Davita Irvington Dialysis

“CFC-PATIENT PLAN OF CARE CFR(s): 494.90 This Condition is not met as evidenced by: 37656 Based on review of medical records, facility document review, and staff interview, it was determined the facility failed to ensure 10 of 14 patients (Patients (P) 26, 27, 28, 29, 30, 31, 33, 34, 35, and 38), scheduled first and second shifts, on 7/10/24, achieved the prescribed dose of dialysis in accordance with the prescriber orders, during an unexpected delay in service during the treatment days. Cross Reference: 494.90 (a)(1) VTag 544 - PoC Achieve Adequate Clearance”

“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: 37656 Based on a review of facility documents and staff interview, it was determined that the facility failed to ensure that the staff verify that the conductivity is within its specified test range for bicarbonate concentrate per facility policy and procedure. Findings include: A review of the Bicarb (bicarbonate) Mix Log - Conductivity revealed the following: The log stated, “Bicarb mixing tank cond. [conductivity] test results B9 (Tank #1) or B10 (Tank #2) Range: 48-52” On 6/3/24, the log contained a conductivity test result of 52.6 and on 6/7/24 the result was 52.8. These results indicated a conductivity outside of normal range. The log did not indicate that the staff recalibrated the meter and did not test the solution again per the facility policy. On 2/28/25 at 12:20 PM, the log was reviewed with Staff (S) 4, Biomedical Technician. S4 stated that the staff should have recalibrated the Myron L 4P meter (the instrument used to measure conductivity) and then retest again. If the result was still outside range, the bicarb solution has to be discarded, and a new batch of bicarbonate has to be mixed. This has to be recorded in the Bicarb mix log. Facility policy titled, “Better Water-Central Bicarb Mixing and Delivery - Using Fresenius Naturalyte Bicarbonate Powder,” origination date: September 2017, stated, “... 14. Test sample of solution valve B9 with Myron L 4P meter for conductivity ... Record result on Bicarb mix log ... Conductivity will be used to check proper concentration (Conductivity range 48-52 mS [milliseconds]) Note: Verify Meter has been calibrated before use. ... If solution is outside established normal range, recalibrate meter and test again. ...””

