Summary:
Summary Statement of Deficiencies D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. In addition, retain the following: This STANDARD is not met as evidenced by: Based on review of calibration records, lack of documentation and interview with general supervisor (GS) #1, 08/12/25, the laboratory failed to retain calibration records for the Pictus 700 for at least 2 years. Findings: Review of calibration records for Albumin (ALB) testing revealed calibration documentation was retained from 11 /11/24 to time of survey 08/12/25, a period of approximately 10 months. Review of calibration records for High-Density Lipoprotein (HDL) testing revealed calibration documentation was retained from 01/21/25 to time of survey 08/12/25, a period of approximately 8 months. Review of calibration records for Triglycerides (TRIG) testing revealed calibration documentation was retained from 02/18/25 to time of survey 08/12/25, a period of approximately 7 months. Interview with GS #1 at approximately 1:30 p.m. confirmed the laboratory failed to retain at least 2 years of calibration records for the testing performed on the Pictus 700. They stated the analyzer only retains the last 19 calibrations and they were unaware the records needed to be retained for 2 years. 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 Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 10 -- 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 laboratory's policies and procedures, review of product inserts and manufacturer's instructions, review of temperature and humidity logs, review of instrument maintenance records, review of quality control, calibration and calibration verification records, lack of documentation and surveyor observations 08/12/25, the laboratory failed to monitor and evaluate the ongoing and overall quality of the analytic systems to identify and correct problems and prevent their recurrence. Findings: 1. The laboratory failed to ensure the Access 2 quality control procedure was complete. See D5403. 2. The laboratory failed to ensure reagents were stored according to manufacturer's requirements. See D5411. 3. The laboratory failed to establish ranges for the environmental conditions required for the performance of testing and for the storage of all reagents used in the performance of testing. See D5413. 4. The laboratory failed to ensure quality control reagents were labeled with correct expiration date. See D5415. 5. The laboratory failed to perform and document required maintenance for the Access 2 analyzer. See D5429. 6. The laboratory failed to perform calibration verifications for the testing performed on the Pictus 700 analyzer. See D5439. 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)