Usrc Tonawanda Dialysis

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 34528 Based on policy review, observation, and interview, staff did not wear personal protective equipment (PPE) appropriately while performing procedures during which the spurting or spattering of blood might occur. Findings include: Review on 10/24/24 of the policy “Personal Protective Equipment,” last revised July 2023 and policy “Initiation of Dialysis Treatment,” last revised July 2024 revealed staff are to don (put on) full PPE includes gown, gloves and face shield or goggles with facemask during the initiation of treatment and full PPE are required for all staff during any procedure/activity where exposure to blood or other potentially infectious body fluids/infectious diseases is anticipated. Review on 10/24/24 of the policy “Accessing and De-Accessing the Dialysis Catheter,” last revised June 2024, indicated full PPE will be worn, including mask for staff and patient. Staff will assist the patient to don a mask. Observation on 10/22/24 at 11:45 AM at Station #12 for Patient #8 revealed Staff (K), Registered Nurse, initiated treatment via catheter, with the front of their PPE gown unsnapped/open and the face shield resting up on their forehead, not covering their eyes and nose. Observation on 10/22/24 at 03:40 PM Station #7 for Patient #10 revealed Staff (P), Registered Nurse, discontinued treatment via catheter. Patient #10’s mask was not covering their nose. Interview on 10/24/24 at 02:30 PM with Staff (H), Clinical Specialist, verified these findings.”

“IC-IF TO STATION=DISP/DEDICATE OR DISINFECT CFR(s): 494.30(a)(1)(i) Items taken into the dialysis station should either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. -- Nondisposable items that cannot be cleaned and disinfected (e.g., adhesive tape, cloth covered blood pressure cuffs) should be dedicated for use only on a single patient. -- Unused medications (including multiple dose vials containing diluents) or supplies (syringes, alcohol swabs, etc.) taken to the patient’s station should be used only for that patient and should not be returned to a common clean area or used on other patients. This Standard is not met as evidenced by: 34528 Based on policy review, observation, and interview, the staff do not ensure items taken into the hemodialysis station are cleaned and disinfected before being taken back to a common clean area to be used on another patient. Findings include: Review on 10/24/24 of the policy “Infection Control and Precautions for All Patients,” last revised July 2023 indicated items taken into the dialysis station will either be disposed of, dedicated for use only on a single patient, or cleaned and disinfected before being taken to a common clean area or used on another patient. Observation on 10/23/24 at 11:10 AM at Station #11 for Patient #7 revealed Staff (K), Registered Nurse entered the station with a container of Purell hand sanitizer gel. Staff (K) exited the station after initiating treatment and returned the Purell hand sanitizer to the common area in front of Station #11, without disinfecting. Interview on 10/24/24 at 02:30 PM with Staff (H), Clinical Specialist, verified these findings.”

“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: 40430 Based on observation, policy review, and interview, staff do not properly handle and/or dispose of potentially infectious waste. Findings include: Observation on 10/22/24 at 09:55 AM at Station #1 for Patient #1 revealed Staff (F), Patient Care Technician, removed both the venous and arterial needles from Patient #1 fistula and placed the needles on the chairside table while they applied a pressure dressing and clamp to each site, and did not immediately dispose the needles into the sharp’s container. Review on 10/24/24 of the policy “Termination of Dialysis Treatment,” revised April 2023, indicated to remove the fistula needle, engage safety device on the fistula needle as the needle is removed, and discard the needle in the sharps container at point of use. Cover site with gauze and apply pressure to occlude bleeding from site. Interview on 10/24/24 at 02:30 PM with Staff (G), Facility Administrator, and Staff (H), Clinical Specialist, verified this finding.”

“IC-ASEPTIC TECHNIQUES FOR IV MEDS CFR(s): 494.30(b)(2) [The facility must-] (2) Ensure that clinical staff demonstrate compliance with current aseptic techniques when dispensing and administering intravenous medications from vials and ampules; and This Standard is not met as evidenced by: 40430 Based on observation, policy review, document review, and interview, staff do not ensure expired medication and supplies are not available for use. Findings include: Observation on 10/22/24 at 10:55 AM in the medication refrigerator revealed a multi dose vial of Epogen (medication used to treat anemia) 20,000 units/two milliliters (ml) with no “opened on” date or staff initials written on the vial. At 11:00 AM on the common supply island/counter area across from Station #3 and #4 revealed a container of E-Z Check Blood Leak Test Strips bottle with an open date of 03/20/23 and expiration date of 05/31/24. Review on 10/24/24 of the policy “Preparation and Administration Erythropoietin-Stimulating Agents (group of medications used to treat anemia that stimulate the bone marrow to produce more red blood cells),” revised April 2021, indicated to check both the expiration date and the date of first puncture (opened on date) of the Epogen vial to ensure the medication has not expired. Multi dose vials of Epogen must be discarded 21 days after initial entry. Review on 10/24/24 of the E-Z Check Blood Leak Test Strips package insert/instructions indicated not to use a test strip (from an opened or unopened bottle) after the expiration date. Interview on 10/24/24 at 02:30 PM with Staff (G), Facility Administrator, Staff (H), Clinical Specialist, and Staff (E) Biomed Technician, verified this finding.”

