Usrc Williamsville Dialysis

“IC-CLEAN/DIRTY;MED PREP AREA;NO COMMON CARTS CFR(s): 494.30(a)(1)(i) Clean areas should be clearly designated for the preparation, handling and storage of medications and unused supplies and equipment. Clean areas should be clearly separated from contaminated areas where used supplies and equipment are handled. Do not handle and store medications or clean supplies in the same or an adjacent area to that where used equipment or blood samples are handled. When multiple dose medication vials are used (including vials containing diluents), prepare individual patient doses in a clean (centralized) area away from dialysis stations and deliver separately to each patient. Do not carry multiple dose medication vials from station to station. Do not use common medication carts to deliver medications to patients. If trays are used to deliver medications to individual patients, they must be cleaned between patients. This Standard is not met as evidenced by: 32261 Based on observation, policy review, and interview, nursing staff do not ensure patient medications are secured. This has the potential for unauthorized access/tampering of patient medications. Findings include: Observation on 03/28/24 at 09:40 AM on the treatment floor revealed pre-draw heparin filled syringes labeled for Patient #17, #21, #22, and #23 that were placed on the back nursing station counter. The syringes were unsecured and not under the custody of staff. Review on 03/29/24 of the policy “Guidelines for Administration of medication,” last revised 02/2024 revealed medications will be locked in a cabinet or a medication fridge. Interview on 03/29/24 at 11:15 AM with Staff (A), Facility Administrator, and Staff (F), Area Clinical Coordinator, confirmed these findings.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [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-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 32261 Based on observation, policy review, and interview, staff do not clean and disinfect all contaminated surfaces at patient stations (Station #1, #2, #3, #4, #5, #6, #7, #8, #9, #10, #11 and #12). This lapse in disinfection places staff and patients at risk for the transmission of bloodborne pathogens and facility acquired infections. Findings include: Observation on 03/27/24 at 02:00 PM in the patient care unit at Station #11 revealed Staff (K), Patient Care Technician, and Staff (G), Licensed Practical Nurse, discontinued treatment for fistula Patient #12. They did not disinfect the sharps container or the biohazard waste bin that were brought into Station #11, prior to placing the container and bin back in a common area. At 02:25 PM at Station #5, Staff (G), Licensed Practical Nurse, initiated treatment for catheter Patient #8, but did not disinfect biohazard waste bin brought into Station #5, prior to placing the bin back in the common area. On 03/28/24 at 09:50 AM at Station #6, Staff (M), Registered Nurse, initiated treatment for catheter Patient #19, but did not disinfect biohazard waste bin brought into Station #6, prior to placing the bin back in the common area. Observation on 03/27/24 from 11:00 AM to 02:20 PM and on 03/28/23 from 09:00 AM to 12:30 PM in the patient care unit revealed that staff did not disinfect the garbage cans in Stations #1-#12 after each patient treatment. Review on 03/28/24 of the policy “Guidelines for Handling and Disposal of Infectious Medical Waste,” last revised 04/2023 revealed biohazard containers will be brought to the point of use (example: near chairside) to dispose of biohazard waste. (The policy does not include the need to disinfect the bins prior to returning to a common/storage area) Review on 03/28/24 of the policy “Disinfection and Cleaning of Dialysis Machine Equipment,” last revised 07/2023 revealed the disinfection procedure for cleaning/disinfecting the dialysis machine, the back counter, and the dialysis chair. (The policy does not include to disinfect garbage cans located in patient stations, between patient treatments). Interview on 03/29/24 at 11:15 AM with Staff (A), Facility Administrator, and Staff (F), Area Clinical Coordinator, confirmed these findings.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 32261 Based on policy review, medical record review, and interview, the facility does not ensure a registered nurse assesses the central venous catheter insertion site each hemodialysis treatment for three of three central venous catheter hemodialysis patients (Patients #8, #9 and #11). Lack of assessment has the potential to delay identification and treatment of a potential catheter infection or issue. Findings include: Review on 03/28/24 of policy “Dialysis Catheter Dressing Change Procedure” last revised 02/2023 revealed that the care of catheters will include an accurate assessment of the insertion site for signs/symptoms of infection and documentation of observations. Review on 03/28/24 of the treatment flowsheets for catheter Patient #8 on 03/11/24, 03/13/24, 03/18/24, 03/20/24, 03/22/24, and 03/25/24; Patient #9 on 03/08/24, 03/09/24, 03/15/24, 03/16/24, 03/18/24, 03/20/24, 03/22/24, 03/25/24, and 03/27/24; and Patient #11 on 12/12/23, 12/14/23, 12/16/23, 12/19/23, 01/20/24, 03/07/24, and 03/12/24 revealed no documentation that a registered nurse assessed the catheter insertion site. Interview on 03/29/24 at 11:15 AM with Staff (A), Facility Administrator, and Staff (F), Area Clinical Coordinator, verified these 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 document review and interview, the facility does not ensure that the water hardness is tested at the end of each treatment day. Findings include: Review on 03/28/24 of the document “Water Treatment Log PM,” dated 12/2023, 01/2024, 02/2024, and 03/2024 revealed that the water hardness testing was not performed after the last dialysis patient had ended treatment. Staff tested the water hardness prior to 07:00 PM 15 of 27 days in December 2023, 18 of 26 days in January 2024, 14 of 25 days in February 2024, and 12 of 22 days in March 2024. Interview on 03/28/24 at 10:30 AM with Staff (A), Facility Administrator, and Staff (F), Area Clinical Coordinator, indicated that the last patient treatment ends at 07:00 PM.”

