substance, while keeping the physiological or psychological risk to the patient at a minimum. This process should also include efforts to motivate and support the patient to seek formal treatment after the detoxification phase. Follow-up—The procedure by which the staff determines the status of a patient who has been referred to an outside service provider for services or who has been discharged from the drug and alcohol service. Treatment and rehabilitation—Following the physiological detoxification phase, activities carried out specifically to effect the reduction of the dysfunction of the patient. This includes the systematic application of social, psychological or medical service methods to assist individuals to deal with the causative effects or consequences of drug or alcohol abuse.

History

Authority: The provisions of this Chapter 157 issued under Articles IX and X of the Public Welfare Code (62 P.
Source: The provisions of this Chapter 157 adopted October 18, 1985, effective November 18, 1985, 15 Pa.

28 Pa. Code § 710.3 Organization.

(a) Inpatient drug and alcohol services shall comply with § § 710.21—710.25 (relating to inpatient hospital activities—detoxification). These detoxification services should be provided in an identified drug and alcohol unit, but may be provided in beds dispersed throughout the hospital.

(b) Those drug and alcohol programs that intend to provide formal treatment beyond the detoxification phase of care shall also comply with § § 710.41—710.44 (relating to inpatient hospital activities—treatment and rehabilitation). The services shall be provided in an identified drug and alcohol treatment and rehabilitation unit within the hospital.

History

Authority: The provisions of this Chapter 157 issued under Articles IX and X of the Public Welfare Code (62 P.
Source: The provisions of this Chapter 157 adopted October 18, 1985, effective November 18, 1985, 15 Pa.

28 Pa. Code § 710.4 Director of drug and alcohol services.

When a hospital provides inpatient drug and alcohol detoxification services or inpatient drug and alcohol detoxification and treatment and rehabilitation services, there shall be a director of the drug and alcohol services who is responsible for the planning, organization, implementation and management of the services and is qualified to perform these functions by education and experience.

History

Authority: The provisions of this Chapter 157 issued under Articles IX and X of the Public Welfare Code (62 P.
Source: The provisions of this Chapter 157 adopted October 18, 1985, effective November 18, 1985, 15 Pa.

28 Pa. Code § 710.21 Admission—detoxification.

(a) Admission procedures other than initial medical or psychiatric care shall be performed at a time when the patient is mentally and physically capable of comprehension and response.

(b) Admission procedures shall include documentation of the following:

(1) Histories, which include the following:

(i) Medical history.

(ii) Drug or alcohol history, or both.

(iii) Personal history.

(2) Consent to treatment.

(3) Physical examination.

(4) Psychosocial evaluation.

This section cited in 28 Pa. Code § 710.3 (relating to organization); and 31 Pa. Code § 89.621 (relating to inpatient detoxification services).

History

Authority: The provisions of this Chapter 157 issued under Articles IX and X of the Public Welfare Code (62 P.
Source: The provisions of this Chapter 157 adopted October 18, 1985, effective November 18, 1985, 15 Pa.

28 Pa. Code § 710.22 Patient management services.

(a) There shall be a written plan that delineates specific service planning and counseling approaches used to promote patient interest in participating in necessary treatment following the detoxification process.

(b) The service staff shall develop a written patient aftercare policy.

This section cited in 28 Pa. Code § 710.3 (relating to organization); and 31 Pa. Code § 89.621 (relating to inpatient detoxification services).

History

Authority: The provisions of this Chapter 157 issued under Articles IX and X of the Public Welfare Code (62 P.
Source: The provisions of this Chapter 157 adopted October 18, 1985, effective November 18, 1985, 15 Pa.

28 Pa. Code § 710.23 Patient records.

(a) In addition to the requirements contained in § 115.32 (relating to contents), the patient’s medical record shall contain a drug and alcohol support plan, follow-up information, and an aftercare plan, if applicable.

(b) Patient records shall be kept confidential in accordance with applicable Federal drug and alcohol regulations and the confidentiality requirements in 4 Pa. Code § § 255.4 and 255.5 (relating to UDCS: confidentiality and access to information and projects; and coordinating bodies: disclosure of client-oriented information).

This section cited in 28 Pa. Code § 710.3 (relating to organization); and 31 Pa. Code § 89.621 (relating to inpatient detoxification services).

History

Authority: The provisions of this Chapter 157 issued under Articles IX and X of the Public Welfare Code (62 P.
Source: The provisions of this Chapter 157 adopted October 18, 1985, effective November 18, 1985, 15 Pa.

28 Pa. Code § 710.24 Uniform Data Collection System.

The drug and alcohol service shall comply with the Department’s Uniform Data Collection System if the service utilizes Department funds.

This section cited in 28 Pa. Code § 710.3 (relating to organization); and 31 Pa. Code § 89.621 (relating to inpatient detoxification services).

History

Authority: The provisions of this Chapter 157 issued under Articles IX and X of the Public Welfare Code (62 P.
Source: The provisions of this Chapter 157 adopted October 18, 1985, effective November 18, 1985, 15 Pa.

28 Pa. Code § 710.25 Notification and termination.

(a) The director shall notify the patient, in writing, of a decision to involuntarily terminate the patient’s treatment in the service. The notice shall include the reasons for termination.

(b) The patient shall have an opportunity to request reconsideration of a decision terminating treatment.

This section cited in 28 Pa. Code § 710.3 (relating to organization); and 31 Pa. Code § 89.621 (relating to inpatient detoxification services).

History

Authority: The provisions of this Chapter 157 issued under Articles IX and X of the Public Welfare Code (62 P.
Source: The provisions of this Chapter 157 adopted October 18, 1985, effective November 18, 1985, 15 Pa.

28 Pa. Code § 710.41 Admission—treatment and rehabilitation.

(a) The service director shall develop a written plan providing for admission which shall include, but not be limited to, the following:

(1) Criteria for admission.

(2) Treatment models utilized by the service.

(3) Requirements for completion of treatment.

(4) Involuntary discharge/termination criteria.

(b) Admission procedures shall include documentation of the following:

(1) Disclosure to the patient of criteria for admission, treatment, completion, and discharge.

(2) Patient orientation to the service which shall include, but not be limited to, a familiarization with the following:

(i) Service policies.

(ii) Services provided.

(3) Initial treatment and rehabilitation plan.

This section cited in 28 Pa. Code § 710.3 (relating to organization).

History

Authority: The provisions of this Chapter 157 issued under Articles IX and X of the Public Welfare Code (62 P.
Source: The provisions of this Chapter 157 adopted October 18, 1985, effective November 18, 1985, 15 Pa.

28 Pa. Code § 710.42 Treatment and rehabilitation services.

(a) The director shall be responsible for a written plan for the coordination of patient treatment and rehabilitation services which shall include, but not be limited to:

(1) Defined target population.

(2) Treatment models utilized by the service.

(3) Written procedures for the development, approval, and ongoing management of treatment/rehabilitation services of patients.

(4) Written procedures for referral outlining cooperation with other service providers.

(b) An individual treatment and rehabilitation plan shall be developed with each patient. This plan shall include, but not be limited to, written documentation of the following:

(1) Short and long-term goals for treatment as formulated by both staff and patient.

(2) Type and frequency of treatment and rehabilitation services.

(3) Proposed type of support services.

(d) Treatment services shall be provided on a regular and scheduled basis in accordance with the individual treatment and rehabilitation plan.

This section cited in 28 Pa. Code § 710.3 (relating to organization).

History

Authority: The provisions of this Chapter 157 issued under Articles IX and X of the Public Welfare Code (62 P.
Source: The provisions of this Chapter 157 adopted October 18, 1985, effective November 18, 1985, 15 Pa.

28 Pa. Code § 710.43 Patient support services.

The service staff shall assist the patient in obtaining the following supportive services, when necessary:

(1) Educational.

(2) Vocational.

(3) Job development and placement.

(4) Economic.

(5) Legal.

(6) Recreational/social.

(7) Medical/dental.

This section cited in 28 Pa. Code § 710.3 (relating to organization).

History

Authority: The provisions of this Chapter 157 issued under Articles IX and X of the Public Welfare Code (62 P.
Source: The provisions of this Chapter 157 adopted October 18, 1985, effective November 18, 1985, 15 Pa.

28 Pa. Code § 710.44 Therapeutic environment.

There shall be adequate space, facilities, and equipment to meet the needs of the patients for privacy and for group interaction.

This section cited in 28 Pa. Code § 710.3 (relating to organization).

History

Authority: The provisions of this Chapter 157 issued under Articles IX and X of the Public Welfare Code (62 P.
Source: The provisions of this Chapter 157 adopted October 18, 1985, effective November 18, 1985, 15 Pa.

Chapter 715 Standards for Approval of Narcotic Treatment Program

28 Pa. Code § 715.1 General provisions.

(a) An entity within this Commonwealth which uses agents for maintenance or detoxification of persons shall obtain the approval of the Department to operate a narcotic treatment program.

(b) The Department’s approval of a narcotic treatment program shall be contingent upon the narcotic treatment program’s compliance with the standards and conditions in this part. In addition, the program shall comply with applicable Federal laws and regulations.

History

Authority: The provisions of this Chapter 715 issued under the Pennsylvania Drug and Alcohol Abuse Control Act (71 P.
Source: The provisions of this Chapter 715 adopted November 15, 2002, effective November 16, 2002, 32 Pa.

28 Pa. Code § 715.2 Relationship of Federal and State regulations.

(a) A narcotic treatment program shall comply with Federal regulations and requirements governing the administration, dispensing and storage of agents.

(b) This chapter is intended to supplement the Federal regulations governing narcotic treatment programs in 21 CFR Chapter II, 1300—1399 (relating to Drug Enforcement Administration, Department of Justice).

History

Authority: The provisions of this Chapter 715 issued under the Pennsylvania Drug and Alcohol Abuse Control Act (71 P.
Source: The provisions of this Chapter 715 adopted November 15, 2002, effective November 16, 2002, 32 Pa.

28 Pa. Code § 715.3 Approval of narcotic treatment programs.

(a) An entity shall apply for and receive approval as required from the Department, DEA and CSAT or an organization designated by the Substance Abuse and Mental Health Services Administration (SAMHSA), under the authority of section 303 of the Controlled Substances Act (21 U.S.C.A. § 823) and sections 501(d), 509(a), 543, 1923, 1927(a) and 1976 of the Public Health Service Act (42 U.S.C.A. § § 290aa(d), 290bb-2(a), 290dd-2, 300x-23, 300x-27(a) and 300y-11), prior to offering services within this Commonwealth as a narcotic treatment program. Application for approval shall be made simultaneously to the Department, DEA and CSAT or SAMHSA designee.

(1) The Department will forward a recommendation for approval to the Federal officials after a review of policies and procedures and an onsite inspection by an authorized representative of the Department and after a determination has been made that the requirements for approval under this chapter have been met.

(2) The decision of the Federal officials set forth in 21 CFR Chapter II (relating to Drug Enforcement Administration, Department of Justice) or other Federal statutes shall constitute the final determination on the application for approval by DEA and CSAT or SAMHSA designee.

(b) A narcotic treatment program shall be licensed under the Department’s regulations for drug and alcohol facilities in Chapter 704, 705, 709, 710 or 711. When a licensee applies to operate a narcotic treatment program, the history component of the application of the licensee shall include the licensee’s record of operation of any facility regulated by any State or Federal entity. A narcotic treatment program may not be recommended for approval unless licensure has been obtained under Chapters 704, 705, 709, 710 or 711.

(c) The Department will grant approval as a narcotic treatment program after an onsite inspection and review of narcotic treatment program policies, procedures and other material, when the Department determines that the requirements for approval have been met.

(d) The Department will inspect a narcotic treatment program at least annually to determine compliance with State narcotic treatment program regulations. This inspection shall consist of an onsite visit and shall include an examination of patient records, reports, files, policies and procedures, and other similar items to enable the Department to make an evaluation of the status of the narcotic treatment program. The Department may inspect the narcotic treatment program without notice during any regular business hours of the narcotic treatment program.

(e) During the inspection process, a narcotic treatment program shall make available to the authorized staff of the Department full and free access to its premises, facilities, records, reports, files and other similar items necessary for a full and complete evaluation. The Department may make copies of materials it deems necessary under 42 CFR 2.53 (relating to audit and evaluation activities) and § § 709.15 and 711.15 (relating to right to enter and inspect; and right to enter and inspect).

(f) The authorized Department representative may interview patients and staff as part of the inspection process.

(g) The Department may grant approval as a narcotic treatment program after an onsite inspection when the Department determines that a narcotic treatment program satisfies the following:

(1) It has substantially complied with applicable requirements for approval.

(2) It is complying with a plan of correction approved by the Department with regard to any outstanding deficiencies.

(3) Its existing deficiencies will not adversely alter the health, welfare or safety of the facility’s patients.

(h) Notification of deficiencies involves the following:

(1) The authorized Department representative will provide the program director with a record of deficiencies with instructions to submit a plan of correction.

(2) The narcotic treatment program shall complete the plan of correction and submit it to the Department within 21 days after the last day of the onsite inspection.

(3) The Department will not grant approval as narcotic treatment program until the Department receives and approves a plan of correction.

History

Authority: The provisions of this Chapter 715 issued under the Pennsylvania Drug and Alcohol Abuse Control Act (71 P.
Source: The provisions of this Chapter 715 adopted November 15, 2002, effective November 16, 2002, 32 Pa.

28 Pa. Code § 715.4 Denial, revocation, or suspension of approval.

(a) The Department will deny, suspend or revoke approval of a narcotic treatment program if the applicant or program fails to comply with this chapter. Procedures for the revocation, suspension or denial of Department approval, and appeals from these actions, shall be the same as procedures in § § 709.17, 709.18, 711.17 and 711.18.

(b) The Department may recommend to the DEA or CSAT or SAMHSA’s designee to initiate proceedings to revoke or deny Federal approval.

(c) The Department may seek an injunction for the closure of a narcotic treatment program in a court of competent jurisdiction.

History

Authority: The provisions of this Chapter 715 issued under the Pennsylvania Drug and Alcohol Abuse Control Act (71 P.
Source: The provisions of this Chapter 715 adopted November 15, 2002, effective November 16, 2002, 32 Pa.

28 Pa. Code § 715.5 Patient capacity.

The Department may increase or decrease the number of patients a narcotic treatment program may treat. The Department may raise the patient capacity, upon the written request of the narcotic treatment program, based upon the Department’s review of the narcotic treatment program. The factors the Department will consider include:

(1) Safety. Considerations include dispensing time, internal patient flow and external traffic patterns.

(2) Physical facility. Considerations include the number and size of counseling offices, waiting areas, restrooms, and dispensing and nursing windows.

(3) Staff size and composition. Considerations include the number of narcotic treatment physicians, dispensing and counseling staff.

(4) Ability to provide required services. Considerations include compliance with licensing and narcotic treatment program regulations as determined during licensing, monitoring and special visits to the narcotic treatment program.

(5) Availability and accessibility of service. Considerations include the location of the narcotic treatment program and the hours of operation.

History

Authority: The provisions of this Chapter 715 issued under the Pennsylvania Drug and Alcohol Abuse Control Act (71 P.
Source: The provisions of this Chapter 715 adopted November 15, 2002, effective November 16, 2002, 32 Pa.

28 Pa. Code § 715.6 Physician staffing.

(a) A narcotic treatment program shall designate a medical director to assume responsibility for administering all medical services performed by the narcotic treatment program.

(1) A medical director shall be a physician and shall have obtained one of the following:

(i) Three years documented experience in the provision of services to persons who are addicted to alcohol or other drugs, including at least 1 year of experience in the treatment of narcotic addiction with a narcotic drug.

(ii) Certification in addiction medicine by the American Society of Addiction Medicine.

(iii) A certificate of added qualifications in addiction psychiatry by the American Board of Psychiatry and Neurology, Inc.

(2) When a narcotic treatment program is unable to hire a medical director who meets the qualifications in paragraph (1), the narcotic treatment program may hire an interim medical director. The narcotic treatment program shall develop and submit to the Department for approval a training plan for the interim medical director, addressing the measures to be taken for the interim medical director to achieve minimal competencies and proficiencies until the interim medical director meets qualifications identified in paragraph (1)(i), (ii) or (iii). The interim medical director shall meet the qualifications within 36 months of being hired.

(3) The medical director’s responsibilities include the following:

(i) Supervision of narcotic treatment physicians.

(ii) Supervision of licensed practical nurses if the narcotic treatment program does not employ a registered nurse to supervise the nursing staff. In addition, the medical director in these instances shall ensure that licensed practical nurses adhere to written protocols for dispensing and administration of medication.

(b) A narcotic treatment program may employ narcotic treatment physicians to assist the medical director. A narcotic treatment physician’s responsibilities include:

(1) Performing a medical history and physical exam.

(2) Determining diagnosis and determining narcotic dependence.

(3) Reviewing treatment plans.

(4) Determining dosage and all changes in doses.

(5) Ordering take-home privileges.

(6) Discussing cases with the treatment team.

(7) Issuing verbal orders pertaining to patient care.

(8) Assessing coexisting medical and psychiatric disorders.

(9) Treating or making appropriate referrals for treatment of these disorders.

(c) A narcotic treatment physician shall be otherwise available for consultation and verbal medication orders at all times when a narcotic treatment program is open and a narcotic treatment physician is not present.

(d) A narcotic treatment program shall provide narcotic treatment physician services at least 1 hour per week onsite for every ten patients.

(e) A physician assistant or certified registered nurse practitioner may perform functions of a narcotic treatment physician in a narcotic treatment program if authorized by Federal, State and local laws and regulations, and if these functions are delegated to the physician assistant or certified registered nurse practitioner by the medical director, and records are properly countersigned by the medical director or a narcotic treatment physician. One-third of all required narcotic treatment physician time shall be provided by a narcotic treatment physician. Time provided by a physician assistant or certified registered nurse practitioner may not exceed two-thirds of the required narcotic treatment physician time.

This section cited in 28 Pa. Code § 701.1 (relating to definitions).

History

Authority: The provisions of this Chapter 715 issued under the Pennsylvania Drug and Alcohol Abuse Control Act (71 P.
Source: The provisions of this Chapter 715 adopted November 15, 2002, effective November 16, 2002, 32 Pa.

28 Pa. Code § 715.7 Dispensing or administering staffing.

(a) A narcotic treatment program shall be staffed as follows:

(1) If it operates an automated dispensing system, one full-time nurse or other person authorized by law to administer or dispense a controlled substance shall be available for every 200 patients.

(2) If it operates a manual or nonautomatic dispensing system, one full-time nurse or other person authorized by law to administer or dispense a controlled substance shall be available for every 150 patients.

(b) Dispensing time shall be prorated for patient census. There shall be sufficient dispensing staff to ensure that all patients are medicated within 15 minutes of arrival at the dispensing area.

History

Authority: The provisions of this Chapter 715 issued under the Pennsylvania Drug and Alcohol Abuse Control Act (71 P.
Source: The provisions of this Chapter 715 adopted November 15, 2002, effective November 16, 2002, 32 Pa.

28 Pa. Code § 715.8 Psychosocial staffing.

A narcotic treatment program shall comply with the following staffing ratios as established in Chapter 704 (relating to staffing requirements for drug and alcohol treatment activities.):

(1) General requirements. A narcotic treatment program shall comply with the patient/staff and patient/counselor ratios in subparagraphs (i)—(vi) during primary care hours. These ratios refer to the total number of patients being treated, including patients with diagnoses other than drug and alcohol addiction served in other facets of the project. Family units may be counted as one patient.

(i) Inpatient nonhospital detoxification (residential detoxification).

(A) There shall be one full-time equivalent (FTE) primary care staff person available for every seven patients during primary care hours.

(B) There shall be a narcotic treatment physician on-call at all times.

(ii) Inpatient hospital detoxification. There shall be one FTE primary care staff person available for every five patients during primary care hours.

(iii) Inpatient nonhospital treatment and rehabilitation (residential treatment and rehabilitation). A narcotic treatment program serving adult patients shall have one FTE counselor for every eight patients.

(iv) Inpatient hospital treatment and rehabilitation (general, psychiatric or specialty hospital). A narcotic treatment program serving adult patients shall have one FTE counselor for every five patients.

(v) Partial hospitalization. A partial hospitalization narcotic treatment program shall have a minimum of one FTE counselor who provides direct counseling services to every ten patients.

(vi) Outpatients. The counseling caseload for one FTE counselor in an outpatient narcotic treatment program may not exceed 35 active patients.

(2) Counselor assistants. A counselor assistant eligible for a counseling caseload may be included in determining FTE ratios.

History

Authority: The provisions of this Chapter 715 issued under the Pennsylvania Drug and Alcohol Abuse Control Act (71 P.
Source: The provisions of this Chapter 715 adopted November 15, 2002, effective November 16, 2002, 32 Pa.

28 Pa. Code § 715.9 Intake.

(a) Prior to administration of an agent, a narcotic treatment program shall screen each individual to determine eligibility for admission. The narcotic treatment program shall:

(1) Verify that the individual has reached 18 years of age.

(2) Verify the individual’s identity, including name, address, date of birth, emergency contact and other identifying data.

(3) Obtain a drug use history and current drug use status of the individual.

(4) Have a narcotic treatment physician make a face- to-face determination of whether an individual is currently physiologically dependent upon a narcotic drug and has been physiologically dependent for at least 1 year prior to admission for maintenance treatment. The narcotic treatment physician shall document in the patient’s record the basis for the determination of current dependency and evidence of a 1 year history of addiction.

(b) Exceptions to the requirements in subsection (a) are:

(1) A 1 year history of physiologic dependency is not required for detoxification or for pregnant patients.

(2) Upon readmitting a patient who has been out of a narcotic treatment program for 6 months or less after a voluntary termination, the narcotic treatment program shall update the information in and review the patient’s file to show current opiate narcotic dependency, but need not conduct a physical examination and applicable laboratory tests. Privileges earned during the previous treatment may be reinstated at the discretion of the narcotic treatment physician.

(3) A patient who has been treated and later detoxified from comprehensive maintenance treatment may be readmitted to maintenance treatment, without evidence to support findings of current physiologic dependence, up to 2 years after discharge, if the following conditions are met:

(i) The narcotic treatment program attended is able to document prior narcotic drug comprehensive maintenance treatment of 6 months or more.

(ii) The admitting narcotic treatment physician, exercising reasonable clinical judgment, finds readmission to comprehensive maintenance treatment to be medically justified.

(c) If a patient was previously discharged from treatment at another narcotic treatment program, the admitting narcotic treatment program, with patient consent, shall contact the previous facility for the treatment history.

(d) A narcotic treatment program shall explain to each patient treatment options; pharmacology of methadone, LAAM and other agents, including signs and symptoms of overdose and when to seek emergency assistance; detoxification rights; grievance procedures; and clinic charges, including the fee agreement signed by the patient.

(e) A narcotic treatment program shall secure a personal history from the patient within the first week of admission. The personal history shall be made a part of the patient record.

History

Authority: The provisions of this Chapter 715 issued under the Pennsylvania Drug and Alcohol Abuse Control Act (71 P.
Source: The provisions of this Chapter 715 adopted November 15, 2002, effective November 16, 2002, 32 Pa.

28 Pa. Code § 715.10 Pregnant patients.

(a) A narcotic treatment program may place a pregnant patient, regardless of age, who has had a documented narcotic dependency in the past and who may return to narcotic dependency, on a comprehensive maintenance regime.

(1) For these patients, evidence of current physiological dependence on narcotic drugs is not needed if a narcotic treatment physician certifies the pregnancy and, exercising reasonable clinical judgment, finds treatment to be medically justified.

(2) Evidence of all findings and the criteria used to determine the findings shall be recorded in the patient’s record by the admitting narcotic treatment physician before the initial dose is administered to the patient.

(b) A narcotic treatment program shall give pregnant patients the opportunity for prenatal care either by the narcotic treatment program or by referral to appropriate health-care providers.

(c) Counseling records and other appropriate patients records shall reflect the nature of prenatal support provided by the narcotic treatment program.

(d) Within 3 months after termination of pregnancy, the narcotic treatment physician shall enter an evaluation of the patient’s treatment status into her record and state whether she should remain in comprehensive maintenance treatment or receive detoxification treatment.

(e) A patient who is or becomes pregnant may not be started or continued on LAAM, except by the written order of a narcotic treatment physician who determines that LAAM is the best therapy for that patient.

(1) An initial pregnancy test shall be performed for each prospective female patient of childbearing potential before admission to LAAM comprehensive maintenance treatment.

(2) A monthly pregnancy test shall be performed thereafter on female patients on LAAM.

(f) The narcotic treatment program shall ensure that each female patient is fully informed of the possible risk to her or her unborn child from continued use of illicit drugs and from use of, or withdrawal from a narcotic drug administered or dispensed by the program in comprehensive maintenance or detoxification treatment.

History

Authority: The provisions of this Chapter 715 issued under the Pennsylvania Drug and Alcohol Abuse Control Act (71 P.
Source: The provisions of this Chapter 715 adopted November 15, 2002, effective November 16, 2002, 32 Pa.

28 Pa. Code § 715.11 Confidentiality of patient records.

A narcotic treatment program shall physically secure and maintain the confidentiality of all patient records in accordance with 42 CFR 2.22 (relating to notice to patients of Federal confidentiality requirements) and § 709.28 (relating to confidentiality).

This section cited in 28 Pa. Code § 715.20 (relating to patient transfers).

History

Authority: The provisions of this Chapter 715 issued under the Pennsylvania Drug and Alcohol Abuse Control Act (71 P.
Source: The provisions of this Chapter 715 adopted November 15, 2002, effective November 16, 2002, 32 Pa.

28 Pa. Code § 715.12 Informed patient consent.

A narcotic treatment program shall obtain an informed, voluntary, written consent before an agent may be administered to the patient for either maintenance or detoxification treatment. The following shall appear on the patient consent form:

(1) That methadone and LAAM are narcotic drugs which can be harmful if taken without medical supervision.

(2) That methadone and LAAM are addictive medications and may, like other drugs used in medical practices, produce adverse results.

(3) That alternative methods of treatment exist.

(4) That the possible risks and complications of treatment have been explained to the patient.

(5) That methadone is transmitted to the unborn child and will cause physical dependence.

History

Authority: The provisions of this Chapter 715 issued under the Pennsylvania Drug and Alcohol Abuse Control Act (71 P.
Source: The provisions of this Chapter 715 adopted November 15, 2002, effective November 16, 2002, 32 Pa.

28 Pa. Code § 715.13 Patient identification.

(a) A narcotic treatment program shall use a system for patient identification for the purpose of verifying the correct identity of a patient prior to administration of an agent.

(b) A narcotic treatment program shall maintain onsite a photograph of each patient which includes the patient’s name and birth date. The narcotic treatment program shall update the photograph every 3 years.

History

Authority: The provisions of this Chapter 715 issued under the Pennsylvania Drug and Alcohol Abuse Control Act (71 P.
Source: The provisions of this Chapter 715 adopted November 15, 2002, effective November 16, 2002, 32 Pa.

28 Pa. Code § 715.14 Urine testing.

(a) A narcotic treatment program shall complete an initial drug-screening urinalysis for each prospective patient and a random urinalysis at least monthly thereafter.

(1) Each test shall be for opiates, methadone, amphetamines, barbiturates, cocaine and benzodiazepines.

(2) If the narcotic treatment program determines that other drugs are abused in that narcotic treatment program’s locality or have been identified in the patient’s drug and alcohol history as being a drug of abuse or use, a narcotic treatment program may conduct a test or analysis for other drugs as well.

(b) A narcotic treatment program shall develop and implement policies and procedures to ensure that urine collected from patients is unadulterated. These policies and procedures shall include random observation which shall be conducted professionally, ethically and in a manner which respects patient privacy.

(c) A narcotic treatment program shall develop and implement policies and procedures to minimize misidentification of urine specimens and to ensure that the tested specimens can be traced to the donor.

(d) A narcotic treatment program shall ensure that a laboratory that performs the testing required under this section shall be in compliance with applicable Federal requirements, specifically the Clinical Laboratory Improvement Amendments of 1998 (42 U.S.C.A. § § 201 note, 263 and 263a notes), and State requirements, specifically the Pennsylvania Clinical Laboratory Act (35 P. S. § § 2151—2165) and Chapter 5 (relating to clinical laboratories).

History

Authority: The provisions of this Chapter 715 issued under the Pennsylvania Drug and Alcohol Abuse Control Act (71 P.
Source: The provisions of this Chapter 715 adopted November 15, 2002, effective November 16, 2002, 32 Pa.

28 Pa. Code § 715.15 Medication dosage.

(a) The narcotic treatment physician shall review the dosage levels at least twice a year, with each review occurring at least 2 months apart, to determine a patient’s therapeutic dosage.

(b) The narcotic treatment physician shall determine the proper dosage level for a patient, except as otherwise provided in this section. If the narcotic treatment physician determining the initial dose is not the narcotic treatment physician who conducted the patient examination, the narcotic treatment physician shall consult with the narcotic treatment physician who performed the examination before determining the patient’s initial dose and schedule.

(c) Methadone shall be administered or dispensed only in oral form and shall be formulated to reduce its potential for parenteral abuse.

(d) A narcotic treatment program shall label all take-home medication with the patient’s name and the narcotic treatment program’s name, address and telephone number and shall package all take-home medication as required by Federal regulation.

(e) LAAM shall be administered or dispensed only in oral form and shall be formulated to reduce its potential for parenteral abuse.

(f) The narcotic treatment program shall develop written policies and procedures relating to narcotic treatment medication dosage which includes the requirements of subsections (a)—(e).

History

Authority: The provisions of this Chapter 715 issued under the Pennsylvania Drug and Alcohol Abuse Control Act (71 P.
Source: The provisions of this Chapter 715 adopted November 15, 2002, effective November 16, 2002, 32 Pa.

28 Pa. Code § 715.16 Take-home privileges.

(a) A narcotic treatment program shall determine whether a patient may be provided take-home medications.

(1) A narcotic treatment program may give take-home medications only to a patient who the narcotic treatment physician has determined is responsible and able to handle narcotic drugs outside the narcotic treatment program.

(2) The narcotic treatment physician shall make this determination after consultations with staff involved in the patient’s care.

(3) The narcotic treatment physician shall document in the patient record the rationale for permitting take-home medication.

(4) A narcotic treatment physician may rescind take-home medication privileges.

(5) A narcotic treatment program shall develop written policies and procedures relating to granting and rescinding take-home medication privileges.

(b) The narcotic treatment physician shall consider the following in determining whether, in exercising reasonable clinical judgment, a patient is responsible in handling narcotic drugs:

(1) Absence of recent abuse of drugs (narcotic or non-narcotic), including alcohol.

(2) Regular narcotic treatment program attendance.

(3) Absence of serious behavioral problems at the narcotic treatment program.

(4) Absence of known recent criminal activity.

(5) Stability of the patient’s home environment and social relationships.

(6) Length of time in comprehensive maintenance treatment.

(7) Assurance that take-home medication can be safely stored within the patient’s home.

(8) Whether the rehabilitative benefit to the patient derived from decreasing the frequency of attendance outweighs the potential risks of drug diversion.

(c) A narcotic treatment program shall require a patient to come to the narcotic treatment program for observation daily or at least 6 days a week for comprehensive maintenance treatment, unless a patient is permitted to receive take-home medication as follows:

(1) A narcotic treatment program may permit a patient to reduce attendance at the narcotic treatment program for observation to three times weekly and receive no more than a 2-day take-home supply of medication when, in the reasonable clinical judgment of the narcotic treatment physician, which is documented in the patient record:

(i) A patient demonstrates satisfactory adherence to narcotic treatment program rules for at least 3 months.

(ii) A patient demonstrates substantial progress in rehabilitation.

(iii) A patient demonstrates responsibility in handling narcotic drugs.

(iv) A patient demonstrates that rehabilitation progress would improve by decreasing the frequency of attendance for observation.

(2) A narcotic treatment program may permit a patient to reduce attendance at the narcotic treatment program for observation to two times weekly and receive no more that a 3-day take-home supply of medication when in the reasonable clinical judgment of the narcotic treatment physician, which is documented in the patient record:

(i) A patient demonstrates satisfactory adherence to narcotic treatment program rules for at least 2 years.

(ii) A patient demonstrates substantial progress in rehabilitation.

(iii) A patient demonstrates responsibility in handling narcotic drugs.

(iv) A patient demonstrates that rehabilitation progress would improve by decreasing the frequency of attendance for observation.

(3) A narcotic treatment program may permit a patient to reduce attendance at the narcotic treatment program for observation to one time weekly and receive no more than a 6-day take-home supply of medication when in the reasonable clinical judgment of the narcotic treatment physician, which is documented in the patient record:

(i) A patient demonstrates satisfactory adherence to narcotic treatment program rules for at least 3 years.

(ii) A patient demonstrates substantial progress in rehabilitation.

(iii) A patient demonstrates responsibility in handling narcotic drugs.

(iv) A patient demonstrates that rehabilitation progress would improve by decreasing the frequency of attendance for observation.

(v) A patient demonstrates no major behavioral problems.

(vi) A patient is employed, is actively seeking employment, attends school, is a homemaker or is considered unemployable for mental or physical reasons.

(vii) A patient is not known to have abused alcohol or other drugs within the previous year.

(viii) A patient is not known to have engaged in any criminal activity within the previous year.

(d) A narcotic treatment program may make exceptions to the requirements in subsection (c) relating to the length of time of satisfactory adherence to narcotic treatment program rules and number of days of take-home medication when, in the reasonable clinical judgment of the narcotic treatment physician, which is documented in the patient record:

(1) A patient has a permanent physical disability.

(2) A patient has a temporary disability.

(3) A patient has an exceptional circumstance such as illness, personal or family crisis, or travel which interferes with the patient’s ability to conform to the applicable mandatory attendance schedules. In all cases, the patient shall demonstrate an ability to responsibly handle narcotic drugs.

(e) With an exception granted under subsection (d), a narcotic treatment program may not permit a patient to receive more than a 2-week take-home supply of medication.

(f) An exception granted under subsection (d) shall continue only for as long as the temporary disability or exceptional circumstance exists. When a patient is permanently disabled, that case shall be reviewed at least annually to determine whether the need for the exception still exists.