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 37656 Based on review of medical records, facility document review, and staff interview, it was determined the facility failed to ensure that 10 of 14 patients (Patients (P) 26, 27, 28, 29, 30, 31, 33, 34, 35, and 38), scheduled first and second shifts, on 7/10/24, achieved the prescribed dose of dialysis in accordance with the prescriber orders, during an unexpected delay in service during the treatment days. Findings include: On 7/10/24, the facility had an interruption in hemodialysis treatments due to conductivity issue of the bicarbonate concentrate mix that affected the patient’s treatment times. On 2/27/25, a request for the “Treatment Details Report,” dated 7/10/24 for the following patients was requested: P25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, and 38. Upon review of the “Treatment Details Reports” for P26, 27, 28, 29, 30, 31, 33, 34, 35, and 38, treatments were shortened for the documented reason, “Patient Choice (AMA [against medical advice]).” A review of P26’s “Treatment Details Report” for 7/10/24 stated, “Dialysis Prescription ... Treatment Time 3h [hours] 15m [minutes] ... Post-Treatment Vitals ... Intradialytic ... Treatment Duration 2h 44m ... Closed Treatment Reason, Patient Choice (AMA, transportation, weather, has other appt [appointment]) ...” P26’s treatment ended 31 minutes earlier than the prescribed treatment time. A review of P27’s “Treatment Details Report” for 7/10/24 stated, “Dialysis Prescription ... Treatment Time 2h 30m (150 min) ... Post-Treatment Vitals ... Intradialytic ... Treatment Duration 1:37 (one hour and 37 minutes) ... Closed Treatment Reason, Patient Choice (AMA, transportation, weather, has other appt) ...” P27’s treatment ended 53 minutes earlier than the prescribed treatment time. A review of P28’s “Treatment Details Report” for 7/10/24 stated, “Dialysis Prescription ... Treatment Time 3h 15m ... Post-Treatment Vitals ... Intradialytic ... Treatment Duration 2h 45m ... Closed Treatment Reason, Patient Choice (AMA, transportation, weather, has other appt) ...” P28’s treatment ended 30 minutes earlier than the prescribed treatment time. A review of P29’s “Treatment Details Report” for 7/10/24 stated, “Dialysis Prescription ... Treatment Time 3h 30m ... Post-Treatment Vitals ... Intradialytic ... Treatment Duration 1h 44m ... Closed Treatment Reason, Patient Choice (AMA, transportation, weather, has other appt) ...” P29’s treatment ended 1 hour and 46 minutes earlier than the prescribed treatment time. A review of P30’s “Treatment Details Report” for 7/10/24 stated, “Dialysis Prescription ... Treatment Time 3h 30m ... Post-Treatment Vitals ... Intradialytic ... Treatment Duration 2h 52m ... Closed Treatment Reason, Patient Choice (AMA, transportation, weather, has other appt) ...” P30’s treatment ended 38 minutes earlier than the prescribed treatment time. A review of P31’s “Treatment Details Report” for 7/10/24 stated, “Dialysis Prescription ... Treatment Time 3h 30m ... Post-Treatment Vitals ... Intradialytic ... Treatment Duration 2h 50m ... Closed Treatment Reason, Patient Choice (AMA, transportation, weather, has other appt) ...” P31’s treatment ended 40 minutes earlier than the prescribed treatment time. A review of P33’s “Treatment Details Report” for 7/10/24 stated, “Dialysis Prescription ... Treatment Time 3h 0m ... Post-Treatment Vitals ... Intradialytic ... Treatment Duration 1h 58m ... Closed Treatment Reason, Patient Choice (AMA, transportation, weather, has other appt) ...” P33’s treatment ended 1 hour and 2 minutes earlier than the prescribed treatment time. A review of P34’s “Treatment Details Report” for 7/10/24 stated, “Dialysis Prescription ... Treatment Time 3h 45m ... Post-Treatment Vitals ... Intradialytic ... Treatment Duration 3h 7m ... Closed Treatment Reason, Patient Choice (AMA, transportation, weather, has other appt) ...” P34’s treatment ended 38 minutes earlier than the prescribed treatment time. A review of P35’s “Treatment Details Report” for 7/10/24 stated, “Dialysis Prescription ... Treatment Time 2h 30m ... Post-Treatment Vitals ... Intradialytic ... Treatment Duration 1h 17m ... Closed Treatment Reason, Patient Choice (AMA, transportation, weather, has other appt) ...” P35’s treatment ended 1 hour and 13 minutes earlier than the prescribed treatment time. A review of P38’s “Treatment Details Report” for 7/10/24 stated, “Dialysis Prescription ... Treatment Time 3h 0m ... Post-Treatment Vitals ... Intradialytic ... Treatment Duration 1h 48m ... Closed Treatment Reason, Patient Choice (AMA, transportation, weather, has other appt) ...” P38’s treatment ended 1 hour and 12 minutes earlier than the prescribed treatment time. On 2/28/25 at 11:58 AM, Staff (S) 1, Facility Administrator (FA), stated that there was no documented evidence of physician orders for shortened treatments for any of the above patients and that there was no documented evidence that any the patients’ nephrologists were informed that patients had shortened treatments on 7/10/24 as a result of the interruption due to a water issue. S1 stated that he/she had a large pile of unfiled paperwork from the previous FA that could obtain the rest of the AMA forms and this surveyor requested that S1 send the AMA forms via email for P26, 28, 29, 30, 31, 33, 34, 35, and 38 by 3/3/25. On 3/3/25, S1 confirmed via e-mail that he/she could not find the requested AMA forms. All of the treatment flow sheets for the above patients lacked documented evidence that the staff educated the patients on the consequences of cutting treatment time, and they lacked evidence that the above patients were offered make up times. Facility policy and procedure titled, “Prescribed Treatment Time Not Met,” Revised April 2024, stated, “... Policy: A. Completion Of The Early Termination of Treatment Against Medical Advice Form 1. The Registered Nurse [RN] will verify that a patient signs the Early Termination of Treatment Against Medical Advice form any time the patient requests to terminate their treatment earlier than the prescribed run time. ... B. Prescribed Treatment Time Not Met 1. If shortened/early termination of treatment time exceeds 30 or more minutes, the RN will notify the patient’s attending nephrologist ... 3. If a patient’s treatment is shortened/early terminated, the RN will document the event in the patient’s electronic health record. Documentation will include, as appropriate: ... Whether the patient’s nephrologist was notified, A description of the follow-up medical orders provided by the patient’s attending nephrologist [if any] ...””