(a) The medical review board (MRB) may assist the department in determining the corrective action required when the results of an inspection or an annual report indicate that significant problems potentially impacting patient outcomes exist. At the conclusion of an on-site inspection, the department may refer a facility to the MRB if the results of the inspection present concerns related to patient outcomes. These facilities may be requested to provide additional information, or may be subject to an on-site inspection, corrective action plan, or enforcement action.
(b) A corrective action plan may be used in accordance with Health and Safety Code, §251.061. This subsection is consistent with Health and Safety Code, §251.061.
  (1) The department may use a corrective action plan as an alternative to enforcement action under the statute.
  (2) Before taking enforcement action, the department shall consider whether the use of a corrective action plan is appropriate. In determining whether to use a corrective action plan, the department shall consider whether:
    (A) the facility has violated the statute or this chapter and the violation has resulted in an adverse patient result;
    (B) the facility has a previous history of lack of compliance with the statute, this chapter, or a previously executed corrective action plan; or
    (C) the facility fails to agree to a corrective action plan.
  (3) The department may use a level one, level two, or level three corrective action plan, as determined by the department in accordance with this subsection, after inspection of the facility.
    (A) If deficiencies are identified after an inspection, the surveyor may request a corrective action plan. The surveyor shall identify the level of corrective action plan required.
    (B) The facility shall develop and implement a corrective action plan approved by the department. The facility shall provide the corrective action plan within the time frames specified by the department. A corrective action plan shall identify dates by which compliance will be accomplished. The dates by which compliance will be accomplished on a corrective action plan shall not exceed 45 days from the date the deficiency is cited.
    (C) The department shall review and approve the corrective action plan. If the corrective action plan is not acceptable, the department shall notify the facility of changes needed in order for the department to approve the plan.
    (D) The facility shall come into compliance within the time frames set out in the corrective action plan. The department will keep a corrective action plan in place as long as necessary or as long as it takes for the facility to come into compliance.
    (E) The department shall verify the correction of deficiencies by mail or on-site inspection.
    (F) Acceptance of a corrective action plan does not preclude the department from taking other enforcement action as appropriate under this subchapter.
  (4) A level one corrective action plan is appropriate, if the department finds that the facility is not in compliance with the statute or this chapter, but the circumstances are not serious or life-threatening. The department or a monitor may supervise the implementation of the plan.
  (5) A level two corrective action plan is appropriate, if the department finds that the facility is not in compliance with the statute or this chapter and the circumstances are potentially serious or life-threatening, or if the department finds that the facility failed to implement or comply with a level one corrective action plan. The department or a monitor shall supervise the implementation of the plan. Supervision of the implementation of the plan may include on-site supervision, observation, and direction.
  (6) A level three corrective action plan is appropriate, if the department finds that the facility is not in compliance with the statute or this chapter and the circumstances are serious or life-threatening, or if the department finds that the facility failed to comply with a level two corrective action plan or to cooperate with the department in connection with that plan. The department may require the appointment of a monitor to supervise the implementation of the plan, the appointment of a temporary manager, or the appointment of a monitor and temporary manager. Appointment of a temporary manager by agreement shall be in accordance with §117.82 of this title (relating to Voluntary Appointment of a Temporary Manager). Involuntary appointment of a temporary manager shall be in accordance with §117.83 of this title (relating to Involuntary Appointment of a Temporary Manager).
  (7) A corrective action plan is not confidential. Information contained in the plan may be excepted from required disclosure under the Government Code, Chapter 552 or other applicable law.
  (8) The department shall approve the monitor for a corrective action plan. The monitor shall be an individual or team of individuals and may include a professional with end stage renal disease experience or a member of the MRB.
    (A) The monitor may not be or include individuals who are current or former employees of the facility that is the subject of the corrective action plan or of an affiliated facility.
    (B) The purpose of the monitor is to observe, supervise, consult, and educate the facility and the employees of the facility under a corrective action plan.
    (C) The facility shall pay the cost of the monitor.

Source Note: The provisions of this §117.81 adopted to be effective July 6, 2010, 35 TexReg 5835