History

Authority: The provisions of this Chapter 715 issued under the Pennsylvania Drug and Alcohol Abuse Control Act (71 P.
Source: The provisions of this Chapter 715 adopted November 15, 2002, effective November 16, 2002, 32 Pa.

28 Pa. Code § 715.17 Medication control.

(a) A narcotic treatment program shall comply with applicable Federal and State statutes and regulations regarding the storing, compounding, administering and dispensing of medication.

(b) A narcotic treatment program shall develop policies and procedures regarding verbal medication orders, including the issuing and receiving of orders, identifying circumstances when orders are appropriate and documenting orders, in accordance with applicable Federal and State statutes and regulations.

(c) A narcotic treatment program shall develop and implement written policies and procedures regarding the medications used by patients which shall include, at a minimum:

(1) Administration of medication.

(i) A narcotic treatment physician shall determine the patient’s initial and subsequent dose and schedule. The physician shall communicate the initial and subsequent dose and schedule to the person responsible for the administration of medication. Each medication order and dosage change shall be written and signed by the narcotic treatment physician.

(ii) An agent shall be administered or dispensed only by a practitioner licensed under the appropriate Federal and State laws to dispense agents to patients.

(iii) Only authorized staff and patients who are receiving medication shall be permitted in the dispensing area.

(iv) There shall be only one patient permitted at a dispensing station at any given time.

(v) Each patient shall be observed when ingesting the agent.

(vi) Administering and dispensing shall be conducted in a manner that protects the patient from disruption or annoyance from other individuals.

(2) Drug storage areas. A narcotic treatment program shall develop and implement written policies and procedures regarding storage of medications and access to the medication storage area. Agents shall be stored in a locked safe that has been approved by the DEA under 21 CFR 1301.72 and 1301.74 (relating to physical security controls; and other security controls).

(3) Inspection of storage areas. A narcotic treatment program shall inspect all drug storage areas and the dispensing station at least quarterly to ensure that the areas are maintained in compliance with Federal, State and local laws and regulations. A narcotic treatment program shall develop and implement written policies and procedures regarding who performs the inspections, how often, and in what manner the inspections are to be documented. The policies and procedures shall include the following:

(i) Disinfectants and drugs for external use shall be stored separately from oral and injectable drugs.

(ii) Drugs requiring special conditions for storage to insure stability shall be properly stored.

(iii) Outdated and contaminated drugs shall be removed and destroyed according to Federal and State regulations.

(iv) Administration of controlled substances shall be documented.

(v) Controlled substances and other abusable drugs shall be stored in accordance with Federal and State regulations.

(4) Method for control and accountability of drugs. A narcotic treatment program shall develop and implement written policies and procedures regarding who is authorized to remove drugs from the storage area and the method for accounting for all stored drugs. An agent or other drug prescribed or administered shall be documented on an individual medication record or sheet in a manner sufficient to maintain an accurate accounting of medication at all times and shall include:

(i) The name of the medication.

(ii) The date prescribed.

(iii) The dosage.

(iv) The frequency.

(v) The route of administration.

(vi) The date and time administered.

(vii) The name of the person administering the medication.

(viii) The take-home schedule, if applicable.

(5) Security of all substances. A narcotic treatment program shall develop and implement written policies and procedures to minimize the likelihood of loss, theft or misuse of an agent or another controlled substance as well as a plan of action if a loss, theft or misuse does occur. In the event of loss, theft or misuse, the Federal and State statutes and regulations regarding reporting shall be followed.

(6) Inventories. A narcotic treatment program shall conduct monthly inventories of agents and other controlled substances stored. Each inventory record shall include:

(i) The date the inventory was conducted.

(ii) The time of day it was conducted.

(iii) The name and amount of each product on hand at the time of the inventory.

(iv) The name of the individual conducting the inventory.

(7) Drug reactions and medication errors. A narcotic treatment program shall report any adverse drug reaction or medication error to a narcotic treatment physician immediately and initiate corrective action. The narcotic treatment program shall record the reaction or error in the drug administration record and the clinical chart, and shall inform each person who is authorized to administer medication or supervise self-medication of the reaction or error.

History

Authority: The provisions of this Chapter 715 issued under the Pennsylvania Drug and Alcohol Abuse Control Act (71 P.
Source: The provisions of this Chapter 715 adopted November 15, 2002, effective November 16, 2002, 32 Pa.

28 Pa. Code § 715.18 Rehabilitative services.

(a) A narcotic treatment program shall provide, either onsite or through referral agreements, a full range of rehabilitative services. Rehabilitative services shall include:

(1) HIV education services.

(2) Employment services.

(3) Adult educational services.

(4) Behavioral health services.

(b) A patient shall also have the opportunity to access legal services.

History

Authority: The provisions of this Chapter 715 issued under the Pennsylvania Drug and Alcohol Abuse Control Act (71 P.
Source: The provisions of this Chapter 715 adopted November 15, 2002, effective November 16, 2002, 32 Pa.

28 Pa. Code § 715.19 Psychotherapy services.

A narcotic treatment program shall provide individualized psychotherapy services and shall meet the following requirements:

(1) A narcotic treatment program shall provide each patient an average of 2.5 hours of psychotherapy per month during the patient’s first 2 years, 1 hour of which shall be individual psychotherapy. Additional psychotherapy shall be provided as dictated by ongoing assessment of the patient.

(2) A narcotic treatment program shall provide each patient at least 1 hour per month of group or individual psychotherapy during the third and fourth year of treatment. Additional psychotherapy shall be provided as dictated by ongoing assessment of the patient.

(3) After 4 years of treatment, a narcotic treatment program shall provide each patient with at least 1 hour of group or individual psychotherapy every 2 months. Additional psychotherapy shall be provided as dictated by ongoing assessment of the patient.

History

Authority: The provisions of this Chapter 715 issued under the Pennsylvania Drug and Alcohol Abuse Control Act (71 P.
Source: The provisions of this Chapter 715 adopted November 15, 2002, effective November 16, 2002, 32 Pa.

28 Pa. Code § 715.20 Patient transfers.

A narcotic treatment program shall develop written transfer policies and procedures which shall require that the narcotic treatment program transfer a patient to another narcotic treatment program for continued maintenance, detoxification or another treatment activity within 7 days of the request of the patient.

(1) The transferring narcotic treatment program shall transfer patient files which include admission date, medical and psychosocial summaries, dosage level, urinalysis reports or summary, exception requests, and current status of the patient, and shall contain the written consent of the patient.

(2) A narcotic treatment program shall maintain the confidentiality of patient records remaining in its possession after the transfer under § 715.11 (relating to confidentiality of patient records).

(3) The transferring narcotic treatment program shall document what materials were sent to the receiving narcotic treatment program.

(4) The receiving narcotic treatment program shall document in writing that it notified the transferring narcotic treatment program of the admission of the patient and the date of the initial dose given to the patient by the receiving narcotic treatment program.

History

Authority: The provisions of this Chapter 715 issued under the Pennsylvania Drug and Alcohol Abuse Control Act (71 P.
Source: The provisions of this Chapter 715 adopted November 15, 2002, effective November 16, 2002, 32 Pa.

28 Pa. Code § 715.21 Patient termination.

A narcotic treatment program shall develop and implement policies and procedures regarding involuntary terminations. Involuntary terminations shall be initiated only when all other efforts to retain the patient in the program have failed.

(1) A narcotic treatment program may involuntarily terminate a patient from the narcotic treatment program if it deems that the termination would be in the best interests of the health or safety of the patient and others, or the program finds any of the following conditions to exist:

(i) The patient has committed or threatened to commit acts of physical violence in or around the narcotic treatment program premises.

(ii) The patient possessed a controlled substance without a prescription or sold or distributed a controlled substance, in or around the narcotic treatment program premises.

(iii) The patient has been absent from the narcotic treatment program for 3 consecutive days or longer without cause.

(iv) The patient has failed to follow treatment plan objectives.

(2) A patient terminated involuntarily, except a patient who commits or threatens to commit acts of physical violence, shall be afforded the opportunity to receive detoxification of at least 7 days. The detoxification may take place at the facility or the patient may be referred to another narcotic treatment program or hospital licensed and approved by the Department for detoxification.

History

Authority: The provisions of this Chapter 715 issued under the Pennsylvania Drug and Alcohol Abuse Control Act (71 P.
Source: The provisions of this Chapter 715 adopted November 15, 2002, effective November 16, 2002, 32 Pa.

28 Pa. Code § 715.22 Patient grievance procedures.

(a) A narcotic treatment program shall develop and utilize a patient grievance procedure.

(b) The procedure shall permit aggrieved patients a full and fair opportunity to be heard, to question and confront persons and evidence used against them and to have a fair review of their grievances by the narcotic treatment program director. If the grievance is filed against the narcotic treatment program director, the review of the case shall be conducted by either a multi-representative group of the narcotic treatment program or a subcommittee of the governing body instituted for the express purposes of grievance adjudication.

(c) Penalties may not be initiated prior to final resolution with the exception that penalties may be initiated against patients who have committed acts of physical violence or who have threatened to commit acts of physical violence in or around the narcotic treatment program premises.

History

Authority: The provisions of this Chapter 715 issued under the Pennsylvania Drug and Alcohol Abuse Control Act (71 P.
Source: The provisions of this Chapter 715 adopted November 15, 2002, effective November 16, 2002, 32 Pa.

28 Pa. Code § 715.23 Patient records.

(a) A narcotic treatment program shall maintain patient records in conformance with 42 CFR 2.16 and 2.22 (relating to security for written records; and notice to patients of Federal confidentiality requirements) and State statutes and regulations. A narcotic treatment program shall maintain a complete file on the premises for each present and former patient of the narcotic treatment program for at least 4 years after the patient has completed treatment or treatment has been terminated. Files shall be updated regularly so that the information is current.

(b) Each patient file shall include the following information:

(1) A complete personal history.

(2) A complete drug and alcohol history.

(3) A complete medical history.

(4) The results of an initial intake physical examination.

(5) The results of all annual physical examinations given by the narcotic treatment program which includes an annual reevaluation by the narcotic treatment physician.

(6) Results of laboratory tests or other special examinations given by the narcotic treatment program.

(7) Documentation of a 1-year history of narcotic dependency, if applicable.

(8) The patient’s current and past narcotic dosage level.

(9) Other drugs prescribed by the narcotic treatment physician and the reasons therefore.

(10) Urine testing results.

(11) Counselor notes regarding patient progress and status.

(12) Applicable consent forms.

(13) Patient record of services.

(14) Case consultation notes regarding the patient.

(15) Psychosocial evaluations of the patient.

(16) Any psychiatric, psychological or other evaluations, if available.

(17) Treatment plans and applicable periodic treatment plan updates.

(18) Federal and State exceptions to the regulations granted to the project on behalf of the patient.

(19) Referrals to other projects or services.

(20) Take-home privileges granted to the patient.

(21) Annual evaluation by the counselor.

(22) Aftercare plan, if applicable.

(23) Discharge summary.

(24) Follow-up information regarding the patient.

(25) Documentation of patient grievances.

(c) An annual evaluation of each patient’s status shall be completed by the patient’s counselor and shall be reviewed, dated and signed by the medical director. The annual evaluation period shall start on the date of the patient’s admission to a narcotic treatment program and shall address the following areas:

(1) Employment, education and training.

(2) Legal standing.

(3) Substance abuse.

(4) Financial management abilities.

(5) Physical and emotional health.

(6) Fulfillment of treatment objectives.

(7) Family and community supports.

(d) A narcotic treatment program shall prepare a treatment plan that outlines realistic short and long-term treatment goals which are mutually acceptable to the patient and the narcotic treatment program.

(1) The treatment plan shall identify the behavioral tasks a patient shall perform to complete each short-term goal.

(2) The narcotic treatment physician or the patient’s counselor shall review, reevaluate, modify and update each patient’s treatment plan as required by Chapters 709, 710 and 711 (relating to standards for licensure of freestanding treatment activities; drug and alcohol services; and standards for certification of treatment activities which are a part of a health care facility).

(e) Patient file records, information and documentation shall be legible, accurate, complete, written in English and maintained on standardized forms or electronically.

(f) If a narcotic treatment program keeps patient information in more than one file or location, it is the responsibility of the narcotic treatment program to provide the entire patient record to authorized persons conducting narcotic treatment program approval activities at the narcotic treatment program, upon request.

History

Authority: The provisions of this Chapter 715 issued under the Pennsylvania Drug and Alcohol Abuse Control Act (71 P.
Source: The provisions of this Chapter 715 adopted November 15, 2002, effective November 16, 2002, 32 Pa.

28 Pa. Code § 715.24 Narcotic detoxification.

If a narcotic treatment program provides narcotic detoxification services, the narcotic treatment program shall develop and implement narcotic detoxification policies and procedures which include the following:

(1) For narcotic detoxification from methadone or any other narcotic, the detoxification service may not exceed 180 days.

(2) For calculating the 1-year narcotic dependency history required for admission to maintenance treatment, the narcotic detoxification period may not be included.

(3) A 1-year physiologic dependence is not required for narcotic detoxification although documentation of current dependency is required.

(4) Minimum requirements for short-term narcotic detoxification treatment are as follows:

(i) Take-home medication is not allowed during a 30-day narcotic detoxification treatment. A narcotic treatment program shall observe the patient ingesting the medication 7 days per week.

(ii) The narcotic treatment program shall perform an initial drug screening test or analysis.

(iii) The narcotic treatment program shall develop a treatment plan. The patient’s counselor shall monitor the patient’s progress toward the goal of short-term narcotic detoxification and possible drug-free treatment referral.

(iv) No narcotic treatment program may provide short-term narcotic detoxification treatment to an individual until at least 7 days after the conclusion of any previous short-term narcotic detoxification treatment.

(5) Minimum requirements for long-term detoxification treatment are as follows:

(i) A narcotic treatment program shall administer medication to allow a patient to attain drug-free status and to make progress in rehabilitation within 180 days or less.

(ii) A narcotic treatment program shall perform an initial drug screening test or analysis. A narcotic treatment program shall perform at least one additional random test or analysis monthly on each patient during long-term narcotic detoxification.

(iii) The narcotic treatment program shall develop an initial treatment plan, and update the plan monthly.

(iv) A narcotic treatment program shall observe the patient while ingesting the medication at least 6 days a week.

(v) No narcotic treatment program may provide long-term narcotic detoxification treatment to an individual until at least 7 days after the conclusion of any previous narcotic detoxification treatment.

History

Authority: The provisions of this Chapter 715 issued under the Pennsylvania Drug and Alcohol Abuse Control Act (71 P.
Source: The provisions of this Chapter 715 adopted November 15, 2002, effective November 16, 2002, 32 Pa.

28 Pa. Code § 715.25 Prohibition of medication units.

Narcotic treatment medication units are prohibited.

History

Authority: The provisions of this Chapter 715 issued under the Pennsylvania Drug and Alcohol Abuse Control Act (71 P.
Source: The provisions of this Chapter 715 adopted November 15, 2002, effective November 16, 2002, 32 Pa.

28 Pa. Code § 715.26 Security.

(a) A narcotic treatment program shall meet the security standards for the distribution and storage of controlled substances as required by Federal regulations, including 21 CFR 1301.72 and 1301.74 (relating to physical security controls; and other security controls) and State statutes and regulations.

(b) Each narcotic treatment program shall provide the Department with a specific plan describing the efforts it will make to avoid disruption of the community by its patients and the actions it will take to assure responsiveness to the community. This plan shall designate a staff member to act as community liaison.

History

Authority: The provisions of this Chapter 715 issued under the Pennsylvania Drug and Alcohol Abuse Control Act (71 P.
Source: The provisions of this Chapter 715 adopted November 15, 2002, effective November 16, 2002, 32 Pa.

28 Pa. Code § 715.27 Readmission.

If a patient requests readmission to a narcotic treatment program after voluntary termination from that narcotic treatment program, that narcotic treatment program shall provide that patient with an evaluation interview and shall give that patient priority consideration for readmission.

History

Authority: The provisions of this Chapter 715 issued under the Pennsylvania Drug and Alcohol Abuse Control Act (71 P.
Source: The provisions of this Chapter 715 adopted November 15, 2002, effective November 16, 2002, 32 Pa.

28 Pa. Code § 715.28 Unusual incidents.

(a) A narcotic treatment program shall develop and implement policies and procedures to respond to the following unusual incidents:

(1) Physical assault by a patient.

(2) Inappropriate behavior by a patient causing disruption to the narcotic treatment program.

(3) Selling of drugs on the premises.

(4) Complaints of patient abuse (physical, verbal, sexual and emotional).

(5) Death or serious injury due to trauma, suicide, medication error or unusual circumstances.

(6) Significant disruption of services due to disaster such as fire, storm, flood or other occurrence.

(7) Incident with potential for negative community reaction or which the facility director believes may lead to community concern.

(8) Theft, burglary, break-in or similar incident at the facility.

(9) Drug related hospitalization of a patient.

(10) Other unusual incidents the narcotic treatment program believes should be documented.

(b) These policies and procedures shall include the following:

(1) Documentation of the unusual incident.

(2) Prompt review and investigation.

(3) Implementation of a timely and appropriate corrective action plan, when indicated.

(4) Ongoing monitoring of the corrective action plan.

(c) A narcotic treatment program shall file a written Unusual Incident Report with the Department within 48 hours following an unusual incident including the following:

(1) Complaints of patient abuse (physical, verbal, sexual and emotional).

(2) Death or serious injury due to trauma, suicide, medication error or unusual circumstances.

(3) Significant disruption of services due to a disaster such as a fire, storm, flood or other occurrence.

(4) Incidents with potential for negative community reaction or which the facility director believes may lead to community concern.

(5) Drug related hospitalization of a patient.

History

Authority: The provisions of this Chapter 715 issued under the Pennsylvania Drug and Alcohol Abuse Control Act (71 P.
Source: The provisions of this Chapter 715 adopted November 15, 2002, effective November 16, 2002, 32 Pa.

28 Pa. Code § 715.29 Exceptions.

A narcotic treatment program is permitted, at the time of application or any time thereafter, to request an exception from a specific regulation.

(1) The request for an exception from a specific regulation shall be in writing, with governing body approval, and shall state how the narcotic treatment program will meet the intent of the regulation.

(2) The Department may withhold the granting of an exception and may require a narcotic treatment program to be in actual operation to assess if the exception is appropriate.

(3) The Department will reserve the right to revoke any exception previously granted.

(4) The narcotic treatment program shall maintain documentation of the Department’s approval of an exception.

(5) If the exception relates to a specific patient, the narcotic treatment program shall maintain documentation of the exception in the patient’s record.

History

Authority: The provisions of this Chapter 715 issued under the Pennsylvania Drug and Alcohol Abuse Control Act (71 P.
Source: The provisions of this Chapter 715 adopted November 15, 2002, effective November 16, 2002, 32 Pa.

28 Pa. Code § 715.30 Applicability.

This chapter applies to the use of any agent which may be approved by the Department for use in narcotic or opioid dependency medication therapy. This chapter applies to the administration of any agent which may be approved by the Department for use in the treatment of opioid dependency.

History

Authority: The provisions of this Chapter 715 issued under the Pennsylvania Drug and Alcohol Abuse Control Act (71 P.
Source: The provisions of this Chapter 715 adopted November 15, 2002, effective November 16, 2002, 32 Pa.

Chapter 717 Standards for Drug and Alcohol Recovery House Licensure.

28 Pa. Code § 717.1 Scope.

(a) This chapter establishes the procedures for the issuance of a drug and alcohol recovery house license.

(b) This chapter provides standards for the licensure of a drug and alcohol recovery house under subarticle B of Article XXIII-A of The Administrative Code of 1929 (71 P.S. § § 613.11—613.18).

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.2 Legal base.

The authority of the Department to license drug and alcohol recovery houses is established under section 2312-A of The Administrative Code of 1929 (71 P.S. § 613.12).

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.3 Definitions.

The following words and phrases when used in this chapter shall have the meanings given to them in this section unless the context clearly indicates otherwise: Drug—As defined in section 2 of the Controlled Substance, Drug, Device and Cosmetic Act (35 P.S. § 780-102). Drug and alcohol recovery house—As defined in section 2311-A of The Administrative Code of 1929 (71 P.S. § 613.11). Full license—A certificate issued by the Department when it has found a licensee in compliance with the requirements of this chapter. Illicit—Unlawful for the person to possess under the laws of the Commonwealth of Pennsylvania. License—A full or provisional certificate which indicates the Department has found a drug and alcohol recovery house to be in full or substantial compliance with the standards established under this chapter. Licensee—A person, society, corporation, governing authority or partnership legally responsible for the administration and operation of a drug and alcohol recovery house to which the Department has issued a license. Provisional license—A certificate issued by the Department when it has found the licensee in substantial but not complete compliance with the requirements of this chapter. Volunteer—A person who assists in implementing daily program activities under the supervision of a project staff person or house manager without promise, expectation or receipt of compensation for services rendered.

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.4 Exceptions.

(a) The Department may in its discretion grant exceptions or extensions of time to this chapter upon a showing by a drug and alcohol recovery house that it meets the policy objectives of this chapter. The Department will not grant an exception that violates any statute.

(b) A drug and alcohol recovery house shall submit all requests for exceptions in writing.

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.5 Revocation of exceptions.

(a) The Department may revoke an exception granted under this chapter. The Department will provide a written notice of revocation that states the reason for the revocation and a specific date when the revocation will take effect.

(b) The Department will allow at least 30 days between the mailing date of the notice of revocation and the date of termination of an exception.

(c) A drug and alcohol recovery house may file a written appeal within 30 days of the mailing date of the notice of revocation of the exception.

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.6 Application and renewal.

(a) An applicant for an initial license shall submit to the Department all of the following for each drug and alcohol recovery house:

(1) An application on a form prescribed by the Department.

(2) A copy of all policies and procedures required under § § 717.17—717.19, 717.22, 717.24—717.28, 717.30 and 717.31.

(3) An application fee of $250.

(b) A licensee applying for renewal of a license shall submit to the Department all of the following for each drug and alcohol recovery house:

(1) An application on a form prescribed by the Department.

(2) A copy of all policies and procedures required under § § 717.17—717.19, 717.22, 717.24—717.28, 717.30 and 717.31 that have been revised since the previous application.

(3) A renewal fee of $250.

(c) The Department will assess a fee of $250 in addition to the fees in subsections (a) and (b) for each issuance of a provisional license under § 717.8 (relating to provisional licensure).

(d) The Department will assess a fee of $100 in addition to the fees in subsections (a), (b) and (c) for issuance of a provisional license under § 717.8 based on a violation cited as a result of a complaint investigation. The Department may waive or reduce the fee under this subsection when the licensee fully implements an approved plan of correction.

(e) The Department will not issue or renew a license until the applicant or licensee has completed and submitted all forms, documents, and fees required under this section.

This section cited in 28 Pa. Code § 717.33 (relating to drug and alcohol recovery house registry).

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.7 Full licensure.

(a) The Department will issue a full license to operate the drug and alcohol recovery house when it determines, after an on-site inspection by an authorized representative of the Department, that the applicant or licensee has met the requirements for licensure under this chapter.

(b) The Department will issue a full license to an applicant or licensee and will indicate the name of the drug and alcohol recovery house, the address and the date of issuance.

(d) The drug and alcohol recovery house shall display the current license in a public and conspicuous place in the drug and alcohol recovery house.

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.8 Provisional licensure.

(a) The Department will issue a provisional license, valid for a specific time period of no more than 6 months when the Department finds that a drug and alcohol recovery house:

(1) has substantially, but not completely, complied with applicable requirements for licensure.

(2) is complying with a course of correction approved by the Department; and

(3) has existing deficiencies that will not adversely alter the health, welfare or safety of the residents.

(b) Within 15 working days of receipt of the deficiency report, the applicant or licensee shall submit a plan to correct deficiencies noted during the site visits.

(d) The Department will issue a full license upon compliance with this part and receipt of the $250 renewal fee.

(e) The drug and alcohol recovery house shall display the current license in a public and conspicuous place in the drug and alcohol recovery house.

This section cited in 28 Pa. Code § 717.6 (relating to application and renewal).

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.9 Restriction on license.

(a) A license applies to the licensee, the named drug and alcohol recovery house and the premises designated in the license and is not transferable prior to proper and timely notification as provided under subsection (b).

(b) The licensee, using Department forms, shall notify the Department within 90 days of the occurrence of any of the following conditions:

(1) Change in ownership.

(2) Change in name of the drug and alcohol recovery house.

(3) Change in location of the drug and alcohol recovery house.

(4) Change in maximum occupancy.

(5) Closing of the drug and alcohol recovery house.

(c) Failure to notify the Department as required under subsection (b) will result in automatic expiration of the license.

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.10 Right to enter and inspect.

(a) An authorized representative of the Department has the right to enter, visit and inspect a drug and alcohol recovery house licensed or applying for a license under this chapter.

(b) The authorized Department representative shall have full and free access to the records of the drug and alcohol recovery house and its residents.

(c) The authorized Department representative has the right to interview residents as part of the visitation and inspection process.

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.11 Notification of deficiencies.

(a) The Department will provide written notice to the applicant or licensee of any noncompliance with regulations, along with instructions for the applicant or licensee to submit and complete a plan to correct the noncompliance.

(b) The applicant or licensee shall complete and submit the plan to correct the noncompliance in accordance with the instructions to the Department within 15 working days after the site visit.

(c) The Department will not renew a license until it has approved a plan of action. The Department will not issue a license to an applicant until the applicant has corrected all noncompliance.

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.12 Refusal or revocation of license.

(a) The Department may revoke or refuse to issue a license for any of the following reasons:

(1) Failure to comply with a directive issued by the Department.

(2) Violation of, or noncompliance with, this chapter.

(3) Failure to comply with a plan of correction approved by the Department, unless the Department approves an extension or modification of the plan of correction.

(4) Gross incompetence, negligence or misconduct in the operation of the drug and alcohol recovery house.

(5) Fraud, deceit, misrepresentation or bribery in obtaining or attempting to obtain a license.

(6) Lending, borrowing or using the license of another drug and alcohol recovery house.

(7) Knowingly aiding or abetting the improper granting of a license.

(8) Mistreating or abusing residents at the drug and alcohol recovery house.

(9) Continued noncompliance in disregard of this part.

(10) Operating a drug and alcohol recovery house that, by nature of its physical condition, endangers the health and safety of the public.

(b) If the Department proposes to revoke or refuse to issue a license, it will give written notice to the applicant or licensee by certified mail, stating the following:

(1) The reasons for the proposed action.

(2) The specific time period for the drug and alcohol recovery house to correct deficiencies.

(c) If the drug and alcohol recovery house does not correct the deficiencies within the specified time, the Department will officially notify the applicant or licensee that it shall show cause why its license should not be denied or revoked under 1 Pa. Code § 35.14 (relating to orders to show cause), and that it has a right to a hearing authorized by the Department on this question. The applicant or licensee shall file a written request within 30 days of receipt of the show cause order.

(d) Subsection (c) supplements 1 Pa. Code § 35.14.

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.13 Hearings.

(a) The Department will convene and conduct a show cause hearing for a drug and alcohol recovery house under 1 Pa. Code § 35.37 (relating to answers to orders to show cause) and this chapter.

(b) An administrative hearing held under this section will be conducted under 1 Pa. Code Part II (relating to General Rules of Administrative Practice and Procedure).

(d) This section supplements 1 Pa. Code Part II.

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.14 Fines.

(a) The Department will impose fines on the operator of an unlicensed recovery house in accordance with section 2316-A(a) of The Administrative Code of 1929 (71 P.S. § 613.16(a)).

(b) For purposes of a violation under section 2316-A(a) of The Administrative Code of 1929, each day of operating a drug and alcohol recovery house that requires a license without a current license shall constitute a separate violation.

The provisions of this § 717.14 added December 10, 2021, effective in 180 days, 51 Pa.B. 7670.

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.15 House manager.

(a) The licensee shall designate a house manager to be the administrator of the drug and alcohol recovery house who is responsible for the management of the drug and alcohol recovery house, staff and volunteers.

(b) The licensee shall identify the house manager in the application submitted to the Department and shall notify the Department in writing any time the house manager changes within 30 days.

(c) The house manager shall complete at least 6 hours of training in one or more of the following areas within 6 months of becoming house manager, and annually thereafter:

(1) Fiscal policy.

(2) Administration.

(3) Program planning.

(4) Quality assurance.

(5) Program licensure.

(6) Personnel management.

(7) Confidentiality.

(8) Ethics.

(9) Trends in drug use and misuse.

(10) Developmental psychology.

(11) Interaction of addiction and mental illness.

(12) Cultural awareness.

(13) Sexual harassment.

(14) Relapse prevention.

(15) Substance use disorders.

(16) Peer support or mutual aid groups.

(17) Best practices for medication control and self-administration.

(18) Infection control.

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.16 Fiscal management.

The licensee shall develop and implement written policies and procedures for management of all funds received and expended by the drug and alcohol recovery house in accordance with standard accounting practices, including an itemized record and documentation of all revenues and expenditures.

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.17 Personnel management.

(a) The licensee shall develop and implement written personnel policies and procedures in compliance with State and Federal employment laws, including:

(1) The Pennsylvania Human Relations Act (43 P.S. § § 951—963).

(2) Title VII of the Civil Rights Act of 1964, (Pub.L. No. 88-352).

(3) Title I of the Americans with Disabilities Act of 1990, (Pub.L. No. 101-336).

(4) The Age Discrimination in Employment Act of 1967, (29 U.S.C.A. § § 621—634).

(b) The written policies and procedures must include all of the following:

(1) Use of volunteers.

(2) Rules of conduct.

(3) Supervision of staff.

(4) Orientation of new employees.

(5) Prohibition on providing or using alcohol or illicit drugs on the premises of the drug and alcohol recovery house, including consequences for a violation of the policy.

(6) Relapse of recovering staff and volunteers, including consequences for a violation of the policy.

(7) Completion of a Pennsylvania State Police criminal history record check for the house manager, all staff and volunteers before engaging in work at the drug and alcohol recovery house.

(c) The licensee shall maintain a personnel record for the house manager and each staff person and volunteer, which must include all of the following:

(1) Application or resume.

(2) A Pennsylvania State Police criminal history record check.

(3) Disciplinary actions.

(4) A written job description for each drug and alcohol recovery house position.

(5) Documentation of training.

This section cited in 28 Pa. Code § 717.6 (relating to application and renewal).

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.18 Training.

(a) The licensee shall develop and implement written staff development policies and procedures that identify the person responsible and the time frames for completion of all of the following:

(1) An assessment of training needs for each staff person and volunteer.

(2) A plan for addressing those needs.

(3) A mechanism to collect feedback on completed training.

(b) The licensee shall conduct and document an evaluation of the training plan annually.

(c) In addition to training identified and provided under subsection (a), staff persons and volunteers shall complete all of the following within 90 days of becoming an employee or volunteer:

(1) Cardiopulmonary resuscitation (CPR) certification.

(2) First aid training, including training on overdose reversal medication.

(3) HIV/AIDS, tuberculosis and sexually transmitted diseases training using a Department approved curriculum.

(4) Fire prevention and emergency preparedness, including use of a fire extinguisher.

This section cited in 28 Pa. Code § 717.6 (relating to application and renewal).

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.19 Resident rights.

(a) The licensee shall develop and implement written policies and procedures on resident rights which must include all of the following:

(1) Residents shall retain all civil rights that have not been specifically curtailed by separate judicial or administrative determination by the appropriate legal authority.

(2) The licensee may not discriminate against a resident on the basis of age, race, sex, religion, ethnic origin, economic status, disability, sexual orientation or gender identity or expression.

(3) Residents have the right to inspect their own records.

(4) Residents have the right to request the correction of information in their records on the basis that it is inaccurate, irrelevant, outdated or incomplete.

(5) Residents have the right to submit a rebuttal to information in their records.

(6) Residents may attend a treatment facility of their choice outside of the drug and alcohol recovery house. The licensee may not require a resident to attend or prohibit a resident from attending a specific treatment facility.

(b) The licensee shall obtain written acknowledgement by residents that they have received notice of their rights.

This section cited in 28 Pa. Code § 717.6 (relating to application and renewal).

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.20 Resident records.

(a) The licensee shall maintain an individual record for each resident which must include all of the following:

(1) All records obtained under § 717.22 (relating to beginning of residency).

(2) Consent to residency form.

(3) Referrals to and from the drug and alcohol recovery house, if applicable.

(b) The licensee shall keep hard copy resident records in a locked cabinet and secure digital resident records on a protected data system.

(c) The licensee shall maintain resident records, regardless of format, for at least 4 years following the ending or completion of residency.

(d) If the licensee discontinues operation of a drug and alcohol recovery house, it shall notify the Department where it will store resident records.

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.21 Resident roster.

(a) The licensee shall maintain a resident roster that identifies the date of each resident’s beginning and end or completion of residency.

(b) The licensee shall maintain the information in subsection (a) on the resident roster for each resident for at least 4 years following the ending or completion of residency.

(c) The licensee shall store physical copies of the resident roster in a locked cabinet or secure digital copies of the resident roster in a protected data system.

(d) A licensee that discontinues operation of a drug and alcohol recovery house shall notify the Department where it will store the resident roster.

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.22 Beginning of residency.

(a) The licensee shall develop and implement written policies and procedures for beginning of residency which include all of the following:

(1) Residency criteria.

(2) Requirements for completion of residency by meeting a resident’s treatment, personal or financial goals or social-emotional or other needs.

(3) Criteria for ending residency before completion under paragraph (2), including a timeline.

(b) The licensee shall complete all of the following documentation, which must be signed by the resident, within 24 hours of arrival:

(1) Disclosure to the resident of criteria for beginning and ending residency.

(2) Resident orientation to the drug and alcohol recovery house which must include all of the following:

(i) Drug and alcohol recovery house rules, including a method to record residents’ expected return time to the drug and alcohol recovery house.

(ii) Fee schedule including any lease agreement.

(iii) Supports provided by the drug and alcohol recovery house, as well as referrals to other essential services as needed.

(iv) Financial policies and procedures.

(v) The location of posted emergency procedures and contact information for the house manager and the Department.

