Summary:
Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: A. Based on review of the laboratory's Competency Assessment procedure, review of Competency Assessment (CA) records, and interview with Technical Supervisor (TS) #1, the Laboratory failed to follow the Laboratory's written procedure to assess the competency of 3 of 3 testing personnel (TP) who performed Mitochondrial Enzyme Activity assays for 2019, 2020, and 2021 Findings Include: 1. The laboratory's Competency Assessment procedure (page 2) under evaluations (points 1, 2, 3, 4, 5, and 6) states: " 1. Direct observation of routine patient test performance to include patient preparation (if applicable), specimen handling, processing and testing. 2. Monitoring the recording and reporting of test results. 3. Review of intermediate test results or worksheets, quality control records, proficiency testing results, and preventive maintenance records. 4. Direct observation of performance of instrument maintenance and function checks. 5. Assessment of test performance through previously analyzed specimens, internal blind samples or external proficiency testing samples. 6. Evaluation of problem solving skills. 2. On the day of survey 08/18/2021, review of the CA records revealed the following: 2019: - 1 of 3 TP (CMS209 personnel #2) CA did not evaluate point 4. - 1 of 3 TP (CMS209 personnel #3) CA did not evaluate points 3, 5, and 6. 2020: - 1 of 3 TP (CMS209 personnel #2) CA did not evaluate point 3 and 5. - 1 of 3 TP (CMS209 personnel #3) CA did not evaluate points 3, 5, and 6. 2021: - 1 of 3 TP (CMS209 personnel #4) CA did not evaluate points 3, 5, and 6. 3. The TS#1 confirmed the findings above on 8/18/2021 at 10:15 a. m. B. Based on review of competency assessment records and interview with the Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- technical supervisor (TS)#1, the laboratory failed to assess 3 of 3 testing personnel (TP) for each assay in chemistry performed from 08/18/2019 to the date of survey. Findings Include: 1. On the day of Survey 08/18/2021, review of the competency assessment records revealed, the forms used to document competency did not separate the two assays (Citrate synthase and Respiratory chain complex-IV) for 3 of 3 TP from 08/18/2019 to the day of survey. 2. The TS#1 confirmed the finding above on 8 /18/2021 at 10:15 a.m. 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: Based on lack of documentation and interview with the technical supervisor (TS)#1, the laboratory failed to verify twice annually the accuracy for Citrate Synthase and Respiratory chain complex-IV assays performed in 2020. Findings include: 1. On the day of survey, 08/18/2021, the laboratory could not provide documentation of verification of accuracy performed for Citrate Synthase and Respiratory chain complex-IV assays in 2020. 2. The TS#1 confirmed the findings above on 08/18/2021 at 10:50 a.m. 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) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)