Summary:
Summary Statement of Deficiencies D0000 Noted deficiencies and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility representative(s) were given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be in compliance with applicable Conditions of Participation in the CLIA program, and recertification is recommended. 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 review of the laboratory policies and records, and confirmed in interview, the laboratory failed to document the competency for 1 of 2 technical supervisor. Findings were: 1. Review of the CMS 209 revealed 2 technical supervisors. 2. Review of the laboratory records revealed no documentation of a competency for 1 of 2 technical supervisors (technical supervisor #2). 3. An interview with the histotech on 10/2/20 at 0930 hours in the laboratory confirmed the above findings. 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: 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 -- Based on review of the laboratory records and confirmed in an interview, the laboratory failed to document at least twice annually the accuracy of 1 of 1 tests in 2018. (Mohs) Findings were: 1. A review of laboratory testing records from 2018 and 2020 revealed no documentation of the laboratory verifying the accuracy for the Mohs test for 2018. 2. An interview with histotech on 10/2/20 at 0940 hours in the laboratory confirmed the above findings. -- 2 of 2 --