Fresenius Kidney Care - Newark

“IC-HANDLING INFECTIOUS WASTE CFR(s): 494.30(a)(4)(i) [The facility must demonstrate that it follows standard infection control precautions by implementing-] (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the- (i) Handling, storage and disposal of potentially infectious waste; This Standard is not met as evidenced by: 16136 Based on document review, observation, and interview, the facility does not ensure that the regulated medical waste was secured/covered in the regulated medical waste storage room. Findings include: Review of the service contact “Daniels Service Agreement,” dated 03/04/22, revealed the use of collection bins for regulated medical waste. The service contractor will remove the filled containers from the designated soiled utility room and replace the containers of equal size and quantity. Both parties agree to handle all waste in a safe, responsible manner, not jeopardizing human health and/or the environment. The customer will ensure the waste presented for collection will be properly segregated, packaged, and labeled. Observation on 02/12/25 at 01:50 PM in the regulated medical waste storage room, revealed that one of three large regulated medical waste containers was not covered. The lids available for covering the containers were approximately one to two inches too small and would not secure the contents when moved for disposal. Interview on 02/12/25 at 01:55 PM with Staff (E), Biomedical Technician, verified the above findings.”

“SOFTENERS: TESTING HARDNESS/LOG CFR(s): 494.40(a) 6.2.4 Softeners: Testing hardness/log Users should ensure that test accuracy and sensitivity are sufficient to satisfy the total hardness monitoring requirements of the reverse osmosis machine manufacturer. Total hardness of the water exiting the water softener should be measured at the end of each treatment day. Water hardness test results should be recorded in a water softener log. This Standard is not met as evidenced by: 16136 Based on observation, policy review, and interview, the facility does not ensure that the salt in the brine tank (used in the process of softening water) is half full of salt pellets or that the salt is above the water level. Findings include: Observation on 02/12/25 at 10:10 AM revealed the salt in the brine tank was below the water level. The salt filled approximately ¼ of the brine tank and the water was approximately ten inches above the salt pellets. Review of the policy “Water Softener,” published 05/03/23, indicated facility staff will monitor and document the water softener each operational day and check the brine tank daily to be sure the tank is at least half filled with salt. Salt levels inside the brine tank will be maintained at a minimum of half full. Interview on 02/12/25 at 10:20 AM with Staff (K), Licensed Practical Nurse, and at 11:00 AM with Staff (E), Area Technical Operations Manager, verified these findings.”

“HOT H20 DISINF SYS-MONITORING CFR(s): 494.40(a) 6.3.4 Bacterial control devices 6.3.4.3 Hot water disinfection systems: monitoring Hot water disinfection systems should be monitored for temperature and time of exposure to hot water as specified by the manufacturer. Also, hot water disinfection should be performed at least as often as recommended by the manufacturer. The temperature of the water should be recorded at a point farthest from the water heater-that is, where the lowest water temperature is likely to occur ...and measured each time a disinfection cycle is performed. A record that verifies successful completion of the heat disinfection should be maintained. Successful completion is defined as meeting temperature and time requirements specified by the equipment manufacturer. This Standard is not met as evidenced by: 16136 Based on policy review, document review, and interview, the facility does not ensure the hot water return temperature is 85 degrees Celsius on the Central Water Plant (CWP- system to purify the water used for hemodialysis) has been obtained from the farthest point on the distribution loop (loop that provides purified water to each dialysis station) when hot water is utilized to disinfect the water system. Findings include: Review of the manufacturer recommendations “The 2012 Mar Cor Purification CWP 100, Model H/S, Revision B,” indicated the return hot water from the distribution loop from the farthest point should be 85 degrees Celsius. Review on 02/11/25 of the “CWP RO (reverse osmosis- process used to purify the water used for hemodialysis treatments) Log,” dated 11/2024 through 01/2025, revealed no documentation that the hot water temperature met or exceeded manufacturer’s recommendations when hot water was utilized to disinfect the water loop daily. Staff are not recording the hot water temperature daily: in 11/2024, the hot water temperature was recorded for 4 (four) of 26 days; in 12/2024, the hot water temperature was recorded for three of 27 days; and in 01/2025, the hot water temperature was recorded for three of 26 days. Interview on 02/11/25 at 11:15 AM with Staff (E), Biomed Technician, verified this finding.”

