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. This STANDARD is not met as evidenced by: Based on review of 2022, 2023, and 2024 coagulation records and interview with the quality manager (QM) 8/27/24, the laboratory failed to retain instrument printouts for all LED calibrations performed on the Sysmex CA-660 coagulation analyzer. Findings: Review of 2022, 2023, and 2024 "Sysmex CA-600 Operator's Maintenance Checklist" logs revealed "Perform LED Calibration" was a task listed on the log under "Quarterly Maintenance". Review of the logs revealed the laboratory documented the LED calibration date on the logs. Review of LED calibration instrument printouts revealed the laboratory had not retained instrument printouts for LED calibrations performed on the following dates documented on the maintenance logs: 4/4/22, 11/25 /22, 2/23/23, and 6/4/23. During interview 8/28/24 at approximately 2:25 p.m., the quality manager stated she was unsure how long the Sysmex CA-660 analyzer retained LED calibration records. She stated she was unable to print records of any LED calibrations performed before 6/29/23. D5213 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(1) The laboratory must verify the accuracy of any analyte or subspecialty without analytes listed in subpart I of this part that is not evaluated or scored by a CMS- approved proficiency testing program. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on review of laboratory policy and review of 2023 and 2024 American Proficiency Institute (API) proficiency testing (PT) records 8/27/24 and 8/28/24, the laboratory failed to evaluate "Not Graded" PT results to ensure the results were acceptable and no