(vi) Medication control and self-administration policies.

(3) Basic personal data including:

(i) Name.

(ii) Birth date.

(iii) Demographic information.

(iv) Medical information provided by the resident, including allergies, asthma, seizure disorder, diabetes, pacemaker and other medical conditions that the resident chooses to have in the house record.

(v) Drug and alcohol history.

(vi) Medical contact information.

(vii) Emergency contact.

(4) Consent to residency.

(5) Disclosure to the resident of the recovery house’s policies and procedures for situations when recovery house staff may notify the resident’s emergency contact.

This section cited in 28 Pa. Code § 717.6 (relating to application and renewal); and 28 Pa. Code § 717.20 (relating to resident records).

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.23 Notification of decision to end residency.

(a) The licensee shall notify the resident in writing of a decision to end residency. The notice must include the reason and a timeframe for ending residency.

(b) The resident shall have an opportunity to request the licensee reconsider a decision to end residency before the decision to end residency takes effect.

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.24 Medication control and self-administration.

The licensee shall develop and implement written policies and procedures on the use of prescription and over-the-counter medications by residents, which must include all of the following:

(1) Self-administration of medication for residents who take medication.

(2) Safe storage of medication by the drug and alcohol recovery house and residents and procedures to address loss, theft, abandonment or misuse of medications. The policy must provide that controlled substances stored at the drug and alcohol recovery house will be kept in a locked container.

(3) Safe disposal of unused, expired or abandoned medication, in accordance with Federal and State regulations.

(4) Emergency procedures if an adverse medication reaction or overdose occurs on premises. The licensee shall have and make available overdose reversal medication on the premises of the drug and alcohol recovery house at all times.

(5) Prohibition on sharing prescription medication.

This section cited in 28 Pa. Code § 717.6 (relating to application and renewal).

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.25 Financial transactions.

(a) The licensee shall develop and implement written policies and procedures to maintain a complete record of collection of fees, payments and deposits between the licensee, the drug and alcohol recovery house or its employees and the resident or on behalf of the resident in accordance with standard accounting practices. The record must include all of the following:

(1) All fee deposits, resident fees and other monetary transactions between the drug and alcohol recovery house and the resident.

(2) Documentation that the drug and alcohol recovery house returned all deposits due to the resident when the resident departed the drug and alcohol recovery house, signed and dated by the licensee and resident.

(b) The licensee shall develop and implement written policies and procedures that prohibit the licensee, staff, volunteers or contractors of the drug and alcohol recovery house from all of the following:

(1) Requiring a resident to sign a document relinquishing the resident’s public assistance benefits, including medical assistance benefits, cash assistance, Supplemental Security Income and Supplemental Nutrition Assistance Program benefits.

(2) Requiring a resident to surrender cash or sign over a paycheck.

(3) Borrowing money from a resident or lending money to a resident.

(4) Buying property from a resident or selling property to a resident.

(5) Directly or indirectly soliciting or accepting a commission, fee or anything of monetary or material value from residents, other related individuals, third-party entities or referral sources, beyond specified rent established in writing at the time of residency.

(d) A licensee may assist a resident in managing the resident’s finances, budgeting and spending. The following apply:

(1) The licensee shall keep a record of financial transactions in accordance with standard accounting practices, including the dates, amounts of deposits, amounts of withdrawals and the current balance.

(2) The licensee shall disburse resident funds during normal business hours within 24 hours of the resident’s request.

(3) The licensee shall obtain a written receipt from the resident for cash disbursements at the time of disbursement.

(4) The licensee shall only use resident funds and property for the resident’s benefit.

(5) The licensee may not commingle resident funds and house funds.

(6) If the licensee is holding more than $200 for a resident for more than 2 consecutive months, the licensee shall notify the resident and offer assistance in establishing an interest-bearing account in the resident’s name at a local Federally-insured financial institution. This does not include security deposits.

(7) The licensee, staff, volunteers or contractors shall not be assigned power of attorney or guardianship of a resident or a resident’s estate.

(8) The licensee shall maintain a copy of the itemized account in the resident’s record.

(9) The licensee shall provide the resident the opportunity to review their own financial record upon request during normal business hours.

(e) The licensee shall establish a written agreement with a resident before assisting in managing the resident’s finances. The following apply:

(1) The licensee and resident shall sign the agreement.

(2) The agreement must include all of the following:

(i) The financial assistance provided by the licensee.

(ii) The right of the resident to at least 30 days advance notice, in writing, of the licensee’s request to change the agreement.

(iii) The right of the resident to rescind the agreement in writing.

(3) The licensee shall maintain a copy of the financial management services agreement in the resident’s record.

This section cited in 28 Pa. Code § 717.6 (relating to application and renewal).

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.26 Complaint management.

The licensee shall develop and implement written policies and procedures for managing complaints from residents, family members and community members, which must include procedures for informing residents, family members and community members of the complaint process, including the ability to file a complaint with the Department.

This section cited in 28 Pa. Code § 717.6 (relating to application and renewal).

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.27 Notification to family member or emergency contact.

(a) The licensee shall develop and implement written policies and procedures that specify the methods and circumstances, including the resident’s hospitalization or death, for notifying the resident’s emergency contact with the resident’s consent. The resident may revoke consent to provide notice to the emergency contact.

(b) The licensee shall make at least one attempt to notify the resident’s emergency contact in accordance with subsection (a) immediately and in no event more than 12 hours after the resident decides to end residency or does not return to the drug and alcohol recovery house as expected. This subsection shall not apply if the licensee knows or has reason to know of allegations of domestic abuse on the resident by the emergency contact.

This section cited in 28 Pa. Code § 717.6 (relating to application and renewal).

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.28 Resident requirements.

The licensee shall develop and implement written policies and procedures that:

(1) promote and require that residents participate in treatment, self-help groups or other drug and alcohol recovery supports; and

(2) require that residents abstain from use and sale of alcohol and illicit drugs, and provide consequences for failure to abstain.

This section cited in 28 Pa. Code § 717.6 (relating to application and renewal).

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.29 Physical plant standards.

(a) Compliance with applicable laws.

The licensee shall follow applicable Federal, State and local laws and ordinances, including the Americans with Disabilities Act of 1990 (Pub.L. No. 101-336).

(b) Building interior, exterior and grounds.

(1) The licensee shall do all of the following:

(i) Keep the interior, exterior, and grounds or yard of the drug and alcohol recovery house clean, safe, sanitary and in good repair and free of hazards at all times.

(ii) Store all trash in noncombustible, covered containers that prevent the penetration of insects and rodents and remove all trash at least once each week.

(iii) Keep the drug and alcohol recovery house free of rodent and insect infestation.

(iv) Limit smoking to designated outside smoking areas.

(v) Keep exterior exits, stairs and walkways lighted at night.

(1) The licensee shall:

(i) provide at least one living room or lounge for the free and informal use by residents, their families and invited guests; and

(ii) maintain furnishings in a state of good repair.

(d) Sleeping accommodations.

(1) Each drug and alcohol recovery house bedroom must have all of the following:

(i) A bed in good repair with a solid foundation and fire-retardant mattress for each resident.

(ii) A pillow, sheets and other bedding in good condition and appropriate for the temperature in the drug and alcohol recovery house for each resident.

(iii) A storage area for clothing for each resident.

(iv) At least 60 square feet of floor space per resident measured wall to wall in each shared bedroom.

(v) At least 50 square feet of floor space per resident measured wall to wall in each shared bedroom with bunk beds. Bunk beds must meet all of the following requirements:

(A) Provide enough space in between each bed and the ceiling to allow a resident to sit up in bed.

(B) Be equipped with a securely attached ladder capable of supporting a resident.

(vi) At least 70 square feet of floor space measured wall to wall in each single bedroom.

(vii) Direct access to a corridor or external exit.

(viii) Ventilation by operable windows or have mechanical ventilation.

(ix) A window with a source of natural light.

(2) A bedroom may not:

(i) be used as a means of egress from or access to another part of the drug and alcohol recovery house unless the bedroom is used as an exit under § 717.30(b)(2) (relating to safety and emergency procedures); or

(ii) contain the sole egress to a stairway or basement.

(3) Notwithstanding requirements in paragraph (1) and (2), bedrooms located in a basement must have all of the following:

(i) Wall, floor and ceiling coverings such as tile, linoleum, paneling or dry wall.

(ii) A protective fire wall between the bedroom and a furnace.

(iii) A direct means of egress from the basement to the outside.

(e) Bathrooms. The licensee shall do all of the following:

(1) Provide bathrooms to accommodate residents, staff, volunteers and guests.

(2) Provide a sink, a wall mirror, a soap dispenser and either individual towels, paper towels, or a mechanical dryer in each bathroom.

(3) Have hot and cold water under pressure. Hot water temperature may not exceed 120°F.

(4) Provide privacy in toilets by doors, and in showers and bathtubs by partitions, doors or curtains. There must be slip-resistant surfaces in all bathtubs and showers.

(5) Ventilate toilet and wash rooms by exhaust fan or window.

(6) Provide toilet paper at each toilet at all times.

(7) Maintain each bathroom in a functional, clean and sanitary manner at all times.

(f) Kitchens. The licensee shall do all of the following:

(1) Provide a kitchen area with capacity for residents to safely store food items and prepare meals. The kitchen area must include refrigerator, sink, stove, oven and cabinet space in a good state of repair.

(2) Ensure that storage areas for foods are free of food particles, dust and dirt.

(3) Ensure that refrigerators maintain cold food at or below 40°F and freezers maintain frozen food at or below 0°F.

(4) Ensure that food items are stored off the floor.

(g) Heating and cooling. The licensee:

(1) shall maintain an indoor temperature in the drug and alcohol recovery house between 65°F and 90°F at all times; and

(2) may not use or permit portable space heaters.

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.30 Safety and emergency procedures.

(a) Policies and procedures. The licensee shall develop and implement written policies and procedures for staff and residents to follow in an emergency which must include provisions for all of the following:

(1) The evacuation and transfer of residents, staff and volunteers to a safe location.

(2) Assignments of staff and volunteers during emergencies.

(3) The evacuation and transfer of residents impaired by alcohol or other drugs.

(4) Notification to the Department within 48 hours of a fire, other disaster or situation which affects the continuation of operations.

(b) Exits. The licensee shall do all of the following:

(1) Ensure that stairways, hallways and exits from rooms and from the drug and alcohol recovery house are unobstructed.

(2) Maintain a minimum of two unobstructed exits that are separated by a minimum distance of 15 feet on every floor that contains resident bedrooms. Equipment such as ladders and escapes located above the ground floor must be securely affixed to the house. Rooms, including resident bedrooms, that contain an exit must be unlocked and accessible to all residents in the event of an emergency.

(3) Maintain each ramp, interior stairway and outside steps exceeding two steps with a well-secured handrail and maintain each porch that has over an 18-inch drop with a well-secured railing.

(4) Clearly indicate exits.

(5) Light interior exits and stairs at all times.

(1) The licensee shall do all of the following:

(i) Maintain at least one operable, automatic smoke detector on each floor, including the basement and attic.

(ii) Maintain a smoke detector within 15 feet of each bedroom door on floors with resident bedrooms.

(iii) Repair inoperable smoke detectors within 48 hours.

(iv) Maintain carbon monoxide detectors in drug and alcohol recovery houses that have heating systems in which carbon monoxide is a byproduct of the heating system and in drug and alcohol recovery houses with attached garages. The carbon monoxide detector must be located within 15 feet of the carbon monoxide source, audible to drug and alcohol recovery house residents and maintained in an operable state.

(v) Inspect, test and document that all smoke detectors and carbon monoxide detectors are functional monthly.

(2) Each smoke detector and carbon monoxide detector must be of a type approved by the Department of Labor and Industry or by the Underwriters Laboratories and must provide both and audible and visual alerts.

(d) Fire extinguishers. The licensee shall do all of the following:

(1) Maintain at least one portable fire extinguisher with a minimum of an ABC rating for every 2,000 square feet of space and fraction of it on each floor.

(2) Maintain at least one portable fire extinguisher with a minimum of an ABC rating in each kitchen in addition to the fire extinguishers required under paragraph (1). The extinguisher in the kitchen must be located near an exit and away from the cooking area.

(3) Ensure fire extinguishers are inspected and approved annually by the local fire department or fire extinguisher company. The date of the inspection must be indicated on the extinguisher or inspection tag; the licensee shall replace or repair a fire extinguisher found to be inoperable within 48 hours.

This section cited in 28 Pa. Code § 717.6 (relating to application and renewal); and 28 Pa. Code § 717.29 (relating to physical plant standards).

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.31 Unusual incidents.

(a) The licensee shall develop and implement written policies and procedures to respond to all of the following unusual incidents:

(1) Physical assault or sexual assault by staff, a volunteer or a resident on or off the premises.

(2) Provision or use of illicit drugs on the premises.

(3) Death or serious injury due to trauma, suicide, medication error or unusual circumstances while residing at the drug and alcohol recovery house.

(4) Significant disruption due to disaster such as fire, storm, flood or other occurrence which closes the drug and alcohol recovery house for more than 1 day.

(5) Theft, burglary, break-in or similar incident at the drug and alcohol recovery house.

(6) Event at the drug and alcohol recovery house requiring the presence of police, fire or ambulance personnel.

(7) Fire or structural damage to the drug and alcohol recovery house.

(8) Outbreak of a contagious disease requiring Centers for Disease Control (CDC) notification.

(b) The licensee shall develop and implement written unusual incident policies and procedures which must include all of the following:

(1) Documentation of the unusual incident.

(2) Prompt review and identification of the direct and indirect causes of the unusual incident.

(3) Implementation of a timely and appropriate plan of correction, when indicated.

(4) Ongoing monitoring of the plan of correction.

(c) The licensee shall file a written unusual incident report with the Department within 3 business days following an unusual incident involving:

(1) Physical or sexual assault by staff, a volunteer or a resident.

(2) Death or serious injury due to trauma, suicide, medication error or unusual circumstances.

(3) Fire, storm, flood or other occurrence that results in the closure of the drug and alcohol recovery house or the relocation of residents for more than 1 day.

(4) An event at the drug and alcohol recovery house requiring the presence of police, fire or ambulance personnel.

(5) Outbreak of a contagious disease requiring CDC notification.

(d) The licensee shall make reports to other boards and agencies as required by applicable law, including section 4(b) of the Disease Prevention and Control Law of 1955 (35 P.S. § 521.4).

This section cited in 28 Pa. Code § 717.6 (relating to application and renewal).

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.32 Complaints about drug and alcohol recovery houses.

(a) The Department will accept complaints from any individual about drug and alcohol recovery houses that have or are required to have licenses.

(b) An individual who submits a complaint may request to remain anonymous. The Department will disclose the individual’s identity as required under law.

(1) Will investigate complaints that allege a violation of subarticle B of Article XXIII-A of The Administrative Code of 1929 (71 P.S. § § 613.11—613.18) or this chapter.

(2) May refer complaints that do not allege a violation of subarticle B of Article XXIII-A of The Administrative Code of 1929 (71 P.S. § § 613.11—613.18) or this chapter to another Federal, State, or local agency or entity within 2 business days.

(3) Will report complaints that allege abuse, neglect or a criminal violation to law enforcement within 2 business days.

(d) The Department will assess complaints under subsection (c)(1) based on the degree of risk to residents’ health or safety. The following apply:

(1) The Department will begin an investigation of a complaint that alleges a direct threat to the health or safety of a resident within 2 business days.

(2) The Department will begin an investigation of a complaint that does not allege a direct threat to the health or safety or a resident within 5 business days.

(e) The Department may conduct an announced or unannounced onsite inspection of any complaint under subsection (c)(1).

(f) The Department will provide a summary of its findings of an investigation of a complaint under subsection (c)(1) to the individual who made the complaint.

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

28 Pa. Code § 717.33 Drug and alcohol recovery house registry.

(a) The Department will create on its website and update at least annually a registry of licensed drug and alcohol recovery houses.

(b) The registry will include, for each licensed drug and alcohol recovery House, all of the following:

(1) The name of the licensee.

(2) The name of the drug and alcohol recovery house.

(3) The street address of the drug and alcohol recovery house.

(4) The contact information listed in the drug and alcohol recovery house’s application under § 717.6 (relating to application and renewal).

(5) The drug and alcohol recovery house’s maximum occupancy.

(6) Any other information the Department determines is in the public interest.

(1) List whether each drug and alcohol recovery house has a full license, a provisional license, or is operating pending appeal of the revocation of its license.

(2) Contain a notice that not all drug and alcohol recovery houses must be licensed and that some licensees may operate both licensed and unlicensed drug and alcohol recovery houses.

History

Authority: The provisions of this Chapter 717 added under section 2313-A of The Administrative Code of 1929 (71 P.
Source: The provisions of this Chapter 717 added December 10, 2021, effective December 11, 2021, 51 Pa.

Part VI Health Care Cost Containment Council

Chapter 903 Appeals Procedure

28 Pa. Code § 903.1 Purpose.

This chapter establishes a grievance procedure for data sources as specified in section 14 of the act (35 P. S. § 449.14).

History

Authority: The provisions of this Chapter 903 issued under the Health Care Cost Containment Act (35 P.
Source: The provisions of this Chapter 903 adopted August 19, 1988, effective August 20, 1988, 18 Pa.

28 Pa. Code § 903.2 Definitions.

History

Authority: The provisions of this Chapter 903 issued under the Health Care Cost Containment Act (35 P.
Source: The provisions of this Chapter 903 adopted August 19, 1988, effective August 20, 1988, 18 Pa.

28 Pa. Code § 903.3 Affected parties.

This chapter applies to data sources subject to reporting requirements under the act.

History

Authority: The provisions of this Chapter 903 issued under the Health Care Cost Containment Act (35 P.
Source: The provisions of this Chapter 903 adopted August 19, 1988, effective August 20, 1988, 18 Pa.

28 Pa. Code § 903.4 General rule.

A request by a data source for an exception to the Council’s reporting requirements or another grievance by a data source against the Council shall follow the procedures set forth in the regulation imposing the reporting requirement or other disputed obligation upon the data source.

History

Authority: The provisions of this Chapter 903 issued under the Health Care Cost Containment Act (35 P.
Source: The provisions of this Chapter 903 adopted August 19, 1988, effective August 20, 1988, 18 Pa.

28 Pa. Code § 903.5 Notice of protest.

A data source wishing to protest an action by the Council, including the denial of a request for an exception or the revocation of an exception, shall initiate its protest by giving notice to the Council of its desire for a hearing on the Council’s action. This notice shall be given by certified mail within 30 days of the receipt by the data source of written notice of the Council’s action and shall be sent to the Council at the Council’s office.

History

Authority: The provisions of this Chapter 903 issued under the Health Care Cost Containment Act (35 P.
Source: The provisions of this Chapter 903 adopted August 19, 1988, effective August 20, 1988, 18 Pa.

28 Pa. Code § 903.6 Reasons for protest.

The data source’s notice of protest shall specify the action of the Council complained of and shall set forth the reasons for the protest.

History

Authority: The provisions of this Chapter 903 issued under the Health Care Cost Containment Act (35 P.
Source: The provisions of this Chapter 903 adopted August 19, 1988, effective August 20, 1988, 18 Pa.

28 Pa. Code § 903.7 Informal hearing on protest.

Upon receipt of a notice of protest from a data source, the Council will schedule an informal hearing to be held within 30 days. The Council will notify the data source of the date, time and place of the hearing at least 21 days in advance of the hearing.

History

Authority: The provisions of this Chapter 903 issued under the Health Care Cost Containment Act (35 P.
Source: The provisions of this Chapter 903 adopted August 19, 1988, effective August 20, 1988, 18 Pa.

28 Pa. Code § 903.8 Clarification of issues.

Between the date of receipt by the Council of the notice of protest and the date scheduled for the hearing, Council staff and representatives of the data source shall meet and attempt to narrow and clarify the issues to be determined at the hearing. Documentation which the data source wishes to provide to the Council in support of its protest shall be submitted at least 7 days before the hearing.

History

Authority: The provisions of this Chapter 903 issued under the Health Care Cost Containment Act (35 P.
Source: The provisions of this Chapter 903 adopted August 19, 1988, effective August 20, 1988, 18 Pa.

28 Pa. Code § 903.9 Conduct of hearing on protest.

(a) The hearing will be conducted before the Executive Director of the Council or a member of the Council who has no financial or other relationship with the data source. The data source may be represented by counsel.

(b) Procedures at the hearing shall be informal. The data source may submit factual data, documents and other information which will facilitate identification of the issues and which will expedite resolution of the issues. The data source may submit oral testimony from persons whose testimony is relevant to the protest.

History

Authority: The provisions of this Chapter 903 issued under the Health Care Cost Containment Act (35 P.
Source: The provisions of this Chapter 903 adopted August 19, 1988, effective August 20, 1988, 18 Pa.

28 Pa. Code § 903.10 Report to the Council.

The Executive Director of the Council or the Council member conducting the hearing will make a written report to the Council within 14 days after the hearing is completed, together with recommendations for disposition of the protest.

This section cited in 28 Pa. Code § 903.11 (relating to decision by the Council).

History

Authority: The provisions of this Chapter 903 issued under the Health Care Cost Containment Act (35 P.
Source: The provisions of this Chapter 903 adopted August 19, 1988, effective August 20, 1988, 18 Pa.

28 Pa. Code § 903.11 Decision by the Council.

At the next regularly scheduled meeting of the Council held at least 14 days after receipt of the report and recommendation described in § 903.10 (relating to report to the Council), if a quorum of the Council is present at the meeting, the Council will make its decision on the protest. Notice of the Council’s decision will be given in writing to the protesting data source by certified mail within 7 days of the decision date.

History

Authority: The provisions of this Chapter 903 issued under the Health Care Cost Containment Act (35 P.
Source: The provisions of this Chapter 903 adopted August 19, 1988, effective August 20, 1988, 18 Pa.

28 Pa. Code § 903.12 Accelerated protest.

Nothing contained in this chapter prevents the parties from accelerating the protest process, altering time constraints or skipping procedures if the changes are agreed upon jointly and expressed in writing.

History

Authority: The provisions of this Chapter 903 issued under the Health Care Cost Containment Act (35 P.
Source: The provisions of this Chapter 903 adopted August 19, 1988, effective August 20, 1988, 18 Pa.

28 Pa. Code § 903.13 Formal appeal.

A data source dissatisfied with the Council’s decision on the protest may invoke its right to a formal hearing. Under 1 Pa. Code § 31.1 (relating to scope of part), 1 Pa. Code Part II (relating to general rules of administrative practice and procedure) is applicable to the activities of and proceedings before the Council and a request for a formal hearing shall proceed under those rules.

History

Authority: The provisions of this Chapter 903 issued under the Health Care Cost Containment Act (35 P.
Source: The provisions of this Chapter 903 adopted August 19, 1988, effective August 20, 1988, 18 Pa.

Chapter 915 Data Access Criteria and Procedure

28 Pa. Code § 915.1 Purpose.

This chapter establishes criteria and procedures for access to Council data under sections 4, 5, 7 and 10 of the act (35 P. S. § § 449.4, 449.5, 449.7 and 449.10).

History

Authority: The provisions of this Chapter 915 issued under section 5 of the Health Care Cost Containment Act (35 P.
Source: The provisions of this Chapter 915 adopted June 2, 1989, effective June 3, 1989, 19 Pa.

28 Pa. Code § 915.2 Principles governing data access.

(a) Confidentiality principle. The Council, under the mandates of and authority provided in the act will assure the confidentiality of information received as a result of the enactment and implementation of the act. This chapter establishes policies and procedures to protect and maintain the confidentiality of individual patient information which is submitted to the Council. These policies and procedures assure that information and data will not be released or be accessible if the release of the information or data could reasonably be expected to reveal the identity of an individual patient. If conflicts between patient confidentiality and release of data arise, patient confidentiality will take priority.

(b) Other principles.

(1) The Council will facilitate the continuing provision of quality, cost-effective health services throughout this Commonwealth by providing data and information to the purchasers and consumers of health care on the cost and quality of health care services.

(2) The Council will assure that information and data received by the Council will be utilized by the Council for the benefit of the public.

(3) The Council will assure that data will not be released or be accessible that does not simultaneously disclose charge or payment as well as provider quality and provider service effectiveness.

(4) The Council will assure that data will not be released or be accessible which could reasonably be expected to reveal the identity of a purchaser, other than a purchaser requesting data on its own group or an entity entitled to the purchaser’s data under the act.

(5) The Council will assure that data will not be released or be accessible which relates to actual payments to an identified provider made by a purchaser, except that this does not apply to a purchaser requesting data on the group for which it purchases or otherwise provides covered services or access to that same data by an entity entitled to the purchaser’s data under the act.

(6) The Council will assure that data which discloses discounts or differentials between payments accepted by providers for services and their billed charges obtained by identified payors from identified providers will not be released or accessible unless comparable data on other payors is also released and the Council determines that the release of the information is not prejudicial or inequitable to an individual payor or provider or group thereof.

(7) The Council will assure that access to data, as defined in this chapter, by a party, including, but not limited to, purchasers, collective bargaining representatives, general public and Council members, will be in accordance with the procedures contained in this chapter.

(8) The Council is required to uphold the act and to prohibit the unauthorized use of Council data as set forth in the act.

(9) The Council will be very restrictive with regard to the release of data. Requests for data will be reviewed in accordance with the confidentiality protections, as enumerated in § § 915.21—915.25 (relating to confidentiality protections). If the Council determines that the request violates the Council’s confidentiality protections, the Council may seek to amend cell sizes, propose alternative ways to examine data, propose alternative ways to look at specific issues and otherwise amend the scope of the report or deny the request.

History

Authority: The provisions of this Chapter 915 issued under section 5 of the Health Care Cost Containment Act (35 P.
Source: The provisions of this Chapter 915 adopted June 2, 1989, effective June 3, 1989, 19 Pa.

28 Pa. Code § 915.3 Definitions.

The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise: Act—The Health Care Cost Containment Act (35 P. S. § § 449.1—449.19). Category—A specifically defined, mutually exclusive division in a classification system. Cell—The smallest unit or compartment of a statistical table or tabulation. Council—The Health Care Cost Containment Council. Data or raw data—Data collected by the Council or the Council’s data vendor under section 6 of the act (35 P. S. § 449.6). Data source—The term includes, but is not limited to, the following:

(i) A hospital.

(ii) An ambulatory service facility.

(iii) A physician.

(iv) A health maintenance organization as the term is defined in the Health Maintenance Organization Act (40 P. S. § § 1551—1567).

(v) A hospital, medical or health service plan with a certificate of authority issued by the Insurance Department, including, but not limited to, hospital plan corporations as defined in 40 Pa.C.S. Chapter 61 (relating to hospital plan corporations) and professional health service plan corporations as defined in 40 Pa.C.S. Chapter 63 (relating to professional health services plan corporations).

(vi) A commercial insurer with a certificate of authority issued by the Insurance Department providing health or accident insurance.

(vii) A self-insured employer providing health or accident coverage or benefits for employes employed in this Commonwealth.

(viii) An administrator of a self-insured or partially self-insured health or accident plan providing covered services in this Commonwealth.

(ix) A health and welfare fund that provides health or accident benefits or insurance pertaining to covered services in this Commonwealth.

(x) The Department of Public Welfare for those covered services it purchases or provides through the Medical Assistance program under the Public Welfare Code (62 P. S. § § 101—1411).

(xi) Other payors for covered services in this Commonwealth, other than an individual. Executive Director—The Executive Director of the Council. Nondisclosable data—Data pertaining to an individual’s health care service encounter that, if disclosed, violate the provisions concerning release of and access to Council data contained in the act. These data are set forth in Appendix A. Nonprotected data—Data pertaining to an individual’s health care service encounter that may be released by the Council without violating provisions concerning release of and access to Council data contained in the act. These data are set forth in Appendix C. Other parties—Entities other than purchasers to which the Council may release data under the act. Protected data—Data pertaining to an individual’s health care service encounter that may only be released by the Council under the act in specific circumstances based on criteria developed by the Council. These data are set forth in Appendix B. Proxy patient identifier—A unique number assigned by the Council to an individual patient which will not breech patient confidentiality provisions contained in the act or in this chapter. Purchaser—A corporation, labor organization or other entity that purchases benefits which provide covered services for employes or members, either through a health care insurer or by means of a self-funded program of benefits, and a certified bargaining representative that represents groups of employes for whom employers purchase a program of benefits which provide covered services. The term does not include entities defined in the act as ‘‘health care insurers.’’

History

Authority: The provisions of this Chapter 915 issued under section 5 of the Health Care Cost Containment Act (35 P.
Source: The provisions of this Chapter 915 adopted June 2, 1989, effective June 3, 1989, 19 Pa.

28 Pa. Code § 915.4 Entities with access.

Data will be available from the Council, in accordance with this chapter, to purchasers and other parties.

History

Authority: The provisions of this Chapter 915 issued under section 5 of the Health Care Cost Containment Act (35 P.
Source: The provisions of this Chapter 915 adopted June 2, 1989, effective June 3, 1989, 19 Pa.

28 Pa. Code § 915.21 Classes of data collected by the Council.

For purposes of this chapter, the data collected by the Council have been classified into three categories:

(1) Nondisclosable data which includes the data set forth in Appendix A.

(2) Protected data which includes the data set forth in Appendix B.

(3) Nonprotected data which includes the data as set forth in Appendix C.

This section cited in 28 Pa. Code § 915.2 (relating to principles governing data access).

History

Authority: The provisions of this Chapter 915 issued under section 5 of the Health Care Cost Containment Act (35 P.
Source: The provisions of this Chapter 915 adopted June 2, 1989, effective June 3, 1989, 19 Pa.

28 Pa. Code § 915.22 Release of nondisclosable data.

Nondisclosable data, as set forth in Appendix A, will not be released by the Council to a party, except to the original data source as provided for under § 915.51(b) (relating to procedures for access to Council data by data sources).

This section cited in 28 Pa. Code § 915.2 (relating to principles governing data access).

History

Authority: The provisions of this Chapter 915 issued under section 5 of the Health Care Cost Containment Act (35 P.
Source: The provisions of this Chapter 915 adopted June 2, 1989, effective June 3, 1989, 19 Pa.

28 Pa. Code § 915.23 Release of protected data.

Protected data, as set forth in Appendix B, will only be released upon approval by the Council and if the release is in accordance with the following criteria and under the following conditions:

(1) Data will be released only if there are a minimum of ten cases in a cell, except for data which is a monetary figure. Cells with less than ten cases will be suppressed.

(2) If there are less than ten cases in a cell, the Council may create categories or may aggregate data to provide some detail on the data element to the data requester.

(3) The following data may be released only to a purchaser and only for those individuals for whom the purchaser provided covered health care services:

(i) Estimated responsibility.

(ii) Prior payments—payor and patient.

(iii) Estimated amount due.

(iv) Payor group number.

(v) Employer name.

(vi) Primary payor payments.

(vii) Other payments.

(4) A data requester may request, and the Council may approve, a different aggregation or categorization of the protected data. There shall be at least ten cases in a cell for data to be released. A requester shall state the reasons for requesting a variation of the standard aggregation process.

(5) The council may, based on a determination of an individual request, release proxy patient identifiers which will preserve patient confidentiality.

(6) Year of birth/age will be released in 5-year categories, beginning with age category 0-4 up to a maximum age category of age 85 and above. If there are less than ten cases in a category, the category will be expanded by grouping it with the next higher or lower categories until there are a minimum of ten cases in the combined category.

(7) Five digit patient zip codes will not be available for geographic places that have fewer than 100,000 people. Small area analyses for geographic places of less than 100,000 people will be prepared by Council staff as a special request. For access to that information, a requester shall submit a request for a special report under § 915.41 (relating to procedure for requesting special reports to be prepared by Council).

(8) If the cell size is less than ten for a code, the Council will develop categories, such as, but not limited to:

(i) Patient is insured.

(ii) Relative of insured.

(iii) Employe of insured.

(iv) Other.

(v) Unknown.

(9) The Council will monitor combinations of certain data elements as follows:

(i) Combinations of certain data elements may enable the identification of an individual patient. Data elements with this potential include, but are not limited to: year of birth/age, patient sex, zip code, race and patient relationship to insured. Before data are released by the Council which include two or more of these data elements, the Council will examine the cell sizes resulting from the combination of these data elements. Data will only be released when the resulting cell size is at least ten cases.

(ii) If there are less than ten cases in the cells as a result of a combination of these data elements, the Council will suppress the zip code first. If the combination of the remaining data elements does not result in cell sizes of at least ten, race will be suppressed, then patient sex will be suppressed, then patient relationship to insured will be suppressed as the final element.

This section cited in 28 Pa. Code § 915.2 (relating to principles governing data access); and 28 Pa. Code § 915.51 (relating to procedures for access to Council data by data sources).

History

Authority: The provisions of this Chapter 915 issued under section 5 of the Health Care Cost Containment Act (35 P.
Source: The provisions of this Chapter 915 adopted June 2, 1989, effective June 3, 1989, 19 Pa.

28 Pa. Code § 915.24 Release of nonprotected data.

(a) Nonprotected data, as set forth in Appendix C, will be released upon request and approval by the Council except as provided for in subsection (b).

(b) The Council may prohibit the release of disaggregated data on sensitive medical conditions, procedures and diagnoses such as, but not limited to, substance abuse, mental diseases and disorders, acquired immunodeficiency syndrome and related conditions and pregnancy terminations, to ensure that the patient confidentiality safeguards contained in the act and this chapter are not violated.

This section cited in 28 Pa. Code § 915.2 (relating to principles governing data access).

History

Authority: The provisions of this Chapter 915 issued under section 5 of the Health Care Cost Containment Act (35 P.
Source: The provisions of this Chapter 915 adopted June 2, 1989, effective June 3, 1989, 19 Pa.

28 Pa. Code § 915.25 Unauthorized use of or access to Council data.

(a) If a person inadvertently or by Council error gains access to data that violates the safeguards in section 10 of the act (35 P. S. § 449.10), the data shall be returned, without duplication, to the Council with proper notice. If the data have been duplicated, duplications shall also be returned to the Council.

