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RULE §117.19Exceptions to These Rules

(a) All ESRD facilities are required to maintain continuous compliance with these rules. The rules do not prohibit the request for temporary exceptions. These may include alternative concepts, methods, procedures, techniques, Food and Drug Administration (FDA) approved equipment, facilities during an emergency disaster situation, or for the conducting of pilot projects or research. Requests for temporary exceptions to these rules shall:

  (1) be submitted to the department in writing;

  (2) identify the specific rule for which an exception is requested;

  (3) describe in detail the specific circumstances which are believed by facility administration to justify the exception;

  (4) describe in detail what alternatives were considered, if any, and why alternatives (including compliance with the rule) were not selected;

  (5) demonstrate that the proposed exception is desirable to maintain or improve the health and safety of the patients, will not jeopardize patient health and safety, and will maintain patient access to care;

  (6) describe the proposed duration of the exception; and

  (7) requests for exceptions for facilities during emergency disaster situations shall be submitted to Health Facility Compliance Group of the Patient Quality Care Unit for the department:

    (A) may only be granted in an emergency situation for a maximum of 120 days, with a single renewal period for an additional 120 days;

    (B) the facility shall develop an action plan to resolve the staffing crisis situation;

    (C) the facility shall submit the action plan to the department not later than the 60th calendar day after the department grants the exception;

    (D) during the period of exception to staffing requirements, the facility shall monitor outcome data related to quality of care and report these outcomes on a monthly basis to the department; and

    (E) an exemption from clinical records for evacuees; except that the facility shall assess and document the hepatitis and tuberculosis status of the affected patient(s). The following items shall be obtained at a minimum:

      (i) patient's name, address, date of birth, payor information if available; and

      (ii) name, address, and telephone number of patient's usual dialysis facility.

(b) Requests for exceptions to the rules shall be submitted to the Facility Licensing Group, Regulatory Licensing Unit, Department of State Health Services, Mail Code 2835, P.O. Box 149347, Austin, TX 78714-9347.

(c) The department may conduct a survey and may consult with the medical review board (MRB) prior to approving an exception.

(d) Upon finding that the facility has satisfied the conditions of this rule, the department may grant an exception, to include the duration of the exception. The department will respond to a waiver request within 90 days.

(e) The facility may implement an exception only after written approval from the department.

(f) Granting of an exception is considered public information, is subject to disclosure, and may be posted on the department web site (http://www.dshs.state.tx.us/hfp/apps.shtm).

Source Note: The provisions of this §117.19 adopted to be effective July 6, 2010, 35 TexReg 5835

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