“CARBON ADSORPTION-10 MINUTES EBCT CFR(s): 494.40(a) 5.2.5 Carbon adsorption: 10 min EBCT Refer to RD62:2001, 4.3.9 Carbon adsorption media: When granulated activated carbon is used as the adsorption medium ... each adsorption bed shall have an [empty bed contact time] EBCT of at least 5 minutes at the maximum product water flow rate (a total EBCT of at least 10 minutes). This Standard is not met as evidenced by: 16136 Based on observation, document review, and interview, the facility does not ensure that the carbon tank has an absorption empty bed contact time (EBCT- the amount of time water is in contact with the activated carbon in the tank) of at least five minutes at the maximum product water flow rate for a total empty bed contact time of 10 minutes. Failure to ensure the proper empty bed contact time is obtained may result in unsafe water being supplied to the dialysis patients. Findings include: Observation on 03/28/24 at 11:13 AM in the water room revealed that two carbon tanks were present. Each tank consisted of 5.5 cubic feet of carbon, providing for a total of 11 cubic feet of carbon. Review on 03/28/24 of the document “Daily Water Log AM,” revealed the water processed through the reverse osmosis unit (water filtration system) was nine gallons per minute. The total empty bed contact time was 9.1 minutes at the product water flow rate and did not reach the required total empty bed contact time of 10 minutes on 12/08/23, 12/14/23, 01/10/24, 01/30/24, and on 02/03/24. Interview on 03/28/24 at 10:40 AM with Staff (Q), 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 or that a rinse cycle has been performed before mixing another batch of acid solution. Findings include: Review on 03/28/24 of the policy “Dry Acid Mixing-Granuflo- #TM 03-05,” last revised 08/2021, indicated that the manufacturer’s recommendation is to change the filter after mixing six batches of acid solution and to perform a rinse cycle before mixing each batch of dry acid. Review on 03/28/24 of the document “Dry Acid Mixing-132 Gallon log,” dated from 11/03/23 to 02/03/24 revealed that the filter had been replaced on 11/03/23 and not again until 02/03/24, after the preparation of 19 batches of acid solution. No documentation was found to indicate the filter is changed after the preparation of six batches of acid and/or that the acid tank was rinsed prior to the mixing of the next new batch of acid solution. Interview on 03/28/24 at 04:30 PM with Staff (Q), Biomed Technician, verified these findings.”

“DIALYS PROPORT-MONITOR PH/CONDUCTIVITY CFR(s): 494.40(a) 5.6 Dialysate proportioning: monitor pH/conductivity It is necessary for the operator to follow the manufacturer’s instructions regarding dialysate conductivity and to measure approximate pH with an independent method before starting the treatment of the next patient. This Standard is not met as evidenced by: 16136 Based on policy review, document review, and interview, the facility does not ensure that an extended calibration is performed monthly on 3 of 3 Phoenix XL meters (meters #1, #2 and #3). Findings include: Review on 03/29/24 of the policy “Phoenix-Phoenix XL, Meter Cleaning and Calibration,” last revised 08/2020, indicated that the biomedical technician will perform extended range calibrations monthly. Review on 03/29/24 of the document “Monthly Phoenix XL Meter Logs,” April 2023 to March revealed that an extended monthly calibration was not performed for meters #1 and #2 in 05/2023, 07/2023, 08/2023 and 10/2023. Review on 03/29/24 of the document “Phoenix XL Meter AM Log” from 01/2024 through 03/2024 revealed that an extended calibration had not been performed for meter #3. Interview on 03/29/24 at 01:20 PM with Staff (Q), Biomed Technician, 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: 32261 Based on policy review, medical record review, and interview, staff do not act within their scope of practice. Specifically, licensed practical nurses and patient care technicians did not notify the registered nurse regarding changes in a patient’s condition and/or treatment prescription for two of four patients (Patient #10 and #11). Lack of notification can delay assessment, treatment, and has the potential for an adverse patient outcome. Findings include: Review on 03/28/24 of policy “Reportable Parameters to Charge Nurse,” last revised 01/2020 revealed that intra-dialysis issues to be reported to the charge nurse include, but not limited to, a systolic blood pressure reading of less than 90 and poor blood flows. Review on 03/28/24 of the treatment flowsheet for Patient #10 (has a fistula access) dated 03/04/24 revealed that Staff (I), Patient Care Technician, decreased the blood flow rate to 250 and did not notify the registered nurse. The ordered blood flow rate was 450. Review on 03/28/24 of the treatment flowsheets for Patient #11 (has a catheter access) dated 12/16/23 revealed Staff (R), Patient Care Technician decreased the blood flow rate to 400. On 12/19/23, Staff (P), Licensed Practical Nurse, decreased the blood flow rate to 400. On 02/01/24, Staff (S), Patient Care Technician, decreased the blood flow rate to 250. There was no evidence the registered nurse was notified. The ordered blood flow rate was 450. Review on 03/28/24 of the treatment flowsheets for Patient #11 (has a catheter access) dated 01/30/24 revealed that Staff (G), Licensed Practical Nurse, administered 200 milliliters of normal saline due to a low blood pressure reading of 86/47. There was no evidence the registered nurse was notified. Interview on 03/29/24 at 11:15 AM with Staff (A), Facility Administrator, and Staff (F), Area Clinical Coordinator, verified these findings.”