Davita Hillside 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 interview, document review, and policy review, it was determined that the facility failed to ensure the “Granuflo” acid solution was in the specific gravity range prior to transferring to the storage tank for three of 20 batches reviewed. This has the potential to affect all 60 in-center hemodialysis patients receiving care at the facility by administering the acid to the patients during dialysis. Findings include: Review of the facility’s form titled, “Granuflo (132 Gallon) Batch Production Record,” dated revised April 2023, indicated, “Checking Specific Gravity values for Granuflo refer to manufactures table in policy.” Review of Granuflo manufacture instruction limits for all three-batches state the acceptable specific gravity range was “1.190 to 1.202.” 1. Review of the “Granuflo batch production record” dated 02/06/24 for the 2 Potassium (K) 2.5 Calcium (CA) revealed the manufacturers acceptable range for the low range was 1.190 and the high range was 1.202. The Hydrometer reading (a method used to determine the specific gravity) was recorded as being 1.210. 2. Review of the “Granuflo batch production record” dated 02/12/24 for the 2 Potassium (K) 2.5 Calcium (CA) revealed the manufacturers acceptable range for the low range was 1.190 and the high range was 1.202. The Hydrometer reading (a method used to determine the specific gravity) was recorded as being 1.210. 3. Review of the “Granuflo batch production record” dated 03/04/24 for the 2 Potassium (K) 2.5 Calcium (CA) revealed the documented manufacturers acceptable range for the low range was 1.192 and the high range was 1.204. The Hydrometer reading (a method used to determine the specific gravity) was recorded as being 1.190. The range the staff recorded was incorrect based on the temperature of 23 degrees Celsius (C). During an interview with Biomed 6 on 04/11/24 at 1:00 PM, he/she verified the staff did not follow the policy and the manufacturers’ instructions. He/She verified the solution was out of range and it was transferred to the holding tank. He/she stated that he/she was not notified that the solution was out of range so that it could be neutralized and sent to the drainage system. In addition, he/she confirmed the staff did not record the right manufactures range for the batch made on 03/04/24. Review of the facility’s policy titled, “Granuflo Concentrate Dissolutions Unit,” dated April 2024, indicated, “11. The results of the hydrometer test, together with the manufactures acceptable range of concentrate specific gravity, is recorded on the Granuflo Batch Productions Record Production Record ...12. Specific Gravity test of each batch of Granuflo acid concentrate is temperature compensated. The chart below provides the temperature range verses specific gravity limits.” N.J.A.C. 8:43A-24.4(a)”

“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: 22676 Based on observation, staff interview, and facility policy review, it was determined that the facility failed to ensure staff discarded expired serum blood leak test strips for one of one bottle observed in the water treatment room. This deficient practice has the potential to affect all 60 in center hemodialysis patients receiving care. Findings include: Observation in the water treatment area on 04/10/24 at 10:25 AM, revealed one bottle of blood leak test strips, “lot #101055” expired on 11/30/23. During an interview on 04/10/24 at 10:25 AM, the Administrator confirmed the manufactures expiration date was 11/30/23 and that the bottle should have been discarded and not available for use. A review of the facility’s policy titled, “Evaluation of a Dialyzer Blood Leak using Serim Blood Leak Test Strips” dated October 2022, 2.” Verify that the serum blood leak test strips are not expired ...” N.J.A.C. 8:43A-24.4(a)”

“POC-IMPLEMENT UPDATE-15 DAYS P PT ASSESS CFR(s): 494.90(b)(2) Implementation of monthly or annual updates of the plan of care must be performed within 15 days of the completion of the additional patient assessments specified in §494.80(d). This Standard is not met as evidenced by: 22676 Based on medical record reviews, interviews, and review of the facility’s policy, it was determined that the facility failed to ensure four of nine patients (Patient (P)3, P5, P7, and P8) plan of care (POC), was completed within 15 days of the reassessment. Failure to ensure the POC was developed using current assessment information has the potential to negatively impact the effectiveness of the dialysis treatments for all 71 patients receiving dialysis at this facility. Findings include: 1. Review of P3’s POC in the electronic medical record (EMR) under the “Plan of Care” section, indicated that the POC meeting was held on 07/27/23. The Registered Dietician (RD) completed the assessment on 06/26/23, the Social Work (SW) completed the assessment on 06/30/23. The assessments were conducted more than 15 days before the POC meeting and there was no evidence of an update. 2. Review of P5’s POC in the EMR under the “Plan of Care” section indicated that the POC meeting was held on 10/26/23. The RN conducted the assessment on 10/04/23, the SW on 09/13/23 and the RD on 09/11/23. All assessments were conducted more than 15 days before the POC meeting and there was no evidence of an update. 3. Review of P7’s POC in the EMR under the “Plan of Care” section indicated that the POC meeting was held on 01/19/24. The RN conducted the assessment on 12/15/23, the SW on 12/13/23 and the RD on 12/29/23. All assessments were conducted more than 15 days before the POC meeting and there was no evidence of an update. 4. Review of P8’s POC in the EMR under the “Plan of Care” section indicated that the POC meeting was held on 08/29/23. The RN conducted the assessment on 08/02/23, the SW on 08/07/23 and the RD on 08/03/23. All assessments were conducted more than 15 days before the POC meeting and there was no evidence of an update. During an interview on 04/11/24 at 12:15 PM, the Administrator and the Manager Clinical Services (MCS) 5, confirmed the above findings. Review of the facility’s policy titled, “Interdisciplinary Team (IDT) patient assessment and Plan of Care” dated 7/23, indicated,” ... the plan of care must be performed within 15 days of the completion of assessments.” N.J.A.C. 8:43A-24.4(a)”