Davita Glen Raven Dialysis

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 32003 Based on policy review, observations, staff interview and personnel worksheet review, the facility staff failed to ensure patients performed hand hygiene for 2 of 2 AVF/G discontinuation observations for patients #5 and #13. The findings include: Review on April 3, 2025 of the facility’s policy, “INFECTION CONTROL FOR DIALYSIS FACILITIES” revised April 2023 revealed, “PURPOSE: ...NOTES: ...POLICY: ...HAND HYGEINE [space] 1. ...2. Patients and caregivers will be encouraged to [space] a. ...b. Perform hand hygiene after treatment before leaving treatment area. ...” 1. Observation on April 9, 2025 at 9:20 AM revealed, Patient #13 was located at dialysis station #17 as Technician #1 removed dialysis needles and the patient held manual pressure with a gloved hand. Observation revealed, hemostasis was achieved, the patient removed the glove and exited the in-center treatment area without performing hand hygiene. Interview on April 9, 2025 at about 2:00 PM with the Manager of Clinical Services revealed monthly infection control audits and OSHA safety audits were not available for review and concerns with hand hygiene had been identified but there was no monitoring oversight. 2. Observation on April 9, 2025 at 9:40 AM revealed, Patient #5 was located at dialysis station #19 as Technician #2 removed dialysis needles and the patient held manual pressure with a gloved hand. Observation revealed, hemostasis was achieved, the patient removed the glove and exited the in-center treatment area without performing hand hygiene. Interview on April 9, 2025 at about 2:00 PM with the Manager of Clinical Services revealed monthly infection control audits and OSHA safety audits were not available for review and concerns with hand hygiene had been identified but there was no monitoring oversight.”

“CARBON ADSORP-ACTION IF FIRST TEST + CFR(s): 494.40(a) 5.2.5 Carbon adsorption: action if first test positive When samples from the first sampling port are positive for chlorine or chloramine, operation may be continued for a short time (up to 72 hours) until a replacement bed is installed, provided that samples from the second sampling port remain negative. The replacement bed should be placed in the second position, and the existing second bed should be moved to the first position to replace the exhausted bed. If it is not possible to rotate the position of the beds, both beds should be replaced. This Standard is not met as evidenced by: 32003 Based on policy review, total chlorine log review and staff interviews, the facility staff failed to ensure chlorine testing was performed before patient treatment start time and within four hours for 1 of 2 months reviewed (March 2025). The findings include: Review on April 9, 2025 of the facility’s policy, “DAILY WATER SYSTEM TOTAL CHLORINE MONITORING” revised October 2024 revealed, “PURPOSE: ...NOTE: ...POLICY:.[space] 1. ...3. Total Chlorine testing is done on a daily basis prior to the use of dialysis quality water for any process and the start of dialysis treatment(s) and within every four (4) hours until all activities that require use of dialysis quality water are completed. ...” Review on April 8, 2025 of the March 2025 total chlorine log revealed on March 17, 2025 at 8:00 AM, the second total chlorine test was performed after patients’ treatment start times. On March 21, 2025 revealed the third and fourth total chlorine tests were not performed. Interview on April 8, 2025 at 11:30 AM with the FA revealed, the days and hours of operation were Monday, Wednesday, and Friday from 5:00 AM to 5:00 PM. The facility doors opened at 5:30 AM and the start time for treatment was 5:40 AM. Interview on April 8, 2025 at about 2:00 PM with the Manager of Clinical Services revealed, March 26, 2025 was the last audit performed and the same concerns were identified secondary to the transition of staff and lack of consistent leadership. Interview revealed that the Manager of Clinical Services and the Biomedical Technician audits occurred twice a year and the intent was to implement monitoring that was not being performed.”

