1. (a) A facility shall develop, implement, maintain, and evaluate an effective, ongoing, facility-wide, data-driven, interdisciplinary quality assessment and performance improvement (QAPI) program. The program shall be individualized to the facility and meet the criteria and standards described in this section.
2. (b) The program shall reflect the complexity of the facility's organization and services involved. All facility services (including services furnished under contract or arrangement), shall focus on indicators related to improved health outcomes and prevention and reduction of medical errors.
3. (c) The program shall include an ongoing program that achieves measurable improvement in health outcomes and reduction of medical errors by using indicators or performance measures associated with improved health outcomes and with identification and reduction of medical errors.
4. (d) The facility shall demonstrate that facility staff evaluate the provision of dialysis care and patient services, set treatment goals, identify opportunities for improvement, develop and implement improvement plans, and evaluate the implementation until resolution is achieved.
5. (e) The facility shall measure, analyze, and track quality indicators or other aspects of performance it adopts or develops that reflect processes of care and facility operations. The facility shall provide evidence to show that it continuously reviews aggregate patient data, including identifying and tracking patient infections for trends.

6. (f) Core staff members shall actively participate in the QAPI activities, including QAPI meetings.

   1. (1) A facility shall hold QAPI meetings monthly, or more often as necessary, to identify or correct problems.
   2. (2) A facility shall conduct QAPI meetings separately from a patient plan of care conference.
   3. (3) A facility shall document QAPI meetings.
   4. (4) A facility shall invite and encourage the facility patient representatives to attend QAPI meetings.

7. (g) The facility's QAPI program shall include:

   1. (1) an ongoing review of key elements of care using comparative and trend data to include aggregate patient data;
   2. (2) identifying areas where performance measures or outcomes indicate an opportunity for improvement, including review of the progress of End Stage Renal Disease (ESRD) Network Program and CMS assigned activities;

   3. (3) appointing interdisciplinary improvement teams to:

      1. (A) identify, measure, analyze, and track indicators for variation from desired outcomes;
      2. (B) create and implement improvement plans;
      3. (C) evaluate improvement plan implementation; and
      4. (D) continue monitoring and improvement activities until the improvement plan resolution; and
   4. (4) establishing and monitoring quality indicators related to improved health outcomes.

8. (h) For each quality assessment indicator, the facility shall establish and monitor a level of performance consistent with current professional knowledge. These performance components shall influence or relate to the desired outcomes themselves. At a minimum, the facility shall measure, analyze, and track monthly:

   1. (1) water quality (chemical, bacteriological analysis, and other indicators specific to the facility's water treatment system);
   2. (2) equipment preventive maintenance and repair;
   3. (3) reprocessing of hemodialyzers (dialyzer performance measures, labeling, and disinfection);
   4. (4) infection control (staff and patient screening; standard precautions; bacteriological monitoring of dialyzers, water, machines, and dialysate; pyrogen reactions; sepsis episodes; patient infections; and peritonitis rate);
   5. (5) adverse events;
   6. (6) vascular access;
   7. (7) reportable incidents as required to be reported under §507.56 of this subchapter (relating to Incident Reports);

   8. (8) mortality (review of each death and monitoring modality specific mortality rates);

      1. (A) complaints and suggestions (from patients, family, or staff);
      2. (B) staffing to include orientation, training, delegation, licensing and certification, and non-adherence to policies and procedures by facility staff;
      3. (C) safety (fire and emergency preparedness, use of a Texas Health and Human Services Commission (HHSC) approved reporting system, and disposal of special waste);
      4. (D) clinical records review to include dialysis treatment errors, and medication errors;
      5. (E) clinical outcomes (laboratory indicators, hospitalizations, vascular access complications, intradialytic complications, fluid management, patient no-shows, patient non-adherence to the dialysis prescription, and transplantation);
      6. (F) patient's health-related quality of life surveys; and
      7. (G) involuntary transfer or discharge of a patient.
   9. (9) The dialysis facility shall continuously monitor performance, take actions that result in performance improvement, and track performance to ensure that improvements are sustained over time. The facility shall immediately correct any identified problems that threaten health and safety of patients.

9. (i) HHSC may review a facility's QAPI activities to determine compliance with this section.

   1. (1) An HHSC inspector shall verify the facility has a QAPI program that addresses concerns relating to quality of care provided to its patients and the core staff members have knowledge of and the ability to access the facility's QAPI program.
   2. (2) HHSC requires disclosure of QAPI program records when disclosure is necessary to determine compliance with this section.

Source Note:The provisions of this §507.43 adopted to be effective December 23, 2025, 50 TexReg 8289.