Summary:
Summary Statement of Deficiencies D5400 ANALYTIC SYSTEMS CFR(s): 493.1250 Each laboratory that performs nonwaived testing must meet the applicable analytic systems requirements in 493.1251 through 493.1283, unless HHS approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub.7), that provides equivalent quality testing. The laboratory must monitor and evaluate the overall quality of the analytic systems and correct identified problems as specified in 493.1289 for each specialty and subspecialty of testing performed. This CONDITION is not met as evidenced by: Based on review of laboratory procedures, policies, calibration records from January 2026 to date August 5, 2026, temperature and humidity logs for November 17, 2025 to date August 5,2026, Centers for Medicare and Medicaid Services Form 116 (CMS- 116), performance verification procedures for the CLC 800 analyzer, verification of performance specifications for the Agilent LC/MS/MS analyzer, verification of performance specifications for the Spectra Max iD3 analyzer, and patient results, observation of mobile phase A and interview with the technical supervisor (TS) #1 and TS #2, the laboratory failed to meet the condition of analytic systems. The laboratory failed to follow the written procedure for urine creatinine (Refer to D5401); the laboratory failed to provide written procedures for Agilent LC/MS/MS quality control (QC) (Refer to D5403); the laboratory failed to ensure the temperature and humidity was maintained according to laboratory's logs for 68 of 187 days (Refer to D5413); the laboratory failed to document accurate expiration dates on mobile phase A (Refer to D5415); the laboratory failed to verify performance specifications prior to reporting patient test results (Refer to D5421); the laboratory failed to verify that the manufacturer's reference intervals (normal ranges) were appropriate for the laboratory's patient population for the Agilent LC/MS/MS analyzer for 67 biomarkers and 1 analyte on the Spectra Max iD3 analyzer (Refer to D5423). Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 8 -- D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) (a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of laboratory procedures, calibration records from January 2026 to date August 5, 2026, patient results, and interview with the technical supervisor (TS) #2, the laboratory failed to follow the written procedure for urine creatinine for 7 of 21 days. Findings: 1. Review of laboratory procedure "Diazyme Enzymatic Urine Creatinine Assay Performance" states "Calibration is performed at least every 14 days and with each new lot of reagents". 2. Review of urine creatinine calibration records from January 2026 to date August 5, 2026 showed the laboratory failed to perform a calibration following written procedure of every 14 days on the following days: 01/21 /2026, 02/03/2026, 02/17/2026, 03/05/2026, 03/24/2026, 05/08/2026, and 06/09/2026. 3. Review of patient results showed the laboratory performed approximately 747 urine creatinine patient tests since testing began on November 19, 2025. 4. Interview with the technical supervisor (TS) #2 on August 5, 2026 at 12:00 PM confirmed the laboratory failed to follow the written procedure for urine creatinine. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) (b) The procedure manual must include the following when applicable to the test procedure: (b)(1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (b)(2) Microscopic examination, including the detection of inadequately prepared slides. (b)(3) Step-by- step performance of the procedure, including test calculations and interpretation of results. (b)(4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (b)(5) Calibration and calibration verification procedures. (b)(6) The reportable range for test results for the test system as established or verified in 493.1253. (b)(7) Control procedures. (b)(8)