“MIX SYS-DFU/MONITOR/PM/LOG/SANITIZE CFR(s): 494.40(a) 5.4.4.1 Mixing systems: follow DFU/monitor/PM/log/sanitization If a concentrate mixing system is used, the preparer should follow the manufacturer’s instructions for mixing the powder with the correct amount of water. If a concentrate mixing system is used, the number of bags or the weight of powder added should be determined and recorded. Manufacturer’s recommendations should be followed regarding any preventive maintenance and sanitization procedures. Records should be maintained indicating the date, time, person performing the procedure, and results (if applicable). 6.4.1 Mixing systems: Systems for preparing either bicarbonate or acid concentrate from powder should be monitored according to the manufacturer’s instructions. This Standard is not met as evidenced by: 16136 Based on policy review, document review, and interview, the facility does not ensure that the filter on the acid mixing system is changed after six batches of acid solution has been prepared. Findings include: Review on 10/23/24 of the policy “Dry Acid Mixing-Granuflo- #TM 03-05,” last revised 07/2024, indicated that the manufacturer’s recommendation is to change the filter after mixing six batches of acid solution. Review on 10/23/24 of the document “Dry Acid Mixing-132 Gallon log,” dated from 05/18/24 to 10/19/24, revealed that the filter had not been replaced on 05/11/24, 07/07/24 and/or 10/05/24. Interview on 10/23/24 at 10:30 AM with Staff (E), Biomed Technician, verified these findings.”

“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 the central bicarbonate system is disinfected weekly. Findings include: Review on 10/24/24 of the policy “TM 04-01-Disinfection Protocols for Bicarbonate mixers and Containers,” last revised 10/2023, indicated the central bicarbonate system will be disinfected with a 1:100 bleach solution on a weekly basis. Review on 10/24/24 of the “Central Bicarb Cleaning Log,” from 05/2024 through 09/2024 indicated disinfection of the central bicarbonate system was not performed the weeks of 05/26/24, 07/17/24 and 08/04/24. Interview on 10/24/24 at 09:30 AM with Staff (E,), Biomed 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 interview, the facility does not ensure a safe environment in the clinic setting for patients, staff, and the public. Specifically, two of two eye wash stations were not tested weekly for functionality. Findings include: Observations on 10/23/24 at 09:10 AM revealed there were two eye wash stations, one in the clinic area, and one in the storeroom where acid and bicarbonate solution is prepared. Review on 10/24/24 of the “Weekly Eye Wash Testing,” documentation from 06/2024 through 10/22/24 revealed the eye wash station in the clinic area was not tested for the weeks of 06/30/24, 07/14/24, 07/28/24, 09/08/24, and 10/13/24. The eye wash station in the storeroom was not tested for the weeks of 06/30/24, 07/14/24, and 07/28/24. The “Facility Guideline Institute - 2010 edition,” requires weekly testing of eye wash stations. Interview on 10/24/24 at 09:30 AM with Staff (E), Biomed Technician, verified this finding.”