“RO-MEETS AAMI/MONITORED, RECORDED ON LOG CFR(s): 494.40(a) 5.2.7 Reverse osmosis: meets AAMI/monitored/recorded on log Refer to RD62:2001, 4.3.7 Reverse osmosis: When used to prepare water for hemodialysis applications, either alone or as the last stage in a purification cascade, reverse osmosis systems shall be shown to be capable, at installation, of meeting the requirements of Table 1, when tested with the typical feed water of the user, in accordance with the methods of [AAMI] 5.2.2. 5.2.7 Reverse osmosis Users should carefully follow the manufacturer’s instructions for feed water treatment and monitoring to ensure that the RO is operated within its design parameters. 6.2.7 Reverse osmosis All results of measurements of RO performance should be recorded daily in an operating log that permits trending and historical review. This Standard is not met as evidenced by: 32003 Based on policy review, RO log reviews, personnel file review and staff interviews, the facility staff failed to ensure a licensed nurse verified the results and the completeness of the daily water monitoring log for 1 of 2 months reviewed (March 2025). The findings include: Review on April 9, 2025 of the facility’s policy, “DAILY WATER TREATMENT SYSTEM MONITORING” revised April 2025 revealed, “PURPOSE: ...POLICY: [space] 1. ...7. The initials and signature of the teammate performing and recording all observations and test results are entered where indicated on the Daily Water Treatment Log. A separate entry of time and initials is provided for the teammate performing end of day hardness testing. 8. A licensed nurse reviews the Daily Water Treatment Log for completeness and verifies that all parameters are within specified limits. ...” Review on April 8, 2025 of the RO log revealed that a licensed nurse failed to verify the results and the completeness of the log on March 4, 2025, March 6, 2025, March 7, 2025, March 14, 2025, and March 21, 2025. Additionally, the end of day hardness test was not performed on March 4, 2025. Review on April 8, 2025 revealed, documentation on the personnel worksheet had Nurse #1 as completed competencies on February 10, 2025 and water/dialysate training completed on February 3, 2025. Review of the personnel file revealed, the nurse had not completed procedural skills verification for water monitoring and testing. Interview on April 8, 2025 at about 2:00 PM with the Manager of Clinical Services revealed that the data was missing and education had been ongoing. Interview on April 9, 2025 at 3:20 PM with the Biomedical technician revealed that Nurse #1 did not have a procedural skill verification for the water treatment system because there may be [electronic learning] that still needed to be performed.”

“MIXING SYSTEMS-PERM RECORD/VERIF TEST CFR(s): 494.40(a) 5.4.4.1 Mixing systems: perm record/verification testing In addition to container labeling, there should be permanent records of batches produced. These records should include the concentrate formula produced, the volume of the batch, the lot numbers of powdered concentrate packages, the manufacturer of the powdered concentrate, the date and time of mixing, any test results, the person performing the mixing, the person verifying mixing and test results, and the expiration date (if applicable). 6.4.1 Mixing systems Acid and bicarbonate concentrates may be tested by using conductivity or by using a hydrometer. Concentrates should not be used or transferred to holding tanks or distribution systems until all tests are completed. The test results and verification that they meet all applicable criteria should be recorded and signed by the individuals performing the tests. This Standard is not met as evidenced by: 32003 Based on policy reviews, acid and bicarbonate log reviews, personnel file review, and staff interviews, the facility staff failed to ensure a second teammate provided a signature verification for the preparation and testing of the bicarbonate mixture for 2 of 2 months reviewed (February and March 2025), failed to ensure a licensed nurse provided a signature verification for the contents utilized for acid batch mixing for 1 of 2 month reviewed (March 2025), failed to ensure a licensed nurse provided a signature verification for the temperature and specific gravity of the mixed acid batch for 1 of 2 months reviewed (March 2025), and failed to document the time that the mixed acid batch was transferred to the holding tank for 2 of 2 months reviewed (February and March 2025). The findings include: Review on April 9, 2025 of the facility’s policy, “BETTER WATER-CENTRAL BICARB MIXING AND DELIVERY” originated July 2020 revealed, “Material required ...Procedure [space] Rational ...18. Document ....Secondary Teammate Verification Signature on the appropriate Bicarb Mixing Log. ...” Review on April 9, 2025 of the facility’s policy, “PREPARATION OF CITRIC COMPLETE TM CONCENTRATE WITH ROCKWELL® DAMX ACID CONCENTRATE MIXER” originated November 2024 revealed, “Material required ...Procedure [space] 1. ...13. Licensed nurse must verify that the complete contents of Citric Complete packages are added to the batch. ...Both teammate preparing the concentrate and the licensed nurse must sign the Citric Complete Batch Production Record where indicated. Once the temperature and specific gravity values are confirmed, and entered on the Batch Production Record, the solution is ready for use. ...” Review failed to reveal that the date and time with signature verification from the teammate and licensed nurse were required when the batch was transferred to the storage tank. 1. Review on April 8, 2025 of the bicarbonate mixing log revealed that the second teammate signature verification was not documented on February 21, 2025, March 7, 2025, March 14, 2025, March 19, 2025 and March 21, 2025. Review on April 8, 2025 revealed, documentation on the personnel worksheet had Nurse #1 as completed competencies on February 10, 2025 and water/dialysate training completed on February 3, 2025. The personnel file review revealed, the nurse had not completed procedural skills verification for water monitoring and testing. Interview on April 8, 2025 at about 2:00 PM with the Manager of Clinical Services revealed that the data was missing and education had been ongoing. Interview on April 9, 2025 at 3:20 PM with the Biomedical technician revealed that Nurse #1 did not have a procedural skill verification for the water treatment system because there may be [electronic learning] that still needed to be performed. 