Alabama Administrative Code Chapter 420-4-5 — Healthcare-Associated Infections Reporting

420 Alabama Department of Public Health

Ala. Admin. Code r. 420-4-5-.01 Definitions And Acronyms

For the purpose of this chapter, the following terms and acronyms shall have the following meanings respectively ascribed to them.

(a) “Accuracy” means the correctness of data reported about Healthcare-Associated Infections (HAIs) submitted to the Alabama Department of Public Health (ADPH) according to standards recommended by the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network (NHSN).

(b) “ADPH” means the Alabama Department of Public Health, Bureau of Communicable Disease, Division of Epidemiology, HAI Branch: The RSA Tower, 201 Monroe Street, Montgomery, Alabama 36104, P.O. Box 303017, Montgomery, Alabama 36130-3017.

(c) “Advisory Council” means the Healthcare Data Advisory Council as referenced in Code of Ala. 1975, §22-11A-118.

(d) “Board” means the State Board of Health.

(e) “CAUTI” means Catheter-Associated Urinary Tract Infection.

(f) “CDC” means the Centers for Disease Control and Prevention.

(g) “CLABSI” means Central Line-Associated Bloodstream Infection.

(h) “Critical Care Unit” means a care area that provides intensive observation, diagnosis, and therapeutic procedures for adults or children or both, or neonatal patients, who are critically ill. “Critical Care” and “Intensive Care” are used interchangeably. Care areas that provide step-down, intermediate care, or telemetry only, and specialty care areas are excluded.

(i) “Data” means patient information submitted by healthcare facilities to carry out the requirements of the Mike Denton Infection Reporting Act, Code of Ala. 1975, §22-11A-110, et seq.

(j) “Electronic Data Submission” means transferring data from a computer used by a reporting entity to the National Healthcare Safety Network (NHSN).

(k) “General Care Ward” means a multidisciplinary care area that provides moderate observation, diagnosis, and therapeutic procedures for adults or children or both who are ill.

(l) “Healthcare-Associated Infection (HAI)” means a localized or systemic condition that results from adverse reaction to the presence of an infectious agent or agents or its toxins, and that was not present or incubating at the time of admission to the healthcare facility. The terms “Health Care Facility Acquired Infection” and “Healthcare-Associated Infection” are synonymous as used in these rules.

(m) “Healthcare Facility” means general, critical access, and specialized hospitals, including pediatric hospitals but excluding psychiatric, rehabilitation, long-term care, and eye hospitals, licensed pursuant to Code of Ala. 1975, §22-21-20.

(n) “Mixed Acuity Ward” means a hospital area for the evaluation and treatment of adult patients whose conditions are of varying levels of acuity (e.g., critical care, ward-1evel care, step down type care, etc.). Such a care area may be comprised of patients followed by different hospital services (e.g., coronary, medical, surgical, etc.). This care area may or may not include “acuity adaptable” or “universal” beds (i.e., this model of patient care allows a patient to stay in the same bed during all phases of his care, from critical care through lower levels of care).

(o) “Mixed Age, Mixed Acuity Ward” means a hospital area for the evaluation and treatment of a mixture of adult and pediatric patients whose conditions are of varying levels of acuity (e.g., critical care, ward-1evel care, step down type care, etc.). Such a care area may be comprised of patients followed by different hospital services (e.g., coronary, medical, surgical, etc.). This care area may or may not include “acuity adaptable” or “universal” beds (i.e., this model of patient care allows a patient to stay in the same bed during all phases of his care, from critical care through lower levels of care).

(p) “NHSN” means the National Healthcare Safety Network, the electronic system developed by the CDC used to capture HAI data.

(q) “Risk Adjusted” means a process used to identify and adjust for variation in patient HAI outcomes which stem from differences in patient characteristics across healthcare organizations. Risk adjustment accounts for patient-related attributes, such as age, gender, and pre-existing conditions.

(r) “SSI” means Surgical Site Infection.

(s) “Validate” means to evaluate the quality and accuracy of patient information submitted by a healthcare facility to ensure consistency across reporting facilities.

History

• Author: Kelly M. Stevens, M.S., Nina C. Hassell, M.P.H.
• Authority: Code of Ala. 1975, §22-11A-113; 22-11A-119; 22-2-2(6).
• New Rule: Filed June 23, 2010; effective July 28, 2010. Amended: Filed January 20, 2012; effective February 24, 2012. Amended: Filed October 21, 2013; effective November 25, 2013.

Ala. Admin. Code r. 420-4-5-.02 Healthcare Facility Responsibilities

(1) Healthcare facilities shall begin collecting HAI data using NHSN to report to ADPH no later than January 1, 2011. Healthcare facilities may begin collecting HAI data to report to ADPH using NHSN prior to January 1, 2011. Data reported prior to January 1, 2011 will be considered test data and will not be publicly reported.

