Carilion Childrens - Pediatric Medicine-Daleville

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Carilion Children's Pediatric Medicine (Daleville) on 11/12/21 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 is in compliance with the applicable COVID-19 reporting requirements. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on the review of Laboratory Personnel Report Form (CLIA) (CMS-209 Form), testing personnel (TP) records, lack of documentation, and interview with the TP A and the technical consultant (TC), the TC failed to perform and document annual competency assessment for one of one TP in 2019. Findings include: 1. Review of the CMS-209 form revealed that TP B performs patient testing. See attached TP code sheet. 2. Review of the TP records revealed lack of documentation by the TC of performance of an annual competency assessment for the calendar year of 2019. 3. An exit interview with the TP A and TC on 11/12/21 at approximately 1200 confirmed the findings. 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 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Carilion Children's Pediatric Medicine-Daleville on July 23, 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: D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. This STANDARD is not met as evidenced by: Based on the review of quality assurance (QA) records, patient test reports and interview with the technical consultant, the laboratory failed to ensure the correct name and address of the testing laboratory was included on four (4) of 4 patient testing reports (Patients 1-4) on July 8, 10, 15 and 17, 2019. Findings include: 1. Review of the QA records for the manual result transcription audits for 2019 revealed that the patient test reports from the EPIC Electronic Medical Record (EMR) did not include the correct laboratory name and address for the following patients: Patient 1- resulted in EPIC EMR on July 8, 2019, Patient 2- resulted in EPIC EMR on July 10, 2019, Patient 3- resulted in EPIC EMR on July 15, 2019 and, Patient 4- resulted in EPIC EMR on July 17, 2019. The name and address provided on the final patient test 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 -- report: Peds Assoc-Botetourt 89 Summers Way, Suite 201 Roanoke, VA 24019. 2. The technical consultant confirmed that the name and address was not correct for the above-listed patients in an interview at approximately 11:30 AM. -- 2 of 2 --