N.D. Admin. Code Title 96 — Board of Clinical Laboratory Practice

Article 96-01 General Administration

Chapter 96-01-01 Organization of Board

N.D. Admin. Code 96-01-01-01 Organization of the board of clinical laboratory practice

1.History and function. The 1989 legislative assembly passed legislation to license clinical laboratory personnel, codified as North Dakota Century Code chapter 43-48.

This chapter requires the governor to appoint a state board of clinical laboratory practice. It is the responsibility of this board to license laboratory personnel.

2.Officers. Officers must be elected by the board. Officers will consist of a chair, secretary, and treasurer.

3.Compensation. In addition to the expenses incurred while engaged in the performance of their duties, each board member shall receive a per diem fee set by the board, not to exceed the fee established by law for the legislative assembly.

4.Staff. The board is authorized to employ an executive director and such other professional and secretarial staff as may be necessary.

5.Inquiries. Inquiries regarding the board may be addressed to:

Board of Clinical Laboratory Practice P.O. Box 4103 Bismarck, ND 58502-4103

History

• History: Effective June 1, 1991; amended effective April 1, 1994; May 1, 2002.
• General Authority: NDCC 28-32-02.1, 43-48-04
• Law Implemented: NDCC 28-32-02

Article 96-02 Clinical Laboratory Personnel Licensure

Chapter 96-02-01 Definitions [Repealed]

N.D. Admin. Code 96-02-01 Definitions [Repealed]

ARTICLE 96-02

CLINICAL LABORATORY PERSONNEL LICENSURE

Chapter 96-02-01Definitions [Repealed] 96-02-02Licensure 96-02-03Fees 96-02-04Continuing Education 96-02-05Name and Address Changes 96-02-06Violations [Repealed] 96-02-07Grievances [Repealed] 96-02-08Board Action [Repealed] 96-02-09Discipline 96-02-10Exemption From Licensure

CHAPTER 96-02-01

DEFINITIONS [Repealed effective May 1, 2002]

Chapter 96-02-02 Licensure

N.D. Admin. Code 96-02-02-01 Initial license requirements

The following requirements apply to all applicants seeking initial licensure by the board:

1.A completed application form.

2.Payment of the appropriate application fee as set by the board.

3.Evidence of the required education.

4.The applicant has passed a national certifying examination approved by the board.

5.The applicant must meet one or more of the following conditions:

a.The applicant has passed a national certifying examination approved by the board within two years of the date of application for initial licensure.

b.The applicant has practiced by performing clinical laboratory testing as defined in subsection 5 of North Dakota Century Code section 43-48-01 for a total of three hundred hours within three years of the date of application for initial licensure. Proof of practice by performing clinical laboratory testing must be provided by the applicant and may be evaluated by the board for sufficiency.

c.The applicant has obtained thirty continuing education hours within two years of the date of application for initial licensure. The continuing education hours obtained must satisfy the requirements for continuing education established in section 96-02-04-01.

6.All applications must be signed or attested to electronically.

1.The board shall license individuals that meet the definition of military spouse set forth in North Dakota Century Code section 43-51-01 who, through the submission of a completed application form, demonstrate the following:

a.The military spouse demonstrates competency in clinical laboratory practice through methods or standards determined by the board which must include experience in clinical laboratory practice for at least two of the four years preceding application.

b.The board determines the issuance of the license will not substantially increase risk of harm to the public.

2.The board may require the submission of any information it deems necessary to assist it in making its determination. The board may deny a license if the board determines the applicant does not meet the above requirements. If the board determines the applicant substantially meets the above requirements, the board may issue a provisional license. When issuing a provisional license, the board may explain the steps necessary for the applicant to fully meet the above requirements and be issued a nonprovisional license. A provisional license must be granted automatically by the board if the board does not deny or grant the license within thirty days of application. The board may place conditions on any license or provisional license.

Military spouses may not be assessed fees for the issuance of a license or provisional license under this section. A provisional license may be valid for up to two years. Provisional licenses expire for reasons, including:

a.The board grants the application for license.

b.The board denies the application for licensure.

c.The provisional license expires.

d.The board revokes the provisional license to protect the public safety.

e.The applicant fails to meet any steps or conditions the board placed on the provisional license.

