Texas Administrative Code
Title 25 - HEALTH SERVICES
Part 1 - DEPARTMENT OF STATE HEALTH SERVICES
Chapter 117 - END STAGE RENAL DISEASE FACILITIES
Subchapter B - APPLICATION AND ISSUANCE OF A LICENSE
Section 117.18 - Inspections
Universal Citation: 25 TX Admin Code ยง 117.18
Current through Reg. 49, No. 38; September 20, 2024
(a) The department may conduct an inspection at any time to verify compliance with the statute or this chapter. By applying for or holding a license, the facility consents to entry and inspection of the facility by the department or representative of the department in accordance with the statute and this chapter.
(1) An
authorized representative of the department (surveyor) may enter the premises
of a license applicant or license holder at reasonable times during business
hours to conduct an on-site inspection incidental to the issuance of a license,
and at other times as the department considers necessary to ensure compliance
with:
(A) the statute or this
chapter;
(B) an order of the
commissioner;
(C) a court order
granting injunctive relief;
(D) a
corrective action plan; or
(E)
other enforcement action(s).
(2) The surveyor is entitled to access all
books, records, or other documents maintained by or on behalf of the facility,
interview patients and staff to the extent necessary to ensure compliance with
the statute, this chapter, an order of the commissioner, a court order granting
injunctive relief, a corrective action plan, or other enforcement action. The
department shall maintain the confidentiality of facility records as applicable
under federal or state law. Ensuring compliance includes permitting
photocopying by the department or providing photocopies to a department
surveyor of any records or other information by or on behalf of the department
as necessary to determine or verify compliance with the statute or this
chapter.
(b) Types of inspections.
(1) Construction inspection.
(A) The department shall conduct an
inspection to determine compliance with the spatial, physical plant, and system
requirements described in §
117.102
of this title (relating to Construction Requirements for a New End Stage Renal
Disease Facility), the requirements in §
117.31(a) and
(c) of this title (relating to Equipment),
and §
117.32(b)
and (c) of this title (relating to Water
Treatment, Dialysate Concentrates, and Reuse) prior to issuance of the initial
license.
(B) During any license
period, the department may conduct a construction inspection to determine
whether modifications or renovations comply with §
117.102
of this title.
(2) A
department surveyor may conduct an initial inspection after the date of
issuance of the initial license to determine if the facility meets the
requirements of the statute and this chapter. The initial inspection is an
evaluation of compliance with all requirements of the statute and this
chapter.
(3) At the department's
discretion, a department surveyor may perform an on-site inspection prior to
renewal of a facility license to verify compliance with the statute and this
chapter. The renewal inspection may include an evaluation of compliance with
all requirements of the statute and this chapter.
(4) The department surveyor shall perform an
inspection of a facility on site or by mail, if the facility has demonstrated
noncompliance with the statute or this chapter, or to investigate a complaint
received by the department.
(5)
After review of a facility's annual report, the department may request
additional information, or conduct an inspection by mail or on site to
determine compliance with the statute and this chapter.
(6) The department may conduct an inspection
incidental to an incident report as described in §
117.48 of this
title (relating to Incident Reports).
(7) A department surveyor shall perform an
inspection on site or by mail to verify completion of a corrective action
plan(s) for deficiencies cited during any of the inspections described in
paragraphs (1) - (6) of this subsection.
(c) Inspection procedures.
(1) The department's surveyor shall hold an
entrance conference with the person who is in charge of the facility prior to
commencing the inspection for the purpose of explaining the nature and scope of
the inspection.
(2) Except for the
purposes of conducting an inspection under subsection (b)(1), (4), (6), or (7)
of this section, an on-site inspection shall include an evaluation to determine
compliance with the statute and this chapter.
(3) Following an inspection of a facility the
surveyor shall hold an exit conference with the facility administrator or his
or her designee. During the exit conference, the surveyor shall:
(A) fully inform the facility representative
of the preliminary finding(s) of the inspection;
(B) inform the facility representative
regarding the preliminary finding(s) of the inspection of those circumstances
which are potentially serious, serious, or life-threatening;
(C) give the facility representative a
reasonable opportunity to submit additional facts or other information to the
surveyor in response to those findings before the surveyor exits the facility;
and
(D) identify any records that
were duplicated.
(4)
Written notice of findings.
(A) The surveyor
shall:
(i) prepare and provide the facility
administrator or his or her designee specific and timely written notice of the
findings in accordance with subparagraphs (B) and (C) of this paragraph;
and
(ii) if the findings result in
a referral described in §
117.81(a)
of this title (relating to Corrective Action Plan), the surveyor may submit a
written summary of the findings to the medical review board for its review and
recommendation for appropriate action by the department.
(B) If no deficiencies are found during an
inspection, the department shall provide a statement indicating this
fact.
(C) If the written notice of
findings includes deficiencies, the department and the facility shall comply
with the procedure set out in this subparagraph.
(i) The department shall provide the facility
with a statement of the deficiencies not later than the 10th working day after
the exit conference.
(ii) The
facility administrator or administrator's designee shall sign the written
statement of deficiencies and return it to the department with an acceptable
corrective action plan(s) for each deficiency no later than 10 working days of
the facility's initial receipt of the statement of deficiencies. The signature
does not indicate the administrator's or designee's agreement with deficiencies
stated on the form. If the corrective action plan(s) is not acceptable to the
department, the department shall notify the facility in writing and request
that the corrective action plan(s) be modified and resubmitted no later than 10
working days from the facility's receipt of such request.
