Current through Register Vol. 49, No. 9, September, 2024
Section 1:
Authority
These Rules are promulgated pursuant to the authority of Act
845 of 2007 as codified in Ark. Code Ann. §
20-9-1201 et
seq. and Ark. Code Ann. §
20-7-101
et seq.
Section 2:
Purpose
In addition to the purposes provided by the Act, these Rules
are promulgated to protect the public health and safety of patients in health
facilities in the State.
Section
3:
Definitions:
(1)
(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 §
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;
(2) "Healthcare-associated infection" means a
localized or systemic condition in a person that:
(A) Results from 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
(3) "Department"
means the Department of Health.
Section 4:
Responsibility
Health facility reports.
(a) A health facility shall collect data on
healthcare-associated infection rates for the following:
(1) Coronary artery bypass surgical site
infections;
(2) Total hip or knee
arthroplasty surgical site infections;
(3) Knee arthroscopy surgical site
infections;
(4) Hernia repair
surgical site infections;
(5)
Central line-associated bloodstream infections in an intensive care unit;
and
(6) Other categories as
provided under §
20-9-1204(e) and Section 5(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.
(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.
Section
5:
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
this subchapter, 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 §
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 §
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 this subchapter and the data collection, analysis, and
dissemination methodologies used under this subchapter.
(e) After release of the second annual report
published under §
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 §
20-9-1203(a).
Section 6:
Data Collection and
Analysis Methodology
Upon recommendation of the Advisory Committee on Healthcare
Associated Infections, the Arkansas 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
Section 7:
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 these Rules to the Chair of the House
Interim Committee on Public Health, Welfare, and Labor and the Chair of the
Senate Interim 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 this subchapter 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.
Section 8:
Privacy and
confidentiality.
(a) It is the intent
of the Arkansas State Board of Health that a patient's right of confidentiality
shall not be violated in any manner under these Rules.
(b) Social security numbers and any other
information that could be used to identify an individual patient shall not be
released under this subchapter.
(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 subchapter 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 §
16-46-105(aXD and shall not be
admissible in any legal proceeding.
(d) Data collected and reported under this
subchapter shall not be deemed to have established a standard of care for any
purposes in a private civil litigation.
Section 9:
Funding.
These Rules are 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.
Section 10:
Severability
If any provision of these Rules or the application thereof to
any health facility or circumstances is held invalid, such invalidity shall not
affect other provisions or applications and to this end the provisions hereto
are declared severable.
CERTIFICATION
This is to certify that the foregoing RULES PERTAINING
TO"THE HEALTH FACILITY INFECTION DISCLOSURE ACT OF 2007"were adopted by
the Arkansas State Board of Health at a regular session of said Board held on
July 23, 2009.
Paul Halverson, DrPH, FACHE Director and State Health Officer
Arkansas Department of Health
A copy of the forgoing Rules have been filed in my office, and
are hereby approved on the 4th day of August, 2009.
The Honorable Mike Beebe Governor
