Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Attica Chang MD PA on 08/01/19. The laboratory is not in compliance with 42 CFR Part 493, Requirements for Laboratories. The following is a description of the standard level 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 interview with the Laboratory Manager the laboratory failed to perform competency evaluations for 3 (#A, #C, and #D) out of 6 (#A-#F) Testing People reviewed. Findings Included: Review of personnel files revealed no competency evaluations for Testing Person #A, #C, or #D. During an interview on 08 /01/19 at 12:03 PM the Laboratory Manager confirmed that Testing Person #A, #C, and #D did not have any competency evaluations performed. 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 with the Laboratory Manager the laboratory failed to verify the accuracy of testing of Potassium hydroxide (KOH) testing and Tzanck testing at least twice a year in 2018. Findings Included: Review of KOH 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 -- testing (subspecialty Mycology) revealed that the accuracy of testing was performed on 06/18. Review of Tzanck testing (subspecialty Virology) revealed that the accuracy of testing was performed on 11/18. During an interview on 08/01/19 at 11:00 AM the Laboratory Manager confirmed that the peer reviews to verify the accuracy of testing was only performed 1 time in 2018 for Mycology and Virology. -- 2 of 2 --