History

• History: Effective June 1, 1991; amended effective May 1, 2002; July 1, 2017.
• Law Implemented: NDCC 43-48-04, 43-48-06, 43-48-07, 43-48-08, 43-48-09, 43-48-13 96-02-02-01.1. Military spouse licensure.
• History: Effective April 1, 2020.
• Law Implemented: NDCC 43-48-04, 43-48-08, 43-48-09, 43-48-13, 43-51-11.1

N.D. Admin. Code 96-02-02-02 Requirements for specific licenses

1.Medical technologist (clinical laboratory scientist) must have earned a bachelor's degree in a science-related discipline, completed the academic requirements of a structured clinical educational program recognized by the board, and passed a national certifying examination approved by the board.

2.A clinical laboratory specialist must have a bachelor's or higher degree with a major in one of the chemical, physical, or biological sciences and may only perform functions directly related to the person's particular specialty.

A clinical laboratory specialist must pass a national certifying examination approved by the board in a specialty area. A license issued to a clinical laboratory specialist will designate the area of specialty.

3.A categorical license issued to a clinical laboratory specialist must designate the area of specialty. Specialty areas include:

a.Blood bank or immunohematology;

b.Chemistry;

c.Hematology;

d.Microbiology; and

e.Molecular biology.

4.A clinical laboratory technician or medical laboratory technician must successfully complete the academic requirements of a structured clinical educational program recognized by the board and must pass a national certifying examination approved by the board.

5.The board may issue a provisional permit to a person who has applied for licensure and is eligible to take a board-recognized national certifying examination.

The provisional permit may not exceed one year. At the board's discretion, the permit may be renewed a maximum of two consecutive times for a period of one year each.

History

• History: Effective June 1, 1991; amended effective May 1, 2002; July 1, 2017; April 1, 2020; January 1, 2025.
• Law Implemented: NDCC 43-48-04, 43-48-07, 43-48-08, 43-48-09, 43-48-11

N.D. Admin. Code 96-02-02-03 Reciprocity

1.The board will evaluate the submission of requests for reciprocity for licensure on an individual

basis and grant such only upon a finding that the requirements for licensure in another state or jurisdiction are equal to or more stringent than those of North Dakota and that the applicant's license in another state or jurisdiction is in good standing.

2.The board may deny a request for reciprocity for licensure if the applicant has had disciplinary action taken against him or her or has engaged in conduct that violates the standards of

section 96-02-09-02 or conduct that meets the requirements for discipline under North Dakota Century Code section 43-48-15 even if the applicant is currently in good standing in another state or jurisdiction.

3.If an individual applying for licensure by reciprocity under this section has been licensed previously by the board to practice in North Dakota, the individual must also meet the continuing education requirements of section 96-02-04-01 before being licensed under this

section.

History

• History: Effective June 1, 1991; amended effective May 1, 2002; July 1, 2017; April 1, 2020.
• Law Implemented: NDCC 43-48-04

N.D. Admin. Code 96-02-02-04 License renewal - Licenses are renewable biennially

1.Notice for renewal of license will be issued by the board in May of even-numbered years to all licenseholders. An applicant for renewal must meet the continuing education requirements described in section 96-02-04-01 and submit a completed application and fees to the board on or before the first of July of the renewal year.

2.Proof of the required continuing education within the prior licensing period must be submitted with renewals.

3.If a licensee fails to receive the renewal notice, it is the responsibility of the licensee to contact the board before the first of July deadline. 4.lf the applicant has not submitted a completed application and fees to the board office or has not met the continuing education requirements described in section 96-02-04-01 on or before the first of July of the renewal year, the applicant must pay the applicable late fee. A licensee may practice until his or her license expires under subsection 5 of this section or final disciplinary action is taken under section 96-02-09-01.

5.Licenses will expire if the applicant has not completed the continuing education requirements described in section 96-02-04-01 or has not submitted a completed renewal form and fees to the board within ninety days from the first of July of the renewal year. The board may waive the late fee or extend the period for license renewal due to extraordinary circumstances as determined in the board's sole discretion.

6.If an individual's license expires, the person must make application for a license in accordance with section 96-02-02-01 and meet the requirements of sections 96-02-02-02 and 96-02-04-01.

History

• History: Effective June 1, 1991; amended effective May 1, 2002; July 1, 2017.
• Law Implemented: NDCC 43-48-04, 43-48-06, 43-48-14

N.D. Admin. Code 96-02-02-05 Registration refused, revoked, or suspended

Repealed effective May 1, 2002.

N.D. Admin. Code 96-02-02-06 Inactive status

Repealed effective May 1, 2002.

