Fmc - Freedom Center of Rochester

“PE-SAFE/FUNCTIONAL/COMFORTABLE ENVIRONMENT CFR(s): 494.60 The dialysis facility must be designed, constructed, equipped, and maintained to provide dialysis patients, staff, and the public a safe, functional, and comfortable treatment environment. This Standard is not met as evidenced by: 16136 Based on document review and interview, the facility does not ensure that the eye wash station is tested weekly for one of two months (April 2025). Findings include: Review of the “Emergency Eyewash Weekly Report,” revealed that the eye wash station was not tested the week of 04/13/25. Eye wash stations must be tested weekly for a minimum of three minutes to ensure that stagnant water flow(water that is not flowing or circulating) from the unit and the piping that is located behind the unit per ANSI (American National Safety Institute). Interview on 06/18/25 at 02:00 PM with Staff (E), Biomedical Technician, verified this finding.”

“PE-BUILDING-CONSTRUCT/MAINTAIN FOR SAFETY CFR(s): 494.60(a) The building in which dialysis services are furnished must be constructed and maintained to ensure the safety of the patients, the staff and the public. This Standard is not met as evidenced by: 16136 Based on document review and interview, the facility does not ensure that the sprinkler system is tested quarterly, that all components of the fire alarm are tested annually, and sensitivity testing is performed per NFPA 25 (National Fire Protection Association- 2011 ed.) on the fire alarm system. Findings include: Review of the “Wet Pipe Sprinkler System Inspection, Testing and Maintenance Reports,” from June 2024 to March 2025 revealed no evidence the sprinkler system was tested in the 3rd quarter of 2024. Review of the 6/25/24, 12/19/24 and 03/25/25 reports did not indicate the dates when the pressure gauges were last replaced, when the 5-year internal inspection was performed, and when the backflow device was last tested. The sprinkler system must be tested, maintained and inspected per NFPA 25 (National Fire Protection Association- 2011 ed.) to ensure the system’s proper operation in the event of an actual emergency. Review of the fire alarm system “Inspection Report,” 08/06/24 revealed the report did not indicate the magnetic door holders were tested, the date the secondary power supply (batteries) were installed in the fire alarm control panel, the voltage of the secondary power supply was disconnected from the primary power source, or when sensitivity testing was performed on the smoke heads per NFPA -72 , 2010 edition. Interview on 06/17/25 at 02:45 PM with Staff (B), Nurse Manager and on 06/18/25 at 01:40 PM with Staff (E), Biomedical Technician, verified these findings.”

“H-MONITOR H20 /DIALYSATE INC ON SITE EVAL CFR(s): 494.100(c)(1)(v) Services include, but are not limited to, the following: (v) Monitoring of the quality of water and dialysate used by home hemodialysis patients including conducting an onsite evaluation This Standard is not met as evidenced by: 16136 Based on document review and interview, the facility does not ensure that monthly water cultures are collected on the PAK (purifies water for home hemodialysis systems) or the SAK (bag of dialysate concentrate used for home hemodialysis treatments) on water samples for four of eight patients (Patients #18, #19, #20 and #21) for four of five months (January 2025 through May 2025). Findings include: Interview on 06/17/25 with Staff (B), Nurse Manager and Staff (P), Facility Administrator, indicated that water samples for the PAK and SAK are tested monthly, but the facility does not have a policy and could not provide the manufacturers manual for the PAK and SAK systems related to obtaining water cultures. Review of the document for “Water Cultures for the PAK and SAK,” 01/2025 to 05/2025 revealed no evidence water sample cultures were obtained for Patient #18 from January 2025 to March 2025; Patient #19 from January 2025 to February 2025; Patient #20 from January 2025 to February 2025; and Patient #21 for April 2025. Review of the online NxStage policy “Transitional Care Policies & Procedures,” no date, indicated the PAK is initially tested near the estimated end of PAK life and annually near the estimated end of PAK life to ensure AAMI (Association for the Advancement of Medical Instrumentation) specifications are met. Dialysate must be tested quarterly or more frequently to ensure the water and dialysate are within AAMI limits. (The online policy used to determine timeframes of testing as the facility does not have a policy and could not provide the manufacturers manual at the time of the onsite survey. Interview on 06/18/25 at 12:00 PM with Staff (E), Biomed Technician, verified these findings.”

