- (a) The medical review board (MRB) may assist the Texas Health and Human Services Commission (HHSC) in determining the corrective action required when the results of an inspection or an annual report indicate significant problems potentially impacting patient outcomes exist. At the conclusion of an on-site inspection, HHSC may refer an end stage renal disease 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 Texas Health and Safety Code §251.061 (relating to Corrective Action Plan).
- (1) HHSC may use a corrective action plan as an alternative to enforcement action under Texas Health and Safety Code §251.061.
(2) Before taking enforcement action, HHSC considers whether the use of a corrective action plan is appropriate. In determining whether to use a corrective action plan, HHSC considers whether:
- (A) the facility has violated Texas Health and Safety Code Chapter 251 (relating to End Stage Renal Disease Facilities), 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.
(c) HHSC may use a level one, level two, or level three corrective action plan, as determined by HHSC in accordance with this subsection, after inspection of the facility.
- (1) A level one corrective action plan is appropriate if HHSC finds the facility is not in compliance with Texas Health and Safety Code Chapter 251 or this chapter, but the circumstances are not serious or life-threatening. HHSC or a monitor may supervise the implementation of the plan.
- (2) A level two corrective action plan is appropriate if HHSC finds the facility is not in compliance with Texas Health and Safety Code Chapter 251 or this chapter and the circumstances are potentially serious or life-threatening, or if HHSC finds that the facility failed to implement or comply with a level one corrective action plan. HHSC or a monitor shall supervise the implementation of the plan. Supervision of the plan's implementation may include on-site supervision, observation, and direction. The facility is expected to comply with all HHSC requests, including supervision, observation, and direction, as requested by HHSC.
- (3) A level three corrective action plan is appropriate if HHSC finds that the facility is not in compliance with Texas Health and Safety Code Chapter 251 or this chapter and the circumstances are serious or life-threatening, or if HHSC finds that the facility failed to comply with a level two corrective action plan or cooperate with HHSC in connection with that plan. HHSC may require the appointment of a monitor to supervise the implementation of the plan, appointment of a temporary manager, or appointment of a monitor and temporary manager. Appointment of a temporary manager by agreement shall be in accordance with §507.88 of this subchapter (relating to Voluntary Appointment of a Temporary Manager). Involuntary appointment of a temporary manager shall be in accordance with §507.89 of this subchapter (relating to Involuntary Appointment of a Temporary Manager).
- (4) A corrective action plan is not confidential. Information contained in the plan may be exempted from required disclosure under Texas Government Code Chapter 552 (relating to Public Information) or other applicable law.
(5) HHSC approves 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 MRB member.
- (A) The monitor shall not be a current employee or former employee within the past two years of the dialysis organization or an affiliated facility.
- (B) The monitor's purpose is to observe, supervise, consult, and educate the facility and the facility's employees under a corrective action plan and bring the facility into substantial compliance with the regulations of this chapter and all other state and federal laws and regulations in as short a time as practicable.
- (C) The monitor shall report their findings no less than once a month to facility management, administrators, and HHSC to report goals and accomplishments and set forth further improvements needed in the facility. Monitors shall reduce their time spent in the facility to allow staff to practice what they have learned, to the point that continued monitoring is no longer necessary nor desired.
- (D) HHSC may conduct an on-site inspection to determine the facility's progress under the monitor's direction. HHSC staff inspects monitored facilities within six months after imposing a facility monitor to determine whether the facility must maintain the corrective action plan under which the monitor was placed.
- (E) The facility shall pay the cost of the monitor.
- (F) A facility shall not use a monitor who is currently acting as a full-time monitor for another facility under a corrective action plan.
- (G) A facility shall select a monitor and submit the monitor's resume for HHSC approval of the monitor. Once the facility selects and HHSC approves a monitor, the facility shall ensure only the approved monitor is used. The facility shall not allow a subcontractor to take the place of the approved monitor.
Source Note:The provisions of this §507.87 adopted to be effective December 23, 2025, 50 TexReg 8289.