Geisinger Health System

“CFC-QAPI CFR(s): 494.110 This Condition is not met as evidenced by: 21832 Based on review of facility Quality assurance and performance improvement documentation (QAPI), and an interview with facility staff the facility failed to ensure documentation of an effective QAPI program for seven (7) of seven (7) months of QAPI documentation reviewed. 12/24-6/25 Findings Include: Cross Reference: 494.100 QAPI Scope, Service, Effectiveness 494.110 (a)(1) Tag V 0627 QAPI Ongoing uses indicators = improvements 494.110 (a) (2) (i) Tag V 0629 QAPI Indicator adequacy of dialysis 494.110(a) (2) (ii) Tag V 0630 QAPI Nutritional status 494.110(a) (2) (a)(2)(iii) Tag V 0631 QAPI Mineral metabolism/bone disease 494.110 (a) (2) (iv) Tag V 0632 Anemia 494.110 (a)(2)(v) QAPI Tag V 0633 Vascular access 494.110 (a) (2) (vi) QAPI Tag V 0634 Medical Injuries/errors 494.110 (a)(2)(ix) QAPI Tag V 0637 QAPI infection control trends 494.110 (c) QAPI Tag 0639 Prioritizing Improvement Activities”

“QAPI-COVERS SCOPE SERV/EFFECTIVE/IDT INVOL CFR(s): 494.110 The dialysis facility must develop, implement, maintain, and evaluate an effective, data-driven, quality assessment and performance improvement program with participation by the professional members of the interdisciplinary team. The program must reflect the complexity of the dialysis facility’s organization and services (including those services provided under arrangement), and must focus on indicators related to improved health outcomes and the prevention and reduction of medical errors. The dialysis facility must maintain and demonstrate evidence of its quality improvement and performance improvement program for review by CMS. This Standard is not met as evidenced by: 21832 Based on review of policies and procedures, facility Quality assurance documentation the facility failed to show evidence of a developed, implemented, maintained, and evaluated quality improvement and performance improvement program for seven (7) of seven (7) months of QAPI documentation. (12/24 through 6/25) Findings Include: Review of policies and procedures on 8/15/25 at approxiamtely 11:30 AM failed to reveal any policies related to QAPI Review of QAPI documntation on 8/15/25 at approximately 11:00 AM revealed the following: The clinic has both an in-patient and out-patient dialysis programs. The QAPI program did not separate the in-patient from the out-patient programs. There was no documentation the facility developed, implemented, maintained, and evaluated an effective, data-driven, quality assessment and performance improvement program that reflected the complexity of the dialysis facility’s organization and services (including those services provided under arrangement), and focused on indicators related to improved health outcomes and the prevention and reduction of medical errors. Additionally, the dialysis facility failed to maintain and demonstrate evidence of its quality improvement and performance improvement program . Interview on 8/15/25 from approximately 11:30 AM with the administrator confirmed the above findings”

“QAPI-ONGOING;USES INDICATORS=IMPROVEMENT CFR(s): 494.110(a)(1) The program must 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. This Standard is not met as evidenced by: 21832 Based on review of policies and procedures, facility Quality assurance and performance improvement documentation (QAPI), and an interview with facility staff the facility failed to ensure an their QAPI program included evidence of measurable improvement in health outcomes and reduction of medical errors for seven (7) of seven (7) months of QAPI documentation. (12/24 through 6/25) Findings Include: Review of policies and procedures on 8/15/25 at approximately 11:30 AM failed to reveal any policies related to QAPI Review of QAPI documentation on 8/15/25 at approximately 11:00 AM revealed the following: The clinic has both an in-patient and out-patient dialysis programs. The QAPI program did not separate the in-patient from the out-patient programs. Additionally there was no documentation of 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 for both the inpatient and outpatient populations receiving treatment. Interviews on 8/15/25 from approximately 9:30 AM through 11:30 AM with the regulatory performance improvement coordinator, GMC/Davita liason, administrator and director of quality and patient safety confirmed the above findings”

“QAPI-INDICATOR-ADEQUACY OF DIALYSIS CFR(s): 494.110(a)(2)(i) The program must include, but not be limited to, the following: (i) Adequacy of dialysis. This Standard is not met as evidenced by: 21832 Based on review of policies and procedures, facility Quality assurance and performance improvement documentation (QAPI), and an interview with facility staff the facility QAPI program failed to address the adequacy of dialysis for seven (7) of seven (7) months of QAPI documentation. (12/24 through 6/25) Findings Include: Review of policies and procedures on 8/15/25 at approximately 11:30 AM failed to reveal any policies related to QAPI Review of QAPI documentation on 8/15/25 at approximately 11:00 AM revealed the following: The clinic has both an in-patient and out-patient dialysis programs. The QAPI program did not separate the in-patient from the out-patient programs. Additionally there was no documentation the QAPI program addressed the adequacy of dialysis. Interviews on 8/15/25 from approximately 9:30 AM through 11:30 AM with the regulatory performance improvement coordinator, GMC/DaVita liason, administrator and director of quality and patient safety confirmed the above findings”

