Summary:
Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at Children's Choice, PC on January 7, 2019 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 proficiency testing (PT) records, Laboratory Personnel Report Form (CLIA) (CMS 209 form), and interview, the laboratory failed to rotate proficiency testing among the four (4) testing personnel (TP) for three (3) of the six (6) events reviewed. Record review included 2017 and 2018 events. Findings include: 1. The review of the American Proficiency Institute (API) PT records revealed that the same TP performed the following events: 2017 Event A- TP A 2017 Event B- TP A 2017 Event C- TP A (See attached personnel code list.) 2. Review of the CLIA CMS 209 form revealed 4 TP that performed testing in 2017. 3. An interview with the primary TP at approximately 11:00 AM confirmed that the laboratory failed to rotate the API PT events among all testing personnel for the above-specified events. 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 --