(b) A person who knowingly releases Council data violating the patient confidentiality, actual payments, discount data or raw data safeguards in section 10 of the act to an unauthorized person commits a misdemeanor of the first degree and shall, upon conviction, be sentenced to pay a fine of $10,000 or to imprisonment of not more than 5 years, or both. An unauthorized person who knowingly receives or possesses the data commits a misdemeanor of the first degree.

(c) Sale by a recipient or exchange or publication by a recipient, other than a purchaser, of raw Council data to other parties without the express written consent of, and under terms approved by, the Council shall be unauthorized use of Council data. Unauthorized use of Council data constitutes a misdemeanor of the first degree and, upon conviction, that person shall be sentenced to pay a fine of $10,000 or to imprisonment for not more than 5 years, or both. This restriction does not apply to data published by the Council in reports.

This section cited in 28 Pa. Code § 915.2 (relating to principles governing data access).

History

Authority: The provisions of this Chapter 915 issued under section 5 of the Health Care Cost Containment Act (35 P.
Source: The provisions of this Chapter 915 adopted June 2, 1989, effective June 3, 1989, 19 Pa.

28 Pa. Code § 915.31 Procedure for requesting access to Council data.

(a) A request for access to data, including computer-to-computer access, shall be made in writing to the Executive Director of the Council on a form prescribed by the Council. This form will require:

(1) The name of the party requesting the data.

(2) The name, title, address and telephone number of the contact person for the request.

(3) A description of the information to which access is requested, including a description of the desired tape format and list of data elements.

(4) Information on the purpose or intended use of the data.

(b) The request form will contain a statement prohibiting the recipient of the data, other than a recipient who is a purchaser, from selling, exchanging or publishing the data without the express written consent of and under the terms and conditions developed and approved by the Council. The statement will also prohibit the recipient of the data from using the data to attempt to identify an individual or to use the data for purposes of disciplining, discharging or penalizing an employe of the recipient. In addition, the statement will indicate that a recipient is prohibited from further releasing data which:

(1) Could reasonably be expected to reveal the identity of an individual patient.

(2) Does not simultaneously disclose payment, as well as provider quality and provider service effectiveness.

(3) Could reasonably be expected to reveal the identity of a purchaser, except if the recipient is a purchaser receiving data on its own group and then that purchaser may reveal his own identity.

(4) Relates to actual payments to an identified provider made by a purchaser.

(5) Discloses discounts or differentials between payments accepted by providers for their billed charges obtained by identified payors from identified providers.

(c) Requesters of data will be required to sign the form to indicate that they have read and understood the prohibitions contained in subsection (b). In addition, a requester who is a purchaser will be required to provide notice to employes that information has been requested on the health care services which they, or dependents who are covered under the purchaser’s health care insurance, have received. This notice shall be required to be posted in prominent location where other similar employe notices are posted.

History

Authority: The provisions of this Chapter 915 issued under section 5 of the Health Care Cost Containment Act (35 P.
Source: The provisions of this Chapter 915 adopted June 2, 1989, effective June 3, 1989, 19 Pa.

28 Pa. Code § 915.32 Approval of request for Council data.

(a) Upon receipt of a completed form requesting access to Council data, including computer-to-computer access, the Executive Director will forward the request to the Council which will make a determination to grant or deny the request.

(b) In making the determination to grant the request, the Council is to be satisfied that:

(i) The limitations on data access contained in the act will not be compromised.

(ii) This chapter’s provisions regarding confidentiality will not be compromised.

(iii) The data will be used for the legal and statutory purposes as specified in the act.

(iv) Other criteria for the release of the data are met.

(c) The Council may choose to delegate the responsibility for reviewing requests for and granting or denying access to Council data to the Executive Director.

History

Authority: The provisions of this Chapter 915 issued under section 5 of the Health Care Cost Containment Act (35 P.
Source: The provisions of this Chapter 915 adopted June 2, 1989, effective June 3, 1989, 19 Pa.

28 Pa. Code § 915.33 Appeal of denial of request for Council data.

(a) If a request for data is denied by the Council, a notice detailing the reasons for the denial will be forwarded to the requester.

(b) If the Council delegates the approval or denial of a request for access to Council data to the Executive Director and the Executive Director denies a request for data, the Executive Director will forward notice of the denial and the reasons for the denial to the requester. Upon request by the party denied access, the Executive Director will forward the request to the members of the Council for their consideration. If the Council subsequently denies the request for data, the Council will forward notice of the denial and the reasons for the denial to the requester.

History

Authority: The provisions of this Chapter 915 issued under section 5 of the Health Care Cost Containment Act (35 P.
Source: The provisions of this Chapter 915 adopted June 2, 1989, effective June 3, 1989, 19 Pa.

28 Pa. Code § 915.41 Procedure for requesting special reports to be prepared by Council.

(a) A request for special reports shall be made in writing to the Executive Director of the Council on a form prescribed by the Council. This form will require:

(1) The name of party requesting the data.

(2) The name, title, address and telephone number of the contact person for the request.

(3) A description of the information to be contained in the special report, including the time period, a description of desired tables, charts, analysis and report format, as applicable.

(4) The purpose or intended use of the report.

(5) The date when the report is to be completed.

(b) The form will also contain a statement prohibiting the recipient of the report, other than a recipient who is a purchaser, from selling, exchanging or publishing the report without the express written consent of and under the terms and conditions developed and approved by the Council. The statement will also prohibit the recipient of the special report from using the information in the special report to attempt to identify an individual or to use the data for purposes of disciplining, discharging or penalizing an employe of the recipient. The statement will indicate that a recipient is prohibited from further releasing information which:

(1) Could reasonably be expected to reveal the identity of an individual patient.

(2) Does not simultaneously disclose payment, as well as provider quality and provider service effectiveness.

(3) Could reasonably be expected to reveal the identity of a purchaser, except where the recipient is a purchaser receiving data on its own group and then that purchaser may reveal his own identity.

(4) Relates to actual payments to an identified provider made by a purchaser.

(5) Discloses discounts or differentials between payments accepted by providers for their billed charges obtained by identified payors from identified providers.

(c) Requesters of special reports will be required to sign the form to indicate that they have read and understood the prohibitions in subsection (b).

This section cited in 28 Pa. Code § 915.23 (relating to release of protected data).

History

Authority: The provisions of this Chapter 915 issued under section 5 of the Health Care Cost Containment Act (35 P.
Source: The provisions of this Chapter 915 adopted June 2, 1989, effective June 3, 1989, 19 Pa.

28 Pa. Code § 915.42 Approval of request for a special report.

Upon receipt of a completed form requesting a special report, the Council will review the request and determine whether the report can be provided by the Council. In making the determination, the Council will consider the utility of the report, the staff resources necessary to complete the report, the purpose of the report with respect to the mandates contained in the act, the time frame in which the report is requested to be produced and other criteria developed by the Council.

History

Authority: The provisions of this Chapter 915 issued under section 5 of the Health Care Cost Containment Act (35 P.
Source: The provisions of this Chapter 915 adopted June 2, 1989, effective June 3, 1989, 19 Pa.

28 Pa. Code § 915.51 Procedure for access to Council data by data sources.

(a) Hospitals, health care facilities, third-party payors and other data sources shall have access to Council data following the same procedures for access and under the same conditions of confidentiality protections as other requesters.

(b) Notwithstanding the provisions of § 915.23(3) (relating to release of protected data), a data source that has submitted data elements to the Council has the right to access data elements which have been submitted to the Council under Chapters 912 and 913 (relating to data reporting requirements; and payor data reporting requirements).

History

Authority: The provisions of this Chapter 915 issued under section 5 of the Health Care Cost Containment Act (35 P.
Source: The provisions of this Chapter 915 adopted June 2, 1989, effective June 3, 1989, 19 Pa.

28 Pa. Code § 915.52 Fees charged for Council data and special reports.

(a) The Council will charge requesters an amount sufficient to cover the costs associated with providing access to Council data, including computer-to-computer access, including, but not limited to, computer time, cost of materials and staff time. Subsequent requests for the same information will require a fee sufficient to cover only the costs of duplicating the original access. Fee quotes will be provided to requesters in advance of the special request being processed. Special requests will be completed only upon an agreement by the requester to pay the quoted fee.

(b) The Council will charge requesters an amount sufficient to cover preparation and provision of special reports, including, but not limited to, computer time, staff time, cost of materials, and the like. Subsequent requests for the same information will pay a fee only to cover the provision of the report. The Council may waive the fee if the Council determines that the special report is of great public interest. The Council will not charge a fee for reports to be provided under the act.

FRM—Facility Reporting Manual

PRM—Payor Reporting Manual

This appendix cited in 28 Pa. Code § 915.3 (relating to definitions); 28 Pa. Code § 915.21 (relating to classes of data collected by the Council); and 28 Pa. Code § 915.22 (relating to release of nondisclosable data).

constructed data element using submitted data elements

FRM—Facility Reporting Manual

PRM—Payor Reporting Manual

This appendix cited in 28 Pa. Code § 915.3 (relating to definitions); 28 Pa. Code § 915.21 (relating to classes of data collected by the Council); and 28 Pa. Code § 915.23 (relating to release of protected data).

constructed data element using submitted data elements

FRM—Facility Reporting Manual

PRM—Payor Reporting Manual

This appendix cited in 28 Pa. Code § 915.3 (relating to definitions); 28 Pa. Code § 915.21 (relating to classes of data collected by the Council); and 28 Pa. Code § 915.24 (relating to release of nonprotected data).

History

Authority: The provisions of this Chapter 915 issued under section 5 of the Health Care Cost Containment Act (35 P.
Source: The provisions of this Chapter 915 adopted June 2, 1989, effective June 3, 1989, 19 Pa.

Part VII Emergency Medical Services

Subpart A EMS System

Chapter 1031 Complaints, Disciplinary Actions, Adjudications and Appeals

28 Pa. Code § 1031.1 Administrative and appellate procedure.

(a) Administrative proceedings. Except as otherwise provided in this chapter, the Department will hold hearings and issue adjudications for proceedings conducted under the act and this subpart in accordance with 2 Pa.C.S. (relating to administrative law and procedure) and will conduct those proceedings under 1 Pa. Code Part II (relating to General Rules of Administrative Practice and Procedure).

(b) Judicial appeals. Department adjudications issued under the act and this chapter may be appealed to the Commonwealth Court under 42 Pa.C.S. § 763 (relating to direct appeals from government agencies).

History

Authority: The provisions of this Chapter 1031 issued under the Emergency Medical Services System Act, 35 Pa.
Source: The provisions of this Chapter 1031 adopted October 11, 2013, effective October 12, 2013, 43 Pa.

28 Pa. Code § 1031.2 Complaints and investigations.

(a) Filing a complaint. A person may file with the Department a complaint about a violation of the act or this subpart by an individual or entity regulated by the Department under the act or an individual or entity believed to have provided EMS or have engaged in any other activity for which some type of authorization under the act or this subpart is required, without that individual or entity having secured a certification, license or other authorization from the Department to engage in that activity as required by the act and this subpart.

(b) Filing office. The complaint shall be filed with the regional EMS council that serves the EMS region where the conduct occurred. The regional EMS council shall provide the Bureau with a copy of the complaint. A complaint concerning the conduct of a regional EMS council shall be filed directly with the Bureau.

(c) Status of complaint. If a person files a complaint seeking to have the Department impose a disciplinary or corrective measure under this chapter, the Department’s action in the handling of the complaint will be on behalf of the Commonwealth to determine whether there has been a violation of a statutory or regulatory requirement over which the Department has jurisdiction under the act.

(d) Processing a complaint. Upon receipt of a complaint filed under this section, the Bureau will assess whether the Department has jurisdiction over the matter about which the complaint is filed. If the matter is within the Department’s jurisdiction and an investigation is needed, the Bureau will investigate the complaint or assign the complaint to a regional EMS council or other appropriate entity to investigate. Unless the Bureau determines that disclosure to the individual or entity about whom the complaint has been filed will compromise the investigation or would be inappropriate for some other reason, the investigation will be initiated by providing that individual or entity with a copy of the complaint and requesting a response. The Department will redact and withhold identifying information of the complainant throughout the investigation and will not provide this information if the Department determines that release of this information may compromise the investigation or that release of this information may endanger the life or physical safety of the complainant. In the event the Department does not release identifying information of the complainant, the Department may disclose this information to those persons authorized by the Department to conduct the investigation or as otherwise required by law. If the matter is not within the Department’s jurisdiction to address, the Bureau will advise the person who filed the complaint and refer the complainant to another agency if the Bureau believes that the matter about which the complaint has been filed may be within the other agency’s jurisdiction.

(e) Notification of results of investigation. When an investigation is completed, the Bureau will notify the complainant of the general results of the investigation of the matter about which the complaint was filed. This notification does not include providing the complainant with a copy of any document collected or prepared during the course of the investigation or communications with persons involved in the investigation, including the subject of the complaint. The Bureau will also provide the same information to the individual or entity about whom the complaint was filed if the individual or entity was officially apprised of the complaint or investigation. If the Department is considering taking disciplinary action against the individual or entity, notification may occur when a disciplinary decision is reached or when disciplinary charges are filed.

History

Authority: The provisions of this Chapter 1031 issued under the Emergency Medical Services System Act, 35 Pa.
Source: The provisions of this Chapter 1031 adopted October 11, 2013, effective October 12, 2013, 43 Pa.

28 Pa. Code § 1031.3 Discipline of EMS providers.

(a) Grounds for discipline. The Department may discipline or impose corrective measures on an EMS provider or an applicant for EMS provider certification for one or more of the following reasons:

(1) Having a lack of physical or mental ability to provide adequate EMS, with reasonable accommodations if the person has a disability.

(2) Deceptively or fraudulently procuring or representing certification or registration credentials, or making misleading, deceptive or untrue representations to secure or aid or abet another person to secure a certification, license, registration or other authorization issued under this subpart.

(3) Engaging in willful or negligent misconduct in providing EMS or engaging in practice beyond the scope of certification authorization without legal authority to do so.

(4) Abusing or abandoning a patient.

(5) Rendering EMS while under the influence of alcohol, illegal drugs or the knowing abuse of legal drugs.

(6) Operating an emergency vehicle in a reckless manner or while under the influence of alcohol, illegal drugs or the knowing abuse of legal drugs.

(7) Disclosing medical or other information about a patient when prohibited by Federal or State law.

(8) Willfully preparing or filing a false medical report or record or inducing another person to do so.

(9) Destroying a medical report or record required to be maintained.

(10) Refusing to render EMS because of a patient’s race, sex, creed, national origin, sexual preference, age, handicap or medical problem or refusing to render emergency medical care because of a patient’s financial inability to pay.

(11) Failing to comply with Department-approved EMS protocols.

(12) Failing to comply with reporting requirements imposed by the act or this subpart.

(13) Practicing without the current registration of a certification.

(14) Being convicted of a felony, a crime related to the practice of the EMS provider or a crime involving moral turpitude.

(15) Willfully falsifying or failing to prepare an EMS PCR or complete details on an EMS PCR.

(16) Misappropriating drugs or EMS agency property.

(17) Having a certification or other authorization to practice a profession or occupation revoked, suspended or subjected to other disciplinary sanction.

(18) Violating, aiding or abetting another person to violate a duty imposed by the act, this subpart or an order of the Department previously entered in a disciplinary proceeding.

(19) Based upon a finding of misconduct by the relevant Federal or State agency, having been excluded from a Federal or State health care program or having had equity or capital stock or profits of an entity equal to 5% or more of the value of the property or assets of the entity when it was excluded from a Federal or State health care program.

(20) Any other reason as determined by the Department that poses a threat to the health and safety of the public.

(b) Types of discipline authorized. If disciplinary action or corrective action is appropriate under subsection (a), the Department may do one or more of the following:

(1) Deny an application for certification or registration of the certification.

(2) Issue a public reprimand.

(3) Revoke, suspend, limit or otherwise restrict the certification.

(4) Require the person to take refresher or other educational courses.

(5) Impose a civil money penalty not exceeding $1,000 for each incident in which the EMS provider engages in conduct that constitutes a basis for discipline.

(6) Stay enforcement of a suspension, revocation or other discipline and place the individual on probation with the right to vacate the probationary order for noncompliance.

(c) Denial of registration. The Bureau will not deny a registration of an EMS provider certification without giving the EMS provider prior notice of the reason for the denial and providing an opportunity for a hearing. If the reason for the denial is the failure of the EMS provider to present prima facie evidence that the continuing education or examination requirement for registration has been satisfied, the opportunity for a hearing may occur after the prior registration has expired.

This section cited in 28 Pa. Code § 1027.3 (relating to licensure and general operating standards); 28 Pa. Code § 1031.6 (relating to temporary suspension of EMS provider and EMS vehicle operator certifications); and 28 Pa. Code § 1031.7 (relating to discipline of EMS instructors).

History

Authority: The provisions of this Chapter 1031 issued under the Emergency Medical Services System Act, 35 Pa.
Source: The provisions of this Chapter 1031 adopted October 11, 2013, effective October 12, 2013, 43 Pa.

28 Pa. Code § 1031.4 Petition for certification after revocation.

(a) Petition for certification after revocation. A person whose certification has been revoked may not apply for reinstatement of that certification. A person whose EMS provider certification has been revoked may petition the Department for allowance to apply for a new certification no earlier than 5 years after the effective date of the revocation. The petition must aver facts to establish that the petitioner has been rehabilitated to the extent that issuing that person a certification would not be detrimental to the public interest. In assessing the public interest, the Department will weigh the facts that tend to show that the petitioner has been rehabilitated against the Department’s duty to maintain public confidence in its ability to regulate EMS providers, deter other EMS providers from engaging in conduct similar to that which resulted in the revocation and protect persons who may require EMS.

(b) Department action on the petition.

(1) The Department will deny a petition for allowance to apply for a new certification, without conducting a hearing, if it accepts as true all facts averred and it concludes that those facts fail to establish that the petitioner has been rehabilitated to the extent that certification would not be detrimental to the public interest.

(2) The Department may grant or hold a hearing on a petition for a new certification if it concludes that the facts averred in the petition, if true, establish a prima facie case that the petitioner has been rehabilitated to the extent that certification would not be detrimental to the public interest.

(c) Grant of petition for a new certification. If the Department grants the petition, the petitioner shall repeat the educational program and the certification examinations that are required for the EMS provider certification the petitioner is seeking and shall satisfy all other requirements for that certification that exist at the time the petitioner files an application for certification after having successfully completed that education and the examinations.

(d) Denial of petition for a new certification. If the Department denies the petition, the petitioner may not again petition the Department for allowance to apply for certification until 1 year has expired from the date of the denial.

History

Authority: The provisions of this Chapter 1031 issued under the Emergency Medical Services System Act, 35 Pa.
Source: The provisions of this Chapter 1031 adopted October 11, 2013, effective October 12, 2013, 43 Pa.

28 Pa. Code § 1031.5 Discipline of EMS vehicle operators.

(a) Grounds for discipline. The Department may discipline or impose corrective measures on an EMSVO or an applicant for EMSVO certification for one or more of the following reasons:

(1) Having a lack of physical or mental ability to operate an EMS vehicle, with reasonable accommodations if the person has a disability.

(2) Deceptively or fraudulently procuring or representing certification or registration credentials, or making misleading, deceptive or untrue representations to secure a certification or registration.

(3) Operating an emergency vehicle in a reckless manner or while under the influence of alcohol, illegal drugs or the knowing abuse of legal drugs.

(4) Having a driver’s license suspended in any jurisdiction due to the use of alcohol or drugs or a moving traffic violation.

(5) Operating a ground EMS vehicle without a driver’s license or while a driver’s license is suspended.

(6) Being convicted of a felony or a crime involving moral turpitude.

(7) Failing to report a criminal conviction that the applicant or EMSVO is required to report or failing to report the suspension of a driver’s license due to the use of alcohol or drugs or a moving traffic violation.

(8) Any other reason as determined by the Department that poses a threat to the health and safety of the public.

(b) Types of discipline authorized. If disciplinary or corrective action is appropriate under subsection (a), the Department may:

(1) Deny an application for certification or registration of the certification.

(2) Issue a public reprimand.

(3) Revoke or suspend the certification.

(4) Impose conditions for lifting a suspension.

(c) Automatic suspension. An EMSVO certification shall be automatically suspended for 4 years if an EMSVO is convicted of a criminal offense that involves driving under the influence of alcohol or drugs, and for 2 years if the EMSVO is convicted of a criminal offense that involves reckless driving or had a driver’s license suspended due to the use of drugs or alcohol or a moving traffic violation.

The provisions of this § 1031.5 adopted October 11, 2013, effective April 10, 2014, 43 Pa.B. 6093.

This section cited in 28 Pa. Code § 1027.3 (relating to licensure and general operating standards); and 28 Pa. Code § 1031.6 (relating to temporary suspension of EMS provider and EMS vehicle operator certifications).

History

Authority: The provisions of this Chapter 1031 issued under the Emergency Medical Services System Act, 35 Pa.
Source: The provisions of this Chapter 1031 adopted October 11, 2013, effective October 12, 2013, 43 Pa.

28 Pa. Code § 1031.6 Temporary suspension of EMS provider and EMS vehicle operator certifications.

(a) Issuance of temporary suspension. The Department will issue an order temporarily suspending an EMS provider or EMS vehicle operator certification, without a hearing, if based upon evidence received that appears to be credible the Department determines that the person is a clear and immediate danger to the public health and safety.

(b) Notice and preliminary hearing. Notice of the temporary suspension will include a written statement of the factual allegations upon which the determination is based. Unless an extension of time is requested by the EMS provider or EMS vehicle operator, within 30 days after an order under subsection (a) is issued, the Department shall conduct a preliminary hearing to determine whether there is a prima facie case supporting the temporary suspension. The EMS provider or EMS vehicle operator may be present at the preliminary hearing and may be represented by counsel, cross-examine witnesses, inspect physical evidence, call witnesses and offer testimony and other evidence to rebut the prima facie case. If and when the Department determines that the evidence does not establish a prima facie case that the EMS provider or EMS vehicle operator is a clear and immediate danger to the public health and safety, the Department will immediately issue an order lifting the suspension.

(c) Beginning of formal disciplinary proceedings. After issuing an order under subsection (a), the Department shall begin formal disciplinary action under § 1031.3 or § 1031.5 (relating to discipline of EMS providers; and discipline of EMS vehicle operators).

(d) Duration of temporary suspension if prima facie case is established. If the Department determines that a prima facie case supporting the temporary suspension is established at the preliminary hearing, the temporary suspension shall remain in effect, but no longer than 180 days unless agreed upon by the parties.

History

Authority: The provisions of this Chapter 1031 issued under the Emergency Medical Services System Act, 35 Pa.
Source: The provisions of this Chapter 1031 adopted October 11, 2013, effective October 12, 2013, 43 Pa.

28 Pa. Code § 1031.7 Discipline of EMS instructors.

(a) Grounds for discipline. The Department may discipline or impose corrective measures on a certified EMS instructor, or an applicant for certification as an EMS instructor, for one or more of the following reasons:

(1) Any reason an EMS provider may be disciplined under § 1031.3 (relating to discipline of EMS providers).

(2) Providing instruction while under the influence of alcohol or illegal drugs or the knowing abuse of legal drugs.

(3) Failing to perform a duty imposed upon an EMS instructor under this subpart.

(4) Any other reason as determined by the Department that poses a threat to the health and safety of students.

(b) Types of discipline authorized. If disciplinary action or corrective action is appropriate under subsection (a), the Department may do one or more of the following:

(1) Deny an application for certification.

(2) Issue a public reprimand.

(3) Revoke, suspend, limit or otherwise restrict the certification.

(4) Impose a civil money penalty not exceeding $1,000 for each incident in which the EMS instructor engages in conduct that constitutes a basis for discipline.

(5) Stay enforcement of a suspension, revocation or other discipline and place the individual on probation with the right to vacate the probationary order for noncompliance.

History

Authority: The provisions of this Chapter 1031 issued under the Emergency Medical Services System Act, 35 Pa.
Source: The provisions of this Chapter 1031 adopted October 11, 2013, effective October 12, 2013, 43 Pa.

28 Pa. Code § 1031.8 Discipline of medical command physicians and medical command facility medical directors.

(a) Grounds for discipline. The Department may discipline or impose corrective measures on a medical command physician or medical command facility medical director for the following reasons:

(1) Violating a responsibility imposed on the physician by § 1023.2 or § 1023.3 (relating to medical command physician; and medical command facility medical director).

(2) Without good cause, failing to comply with an EMS protocol established or approved by the Department.

(b) Types of discipline authorized. If disciplinary action or corrective action is appropriate under subsection (a), the Department may do one or more of the following:

(1) Deny the application for certification.

(2) Issue a public reprimand.

(3) Revoke, suspend, limit or otherwise restrict or condition the certification.

(4) Impose a civil money penalty not exceeding $1,000 for each incident in which the physician engages in conduct that constitutes a basis for discipline.

(5) Stay enforcement of any suspension, revocation or other discipline and place the individual on probation with the right to vacate the probationary order for noncompliance.

History

Authority: The provisions of this Chapter 1031 issued under the Emergency Medical Services System Act, 35 Pa.
Source: The provisions of this Chapter 1031 adopted October 11, 2013, effective October 12, 2013, 43 Pa.

28 Pa. Code § 1031.9 Automatic suspension for incapacity.

The Department will automatically suspend a certification issued under this subpart upon receiving a certified copy of court records establishing that the person has been adjudicated as incapacitated under 20 Pa.C.S. § 5511 (relating to petition and hearing; independent evaluation) or an equivalent statutory provision, and will lift the suspension upon receiving a certified copy of court records establishing that the person has regained capacity under 20 Pa.C.S. § 5517 (relating to adjudication of capacity and modification of existing orders) or an equivalent statutory provision.

History

Authority: The provisions of this Chapter 1031 issued under the Emergency Medical Services System Act, 35 Pa.
Source: The provisions of this Chapter 1031 adopted October 11, 2013, effective October 12, 2013, 43 Pa.

28 Pa. Code § 1031.10 Discipline of EMS agencies.

(a) Grounds for discipline. The Department may discipline an EMS agency or an applicant for an EMS agency license for one or more of the following reasons:

(1) Violating a requirement of the act or a regulation adopted under the act.

(2) Failing to submit a plan of correction acceptable to the Department to correct a violation cited by the Department or failing to comply with a plan of correction accepted by the Department.

(3) Refusing to accept a conditional temporary license properly sought by the Department or to abide by its terms.

(4) Engaging in fraud or deceit in obtaining or attempting to obtain a license.

(5) Lending its license or, except as authorized by the Department in acting upon the license application or an application to amend the license, enabling another person to manage or operate the EMS agency or any service the EMS agency is licensed to provide.

(6) Engaging in incompetence, negligence or misconduct in operating the EMS agency or in providing EMS to patients.

(7) Using the license of another or in any way knowingly aiding or abetting the improper granting of a license, certification, accreditation or other authorization issued under the act.

(8) Failing to meet or continue to meet applicable licensure standards.

(9) The EMS agency is not a responsible person or is not staffed by responsible persons and refuses to remove from its staff the irresponsible person or persons when directed to do so by the Department.

(10) Being convicted of a felony or a crime involving moral turpitude or related to the practice of the EMS agency.

(11) Making misrepresentations in seeking funds made available through the Department.

(12) Refusing to render EMS because of a patient’s race, sex, creed, national origin, sexual preference, age, handicap, medical problem or refusing to respond to an emergency and render EMS because of a patient’s financial inability to pay.

(13) Violating an order previously issued by the Department in a disciplinary matter.

(b) Types of discipline authorized. If disciplinary action is appropriate under subsection (a), the Department may do one or more of the following:

(1) Deny an application for a license.

(2) Issue a public reprimand.

(3) Revoke, suspend, limit or otherwise restrict the license.

(4) Impose a civil money penalty not exceeding $5,000 for each incident in which the EMS agency engages in conduct that constitutes a basis for discipline.

(5) Stay enforcement of a suspension, revocation or other discipline and place the EMS agency on probation with the right to vacate the probationary order for noncompliance.

The provisions of this § 1031.10 adopted October 11, 2013, effective April 10, 2014, 43 Pa.B. 6093.

This section cited in 28 Pa. Code § 1031.16 (relating to discipline of management companies).

History

Authority: The provisions of this Chapter 1031 issued under the Emergency Medical Services System Act, 35 Pa.
Source: The provisions of this Chapter 1031 adopted October 11, 2013, effective October 12, 2013, 43 Pa.

28 Pa. Code § 1031.11 Discipline of medical command facilities.

(a) Grounds for discipline. The Department may discipline a medical command facility or an applicant for a medical command facility certification for one or more of the following reasons:

(1) Submitting a fraudulent or deceptive application for certification or registration of the certification.

(2) Violating a requirement in § 1029.1 or § 1029.2 (relating to general provisions; and operational requirements).

(3) Refusing to permit an inspection or to respond to an inquiry as required under § 1029.4 (relating to inspections and investigations).

(4) Failing to comply, without just cause, with an EMS protocol approved by the Department.

(5) Failing to submit a plan of correction acceptable to the Department to correct a violation cited by the Department or failing to comply with a plan of correction accepted by the Department.

(b) Types of discipline authorized. If disciplinary action is appropriate under subsection (a), the Department may do one or more of the following:

(1) Deny an application for certification.

(2) Issue a public reprimand.

(3) Revoke, suspend, limit or otherwise restrict or condition the certification.

(4) Impose a civil money penalty not exceeding $5,000 for each act that constitutes a basis for discipline.

(5) Stay enforcement of a suspension, revocation or other discipline and place the medical command facility on probation with the right to vacate the probationary order for noncompliance.

History

Authority: The provisions of this Chapter 1031 issued under the Emergency Medical Services System Act, 35 Pa.
Source: The provisions of this Chapter 1031 adopted October 11, 2013, effective October 12, 2013, 43 Pa.

28 Pa. Code § 1031.12 Discipline of EMS educational institutes.

(a) Grounds for discipline. The Department may discipline an EMS educational institute or an applicant for an EMS educational institute certification for one or more of the following reasons:

(1) Failure to satisfy the responsibilities imposed upon it under § § 1025.1—1025.3 (relating to accreditation and operational requirements of EMS educational institutes; accreditation process; and advertising).

(2) An absence of students in the program for 2 consecutive years.

(3) Submission of a fraudulent or deceptive application for accreditation.

(b) Types of discipline authorized. If disciplinary action is appropriate under subsection (a), the Department may do one or more of the following:

(1) Deny the application for accreditation or reaccreditation.

(2) Impose terms of probation.

(3) Revoke, suspend, limit or otherwise restrict the accreditation.

(4) Impose a civil money penalty not exceeding $1,000 for each infraction.

The provisions of this § 1031.12 adopted October 11, 2013, effective April 10, 2014, 43 Pa.B. 6093.

History

Authority: The provisions of this Chapter 1031 issued under the Emergency Medical Services System Act, 35 Pa.
Source: The provisions of this Chapter 1031 adopted October 11, 2013, effective October 12, 2013, 43 Pa.

28 Pa. Code § 1031.13 Discipline of providers of EMS continuing education.

(a) Grounds for discipline. The Department may discipline a continuing education sponsor or an applicant for accreditation or reaccreditation as a continuing education sponsor for one or both of the following reasons:

(1) Failure to satisfy the requirements in Chapter 1025, Subchapter B (relating to EMS continuing education courses).

(2) Submission of a fraudulent or deceptive application for accreditation or reaccreditation.

(b) Types of discipline authorized. If disciplinary action is appropriate under subsection (a), the Department may do one or more of the following:

(1) Deny or withdraw its accreditation or reaccreditation.

(2) Downgrade its accreditation status to provisional accreditation, subject to withdrawal if deficiencies are not resolved within a time period prescribed by the Department.

(3) Withdraw approval of a continuing education course applicable to any future presentation of the course.

(4) Impose terms of probation.

(5) Revoke, suspend, limit or otherwise restrict the accreditation or reaccreditation.

(6) Impose a civil money penalty not exceeding $1,000 for each infraction.

The provisions of this § 1031.13 adopted October 11, 2013, effective April 10, 2014, 43 Pa.B. 6093.

History

Authority: The provisions of this Chapter 1031 issued under the Emergency Medical Services System Act, 35 Pa.
Source: The provisions of this Chapter 1031 adopted October 11, 2013, effective October 12, 2013, 43 Pa.

28 Pa. Code § 1031.14 Civil money penalty for practicing without a license or certification.

(a) Operating an EMS agency without a license. The Department may impose a civil money penalty of up to $5,000 per day upon a person who owns or operates an EMS agency in this Commonwealth without having a license to operate that EMS agency.

(b) Practicing as an EMS provider without a certification. The Department may impose a civil money penalty of up to $1,000 per day upon a person who provides EMS without an EMS provider’s certification or other legal authority to provide EMS.

History

Authority: The provisions of this Chapter 1031 issued under the Emergency Medical Services System Act, 35 Pa.
Source: The provisions of this Chapter 1031 adopted October 11, 2013, effective October 12, 2013, 43 Pa.

28 Pa. Code § 1031.15 Discipline of vendors of EMS PCR software.

The Department may assess a vendor of EMS PCR software a civil money penalty of up to $5,000 for each day a vendor violates a duty imposed by § 1021.43(b) or (d) (relating to vendors of EMS patient care reports).

History

Authority: The provisions of this Chapter 1031 issued under the Emergency Medical Services System Act, 35 Pa.
Source: The provisions of this Chapter 1031 adopted October 11, 2013, effective October 12, 2013, 43 Pa.

28 Pa. Code § 1031.16 Discipline of management companies.

(a) The Department may deny, withdraw or condition the approval of an entity to offer management services for one or more of the following reasons:

(1) The entity is not a responsible person.

(2) Persons having a substantial ownership interest in the entity are not responsible persons.

(3) The entity will not be staffed by or conduct its activities through responsible persons.

(4) The entity refuses to provide the Department with records or information reasonably requested by the Department to make a determination regarding paragraphs (1)—(3).

(5) The entity conducts the operation or managerial control of an EMS agency, or conducts the day-to-day operations of the EMS agency, in a manner that subjects the EMS agency to possible disciplinary action under § 1031.10 (relating to discipline of EMS agencies).