“H-PRECONFIG HD SYS-TEST H20/DIALY PER DFU/FDA CFR(s): 494.100(c)(1)(v) Services include, but are not limited to, the following: testing of the water and dialysate system in accordance with- (A) The recommendations specified in the manufacturers’ instructions; and (B) The system’s FDA-approved labeling for preconfigured systems designed, tested, and validated to meet AAMI quality (which includes standards for chemical and chlorine/chloramine testing) water and dialysate. This Standard is not met as evidenced by: 16136 Based on policy review, document review, and interview, the facility does not ensure that chemical analysis of product water (sampling of water used for hemodialysis treatment) was performed quarterly. Findings include: Review of the policy “New York State Specific NxStage Pure Flow SL for Water Quality- Chemical,” published 05/02/22, indicated AAMI (Association for the Advancement of Medical Instrumentation) Chemical Analysis of product water would be tested quarterly. Review of the document “AAMI Chemical Analysis,” dated February 2025 and May 2025 revealed water samples were not collected for Patient #16 in February 2025, for Patient #17 in May 2025, and for Treatment Room #3 in May 2025. Interview on 06/18/25 at 12:00 PM with Staff (E), Biomedical Technician, verified these findings and stated that the facility collects AAMI water samples from product water every three months.”

“H-PROVIDE ORDERED SUPPLIES/EQUIPMENT CFR(s): 494.100(c)(1)(vi) Services include, but are not limited to, the following: (vi) Purchasing, leasing, renting, delivering, installing, repairing and maintaining medically necessary home dialysis supplies and equipment (including supportive equipment) prescribed by the attending physician. This Standard is not met as evidenced by: 16136 Based on document review, medical record review, and interview, for three of three patients reviewed, the facility does not ensure maintenance on the home dialysis equipment is performed (Patient #14, #15, and #16). Findings include: Review of the manufacturer’s recommendations for the “NxStage Hemodialysis Machine (a hemodialysis machine that filters blood outside the body to remove waste and excess fluid),” dated 09/09/15, indicated the blood leak detector must be cleaned monthly; the drain line must be flushed and disinfected monthly; the air filter must be cleaned or replaced quarterly; the prefilter must be replaced annually; and the sediment filter must be replaced annually. The manufacturer recommends that the PAK (filters and purifies water) be replaced every 12 weeks. Medical record review from February 2024 to June 2025 revealed no evidence that the routine maintenance for the following patients: -Patient #14- There was no evidence that the blood leak detector was cleaned monthly; the drain line was flushed monthly in March 2025 and April 2025; the air filter was cleaned/replaced quarterly; the sediment filter was replaced annually; and the PAK was not replaced every 12 weeks. -Patient #15- There was no evidence that the blood leak detector was cleaned monthly; the drain line was flushed monthly in March 2025 and April 2025; the air filter was cleaned/replaced quarterly; the sediment filter was replaced annually; and the PAK) was not replaced every 12 weeks. -Patient #16- There was no evidence of monthly and quarterly maintenance from 12/21/24 through 06/18/25, or that annual maintenance had been performed in 2024 or 2025. There was no evidence the PAC was replaced every 12 weeks. Interview on 06/18/25 at 02:45 PM with Staff (P), Facility Administrator, and Staff (M), Patient Care Technician verified these findings. Patients are responsible for performing weekly, monthly, quarterly, and annual routine maintenance on the NxStage Pure Flow SL home hemodialysis equipment.”