“QAPI-INDICATOR-NUTRITIONAL STATUS CFR(s): 494.110(a)(2)(ii) The program must include, but not be limited to, the following: (ii) Nutritional status. This Standard is not met as evidenced by: 21832 Based on review of policies and procedures, facility Quality assurance and performance improvement documentation (QAPI), and an interview with facility staff the facilities QAPI program failed to track and trend problems with patient nutritional status for seven (7) of seven (7) months reviewed. (12/24 through 6/25) Findings Include: Review of policies and procedures on 8/15/25 at approximately 11:30 AM failed to reveal any policies related to QAPI Review of QAPI documentation on 8/15/25 at approximately 11:00 AM revealed the following: The clinic has both an in-patient and out-patient dialysis programs. The QAPI program did not separate the in-patient from the out-patient programs. Additionally, there was no documentation the QAPI program addressed patient nutritional status Interviews on 8/15/25 from approximately 9:30 AM through 11:30 AM with the regulatory performance improvement coordinator, GMC/DaVita liason, administrator and director of quality and patient safety confirmed the above findings”

“QAPI-INDICATOR-CKD-MBD CFR(s): 494.110(a)(2)(iii) The program must include, but not be limited to, the following: (iii) Mineral metabolism and renal bone disease. This Standard is not met as evidenced by: 21832 Based on review of policies and procedures, facility Quality assurance and performance improvement documentation (QAPI), and an interview with facility staff the facilities QAPI program failed to track and trend patient mineral metabolism and renal bone disease for seven (7) of seven (7) months reviewed. (12/24 through 6/25) Findings Include: Review of policies and procedures on 8/15/25 at approximately 11:30 AM failed to reveal any policies related to QAPI Review of QAPI documentation on 8/15/25 at approximately 11:00 AM revealed the following: The clinic has both and in-patient and out-patient dialysis programs. The QAPI program did not separate the in-patient from the out-patient programs. Additionally, there was no documentation showing the QAPI program addressed patient mineral metabolism and bone disease. Interviews on 8/15/25 from approximately 9:30 AM through 11:30 AM with the regulatory performance improvement coordinator, GMC/DaVita liason, administrator and director of quality and patient safety confirmed the above findings”

“QAPI-INDICATOR-ANEMIA MANAGEMENT CFR(s): 494.110(a)(2)(iv) The program must include, but not be limited to, the following: (iv) Anemia management. This Standard is not met as evidenced by: 21832 Based on review of policies and procedures, facility Quality assurance and performance improvement documentation (QAPI), and an interview with facility staff the facilities QAPI program failed to track and trend anemia management for seven (7) of seven (7) months reviewed. (12/24 through 6/25) Findings Include: Review of policies and procedures on 8/15/25 at approximately 11:30 AM failed to reveal any policies related to QAPI Review of QAPI documentation on 8/15/25 at approximately 11:00 AM revealed the following: The clinic has both and in-patient and out-patient dialysis programs. The QAPI program did not separate the in-patient from the out-patient programs. Additionally, there was no documentation the QAPI program addressed anemia management Interviews on 8/15/25 from approximately 9:30 AM through 11:30 AM with the regulatory performance improvement coordinator, GMC/Davita liason, administrator and director of quality and patient safety confirmed the above findings”

“QAPI-INDICATOR-VASCULAR ACCESS CFR(s): 494.110(a)(2)(v) The program must include, but not be limited to, the following: (v) Vascular access. This Standard is not met as evidenced by: 21832 Based on review of policies and procedures, facility Quality assurance and performance improvement documentation (QAPI), and an interview with facility staff the facilities QAPI program failed to track and trend patient vascular accesses for patients with long standing catheters for seven (7) of seven (7) months reviewed. (12/24 through 6/25) Findings Include: Review of policies and procedures on 8/15/25 at approximately 11:30 AM failed to reveal any policies related to QAPI Review of QAPI documentation on 8/15/25 at approximately 11:00 AM revealed the following: The clinic has both and in-patient and out-patient dialysis programs. The QAPI program did not separate the in-patient from the out-patient programs. Additionally, there was no documentation the QAPI program addressed vascular access Interviews on 8/15/25 from approximately 9:30 AM through 11:30 AM with the regulatory performance improvement coordinator, GMC/DaVita liason, administrator and director of quality and patient safety confirmed the above findings”

