Summary:
Summary Statement of Deficiencies D0000 An announced CLIA Validation survey was conducted at the Pediatric Associates of Richmond on July 27, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: The laboratory is performing COVID-19 testing and in compliance with the applicable COVID-19 reporting requirements. 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 the review of policy and procedures (P&P), lack of documentation, and interview, the laboratory did not have an established P&P for performing competency assessments on testing personnel at the date of the survey on 07/27/21. Findings include: 1. Review of the available P&P's revealed lack of documentation of a policy for performing competency assessments on testing personnel performing patient testing in the specialty of hematology and subspecialty of bacteriology. 2. During an exit interview with the laboratory director and primary testing personnel on 07/27/21 at approximately 2:30 PM, the document was not available upon request for review, in addition, the above-specified findings were confirmed. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)