(2) HAI data shall be reported to ADPH from the following categories:

(a) Central Line-Associated Bloodstream Infections (CLABSI) from the following critical care units within a healthcare facility:

1. Adult Critical Care Units

2. Pediatric Critical Care Units

3. Neonatal Critical Care Units

(b) Surgical Site Infections (SSI) from the following procedures:

1. Colon

2. Hysterectomy - abdominal

(c) Catheter-Associated Urinary Tract Infections (CAUTI) from the following patient care locations within a healthcare facility:

1. General Medical Wards

2. General Surgical Wards

3. General Medical/Surgical Wards

4. Adult Critical Care Units

5. Pediatric Critical Care Units

6. Healthcare facilities that cannot comply with reporting CAUTIs from General Medical, General Surgical, and General Medical/Surgical Wards shall report CAUTIs from Mixed Acuity and Mixed Age, Mixed Acuity Wards.

(3) The Advisory Council and ADPH shall review and make recommendations for regulatory modifications of HAI reporting categories annually.

(4) Healthcare facilities shall perform the following NHSN administrative responsibilities no later than January 1, 2011.

(a) Assign an NHSN Facility Administrator and primary HAI contacts.

(b) Submit contact information to ADPH including the healthcare facility name, and names, email addresses, and phone numbers of the NHSN Facility Administrator and primary HAI contacts.

(c) Notify ADPH in writing of changes in healthcare facility staff assigned as NHSN Facility Administrator and primary HAI contacts no later than 30 days after the change occurs.

(d) Ensure appropriate personnel, including healthcare facility individuals with HAI surveillance program oversight responsibilities and other facility personnel responsible for entering data into NHSN, complete the initial CDC NHSN training modules and any subsequent updates.

(e) Maintain a list of NHSN users and their initial and subsequent CDC NHSN training dates, and submit this information to ADPH by January 31 of each calendar year.

(f) Distribute the appropriate NHSN instruction manuals, training materials, data collection forms, and methods for data entry submission to appropriate staff.

(g) Join the ADPH NHSN group and report mandatory HAI data to ADPH.

(h) Follow the CDC NHSN definitions and guidelines for reporting HAI data as referenced in The National Healthcare Safety Network (NHSN) Manual: “Patient Safety Component Protocol”, CDC, Atlanta, GA, March 2009, which is hereto adopted by reference, including but not limited to definitions, key terms, location codes, and selected module protocols.

(i) Follow the collection methods as described in Rule 420-4-5-.04.

(j) Ensure a method of quality control in reporting HAI data is established and maintained.

History

• Author: Kelly M. Stevens, M.S.
• Authority: Code of Ala. 1975, §22-11A-113; 22-11A-119; 22-2-2(6).
• New Rule: Filed June 23, 2010; effective July 28, 2010. Amended: Filed January 20, 2012; effective February 24, 2012. Amended: Filed October 21, 2013; effective November 25, 2013.

Ala. Admin. Code r. 420-4-5-.03 Healthcare Data Advisory Council Responsibilities

The Advisory Council shall review and serve as consultants to ADPH on all matters pertaining to the collection and reporting of HAI rates including the cost of providing this information.

(a) Specifically, the Advisory Council shall assist in activities such as the development of reporting categories, the corresponding definitions and the development of reports, both internal and to the public.

(b) The Advisory Council shall review and approve any amendments to the rules and regulations, or policies and procedures, on healthcare facility infection reporting.

(c) All meetings of the Advisory Council shall be announced in advance and conducted pursuant to the Open Meetings Act, Code of Ala. 1975, §36-25A-1, et seq.

(d) A quorum shall be a majority of the appointed members of the Advisory Council.

(e) Voting by proxy shall not be allowed.

(f) The State Health Officer shall serve as chair of the Advisory Council, without a vote, except where there is a tie vote of the other members present at the meeting.

(g) The Advisory Council may appoint technical advisory committees. The technical advisory committee members do not have to be members of the Advisory Council.

(h) The Advisory Council shall meet at least annually to review reports, and may meet more often at the call of the chair, or upon written request of at least three members of the Advisory Council, to review and approve amendments to the rules and regulations.

History

• Author: Kelly M. Stevens, M.S.
• Authority: Code of Ala. 1975, §22-11A-113; 22-11A-119; 22-2-2(6).
• New Rule: Filed June 23, 2010; effective July 28, 2010.

Ala. Admin. Code r. 420-4-5-.04 Collection Methods

(1) ADPH shall establish a group NHSN account for healthcare facilities to join.

(2) Healthcare facilities shall report inpatient HAI data using the NHSN internet-based surveillance system and submit this information through the established ADPH group NHSN account. Healthcare facilities shall report HAI data monthly. Monthly reporting of HAI data shall be completed by midnight on the final day of the subsequent month.

History

• Author: Kelly M. Stevens, M.S., Nina C. Hassell, M.P.H.
• Authority: Code of Ala. 1975, §22-11A-113; 22-11A-119; 22-2-2(6).
• New Rule: Filed June 23, 2010; effective July 28, 2010. Amended: Filed November 19, 2010; effective December 24, 2010.

Ala. Admin. Code r. 420-4-5-.05 Risk Adjustment

ADPH shall develop policies and procedures, or protocols, or both, approved by the Advisory Council, to ensure that reported HAI data are risk adjusted to allow for comparisons between healthcare facilities and to reduce the possibility that reported data will be misleading.

