Texas Administrative Code › Title 25 - HEALTH SERVICES › Part 1 - DEPARTMENT OF STATE HEALTH SERVICES › Chapter 117 - END STAGE RENAL DISEASE FACILITIES › Subchapter F - CORRECTIVE ACTION PLAN AND ENFORCEMENT › Section 117.81 - Corrective Action Plan

Current through Reg. 49, No. 28; July 12, 2024
(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.