20 CAR Part 51 — Rules Pertaining to the Health Facility Infection Disclosure Act of 2007

Chapter I

Subchapter B

Subpart 1

20 CAR § 51-101 Purpose {#sec-20-car-51-101 omnilex-key=us-ar-regs-official--title-20-part-51--20 CAR § 51-101}

20 CAR § 51-101. Purpose.

In addition to the purposes provided by the Health Facility Infection Disclosure Act of 2007, Arkansas Code § 20-9-1201 et seq., this part is promulgated to protect the public health and safety of patients in health facilities in the state.

20 CAR § 51-102 Definitions {#sec-20-car-51-102 omnilex-key=us-ar-regs-official--title-20-part-51--20 CAR § 51-102}

20 CAR § 51-102. Definitions.

As used in this part:

(1) "Department" means the Department of Health;

(2)(A) "Health facility" means any of the following facilities:

(i) A hospital, outpatient surgery center, public health center, or recuperation center, as those facilities are defined in Arkansas Code § 20-9-201; and

(ii) Any other facility determined to be a source of healthcare-associated infections and designated as such by the Department of Health.

(B) "Health facility" does not include:

(i) A physician's office unless the office is otherwise licensed as an outpatient surgery center; or

(ii) An establishment furnishing primarily domiciliary care;

(3) "Healthcare-associated infection" means a localized or systemic condition in a person that:

(A) Results from an adverse reaction to the presence of an infectious agent or a toxin of an infectious agent; and

(B) Was not present or incubating in the person at the time of admission to the health facility; and

(4) "National Healthcare Safety Network" means the secure internet-based data collection surveillance system managed by the Division of Healthcare Quality Promotion at the Centers for Disease Control and Prevention created by the center for accumulating, exchanging, and integrating relevant information on infectious adverse events associated with healthcare delivery.

20 CAR § 51-103 Responsibility - Health facility reports {#sec-20-car-51-103 omnilex-key=us-ar-regs-official--title-20-part-51--20 CAR § 51-103}

20 CAR § 51-103. Responsibility - Health facility reports.

(a) A health facility shall collect data on healthcare-associated infection rates for the following:

(1) Central line-associated bloodstream infections in an intensive care unit; and

(2) Other categories as provided under Arkansas Code § 20-9-1204(e) and 20 CAR § 51-104(e) herein.

(b)(1)(A) A health facility may voluntarily submit quarterly reports to the Department of Health on the health facility's healthcare-associated infection rates for any one (1) or more of the following healthcare-associated infections:

(i) The healthcare-associated infections specified in subsection (a) of this section; and

(ii) Any other healthcare-associated infections accepted by the department.

(B)(i) If a health facility elects to submit quarterly reports, the reports shall be submitted to the department:

(a) In a format prescribed by the department; and

(b) By April 30, July 31, October 31, and January 31 of each year.

(ii) Each quarterly report shall cover the immediately preceding calendar quarter.

(C) Data in the quarterly reports shall cover a period ending not earlier than one (1) month before the submission of the report.

(2) If the health facility is a division or subsidiary of another entity that owns or operates other health facilities, the quarterly report shall be for the specific division or subsidiary and not for the other entity.

(c) A health facility participating in the Centers for Medicare and Medicaid Services Hospital Inpatient Quality Reporting Program or its successor shall authorize the department to have access to the following information that the health facility submits to the National Healthcare Safety Network:

(1) The name of the health facility; and

(2) Any information submitted to the National Healthcare Safety Network in order to satisfy the requirements of the Hospital Inpatient Quality Reporting Program.

(d)(1) Any health facility participating in the National Healthcare Safety Network may authorize the department to have access to all or part of the information that the health facility submits.

(2) Any identifying information shared with the department shall be kept confidential and fully protected under the provisions of Arkansas Code § 20-9-1206 and 20 CAR § 51-107.

(e) The information contained in the National Healthcare Safety Network database and obtained by the department under this section:

(1) May be used by the department for surveillance and prevention purposes only; and

(2) Shall not be used for regulatory purposes.

20 CAR § 51-104 Advisory Committee on Healthcare Associated Infections {#sec-20-car-51-104 omnilex-key=us-ar-regs-official--title-20-part-51--20 CAR § 51-104}

20 CAR § 51-104. Advisory Committee on Healthcare Associated Infections.

(a) The Director of the Department of Health shall appoint an Advisory Committee on Healthcare Acquired Infections, including without limitation representatives of:

(1) Public and private hospitals, including representatives of hospitals with fewer than fifty (50) beds and representatives of hospitals with more than fifty (50) beds;

(2) Outpatient surgery centers;

(3) Direct-care nursing staff;

(4) Physicians;

(5) Infection-control professionals with expertise in healthcare-associated infections;

(6) Academic researchers; and

(7) At least one (1) representative of a consumer organization.

(b) The advisory committee shall assist the Department of Health in the development of all aspects of the department's methodology for collecting, analyzing, and disclosing the data collected under Arkansas Code § 20-9-1201 et seq., including without limitation:

(1) Collection methods;

(2) Formatting; and

(3) Methods and means for the release and dissemination of the data.

(c)(1) In developing the methodology for collecting and analyzing the infection-rate data, the department and the advisory committee shall consider existing methodologies and systems for data collection.

