Summary:
Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on August 06, 2019. 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 manager, revealed that the laboratory director failed to provide annual Competency Assessment for ALL its testing personnel. Findings include: 1. A review of testing personnel records revealed there was no competency evaluations for testing personnel (TP#s 3,4,5,7 CMS 209) in 2018. 2. An interview with the laboratory manager on August 06, 2019 at 12:36 PM in the review room confirmed that there were no annual competencies performed on testing personnel #s 3,4,5 and 7 on CMS 209. 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 --