2. Review on April 8, 2025 of the “Citric Complete TM Batch Productive Record” revealed on February 12, 2025 and March 4, 2025, the time the acid batch was transferred to the storage tank was not documented. On March 17, 2025, the licensed nurse failed to provide a signature verification for the contents utilized for acid batch mixing and for the temperature and specific gravity for the acid batch that was mixed. On March 19, 2025, the licensed nurse failed to provide a signature verification for the contents utilized for acid batch mixing and the teammate along with the licensed nurse also failed to document the time the acid batch was transferred to the storage tank. Review on April 8, 2025 revealed, documentation on the personnel worksheet had Nurse #1 as completed competencies on February 10, 2025 and water/dialysate training completed on February 3, 2025. The personnel file review revealed, the nurse had not completed procedural skills verification for water monitoring and testing. Interview on April 8, 2025 at about 2:00 PM with the Manager of Clinical Services revealed that the data was missing and education had been ongoing. Interview on April 9, 2025 at 3:20 PM with the Biomedical technician revealed that Nurse #1 did not have a procedural skill verification for the water treatment system because there may be [electronic learning] that still needed to be performed.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 32003 Based on policy review, observations and staff interview, the facility staff failed to ensure post-treatment nursing assessments were performed for 4 of 4 patient treatment discontinuations (Patients #4, #9, #10 and #13) and failed to ensure the heparin infusion was set at the prescribed rate for 1 of 3 patient chairside treatment verifications (Patient #8). The findings include Review on April 9, 2025 of the facility’s policy, “PRE-INTRA-POST TREATMENT DATA COLLECTION, MONITORING AND NURSING ASSESSMENT” revised April 2024 revealed, “NOTE: ...PURPOSE: ...POLICY:[space] 1. ...2. The Nursing assessment will be performed and documented by a licensed nurse ...3. Patient identity, prescription and machine settings are verified by teammate prior to initiation of treatment ...The prescription components are confirmed by a licensed nurse within one (1) hour of treatment initiation ...Prescription components include but are not necessarily limited to: [space] a. ...j. Heparinization (intradialytic infusion setting) ...PRE-TREATMENT DATA COLLECTION ASSESSMENT ...INTRADIALYTIC DATA COLLECTION/ASSESSMENT ...POST TREATMENT DATA COLLECTION ASSESSMENT [space] 15. ...16. ...The licensed nurse will assess the patient prior to discharge. ...” 1. Observation on April 9, 2025 at 9:15 AM revealed Patient #4 was located at Station #13 as treatment discontinuation was in progress. Once the technician obtained vital signs and completed the necessary tasks for the CVC, the patient exited the treatment area without the nurse performing a post-treatment nursing assessment. Interview on April 9, 2025 at about 9:30 AM with Nurse #1 revealed, the nurse had been employed at the facility for about 4-weeks and according to training, the post-treatment nursing assessment at the facility was not required and only performed if certain parameters were not met. 2. Observation on April 9, 2025 at 9:20 AM revealed Patient #13 was located at Station #17 as treatment discontinuation was in progress. Once the technician obtained vital signs, dialysis needles removed and hemostasis was achieved, the patient exited the treatment area without the nurse performing a post-treatment nursing assessment. Interview on April 9, 2025 at about 9:30 AM with Nurse #1 revealed, the nurse had been employed at the facility for about 4-weeks and according to training, the post-treatment nursing assessment at the facility was not required and only performed if certain parameters were not met. 3. Observation on April 9, 2025 at 9:50 AM revealed Patient #9 was located at Station #15 as treatment discontinuation was in progress. Once the technician obtained vital signs and completed the necessary tasks for the CVC, the patient exited the treatment area without the nurse performing a post-treatment nursing assessment. Interview on April 9, 2025 at about 9:30 AM with Nurse #1 revealed, the nurse had been employed at the facility for about 4-weeks and according to training, the post-treatment nursing assessment at the facility was not required and only performed if certain parameters were not met. 4. Observation on April 9, 2025 at 10:5 AM revealed Patient #10 was located at Station #12 as treatment discontinuation was in progress. Once the technician obtained vital signs and completed the necessary tasks for the CVC, the patient exited the treatment area without the nurse performing a post-treatment nursing assessment. Interview on April 9, 2025 at about 9:30 AM with Nurse #1 revealed, the nurse had been employed at the facility for about 4-weeks and according to training, the post-treatment nursing assessment at the facility was not required and only performed if certain parameters were not met. 5. Observation on April 9, 2025 at 11:05 AM revealed, Patient #8 was located at Station #17 as treatment and heparin was infusing at 0.6 units per hour. Order review at the chairside revealed, the prescribed rate for heparin was 0.8 units per hour. Interview on April 9, 2025 at 11:05 with Nurse #1 at the chairside revealed, Patient #8 heparin rate was not set at the prescribed rate of 0.8 units per hour.”