Summary:
Summary Statement of Deficiencies D0000 An initial certification survey conducted at LABORANT LLC DBA ARCPOINTLABS OF TAMARAC FL on 04/18/2022 found the clinical laboratory was not compliance with 42 CFR Part 493, Requirements for Laboratories. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) The technical consultant is responsible for evaluating and documenting the performance of individuals responsible for moderate complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of personnel records and staff interview, the Technical Consultant (TC) failed to document the initial competency evaluation for 3 out of 3 testing personnel (TP) when the laboratory started testing on 10/15/2021. Findings include: - Review of laboratory records showed that the laboratory started testing on 10/15 /2021. -Review of personnel records revealed that the laboratory had 3 TP. -Review of the Laboratory Compliance Policy, revealed that the TP will be required to be Competent before started patient testing. -Review of personnel records for TP, revealed no documentation for the Initial Competency for 3 out of 3 TP. The competency forms in records for 3 out of 3 TP stated: "Annual Evaluation of Testing Personnel Competency" and they were signed on 03/16/2022, During an interview on 04/18/2022 at 12:30 PM, with the TC, he confirmed that there were no records of the initial competency evaluation for 3 out of 3 TP. 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 --