Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on November 06, 2018. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: 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 review of laboratory personnel records and an interview with the laboratory director and General Supervisor (TP # 2 CMS 209), it was determined that the laboratory director failed to provide annual Competency Assessment for its testing personnel in the specialty of Histopathology for 2017 and 2018. Findings include: 1. A review of testing personnel records revealed there was no annual competency evaluations for testing personnel (TP# 2, 3 CMS 209) for 2017 and 2018. 2. An interview with the laboratory director and General Supervisor TP # 2 (CMS 209) on November 06, 2018 at approximately 11:50 AM in the review room confirmed the abscence of annual competency assessment for TP #s 2 and 3 (CMS 209) in 2017 and 2018. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --