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 a surveyor's review of the laboratory policies/procedures, annual competency records and an interview with the Moh's technician, the laboratory failed to have a complete policy and procedure for personnel competency. Finding Include: It was confirmed by the Moh's technician on November 1, 2018, at approximately 10: 50 am that the laboratory failed to have a complete written procedure for annual competency to include direct observation for three of three Moh's processors who perform the processing of Moh's pathology slides from the date of the last survey (May 10, 2017) to the date of this survey. 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 a lack of proficiency test verification records and an interview with the Moh's processor, the laboratory failed to verify the accuracy of the Moh's slide procedure. Findings Include: On November 1, 2018, at approximately 11:45 AM the Moh's processor confirmed that the laboratory failed to perform twice annual verification for the Moh's slide procedure performed for the year 2017 through 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 2 -- date of this survey. Approximately 3800 patient specimens were tested and results reported for Moh's surgery. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on a lack of procedures and an interview with the Moh's processor, the laboratory director failed to ensure that the laboratory's quality assurance (QA) program was maintained as part of the laboratory's overall quality systems program. Refer to D5209 and D5217 -- 2 of 2 --