N.D. Admin. Code 96-02-02-07 Scope of practice

The profession of clinical laboratory encompasses the design, performance, evaluation, reporting, interpreting, and clinical correlation of clinical laboratory testing, and the management of all aspects of these services. Clinical laboratory tests are utilized for the purpose of diagnosis, treatment, monitoring, and prevention of disease. The profession includes generalists as well as individuals qualified in several specialized areas of expertise including blood bank, chemistry, hematology, microbiology, and molecular biology. Integral features of each of the specialties include diagnostic testing, research, consultation, education, information management, marketing, and administration.

History

• History: Effective January 1, 2025.
• Law Implemented: NDCC 43-48-04

Chapter 96-02-03 Fees

N.D. Admin. Code 96-02-03-01 Fees

The board shall set fees in an amount to reimburse the operational cost of licensure services rendered.

1.Initial fee for licensing

a.Application for license received on or after May first of the even-numbered year and before January first of the odd-numbered year:

(1)Medical technologist$140.00 (2)Clinical laboratory scientist$140.00 (3)Clinical laboratory specialist$140.00 (4)Clinical laboratory technician$120.00 (5)Medical laboratory technician$120.00

b.Application for license received on or after January first of the odd-numbered year and before July first of the odd-numbered year:

(1)Medical technologist$115.00 (2)Clinical laboratory scientist$115.00 (3)Clinical laboratory specialist$115.00 (4)Clinical laboratory technician$100.00 (5)Medical laboratory technician$100.00

c.Application for license received on or after July first of the odd-numbered year and on or before December thirty-first of the odd-numbered year:

(1)Medical technologist$90.00 (2)Clinical laboratory scientist$90.00 (3)Clinical laboratory specialist$90.00 (4)Clinical laboratory technician$80.00 (5)Medical laboratory technician$80.00

d.Application for license received on or after January first of the even-numbered year and before May first of the even-numbered year:

(1)Medical technologist$65.00 (2)Clinical laboratory scientist$65.00 (3)Clinical laboratory specialist$65.00 (4)Clinical laboratory technician$60.00 (5)Medical laboratory technician$60.00

2.License fee for biennial license renewal

a.Medical technologist$140.00

b.Clinical laboratory scientist$140.00

c.Clinical laboratory specialist$140.00

d.Clinical laboratory technician$120.00

e.Medical laboratory technician$120.00

3.Late fees $140.00

4.Provisional permit fee$90.00

5.Provisional permit extension fee$90.00

6.The provisional permit fee may be applied toward the initial fee for licensing if the application for licensure is submitted before the provisional permit expires.

7.Any request for the purchase of a list of licensees' names and employment addresses for offering continuing education opportunities, research, and professional organizations building lists of contacts in the state of North Dakota must be accompanied by a one hundred forty dollar administrative service fee.

History

• History: Effective June 1, 1991; amended effective May 1, 2002; July 1, 2017; April 1, 2022; January 1, 2026.
• General Authority: NDCC 43-48-04, 43-48-06
• Law Implemented: NDCC 43-48-04, 43-48-06

Chapter 96-02-04 Continuing Education

N.D. Admin. Code 96-02-04-01 Continuing education

1.Effective until June 30, 2018, an individual licensed by the board must complete twenty continuing education contact hours for the two-year licensing period to maintain licensure in North Dakota after the individual's initial continuing education licensure period. During the individual's initial continuing education licensure period, continuing education hours must be earned pursuant to the following schedule:

a.Twenty continuing education hours are required if licensed after June thirtieth of the even-numbered year and before July first of the odd-numbered year.

b.Ten continuing education hours are required if licensed after June thirtieth and on or before December thirty-first of the odd-numbered year.

c.No continuing education hours are required if licensed on or after January first of an even-numbered year.

2.Effective July 1, 2018, an individual licensed by the board must complete twenty-four continuing education contact hours for the two-year licensing period to maintain licensure in North Dakota after the individual's initial continuing education licensure period. During the individual's initial continuing education licensure period, continuing education hours must be earned pursuant to the following schedule:

a.Twenty-four continuing education hours are required if licensed after June thirtieth of the even-numbered year and before July first of the odd-numbered year.

b.Twelve continuing education hours are required if licensed after June thirtieth and on or before December thirty-first of the odd-numbered year.

c.No continuing education hours are required if licensed on or after January first of an even-numbered year.