(6) The entity violates a requirement of the act or a regulation adopted under the act that is applicable to the entity.

(7) Engaging in fraud or deceit in obtaining or attempting to obtain or maintain Department approval.

(b) For purposes of subsection (a):

(1) A responsible person is a person who has not engaged in an act contrary to justice, honesty or good morals which indicates that the person is likely to betray the public trust in managing the operation of the EMS agency, or is a person who has engaged in this conduct but has been rehabilitated and is not likely to again betray the public trust.

(2) A person has a substantial ownership in the entity if the person has equity in the capital, stock or the profits of the applicant equal to 5% or more of the property or assets of the applicant.

(3) A person staffs an entity that manages an EMS agency if the person manages activity integral to the operation of the EMS agency.

The provisions of this § 1031.16 adopted October 11, 2013, effective April 10, 2014, 43 Pa.B. 6093.

This section cited in 28 Pa. Code § 1027.14 (relating to management companies).

History

Authority: The provisions of this Chapter 1031 issued under the Emergency Medical Services System Act, 35 Pa.
Source: The provisions of this Chapter 1031 adopted October 11, 2013, effective October 12, 2013, 43 Pa.

Chapter 1033 Special Event EMS

28 Pa. Code § 1033.1 Special event EMS planning requirements.

(a) Procedure for obtaining required plan approval. The entity responsible for the management and administration of a special event may submit a special event EMS plan to the Department, through the regional EMS council assigned responsibility for the region in which the special event is to occur, to secure a determination from the Department as to whether the plan is adequate to address the EMS needs presented by a special event or a series of special events conducted at the same location.

(1) The applicant shall submit its plan at least 90 days prior to the date of the first day of the event.

(2) The Department will approve or disapprove a special event EMS plan within 60 days after a complete plan is filed with the regional EMS council.

(3) The Department’s approval of a special event EMS plan will be for the special event or series of special events in a calendar year, as identified in the plan. The entity shall submit a new special event EMS plan to secure Department approval of a plan for a special event or series of special events in a subsequent calendar year.

(b) Plan content. The special event EMS plan must contain the following information:

(1) The type and nature of event, location, length and anticipated attendance.

(2) Identification of sponsoring organization.

(3) The name and qualifications of the special event EMS medical director and the special event EMS director.

(4) A listing of all EMS agencies that will be involved, the type of EMS service each EMS agency will provide and the number and level of certification of EMS providers each EMS agency will provide, as well as the number and type of health care practitioners who are not participating on behalf of an EMS agency, including EMS providers who are not participating on behalf of an EMS agency, who will be involved.

(5) The type and quantity of EMS vehicles and other vehicles, equipment and supplies to be utilized by each EMS agency that will be involved.

(6) A written agreement with each EMS agency that has agreed to participate, in which the EMS agency identifies the type of EMS service, the number of EMS providers by certification level, the vehicles, the equipment and supplies it will provide.

(7) A description of the onsite treatment facilities including maps of the special event site.

(8) A description of the special event emergency medical communications capabilities.

(9) A risk assessment for the event, and a plan for responding to a possible disaster or mass casualty incident at the event site, including a plan for emergency evacuation of the event site.

(10) A plan for educating event attendees regarding EMS system access and specific hazards, such as severe weather.

(11) Measures that have and will be taken to coordinate EMS for the special event or events with local emergency care services and public safety agencies—such as EMS, police, fire, rescue, and hospital agencies or organizations.

(c) Plan approval. To secure Department approval of a special event EMS plan, the applicant shall satisfy the requirements in this chapter.

This section cited in 28 Pa. Code § 1033.2 (relating to administration, management and medical direction requirements).

History

Authority: The provisions of this Chapter 1033 issued under the Emergency Medical Services System Act, 35 Pa.
Source: The provisions of this Chapter 1033 adopted October 11, 2013, effective October 12, 2013, 43 Pa.

28 Pa. Code § 1033.2 Administration, management and medical direction requirements.

(a) Special event EMS director. EMS provided at a special event shall be supervised by a special event EMS director.

(1) Responsibilities. The responsibilities of the special event EMS director include:

(i) Preparing a plan under § 1033.1 (relating to special event EMS planning requirements).

(ii) Managing the delivery of special event EMS.

(iii) Ensuring implementation of the EMS coordination measures contained in the special event EMS plan.

(iv) Ensuring that a record is kept that lists the individuals that requested or received EMS and the disposition of each case, including identification of the transporting EMS agency and ambulance, and the receiving facility, if the individual was transported to a receiving facility.

(2) Qualifications. A special event EMS director shall be experienced in the administration and management of EMS at the level of EMS provided for in the special event EMS plan.

(b) Special event EMS medical director.

(1) Responsibilities. The responsibilities of a special event EMS medical director include:

(i) Ensuring that each EMS provider provided by an EMS agency that is used under the special event EMS plan has been appropriately credentialed by the provider’s EMS agency medical director to provide EMS at the level required in the plan.

(ii) Ensuring that if onsite medical command is provided, that it be provided through a medical command facility and that medical command communications are documented.

(iii) Ensuring that equipment and medications are appropriately stored and secured.

(iv) Reviewing with the EMS agency medical directors for the EMS agencies involved, quality improvement issues related to the special event.

(v) Ensuring that adequate EMS PCRs and records are maintained for patients who receive EMS during the special event.

(2) Qualifications. A special event EMS medical director shall be an EMS agency medical director or satisfy the standards for being an EMS agency medical director in § 1023.1(b) (relating to EMS agency medical director) without serving as an EMS agency medical director.

This section cited in 28 Pa. Code § 1033.7 (relating to special event report).

History

Authority: The provisions of this Chapter 1033 issued under the Emergency Medical Services System Act, 35 Pa.
Source: The provisions of this Chapter 1033 adopted October 11, 2013, effective October 12, 2013, 43 Pa.

28 Pa. Code § 1033.3 Special event EMS personnel and capability requirements.

(a) Special event EMS providers shall be certified at appropriate levels based on the level of EMS approved by the Department in the special event EMS plan.

(b) One ambulance shall be stationed onsite at a special event if the event is expected to involve the presence of between 5,000 and 25,000 persons at any one time.

(c) Two ambulances shall be stationed onsite at a special event if the event is expected to involve the presence of more than 25,000 but less than 55,000 persons at any one time.

(d) Three ambulances shall be stationed onsite at a special event if the event is expected to involve the presence of more than 55,000 persons at any one time.

(e) Sufficient EMS providers shall be available to enssure the availability of EMS to persons present at the special event.

History

Authority: The provisions of this Chapter 1033 issued under the Emergency Medical Services System Act, 35 Pa.
Source: The provisions of this Chapter 1033 adopted October 11, 2013, effective October 12, 2013, 43 Pa.

28 Pa. Code § 1033.4 Onsite facility requirements.

A special event expected to involve the presence of more than 25,000 persons at any one time shall require the use of onsite treatment facilities. The onsite treatment facilities shall provide:

(1) Environmental control, providing protection from weather elements to ensure patient safety and comfort.

(2) Sufficient beds, cots and equipment to provide for evaluation and treatment of at least four simultaneous patients.

(3) Adequate lighting and ventilation to allow for patient evaluation and treatment.

History

Authority: The provisions of this Chapter 1033 issued under the Emergency Medical Services System Act, 35 Pa.
Source: The provisions of this Chapter 1033 adopted October 11, 2013, effective October 12, 2013, 43 Pa.

28 Pa. Code § 1033.5 Communications system requirements.

A special event EMS system shall have onsite communications capabilities to ensure:

(1) Uniform access to care for patients in need of EMS.

(2) Onsite coordination of the activities of EMS providers, including capability for interoperable communication with all EMS agencies involved in the plan and with EMS agencies local to the event site that are not involved in the special event EMS plan.

(3) Communication with existing community PSAPs.

(4) Communication interface with other involved public safety agencies.

(5) Communication with receiving facilities.

(6) Communication with ambulances providing emergency transportation.

(7) Communication with medical command physicians.

History

Authority: The provisions of this Chapter 1033 issued under the Emergency Medical Services System Act, 35 Pa.
Source: The provisions of this Chapter 1033 adopted October 11, 2013, effective October 12, 2013, 43 Pa.

28 Pa. Code § 1033.6 Requirements for educating event attendees regarding access to EMS.

(a) The entity responsible for the management and administration of a special event shall develop and implement a plan to educate special event participants and spectators about the following:

(1) The presence and location of EMS at the special event.

(2) The methods of obtaining EMS at the special event.

(b) The entity responsible for the management and administration of a special event shall establish a procedure and means for alerting the participants and spectators of specific hazards or serious changing conditions, such as severe weather, and for providing event evacuation instructions.

History

Authority: The provisions of this Chapter 1033 issued under the Emergency Medical Services System Act, 35 Pa.
Source: The provisions of this Chapter 1033 adopted October 11, 2013, effective October 12, 2013, 43 Pa.

28 Pa. Code § 1033.7 Special event report.

An entity for which the Department has approved a special event EMS plan shall complete a special event report form prepared by the Department and provided to it by the relevant regional EMS council and file the completed report with that regional EMS council within 30 days following the last day of a special event. Among other matters, the report shall provide a summary of the patient information required to be kept under § 1033.2(a)(1)(iv) (relating to administration, management and medical direction requirements).

History

Authority: The provisions of this Chapter 1033 issued under the Emergency Medical Services System Act, 35 Pa.
Source: The provisions of this Chapter 1033 adopted October 11, 2013, effective October 12, 2013, 43 Pa.

Subpart B Matters Anciliary to Emergency Medical Services Systems

Chapter 1051 Out-of-Hospital Do-Not-Recuscitate Orders

28 Pa. Code § 1051.1 Purpose.

This chapter provides standards for the issuance and revocation of out-of-hospital DNR orders and compliance with those orders. An additional purpose of this chapter is to address how health care providers are to deal with orders or directions to not provide life-sustaining treatment, CPR, nutrition or hydration to a pregnant woman.

The provisions of this § 1051.1 amended February 6, 2004, effective February 7, 2004, 34 Pa.B. 677. Immediately preceding text appears at serial page (294014).

History

Authority: The provisions of this Chapter 1051 issued under the Do-Not-Resuscitate Act, 20 Pa.
Source: The provisions of this Chapter 1051 were adopted February 6, 2004, effective February 7, 2004, replacing interim regulations which were adopted December 13, 2002, effective March 1, 2003, 32 Pa.

28 Pa. Code § 1051.2 Definitions.

The following words and terms, when used in this chapter, have the following meanings, unless the context clearly indicates otherwise: Advance directive—A directive for health care in a declaration issued under 20 Pa.C.S. Chapter 54 (relating to the Advance Directive for Health Care Act). Attending physician—A physician who has primary responsibility for the medical care and treatment of a patient. A patient may have more than one attending physician. CPR—Cardiopulmonary resuscitation—Cardiac compression, invasive airway techniques, artificial ventilation, defibrillation and other related procedures used to resuscitate a patient or to prolong the life of a patient. DNR—Do not resuscitate. Declarant—As defined in 20 Pa.C.S. § 5403 (relating to definitions). Declaration—As defined in 20 Pa.C.S. § 5403. Department—The Department of Health of the Commonwealth. EMS personnel—Emergency medical services personnel—Prehospital personnel and individuals given good Samaritan civil immunity protection when using an automated external defibrillator under 42 Pa.C.S. § 8331.2 (relating to good Samaritan civil immunity for use of automated external defibrillators). EMS provider—Emergency medical services provider—EMS personnel, a medical command physician and, as defined in § 1001.2 (relating to definitions), an advance life support service medical director, medical command facility medical director, medical command facility, ambulance service and quick response service. Health care provider—A person who is licensed, certified or otherwise authorized to administer health care in the ordinary course of a business or practice of a profession. The term includes EMS providers. Invasive airway technique—Any advanced airway technique, including endotracheal intubation. Life-sustaining treatment—

(i) A medical procedure or intervention that, when administered to a patient, will serve only to prolong the process of dying or to maintain the patient in a state of permanent unconsciousness.

(ii) The term includes nutrition and hydration administered by gastric tube or intravenously or any other artificial or invasive means if the order of the patient so specifically provides. Medical command physician—A physician who is approved by a regional emergency medical services council to provide medical command. Out-of-hospital DNR bracelet—A bracelet which signifies that an out-of-hospital DNR order has been issued. Out-of-hospital DNR necklace—A necklace which signifies that an out-of-hospital DNR order has been issued. Out-of-hospital DNR order—A written order, the form for which is supplied by the Department or its designee under this chapter, that is issued by an attending physician and directs EMS providers to withhold CPR from the patient in the event of cardiac or respiratory arrest. Out-of-hospital DNR patient—A patient for whom an attending physician has issued an out-of-hospital DNR order. Patient—One of the following:

(i) An individual who is in a terminal condition.

(ii) A declarant whose declaration has become operative under 20 Pa.C.S. § 5405(2) (relating to when declaration becomes operative) and which provides that CPR may not be provided in the event of the declarant’s cardiac or respiratory arrest if the declarant becomes permanently unconscious, or designates a surrogate to make that decision under those circumstances. Permanently unconscious—

(i) A medical condition that has been diagnosed in accordance with currently accepted medical standards and with reasonable medical certainty as total and irreversible loss of consciousness and capacity for interaction with the environment.

(ii) The term includes, without limitation, a persistent vegetative state or irreversible coma. Person—An individual, corporation, partnership, association or Federal, State or local government or governmental agency. Physician—An individual who has a currently registered license to practice medicine or osteopathic medicine in this Commonwealth. Prehospital personnel—The term includes any of the following prehospital practitioners:

(i) Ambulance attendants.

(ii) First responders.

(iii) Emergency medical technicians (EMTs).

(iv) EMT-paramedics.

(v) Prehospital registered nurses.

(vi) Health professional physicians. Surrogate—An individual who has, or individuals who collectively have, legal authority to request an out-of-hospital DNR order for another individual or to revoke that order. Terminal condition—An incurable and irreversible medical condition in an advanced state caused by injury, disease or physical illness which will, in the opinion of the attending physician, to a reasonable degree of medical certainty, result in death regardless of the continued application of life-sustaining treatment.

The provisions of this § 1051.2 amended February 6, 2004, effective February 7, 2004, 34 Pa.B. 677. Immediately preceeding text appears at serial pages (294014) to (294016).

History

Authority: The provisions of this Chapter 1051 issued under the Do-Not-Resuscitate Act, 20 Pa.
Source: The provisions of this Chapter 1051 were adopted February 6, 2004, effective February 7, 2004, replacing interim regulations which were adopted December 13, 2002, effective March 1, 2003, 32 Pa.

28 Pa. Code § 1051.3 Applicability.

(a) This chapter applies to the following:

(1) Health care providers.

(2) Attending physicians.

(3) Patients.

(4) Surrogates.

(b) This chapter neither compels nor prohibits health care provider compliance with an out-of-hospital DNR order in a hospital, except that in a hospital an EMS provider shall comply with an out-of-hospital DNR order in the course of providing care to or transportation of an out-of-hospital DNR patient on behalf of an ambulance service.

(c) This chapter does not regulate the issuance of or compliance with a DNR order issued in a hospital to be followed in that hospital.

(d) This chapter permits EMS providers to comply with out-of-hospital DNR orders in all settings other than a hospital, except as set forth in subsection (b), including personal care facilities and all other health care facilities.

The provisions of this § 1051.3 amended February 6, 2004, effective February 7, 2004, 34 Pa.B. 677. Immediately preceeding text appears at serial page (294016).

History

Authority: The provisions of this Chapter 1051 issued under the Do-Not-Resuscitate Act, 20 Pa.
Source: The provisions of this Chapter 1051 were adopted February 6, 2004, effective February 7, 2004, replacing interim regulations which were adopted December 13, 2002, effective March 1, 2003, 32 Pa.

28 Pa. Code § 1051.11 Patient qualifications to request and revoke out-of-hospital DNR order.

(a) Patient requesting an out-of-hospital DNR order. A patient may request and receive an out-of-hospital DNR order from the patient’s attending physician if the patient has a terminal condition and the patient is at least 18 years of age, has graduated from high school, has married or is emancipated.

(b) Patient revoking an out-of-hospital DNR order. An out-of-hospital DNR patient, regardless of age or physical or mental condition, may revoke an out-of-hospital DNR order issued for the out-of-hospital DNR patient whether the order was issued pursuant to the request of the patient or the patient’s surrogate.

The provisions of this § 1051.11 amended February 6, 2004, effective February 7, 2004, 34 Pa.B. 677. Immediately preceeding text appears at (294017).

This section cited in 28 Pa. Code § 1051.22 (relating to issuance of out-of-hospital DNR order); 28 Pa. Code § 1051.23 (relating to disclosure to patient requesting out-of-hospital DNR order); and 28 Pa. Code § 1051.26 (relating to physician refusal to issue an out-of-hospital DNR order).

History

Authority: The provisions of this Chapter 1051 issued under the Do-Not-Resuscitate Act, 20 Pa.
Source: The provisions of this Chapter 1051 were adopted February 6, 2004, effective February 7, 2004, replacing interim regulations which were adopted December 13, 2002, effective March 1, 2003, 32 Pa.

28 Pa. Code § 1051.12 Surrogate’s authority to request and revoke out-of-hospital DNR order.

(a) Surrogate requesting an out-of-hospital DNR order. The surrogate of a patient may request and receive from the patient’s attending physician an out-of-hospital DNR order for the patient, regardless of the patient’s age or other physical or mental condition.

(b) Surrogate revoking an out-of-hospital DNR order. A patient’s surrogate may revoke an out-of-hospital DNR order for the patient if the out-of-hospital DNR order was issued at the request of a surrogate.

The provisions of this § 1051.12 amended February 6, 2004, effective February 7, 2004, 34 Pa.B. 677. Immediately preceeding text appears at (294017).

History

Authority: The provisions of this Chapter 1051 issued under the Do-Not-Resuscitate Act, 20 Pa.
Source: The provisions of this Chapter 1051 were adopted February 6, 2004, effective February 7, 2004, replacing interim regulations which were adopted December 13, 2002, effective March 1, 2003, 32 Pa.

28 Pa. Code § 1051.13 Duties when person loses authority to function as a surrogate.

(a) No authority to revoke out-of-hospital DNR order. A person who acted as a patient’s surrogate when requesting an out-of-hospital DNR order for the patient may not revoke the out-of-hospital DNR order if the person loses the legal authority to serve as the patient’s surrogate.

(b) Duty when person loses surrogate status. If capable of doing so, a person who loses the authority to act as a patient’s surrogate after the person obtained an out-of-hospital DNR order for the patient shall apprise a replacement surrogate, if any, of the patient’s out-of-hospital DNR items and of other pertinent information relating to those items. The former surrogate shall also provide to the replacement surrogate or to the patient if the patient is no longer represented by a surrogate, the name of the physician who issued the out-of-hospital DNR order and any information the person has to help the patient or new surrogate locate the physician. The former surrogate, if capable of doing so, shall also make a reasonable effort to apprise the physician who issued the out-of-hospital DNR order of the change in that person’s status, as well as the name of the person, if any, who replaced that person as the patient’s surrogate and any information the former surrogate has to help the physician locate the patient and the patient’s current surrogate.

(c) Duty when contacted by physician. If a patient’s former surrogate did not attempt to contact the patient’s attending physician as required by subsection (b), or made the attempt but was unsuccessful, and is contacted by the patient’s attending physician for the purpose of communicating information regarding the patient, the patient’s former surrogate shall apprise the physician that the person is no longer the patient’s surrogate and provide the physician any information the former surrogate has to help the physician locate the patient or the patient’s current surrogate.

(d) Duty of replacement surrogate. A person who replaces another person as the patient’s surrogate after an out-of-hospital DNR order has been issued for the patient, and who is made aware of the order and given information regarding the attending physician who issued the order, shall make a reasonable effort to contact the physician to apprise the physician of the change in surrogates unless the new surrogate is able to confirm that the former surrogate has already made the disclosure.

The provisions of this § 1051.13 amended February 6, 2004, effective February 7, 2004, 34 Pa.B. 677. Immediately preceeding text appears at serial pages (294017) to (294018).

History

Authority: The provisions of this Chapter 1051 issued under the Do-Not-Resuscitate Act, 20 Pa.
Source: The provisions of this Chapter 1051 were adopted February 6, 2004, effective February 7, 2004, replacing interim regulations which were adopted December 13, 2002, effective March 1, 2003, 32 Pa.

28 Pa. Code § 1051.21 Securing out-of-hospital DNR orders, bracelets and necklaces.

(a) Securing order forms. A physician or the physician’s agent may secure out-of-hospital DNR order forms from the Department unless the Department has contracted with a vendor to provide the order forms, in which case the physician shall secure the order forms by purchasing them from the contracted vendor.

(b) Securing bracelets and necklaces. A physician may secure out-of-hospital DNR bracelets and necklaces by purchasing them from the vendor with which the Department has contracted to produce the bracelets and necklaces.

(c) Vendors. The Department will publish in a Pennsylvania Bulletin notice the name and address of the vendors with which it has contracted under this section and publish superseding Pennsylvania Bulletin notices when there are vendor changes.

The provisions of this § 1051.21 amended February 6, 2004, effective February 7, 2004, 34 Pa.B. 677. Immediately preceeding text appears at serial page (294018).

History

Authority: The provisions of this Chapter 1051 issued under the Do-Not-Resuscitate Act, 20 Pa.
Source: The provisions of this Chapter 1051 were adopted February 6, 2004, effective February 7, 2004, replacing interim regulations which were adopted December 13, 2002, effective March 1, 2003, 32 Pa.

28 Pa. Code § 1051.22 Issuance of out-of-hospital DNR order.

(a) Authority to issue. A patient’s attending physician shall issue an out-of-hospital DNR order for the patient if the patient who is qualified to request the order under § 1051.11(a) (relating to patient qualifications to request and revoke out-of-hospital DNR order) or the patient’s surrogate requests the attending physician to issue an out-of-hospital DNR order for the patient and the attending physician determines that the patient has a terminal condition or is permanently unconscious.

(b) Review of order before signing. Before completing, signing and dating an out-of-hospital DNR order, a patient’s attending physician shall ensure that the patient is identified in the order, that all other provisions of the order have been completed, and that the patient or the patient’s surrogate, as applicable, has signed the order.

(c) Order form. A patient’s attending physician shall issue an out-of-hospital DNR order for the patient only on a form provided by the Department or its designee.

The provisions of this § 1051.22 amended February 6, 2004, effective February 7, 2004, 34 Pa.B. 677. Immediately preceeding text appears at serial page (294018).

History

Authority: The provisions of this Chapter 1051 issued under the Do-Not-Resuscitate Act, 20 Pa.
Source: The provisions of this Chapter 1051 were adopted February 6, 2004, effective February 7, 2004, replacing interim regulations which were adopted December 13, 2002, effective March 1, 2003, 32 Pa.

28 Pa. Code § 1051.23 Disclosures to patient requesting out-of-hospital DNR order.

When a patient qualified under § 1051.11(a) (relating to patient qualifications to request and revoke out-of-hospital DNR order) requests an out-of-hospital DNR order, the attending physician shall disclose the following information to the patient before issuing an out-of-hospital DNR order for the patient:

(1) The diagnosed condition is a terminal condition.

(2) An out-of-hospital DNR order directs an EMS provider to withhold providing CPR to the patient in the event of the patient’s cardiac or respiratory arrest.

(3) The attending physician may also issue an out-of-hospital DNR bracelet or necklace for the patient, and that the necklace and bracelet also direct an EMS provider to withhold providing CPR in the event of the patient’s cardiac or respiratory arrest.

(4) An out-of-hospital DNR order, bracelet or necklace requested by a patient is effective only when the patient possesses and displays the order, bracelet or necklace.

(5) An out-of-hospital DNR order is not effective when the patient is in a hospital, unless an EMS provider has been dispatched to provide EMS to the patient in the hospital, but it may be possible for a DNR order to be issued for the patient in a hospital in accordance with other procedures.

(6) The patient may revoke the out-of-hospital DNR order; the patient may do so without the physician’s approval or knowledge; revocation may be accomplished by destroying or not displaying the order, bracelet or necklace, or by conveying the decision to revoke the out-of-hospital DNR order verbally or otherwise at the time the patient experiences respiratory or cardiac arrest; and neither the patient’s physical nor mental condition will be considered to void the patient’s decision to revoke the out-of-hospital DNR order if that decision is clearly communicated in some manner.

(7) The possibility exists that the EMS provider may administer CPR in the event of the patient’s cardiac or respiratory arrest if an EMS provider is uncertain regarding the validity or applicability of the out-of-hospital DNR order, bracelet or necklace.

(8) An EMS provider who complies with the patient’s out-of-hospital DNR order may provide other medical interventions to the patient to provide comfort or alleviate pain.

(9) The physician will make every reasonable effort to contact the patient to ask the patient to return the out-of-hospital DNR order, bracelet and necklace to the physician, for destruction by the physician, if the physician discovers that the diagnosis of the terminal condition was in error.

(10) If the patient is female, there are additional procedures that an EMS provider will need to follow to implement an out-of-hospital DNR order if the patient is pregnant at the time of cardiac or respiratory arrest. If the patient is pregnant or requests information regarding the additional procedures, the physician shall explain the requirements of § 1051.61 (relating to pregnant patients).

The provisions of this § 1051.23 amended February 6, 2004, effective February 7, 2004, 34 Pa.B. 677. Immediately preceding text appears at serial pages (294018) to (294020).

This section cited in 28 Pa. Code § 1051.24 (relating to disclosures to surrogate requesting out-of-hospital DNR order); and 28 Pa. Code § 1051.25 (relating to disclosures to patient when surrogate requests out-of-hospital DNR order).

History

Authority: The provisions of this Chapter 1051 issued under the Do-Not-Resuscitate Act, 20 Pa.
Source: The provisions of this Chapter 1051 were adopted February 6, 2004, effective February 7, 2004, replacing interim regulations which were adopted December 13, 2002, effective March 1, 2003, 32 Pa.

28 Pa. Code § 1051.24 Disclosures to surrogate requesting out-of-hospital DNR order.

Before issuing an out-of-hospital DNR order for a patient that is requested by the patient’s surrogate, the attending physician shall disclose the following information to the surrogate:

(1) The diagnosed condition is a terminal condition or that the physician has diagnosed the patient to be permanently unconscious.

(2) The disclosures required by § 1051.23(2), (3), (5), (7) and (8) (relating to disclosures to patient requesting out-of-hospital DNR order).

(3) An out-of-hospital DNR order, bracelet or necklace requested by the surrogate is effective only when the order, bracelet or necklace is displayed with the patient or the surrogate presents the order to the EMS provider at the time the patient experiences cardiac or respiratory arrest.

(4) The patient or surrogate may revoke the out-of-hospital DNR order; the patient or surrogate may do so without the physician’s approval or knowledge; revocation may be accomplished by destroying or not displaying the order, bracelet or necklace, or by conveying the decision to revoke the out-of-hospital DNR order verbally or otherwise at the time the patient experiences cardiac or respiratory arrest; and neither the physical nor mental condition of the patient will be considered to void the decision of the patient or surrogate to revoke the out-of-hospital DNR order if that decision is clearly communicated in some manner. The physician shall also apprise the surrogate, if it seems appropriate under the circumstances, that the power of the surrogate to revoke the out-of-hospital DNR order for the patient will terminate if the surrogate loses the legal authority to make that decision.

(5) The physician will make every reasonable effort to contact the surrogate to ask the surrogate to return the out-of-hospital DNR order, bracelet and necklace to the physician, for destruction by the physician, if the physician discovers that the diagnosis of the terminal condition or that the patient is permanently unconscious was in error.

(6) If the patient is female, there are additional procedures that an EMS provider will need to follow to implement an out-of-hospital DNR order if the patient is pregnant at the time of cardiac or respiratory arrest. If the patient is pregnant or the patient’s surrogate requests information regarding the additional procedures, the physician shall explain the requirements of § 1051.61 (relating to pregnant patients).

The provisions of this § 1051.24 amended February 6, 2004, effective February 7, 2004, 34 Pa.B. 677. Immediately preceeding text appears at (294020).

History

Authority: The provisions of this Chapter 1051 issued under the Do-Not-Resuscitate Act, 20 Pa.
Source: The provisions of this Chapter 1051 were adopted February 6, 2004, effective February 7, 2004, replacing interim regulations which were adopted December 13, 2002, effective March 1, 2003, 32 Pa.

28 Pa. Code § 1051.25 Disclosures to patient when surrogate requests out-of-hospital DNR order.

Before issuing an out-of-hospital DNR order for a patient that is requested by the patient’s surrogate, the attending physician shall disclose to the patient the information in § 1051.23 (relating to disclosures to patient requesting out-of-hospital DNR order) that the physician in good faith believes the patient needs to have to make a future decision to revoke or not revoke the order. In making this assessment, the physician shall consult with the patient’s surrogate and consider factors such as the reason the patient is not able to request an out-of-hospital DNR order, the patient’s ability to comprehend and retain the information, and the patient’s age and maturity. The attending physician shall refuse to issue the order if the physician and surrogate cannot agree to the information that is to be disclosed to the patient by the physician.

The provisions of this § 1051.25 amended February 6, 2004, effective February 7, 2004, 34 Pa.B. 677. Immediately preceeding text appears at serial page (294021).

This section cited in 28 Pa. Code § 1051.26 (relating to physician refusal to issue an out-of-hospital DNR order).

History

Authority: The provisions of this Chapter 1051 issued under the Do-Not-Resuscitate Act, 20 Pa.
Source: The provisions of this Chapter 1051 were adopted February 6, 2004, effective February 7, 2004, replacing interim regulations which were adopted December 13, 2002, effective March 1, 2003, 32 Pa.

28 Pa. Code § 1051.26 Physician refusal to issue an out-of-hospital DNR order.

An attending physician who is not willing to issue an out-of-hospital DNR order for a reason other than described in § 1051.25 (relating to disclosures to patient when surrogate requests out-of-hospital DNR order) shall explain the reason to the patient or the patient’s surrogate, as appropriate. If the request is made by a patient’s surrogate, or by a patient who qualifies to make the request under § 1051.11 (relating to patient qualifications to request and revoke out-of-hospital DNR order), and the physician determines that the patient is qualified to receive an out-of-hospital DNR order, the physician shall also do the following:

(1) Explain to the patient or surrogate that an out-of-hospital DNR order may be issued only by a physician who has primary responsibility for the treatment and care of a patient.

(2) Make every reasonable effort to assist the patient or surrogate to secure the services of another physician who is willing to issue an out-of-hospital DNR order for the patient and who will undertake primary responsibility for the treatment and care of the patient in addition to or instead of the attending physician, as the patient or surrogate chooses.

The provisions of this § 1051.26 amended February 6, 2004, effective February 7, 2004, 34 Pa.B. 677. Immediately preceeding text appears at serial page (294021).

History

Authority: The provisions of this Chapter 1051 issued under the Do-Not-Resuscitate Act, 20 Pa.
Source: The provisions of this Chapter 1051 were adopted February 6, 2004, effective February 7, 2004, replacing interim regulations which were adopted December 13, 2002, effective March 1, 2003, 32 Pa.

28 Pa. Code § 1051.27 Providing out-of-hospital DNR bracelet or necklace.

(a) Bracelet and necklace. A patient’s attending physician may provide to the patient, or to the patient’s surrogate for the patient, an out-of-hospital DNR bracelet or necklace, or both, if the physician has issued or is issuing an out-of-hospital DNR order for the patient and the patient or the surrogate requests the item.

(b) Order also required. A patient’s attending physician may not provide an out-of-hospital DNR bracelet or necklace for the patient without also issuing, or having issued, an out-of-hospital DNR order for the patient.

(c) Department vendor. A patient’s attending physician may provide to or for the patient only an out-of-hospital DNR bracelet or necklace produced by a vendor with which the Department has contracted to produce the bracelet or necklace.

The provisions of this § 1051.27 amended February 6, 2004, effective February 7, 2004, 34 Pa.B. 677. Immediately preceeding text appears at serial pages (294021) to (294022).

History

Authority: The provisions of this Chapter 1051 issued under the Do-Not-Resuscitate Act, 20 Pa.
Source: The provisions of this Chapter 1051 were adopted February 6, 2004, effective February 7, 2004, replacing interim regulations which were adopted December 13, 2002, effective March 1, 2003, 32 Pa.

28 Pa. Code § 1051.28 Documentation.

An attending physician who issues an out-of-hospital DNR order for a patient shall maintain a copy of that order in the patient’s medical record and shall document in that order whether the physician also provided an out-of-hospital DNR bracelet or necklace, or both. If the attending physician provides an out-of-hospital DNR bracelet or necklace after issuing the out-of-hospital DNR order, the physician shall document the patient’s medical record to reflect that the bracelet or necklace was also provided for the patient.

The provisions of this § 1051.28 amended February 6, 2004, effective February 7, 2004, 34 Pa.B. 677. Immediately preceeding text appears at serial page (294022).

History

Authority: The provisions of this Chapter 1051 issued under the Do-Not-Resuscitate Act, 20 Pa.
Source: The provisions of this Chapter 1051 were adopted February 6, 2004, effective February 7, 2004, replacing interim regulations which were adopted December 13, 2002, effective March 1, 2003, 32 Pa.

28 Pa. Code § 1051.29 Duty to contact patient or surrogate.

If a physician who issued an out-of-hospital DNR order for the patient subsequently determines that the diagnosis that the patient is in a terminal condition or is permanently unconscious was in error, the physician shall make every reasonable effort to promptly contact the patient or the patient’s surrogate to disclose the error. The physician shall also request the return of the order, and the bracelet and necklace if the physician provided those items.

The provisions of this § 1051.29 amended February 6, 2004, effective February 7, 2004, 34 Pa.B. 677. Immediately preceeding text appears at serial page (294022).

This section cited in 28 Pa. Code § 1051.30 (relating to physician destruction of out-of-hospital DNR order, bracelet or necklace).

History

Authority: The provisions of this Chapter 1051 issued under the Do-Not-Resuscitate Act, 20 Pa.
Source: The provisions of this Chapter 1051 were adopted February 6, 2004, effective February 7, 2004, replacing interim regulations which were adopted December 13, 2002, effective March 1, 2003, 32 Pa.

