| (a) General. An on-site inspection shall determine
if the requirements of the Act and this chapter are being met.
(1) An authorized representative of the commission
(surveyor) may enter the premises of a licensed abortion facility
at reasonable times during business hours and at other times as it
considers necessary to ensure compliance with:
(A) the Act and this chapter;
(B) an order of the executive commissioner;
(C) a court order granting injunctive relief; or
(D) other enforcement actions.
(2) The surveyor is entitled to access all books, records,
or other documents maintained by or on behalf of the facility to the
extent necessary to ensure compliance with the Act, this chapter,
an order of the executive commissioner, a court order granting injunctive
relief, or other enforcement action. The commission shall maintain
the confidentiality of facility records as applicable under federal
or state law. Ensuring compliance includes permitting photocopying
by a department surveyor or providing photocopies to a commission
surveyor of any records or other information by or on behalf of the
commission as necessary to determine or verify compliance with the
Act or this chapter.
(3) By applying for or holding a license, the facility
consents to entry and inspection of the facility by the commission
or representative of the commission in accordance with the Act and
this chapter.
(b) Inspection procedures.
(1) Except for purposes of an initial license application,
all on-site inspections shall be unannounced and conducted at least
annually. An on-site inspection for an initial license application,
in accordance with §139.23(c) of this title (relating to Application
Procedures and Issuance of Licenses), shall be scheduled with the
applicant.
(2) The commission's surveyor shall hold a conference
with the person who is in charge of a licensed abortion facility or
a facility subject to an application prior to commencing the inspection
for the purpose of explaining the nature and scope of the inspection.
The surveyor shall hold an exit conference with the person who is
in charge of the facility when the inspection is completed, and the
surveyor shall identify any records that were duplicated. Any original
facility records that are removed from a facility shall be removed
only with the consent of the facility.
(3) The commission's authorized representative shall
hold an exit conference and fully inform the person who is in charge
of the facility of the preliminary finding(s) of the inspection, and
shall give the person a reasonable opportunity to submit additional
facts or other information to the surveyor in response to those findings.
The response shall be made a part of the inspection for all purposes,
and shall be received by the commission within 14 calendar days of
receipt of the preliminary findings of the inspection by the facility.
(4) After the inspection is completed, the commission
shall provide the administrator of the facility specific and timely
written notice of the findings of the inspection in accordance with
paragraph (7) of this subsection.
(5) If the commission determines that the facility
is in compliance with minimum standards at the time of the on-site
inspection, the commission shall issue a license to the facility,
if applicable.
(6) If the surveyor finds there are deficiencies, the
commission shall provide the facility with a statement of the deficiencies;
the surveyor's recommendation for further action; or if there are
no deficiencies found, a statement indicating this fact.
(7) If the commission representative finds there are
deficiencies, the facility and the commission shall comply with the
following procedure.
(A) The commission shall provide the facility with
a statement of deficiencies on site at the time of the exit conference
or within 14 calendar days of the exit conference.
(B) The facility administrator or person in charge
shall sign the written statement of deficiencies and return it to
the commission with its plan of correction(s) for each deficiency
within 14 calendar days of its receipt of the statement of deficiencies.
The signature does not indicate the person's agreement with deficiencies
stated on the form.
(C) The facility shall have the option to challenge
any deficiency cited after receipt of the statement of deficiencies.
A challenge to a deficiency(ies) shall be in accordance with this
subparagraph.
(i) An initial challenge to a deficiency(ies) shall
be submitted in writing no later than 14 calendar days from the facility's
receipt of the statement of deficiencies to the Manager, Health Care
Quality, Health Facility Compliance Texas Health and Human Services
Commission, Post Office Box 149347, Austin, Texas 78714-9347. The
initial written challenge shall include any and all documents supporting
the facility's position.
(ii) If the initial challenge is favorable to the commission,
the facility may request a review of the initial challenge by submitting
a written request to the Director, Health Care Quality, Texas Health
and Human Services Commission, Post Office Box 149347, Austin, Texas
78714-9347. The facility shall submit its written request for review
of the initial challenge no later than 14 calendar days of its receipt
of the commission's response to the initial challenge. The commission
shall not accept or review any documents that were not submitted with
the initial challenge. A determination by the Director of Health Care
Quality, relating to a challenge to a deficiency(ies) shall be considered
the final determination by the commission.
(iii) The commission shall respond to any written challenge
submitted under clauses (i) or (ii) of this subparagraph no later
than 14 calendar days from its receipt.
(D) The commission shall determine if the written
plan of correction is acceptable. If the plan of correction(s) is
not acceptable to the commission, the commission shall notify the
facility and request that the plan of correction be modified by telephone
or resubmitted no later than 14 calendar days from receipt of such
request by the facility.
(E) If the facility does not come into compliance by
the required date of correction, the commission may propose to deny,
suspend, place on probation, or revoke the license in accordance with §139.32
of this title (relating to License Denial, Suspension, Probation,
or Revocation).
(F) Acceptance of a plan of correction by the commission
does not preclude the commission from taking enforcement action as
appropriate under §139.32 of this title.
(8) The commission shall refer issues and complaints
relating to the conduct or action(s) by licensed health care professionals
to their appropriate licensing boards.
(c) Complaints.
(1) In accordance with §139.50 of this title (relating
to Disclosure Requirements), all licensed abortion facilities are
required to provide the woman on whom the abortion is to be performed
and her guardian, if present, if the patient is a minor at time of
the initial visit or if guardianship is required, with a written statement
that complaints relating to the abortion facility may be registered
with the Manager, Health Care Quality, Health Facility Compliance,
Texas Health and Human Services Commission, Post Office Box 149347,
Austin, Texas 78714-9347, (888) 973-0022.
(2) The commission shall evaluate all complaints against
licensed abortion facilities. All complaints submitted to the commission
shall be in writing and signed by the complainant. Only those allegations
determined to be relevant to the Act or this chapter shall be authorized
for investigation. All information pertaining to a complaint is strictly
confidential.
(3) The commission or its authorized representative
may enter the premises of an abortion facility during normal business
hours as necessary to assure compliance with the Act and this chapter.
The investigation may be conducted on site, by phone or by mail.
(4) Conduct of the on-site investigation of a licensed
abortion facility shall include, but not be limited to:
(A) a conference prior to commencing the on-site investigation
for the purpose of explaining the nature and scope of the investigation
between the commission's authorized representative and the administrator
of the abortion facility, or his or her designee;
(B) an inspection of the facility;
(C) an inspection of medical records, personnel records,
administrative files, reports, other records, and/or working papers;
(D) an interview with any physician or other health
care practitioner, including abortion facility personnel who care
for the recipient of abortion services;
(E) a conference at the conclusion of the inspection
between the commission's representative and the administrator, or
his or her designee of the facility; and
(F) identification by the commission's representative
of any facility documents that have been reproduced.
(5) If the commission finds that there are deficiencies
following the on-site inspection, the provisions of subsection (b)(6)
and (7) of this section shall apply.
(6) The commission shall review the report of the investigation
and determine the validity of the complaint.
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