(iii) The facility shall come into compliance
60 calendar days prior to the expiration date of the license or no later than
the dates designated in the corrective action plan(s), whichever comes
first.
(iv) The requirements in
clause (i) of this subparagraph do not apply if the surveyor's written notice
of findings results in a referral to the medical review board as described in
subparagraph (A)(ii) of this paragraph.
(v) A corrective action plan completion date
shall not exceed 45 calendar days from the date the deficiency(ies) is cited
(exit date of the survey).
(vi) The
facility may 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) The facility shall comply
with clause (ii) of this subparagraph regardless of its intent to challenge the
deficiency(ies).
(II) An initial
challenge to a deficiency(ies) shall be submitted in writing no later than five
working days from the facility's receipt of the statement of deficiencies to
the applicable zone office.
(III)
If the initial challenge is favorable to the department, the facility may
request a review of the initial challenge by submitting a written request to
the Director or his or her designee, Patient Quality Care Unit, Department of
State Health Services. The facility shall submit its written request for review
of the initial challenge no later than five working days from its receipt of
the department's response to the initial challenge. The department shall not
accept or review any documents that were not submitted with the initial
challenge. A determination by the director of the patient quality care unit
relating to a challenge to a deficiency(ies) is the department's final
determination concerning the challenge.
(IV) The department shall respond to any
written challenge submitted under subclause (II) or (III) of this clause no
later than 15 working days from its receipt.
(V) The department shall determine if a
written corrective action plan(s) is acceptable. If the corrective action
plan(s) is not acceptable to the department, the department shall notify the
facility in writing and request that the corrective action plan(s) be modified
and resubmitted no later than 10 working days from the facility's receipt of
such request.
(vii) If
the facility does not come into compliance by the required date of correction
reflected on the corrective action plan(s), the department may:
(I) appoint a monitor as described in §
117.81 of
this title (relating to Corrective Action Plan);
(II) appoint a temporary manager as described
in §
117.83
of this title (relating to Involuntary Appointment of a Temporary
Manager);
(III) propose to deny,
suspend, or revoke the license in accordance with §
117.84 of
this title (relating to Disciplinary Action);
(IV) assess an administrative penalty(ies) in
accordance with §
117.85
of this title (relating to Administrative Penalties); or
(V) take all of the actions described in
subclauses (I) - (IV) of this clause.
(viii) The department may verify the
correction of deficiencies by mail or on-site inspection.
(ix) Acceptance of a corrective action plan
does not preclude the department from taking enforcement action as appropriate
under §§
117.83,
117.84, or
117.85
of this title.
(x) The department
shall refer issues and complaints relating to the conduct of or action(s) by
licensed health care professionals to the appropriate licensing
board(s).
(d) Complaint against a department surveyor.
(1) An ESRD facility may register a complaint
against a Department of State Health Services surveyor who conducts an
inspection or investigation.
(2) A
complaint against a surveyor shall be registered with the Patient Quality Care
Unit, Department of State Health Services, Mail Code 1979, P.O. Box 149347,
Austin, Texas 78714-9347, telephone (512) 834-6650 or (888) 973-0022.
(A) A complaint against a surveyor which is
received by telephone will be referred not later than the second working day to
the appropriate supervisor. The caller will be requested to submit the
complaint in writing.
(B) When a
complaint is received in writing, it will be forwarded to the appropriate
supervisor not later than the second working day. Not later than the 10th
calendar day after the department receives the complaint, the department will
inform the complainant in writing that the complaint has been forwarded to the
appropriate supervisor.
(C) Not
later than the 10th calendar day after the supervisor receives the complaint,
the supervisor will notify the complainant in writing that an investigation
will be done.
(D) The supervisor
will review the documentation in the survey packet and interview the surveyor
identified in the complaint to obtain facts and assess the objectivity of the
surveyor in the surveyor's application of this chapter during the ESRD
facility's inspection or investigation.
(E) The supervisor will review the applicable
rules, personnel policies, and review the training and qualifications of the
surveyor as it relates to the inspection or investigation.
(F) The supervisor will document the
investigation. A report of the investigation will be placed in the ESRD
facility file if the complaint and investigation affected the inspection
process. A counseling form will be used and placed in the surveyor's personnel
file if the complaint relates to personnel performance.
(G) The supervisor shall offer to meet with
the complainant to resolve the issue. The surveyor identified in the complaint
will participate in the discussion. The resolution meeting may be conducted at
the division's office or during an on-site follow-up visit to the
hospital.
(H) Changes and deletions
will be made to the inspection report, if necessary.
(I) The supervisor will notify the
complainant in writing of the status of the investigation not later than the
30th calendar day after the date the supervisor received the
complaint.
(J) The supervisor will
forward all final documentation to the director of the Patient Quality Care
Unit and notify the complainant of the results.
Disclaimer: These regulations may not be the most recent version. Texas may have more current or accurate information. We make no warranties or guarantees about the accuracy, completeness, or adequacy of the information contained on this site or the information linked to on the state site. Please check official sources.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