3.Before being relicensed in North Dakota, an individual who was licensed by the board but whose license has expired must complete all continuing education hours that were outstanding at the time their license expired, plus additional continuing education hours within two years of the date of the application for licensure according to the following schedule:

a.No additional continuing education hours are required if the individual's license has been expired less than six months when the application for licensure is submitted.

b.Twelve additional continuing education hours are required if the individual's license has been expired six months or more but less than eighteen months when the application for licensure is submitted.

c.Twenty-four additional continuing education hours are required if the individual's license has been expired eighteen months or more when the application for licensure is submitted.

4.Board-approved continuing education must be directly related to or supportive of clinical laboratory practice. Continuing education includes:

a.Workshops, refresher courses, professional conferences, seminars, and educational programs presented by providers approved by the board.

b.Presentations by licensee:

(1)Professional presentations, e.g., workshops, institutes. A presentation may be counted only one time and there is no limit on hours that may be earned under this paragraph.

(2)Community or service organization presentations. A general public presentation may be counted only one time and no more than three hours may be earned under this paragraph.

c.Formal academic coursework. One credit hour class is equal to ten contact hours.

d.Formal self-study course with a completion certificate, and there is no limit on hours under this subdivision.

e.Research approved by the board.

f.Supervised clinical practice approved by the board.

g.Facility-based continuing education program.

5.Nonacceptable continuing education topics include courses in general safety not directly related to clinical laboratory practice, annual training required by a medical facility such as cardiopulmonary resuscitation or first aid, breath alcohol instrument training, personal reading of professional journals, committee meetings, computer classes, personal enrichment courses, and programs delivered through the mass media.

6.The board requires verification of continuing education completion, which must be received by the board office on or before the licensure expiration date. Verification must include name of licensee; dates of attendance; title of program, course, or workshop; sponsor's name and address; and number of earned contact hours. Verification documentation must be submitted on a board-approved continuing education record form and include a copy of a continuing education certificate signed by the provider or sponsor.

7.Failure to meet the continuing education requirements by the deadline referenced in section 96-02-02-04 will result in nonrenewal of license.

8.The board may waive continuing education requirements or allow exceptions due to extraordinary circumstances.

History

• History: Effective June 1, 1991; amended effective May 1, 2002; July 1, 2017.
• General Authority: NDCC 43-48-04
• Law Implemented: NDCC 43-48-04

Chapter 96-02-05 Name and Address Changes

N.D. Admin. Code 96-02-05-01 Name and address changes

Any licensee must promptly report a change of contact information including the licensee's name, address, phone, and email address to the board in writing or by electronic communication.

History

• History: Effective June 1, 1991; amended effective May 1, 2002; July 1, 2017.
• General Authority: NDCC 43-48-04
• Law Implemented: NDCC 43-48-04

Chapter 96-02-06 Violations [Repealed]

N.D. Admin. Code 96-02-06 Violations [Repealed]

CHAPTER 96-02-06

VIOLATIONS [Repealed effective May 1, 2002]

Chapter 96-02-07 Grievances [Repealed]

N.D. Admin. Code 96-02-07 Grievances [Repealed]

CHAPTER 96-02-07

GRIEVANCES [Repealed effective May 1, 2002]

Chapter 96-02-08 Board Action [Repealed]

N.D. Admin. Code 96-02-08 Board Action [Repealed]

CHAPTER 96-02-08

BOARD ACTION [Repealed effective May 1, 2002]

Chapter 96-02-09 Discipline

N.D. Admin. Code 96-02-09-01 Disciplinary procedure

1.Upon filing of a written and signed complaint alleging a licensee engaged in conduct identified as grounds for disciplinary action under North Dakota Century Code section 43-48-15, the board shall notify the licensee of the complaint and require a written response from the licensee. The board may initiate a complaint on its own motion upon learning of conduct identified as grounds for disciplinary action under North Dakota Century Code section 43-48-15, and shall notify the licensee of the complaint and require a written response from the licensee.

2.The board may designate a board member to investigate the complaint. After completing the investigation, the board member will recommend whether the board should take disciplinary action against the licensee.

3.The board shall determine if there is a reasonable basis to believe the licensee engaged in conduct identified as grounds for disciplinary action under North Dakota Century Code section

N.D. Admin. Code 43-48-15 If the board determines there is not a reasonable basis to believe a violation occurred, the board will notify the complainant and the licensee. If the board determines there is a reasonable basis to believe a violation occurred, the board will proceed with a disciplinary action in accordance with North Dakota Century Code chapter 28-32

4.The board may, at any time, offer or accept a proposal for informal resolution of the complaint or disciplinary action.