“QAPI-INDICATOR-MEDICAL INJURIES/ERRORS CFR(s): 494.110(a)(2)(vi) The program must include, but not be limited to, the following: (vi) Medical injuries and medical errors identification. This Standard is not met as evidenced by: 21832 Based on review of policies and procedures, facility Quality assurance and performance improvement documentation (QAPI), and an interview with facility staff the facilities QAPI program failed to track and trend medical injuries and errors for seven (7) of seven (7) months reviewed. (12/24 through 6/25) Findings Include: Review of policies and procedures on 8/15/25 at approximately 11:30 AM failed to reveal any policies related to QAPI Review of QAPI documentation on 8/15/25 at approximately 11:00 AM revealed the following: The clinic has both and in-patient and out-patient dialysis programs. The QAPI program did not separate the in-patient from the out-patient programs. Additionally, there was no documentation the QAPI program addressed medical injuries and medical error identification Interviews on 8/15/25 from approximately 9:30 AM through 11:30 AM with the regulatory performance improvement coordinator, GMC/DaVita liason, administrator and director of quality and patient safety confirmed the above findings”

“QAPI-INDICATOR-INF CONT-TREND/PLAN/ACT CFR(s): 494.110(a)(2)(ix) The program must include, but not be limited to, the following: (ix) Infection control; with respect to this component the facility must- (A) Analyze and document the incidence of infection to identify trends and establish baseline information on infection incidence; (B) Develop recommendations and action plans to minimize infection transmission, promote immunization; and (C) Take actions to reduce future incidents. This Standard is not met as evidenced by: 21832 Based on review of policies and procedures, facility Quality assurance and performance improvement documentation (QAPI), and interviews with facility staff, the facilities QAPI program failed to track and trend infections and establish baseline information on infection incidence for seven (7) of seven (7) months reviewed. (12/24 through 6/25) Findings Include: Review of policies and procedures on 8/15/25 at approximately 11:30 AM failed to reveal any policies related to QAPI Review of QAPI documentation on 8/15/25 at approximately 11:00 AM revealed the following: The clinic has both and in-patient and out-patient dialysis programs. The QAPI program did not separate the in-patient from the out-patient programs. Additionally, there was no documentation the QAPI program analyzed and documented the incidence of infection to identify trends and establish baseline information on infection incidence Interviews on 8/15/25 from approximately 9:30 AM through 11:30 AM with the regulatory performance improvement coordinator, GMC/DaVita liason, administrator and director of quality and patient safety confirmed the above findings”

“QAPI-PRIORITIZING IMPROVEMENT ACTIVITIES CFR(s): 494.110(c) The dialysis facility must set priorities for performance improvement, considering prevalence and severity of identified problems and giving priority to improvement activities that affect clinical outcomes or patient safety. This Standard is not met as evidenced by: 21832 Based on review of policies and procedures, facility Quality assurance and performance improvement documentation (QAPI), and an interview with facility staff, the facility failed to set priorities for to improve activities that affect clinical outcomes or patient safety for seven (7) of seven (7) months reviewed. (12/24 through 6/25) Findings Include: Review of policies and procedures on 8/15/25 at approximately 11:30 AM failed to reveal any policies related to QAPI Review of QAPI documentation on 8/15/25 at approximately 11:00 AM revealed the following: The clinic has both and in-patient and out-patient dialysis programs. The QAPI program did not separate the in-patient from the out-patient programs. Additionally, there was no documentation the facility set priorities for performance improvement, considering prevalence and severity of identified problems and giving priority to improvement activities that affect clinical outcomes or patient safety. Interviews on 8/15/25 from approximately 9:30 AM through 11:30 AM with the regulatory performance improvement coordinator, GMC/DaVita liason, administrator and director of quality and patient safety confirmed the above findings”

“GOV-RESPONDS TO NW REQUEST/WORKS TOWARD GOALS CFR(s): 494.180(i) The governing body receives and acts upon recommendations from the ESRD network. The dialysis facility must cooperate with the ESRD network designated for its geographic area, in fulfilling the terms of the Network’s current statement of work. Each facility must participate in ESRD network activities and pursue network goals. This Standard is not met as evidenced by: 21832 Based on review of policies and procedures, facility documentation, and an interview with facility staff, the governing body failed to receive and act upon recommendations from the ESRD network. There was no documentation the facility participated in ESRD network activities or pursued network goals for (2) two of (2) years reviewed. (2023 & 2024) Findings Include: Review of policies and procedures on 8/15/25 at approximately 11:30 AM failed to reveal any policies related to the ESRD network Review of facility documentation on 8/15/25 at approximately 11:00 AM failed to reveal any documentation or communication regarding the ESRD network. Interview on 8/15/25 at approximately 11:30 AM with the facility administrator confirmed the above findings and revealed the facility did not know anything about the ESRD network or purpose for same.”