Davita Newton County Dialysis

“POC-INITIAL IMPLEMENTED-30 DAYS/13 TX CFR(s): 494.90(b)(2) Implementation of the initial plan of care must begin within the latter of 30 calendar days after admission to the dialysis facility or 13 outpatient hemodialysis sessions beginning with the first outpatient dialysis session. This Standard is not met as evidenced by: 50523 Based on a review of medical records, staff interview and a review of facility Policy and Procedures (P&P) it was determined that the facility failed to ensure that an individualized plan of care was developed and implemented within 30 days of admission, for one of one patient (P) (P#1) sampled for new admission. This deficient practice had the potential to negatively affect the health and safety of P#1. The facility incenter census was 73. Findings include: - During a review of medical records, the following was revealed: - P#1 was admitted to this facility on 10/15/24, who was new to dialysis. There was no documentary evidence that an initial plan of care was completed for this patient. The Facility Administrator (FA) was notified of this finding on 12/3/24 at 12:35 p.m. and he confirmed that it was greater than 30 days since P#1 admission and the patient had 13 hemodialysis treatments, yet there was no care plan developed and implemented for the patient sampled. A review of facility Policy: 1-14-01 titled, “Interdisciplinary Team (IDT) Patient Assessment and Plan of Care” with latest revision date of October 2024 showed: 4. A comprehensive assessment will be conducted on all new patients within 30 calendar days (or 13 outpatient dialysis sessions for hemodialysis) beginning with the first outpatient dialysis treatment or per state guidelines. - An initial Plan of Care, based on the findings from the comprehensive assessment, will be completed on all patients new to dialysis within 30 calendar days or 13 outpatient dialysis sessions for hemodialysis beginning with the first outpatient dialysis treatment...”

“QAPI-INDICATOR-NUTRITIONAL STATUS CFR(s): 494.110(a)(2)(ii) The program must include, but not be limited to, the following: (ii) Nutritional status. This Standard is not met as evidenced by: 50523 Based on a review of facility records and staff interviews, it was determined that the facility failed to effectively manage albumin (protein found in blood) levels, and to evaluate the effectiveness of the facility’s albumin plan of intervention in six of six months of Quality Assessment and Performance Improvement (QAPI) meeting minutes reviewed (May 2024 - October 2024). This deficient practice had the potential to negatively affect the health and safety of 73 in-center hemodialysis (ICHD) patients, and six Peritoneal Dialysis (PD) patients who were under the care of this facility. Findings include: A review of Fiscal Year 2024 Quarterly Dialysis Facility Report (QDFR: A report prepared by Centers for Medicare and Medicaid Services to provide a comparative summary of treatment patterns and patient outcomes for dialysis patients of this facility, as compared to other facilities in the U.S.), revealed that 64.3 % of ICHD patients and 81.3% of PD patients at this facility had albumin levels of less than (<) 4 g/dL (grams per deciliter). The U.S. average was 51.8.0%. The average albumin less than 4 g/dL for the past six months reviewed (May 2024 - October 2024), was 70% for ICHD and was 100% for PD. A review of this facility’s ICHD Albumin report for the last six months, revealed the following: - In May 2024, 59% of patients had Albumin levels of <4.0 g/dL. - In June 2024, 66% of patients had Albumin levels of <4.0 g/dL. - In July 2024, 75% of patients had Albumin levels of <4.0 g/dL. - In August 2024, 63% of patients had Albumin levels of <4.0 g/dL. - In September 2024, 58% of patients had Albumin levels of <4.0 g/dL; and - In October 2024, 70% of patients had Albumin levels of <4.0 g/dL. Although the facility data was collected monthly, there was no documented evidence that the data was analyzed. The QAPI meeting minutes showed that plans and root cause analysis were developed. However, the improvement plan was replicated without a reassessment of its effectiveness to mprove and sustain the facility’s outcomes. A review of this facility’s PD Albumin report for the last six months, revealed the following: - In May 2024, 75% of patients had Albumin levels of <4.0 g/dL. - In June 2024, 75% of patients had Albumin levels of <4.0 g/dL. - In July 2024, 100% of patients had Albumin levels of <4.0 g/dL. - In August 2024, 100% of patients had Albumin levels of <4.0 g/dL. - In September 2024, 80% of patients had Albumin levels of <4.0 g/dL; and - In October 2024, 100% of patients had Albumin levels of <4.0 g/dL. Again, the monthly QAPI meeting minutes showed that plans for adjustments and a root cause analysis were developed. However, the written plan was replicated without a reassessment of its effectiveness. Again, the facility’s QAPI meeting minutes showed that the interdisciplinary team IDT conducted a review of albumin levels with no changes made to the action plans to attain and sustain improvement. The Facility Administrator acknowledged the findings on 12/4/24 at 12:50 p.m. At 1:24 p.m. on 12/4/24, the Medical Director stated that a deeper dive needed to be implemented to discover the root causes for both modalities..”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 50523 Based on observation, staff interview, a review of the Food and Drug Administration (FDA) recommendations and a review of facility Policy and Procedures (P&P) it was determined that the facility failed to ensure that expired medication in one of one Medication Cabinet were removed and not made available for use; and expired laboratory (lab) supplies found in one of one Supply Cabinet were not made available for use per facility P&P. This deficient practice had the potential to negatively affect the health and safety of six Peritoneal Dialysis (PD) patients who were under the care of this facility. Findings include: During a tour of the facility on 12/2/24 from 10:30 a.m. though 11:37 a.m., the following medication and supplies had expired, being unfit for use. In the PD Exam Room Medication Cabinet: - There were three bottles of Jardiance (used to help lower blood sugar levels in people with type 2 diabetes)10 milligrams (mg) that expired 6/2024. In the PD Exam Room supply cabinet: - There were 100 gold top lab tubes that expired 10/31/24. On 12/2/24, Registered Nurse/ Clinical Coordinator (RN/CC) acknowledged these findings at 11:18 a.m. According to FDA recommendations dated 2/8/21, drug and supplies’ expiration dates reflect the time period during which the product is known to remain stable, which means it retains its strength, quality, and purity when it is stored according to its labeled storage conditions. Several potential harms may occur from taking an expired medication or using expired supplies. Once the expiration date has passed there is no guarantee that the medicine or supplies will be safe and effective. A review of facility Policy: 1-06-01, titled, “Medication Policy” with latest revision date of November 2023, stated: 13. All open or unopened medication packages (i.e. vials, ampules, etc.) are stored according to the manufacturer’s directions. Do not use any medication that has been stored improperly or has expired.”