History

• History: Effective May 1, 2002; amended effective July 1, 2017; January 1, 2025.
• Law Implemented: NDCC 43-48-15

N.D. Admin. Code 96-02-09-02 Unprofessional conduct

Unprofessional conduct includes:

1.Scientific and professional misconduct including falsification, fabrication, plagiarism, concealment, inappropriate omission of information, and making false or deceptive statements.

2.Dishonest or illegal compensation for services rendered.

3.Failure to comply with all laws regarding confidentiality and security of patient information and test results.

4.Failure to protect the safety and welfare of patients, employees, coworkers, the public, and the environment as it relates to clinical laboratory practice.

5.Failure to report a violation of clinical laboratory practice law or rules to the board.

6.Suspension or revocation of, or disciplinary action against, an individual's license in another jurisdiction.

7.Failure to meet minimum standards of clinical laboratory practice.

8.Practice beyond the scope of practice allowed by an individual's current license.

9.Conviction of an offense determined by the board to have a direct bearing upon that individual's ability to practice clinical laboratory science or is failure to sufficiently rehabilitate as determined by the board in accordance with North Dakota Century Code section 12.1-33-02.1.

10.Addiction to the habitual use of alcoholic beverages, narcotics, stimulants, or other addictive substances which impairs the licensee's ability to practice clinical laboratory science.

History

• History: Effective January 1, 2010; amended effective January 1, 2025.
• Law Implemented: NDCC 43-48-15

N.D. Admin. Code 96-02-09-03 Code of ethics

A licensee shall comply with the following code of ethics in the licensee's professional practice and conduct. The code reflects the ethical principles of the clinical laboratory profession and outlines the obligations of licensees to self, client, society, and the profession and sets forth mandatory standards of conduct for all licensees.

1.A licensee's primary duty is to the patient, placing the welfare of the patient above the licensee's own needs and desires and ensuring each patient receives the highest quality of care according to current standards of practice. High quality laboratory services are safe, effective, efficient, timely, equitable, and patient centered. A licensee shall work with all patients and all patient samples without regard to disease state, ethnicity, race, religion, or sexual orientation. A licensee shall prevent and avoid conflicts of interest that undermine the best interests of patients.

2.A licensee is accountable for the quality and integrity of the laboratory services the licensee provides. This obligation includes maintaining the highest level of individual competence as patient needs change, yet practicing within the limits of the licensee's level of practice. A licensee shall exercise sound judgment in all aspects of laboratory services they provide.

Furthermore, a licensee shall safeguard patients from others' incompetent or illegal practice through identification and appropriate reporting of instances where the integrity and high quality of laboratory services have been breached.

3.A licensee shall maintain strict confidentiality of patient information and test results. A licensee shall safeguard the dignity and privacy of patients and provide accurate information to patients and other health care professionals. A licensee shall respect patients' rights to make decisions regarding the patient's own medical care.

4.A licensee shall uphold the dignity and respect of the profession and maintain a reputation of honesty, integrity, competence, and reliability. A licensee shall contribute to the advancement of the profession by improving and disseminating the body of knowledge, adopting scientific advances that benefit the patient, maintaining high standards of practice and education, and seeking fair socioeconomic working conditions for members of the profession.

5.A licensee shall establish cooperative, honest, and respectful working relationships within the clinical laboratory and with all members of the health care team with the primary objective of ensuring a high standard of care for the patients they serve.

6.As a practitioner of an autonomous profession, a licensee has the responsibility to contribute from the licensee's sphere of professional competence to the general well-being of society. A licensee shall serve as a patient advocate, applying the licensee's expertise to improve patient health care outcomes by eliminating barriers to access to laboratory services and promoting equitable distribution of health care resources.

7.A licensee shall comply with all relevant laws and regulations pertaining to the practice of clinical laboratory science.

History

• History: Effective January 1, 2025.
• Law Implemented: NDCC 43-48-04

Chapter 96-02-10 Exemption from Licensure

N.D. Admin. Code 96-02-10-01 Exempt tests and methods

An individual is exempt from the provisions of North Dakota Century Code chapter 43-48 if the individual is supervised by an individual licensed by the board, an advanced practice registered nurse, or a physician and the individual is performing the following food and drug administration-waived tests and using the following methods, or performing tests determined by the board to be equivalent to those listed in this section:

1.Any of the following tests by nonautomated or automated urinalysis by dipstick:

a.Bilirubin.

b.Blood.

c.Glucose.

d.Ketone.

e.Leukocyte.

f.Nitrate.

g.Potential of hydrogen (pH).

h.Protein.

i.Specific gravity.

j.Urobilinogen.