28 Pa. Code § 1051.30 Physician destruction of out-of-hospital DNR order, bracelet or necklace.

(a) Destruction of order, bracelet and necklace. A physician shall destroy an out-of-hospital DNR order, bracelet or necklace returned to the physician under § 1051.29 (relating to duty to contact patient or surrogate), as follows:

(1) The physician shall shred or otherwise destroy beyond identification the original order and mark all copies of the order in the physician’s possession as having been revoked.

(2) The physician shall cut the bracelet or necklace pendant in half or take other action that renders the bracelet or necklace incapable of being used again as an out-of-hospital DNR bracelet or necklace.

(b) Documentation of order when items not destroyed. A physician who requests the return of an out-of-hospital DNR order, bracelet or necklace under § 1051.29 may not mark copies of the order in the physician’s possession as having been revoked without having destroyed, or confirmed from a reliable person the destruction of the original out-of-hospital DNR order and any out-of-hospital DNR bracelet or necklace the physician provided for the patient.

The provisions of this § 1051.30 amended February 6, 2004, effective February 7, 2004, 34 Pa.B. 677. Immediately preceeding text appears at serial pages (294022) to (294023).

This section cited in 28 Pa. Code § 1051.13 (relating to duties when person loses authority to function as a surrogate).

History

Authority: The provisions of this Chapter 1051 issued under the Do-Not-Resuscitate Act, 20 Pa.
Source: The provisions of this Chapter 1051 were adopted February 6, 2004, effective February 7, 2004, replacing interim regulations which were adopted December 13, 2002, effective March 1, 2003, 32 Pa.

28 Pa. Code § 1051.51 Implementation of out-of-hospital DNR order.

(a) Display of order, bracelet or necklace. An EMS provider may not provide CPR to a patient who is experiencing cardiac or respiratory arrest if an out-of-hospital DNR order, bracelet or necklace is displayed with the patient or the patient’s surrogate presents the EMS provider with an out-of-hospital DNR order for the patient, and neither the patient nor the patient’s surrogate acts to revoke the order at that time. When an EMS provider observes an out-of-hospital DNR order without also observing an out-of-hospital DNR bracelet or necklace, the EMS provider shall implement the out-of-hospital DNR order only if it contains original signatures.

(b) Discovery after CPR initiated. If after initiating CPR an EMS provider becomes aware of an out-of-hospital DNR order that is effective under subsection (a), the EMS provider shall discontinue CPR.

(c) Prehospital practitioner uncertainty. If a prehospital practitioner is uncertain as to whether an out-of-hospital DNR order has been revoked for a patient who is experiencing cardiac or respiratory arrest, the prehospital practitioner shall provide CPR to the patient subject to the following:

(1) If the prehospital practitioner is in contact with a medical command physician prior to initiating CPR, the prehospital practitioner shall initiate or not initiate CPR as directed by the medical command physician.

(2) If the prehospital practitioner is in contact with a medical command physician after initiating CPR, the prehospital practitioner shall continue or not continue CPR as directed by the medical command physician.

(d) Discontinuation of CPR not initiated by prehospital practitioner. If CPR had been initiated for the patient before a prehospital practitioner arrived at the scene, and the prehospital practitioner determines that an out-of-hospital DNR order is effective under subsection (a), the prehospital practitioner may not discontinue the CPR without being directed to do so by a medical command physician.

(e) AED good Samaritan. If an individual who is given good Samaritan civil immunity protection when using an automated external defibrillator (AED) under 42 Pa.C.S. § 8331.2 (relating to good Samaritan civil immunity for use of automated external defibrillators) is uncertain as to whether an out-of-hospital DNR order has been revoked for a patient who is experiencing cardiac arrest, the individual may provide CPR to the patient as permitted by 42 Pa.C.S. § 8331.2, but shall discontinue CPR if directed by a medical command physician directly or as relayed by a prehospital practitioner.

(f) Providing comfort and alleviating pain. When a prehospital practitioner complies with an out-of-hospital DNR order, the prehospital practitioner, within the practitioner’s scope of practice, shall provide other medical interventions necessary and appropriate to provide comfort to the patient and alleviate the patient’s pain, unless otherwise directed by the patient or the prehospital practitioner’s medical command physician.

The provisions of this § 1051.51 amended February 6, 2004, effective February 7, 2004, 34 Pa.B. 677. Immediately preceeding text appears at serial pages (294023) to (294024).

This section cited in 28 Pa. Code § 1051.52 (relating to procedure when both advance directive and out-of-hospital DNR order are present); and 28 Pa. Code § 1051.101 (relating to recognition of other states’ out-of-hospital DNR orders).

History

Authority: The provisions of this Chapter 1051 issued under the Do-Not-Resuscitate Act, 20 Pa.
Source: The provisions of this Chapter 1051 were adopted February 6, 2004, effective February 7, 2004, replacing interim regulations which were adopted December 13, 2002, effective March 1, 2003, 32 Pa.

28 Pa. Code § 1051.52 Procedure when both advance directive and out-of-hospital DNR order are present.

If a patient with cardiac or respiratory arrest has both an advance directive directing that no CPR be provided and an out-of-hospital DNR order, an EMS provider shall comply with the out-of-hospital DNR order as set forth in § 1051.51 (relating to implementation of an out-of-hospital DNR order).

The provisions of this § 1051.52 amended February 6, 2004, effective February 7, 2004, 34 Pa.B. 677. Immediately preceeding text appears at serial page (294024).

This section cited in 28 Pa. Code § 1051.101 (relating to recognition of other states’ out-of-hospital DNR orders).

History

Authority: The provisions of this Chapter 1051 issued under the Do-Not-Resuscitate Act, 20 Pa.
Source: The provisions of this Chapter 1051 were adopted February 6, 2004, effective February 7, 2004, replacing interim regulations which were adopted December 13, 2002, effective March 1, 2003, 32 Pa.

28 Pa. Code § 1051.61 Pregnant patients.

Notwithstanding the existence of an order or direction to the contrary, life-sustaining treatment, CPR, nutrition and hydration shall be provided to a pregnant patient by a health care provider unless, to a reasonable degree of medical certainty as certified on the patient’s medical record by the patient’s attending physician and a second physician who is an obstetrician who has examined the patient, life-sustaining treatment, nutrition and hydration will have one of the following consequences:

(1) They will not maintain the pregnant patient in such a way as to permit the continuing development and live birth of the unborn child.

(2) They will be physically harmful to the pregnant patient.

(3) They will cause pain to the pregnant patient which cannot be alleviated by medication.

The provisions of this § 1051.61 amended February 6, 2004, effective February 7, 2004, 34 Pa.B. 677. Immediately preceeding text appears at serial page (294024).

This section cited in 28 Pa. Code § 1051.23 (relating to disclosures to patient requesting out-of-hospital DNR order); 28 Pa. Code § 1051.24 (relating to disclosures to surrogate requesting out-of-hospital DNR order); and 28 Pa. Code § 1051.101 (relating to recognition of other states’ out-of-hospital DNR orders).

History

Authority: The provisions of this Chapter 1051 issued under the Do-Not-Resuscitate Act, 20 Pa.
Source: The provisions of this Chapter 1051 were adopted February 6, 2004, effective February 7, 2004, replacing interim regulations which were adopted December 13, 2002, effective March 1, 2003, 32 Pa.

28 Pa. Code § 1051.81 Medical command physician responsibilities.

(a) Compliance with out-of-hospital DNR order. If a medical command physician is in contact with a prehospital practitioner when the prehospital practitioner is attending to a patient in cardiac or respiratory arrest and the prehospital practitioner is made aware of an out-of-hospital DNR order for the patient by examining an out-of-hospital DNR order, bracelet or necklace, the medical command physician shall honor the out-of-hospital DNR order. If appropriate, the medical command physician shall direct the prehospital practitioner to provide other medical interventions within the practitioner’s scope of practice to provide comfort to the patient and alleviate the patient’s pain, unless the prehospital practitioner is otherwise directed by the patient.

(b) Prehospital practitioner uncertainty. If a medical command physician is in contact with a prehospital practitioner when the prehospital practitioner is attending to a patient in cardiac or respiratory arrest and the prehospital practitioner communicates uncertainty as to whether an out-of-hospital DNR order for the patient has been revoked, the medical command physician shall ask the prehospital practitioner to explain the reason for the uncertainty. Based upon the information provided, the medical command physician shall make a good faith assessment of whether the described circumstances constitute a revocation, and then direct the prehospital practitioner to withdraw or continue CPR based upon whether the physician determines that the out-of-hospital DNR order has been revoked or not revoked.

(c) Pregnant patient. If a medical command physician is in contact with a prehospital practitioner when the prehospital practitioner is attending to a pregnant patient in cardiac or respiratory arrest, and the prehospital practitioner is made aware of an out-of-hospital DNR order for the pregnant patient by examining an out-of-hospital DNR order, bracelet or necklace for the patient, and apprises the medical command physician of the out-of-hospital DNR order, the medical command physician shall direct the prehospital practitioner to ignore the out-of-hospital DNR order unless the medical command physician has knowledge that the patient’s attending physician and a second physician who is an obstetrician had examined the patient, and both certified in the patient’s medical record that, to a reasonable degree of medical certainty, life-sustaining treatment, nutrition, hydration and CPR will have one of the following consequences:

(1) They will not maintain the pregnant patient in such a way as to permit the continuing development and live birth of the unborn child.

(2) They will be physically harmful to the pregnant patient.

(3) They will cause pain to the pregnant patient which cannot be alleviated by medication.

(d) Inconsistencies. Subsections (a) and (b) apply when the patient is a pregnant patient, except to the extent they are inconsistent with subsection (c).

The provisions of this § 1051.81 amended February 6, 2004, effective February 7, 2004, 34 Pa.B. 677. Immediately preceeding text appears at serial pages (294025) to (294026).

This section cited in 28 Pa. Code § 1051.101 (relating to recognition of other states’ out-of-hospital DNR orders).

History

Authority: The provisions of this Chapter 1051 issued under the Do-Not-Resuscitate Act, 20 Pa.
Source: The provisions of this Chapter 1051 were adopted February 6, 2004, effective February 7, 2004, replacing interim regulations which were adopted December 13, 2002, effective March 1, 2003, 32 Pa.

28 Pa. Code § 1051.101 Recognition of other states’ out-of-hospital DNR orders.

(a) Validity of orders, bracelets and necklaces from other states. An out-of-hospital DNR order, bracelet or necklace valid in a state other than this Commonwealth is effective in this Commonwealth to the extent the order, bracelet or necklace is consistent with the laws of this Commonwealth.

(b) Department acceptance. The Department will review the applicable laws of other states, and the out-of-hospital DNR orders, bracelets and necklaces provided in other states, and list in a notice in the Pennsylvania Bulletin the states that provide out-of-hospital DNR orders, bracelets and necklaces that are consistent with the laws of the Commonwealth. The notice will also include, for each state listed, a description of the out-of-hospital DNR order, bracelet and necklace the state issues consistent with the laws of the Commonwealth. The Department will update the list and descriptions, as needed, in a superseding notice in the Pennsylvania Bulletin.

(c) Compliance by EMS providers. An EMS provider shall comply with § § 1051.51, 1051.52, 1051.61 and 1051.81 when encountering a patient with an apparently valid out-of-hospital DNR order, bracelet or necklace issued by another state listed in a notice in the Pennsylvania Bulletin issued under subsection (b).

The provisions of this § 1051.101 amended February 6, 2004, effective February 7, 2004, 34 Pa.B. 677. Immediately preceeding text appears at serial page (294026).

History

Authority: The provisions of this Chapter 1051 issued under the Do-Not-Resuscitate Act, 20 Pa.
Source: The provisions of this Chapter 1051 were adopted February 6, 2004, effective February 7, 2004, replacing interim regulations which were adopted December 13, 2002, effective March 1, 2003, 32 Pa.

Part VIII Supplemental Nutrition Program for Women, Infants and Children (WIC Program)

Chapter 1101 General Provisions

28 Pa. Code § 1101.1 Background and scope.

(a) Background. Through an amendment to section 17 of the Child Nutrition Act of 1966 (42 U.S.C.A. § 1786), Congress has authorized the USDA-FNS to contract with state agencies for the establishment of the WIC Program. The USDA-FNS contracts with and makes funds available to the Department to administer the WIC Program in this Commonwealth.

(1) The purpose of the WIC Program is to provide allowable foods to income eligible pregnant, breast-feeding or postpartum women, infants and children up to 5 years of age, who are at nutritional risk because of medical problems or poor diets. The WIC Program provides these individuals with nutritious foods to supplement their diets during critical stages of growth and development. These foods are chosen to correct, prevent or minimize health and nutritional problems. The foods are not intended to be a complete diet, but, rather, to supplement other foods available to the participants.

(2) In addition to providing supplemental foods, the WIC Program refers applicants and participants to health services and offers nutrition education so that the food will be properly used and will improve the dietary and health habits of the entire family. The Department uses a retail purchase system to provide the majority of food benefits to participants.

(b) Scope. This part establishes design and operational requirements for the food delivery system for the WIC Program, and prescribes procedures to be used by applicants, participants and stores to appeal actions of the Department and local agencies that may adversely impact upon them.

The provisions of this § 1101.1 amended under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

The provisions of this § 1101.1 amended October 3, 2003, effective October 4, 2003, 33 Pa.B. 4900. Immediately preceding text appears at serial pages (272421) to (272422).

History

Authority: The provisions of this § 1101.
Source: The provisions of this § 1101.

28 Pa. Code § 1101.2 Definitions.

The following words and terms, when used in this part, have the following meanings, unless the context clearly indicates otherwise: Above-50-percent-store—A store that derives more than 50% of its annual food sales revenue from WIC checks, and a new store applicant expected to meet this criterion under guidelines approved by USDA-FNS. Allowable foods—Foods and infant formula on the WIC food list. These products meet nutritional standards established by the USDA-FNS and are authorized by the Department for purchase with WIC checks. Applicant—An individual applying to become a participant. Authorization—The grant of authority to a store to serve as a WIC authorized store. Authorized representative—

(i) For an applicant or participant, a parent or guardian of an applicant or participant who is an infant or child, a proxy or endorser, or an individual designated to represent the applicant or participant in administrative proceedings involving the WIC Program.

(ii) For a store, an individual designated by the store to represent it in administrative proceedings involving the WIC Program.

(iii) For a compliance buy or WIC transaction review, the person conducting the compliance buy or WIC transaction review. Breastfeeding woman—A woman, during 1 year postpartum, who is breastfeeding her infant. Certification—The Department’s acceptance of an applicant to participate in the WIC Program as a participant. Child—A person 1 year of age or older but under 5 years of age. Claim—A demand for reimbursement of an overcharge or other improper charge to the WIC Program as a result of a store violation. Clinic—A facility where applicants apply for and participants receive WIC Program services other than food benefits. Competitive price—The price established by the Department, at or below which a store shall maintain the required minimum inventory. Compliance buy—A covert purchase at a WIC authorized store, with a WIC check, conducted to enable the Department to evaluate adherence by a WIC authorized store with this part governing the store’s participation in the WIC Program. Compliance investigation—A series of at least two compliance buys conducted at the same WIC authorized store. Competent professional authority—

(i) An individual on the staff of the local agency authorized to determine nutritional risk and prescribe supplemental foods. The following persons are the only persons the Department will authorize to serve as a competent professional authority: physicians, nutritionists (Bachelor’s or Master’s Degree in Nutritional Sciences, Community Nutrition, Clinical Nutrition, Dietetics, Public Health Nutrition or Home Economics with emphasis on nutrition), dieticians, registered nurses, physician’s assistants (certified by the National Committee on Certification of Physician’s Assistants or certified by the State medical certifying authority), or State or local medically trained health officials.

(ii) The term also applies to an individual who is not on staff at the local agency but who is qualified to provide data upon which nutritional risk determinations are made by a competent professional authority on staff of the local agency. Contract brand—The specific manufacturer brand of an allowable food that the Department is contractually bound to prescribe for participants. Department—The Department of Health of the Commonwealth. Disqualification—

(i) For the purposes of this chapter and 1103, 1105, 1107, 1109 and 1113, the term means the action by the Department to end participation of a WIC authorized store in the WIC Program for reasons of fraud, abuse or other violations of this part governing the store’s participation in the WIC Program.

(ii) For purposes of Chapter 1111 (relating to applicant and participant appeals), the term means action by the Department or local agency to end participation of a participant who no longer meets the qualifications necessary to participate in the WIC Program or for reasons of fraud, abuse or violation of standards governing the participant’s enrollment in the WIC Program. Division of WIC—Division of WIC in the Department. Endorser—The parent or guardian of an infant or child participant who is authorized to use and sign the WIC checks of the infant or child for purchase of allowable foods. Filing date—The date on which the local agency or the Department receives an appeal. Food items—Items sold for human consumption that are eligible for purchase under the Food Stamp Program. Food prescription—A designation by a competent professional authority of allowable foods in specified quantities to meet a participant’s nutritional needs based upon a determination of nutritional risk. Food sales—

(i) Sales of all Food Stamp Program eligible foods intended for home preparation and consumption, including meat, fish, and poultry; bread and cereal products; dairy products; fruits and vegetables.

(ii) Food items such as condiments and spices, coffee, tea, cocoa and carbonated and noncarbonated drinks may be included in food sales when offered for sale along with foods in the categories identified in this definition.

(iii) The term does not include the sale of any item that cannot be purchased with food stamp benefits, such as hot foods or food that will be eaten in the store. Food Stamp Program—The government benefits program operated under the authority of the Food Stamp Act of 1964 (7 U.S.C. Chapter 51) and 55 Pa. Code Part II, Subpart L (relating to Food Stamp Program), and administered by the USDA-FNS and the Department of Public Welfare. Full line grocery store—A store that:

(1) Offers for sale, in addition to WIC authorized foods, food items from each of the following four food categories on a continuous basis:

(i) Meat, poultry or fish.

(ii) Bread or cereal.

(iii) Vegetables or fruits.

(iv) Dairy.

(2) Has available for sale at all times of operation and displays in a public area of the store, a minimum of three different varieties of food items in each of the four above listed food categories. Health services—Routine pediatric and obstetric care (such as infant and child care and prenatal and postpartum examinations) or referral for treatment. High risk store—A store identified as a possible perpetrator of fraud or abuse through analysis of redemption patterns of WIC checks or WIC sales, or by complaints of participants or WIC Program staff. Infant—A person under 1 year of age. Inventory audit—A comparison of a WIC authorized store’s inventory levels of a particular allowable food over a specific period of time, to purchases of the allowable food with WIC checks during the same period of time, to determine if the store had a quantity of the allowable food available for sale during that time sufficient to support its claim for reimbursement for the sale of the allowable food. Local agency—A public or private nonprofit health or human service agency with which the Department contracts to provide WIC Program services for a specific geographic area. Maximum allowable price—The maximum price the Department will pay for an allowable food. Nutritional risk—A determination that one of the following exists:

(i) Detrimental or abnormal nutritional conditions detectable by biochemical or anthropometric measurements.

(ii) Other documented nutritionally related medical conditions.

(iii) Dietary deficiencies that impair or endanger health.

(iv) Conditions that predispose persons to inadequate nutritional patterns or nutritionally related medical conditions. Onsite review—A visit to a store by Federal, Department or local agency personnel to determine if the store meets the selection criteria necessary to be a WIC authorized store, or a visit to a WIC authorized store to determine whether the store is complying with this part governing the store’s participation in the WIC Program. An onsite review may be announced or unannounced. Overcharge—A charge by a WIC authorized store to the WIC Program through redemption of a WIC check for an allowable food in excess of the store’s shelf price for that food or in excess of the price charged a non-WIC participant for that food. Overpayment—Payment to a WIC authorized store of a WIC check redeemed by the store in an amount in excess of the amount to which the store was entitled based upon the maximum allowable price applicable to the store’s peer group for each allowable food authorized for purchase on the WIC check. Participant—A pregnant woman, breast-feeding woman, postpartum woman, infant or child enrolled in the WIC Program. Participant certification period—The period of time during which an individual is authorized to participate in the WIC Program. Peer group—The classification of an authorized store under the store peer group system, as determined by the criteria selected by the Department, including size of a store sales floor, number of cash registers in the store, number of stores owned, and county where the store is located. Periodic review—Contemporaneous announced onsite reviews of stores in a trade area conducted not less than once every 3 years to select stores for reauthorization. Postpartum woman—A woman, during 6 months after termination of pregnancy. Pregnant woman—A woman determined to have one or more embryos or fetuses in utero. Premises—The sales floor and storage areas within the building housing the WIC authorized store. Price adjustment—The retroactive reduction in the amount paid for a redeemed check as a result of a determination of overpayment. Probationary authorization—The Department’s probationary authorization of a WIC authorized store when inadequate participant access would occur if the store were not authorized or reauthorized or when the store is reviewed prior to opening to the public and has not yet stocked its dairy section or its frozen juice section. Proxy—A person authorized by the local agency and the participant, or by the participant’s parent or guardian if the participant is an infant or child, to pick up or use WIC checks to make purchases for that participant. Reauthorization—The Department’s renewal of authorization. Redemption—Submission of a WIC check by a WIC authorized store to its bank for the purpose of securing a money payment for the amount appearing in the ‘‘Pay Exactly’’ box on the WIC check. Routine review—An unannounced onsite review of a WIC authorized store to evaluate adherence by the store with the requirements in this part governing the store’s participation in the WIC Program. Sales floor—The display shelving, the floor in the area normally used for retail trade and the area behind the customer service desk, excluding other areas not accessible to the general public. Sanction—

(i) A penalty imposed by the Department upon a WIC authorized store for violation of this part governing the store’s participation in the WIC Program.

(ii) The term does not include a decision to deny authorization or reauthorization following an announced onsite review. Secretary—The Secretary of the Department. Selection criteria—Criteria in § 1103.4 (relating to selection criteria for authorization and reauthorization) which the Department has established which a store seeking to be authorized or reauthorized is required to satisfy. Stale-dated—After the date imprinted on the product as the recommended last date for sale or use. Standard formula—Infant formula products that do the following:

(i) Meet the Federal WIC regulatory definition of an iron-fortified formula (7 CFR 246.10(c)(1)(I) (relating to supplemental foods)).

(ii) Comply with the Infant Formula Act of 1980, the act of September 26, 1980 (Pub. L. No. 96-359, 94 Stat. 1190), which amended the Food and Drug Act.

(iii) Meet the requirements of an ‘‘infant formula’’ as opposed to an ‘‘exempt infant formula’’ or ‘‘medical food’’ as determined by the Food and Drug Administration (FDA), United States Department of Health and Human Services. Store peer group system—A classification of authorized stores into groups based on common characteristics or criteria including size of a store sales floor, number of cash registers in the store, number of stores owned, and a measure of geography, such as metropolitan or other statistical areas that form distinct labor and product markets that affect food prices, for the purposes of applying appropriate competitive pricing criteria to stores at authorization and reauthorization and limiting payment for foods to competitive levels. Store violation—Intentional or unintentional action by the owners, officers, managers, agents or employees of a WIC authorized store that violates the requirements in this part governing the store’s participation in the WIC Program and that may result in a claim. Temporary authorization—The Department’s temporary and conditional authorization of a WIC authorized store that fails to meet specified selection criteria during the initial onsite review for purpose of reauthorization. Trade area—A designated geographic area within the geographical area assigned to a local agency, which is organized to serve the participant populations in that designated area. USDA-FNS—The United States Department of Agriculture, Food and Nutrition Service. WIC authorized store—A retail food store which is authorized or reauthorized in accordance with § 1103.1 (relating to authorization and reauthorization process and requirements) to provide allowable foods to participants by accepting WIC checks. WIC check—A negotiable instrument issued to participants to purchase allowable foods at WIC authorized stores. WIC food list—A list published by the Department in the Pennsylvania Bulletin of foods and infant formula which may be purchased with WIC checks. WIC identification card—A document issued by the Department to a participant, which is used for identification purposes and verification of eligibility to purchase allowable foods with WIC checks at a WIC authorized store. WIC Program—The Special Supplemental Nutrition Program for Women, Infants and Children. WIC Program benefits—Supplemental foods, nutrition education and referral to health services. WIC transaction—The presentation of a WIC check by a participant or authorized representative to a WIC authorized store resulting in the purchase of one or more of the allowable foods designated on the check. WIC transaction review—The presentation of a WIC check by a Federal, Department or local agency representative to purchase foods at a WIC authorized store, which does not result in the actual tender of the WIC check or the purchase of the foods, to evaluate adherence by a WIC authorized store with the requirements in this part governing the store’s participation in the WIC Program.

The provisions of this § 1101.2 amended under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

The provisions of this § 1101.2 amended December 22, 2000, effective December 23, 2000, 30 Pa.B. 6853; amended October 3, 2003, effective October 4, 2003, 33 Pa.B. 4900; amended September 11, 2009, effective immediately, 39 Pa.B. 5292. Immediately preceding text appears at serial pages (300324) to (300329).

History

Authority: The provisions of this § 1101.
Source: The provisions of this § 1101.

28 Pa. Code § 1101.3 Administration.

(a) Department responsibilities. The Department will develop policies and procedures for the operation of the WIC Program, distribute funds to local agencies to assist the Department in operating the WIC Program, authorize stores to participate in the WIC Program, monitor and evaluate WIC Program services provided by WIC authorized stores, maintain fiscal records, submit reports and carry out all other responsibilities delegated to it by the USDA-FNS for the operation of the WIC Program.

(b) Vendor Advisory Workgroup. The Department will form a Vendor Advisory Workgroup with representation from the retail store community, appropriate advocacy groups and associations for retail stores and participants, and from the State and local agencies. The Department will schedule at least two meetings of the Vendor Advisory Workgroup annually to review and discuss retail store and food delivery issues. The Vendor Advisory Workgroup shall function in an advisory capacity only; acceptance of Workgroup recommendations shall be at the discretion of the Department.

(c) Local agency responsibilities. Local agencies shall determine whether participants meet eligibility criteria developed by the Department, develop food prescriptions for participants, provide nutrition education to participants, provide referral information regarding ongoing health services, issue WIC checks to participants to purchase allowable foods and ensure that all participants are served without discrimination. Local agencies shall function as representatives of the Department in conducting onsite reviews, and in monitoring the activities of WIC authorized stores.

The provisions of this § 1101.3 amended under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

The provisions of this § 1101.3 amended October 3, 2003, effective October 4, 2003, 33 Pa.B. 4900. Immediately preceding text appears at serial pages (272426).

History

Authority: The provisions of this § 1101.
Source: The provisions of this § 1101.

Chapter 1103 Authorization of Stores

28 Pa. Code § 1103.1 Authorization and reauthorization process and requirements.

(a) Duration of authorization or reauthorization. To serve as a WIC authorized store, a store shall be authorized in accordance with subsection (b) or reauthorized in accordance with subsection (c). A store’s authorization or reauthorization shall remain in effect until the Department acts on the store’s application for reauthorization when the next periodic review is conducted in the trade area in which the store is located, unless terminated earlier in accordance with subsection (d). At least once every 3 years, the Department will conduct a periodic review in each trade area. Failure to submit an application for reauthorization as prescribed under subsection (c) shall result in expiration of the store’s authorization or reauthorization. The Department will provide 30 days written notice to the store prior to expiration of authorization or reauthorization for any store failing to submit an application. A store that has received a letter of authorization dated less than 60 days prior to the date of the notice of the periodic review in the store’s trade area shall be exempt from the periodic review.

(b) Authorization process.

(1) The store’s representative shall contact the local agency responsible for the trade area where the store is located to request an application for authorization. The local agency shall send WIC Program information and an application for authorization to the store. The store shall complete the application for authorization and return it to the local agency.

(2) The Department will refuse to accept an application from a store if the store has been provided notice of disqualification or is disqualified from the WIC Program, if the Department determines that the store relocated or effected a change of ownership to avoid a disqualification, or if the store has been denied authorization or reauthorization and is not eligible to apply for authorization.

(3) The Department will not accept an application for authorization less than 90 days prior to the scheduled start date of the periodic review in that trade area unless the Department finds that there would be inadequate participant access, as set forth in § 1103.7 (relating to inadequate participant access), if it does not consider the application.

(4) If the store’s application for authorization is accepted, the local agency shall schedule, as expeditiously as possible, an announced onsite review of the store to determine if the store meets the selection criteria in § 1103.4 (relating to selection criteria for authorization and reauthorization). The local agency shall notify the store in advance of the approximate date of the review.

(5) The Department may request from the store any information necessary for the Department to determine whether the store qualifies as an above-50-percent-store. This information may include official State and Federal Income Tax filings, official State Sales Tax records, inventory purchase records, sales records or a self-declaration from the applicant.

(6) The local agency shall conduct the onsite review and forward the results to the Department for a decision on the store’s application.

(7) The Department will deny the application if the selection criteria in § 1103.4 are not satisfied, unless the Department grants probationary authorization under § 1103.2 (relating to probationary authorization). The Department will notify the store in writing whether the store’s application for authorization is granted or denied. If the Department denies the application for authorization, the store shall be eligible to reapply for authorization 6 months after the effective date of the denial.

(1) The Department will include an application for reauthorization with the notice of periodic review it sends to the store. The local agency will collect the application for reauthorization at the time of the announced onsite review of the store to determine if the store meets the selection criteria in § 1103.4. The local agency shall notify the store in advance of the approximate date of the review.

(2) The Department may request from the store any information necessary for the Department to determine whether the store qualifies as an above-50-percent-store. This information may include official State and Federal Income Tax filings, Official State Sales Tax records, inventory purchase records, sales records or a self-declaration from the applicant.

(3) The local agency shall conduct the onsite review and forward the results to the Department for a decision on the store’s application.

(4) The Department will deny the application without advance warning if the selection criteria in § 1103.4 are not satisfied, unless the store requests and the Department grants temporary authorization in accordance with § 1103.3 (relating to temporary authorization) or the Department grants probationary authorization in accordance with § 1103.2. The Department will notify the store in writing whether the store’s application for reauthorization is granted or denied. If the Department denies the application for reauthorization, the store shall be eligible to apply for authorization 6 months after the effective date of the denial. If the Department grants and later rescinds temporary authorization, the store shall be eligible to apply for authorization 1 year from the date of the first onsite review for reauthorization.

(d) Termination of authorization or reauthorization. The Department will terminate a store’s authorization or reauthorization if:

(1) The store has been disqualified.

(2) The store supplied false information in the application for authorization or reauthorization.

(3) The store is not serving at least 25 participants 8 months following authorization.

(4) Ownership of the store changes

(5) The store relocates in excess of 1 mile of its current location and to a geographical area assigned to another local agency.

(6) The store closes for more than 3 business days and does not notify the Department.

(7) The Department does not receive from the store, within 20 calendar days of the store’s receipt of a written notice from the Department, the information the Department has requested necessary for it to determine whether the store qualifies as an above-50-percent-store.

(8) After authorization of the store, the Department determines if the store qualifies as an above-50-percent-Store. This paragraph does not apply to stores solely owned or operated by nonprofit entities.

The provisions of this § 1103.1 amended under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

The provisions of this § 1103.1 amended December 22, 2000, effective December 23, 2000, 30 Pa.B. 6853; amended October 3, 2003, effective October 4, 2003, 33 Pa.B. 4900; amended September 11, 2009, effective immediately, 39 Pa.B. 5292. Immediately preceding text appears at serial pages (300331) to (300333).

Compliance of Regulatory Scheme

The Department’s regulatory scheme which distinguishes between certification/recertification reviews and monitoring reviews, in terms of the sanctions imposed for failure to meet regulatory requirements, is based on a sound rationale. Giant Food Stores, LLC v. Department of Health, 808 A.2d 299 (Pa. Cmwlth. 2002).

The Department has the authority to deny a store’s application for certification/recertification based upon a single violation of mandatory selection criteria. Giant Food Stores, LLC v. Department of Health, 808 A.2d 299 (Pa. Cmwlth. 2002).

Interpretation of Regulations

The Department of Health’s interpretations of its own regulations are given great weight unless plainly erroneous or inconsistent with the regulation, neither of which occurred here. Valesky’s Market v. Department of Health, 779 A.2d 1251 (Pa. Cmwlth. 2001).

Requirements Mandatory

To qualify for WIC recertification, a store must meet all of the selection criteria of § 1103.4(a). Valesky’s Market v. Department of Health, 779 A.2d 1251 (Pa. Cmwlth. 2001).

This section cited in 28 Pa. Code § 1101.2 (relating to definitions); and 28 Pa. Code § 1103.4 (relating to selection criteria for authorization and reauthorization); 28 Pa. Code § 1103.8 (relating to store peer group system); 28 Pa. Code § 1105.3 (relating to terms and conditions of participation); and 28 Pa. Code § 1113.1 (relating to right to administrative appeal).

History

Authority: The provisions of this § 1103.
Source: The provisions of this § 1103.

28 Pa. Code § 1103.2 Probationary authorization.

(a) Criteria for probationary authorization. If during the onsite review, the store fails to meet selection criteria in § 1103.4(3), (4), (5), (6), (7) or (8) (relating to selection criteria for authorization and reauthorization), the Department will grant probationary authorization to the store for a period not to exceed 6 months when either of the following applies:

(1) Inadequate participant access would occur if the store is not authorized or reauthorized.

(2) A store is reviewed prior to opening to the public and the store has not yet stocked its dairy section or its frozen juice section.

(b) Reviews during probationary authorization period. If a store receives probationary authorization, the Department will conduct an unannounced onsite review during the probationary authorization period to determine whether the store is in compliance with selection criteria in § 1103.4. The Department will rescind probationary authorization and deny the store’s application to serve as a WIC authorized store if the store fails to meet one or more of the selection criteria during this review, unless extension is required under subsection (c). The Department will grant authorization or reauthorization, as applicable, if the store meets all selection criteria during the second onsite review.

(c) Extension of probationary authorization. If the store fails the review conducted during the probationary authorization period, and inadequate participant access exists as determined by the Department, the Department will extend probationary authorization for an additional 3 months during which time at least one representative of the store who is responsible for training store personnel on the WIC Program shall attend corrective training.

