Wellmont Medical Associates, Inc

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Wellmont Medical Associates on 12/20/22 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. 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. 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, the technical consultant (TC) failed to perform and document the semi-annual competency assessment for one of one new TP. Dates of record review include 02/01/21 up to the date of survey on 12/20/22. Findings include: 1. Review of the CMS-209 form revealed that TP A was trained and performing patient testing as of 04/22/21. See attached TP code sheet. 2. Review of TP A records revealed a lack of documentation of a semi-annual competency assessment by the TC. 3. An exit interview with the TC on 12/20/22 at approximately 14:15 PM 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 on-site survey was conducted at the Wellmont Medical Associates, Inc (Bristol) on March 17, 2021 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. The initial contact and entrance interview with laboratory conducted on February 19, 2021 with off-site record review of documentation and a follow-up phone conference on March 16, 2021. Specific deficiencies cited are as follows: The laboratory is performing COVID-19 testing and in compliance with the applicable COVID-19 reporting requirements. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on the review of manufacturer's Food and Drug Administration's (FDA) Emergency Use Authorizations (EUA), available patient/quality control (QC) logs, lack of documentation and interviews, the laboratory failed to perform external positive and negative QC for six (6) of 8 days and 11 patients reviewed. 1. Review of the Cepheid Xpert Xpress SARS-CoV-2/Flu/RSV manufacturer's FDA EUA revealed the following statement "Testing of nasopharyngeal swab, nasal swab, or nasal wash /aspirate specimens using the Xpert Xpress SARS-CoV-2/Flu/RSV test run on the GeneXpert Dx and GeneXpert Infinity systems is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, that meet requirements to perform high or moderate complexity tests." 2. In an interview with the primary testing personnel and lab manager on 03/17/21 at 11:40 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 -- AM and review of records, it was revealed the lab utilizes the GeneXpert DX instrument (serial number 738085) and began testing patients on 02/01/21. In addition, the lab performed external QC procedures on 02/01/21 and 03/03/21. 3. Review of available patient and QC logs revealed the following dates and patients tested: 02/09/21- Patient 1, 02/10/21- Patient 1, 02/16/21- Patient 1 and 2, 02/26/21- Patient 1 and 2, 03/01/21- Patient 1 and 03/05/21- Patient 1, 2, 3 and 4. The inspector requested to review the daily external positive and negative QC documents for the above-specified dates. The lab lacked documentation of the requested QC. 4. An interview with the primary testing personnel and lab manager on 03/17/21 at 11:45 AM confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Wellmont Medical Associates on November 15, 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: D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Analytic systems records. Retain quality control and patient test records (including instrument printouts, if applicable) and records documenting all analytic systems activities specified in 493.1252 through 493.1289 for at least 2 years. This STANDARD is not met as evidenced by: Based on a review of quality control (QC) records, and interviews, the laboratory failed to retain the Beckman Coulter "6C Cell control " manufacturer's assay information inserts documenting Complete Blood Cell (CBC) count QC acceptable ranges for ten (10) of ten (10) QC lot numbers utilized from May 2017 until October 2018. Findings include: 1. Review of the laboratory's Intralaboratory Quality Assurance Program (IQAP) documents for the Beckman Coulter AcT diff 2 from May 2017 until October 2018 revealed 10 lot numbers of "6C Cell control" QC material were utilized to document and evaluate patient testing on the DxH 600 analyzer. The following QC lot numbers had no acceptable ranges or manufacturer's package inserts : 123171640/133181640/143191649 exp May 27, 2017, 123171860/133181860 /143191860 exp December 8, 2017, 123171920/133181920/143191920 exp January, 22, 2018, 123172000/133182000/143192000 exp March 16, 2018, 123172030 /133182030/143192030 exp April 6, 2018, 123172060/133182060/143192060 exp Aril 27, 2018, 123172110/133182110/143192110 exp June 8 2018, 123172140 /133182140/143192140 exp July 6 2018, 123172180/133182180/143192180 exp August 3 2018, 12317220/133182220/143192220 exp Sept 7 2018. A total of 10 "6C Cell control" QC lot numbers with no acceptable ranges or manufacturer's package 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 -- inserts. 2. The surveyor requested to review the package inserts for the 10 lot numbers of QC listed above. No documentation was provided at the date of survey. 3. An interview with the laboratory manager and technical supervisor at approximately 2:45 PM confirmed the findings. -- 2 of 2 --