2.Fecal occult blood by any accepted method.

3.Ovulation test by visual color comparison.

4.Qualitative urine pregnancy test by visual color comparison.

5.Erythrocyte sedimentation rate by any accepted nonautomated method.

6.Whole blood glucose by any accepted single analyte method.

7.Spun microhematocrit by any accepted method.

8.Hemoglobin by single analyte instrument or manual copper sulfate method.

9.Any of the following tests by immunoassay using a rapid test device that detects antibodies or antigens:

a.Helicobacter pylori.

b.Influenza.

c.Mononucleosis.

d.Streptococcus group A.

e.Hepatitis C virus.

f.Respiratory syncytial virus.

g.SARS-CoV-2

10.Prothrombin time international normalized ratio by mechanical endpoint.

11.Antibodies to human immunodeficiency virus types 1 and 2 by clearview complete HIV 1/2 assay.

12.Alere cholestech analyzer, but only for the following analytes:

a.Total cholesterol; and

b.High-density lipoprotein (HDL) cholesterol.

13.Syphilis health check.

14.CoaguCheck XS system.

15.UltraCrit hematocrit.

16.Abaxis piccolo xpress analyzer whole blood methods, but only for the following analytes:

a.Total cholesterol.

b.HDL cholesterol.

c.Triglycerides.

d.Glucose.

e.Blood urea nitrogen (BUN).

f.Creatinine.

g.Sodium.

h.Chloride.

i.Potassium.

j.Bicarbonate.

k.Total protein.

l.Total bilirubin.

m.Aspartate aminotransferase (AST).

n.Alanine aminotransferase (ALT)

o.Albumin.

p.Total calcium.

q.Alkaline phosphatase. 17.i-STAT creatinine when performed by radiology technologists or technicians.

18.Alere affinion AS100 glycosylated hemoglobin (A1C).

19.Urine drug screen, if positive results are confirmed by utilizing additional confirmation tests.

20.Any of the following tests by polymerase chain reaction using a closed system that detects DNA or RNA:

a.SARS-CoV-2.

b.Streptococcus group A.

c.Respiratory syncytial virus.

d.Influenza.

e.Human rhinovirus.

July 1, 2017; April 1, 2020; April 1, 2022; January 1, 2026; April 1, 2026.

An individual, supervised by an individual licensed by the board, advanced practice registered nurse, or physician performing total protein tests by Reichert digital refractometer, is exempt from the provisions of North Dakota Century Code chapter 43-48.

History

• History: Effective January 1, 2006; amended effective January 1, 2008; April 1, 2012; April 1, 2013;
• General Authority: NDCC 43-48-03, 43-48-04 96-02-10-01.1. Exempt test and method.
• History: Effective January 1, 2010; amended effective April 1, 2020.
• General Authority: NDCC 43-48-03, 43-48-04

N.D. Admin. Code 96-02-10-02 Supervision

As used in subsection 9 of North Dakota Century Code section 43-48-03 and North Dakota Administrative Code sections 96-02-10-01 and 96-02-10-01.1, "supervised" means the following:

1.The supervisor shall identify the individuals being supervised on a form provided by the board and promptly shall notify the board of any changes to the information provided.

2.The supervisor shall ensure the individuals being supervised are trained appropriately in all tests and methods performed by the supervised individuals.

3.The supervisor:

a.Shall perform annual competency assessments of the individuals supervised using generally accepted clinical laboratory standards.

b.May not allow an individual supervised to start or continue performing tests until the individual has been properly trained and demonstrated competency.

c.Shall document training and competency assessments, retain the documentation for three years, and submit the documentation to the board upon request.

d.Shall ensure acceptable cleanliness testing is completed at least monthly at all locations that perform DNA or RNA detection testing for individuals supervised.

4.The supervisor regularly shall monitor and be available to consult with the individuals being supervised.

Failure by the licensee to supervise is unprofessional conduct and the licensee may be subject to disciplinary action by the board.

History

• History: Effective January 1, 2006; amended effective January 1, 2010; January 1, 2026.
• General Authority: NDCC 43-48-04