Summary:
Summary Statement of Deficiencies D0000 An announced CLIA validation survey was conducted at Children's Hospital King's Daughter Urgent Care at Loehman's Plaza on February 19, 2020 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 D2007 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The samples must be examined or tested with the laboratory's regular patient workload by personnel who routinely perform the testing in the laboratory, using the laboratory's routine methods This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), proficiency testing (PT) records, and interview, the laboratory failed to rotate hematology PT among personnel performing patient Complete Blood Count (CBC) testing in calendar years 2018 and 2019. Findings include: 1. Review of the CMS 209 revealed seven (7) Testing Personnel (TP) identified as responsible for moderate complexity CBC patient testing. 2. Review of the laboratory's College of American Pathologists (CAP) FH Hematology Module PT documentation for 2018 (Events A-C) and 2019 (Events A-C) revealed that Testing Personnel A signed attestation statements for the following CAP FH module events: 2018 A, 2018 B, 2018 C, 2019 A, 2019 B; a total of five (5) of six (6) events reviewed. (See Personnel Code Sheet.) 3. In an exit interview with the laboratory manager and primary TP on 2/19/20 at approximately 5:45 PM, the above findings were confirmed. D6053 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(9) 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 -- 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 the Centers for Medicare and Medicaid Services Laboratory Personnel Report form (CMS 209), testing personnel competency assessment records, lack of documentation, and interviews, the technical consultant (TC) failed to perform the semi-annual hematology competency assessment for one (1) new laboratory testing personnel (TP) in calendar year 2018. Findings include: 1. Review of the CMS 209 revealed seven (7) TP identified as responsible for resulting moderate complexity hematology Complete Blood Count (CBC) patient testing. TP B was identified as being a new TP in calendar year 2018. (See Personnel Code Sheet.) 2. Review of personnel records revealed that TP B was initially trained and responsible for performing patient CBC testing in March 2018. The review of records revealed no semi-annual hematology CBC competency assessment documented for TP B. The inspector requested to view the semi-annual competency assessment documentation. The documentation could not be presented for review. The laboratory manager stated on 2/19/20 at approximately 4:30 PM: "I was not the manager at the time of this training and do not have any additional records for the semi annual training". 3. In an exit interview with the laboratory manager and primary TP, on 2/19/20 at approximately 5:45 PM, the above findings were confirmed. -- 2 of 2 --