Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 133 - HOSPITAL LICENSING
Subchapter F - INSPECTION AND INVESTIGATION PROCEDURES
Section 133.101 - Inspection and Investigation Procedures
Universal Citation: 25 TX Admin Code ยง 133.101
Current through Reg. 49, No. 38; September 20, 2024
(a) Routine inspections. The Department of State Health Services (department) may conduct an inspection of each hospital prior to the issuance or renewal of a hospital license.
(1) A hospital is not
subject to routine inspections subsequent to the issuance of the initial
license while the hospital maintains:
(A)
certification under Title XVIII of the Social Security Act, 42 United States
Code (USC), §§1395 et seq; or
(B) accreditation by a Centers for Medicare
and Medicaid Services-approved organization.
(2) The department may conduct an inspection
of a hospital exempt from an annual licensing inspection under paragraph (1) of
this subsection before issuing a renewal license to the hospital if the
certification or accreditation body has not conducted an on-site inspection of
the hospital in the preceding three years and the department determines that an
inspection of the hospital by the certification or accreditation body is not
scheduled within 90 days.
(b) Complaint investigations.
(1) Complaint investigations are conducted if
the department finds that reasonable cause exists to believe that the hospital
has violated provisions of the Act, this chapter, special license conditions,
or orders of the commissioner of state health services
(commissioner).
(2) Complaints
received by the department concerning abuse and neglect, or illegal,
unprofessional, or unethical conduct will be conducted in accordance with
§
133.47(d)
of this title (relating to Abuse and Neglect Issues).
(3) Complaint investigations may be
coordinated with the federal Centers for Medicare and Medicaid Services and its
agents responsible for the inspection of hospitals to determine compliance with
the conditions of participation under Title XVIII of the Social Security Act,
(42 USC,
§§1395 et seq), so as to avoid
duplicate investigations.
(4)
Complaint investigations are unannounced.
(5) Following the investigation of a
complaint, the department shall notify the complainant if the complaint was
substantiated and if regulatory violations were identified.
(c) Reinspection.
(1) Reinspections may be conducted by the
department if a hospital applies for the reissuance of its license after the
suspension or revocation of the hospital's license, the assessment of
administrative or civil penalties, or the issuance of an injunction against the
hospital for violations of the Act, this chapter, a special license condition,
or an order of the commissioner.
(2) A reinspection may be conducted to
ascertain compliance with either health or construction requirements or
both.
(d) General.
(1) The department may make any inspection,
survey, or investigation that it considers necessary. A representative of the
department may enter the premises of a hospital at any reasonable time to make
an inspection or an investigation to ensure compliance with or prevent a
violation of the Act, the rules adopted under the Act, an order or special
order of the commissioner, a special license provision, a court order granting
injunctive relief, or other enforcement procedures. Ensuring compliance
includes permitting photocopying of any records or other information by or on
behalf of the department as necessary to determine or verify compliance with
the statute or rules adopted under the statute, except that the department may
not photocopy, reproduce, remove or dictate from any part of the root cause
analysis or action plan required under §133.48 of
this title (relating to Patient Safety Program).
(2) The department or a representative of the
department is entitled to access to all books, records, or other documents
maintained by or on behalf of the hospital to the extent necessary to enforce
the Act, this chapter, an order or special order of the commissioner, a special
license provision, a court order granting injunctive relief, or other
enforcement procedures. The department shall maintain the confidentiality of
hospital records as applicable under federal or state law.
(3) By applying for or holding a hospital
license, the hospital consents to entry and inspection or investigation of the
hospital by the department or a representative of the department in accordance
with the Act and this chapter.
(e) Inspection and investigation protocol.
(1) The department surveyor(s) shall hold a
conference with the hospital administrator or designee before beginning the
on-site inspection or investigation to explain the nature, scope, and estimated
time schedule of the inspection or investigation.
(2) Department surveyor(s) may conduct
interviews with any person with knowledge of the facts.
(3) The department surveyor(s) shall inform
the hospital administrator or designee of the preliminary findings of the
inspection or investigation and shall give the person a reasonable opportunity
to submit additional facts or other information to the department's authorized
representative in response to those findings.
(4) Following an inspection or investigation
of a hospital by the department, the department surveyor(s) shall hold an exit
conference with the hospital administrator or designee and other invited staff
and provide the following to the hospital administrator or designee:
(A) the specific nature of the inspection or
investigation;
(B) any alleged
violations of a specific statute or rule;
(C) identity of any records that were
duplicated;
(D) the specific nature
of any finding regarding an alleged violation or deficiency;
(E) if the deficiency is alleged, the
severity of the deficiency; and
(F)
if there are no deficiencies found, a statement indicating this fact.
(5) If deficiencies are cited, the
department surveyor(s) shall obtain either at the time of the exit conference
or within 10 days of the hospital's receipt of the statement of deficiencies a
plan of correction which is provided by the hospital and indicates the date(s)
by which correction(s) will be made and any other written comments, if any, by
the hospital administrator or designee concerning the inspection or
investigation. Additional facts, written comments, or other information
provided by the hospital in response to the findings shall be made a part of
the record of the inspection or investigation for all purposes.
(6) The department surveyor(s) shall obtain
the signature of the hospital administrator or designee acknowledging the
receipt of the statement of deficiencies and plan of correction form.
(7) The department surveyor(s) shall inform
the administrator or designee of the hospital's right to an informal
administrative review when there is disagreement with the surveyor's findings
and recommendations or when additional information bearing on the findings is
available.
(8) If deficiencies are
cited and the plan of correction is not acceptable, the department shall notify
the hospital in writing and request that the plan of correction be resubmitted
within 10 calendar days of the hospital's receipt of the department's written
notice. Upon resubmission of an acceptable plan of correction, written notice
shall be sent by the department to the hospital acknowledging same.
(9) Responses to the department may be
submitted by facsimile.
(10) The
hospital shall come into compliance by the completion date provided on the
statement of deficiencies and plan of correction form.
(11) The department shall verify the
correction of deficiencies either by mail or by an on-site inspection or
investigation.
(12) Acceptance of a
plan of correction does not preclude the department from taking enforcement
action under §
133.121 of
this title (relating to Enforcement Action).
(f) Release of information by the department.
(1) Upon written request, the department
shall provide information on the identity, including the signature, of each
department representative conducting, reviewing, or approving the results of
the inspection or investigation, and the date on which the department
representative acted on the matter.
(2) Upon written request, the department
shall release inspection documents in accordance with state and federal
law.
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