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: Based on record review and staff interview, the laboratory failed to perform and document annual competency assessment on 1 of 1 moderate complexity testing personnel from 3/22/17 to 3/22/19. Findings: Review of the competency records showed that the laboratory failed to have documentation of annual competency assessments for moderate complexity Testing Personnel A who performed Potassium Hydroxide (KOH) and Scabies testing from 3/22/17 to 3/22/19. During an interview on 3/22/19 at 10:55 AM, the Director of Compliance and Risk Management stated they did not perform and document annual competency assessments on the moderate complexity Testing Personnel A who performed KOH and Scabies testing. 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 record review and interview, the laboratory failed to verify the accuracy of the Potassium Hydroxide (KOH) and Scabies testing at least twice a year for 2 out of 2 years (2017-2018). Findings: The laboratory is enrolled in proficiency testing (PT) with American Proficiency Institute (API) for KOH and Scabies testing. API provides 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 -- samples for PT three times a year for KOH and Scabies testing. The laboratory participated in KOH and Scabies testing for the 2nd and 3rd events in 2017, and for the 1st, 2nd, and 3rd events in 2018. No other documentation of the laboratory's attempts to verify the accuracy of KOH and Scabies testing were available. A laboratory must obtain PT score of at least 80% to be successful. Review of the AP results showed the following unsuccessful results: 2017 3rd event 50% 2018 1st event 50% 2018 3rd event 50% During an interview on 3/22/19 at 11:30 AM, the Director of Compliance and Risk Management, acknowledged the unsuccessful API results for KOH and Scabies. The Director of Compliance and Risk Management stated that if the laboratory had verified the accuracy of KOH and Scabies it would have been performed using a split sample and it would have been put in the binder. 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)