(d) Extended probationary authorization reviews. The Department will conduct an unannounced onsite review during the extended probationary authorization period after the store representative has attended corrective training, to determine whether the store is in compliance with the selection criteria in § 1103.4. The Department will rescind probationary authorization and deny the store’s application to serve as a WIC authorized store if the store fails to meet one or more of the selection criteria during this review. The Department will grant authorization or reauthorization, as applicable, if the store meets all selection criteria during the third and final unannounced onsite review.

(e) Rescission of probationary authorization. If the Department rescinds the probationary or extended probationary authorization of a store, the store is eligible to apply for authorization 6 months from the date of the Department’s rescission of probationary or extended probationary authorization.

The provisions of this § 1103.2 amended under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

The provisions of this § 1103.2 amended December 22, 2000, effective December 23, 2000, 30 Pa.B. 6853; amended October 3, 2003, effective October 4, 2003, 33 Pa.B. 4900. Immediately preceding text appears at serial pages (295339) to (295340).

This section cited in 28 Pa. Code § 1103.1 (relating to authorization and reauthorization process and requirements); and 28 Pa. Code § 1105.1 (relating to training).

History

Authority: The provisions of this § 1103.
Source: The provisions of this § 1103.

28 Pa. Code § 1103.3 Temporary authorization.

(a) Failure to meet selection criteria during onsite review. If a WIC authorized store that applies for reauthorization fails to meet one or more of the selection criteria in § 1103.4 (relating to selection criteria for authorization and reauthorization) during the announced onsite review, the store may request temporary authorization, except that a store that fails to meet the price and minimum inventory requirements of § 1103.4(5) shall be ineligible for temporary authorization. A store that is a high risk store or the subject of an ongoing compliance investigation also shall be ineligible for temporary authorization.

(b) Conditions of temporary authorization. Temporary authorization shall be conditioned upon the following:

(1) The Department will conduct a second announced onsite review during the temporary authorization period to determine whether the store is in compliance with the selection criteria in § 1103.4. The Department will grant reauthorization if the store meets all selection criteria during this review. The Department will rescind temporary authorization and deny the store’s application for reauthorization if the store fails to meet one or more of the selection criteria during the second review.

(2) If the Department rescinds the temporary authorization of a store, the store is eligible to apply for authorization 1 year after the date of the first onsite review that was conducted following the Department’s receipt of the store’s application for reauthorization.

(3) The Department will reduce by 10% the maximum allowable prices for foods authorized for purchase on WIC checks the store redeems for WIC transactions that occur during the first 90 days of the temporary authorization period.

The provisions of this § 1103.3 amended under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

The provisions of this § 1103.3 amended December 22, 2000, effective December 23, 2000, 30 Pa.B. 6853; amended October 3, 2003, effective October 4, 2003, 33 Pa.B. 4900. Immediately preceding text appears at serial pages (295340) and (286005).

This section cited in 28 Pa. Code § 1103.1 (relating to authorization and reauthorization process and requirements); 28 Pa. Code § 1103.4 (relating to selection criteria for authorization and reauthorization).

History

Authority: The provisions of this § 1103.
Source: The provisions of this § 1103.

28 Pa. Code § 1103.4 Selection criteria for authorization and reauthorization.

The Department will use the following selection criteria to identify stores that meet the operational criteria to serve as a WIC authorized store:

(1) The store shall be located within this Commonwealth.

(2) A store seeking reauthorization shall serve at least 25 participants per month. The Department will deny reauthorization if the store is not serving 25 participants per month in the most recent month for which the Department has participant data at the time the onsite review for reauthorization is conducted.

(3) The store shall have allowable foods properly stored and refrigerated.

(4) The store may not have stale-dated allowable foods on its sales floor.

(5) The store shall at all times have available on the premises the minimum inventory of allowable foods as established by the Department under § 1103.5 (relating to minimum inventory) at shelf prices that are equal to or less than the competitive prices applicable to the store’s peer group for those foods. On a quarterly basis, the Department will publish in the Pennsylvania Bulletin and mail to all WIC authorized stores, the competitive prices and maximum allowable prices applicable to all peer groups for allowable foods for the next quarter.

(6) The store shall be open for business and able to serve participants at least 8 hours per day, 6 days per week.

(7) The store shall be sanitary. There may not be unremoved rubbish, vermin, or general lack of cleanliness.

(8) The store shall operate as a full line grocery store in a permanent fixed location where participants may purchase allowable foods with their WIC checks.

(9) If the store has been denied authorization or reauthorization within the past 12 months, the store must be eligible to apply for authorization under § 1103.1(b) or (c) or § 1103.3(b)(2) (relating to authorization and reauthorization process and requirements; and temporary authorization).

(10) The store may not be currently disqualified from participation in the Food Stamp Program or have been assessed a civil money penalty in lieu of a disqualification from the Food Stamp Program that, had it been imposed, would not yet have expired.

(11) The store may not be currently disqualified from the WIC Program.

(12) The store shall have implemented all required corrective actions resulting from monitoring by the Department, including reimbursement of any overcharges or overpayments, and shall be in compliance with the applicable Federal and State regulations.

(13) None of the store’s current owners, officers, or managers shall have been convicted of or had a civil judgment entered against them for conduct demonstrating a lack of business integrity.

(14) The store will not qualify or will not be expected to qualify as an above-50-percent-store. This paragraph does not apply to stores solely owned or operated by nonprofit entities.

(15) The store shall meet the minimum information technology requirements set by the Department. The Department will publish in the Pennsylvania Bulletin and mail to all WIC authorized stores, by September 15 of each year, the minimum technology requirements applicable for the following calendar year. This paragraph does not apply to stores authorized prior to September 12, 2009, and maintaining an uninterrupted authorized status.

The provisions of this § 1103.4 amended under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

The provisions of this § 1103.4 amended December 22, 2000, effective December 23, 2000, 30 Pa.B. 6853; amended October 3, 2003, effective October 4, 2003, 33 Pa.B. 4900; corrected October 10, 2003, effective October 4, 2003, 33 Pa.B. 5080; amended September 11, 2009, effective immediately, 39 Pa.B. 5292. Immediately preceding text appears at serial pages (300335) to (300337).

Interpretation of Regulations

Minimum Participation

The Department of Health correctly denied WIC recertification where the store had not served 25 participants in the most recent month for which the Department had data. Valesky’s Market v. Department of Health, 779 A.2d 1251 (Pa. Cmwlth. 2001).

State-dated Allowable Foods not Permitted

The petitioner chose to stock a brand of formula not subject to minimum inventory requirements. Even though not subject to minimum inventory requirements, the formula was a WIC allowable food and, therefore, subject to product freshness requirements. Therefore, the presence of out-dated lacto-free Enfamil formula was sufficient cause for the Department of Health to deny the petitioner’s application for recertification. Valesky’s Market v. Department of Health, 779 A.2d 1251 (Pa Cmwlth. 2001).

This section cited in 28 Pa. Code § 1101.2 (relating to definitions); 28 Pa. Code § 1103.1 (relating to authorization and reauthorization process and requirements); 28 Pa. Code § 1103.2 (relating to probationary authorization); 28 Pa. Code § 1103.3 (relating to temporary authorization); 28 Pa. Code § 1103.7 (relating to inadequate participant access); 28 Pa. Code § 1105.3 (relating to terms and conditions of participation); and 28 Pa. Code § 1107.1a (relating to disqualifications).

History

Authority: The provisions of this § 1103.
Source: The provisions of this § 1103.

28 Pa. Code § 1103.5 Minimum inventory.

(a) Minimum inventory requirements.

(1) The Department will adopt minimum inventory requirements and their effective dates, for the following WIC allowable foods:

(i) Contract brand infant formula.

(ii) Milk.

(iii) Natural domestic cheese.

(iv) Grade ‘‘A’’ eggs.

(v) Juice.

(vi) Cereal.

(vii) Peanut butter.

(viii) Dried peas and beans.

(ix) Tuna.

(x) Carrots.

(2) The Department will set minimum inventory requirements for all allowable foods for which minimum inventory requirements exist at a level not to exceed the maximum quantity of supplemental food authorized per month as set forth in 7 CFR 246.10(c)(1)—(7) (relating to supplemental foods).

(3) The Department will publish minimum inventory requirements in the Pennsylvania Bulletin and distribute those requirements to all WIC authorized stores by September 15 of each year, and when manufacturer product or packaging changes occur.

(b) Exceptions to minimum inventory requirements. The Department will grant an exception to the minimum inventory requirements for an allowable food listed in subsection (c) when the Department’s most recent check redemption information for a store shows no purchases of the allowable food for a period in excess of 90 days.

(1) Contract brand milk-based with iron liquid concentrate infant formula.

(2) Contract brand milk-based with iron ready-to-feed infant formula.

(3) Contract brand milk-based with iron powdered infant formula.

(4) Contract brand soy-based liquid concentrate infant formula.

(5) Contract brand soy-based ready-to-feed infant formula.

(6) Contract brand soy-based powdered infant formula.

(7) Nonfat dry milk.

(8) Evaporated milk.

(9) Carrots.

(10) Tuna.

(d) Expiration of exception to minimum inventory requirements. The exception to minimum inventory requirements for an allowable food granted by the Department shall expire upon the presentation to the store, on behalf of a participant, of a WIC check for the purchase of that allowable food. The WIC authorized store shall provide the food item within 48 hours after presentation of the WIC check.

The provisions of this § 1103.5 amended under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

The provisions of this § 1103.5 amended December 22, 2000, effective December 23, 2000, 30 Pa.B. 6853; amended October 3, 2003, effective October 4, 2003, 33 Pa.B. 4900. Immediately preceding text appears at serial pages (286008) to (286010).

Interpretation of Regulations

Grace Period Limited

The grace period is provided to give a store time to come into compliance with minimum inventory requirements for a WIC allowable food for which the store had been granted a waiver. No grace period is provided to achieve compliance with product freshness requirements. If a store chooses to stock a WIC allowable food not subject to minimum inventory requirements, the food must meet product freshness requirements. Valesky’s Market v. Department of Health, 779 A.2d 1251 (Pa. Cmwlth. 2001).

This section cited in 28 Pa. Code § 1103.4 (relating to selection and limitation criteria; authorization process).

History

Authority: The provisions of this § 1103.
Source: The provisions of this § 1103.

28 Pa. Code § 1103.7 Inadequate participant access.

(a) The Department will consider whether there is inadequate participant access when considering whether to place a store on probation, rather than deny authorization or reauthorization, for failure to meet selection criteria in § 1103.4 (relating to selection criteria for authorization and reauthorization) during the onsite review.

(b) The Department may consider whether there is inadequate participant access when deciding whether to impose a civil money penalty in lieu of disqualification under § 1107.1 (relating to imposition of sanctions).

(1) Ten or more participants whose specific nationality, ethnicity or religious dietary needs can not be served properly by another WIC authorized store located in accordance with one of the following:

(i) Less than 3 miles of the store for counties with participant density less than 25 participants per square mile.

(ii) Less than 2 miles of the store for counties with participant density of 25 to 100 participants per square mile.

(iii) Less than 1 mile of the store for counties with participant density greater than 100 participants per square mile.

(2) Ten or more participants will be required to travel in accordance with one of the following:

(i) Three or more miles to the next closest WIC authorized store for counties with participant density less than 25 participants per square mile.

(ii) Two or more miles to the next closest WIC authorized store for counties with participant density of 25 to 100 participants per square mile.

(iii) One or more miles to the next closest WIC authorized store for counties with participant density greater than 100 participants per square mile.

(3) A participant has a physical disability that cannot be accommodated by another WIC authorized store in accordance with one of the following:

(i) Within 3 miles of the store for counties with participant density less than 25 participants per square mile.

(ii) Within 2 miles of the store for counties with participant density of 25 to 100 participants per square mile.

(iii) Within 1 mile of the store for counties with participant density greater than 100 participants per square mile.

(4) Ten or more participants are affected by physical barriers or conditions which make normal travel to another WIC authorized store impractical.

The provisions of this § 1103.7 amended under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

The provisions of this § 1103.7 amended December 22, 2000, effective December 23, 2000, 30 Pa.B. 6853; amended October 3, 2003, effective October 4,2003, 33 Pa.B. 4900. Immediately preceding text appears at serial pages (286011) to (286012).

This section cited in 28 Pa. Code § 1103.1 (relating to authorization and reauthorization process and requirements); 28 Pa. Code § 1107.1 (relating to imposition of sanctions); and 28 Pa. Code § 1107.2 (relating to civil money penalties).

History

Authority: The provisions of this § 1103.
Source: The provisions of this § 1103.

28 Pa. Code § 1103.8 Store peer group system.

(a) The Department will establish a store peer group system, including distinct competitive pricing criteria and allowable reimbursement levels for each peer group.

(b) The Department will create peer groups based upon at least two criteria selected by the Department. These criteria may include the size of a store sales floor, number of cash registers in the store, number of stores owned, and a measure of geography, such as metropolitan or other statistical areas that form distinct labor and product markets. The Department will annually publish the peer group selection criteria in the Pennsylvania Bulletin.

(c) The Department will place a store seeking authorization into an appropriate peer group based upon information gathered from the store’s application as completed by the store and returned to the local agency in accordance with § 1103.1(b)(1) (relating to authorization and reauthorization process and requirements). The Department will notify a store of its peer group classification prior to conducting an onsite review under § 1103.1(b)(5). A WIC authorized store seeking reauthorization shall remain in the peer group previously selected for the store unless otherwise notified by the Department.

(d) A WIC authorized store shall adhere to the competitive prices and maximum allowable prices applicable to the store’s peer group.

(e) A WIC authorized store shall inform the Department of any store changes applicable to the peer group selection criteria in effect.

The provisions of this § 1103.8 adopted under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

The provisions of this § 1103.8 adopted September 11, 2009, effective immediately, 39 Pa.B. 5292.

History

Authority: The provisions of this § 1103.
Source: The provisions of this § 1103.

Chapter 1105 Requirements for WIC Authorized Stores

28 Pa. Code § 1105.1 Training.

(a) Initial training. Following authorization, the local agency shall provide initial training for the personnel the WIC authorized store designates. The training shall be mandatory and shall occur within 30 days after the date of authorization. A store receiving authorization may not accept WIC checks prior to having its designated personnel attend the initial mandatory training.

(b) Annual training. The Department will provide for WIC authorized stores annual training which is designed to prevent WIC Program errors and abuses and to improve WIC Program services. The following apply to annual training:

(1) A WIC authorized store shall ensure that at least one representative from the store who is responsible for training store personnel on the WIC Program shall attend.

(2) Attendance is mandatory.

(3) The Department will offer each WIC authorized store two opportunities to attend.

(4) The Department will ensure that annual training is offered to a WIC authorized store either within the county in which it is located or in an adjoining county within the appropriate local agency’s jurisdiction.

(5) Failure to have at least one representative attend training shall result in the Department imposing sanctions against the WIC authorized store under § 1107. 1a(d)(15) (relating to disqualifications).

(c) Corrective training. The Department will provide corrective training as set forth in § § 1103.2 and 1105.6 (relating to probationary, authorization; and monitoring of WIC authorized stores). Attendance is mandatory.

The provisions of this § 1105.1 amended under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

The provisions of this § 1105.1 amended December 22, 2000, effective December 23, 2000, 30 Pa.B. 6853; amended October 3, 2003, effective October 4, 2003, 33 Pa.B. 4900; amended September 11, 2009, effective immediately, 39 Pa.B. 5292. Immediately preceding text appears at serial pages (300341) to (300342).

This section cited in 28 Pa. Code § 1105.3 (relating to terms and conditions of participation).

History

Authority: The provisions of this § 1105.
Source: The provisions of this § 1105.

28 Pa. Code § 1105.2 Price adjustment.

(a) Determination of overpayment. In each calendar quarter, the Department will compare the maximum amount for which a WIC authorized store could have redeemed a WIC check, based upon the maximum allowable prices applicable to the store’s peer group for foods authorized for purchase on the check, against the actual amount for which the WIC check was redeemed, to determine whether there was an overpayment.

(b) Pursuit of reimbursement. The Department will seek reimbursements from a WIC authorized store when the price comparison reveals overpayments to the store in excess of $10 in a calendar quarter.

(c) Reimbursement of overpayments. A WIC authorized store shall reimburse the Department for overpayments within 20-calendar days of the date on the Department’s notice of the overpayment, unless the WIC authorized store disputes the determination of overpayment.

(d) Dispute of overpayments. A WIC authorized store that disputes a determination of overpayment shall submit the basis for its dispute in writing to the Department, postmarked within 15-calendar days of the date on the Department’s notice. Reimbursement the Department determines is owed shall be due within 15-calendar days of the mailing date of the Department’s notification of its resolution of the dispute. The Department’s resolution of a dispute regarding overpayments is not an adverse action that may be appealed.

(e) Sanctions. The Department will impose a sanction against a WIC authorized store under § 1107.1a(d)(11) (relating to disqualifications) if the store fails to reimburse the Department for an overpayment within the time required under subsections (c) and (d).

The provisions of this § 1105.2 amended under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

The provisions of this § 1105.2 amended December 22, 2000, effective December 23, 2000, 30 Pa.B. 6853; amended October 3, 2003, effective October 4, 2003, 33 Pa.B. 4900; amended September 11, 2009, effective immediately, 39 Pa.B. 5292. Immediately preceding text appears at serial page (300342).

This section cited in 28 Pa. Code § 1113.1 (relating to right to administrative appeal).

History

Authority: The provisions of this § 1105.
Source: The provisions of this § 1105.

28 Pa. Code § 1105.3 Terms and conditions of participation.

(a) General terms and conditions. A WIC authorized store shall adhere to this subsection. Failure to do so shall result in the imposition of sanctions under § 1107.1 (relating to imposition of sanctions). A WIC authorized store shall:

(1) Adhere to all applicable statutes and State and Federal regulations, regulating the WIC Program, including the nondiscrimination provisions of 7 CFR Parts 15, 15a, 15b and 246, and this part.

(2) Inform the public of its participation in the WIC Program by displaying at least one WIC decal supplied by the Department in a place conspicuously visible to the general public.

(3) Be accountable for the actions of owners, officers, managers, agents and employees in the handling of WIC checks, the selling of allowable foods, and the performance of other conduct related to the WIC Program.

(4) Comply with the selection criteria in § 1103.4 (relating to selection criteria for authorization and reauthorization) throughout the authorization period.

(5) Provide orientation and training to employees regarding applicable regulations governing the WIC Program.

(6) Maintain a copy of the current WIC food list at each check-out aisle.

(7) Send at least one representative who is responsible for training store personnel on the WIC Program to WIC Program training annually, or more often if required by the Department under § 1105.1(c) (relating to training).

(8) Immediately notify the Department when store ownership changes, when store operations cease on a permanent or temporary basis, or when any other circumstance impacting service to participants occurs.

(9) Allow Federal, State, Department and local agency representatives who are involved in monitoring the store’s compliance with statutes and regulations governing the WIC Program, to visit the store to observe its procedures for accepting and handling WIC checks and to conduct announced or unannounced onsite reviews to determine compliance with applicable Federal and State regulations.

(10) Provide Federal, State, Department and local agency representatives who are involved in monitoring the store’s compliance with statutes and regulations governing the WIC Program, access to all WIC checks accepted by the store and on its premises at the time of an onsite review.

(11) Provide Federal, State, Department and local agency representatives who are involved in monitoring the store’s compliance with statutes and regulations governing the WIC Program, access, which includes providing copies if requested by the Department, to purchase records used for Federal tax reporting purposes and other records as requested to determine compliance with WIC Program requirements.

(12) Agree that authorization does not constitute a license or a property interest, that the store must reapply for authorization in accordance with § 1103.1(c) (relating to authorization and reauthorization process and requirements), and that neither the Department nor the WIC authorized store has an obligation to renew the store’s authorization to participate in the WIC Program.

(13) Agree that the store’s authorization to participate in the WIC Program shall become void when ownership of the store changes.

(14) Display the current shelf price of each allowable food either on the allowable food, on the shelf immediately above or below the allowable food, or prominently on an allowable food price list easily located by participants and clearly visible to them.

(15) Not transfer or assign its WIC authorization or reauthorization to another person or entity.

(16) Maintain purchase records and records used for Federal tax reporting purposes for allowable foods for a minimum of 2 years.

(17) Purchase infant formula for resale to WIC participants only from Department authorized infant formula manufacturers, wholesalers, distributors or retailers. Information on where to obtain the list will be published by the Department in the Pennsylvania Bulletin simultaneously with the initial publishing of this subsection.

(18) Provide the Department, within 20 calendar days of the store’s receipt of a written notice from the Department requesting the additional information, any information the Department has requested necessary to determine whether the store qualifies as an above-50-percent-store. This paragraph does not apply to stores solely owned or operated by nonprofit entities.

(b) Terms and conditions of participation with regard to participants. A WIC authorized store shall serve participants and authorized representatives as set forth in this subsection. The Department will impose sanctions against a WIC authorized store that fails to do so, as set forth in § 1107.1. A WIC authorized store shall:

(1) Provide allowable foods to a participant or authorized representative only as authorized on the WIC food list as specified on the WIC check.

(2) Not encourage or discourage a participant or authorized representative from purchasing an allowable food specified on the WIC check.

(3) Provide an allowable food to a participant or authorized representative at or below the current price the store charges other customers, and at or below the maximum allowable price applicable to the store’s peer group.

(4) Not seek restitution or payment from a participant or authorized representative for a WIC check not reimbursed by the Department, or contact a participant or authorized representative concerning a WIC transaction that occurs in the store.

(5) Not seek restitution or payment from a participant or authorized representative for an allowable food authorized for purchase on the WIC check tendered by the participant or authorized representative.

(6) Not request the personal address, telephone number or other personal identification of a participant or authorized representative.

(7) Offer each participant or authorized representative the same courtesies offered other customers, and not distinguish or identify a participant or authorized representative from other customers, if no other terms and conditions of participation are violated in doing so.

(8) Provide services to each participant or authorized representative without regard to race, color, age, sex, religion, mationality origin or disability.

(9) Provide the same promotional incentive for a purchase made with a WIC check as given for a cash purchase.

(10) Accept cents-off coupons, a store discount card or other discounts from a participant or authorized representative for an allowable food, and deduct the savings in calculating the total purchase price entered into the "Pay Exactly’’ amount on WIC checks.

(11) Accept ‘‘buy one get one free’’ coupons and manufacturers’ promotional free product offers from a participant or authorized representative.

(12) Provide a promotional incentive for use of a WIC check only if the same incentive is offered for a cash purchase.

(c) Terms and conditions of participation with regard to WIC check processing and redemption. A WIC authorized store shall adhere to the requirements of this subsection with regard to WIC check processing and redemption. The Department will impose sanctions against a WIC authorized store that fails to do so, as set forth in § 1107.1. A WIC authorized store shall:

(1) Treat the acceptance of a WIC check as a financial transaction between the WIC authorized store and the Department, not the participant.

(2) Accept a WIC check only if the participant or authorized representative presents the WIC check on or between the ‘‘First Day to Use’’ and the ‘‘Last Day to Use’’ designations on the WIC check.

(3) Accept a WIC check only if a valid WIC identification card is presented at the time of the WIC transaction.

(4) Accept a WIC check only if the signature of the participant or authorized representative is obtained on the WIC check at the time of the WIC transaction and the family identification number on the WIC check matches the family identification number on the identification card.

(5) Accept a WIC check only if there is no visible alteration on the WIC check.

(6) Charge the WIC Program only for the types and quantities of allowable foods specified on the WIC check and selected for purchase by the participant or authorized representative.

(7) Record in ink, on each WIC check immediately after completion of the WIC transaction and prior to the participant or authorized representative signing the WIC check, the actual purchase amount of the transaction net of any cents-off coupons or other discounts.

(8) Properly correct an error made in recording the ‘‘Pay Exactly’’ amount of a WIC check by drawing a single line through the incorrect amount and writing the correct amount above or below the error and having the participant or authorized representative initial next to the corrected amount. No other corrections are permissible.

(9) Not alter any information on the WIC check as presented by the participant or authorized representative.

(10) Not provide a substitute item, raincheck or cash reimbursement for an allowable food that is unavailable.

(11) Not provide cash or credit for a WIC check.

(12) Not provide change for a coupon tendered during the WIC transaction.

(13) Not provide an exchange to replace an allowable food returned by a participant or authorized representative unless the exchange is to replace an identical product that was found to be damaged or otherwise unusable.

(14) Not refund money for an allowable food purchased in a WIC transaction that is returned by a participant or authorized representative.

(15) Not accept a WIC check as payment for an item other than an allowable food specified on the WIC check.

(16) Not charge the WIC Program for an allowable food not received by the participant or authorized representative or for an allowable food in excess of the quantity prescribed on the WIC check.

(17) Not charge the WIC Program for the sale of an amount of an allowable food which exceeds the store’s documented inventory of that food item covering the period of time under review and in which the sale was made.

(18) Prior to depositing WIC checks, transmit records of WIC check numbers from WIC checks accepted by the store to the Department through transmission mechanisms made available by the Department.

(19) Deposit a WIC check accepted by it directly to its bank account no later than 45 days after the ‘‘First Day to Use’’ date on the WIC check.

(20) Not receive, transact, redeem or otherwise dispose of a WIC check in violation of check redemption procedures set forth in this section.

(21) Not use a WIC check for the purchase of any item other than an allowable food or for the payment of any debt.

(22) Not collect Sales Tax in connection with a WIC transaction.

(d) Denial of. When the Department determines, prior to payment of a check submitted for redemption, that the store has committed a violation of this section that affects the payment to the store, the Department may deny payment. If payment already has been made, the Department may establish a claim for reimbursement by sending the store a written notice of the overcharge or other improper charge. The store may dispute the Department’s claim and shall submit the basis for its dispute in writing within 15-calendar days of the date of the Department’s written notice. The Department will notify the store of the resolution of the claim dispute. The Department’s resolution of a claim dispute is not an adverse action that may be appealed.

The provisions of this § 1105.3 amended under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

The provisions of this § 1105.3 amended December 22, 2000, effective December 23, 2000, 30 Pa.B. 6853; amended October 3, 2003, effective October 4, 2003, 33 Pa.B. 4900; amended September 11, 2009, effective immediately, 39 Pa.B. 5292. Immediately preceding text appears at serial pages (300343) to (300347).

This section cited in 28 Pa. Code § 1105.6 (relating to monitoring of WIC authorized stores).

History

Authority: The provisions of this § 1105.
Source: The provisions of this § 1105.

28 Pa. Code § 1105.4 Change of ownership of a WIC authorized store.

(a) A store’s status as a WIC authorized store is void when a change of ownership of the store occurs.

(b) To allow uninterrupted service to participants subsequent to a change of ownership of a WIC authorized store, the Department may accept an application for authorization from the prospective new owner of the store prior to a change of ownership.

(c) The Department will not accept a store’s application for authorization if the Department determines that the store submitting the application, either under prior ownership or in a previous location, was disqualified and the purpose of the relocation or sale of the store was to avoid a disqualification.

The provisions of this § 1105.4 amended under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

The provisions of this § 1105.4 amended December 22, 2000, effective December 23, 2000, 30 Pa.B. 6853; amended October 3, 2003, effective October 4, 2003, 33 Pa.B. 4900. Immediately preceding text appears at serial page (272445).

History

Authority: The provisions of this § 1105.
Source: The provisions of this § 1105.

28 Pa. Code § 1105.5 Changes in availability or location of WIC authorized stores.

(a) Notification of store closing. A WIC authorized store shall notify the Department at least 15 days prior to a temporary or permanent closing of the store, and provide the reason for closing and the expected duration of a temporary closing, if it has at least 15 days prior knowledge. Otherwise, it shall provide this information to the Department immediately after it acquires the information.

(b) Temporary store closing. The Department may permit a WIC authorized store to temporarily close for reasons such as a natural disaster, death in immediate family or personal illness, without imposing a sanction against the store. In making a determination to permit a temporary closure, as well as the length of time of the closure, the Department will consider circumstances such as the nature of the disaster, number of WIC authorized stores affected by the disaster, nature and expected duration of illness, length of closing anticipated by the WIC authorized store, number of and distance to other WIC authorized stores, number of participants served by the store, or any other information that the Department may determine to be relevant.

(1) A WIC authorized store that closes for less than 15 days for remodeling shall continue as a WIC authorized store if it notifies the Department at least 15-calendar days prior to the day the store closes for remodeling.

(2) A WIC authorized store that closes in excess of 15 store operation days for remodeling, shall automatically lose its status as a WIC authorized store and shall apply for and secure authorization before it may again serve as a WIC authorized store.

(d) Store relocations.

(1) A WIC authorized store that relocates 1 mile or less from its current location or within the same geographical area assigned to the local agency, and reopens within 15-calendar days at its new location, shall provide the Department with written notification of its new address. The store will continue as a WIC authorized store if it notifies the Department at least 15-calendar days prior to the day the store closes for relocating.

(2) A WIC authorized store that relocates in excess of 1 mile of its current location and to a geographical area assigned to another local agency shall automatically lose its status as a WIC authorized store and shall apply for authorization at its new location to again serve as a WIC authorized store.

(3) A WIC authorized store that closes in excess of 3 store operation days for relocating shall notify the Department before doing so, or shall automatically lose its status as a WIC authorized store and shall apply for authorization to again serve as a WIC authorized store.

The provisions of this § 1105.5 amended under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

The provisions of this § 1105.5 amended October 3, 2003, effective October 4, 2003, 33 Pa.B. 4900; amended September 11, 2009, effective immediately, 39 Pa.B. 5292. Immediately preceding text appears at serial pages (300347) to (300348).

History

Authority: The provisions of this § 1105.
Source: The provisions of this § 1105.

28 Pa. Code § 1105.6 Monitoring of WIC authorized stores.

(a) Purpose and types of monitoring of WIC authorized stores.

(1) Federal, State or local representatives will conduct announced and unannounced onsite reviews of WIC authorized stores to determine compliance with applicable Federal and State regulations, and to investigate complaints regarding a store. The types of onsite reviews that may be conducted for monitoring purposes are compliance investigations, inventory audits, routine reviews and WIC transaction reviews. The monitoring process, to determine compliance with applicable Federal and State regulations, operates independently of the authorization process and may overlap more than one authorization period.

(2) The Department will conduct an annual analysis of a WIC authorized store’s sales data to determine whether the store qualifies as an above-50-percent-store, except that stores solely owned or operated by nonprofit entities shall not be subject to this annual analysis.

(b) Compliance investigations. The following standards apply:

(1) The Department will conduct at least two compliance buys during a compliance investigation.

(2) The Department will not notify the WIC authorized store that a compliance buy is scheduled.

(3) The Department will provide written notification to the WIC authorized store of the results of each compliance buy, including the store’s violation of a statute or regulation governing its participation in the WIC Program, unless paragraph (8) applies.

(4) The Department will provide to the personnel of the WIC authorized store mandatory corrective training after two compliance buys detect violations of a statute or regulation governing the store’s participation in the WIC Program, unless paragraph (8) applies.

(5) If paragraph (8) does not apply, the Department will continue a compliance investigation of the WIC authorized store after store personnel have attended mandatory corrective training.

(6) The Department will impose a sanction in accordance with § 1107.1 (relating to imposition of sanctions) if three compliance buys detect violations of a statute or regulation governing the store’s participation in the WIC Program. If multiple violations are found during the compliance investigation, the Department will impose the sanction against the store for the term corresponding to the most serious violation.

(7) The Department will close the compliance investigation on a WIC authorized store if the Department discovers no violation of a statute or regulation governing the store’s participation in the WIC Program after two consecutive compliance buys.

(8) The Department may withhold notification of compliance buy results, and may withhold providing training or conducting further compliance investigations, when fraudulent activity by the WIC authorized store is indicated during a compliance investigation or by local agency or participant complaint.

(c) Inventory audits. The Department will disqualify a WIC authorized store when an inventory audit establishes that the store has redeemed or attempted to redeem WIC checks for the purported sale of an allowable food in excess of documented inventory. No warning letter will be issued.

(d) Routine reviews. The Department will use routine reviews as follows to determine whether a WIC authorized store is in compliance with the terms and conditions of participation in § 1105.3 (relating to terms and conditions of participation):

(1) The Department will not notify the WIC authorized store that a routine review is scheduled.

(2) The Department will provide written notification to the WIC authorized store of the results of each routine review, including violation of a statute or regulation governing the store’s participation in the WIC Program.

(3) The Department will conduct a second routine review of the WIC authorized store if the first routine review detects violations of a statute or regulation governing the store’s participation in the WIC Program.

(4) The Department will provide to the personnel of the WIC authorized store mandatory corrective training after two routine reviews detect violations of a statute or regulation governing the store’s participation in the WIC Program.

(5) The Department will conduct a third routine review of a WIC authorized store after store personnel have attended mandatory corrective training.

(6) The Department will impose a sanction in accordance with § 1107.1 against a store if a third routine review detects violations of a statute or regulation governing the store’s participation in the WIC Program. If multiple violations are found during the routine reviews, the Department will impose against the store the most severe sanction the Department may impose for any one of the violations committed by the store.

(e) WIC transaction reviews. The Department will use WIC transaction reviews to monitor WIC transaction procedures and compliance with statutes and regulations governing the store’s participation in the WIC Program. The following standards apply:

(1) The Department will not notify the WIC authorized store that a WIC transaction review is scheduled.

(2) The Department will provide written notification to the WIC authorized store of the results of each WIC transaction review, including violations of a statute or regulation governing the store’s participation in the WIC Program.

(3) The Department will conduct a second WIC transaction review at the WIC authorized store if the first WIC transaction review detects a violation of a statute or regulation governing the store’s participation in the WIC Program.

(4) The Department will provide the personnel of the WIC authorized store mandatory corrective training after two WIC transaction reviews detect violations of a statute or regulation governing the store’s participation in the WIC Program.

(5) The Department will conduct a third WIC transaction review at the WIC authorized store after store personnel have attended the mandatory corrective training.

(6) The Department will impose a sanction in accordance with § 1107.1 if a third WIC transaction review detects a violation of a statute or regulation governing the store’s participation in the WIC Program. If multiple violations are found during the WIC transaction reviews, the Department will impose against the store the most severe sanction the Department may impose for any one of the violations committed by the store.

