Summary:
Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) (2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1). This STANDARD is not met as evidenced by: Based on a review of Proficiency Testing (PT) results and an interview with the laboratory director, the laboratory failed to verify the accuracy of Vitamin D results at least twice annually in 2024. Findings include: 1. A request was made to review the proficiency testing or other verification of accuracy for Vitamin D in 2024, and documentation could not be provided. 2. In an on-site interview on 4/2/25 at 2:30 PM, the laboratory director confirmed the laboratory was not enrolled in PT or other program to verify the accuracy of Vitamin D in 2024. 3. The laboratory reports performing approximately 300 Vitamin D tests annually. D5807 TEST REPORT CFR(s): 493.1291(d) (d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of patient test results and an interview with the laboratory director, the laboratory failed to use the race-free estimated glomerular filtration rate (EGFR) equation designed to provide a more accurate estimation of kidney function on patient reports as recommended by the American Society of Nephrology and the National Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- Kidney Foundation in 2021 (CKD-EPI 2021 equation). Findings include: 1. A review of patient test results revealed the laboratory was not using the updated race-free calculation (CKD-EPI 2021 equation) to determine the EGFR that was recommended by the National Kidney Foundation and the American Society of Nephrology in 2021. 2. An interview with the laboratory director on 4/2/25 at 2:30 PM, confirmed the use of the traditional race-based EGFR calculation on patient reports. 3. The laboratory reports performing approximately 2500 EGFR calculations annually. -- 2 of 2 --