“BICARB CONC DISTRIB-WKLY DISINFECT/DWELL/CONC CFR(s): 494.40(a) 5.5.4 Bicarbonate concentrate distribution systems: weekly disinfection/dwell times/conc Bicarbonate concentrate delivery systems should be disinfected on a regular basis to ensure that the dialysate routinely achieves the level of bacteriological purity [required by these regulations]. For piped distribution systems, the entire system, including patient station ports, should be purged of bicarbonate concentrate before disinfection. Each patient station port should be opened and flushed with disinfectant and then rinsed; otherwise, it would be a “dead leg” in the system. Appropriate dwell times and concentrations should be used as recommended by the manufacturer of the concentrate system. If this information is not available, bleach may be used at a dilution of 1:100 and proprietary disinfectants at the concentration recommended by the manufacturer for disinfecting piping systems. 6.5 Concentrate distribution: The interval between disinfection should not exceed 1 week. If the manufacturer does not supply disinfection procedures, the user must develop and validate a disinfection protocol. This Standard is not met as evidenced by: 16136 Based on policy review, document review, and interview, the facility does not ensure that all points of use (points where bicarbonate solution is utilized) on the bicarbonate loop (system to supply machines with bicarbonate) are tested for the presence of chemical disinfectant after disinfection and are not allowing the disinfectant to dwell in the bicarbonate loop for one hour to ensure proper disinfection occurs. Findings include: Review of the operator’s manual “Dual Tank Mix & Delivery Bicarb System,” effective 12/29/17, indicated for the disinfection of the bicarbonate loop, the recommended total contact time (time the disinfectant is left in the bicarbonate loop) is one hour (dwell time). The contact time begins at the time the disinfecting solution was introduced into the system. Review on 02/11/25 of the “Bicarb Mixer with Loop Disinfect Log,” for 11/2024, 12/2024, and 01/2025, revealed no documentation staff verified whether disinfectant was detected or not at all points of use on the bicarbonate loop (each station, in the tech room and any other location where bicarbonate solution is utilized from the diatribution system). Staff were only testing at the mixing tank and the loop return. Additionally, on 11/2024 to 01/2025 the log indicated staff documented a disinfectant dwell time of five minutes before rinsing the loop, instead of one hour. Interview on 02/12/25 at 09:40 AM with Staff (E), Biomedical Technician, verified this finding.”

“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 observation, document review and staff interview, the facility is not maintained to provide dialysis patients, staff, and the public a safe and functional treatment environment. Specifically, five of five emergency eye wash stations were not tested weekly; the temperature of eyewash #2 was not within a safe temperature range; the emergency drench shower was not tested weekly; full and empty oxygen tanks were not stored separately; there was no hot water at the medication counter; and there was not adequate separation around the hot water tank and the electrical panel box. Additionally, the electrical panel and/or the room containing the electrical panel was not secure. Findings include: Review on 02/12/25 of the “Emergency Eyewash Log,” from 11/2024 through 02/08/25, revealed five of five eyewash stations were not tested the week of 11/03/24, 12/08/25 and 02/02/25. Observation on 02/12/25 at 01:15 PM of emergency eyewash #2 revealed a water temperature of 112.6 degrees Fahrenheit. Emergency eyewash stations must maintain a tepid water temperature of 60-100 degrees Fahrenheit per ANSI (American National Standards Institute), Z328.1. Interview on 02/12/25 at 01:27 PM with Staff (K), Licensed Practical Nurse, verified this finding. Review on 02/12/25 of the Emergency Drench Shower Log, from 11/2024 through 02/08/25, revealed the emergency drench shower was not tested the week of 11/03/24 and 12/22/24. Weekly testing is required per ANSI (American National Standard Institute) Z328.1. Observation on 02/10/25 at 10:40 AM at the clean sink located in the patient care unit across from the Team One medication counter had no hot water. Hot water is required by NFPA 101, 2012 edition. Interview with Staff (F), Licensed Practical Nurse, verified this finding. Observation on 02/12/25 at 01:50 PM revealed three full and one empty oxygen tank were stored together on a rack adjacent/outside to the soiled utility room. These tanks must not be stored in the same racks and must have labeling indicating if the tanks are full or empty per NFPA 99 (National Fire Protection Association), 2012 edition. Observation on 02/12/25 at 01:20 PM in the biomedical work area revealed adequate separation was not maintained around the electrical panels or the propane-fueled hot water tank. A minimum clearance of three feet must be maintained around the electrical panels to ensure they are always readily available per NFPA 70. The electrical panels and/or the room were secured to prevent unauthorized access to the panels per NFPA 70 (National Fire Protection Association), 2011 edition. Observation on 02/12/25 at 01:30 PM revealed that adequate separation was not maintained around the propane-fueled hot water tank located in the BioMed work area. A minimum separation of at least 24 inches must remain clear in front (on the burner/controls side) according to NFPA 58.. Wood pallets and 30-35 cardboard boxes containing supplies, were stored adjacent to the water heater. Interview on 02/12/25 at 01:55 PM with Staff (E), Biomedical Technician, verified the above findings.”

