Davita Birmingham North Dialysis

“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: 22676 Based on observation, record review, interview, and review of the facility’s policy, the facility staff failed to test the bicarbonate solution (part of the solutions used in the dialysis treatment) prior to releasing the solution to the treatment floor as required for three months of three months of bicarbonate mixing records reviewed from (04/02/25-06/25/25). This deficient practice had the likelihood of affecting all 44 in-center hemodialysis patients receiving care at the facility. Findings include: During a review of the bicarbonate mixing log from 04/02/25 through 06/25/25 revealed there was no documentation of conductivity or specific gravity on the log. An interview with Biomedical Technician on 06/25/25 at 9:15 AM confirmed staff does not record the testing of the bicarb on the log, and they do not test the bicarbonate prior to releasing the solution to the holding tank. The Biomedical Technician confirmed the manufacturer did not specify a conductivity or specific gravity range. A review of the manufacturer’s instruction for “Nipro Bicarbonate Powder” revealed the manufacturer had no recommendations regarding the testing of reconstituted bicarbonate concentrate for conductivity, specific gravity, or pH (acidity or alkalinity of a solution). A review of the facility’s policy titled, “Bicarbonate Concentrate Mixing System” dated 09/24, revealed the following, “All bicarbonate concentrate will be performed in accordance with the bicarbonates manufacturer’s recommendations.” The federal regulations adopted the “ANSI/AAMIRD52:2004” which gives guidance on the mixing of bicarbonate solutions revealed the following, “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 concentration 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 meet all applicable criteria should be recorded and signed by the individuals performing the tests.” The facility failed to have a policy that sets the test range for the facility staff to follow.”

“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: 22676 Based on record review, interview, and policy review, the facility failed to follow the individualized dialysis plan (an artificial means of kidney function that removes the waste and excess fluid from the blood by passing through a filter) by following the physician prescription as determined by the medical provider for three of five sampled in-center dialysis patients (Patient (P1), P3 and P5). Failure to follow the medical providers’ dialysis prescription had the potential to negatively impact on the effectiveness of the prescribed dialysis treatments for all 44 patients receiving in-center dialysis treatments at this facility. Findings include: 1. Review of P1’s “Treatment Detail Report” in the electronic medical record (EMR) revealed a prescribed Blood Flow Rate (BFR) of 450 milliliters per minute (ml/min). Review of one of six flowsheets from 06/11/25 through 06/23/25 indicated the following: a. On 06/16/25 from 5:54 AM until 9:00 AM, the BFR was documented at 400 ml/min. There was no documentation for the change to the prescribed BFR. 2. Review of P3’s “Treatment Detail Report” in the EMR revealed a prescribed BFR of 450 ml/min. Review of one of six flowsheets from 06/11/25 through 06/23/25 indicated the following: a. On 06/16/25 from 1:01 PM until 2:36 PM, the BFR was documented at 395 ml/min. b. On 06/20/25 from 11:01 AM until 2:14 PM the BFR was documented at 400 ml/min. c. On 06/23/25 from 11:01 AM until 2:30 PM the BFR was documented at 400 ml/min. There was no documentation for the change to the prescribed BFR. 3. Review of P5’s “Treatment Detail Report” in the EMR revealed a prescribed BFR 400 ml/min. Review of one of six flowsheets from 06/11/25 through 06/23/25 indicated the following: a. On 06/16/25 from 6:01 AM until 9:20 AM, the BFR was documented at 300 ml/min. There was no documentation for the change to the prescribed BFR. During an interview on 06/27/25 at 11:30 AM, the Administrator confirmed the above findings, and that staff did not follow the physician’s order for dialysis treatment. Review of the facility’s policy titled, “Pre-Intra-Posttreatment Data, Collection, Monitoring and Nursing Assessment,” dated April 2024, states identity, prescription, and machine settings are verified by teammate ... f. Blood flow rate ...”

“MR-COMPLETE, ACCURATE, ACCESSIBLE CFR(s): 494.170 The dialysis facility must maintain complete, accurate, and accessible records on all patients, including home patients who elect to receive dialysis supplies and equipment from a supplier that is not a provider of ESRD services and all other home dialysis patients whose care is under the supervision of the facility. This Standard is not met as evidenced by: 22676 Based on interview, document review, and policy review, the facility failed to prevent the staff from obliterating numbers when identifying an incorrect entry in a record one day of 37 days of Citric Acid Records reviewed. Failure to correct the records correctly has the potential to affect the release of information for all 44 patients receiving treatments at this facility. Findings include: Review of the facility’s document titled, “Water and testing Devices Procedure” for the “2% Citric Acid Mixing Log” on 06/26/25 at 11:30 PM, it was identified that on 04/07/25 under the column titled “Lot Numbers” the staff obliterated by writing over a number and wrote another number in the column titled “Container Labeled with Date/Time and initial.” In an interview with the Administrator on 06/26/25 at 11:30 AM, it was confirmed an obliteration was done to a recorded number and that staff failed to follow the facility policy. Review of the facility’s policy titled, “Medical Record Corrections” states, “No paper medical record entry is to be erased (including the use of correction fluid), obliterated, altered or destroyed.””