| (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. (b) The program shall reflect the complexity of the facility's organization and services involved. All facility services (including those services furnished under contract or arrangement); shall focus on indicators related to improved health outcomes and the prevention and reduction of medical errors. (c) The program shall include, but not be limited to, 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 the identification and reduction of medical errors. (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. The dialysis facility shall measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. Evidence shall support that aggregate patient data, including identification and tracking of patient infections, is continuously reviewed for trends. (e) Core staff members shall actively participate in the QAPI activities and monthly meetings. (f) Core staff members shall actively participate in QAPI meetings more often as necessary to identify or correct problems. The QAPI meetings shall be conducted separately from a patient plan of care conference and the meetings shall be documented. (g) The facility's QAPI program shall include: (1) an ongoing review of key elements of care using comparative and trend data to include aggregate patient data; (2) identification of areas where performance measures or outcomes indicate an opportunity for improvement; (3) appointment of interdisciplinary improvement team(s) to: (A) identify, measure, analyze, and track indicators for variation from desired outcomes; (B) create and implement improvement plan(s); (C) evaluate the implementation of the improvement plan(s); and (D) continue monitoring and improvement activities until resolution of the improvement plan. (4) establishment and monitoring of quality indicators related to improved health outcomes. 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 following indicators shall be measured, analyzed, and tracked on a monthly basis: (A) water quality (chemical, bacteriological analysis, and other indicators specific to the facility's water treatment system); (B) equipment preventive maintenance and repair; (C) reprocessing of hemodialyzers (dialyzer performance measures, labeling, and disinfection); (D) infection control (staff and patient screening; standard precautions; bacteriological monitoring of dialyzer(s), water, machine(s), and dialysate; pyrogen reactions; sepsis episodes; patient infections; and peritonitis rate); (E) adverse event; (F) vascular access; (G) reportable incidents as required to be reported under §117.48 of this title (relating to Incident Reports); (H) mortality (review of each death and monitoring modality specific mortality rate(s)); (I) complaints and suggestions (from patients, family, or staff); (J) staffing to include, but not limited to orientation, training, delegation, licensing and certification, and non-adherence to policies and procedures by facility staff; (K) safety (fire and disaster preparedness, use of a department approved reporting system, and disposal of special waste); (L) clinical records review to include dialysis treatment errors, and medication errors; (M) clinical outcomes (laboratory indicators, hospitalizations, vascular access complications, intradialytic complications, patient no-shows, patient non-adherence to the dialysis prescription, and transplantation); (N) patient's health-related quality of life surveys; and (O) involuntary transfer or discharge of a patient. (5) The dialysis facility shall continuously monitor the 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 the health and safety of patients. (h) The department shall review a facility's QAPI activities to determine compliance with this section. (1) A department surveyor shall verify that the facility has a QAPI program which addresses concerns relating to quality of care provided to its patients and that the core staff members have knowledge of and the ability to access the facility's QAPI program. (2) The department shall require disclosure of QAPI program records when disclosure is necessary to determine compliance with this section. |