“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, observation, and interview, the facility does not ensure the building was maintained to ensure the safety of patients, the staff and the public. Specifically, fire doors were not inspected annually and latch when closed; the sprinkler system was not tested quarterly; the mechanical exhaust was not operational; and specific load testing (percent of rated placed on the emergency generator) requirements for the emergency generator was not conducted. Findings include: Review on 02/10/25 of the “2024 Fire Inspection Reports,” revealed no evidence facility fire doors were inspected annually per National Fire Protection Agency (NFPA) 80, 2010 edition. Observation on 02/10/25 at 10:45 AM revealed the exit door, adjacent to Station #12, did not latch. The door must latch when closed according to NFPA 101, 2012 edition.. Review on 02/10/25 of the “2024 Dry Pipe Sprinkler Inspection, Testing, and Maintenance Reports,” revealed no evidence the sprinkler system was tested for the second quarter (April-June) of 2024. Quarterly testing is required by NFPA 25(National Fire4 Protection Association), 2011 edition. Observation on 02/12/25 at 01:25 PM in the soiled utility room and regulated waste room revealed that the mechanical exhaust was not operational according to NFPA 101, 2010 edition. The exhaust vent in the regulated medical waste room had a significant amount of debris. Review on 02/10/25 of the “Emergency Generator Preventative Maintenance Checklist,” dated 09/17/24, indicated a full load test was performed but the report does not indicate if the generator was tested at 25% load for 30 minutes, 50% load for one hour, and 75% load for 30 minutes according to NFPA (National Fire Protection Association) 110-2010 edition. Interview on 02/12/25 01:35 PM with Staff (E), Biomedical Technician, verified these findings.”

“PA-ASSESS CURRENT HEALTH STATUS/COMORBIDS CFR(s): 494.80(a)(1) The patient’s comprehensive assessment must include, but is not limited to, the following: (1) Evaluation of current health status and medical condition, including co-morbid conditions. This Standard is not met as evidenced by: 32261 Based on policy review, medical record review, and interview, in three of four medical records reviewed, the registered nurse (RN) post-treatment assessments were completed prior to termination of dialysis treatment (Patient #7, Patient #9, and Patient #19). Findings include: Review of the policy “Nursing Supervision and Delegation,” published 11/06/23, revealed prior to discharge, the RN must review the treatment record to confirm the patient is stable for discharge. Review on 02/11/25 of the medical record treatment flowsheets for Patient #7 from 01/15/25 to 02/07/25 revealed the RN post assessment was completed prior to the termination of treatment on 02/03/25. Review on 02/11/25 of the medical record treatment flowsheets for Patient #9 from 01/17/25 to 02/09/25 revealed the RN post assessment was completed prior to the termination of treatment on 01/31/25 and 02/05/25. Review on 02/11/25 of the medical record treatment flowsheets for Patient #19 from 01/15/25 to 02/08/25 revealed the RN post assessment was completed prior to the termination of treatment on 02/01/25 and 02/04/25. Interview on 02/12/25 at 10:00 AM with Staff (A), Director of Operations, and Staff (L), Nurse Manager, confirmed these findings.”