Summary:
Summary Statement of Deficiencies D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: The laboratory failed to verify the accuracy twice annually for six of six tests the laboratory performed. Findings include: 1. Review of the CMS 116 revealed that the laboratory performed six tests: MindX Sciences Pain Test, MindX Sciences Mood Test, MindX Science Stress Test, MindX Sciences Suicidality Test, MindX Sciences Longevity Test, and MindX Sciences Memory Test. 2. Review of the laboratory's proficiency testing records revealed Test Name "Precision & accuracy Pain" was performed 10/13/2021 and "Precision & accuracy Mood" was performed on 06/03 /2022. 3. Review of procedure "Quality Assurance_V1" section "5.10 Proficiency Testing" revealed no frequency listed for proficiency testing. 4. The laboratory director confirmed on September 7, 2022 at approximately 4:45 P.M. that the laboratory did not verify the accuracy of all six test twice annually. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (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. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) 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 -- The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)