“PE-EQUIPMENT MAINTENANCE-MANUFACTURER’S DFU CFR(s): 494.60(b) The dialysis facility must implement and maintain a program to ensure that all equipment (including emergency equipment, dialysis machines and equipment, and the water treatment system) are maintained and operated in accordance with the manufacturer’s recommendations. This Standard is not met as evidenced by: 16136 Based on observation, policy review, document review and staff interview, the facility does not ensure one of two pHoenix XL meters (Meter #1) is maintained and an extended calibration (calibration to verify and adjust high and low pH and conductivity value) is performed monthly on all pHoenix XL (a meter designed to quickly check the condctivity (a measure of a solution’s ability to conduct electricity), pH (a measure of acidity and alkalinity of a solution) and temperature (a measure of the average kinetic energy of the particles in an object, which is a type of energy associated with motion) of liquids. (Meters #1, and #2) Findings include: Observation on 10/23/24 at 02:00 PM in the clinic area at the sink where where the Super Station Assembly is located, revealed the syringe for Meter #1 was leaking when Staff (E), Biomed Technician, obtained a sample from the Care and Calibration Station. Review on 10/24/24 of the policy “TM 06-05 - Phoenix-Phoenix XL Meter Cleaning and Calibration,” last revised 08/2020, indicated “Level 1 and 2” calibrations will be performed monthly, and the results documented on the “Phoenix Meter Cleaning and Calibration Log.” Review on 10/23/24 of the “Monthly Phoenix XL Meter Log,” dated May 2024 through September 2024 revealed a Level 2 calibration was not performed on two of two meters (Meter #1 and #2) in 07/2024 and 08/2024. Interview on 10/23/24 at 03:15 PM with Staff (E), Biomed Technician,, verified this finding.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 34528 Based on policy review, medical record review, and interview, staff did not ensure dialysate flow rates were maintained per physician order for three of eight patients (Patient #16, Patient #17, and Patient #18). Findings include: Review on 10/24/24 of the policy “Intradialytic Monitoring of Patient,” last revised July 2024, indicated any variance from prescribed dialysate order requires documentation of reason. Review on 10/24/24 of the hemodialysis treatment flowsheets for Patient #16 from 10/07/24 to 10/22/24 revealed the prescribed dialysate flow rate of 600 ml/min was not maintained on 10/14/24. There was no documentation in the medical record indicating why the dialysate flow rate was not maintained. Review on 10/24/24 of the hemodialysis treatment flowsheets for Patient #17 dated 09/10/24 to 10/12/24 revealed the prescribed dialysate flow rate of 600 ml/min was not maintained on 10/12/24. There was no documentation in the medical record indicating why the dialysate flow rate was not maintained. Review on 10/24/24 of the hemodialysis treatment flowsheets for Patient #18 dated 09/28/24 to 10/19/24 revealed the prescribed dialysate flow rate of 800 ml/minute (min) was not maintained on 09/28/24. There was no documentation in the medical record indicating why the dialysate flow rate was not maintained. Interview on 10/24/24 at 02:30 PM with Staff (H), Clinical Specialist, verified these findings.”

“PQ-STAFF LIC AS REQ/QUAL/DEMO COMPETENCY CFR(s): 494.140 All dialysis facility staff must meet the applicable scope of practice board and licensure requirements in effect in the State in which they are employed. The dialysis facility’s staff (employee or contractor) must meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients. The dialysis facility’s staff must have the ability to demonstrate and sustain the skills needed to perform the specific duties of their positions. This Standard is not met as evidenced by: 34528 Based on policy review, medical record review, and interview, pre and/or post treatment assessments were not completed timely by a registered nurse for three of eight patients (Patient #14, Patient #15, and Patient # 18). Findings include: Review on 10/24/24 of the policies “Pre-Treatment Assessments of Patient,” and “Post Dialysis Assessment of Patient,” both revised January 2020, indicated pre dialysis nursing assessments will occur within the first hour of patient contact. Post dialysis assessments are performed by a registered nurse to address any issues prior to discharging a patient. Review on 10/24/24 of the hemodialysis treatment flowsheets for Patient #14 from 09/28/24 to 10/19/24 revealed on 10/15/24 treatment was initiated at 03:01 PM by a patient care technician. The registered nurse pre-treatment assessment was signed off as completed at 04:49 PM. The treatment was discontinued at 06:37 PM by a patient care technician and the registered nurse post treatment assessment was signed off as completed at 08:15 PM. Review on 10/24/24 of the hemodialysis treatment flowsheets for Patient #15 from 09/26/24 to 10/22/24 revealed on 10/12/24 treatment was discontinued by a licensed practical nurse at 11:25 AM. The registered nurse post dialysis assessment was signed off as completed at 03:28 PM. Review on 10/24/24 of the hemodialysis treatment flowsheets for Patient #18 from 09/28/24 to 10/19/24 revealed on 10/08/24 treatment was initiated at 02:21 PM by a patient care technician. The registered nurse pre- treatment assessment was signed off as completed at 04:56 PM. On 10/10/24 treatment was initiated at 02:48 PM by a licensed practical nurse. The registered nurse pre-treatment was signed off as completed at 04:04 PM. On 10/15/24, treatment was initiated on 02:27 PM by a patient care technician. The registered nurse pre-treatment assessment was signed off as completed at 06:26 PM. Interview on 10/24/24 at 02:30 PM with Staff (H), Clinical Specialist, verified these findings.Review on 10/24/24 of the hemodialysis treatment flowsheets for Patient #18 dated 09/28/24 to 10/19/24 revealed on 10/08/24 treatment was initiated at 02:21 PM by a patient care technician. The registered nurse pre- treatment assessment was signed off as completed at 04:56 PM. On 10/10/24 treatment was initiated at 2:48 PM by a licensed practical nurse. The registered nurse pre-treatment was signed off as completed at 04:04 PM. On 10/15/24, treatment was initiated on 02:27 PM by a patient care technician. The registered nurse pre-treatment assessment was signed off as completed at 06:26 PM. Interview on 10/24/24 at 02:30 PM with Staff (H), Clinical Specialist verified these findings.”