Walk In Care - Forest

Summary Statement of Deficiencies D0000 An announced on-site CLIA recertification survey was conducted at Walk In Care- Forest on October 20, 2020 by the Virginia Department of Health's Office of Licensure and Certification. The survey included an entrance interview on 10/05/2020 and virtual record review conducted on 10/14/2020. The laboratory was surveyed under 42 CFR part 493 CLIA Regulations. Specific deficiency cited 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 a review of the laboratory's Centers for Medicare and Medicaid Services (CMS) 116 form, patient test logs, four (4) randomly selected patient reports, and an interview, the laboratory's complete blood count (CBC) test report failed to include the correct performing laboratory name and address during the timeframe of July 25, 2019 to the date of the record review on October 14, 2020. Findings include: 1. Review of the laboratory's CMS 116 form revealed a laboratory name and physical facility location as follows: Walk In Care-Forest 1175 Corporate Park Drive Forest, Virginia 24551 2. The inspector requested to review the following CBC results from the patient test logs: medical record number (MR #) 9758764 from 7/25/19, MR # 9584942 from 11/ 5/19, MR # 9742888 from 1/14/20, and MR # 9754861 from 10/14 /20. The inspector's review noted that the 4 randomly selected patient CBC reports 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 -- revealed performing laboratory name and testing location as: Blue Ridge Immediate Care 2137 Lakeside Drive Lynchburg, Virginia 24501 The primary testing personnel stated at, approximately 11 AM, that the facility had been re-branded in July of 2019 and that they failed to note and enter the updated name and address on the CBC printed report. 3. In an interview with the Clinical Laboratory Resource Specialist on 10/14/20 at approximately 11:30 AM, the above findings were confirmed. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the CVFP Immediate Care Lakeside on August 9, 2018 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: D5807 TEST REPORT CFR(s): 493.1291(d) Pertinent "reference intervals" or "normal" values, as determined by the laboratory performing the tests, must be available to the authorized person who ordered the tests and, if applicable, the individual responsible for using the test results. This STANDARD is not met as evidenced by: Based on a review of five (5) patient Complete Blood Count (CBC) test reports from the laboratory's electronic health record (EHR) and interview, the laboratory's Athena EHR patient CBC report failed to contain CBC reference intervals or normal values at the date of survey on August 9, 2018. Findings include: 1. Review of 5 patient Complete Blood Count (CBC) test reports generated from the Athena EHR revealed that the reports lacked CBC reference intervals or normal values. 2. An interview with the primary testing personnel and laboratory clinical coordinator at approximately 12: 00 PM, it was confirmed that the Athena EHR lacked CBC reference intervals or normal values. 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. 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 -- This STANDARD is not met as evidenced by: Based on the review of CMS-209 Laboratory Personnel Report Form (CLIA), testing personnel (TP) records, and interview, the technical consultant failed to perform and document semi-annual competency assessments for three (3) of three (3) TP in 2018. Findings include: 1. Review of the CMS-209 form revealed that the lab director also performs the duties of technical consultant and that there were 3 new TP hired in 2017. (See attached personnel code list.) 2. Review of the TP records revealed: TP A- hired and trained December 11, 2017; TP B- hired and trained October 1, 2017; TP C- hired and trained September 18, 2017. Record review revealed no documentation of the evaluation and review of the semi-annual competency assessments by the technical consultant in 2018. 3. An interview with the primary testing personnel and laboratory clinical coordinator at approximately 12:00 PM confirmed that the technical consultant failed to perform the evaluation and review of the semi-annual competency assessments in 2018 for the new TP. D6054 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 annually, after the first year. This STANDARD is not met as evidenced by: Based on the review of CMS 209 Laboratory Personnel Report Form (CLIA), testing personnel (TP) records, and interviews, the technical consultant failed to perform and document annual competency assessments for one (1) of one (1) TP in 2017. Findings include: 1. Review of the CMS-209 form revealed that the lab director also performs the duties of technical consultant and that TP D was performing patient testing in 2017. (See attached personnel code list.) 2. Review of the TP D records revealed no documentation of a competency assessment performed by the technical consultant in 2017. The inspector requested the competency assessment for TP D. The documentation was not available for review. 3. An interview with the primary testing personnel and laboratory clinical coordinator at approximately 12:00 PM confirmed that the technical consultant failed to perform the competency assessment for TP D in 2017. -- 2 of 2 --