Wellmont Medical Associates Inc

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Wellmont Medical Associates DBA Ballad Health Medical Associates on 08/30/22 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. D2009 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(1) The individual testing or examining the samples and the laboratory director must attest to the routine integration of the samples into the patient workload using the laboratory's routine methods. This STANDARD is not met as evidenced by: Based on the review of proficiency testing (PT) records, lack of documentation, and interview with the lab manager and technical consultant, the lab director failed to review and sign one of two attestation statements in 2022. Findings include: 1. Review of the American Proficiency Institute (API) PT records revealed the lack of documentation of the lab director review and signature on the 2022 Chemistry second event attestation statement. 2. An exit interview with the laboratory manager and technical consultant on 08/30/22 at approximately 1500 confirmed the above findings. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. 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 proficiency testing (PT) records, lack of documentation and interviews, the lab failed to verify the accuracy of the folate and vitamin B12 analytes twice a year in 2021. Findings include: 1. The laboratory utilizes American Proficiency Institute (API) PT for verification of accuracy of the folate and vitamin B12 analytes, categorized as a non-regulated analyte. 2. API provides three events per calendar year for the folate and vitamin B12 analytes. Review of API PT results revealed the laboratory received the following scores: 2021 Routine Chemistry Event 1- unsatisfactory score of 60% for folate and vitamin B12, 2021 Routine Chemistry Event 2- 100% for folate and vitamin B12, and 2021 Routine Chemistry Event 3- unsatisfactory score of 60% for folate and vitamin B12. On 08/30/22 at approximately 11:15 AM, the surveyor requested the laboratory manager and technical consultant (TC) provide documentation of an alternative method(s) for verification of accuracy twice a year for the above-specified analyte in 2021. The documentation was not available for review. 3. An exit interview with the laboratory manager and technical consultant on 08/30/22 at approximately 1500 confirmed the above findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced CLIA Recertification survey was conducted at the Wellmont Medical Associates on July 25 and 26, 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: D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: A. Based on the initial tour of the laboratory, review of the manufacturer's verification protocol, policy manual, patient test logs and interviews, the laboratory failed to follow the written procedure in performing initial verification procedures for the automated Estimated Sedimentation Rate (ESR) Excyte Mini test system on February 6, 2017 prior to reporting one-thousand nine-hundred and ninety-six (1996) from February 6, 2017 to the date of survey on July 26, 2018. Findings include: 1. The initial tour of the laboratory on July 25, 2018 revealed that the laboratory was performing ESR tests using the automated ESR Excyte Mini test system. 2. Review of the manufacturer's recommended verification protocol for the automated ESR Excyte Mini test system revealed the following statements: "The laboratory must compare the accuracy and precision of the test results it obtains using a test system to the manufacturer's accuracy claims. This should be done by testing commercially available quality control materials with known values. If test results for these samples Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- fall within the manufacturer's published acceptable limits and are reproducible, a laboratory has demonstrated accuracy and precision of the test system." 3. Review of the general laboratory quality systems policy revealed the following statements: " 6. Performance Specifications- Before a new nonwaived quantitative test is added or a different test system is put into use, we will ensure that our laboratory verifies the performance specifications by the following methods: - We will run at least two levels of controls at least 10 times each to show accuracy and precision. - Our clinical consultant will evaluate our patient demographics to determine if the manufacturer's reference intervals are applicable. The laboratory director and/or the technical consultant will review all above data prior to the release of any patient results. All data will be stored with other instrument installation records." 4. The inspector requested to review the initial verification procedures performed for the new test system on or prior to testing patients on February 6, 2017. The documentation was not available for review. Review of the patient test logs revealed that 1996 patients were assayed and resulted from February 6, 2017 up to the date of survey on July 26, 2018. 5. An interview with the technical consultant and testing personnel on July 26, 2018 at approximately 1:00 PM confirmed that the laboratory failed to perform the initial verification procedures for the automated ESR Excyte Mini test system prior to resulting patients. B. Based on the tour of the laboratory, review of the policy manual, patient test logs and interviews, the laboratory failed to follow the written procedure for performing initial verification procedures for the Meridian ImmunoCard Mycoplasma EIA test system prior to resulting one-hundred and fourteen (114) patients from February 23, 2018 up to the date of survey on July 26, 2018. Findings include: 1. The initial tour of the laboratory on July 25, 2018 revealed that the laboratory was performing patient testing using the Meridian ImmunoCard Mycoplasma EIA test system. 2. Review of the general laboratory quality systems policy revealed the following statements: " 6. Performance Specifications- "Before a new nonwaived test or test system is used, we will run external negative and positive controls to establish that we can achieve results established by the manufacturer. The laboratory director and/or the technical consultant will review all above data prior to the release of any patient results. All data will be stored with other instrument installation records." 3. The inspector requested to review the initial verification procedures performed for the new test system prior to testing patients on February 23, 2017. The documentation was not available for review. Review of the patient test logs revealed 114 patients were resulted from February 23, 2017 up to the date of survey on July 26, 2018. 4. An interview with the technical consultant and testing personnel on July 26, 2018 at approximately 1:00 PM confirmed that the laboratory failed to perform the initial verification procedures for the Meridian ImmunoCard Mycoplasma EIA test system prior to resulting patients. D6023 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(6) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(6) Ensure the establishment and maintenance of acceptable levels of analytical performance for each test system; This STANDARD is not met as evidenced by: Based on the tour of the laboratory, review of the policy manual, patient test logs and -- 2 of 3 -- interviews, the laboratory director failed to ensure that written procedure for performing initial verification procedures for the automated Estimated Sedimentation Rate (ESR) Excyte Mini and Meridian ImmunoCard Mycoplasma EIA test systems was followed prior to testing and reporting patients in February 2017 (Cross Reference D5421). Findings include: 1. The initial tour of the laboratory on July 25, 2018 revealed that the laboratory was performing the automated Estimated Sedimentation Rate (ESR) Excyte Mini and the Meridian ImmunoCard Mycoplasma EIA test systems. 2. Review of the general laboratory quality systems policy (signed by lab director on March 16, 2016 and on April 17, 2017) revealed the following statements: " 6. Performance Specifications- Before a new nonwaived quantitative test is added or a different test system is put into use, we will ensure that our laboratory verifies the performance specifications by the following methods: - We will run at least two levels of controls at least 10 times each to show accuracy and precision. - Our clinical consultant will evaluate our patient demographics to determine if the manufacturer's reference intervals are applicable. Before a new nonwaived test or test system is used, we will run external negative and positive controls to establish that we can achieve results established by the manufacturer. The laboratory director and/or the technical consultant will review all above data prior to the release of any patient results. All data will be stored with other instrument installation records." 3. The inspector requested to review the initial verification performance documentation of each system listed. The documentation was not available for review. 4. An interview with the technical consultant and testing personnel on July 26, 2018 at approximately 1:00 PM confirmed that the laboratory director failed to ensure that the initial verification procedures were followed for the two (2) test system specified above prior to resulting patients. -- 3 of 3 --