History

• Author: Kelly M. Stevens, M.S., Nina C. Hassell, M.P.H.
• Authority: Code of Ala. 1975, §22-11A-113; 22-11A-119; 22-2-2(6).
• New Rule: Filed June 23, 2010; effective July 28, 2010.

Ala. Admin. Code r. 420-4-5-.06 Data Validation And Quality Assurance

(1) ADPH, with input from the Advisory Council, shall devise a method to quality check HAI reported data, and shall develop and test a data validation program. Methodologies for data validation shall be approved by the Advisory Council.

(2) Each healthcare facility shall utilize and maintain the NHSN data dictionary and coding schema contained in the NHSN Patient Safety Component Protocol of the National Healthcare Safety Network Manual which is adopted by reference in Rule 420-4-5-.02.

(3) The NHSN has several inherent validation checkpoints. ADPH shall monitor and assess the information, and provide operational guidance for healthcare facilities that target the detected issues.

(4) Healthcare facilities shall be open to site visits by ADPH to assure the timeliness of reporting and to cooperate in problem resolution.

History

• Author: Kelly M. Stevens, M.S., Nina C. Hassell, M.P.H.
• Authority: Code of Ala. 1975, §22-11A-113; 22-11A-119; 22-2-2(6).
• New Rule: Filed June 23, 2010; effective July 28, 2010.

Ala. Admin. Code r. 420-4-5-.07 Studies And Publications

(1) Reports and studies prepared and released by ADPH, and approved by the Advisory Council, based on healthcare facility HAI data shall be public information, and shall follow the privacy and confidentiality provisions as described in Rule 420-4-5.08.

(2) ADPH shall provide comparative HAI rates among healthcare facilities.

(3) ADPH shall allow all healthcare facilities that have submitted HAI data which will be used in any report to review and comment on the healthcare facility specific information prior to its publication or release for general public use.

(a) Comments of healthcare facilities shall be included, at the option of the healthcare facility, with information publically reported if it is not changed based upon those comments.

(b) Comments must be submitted in a format approved by ADPH and the Advisory Council within 45 days of the receipt of the report.

(4) ADPH shall prepare and publish reports providing comparative HAI rates for general public use at least annually. Reports may be produced electronically or in hard copy at the discretion of ADPH and the Advisory Council.

History

• Author: Kelly M. Stevens, M.S.
• Authority: Code of Ala. 1975, §22-11A-113; 22-11A-119; 22-2-2(6).
• New Rule: Filed June 23, 2010; effective July 28, 2010.

Ala. Admin. Code r. 420-4-5-.08 Privacy And Confidentiality

(1) Individual patient information submitted to ADPH shall not be public records and shall not be subject to discovery.

(2) ADPH shall not release the HAI data or any information obtained from the data in a form which could be used to identify a patient.

(3) ADPH shall develop policies and procedures, approved by the Advisory Council, addressing the release of HAI data to legitimate research organizations so that patient confidentiality and privilege protections are maintained.

(4) Individual patient data submitted to ADPH by healthcare facilities shall at all times remain confidential and privileged from discovery.

(5) All information and records acquired or developed shall be secured, have restricted access, and shall be maintained based on the policies established by the Advisory Council and ADPH.

History

• Author: Kelly M. Stevens, M.S.
• Authority: Code of Ala. 1975, §22-11A-113; 22-11A-119; 22-2-2(6).
• New Rule: Filed June 23, 2010; effective July 28, 2010.

Ala. Admin. Code r. 420-4-5-.09 Penalties

(1) The willful and intentional failure of a healthcare facility to comply with the HAI reporting requirements of these rules may result in the imposition of a civil monetary penalty not to exceed $5,000 per violation.

(a) Willful and intentional failure to comply with the reporting requirements of these rules includes the following:

1. Failure to submit required data by the deadline set forth in these rules, followed by the facility’s failure to submit the data within sixty days of being notified by ADPH of the overdue submission, and

2. Deliberate falsification of data submitted.

(b) A healthcare facility may appeal the assessment of a civil penalty by requesting a hearing that shall be held in accordance with the Board’s Rules for Hearing of Contested Cases, Ala. Admin. Code, Chapter 420-1-3, and the Alabama Administrative Procedure Act, Code of Ala. 1975, §41-22-1, et seq.

(2) All civil monetary penalties collected shall be deposited into the General Fund.

History

• Author: Kelly M. Stevens, M.S.
• Authority: Code of Ala. 1975, §22-11A-113; 22-11A-119; 22-2-2(6).
• New Rule: Filed June 23, 2010; effective July 28, 2010.

Ala. Admin. Code r. 420-4-5-.10 Force Or Effect

These rules shall no longer have any force or effect and shall not be enforceable after ADPH determines that there has been an enactment of a United States government program for collecting and disseminating HAI data which mandates, at a minimum, the reporting, collection, and dissemination of the same categories of data required in Rule 420-4-5-.02.

History

• Author: Kelly M. Stevens, M.S.
• Authority: Code of Ala. 1975, §22-11A-113; 22-11A-119; 22-2-2(6).
• New Rule: Filed June 23, 2010; effective July 28, 2010.