(f) Use of law enforcement agency. The Department may utilize a law enforcement agency in the investigation of a WIC authorized store or other store suspected of trafficking WIC checks or other fraud or abuse of the WIC Program.

(g) Reimbursement. The Department will seek reimbursement from a WIC authorized store that received funds improperly due to a violation of regulations governing the store’s participation in the WIC Program discovered during monitoring reviews. The Department will send notice to the store of the amount of money to be reimbursed to the WIC Program. The store shall make payment within 20 days from the date on the notice.

(h) Annual determination of WIC sales percentage. The Department may request from a store information necessary for the Department to determine whether the store qualifies as an above-50-percent store. This information may include a request for State or Federal Income Tax returns, State Sales Tax records, Department of Revenue Form PA-3 filings, and sales records. This paragraph does not apply to stores owned by nonprofit entities.

The provisions of this § 1105.6 amended under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

The provisions of this § 1105.6 amended December 22, 2000, effective December 23, 2000, 30 Pa.B. 6853; amended October 3, 2003, effective October 4, 2003, 33 Pa.B. 4900; amended September 11, 2009, effective immediately, 39 Pa.B. 5292. Immediately preceding text appears at serial pages (300348) to (300351).

This section cited in 28 Pa. Code § 1105.1 (relating to training).

History

Authority: The provisions of this § 1105.
Source: The provisions of this § 1105.

Chapter 1107 Sanctions.

28 Pa. Code § 1107.1 Imposition of sanctions.

(a) The Department may disqualify a WIC authorized store or impose a civil money penalty in lieu of disqualification for reasons of WIC Program abuse. In the case of fraud, trafficking, sale of alcohol or alcoholic beverages or tobacco products the Department will not provide the store with a prior warning that violations were occurring before imposing the sanctions. For other serious program violations or offenses, the Department may choose to not provide the store with prior warning that violations were occurring before imposing the sanctions. The store may appeal a Department decision pertaining to disqualification, denial of authorization or reauthorization, or other adverse action that affects the store’s status as a WIC authorized store in accordance with § 1113.1 (relating to right to administrative appeal). Expiration of authorization, disqualification of a store as a result of disqualification from the Food Stamp Program, and the Department’s determination regarding inadequate participant access are not subject to review.

(b) The Department will disqualify a store which has been disqualified from the Food Stamp Program unless the Department determines that the disqualification of the store would result in inadequate participant access under § 1103.7 (relating to inadequate participant access). If the Department determines that disqualification of the store would result in inadequate participant access under § 1103.7, the Department will give the store the option of paying a civil money penalty in lieu of disqualification.

(c) The Department will disqualify a store that has been assessed a civil money penalty in lieu of disqualification under the Food Stamp Program unless disqualification of the store from the WIC Program would result in inadequate participant access or would otherwise adversely affect the interest of participants. If the Department disqualifies a store under this subsection, the length of the disqualification will correspond to the period for which the store would otherwise have been disqualified from participating in the Food Stamp Program.

(d) The Department will disqualify a store for WIC Program violations in § 1107.1a (relating to disqualifications) unless the Department determines that disqualification of the store under § 1107.1a(b)—(d) would result in inadequate participant access. In that case, the Department will give the store the option of paying a civil money penalty in lieu of disqualification. The Department will not give the store the option of paying a civil money penalty in lieu of disqualification for third or subsequent violations. A violation committed during a prior authorization period will support a disqualification.

(e) Disqualification from the WIC Program may result in disqualification as a retailer in the Food Stamp Program under regulations governing the Food Stamp Program. Applicable Federal regulations may prohibit administrative or judicial review of a disqualification from the Food Stamp Program based upon a disqualification from the WIC Program.

(f) In addition to imposing a sanction against a WIC authorized store that commits fraud or abuse of the WIC Program, the Department may prosecute or make a referral of the WIC authorized store to a criminal prosecution agency for prosecution under applicable Federal, State, or local laws.

(g) A WIC authorized store that has a sanction imposed against it by the Department for accepting a WIC check for an item other than those specified on the WIC check shall also reimburse the Department for moneys it receives through the WIC check redemption process after accepting a WIC check for the purchase of the item.

(h) The Department may impose a sanction against a WIC authorized store for failing to remit any amount demanded due to violations of statutes or regulations governing its participation in the WIC Program within the time frame imposed by regulation or in the notice given to the store by the Department of the store’s obligation to reimburse the Department.

The provisions of this § 1107.1 amended under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

The provisions of this § 1107.1 amended December 22, 2000, effective December 23, 2000, 30 Pa.B. 6853; amended October 3, 2003, effective October 4, 2003, 33 Pa.B. 4900. Immediately preceding text appears at serial pages (272451) to (272452).

This section cited in 28 Pa. Code § 1103.4 (relating to selection criteria for authorization and reauthorization); 28 Pa. Code § 1103.7 (relating to inadequate participant access); 28 Pa. Code § 1105.3 (relating to terms and conditions of participation); 28 Pa. Code § 1105.6 (relating to monitoring of WIC authorized stores); and 28 Pa. Code § 1107.2 (relating to civil money penalties).

History

Authority: The provisions of this § 1107.
Source: The provisions of this § 1107.

28 Pa. Code § 1107.1a Disqualifications.

(a) Permanent disqualification. The Department will permanently disqualify a WIC authorized store convicted of trafficking in WIC checks or selling firearms, ammunition, explosives or controlled substances (as defined in section 102 of the Controlled Substances Act (21 U.S.C.A. § 802)) in exchange for WIC checks. The Department will not compensate the store for revenues lost as a result of the violation.

(b) Six-year disqualification. The Department will disqualify a WIC authorized store for 6 years for either of the following:

(1) One incidence of buying or selling WIC checks for cash (trafficking).

(2) One incidence of selling firearms, ammunition, explosives, or controlled substances as defined in section 102 of the Controlled Substances Act, in exchange for WIC checks.

(c) Three-year disqualification. The Department will disqualify a WIC authorized store for 3 years for any of the following violations:

(1) One incidence of the sale of alcohol or alcoholic beverages or tobacco products in exchange for WIC checks.

(2) A pattern of claiming reimbursement for the sale of an amount of a specific allowable food, which exceeds the store’s documented inventory of that specific allowable food for a specific period of time. A pattern may be established during a single inventory audit encompassing a 2-month period when a WIC authorized store’s records indicate that the WIC authorized store’s WIC check redemptions for a specific allowable food exceed the WIC authorized store’s documented inventory for that allowable food.

(3) Two or more incidences of overcharges.

(4) Two or more incidences of receiving, transacting or redeeming a WIC check that the store is not authorized to receive, transact or redeem.

(5) Two or more incidences of charging for allowable food not received by the participant.

(6) Two or more incidences of providing credit or nonfood items, other than alcohol, alcoholic beverages, tobacco products, cash, firearms, ammunition, explosives, or controlled substances as defined in section 102 of the Controlled Substances Act, in exchange for WIC checks.

(d) One-year disqualification. The Department will disqualify a WIC authorized store for 1 year for any of the following violations:

(1) Two or more incidences of providing a food item other than an allowable food in exchange for WIC checks.

(2) Two or more incidences of providing an allowable food in excess of the amount authorized for purchase on the WIC check.

(3) Having a stale-dated allowable food on the sales floor.

(4) Failing to maintain on the premises, at all times minimum inventory requirements of an allowable food at or below the current competitive price applicable to the store’s peer group for that food.

(5) Two or more incidences of failing to request a WIC identification card prior to accepting a WIC check.

(6) Failing to maintain a clean and sanitary store.

(7) Failing to properly store or refrigerate an allowable food.

(8) Closure of the store by a city, local or county health department.

(9) Charging or demanding that a participant or authorized representative pay for an allowable food with money or with another WIC check for purchases made with a WIC check.

(10) Two or more incidences of securing the signature of the participant or authorized representative prior to completing the ‘‘Pay Exactly’’ box on the WIC check.

(11) Two or more incidences of charging the WIC Program sales tax.

(12) Giving monetary change to the person who tenders a WIC check.

(13) Failing to reimburse the Department for overpayments, overcharges or other improper charges within the specified time frame.

(14) Physically altering or changing on the face of a WIC check the store name, food type or quantity, participant information, date, or printed dollar amount.

(15) Failing to have at least one representative of the store attend required training.

(16) Providing false information on the application for authorization or reauthorization.

(e) Second mandatory sanction. If a WIC authorized store, which previously has been assessed a sanction for any of the violations in subsections (b)—(d), receives another sanction for any of these violations, the Department will double the second sanction. The Department will double civil money penalties up to the limits allowed under § 1107.2(c) (relating to civil money penalties).

(f) Third or subsequent mandatory sanction. If a WIC authorized store, which previously has been assessed two or more sanctions for any of the violations listed in subsections (b)—(d), receives another sanction for any of these violations, the Department will double the third sanction and all subsequent sanctions. The Department will not permit the store to pay a civil money penalty in lieu of disqualification for third or subsequent violations listed in subsections (b)—(d).

(g) Multiple violations during a single investigation. When during the course of a single investigation the Department determines a WIC authorized store has committed multiple violations, the Department will disqualify the WIC authorized store for the period corresponding to the most serious violation. However, the Department will include all violations in the notice of disqualification.

(h) Disqualification based on a Food Stamp Program disqualification. The Department will disqualify a WIC authorized store which has been disqualified from the Food Stamp Program. The disqualification shall be for the same length of time as the Food Stamp Program disqualification, but may begin at a later date than the Food Stamp Program disqualification. Under 7 CFR 246.12(k) (1)(vii) (relating to food delivery systems) and § 1113.1(b)(3) (relating to right to administrative appeal), the WIC Program disqualification is not subject to administrative or judicial review.

(i) Voluntary withdrawal or nonrenewal of agreement. The Department will not accept voluntary withdrawal of the WIC authorized store from the WIC Program as an alternative to disqualification for the violations listed in subsections (a)—(d), but will enter the disqualification on the record. The Department will not permit the store to use expiration of authorization as an alternative to disqualification.

(j) Other violations. For a violation of a statute or regulation governing the store’s participation in the WIC Program which is not specifically classified in subsections (a)—(d), the Department will determine the appropriate type and level of sanction to be imposed upon the store based upon the nature and severity of the violation. A disqualification imposed under this subsection will not exceed 1 year.

(k) Advance notice. The Department will provide a WIC authorized store at least 30 days advance notice of the effective date of a disqualification. The notice will include the store’s appeal rights, if applicable.

(l) Authorization following expiration of disqualification period. A store that has been disqualified from the WIC Program may apply for authorization following expiration of the disqualification period. If the store chooses to apply for authorization after expiration of the disqualification, the Department will not consider the prior disqualification when determining eligibility. The Department will consider the store’s application in accordance with § 1103.4 (relating to selection criteria for authorization and reauthorization).

The provisions of this § 1107.1a amended under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

The provisions of this § 1107.1a adopted December 22, 2000, effective December 23, 2000, 30 Pa.B. 6853; amended October 3, 2003, effective October 4, 2003, 33 Pa.B. 4900; amended September 11, 2009, effective immediately, 39 Pa.B. 5292. Immediately preceding text appears at serial pages (300354) to (300357).

This section cited in 28 Pa. Code § 1105.1 (relating to training); 28 Pa. Code § 1105.2 (relating to overcharge recovery system); 28 Pa. Code § 1107.1 (relating to imposition of sanctions); 28 Pa. Code § 1107.2 (relating to civil money penalties); and 28 Pa. Code § 1113.1 (relating to right to appeal).

History

Authority: The provisions of this § 1107.
Source: The provisions of this § 1107.

28 Pa. Code § 1107.2 Civil money penalties.

(a) Option available in lieu of a disqualification or denial of reauthorization. The Department may offer to a WIC authorized store the option of paying a civil money penalty in lieu of a denial of reauthorization or a disqualification required under § 1107.1 (relating to imposition of sanctions), only if the Department finds inadequate participant access as set forth in § 1103.7 (relating to inadequate participant access). The Department will not provide this option for third or subsequent violations under § 1107.1a(b)—(d) (relating to disqualifications) or for any permanent disqualifications under § 1107.1a(a).

(b) Calculation of civil money penalty.

(1) For a civil money penalty in lieu of a disqualification under § 1107.1a(b), (c) or (d)(1) and (2), the Department will calculate the civil money penalty for each violation identified by multiplying 10% of the average monthly total value of WIC checks redeemed for the most recent 6-month period by the number of months the store would be disqualified under § 1107.1. If 6 months of information relating to the monthly value of WIC checks redeemed is not available, the Department will calculate the monthly average based upon the number of months for which information is available.

(2) For a civil money penalty in lieu of disqualification under § 1107.1a(d)(3)—(15), the Department will calculate the civil money penalty for each violation identified by multiplying 5% of the average monthly total value of WIC checks redeemed for the most recent 6-month period by the number of months the store would be disqualified under § 1107.1. For a store to which the Department may deny reauthorization and for which this option is available, the Department will multiply 5% of the average monthly total value of WIC checks for the most recent 6-month period by 6 months to determine the civil money penalty to be paid. If 6 months of information relating to the monthly value of WIC checks redeemed is not available, the Department will calculate the monthly average based upon the number of months for which information is available.

(c) Limitation of penalties. The amount of the civil money penalty will not exceed $10,000 for each violation. If, during the course of a single investigation, the Department determines a store has committed multiple violations, the Department will impose a civil money penalty for each violation. The total civil money penalty for all violations investigated as part of a single investigation will not exceed $40,000.

(d) Written agreement. If the Department offers and the store agrees to pay a civil money penalty in lieu of disqualification, the Department and store shall set forth the terms of the agreement in writing. The terms may include a probationary period during which the Department may conduct monitoring to ensure action has been taken by the store to correct problems. The agreement will be effective when it is signed by the Director of the Division of WIC or the Director’s designee.

(e) Payment of the civil money penalty. If a WIC authorized store does not pay, only partially pays, or fails to timely pay a civil money penalty assessed in lieu of disqualification, the Department will disqualify the WIC authorized store for the length of the disqualification authorized for the violation for which the civil money penalty was assessed. If a civil money penalty is assessed for more than one violation, the Department will impose the disqualification for the period authorized for the most serious violation. The Department may permit payment of a civil money penalty by installments.

(f) Outstanding financial liabilities. Payment of the civil money penalty, unless specifically provided for in a written agreement between the Department and the store, does not relieve the store of any other past or future financial liability incurred by the store by reason of its participation in the WIC Program. This includes, by way of example, reimbursement to the Department of overpayments.

The provisions of this § 1107.2 amended under section 2102(g) of The Administrative Code of 1929 (71 P.S. § 532(g)).

The provisions of this § 1107.2 amended December 22, 2000, effective December 23, 2000, 30 Pa.B. 6853; amended October 3, 2003, effective October 4, 2003, 33 Pa.B. 4900; amended September 11, 2009, effective immediately, 39 Pa.B. 5292. Immediately preceding text appears at serial pages (300357) to (300359).

This section cited in 28 Pa. Code § 1107.1a (relating to disqualifications).

History

Authority: The provisions of this § 1107.
Source: The provisions of this § 1107.

Chapter 1109 Administrative Appeals

28 Pa. Code § 1109.1 Applicability of general rules.

1 Pa. Code Part II (relating to general rules of administrative practice and procedure) applies to proceedings under this part, except as otherwise provided in this part.

History

Authority: The provisions of this § 1109.
Source: The provisions of this § 1109.

28 Pa. Code § 1109.2 Scope and purpose.

Chapters 1111 and 1113 (relating to applicant and participant appeals; and store appeals) apply to hearings held under 42 U.S.C.A. § 1786(f)(9), regarding the WIC Program. Those chapters supplement the Federal regulations, 7 CFR Part 246 (relating to special supplemental nutrition program for women, infants and children) governing hearings afforded under this part to applicants, participants, and stores, and supplement or supersede regulations in 1 Pa. Code Part II (relating to General Rules of Administrative Practice and Procedure) when their application would be inappropriate or inadequate.

The provisions of this § 1109.2 amended under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

The provisions of this § 1109.2 amended October 3, 2003, effective October 4, 2003, 33 Pa.B. 4900. Immediately preceding text appears at serial page (260441).

History

Authority: The provisions of this § 1109.
Source: The provisions of this § 1109.

28 Pa. Code § 1109.3 Time limits for action.

Time limits in § § 1111.10(d) and 1113.3(b) (relating to hearing examiner decisions; and adjudication and order) are directory.

History

Authority: The provisions of this § 1109.
Source: The provisions of this § 1109.

Chapter 1111 Applicant and Participant Appeals

28 Pa. Code § 1111.1 Applicant and participant appeal rights.

This chapter applies to applicants, participants and their authorized representatives, in pursuing appeals from decisions that adversely impact upon the participation of applicants and participants in the WIC Program.

28 Pa. Code § 1111.2 Notification of appeal rights.

(a) At the time of the denial of an application to become a participant, removal from the WIC Program as a participant, or placement on a waiting list to become a participant, the local agency shall inform in writing the adult applicant or participant, or the parent or guardian of a child or infant applicant or participant, of the right to appeal the decision, of the method by which an appeal may be filed, and that any positions or arguments on behalf of the applicant or participant may be presented personally or by an authorized representative, such as a relative, friend, legal counsel or other spokesperson. The expiration of the participant’s certification period occurs automatically and is not appealable.

(b) The local agency shall use forms provided by the Department to provide notice of appeal rights to the adult applicant or participant, or the parent or guardian of an infant or child applicant or participant.

28 Pa. Code § 1111.3 Appeal of a local agency decision.

(a) An appeal is any clear expression by the applicant, participant or authorized representative, that the decision of the local agency is contested and that an opportunity to challenge the decision and to present the case of the applicant or participant to a higher authority is desired. The Department or local agency will not limit or interfere with the freedom of the applicant, participant or authorized representative to appeal the decision and will provide whatever assistance is necessary to reduce an oral appeal to writing.

(b) When an appeal is made orally, the local agency shall docket it as being filed when the local agency receives the oral communication.

28 Pa. Code § 1111.4 Time for appeal of a local agency decision.

The applicant, participant or authorized representative shall appeal within 90 days after the date the local agency mails or delivers to the adult applicant or participant, or parent or guardian of an infant or child applicant or participant, written notice of the action to deny or terminate benefits under the WIC Program. An appeal is timely filed if it is received by the local agency within the 90-day period.

This section cited in 28 Pa. Code § 1111.6 (relating to denial or dismissal of appeal).

28 Pa. Code § 1111.5 Scheduling the hearing.

(a) Appointment of a hearing examiner. The local agency shall appoint a hearing examiner to preside over the appeal. The hearing examiner shall be an impartial official who does not have a personal stake or involvement in the decision, and who was not directly involved in the action being contested.

(b) Notification of the appeal. The local agency shall notify the hearing examiner of the appeal and the date on which it was docketed.

(c) Time frame for scheduling a hearing. The hearing examiner shall schedule the hearing within 3 weeks from the docketed date of the appeal. The hearing examiner shall provide the appellant participant or authorized representative with a minimum of 10 days advance written notice of the time and place of the hearing.

(d) Standards for scheduling the hearing. The hearing examiner shall use the following standards in scheduling a hearing:

(1) The place of the hearing may not be further from the residence of the applicant or participant than the county seat of the county in which the applicant or participant resides. If the county seat is unsuitable due to the health of the applicant or participant, transportation problems, convenience of witnesses or for other legitimate reasons, an alternative place of hearing shall be a location convenient to the home of the applicant or participant.

(2) If the applicant, participant or authorized representative wants to postpone the hearing, that individual shall contact the hearing examiner, and the local agency and provide them with a reason for postponement. If the hearing is postponed by the hearing examiner, the hearing examiner shall reschedule it as soon as possible.

(3) An applicant, participant or authorized representative may withdraw the appeal at any time before a decision is issued by the hearing examiner. This withdrawal shall be in writing and directed to the hearing examiner.

(4) If the applicant or participant fails to appear at the scheduled hearing in person or by authorized representative, without good cause as determined by the hearing examiner, the appeal shall be considered abandoned and shall be discontinued.

(e) Independent assessment. The hearing examiner shall order, when relevant and necessary, an independent medical assessment or professional evaluation of the applicant or participant from a source mutually satisfactory to the applicant or participant or its authorized representative, and the local agency.

(f) Supersession. Subsection (d)(3) supersedes 1 Pa. Code § 35.51 (relating to withdrawal of pleadings).

28 Pa. Code § 1111.6 Denial or dismissal of appeal.

The hearing examiner may not deny or dismiss an appeal unless one of the following occurs:

(1) The appeal is not received by the local agency within the time limit in § 1111.4 (relating to time for appeal of a local agency decision).

(2) The appeal is withdrawn in writing by the applicant, participant or authorized representative.

(3) The applicant, participant or authorized representative fails, without good cause, to appear at the scheduled hearing.

28 Pa. Code § 1111.7 Continuation of benefits.

(a) If at any time during a participant’s certification period, the local agency finds the participant to be ineligible to continue enrollment in the WIC Program, the local agency shall advise the participant in writing not less than 15 days before termination of the reason for ineligibility and of the right to appeal. If an appeal is received within 15 days after service of the notice of ineligibility, benefits shall continue until the hearing examiner reaches a decision or the certification period expires, whichever occurs first.

(b) An applicant denied initial enrollment, or an authorized representative of the applicant, may appeal the denial, but the applicant may not receive benefits while awaiting disposition of the appeal.

28 Pa. Code § 1111.8 Rights of the appellant.

(a) When an appeal is filed, the local agency shall inform the applicant or participant denied benefits, or an authorized representative, of the rights set forth in subsection (b).

(b) An applicant or participant who files an appeal, or on whose behalf the appeal is filed, has the following rights:

(1) To appear in person at the hearing.

(2) To represent himself, or to be represented by an authorized representative such as an attorney, friend or other person at the hearing.

(3) To receive an explanation that he may contact the local bar association for assistance in locating legal services.

(4) To present oral or documentary evidence, witnesses and arguments to support the position of the applicant or participant in accordance with procedures established by the hearing examiner.

(5) To request a subpoena from the hearing examiner for the production of evidence or witnesses that the applicant, participant or authorized representative, determines are important to establish necessary facts

(6) To request that the local agency provide an interpreter at the hearing if an adult applicant or participant, or the parent or guardian of an infant or child applicant or participant, does not understand English or is hearing impaired.

(7) To examine upon request, both before and during the hearing, the materials which the Department or local agency has on file relative to the case which are not confidential.

(8) To be provided with the names of the local agency staff members and witnesses who will be present at the hearing.

(9) To question or refute any testimony or other evidence presented against the applicant or participant and to confront and cross-examine adverse witnesses.

(10) To examine, prior to and during the hearing, documents and records that will be presented to support the decision under appeal.

(11) To further appeal the final decision of the hearing examiner to the Secretary within 15 days of the mailing date of the hearing examiner’s decision.

(12) To appeal the adjudication and order of the Secretary or agency head designated by the Secretary to the Commonwealth Court within 30 days of the mailing date of the adjudication and order.

(c) Supersession. Subsection (b)(1) supplements 1 Pa. Code § 31.21 (relating to appearance in person). Subsection (b)(2) supersedes 1 Pa. Code § § 31.22 and 31.23 (relating to appearance by attorney; and other representation prohibited at hearings). Subsection (b)(5) supplements 1 Pa. Code § 35.142 (relating to subpoenas).

28 Pa. Code § 1111.9 Hearing record.

(a) Contents of the record. The verbatim transcript or recording of testimony and exhibits, or an official report containing the substance of what transpired at the hearing, together with all papers and requests filed in the proceeding, shall constitute the hearing record. This record shall be available to the applicant, participant or authorized representative, for copying and inspection at any reasonable time

(b) Retention of the record. This record shall be retained for 3 years.

(c) Public inspection of the record. Department and local agency hearing records and decisions shall be available for public inspection and copying, provided the names and addresses of participants and other members of the public are kept confidential.

(d) Supersession. Subsection (a) supersedes 1 Pa. Code § 35.131 (relating to recording of proceedings).

28 Pa. Code § 1111.10 Hearing examiner decisions.

(a) The hearing examiner shall render a decision based exclusively on the evidence contained in the hearing record.

(b) The decision of the hearing examiner shall comply with applicable Federal law, and Federal and State regulations.

(c) A decision by the hearing examiner shall summarize the facts of the case, specify the reasons for the decision, and identify the supporting evidence and the pertinent regulations or policy. The decision shall become a part of the record. A decision adverse to the position of the local agency shall be binding on the local agency.

(d) Within 45 days after the filing date of the appeal, the hearing examiner shall provide the applicant, participant, or authorized representative, and the local agency, a copy of the hearing examiner’s decision.

(e) If the decision of the hearing examiner is in favor of the applicant or participant and benefits had been denied or discontinued, the local agency shall begin or resume providing benefits immediately upon the mailing date of the decision.

(f) If the decision is in favor of the local agency, the notice accompanying the decision of the hearing examiner to the applicant, participant or authorized representative shall include notice of the right to appeal to the Secretary. Immediately upon the date of the hearing examiner’s decision, the local agency shall discontinue providing any benefits which had been continued pending issuance of the hearing examiner’s decision.

(g) Subsection (a) supersedes 1 Pa. Code § 35.201 (relating to certification of record without proposed report).

This section cited in 28 Pa. Code § 1109.3 (relating to time limits for action).

28 Pa. Code § 1111.11 Appeal to the Secretary.

If the applicant, participant or authorized representative, chooses to appeal the decision of the hearing examiner, that individual shall file a written appeal with the Secretary within 15 days of the mailing date of the decision of the hearing examiner. The appeal shall contain a statement of reasons for reversing the decision of the hearing examiner. If the appeal asks for permission to present additional evidence, it shall:

(1) Identify the additional evidence.

(2) Explain why it was not previously introduced.

(3) Explain its materiality unless it is obvious.

28 Pa. Code § 1111.12 Adjudication and order procedures.

(a) In reaching a decision on the appeal, the Secretary or an agency head designated by the Secretary may:

(1) Reconsider the decision on the basis of the evidence in the record.

(2) Admit additional evidence.

(3) Order a new hearing.

(b) In cases in which the hearing examiner’s decision has resulted in a termination of benefits to the participant, there shall be no reinstatement of benefits upon filing of an appeal to the Secretary. The reinstatement of benefits, if granted, shall be solely as a result of the adjudication and order of the Secretary or designated agency head.

28 Pa. Code § 1111.13 Judicial review.

The Secretary or designated agency head will issue an adjudication and order after considering the appeal. If the adjudication and order is adverse to the interest of the applicant or participant, the adjudication and order shall state, or be accompanied by a notice stating, that the applicant or participant has the right to appeal the adjudication and order to Commonwealth Court within 30 days after the mailing of the adjudication and order.

Chapter 1113 Store Appeals

28 Pa. Code § 1113.1 Right to administrative appeal.

(a) A store has the right to appeal an adverse action of the Division of WIC that affects the store’s participation in the WIC Program as a WIC authorized store. Adverse actions include:

(1) Termination of authorization or reauthorization in accordance with § 1103.1(d) (relating to authorization and reauthorization process and requirements).

(2) Denial of an application for authorization or reauthorization.

(3) Refusal to accept an application for authorization or reauthorization.

(b) A store may not appeal the following:

(1) The expiration of authorization or reauthorization.

(2) The validity or appropriateness of selection criteria.

(3) The validity or appropriateness of the Department’s participant access criteria and the Division of WIC’s participant access determination.

(4) The validity or appropriateness of the Department’s store peer group system criteria and the criteria used by the Department to identify stores that qualify as an above-50-percent-store or that are comparable to above-50-percent-stores.

(5) Disqualification from the WIC Program as a result of disqualification from the Food Stamp Program.

(6) The resolution of an overpayment dispute under § 1105.2(d) (relating to price adjustment) or the resolution of an overcharge dispute under § 1105.3(d) (relating to terms and conditions of participation).

(c) A denial of authorization under § 1103.1(b)(7) and a disqualification imposed under § 1107.1a(a) (relating to disqualifications) shall be effective on the date of the store’s receipt of notice of the adverse action. All other adverse actions shall be effective on the date set forth in the written notice.

The provisions of this § 1113.1 amended under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

The provisions of this § 1113.1 amended December 22, 2000, effective December 23, 2000, 30 Pa.B. 6853; amended October 3, 2003, effective October 4, 2003, 33 Pa.B. 4900; amended September 11, 2009, effective immediately, 39 Pa.B. 5292. Immediately preceding text appears at serial pages (303225) to (303226).

This section cited in 28 Pa. Code § 1107.1 (relating to imposition of sanctions); and 28 Pa. Code § 1107.1a (relating to disqualifications).

History

Authority: The provisions of this § 1113.
Source: The provisions of this § 1113.

28 Pa. Code § 1113.2 Administrative procedures.

(a) Notification. The Division of WIC will provide to the store written notice of the adverse action, the procedures to follow to appeal the adverse action and the cause for and the effective date of the action.

(b) Form of administrative appeal. The appeal shall be made by the store or its authorized representative, in writing, stating the reasons for the appeal.

(c) Time for and effect of filing an administrative appeal. The appeal shall be filed with the Director of the Division of WIC within 30 days from the date the notice of adverse action is mailed. The filing of an appeal shall serve to stay the Department’s adverse action pending issuance of an adjudication and order by the hearing examiner under § 1113.3 (relating to adjudication and order). The stay shall be lifted upon receipt of the hearing examiner’s adjudication and order affirming the adverse action, or upon receipt of the store’s written notice of withdrawal of the appeal.

(d) Scheduling the hearing.

(1) The Director of the Division of WIC shall forward the appeal to the office of the hearing examiner.

(2) The hearing examiner shall set a time, date and place for the hearing.

(3) The hearing examiner shall send notice to the store, or its authorized representative, at least 10 days in advance of the date of the hearing.

(4) The hearing examiner shall schedule the hearing to be held within 21 days after the date of receipt by the Division of WIC of the store appeal.

(5) The Division of WIC or the store may request in writing that the hearing be rescheduled for another time or date and the hearing examiner shall consider the request.

(e) Hearing examiner. The Secretary will appoint a hearing examiner to preside over the appeal. The person shall be an impartial decision-maker, whose determination is based solely on whether the Division of WIC has correctly applied Federal and State statutes, regulations, policies and procedures governing the WIC Program, according to the evidence presented at the hearing.

(f) Hearing procedures.

(1) The store may be assisted or represented by an attorney or other authorized representative.

(2) The store, or its authorized representative, may examine, prior to and during the hearing, the documents and records considered by the Division of WIC in reaching its decision under appeal.

(3) The hearing shall be open to the public.

(4) Each party shall have the opportunity to present and cross-examine witnesses.

(5) Each party may present oral or documentary evidence and arguments to support its position in narrative form.

(6) Each party may object to or attempt to refute any testimony or other evidence presented by the other party.

(g) Supersession. Subsection (d) supersedes 1 Pa. Code § 35.105 (relating to notice of nonrulemaking procedures). Subsection (e) supersedes 1 Pa. Code § 35.185 (relating to designation of presiding officers). Subsection (f) supplements 1 Pa. Code § 31.21 (relating to appearance in person) and supersedes 1 Pa. Code § § 31.22 and 31.23 (relating to appearance by attorney; and other representation prohibited at hearings).

The provisions of this § 1113.2 amended under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

The provisions of this § 1113.2 amended December 22, 2000, effective December 23, 2000, 30 Pa.B. 6853; amended October 3, 2003, effective October 4, 2003, 33 Pa.B. 4900. Immediately preceding text appears at serial pages (272458) to (272459).

History

Authority: The provisions of this § 1113.
Source: The provisions of this § 1113.

28 Pa. Code § 1113.3 Adjudication and order.

(a) The adjudication and order shall include findings of fact and conclusions of law. The findings of fact shall be based only on the oral and documentary evidence in the hearing record.

(b) The hearing examiner shall provide the Director of the Division of WIC and the store, or its authorized representative, with the adjudication and order within 60 days after the date of the receipt by the Division of WIC of the appeal, adjusted for any continuance of the hearing that causes it to be held more than 21 days after the date the appeal was filed.

(c) If the hearing examiner upholds the Department’s adverse action, the adverse action shall be effective as of the date of the store’s receipt of written notice of the hearing examiner’s adjudication and order.

(d) The hearing examiner shall maintain a written record of the hearing. The record shall include a docket number and caption for the appeal, any documentary evidence submitted, the transcript of the testimony presented at the hearing, the adjudication and order of the hearing examiner, and a copy of the document transmitting the adjudication and order to the store, or its authorized representative.

(e) Subsections (a)—(c) supersede 1 Pa. Code § § 35.131, 35.201, 35.202 and 35.205.

The provisions of this § 1113.3 amended under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

The provisions of this § 1113.3 amended October 3, 2003, effective October 4, 2003, 33 Pa.B. 4900.

This section cited in 28 Pa. Code § 1109.3 (relating to time limits for action); and 28 Pa. Code § 1113.2 (relating to administrative appeal procedures).

History

Authority: The provisions of this § 1113.
Source: The provisions of this § 1113.

28 Pa. Code § 1113.4 Continuing responsibilities.

Appealing an action does not relieve the store from the responsibility of continued compliance with regulations under this part applicable to a WIC authorized store.

The provisions of this § 1113.4 amended under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

The provisions of this § 1113.4 amended October 3, 2003, effective October 4, 2003, 33 Pa.B. 4900. Immediately preceding text appears at serial page (272459).

History

Authority: The provisions of this § 1113.
Source: The provisions of this § 1113.

28 Pa. Code § 1113.5 Judicial review.

If the adjudication and order of the hearing examiner upholds the Department’s adverse action, the hearing examiner will inform the store within the adjudication and order, or by notice accompanying the adjudication and order, of the right to pursue judicial review of the adjudication and order.

The provisions of this § 1113.5 amended under section 2102(g) of The Administrative Code of 1929 (71 P. S. § 532(g)).

The provisions of this § 1113.5 amended October 3, 2003, effective October 4, 2003, 33 Pa.B. 4900. Immediately preceding text appears at serial page (272460).

History

Authority: The provisions of this § 1113.
Source: The provisions of this § 1113.