(a)The ambulatory surgical center (ASC) shall make
a report of the following incidents to the Texas Health and Human
Services Commission (HHSC) [department]. An
incident report form shall be submitted to HHSC Complaint and Incident
Intake [A written letter of explanation with supporting
documents shall be mailed to the department] within 10 business
days of the incident. [The mailing address is Department of State
Health Services, Facility Licensing Group, Post Office Box 149347,
Austin, Texas 78714-9347.]
(1)The death of a patient while under the care of
the ASC;
(2)The transfer of a patient to a hospital;
(3)Patient development of complications within 24
hours of discharge from the ASC resulting in admission to a hospital;
and
(4)A patient stay exceeding 23 hours.
(b)On an annual basis, the ASC shall report the types
and numbers of procedures performed and the average length of stay
during the previous 12-month period. The report shall be made using
a form to be prescribed by the department.
(c)Any theft of drugs and/or diversion of controlled
drugs shall be reported to the local police agency, the Texas State
Board of Pharmacy, the Texas Department of Public Safety, and/or the
Drug Enforcement Administration, and HHSC [the Department
of State Health Services].
(d)An ASC that performs abortions shall comply with
the reporting requirements specified in the Texas Health and Safety
Code, Chapters 171 and 245, and Chapter 139 of this title.
(e)The ASC shall submit reports to the Department
of State Health Services [department] in accordance
with the reporting requirements in Texas Health and Safety Code, §98.103
and §98.1045 (relating to Reportable Infections and Reporting
of Preventable Adverse Events), and associated rules.
(f)Occurrences of fire in the ASC shall be reported
as specified under §135.41(a)(2) of this title (relating to Fire
Prevention and Protection) and §135.43(b)(6) of this title (relating
to Handling and Storage of Gases, Anesthetics, and Flammable Liquids).
(g)An ASC that donates human fetal tissue under Texas
Health and Safety Code, Chapter 173, shall submit an annual report
to the Health and Human Services Commission that includes, for
each donation, the specific type of fetal tissue donated
and the accredited public or private institution of higher learning
that received the donation. The ASC shall submit the annual report
no later than January 31st of the subsequent year.
The agency certifies
that legal counsel has reviewed
the proposal and found it to be within the state agency's legal authority
to adopt.
Filed with the Office
of the Secretary of State on November 6, 2020
TRD-202004718 Karen Ray
Chief Counsel
Department of State Health Services
Earliest possible date of adoption: December 20, 2020
For further information, please call: (512) 834-4591
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