(2) Any data collection and analytical methodologies used shall be:

(A) Capable of being validated; and

(B) Based upon nationally recognized and recommended standards that may include those developed by the Centers for Disease Control and Prevention, the Centers for Medicare and Medicaid Services, the Agency for Healthcare Research and Quality, or the National Quality Forum.

(3) The proposed data collection and analysis methodology shall be disclosed for public comment before any public disclosure of healthcare-associated infection rates in an annual report under Arkansas Code § 20-9-1205.

(4)(A) The data collection and analysis methodology shall be presented to all health facilities in this state on or before September 1, 2008.

(B) The methodology may be amended based upon input from the health facilities.

(5)(A) The first voluntary quarterly report under Arkansas Code § 20-9-1203(b) shall be presented to the department on or before January 31, 2009.

(B) Health facilities may begin voluntarily reporting data on January 31, 2009, or at any time thereafter.

(d) The department and the advisory committee shall evaluate on a regular basis the quality and accuracy of health facility data reported under Arkansas Code § 20-9-1201 et seq. and the data collection, analysis, and dissemination methodologies used under Arkansas Code § 20-9-1201 et seq.

(e) After release of the second annual report published under Arkansas Code § 20-9-1205 and upon consultation with the advisory committee and with other technical advisors who are recognized experts in the prevention, identification, and control of healthcare-associated infections and the reporting of performance data, the department may add categories of infections to those set forth in Arkansas Code § 20-9-1203(a).

20 CAR § 51-105 Data collection and analysis methodology {#sec-20-car-51-105 omnilex-key=us-ar-regs-official--title-20-part-51--20 CAR § 51-105}

20 CAR § 51-105. Data collection and analysis methodology.

Upon recommendation of the Advisory Committee on Healthcare Associated Infections, the State Board of Health adopts the following data collection and analysis methodology:

The National Healthcare Safety Network (NHSN) Manual Patient Safety Component Protocol Division of Healthcare Quality Promotion National Center for Infectious Diseases Centers for Disease Control and Prevention Atlanta, GA, USA Last Updated January 2008

20 CAR § 51-106 Reports regarding healthcare-associated infections {#sec-20-car-51-106 omnilex-key=us-ar-regs-official--title-20-part-51--20 CAR § 51-106}

20 CAR § 51-106. Reports regarding healthcare-associated infections.

(a)(1)(A) In consultation with the Advisory Committee on Healthcare Acquired Infections, the Department of Health shall submit annually a report summarizing the health facility quarterly reports required under this part to the Chair of the House Committee on Public Health, Welfare, and Labor and the Chair of the Senate Committee on Public Health, Welfare, and Labor.

(B) No health facility-identifiable data shall be included in the annual report, but aggregate statistical data may be included.

(2) The department shall publish the annual report on the department's website.

(3) The first annual report shall be submitted and published on or before January 1, 2010.

(b) The annual report prepared by the department under Arkansas Code § 20-9-1201 et seq. regarding healthcare-associated infections shall be appropriately risk-adjusted.

(c) The annual report shall include an executive summary written in plain language that shall include without limitation:

(1) A discussion of findings, conclusions, and trends concerning the overall status of healthcare-associated infections in the state, including a comparison to previous years; and

(2) Policy recommendations of the department and the advisory committee.

(d) The annual report shall be made available to any person upon request.

(e) No health facility report or department disclosure shall contain information identifying a patient, employee, or healthcare professional in connection with a specific infection incident.

(f) No annual report or other department disclosure shall contain information that identifies or could be used to identify a specific health facility.

(g)(1) As part of the process of preparing the annual report, effective safeguards to protect against the dissemination of inconsistent, incomplete, invalid, inaccurate, or subjective health facility data shall be developed and implemented.

(2) These safeguards may include the exclusion of certain data or data from health facilities with a low volume of patients or procedures if the use of the data would skew the results reported.

(h) The department shall develop, with the assistance of the advisory committee, a process of regular and confidential feedback for health facilities regarding the data collected so that each health facility's data will be available to that health facility for its quality improvement efforts.

20 CAR § 51-107 Privacy and confidentiality {#sec-20-car-51-107 omnilex-key=us-ar-regs-official--title-20-part-51--20 CAR § 51-107}

20 CAR § 51-107. Privacy and confidentiality.

(a) It is the intent of the State Board of Health that a patient's right of confidentiality shall not be violated in any manner under this part.

(b) Social security numbers and any other information that could be used to identify an individual patient shall not be released under Arkansas Code § 20-9-1201 et seq.

(c) Except for the annual report that shall be a public document available to any person upon request, any data and materials collected or compiled by a health facility or obtained by the Department of Health under this part shall be exempt from discovery and disclosure to the same extent that records of and testimony before committees evaluating quality of medical or hospital care are exempt under Arkansas Code § 16-46-105(a)(1) and shall not be admissible in any legal proceeding.

(d) Data collected and reported under Arkansas Code § 20-9-1201 et seq., shall not be deemed to have established a standard of care for any purposes in a private civil litigation.

20 CAR § 51-108 Funding {#sec-20-car-51-108 omnilex-key=us-ar-regs-official--title-20-part-51--20 CAR § 51-108}

20 CAR § 51-108. Funding.

This part is contingent upon the appropriation and availability of funding necessary for the Department of Health to implement these provisions, and any requirements that actions be accomplished by a specific date shall be extended until the necessary funding is available.