Mountaineer Family Medicine Lab

Summary Statement of Deficiencies D6093 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) (e)(5) Ensure that the quality control and quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur; This STANDARD is not met as evidenced by: No deficiency details available. 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 A routine recertification survey was conducted at Mountaineer Family Medicine Lab on March 18, 2025, by the West Virginia Office of Laboratory Services. The laboratory was assessed for compliance with the CLIA regulations under 42 CFR 493, Requirements for Laboratories. Specific deficiencies cited are explained below. D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on review of written policies and procedures, lack of documentation, and interview with the technical supervisor (TS1), the laboratory failed to establish and follow a process to assess the competency of clinical consultant (CC), technical supervisor (TS), and general supervisor (GS) positions based on the position responsibilities listed in Subpart M. Findings: 1. Review of "Laboratory Quality Management Plan" identified "Personnel, New Employee Orientation, Training, and Competency Assessment" stating the requirements and frequency of competency assessment for testing personnel. 2. No written policy or procedure to assess the competency of the clinical consultant, technical supervisor, and general supervisor based on the position responsibilities could be located. 3. During an interview with the TS1, 3/18/25 at 9:45 AM, the TS1 stated that no competency of the CC, TS, and GS based on position responsibilities had been documented and no written policy or procedure could be located. 4. An exit interview with TS1 and GS, 3/18/25 at 5:35 PM, confirmed the findings. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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. This STANDARD is not met as evidenced by: Based on review of College of American Pathologists (CAP) proficiency testing (PT) records, current laboratory test menu, lack of documentation, and interview with the technical supervisor (TS2), the laboratory failed to verify the accuracy of 9 of the 35 analytes tested in a toxicology confirmation panel on the AB Sciex 3200 toxicology analyzer twice in 2024. Findings: 1. Review of CAP PT records for 2024 revealed 9 analytes that are on the current laboratory test menu for the AB Sciex 3200 confirmation panel and not enrolled in commercial PT (7-aminoclonzepam, Amitriptyline, Gabapentin, Lorazepam, MDMA, Meperidine, PCP, Tapentadol, Venlafaxine). All 9 are unregulated analytes and not included in Subpart I. 2. No documentation that the laboratory performed an alternate accuracy verification twice in 2024 could be located for the 9 analytes. 3. A phone interview with TS2, 3/18/25 at approximately 4:05 PM, confirmed the lack of alternative verification for the 9 analytes in 2024. TS2 stated the commercial PT program did not cover the whole test menu and an alternative verification will happen. 4. An exit interview with TS1 and GS, 3/18/25 at 5:35 PM, confirmed the findings. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) 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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493. 1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on review of written policies and procedures, AB Sciex 3200 LCMS toxicology analyzer external quality control (QC) records, interview with the technical supervisor (TS1) and interview with the general supervisor (GS), the laboratory failed to perform and document three levels of external quality control (QC) with each run of patient specimens as established by the laboratory. Findings: 1. Review of "3200 Confirmation Procedure" revealed "Quality Control Protocol" stating "for the assay run to be deemed acceptable, the following criteria must be met: Negative QC level within range and One of two Positive QC levels within range". Reference charts for quality control materials used and the expected concentrations state "QC-1 Low QC- 75% of cutoff, QC-2 2x cutoff, QC-3 7x cutoff". 2. Review of 2025 AB Sciex 3200 QC records (November 2024 thru date of survey) identified two levels of QC evaluated for acceptability with each run of patient samples: QC-1-Low QC 75% of cutoff and QC-2 2x cutoff for 35 of 35 analytes. No documentation that the QC-3 7x cutoff level of QC was performed could be located. 3. During an interview with the GS, 3/18/25 at approximately 12:25 PM, GS stated that only two levels of QC are evaluated and documented as acceptable for the toxicology testing in the Stratus -- 2 of 4 -- laboratory information system (LIS) for each patient run. 4. An exit interview with TS1 and GS, 3/18/25 at 5:35 PM, confirmed the findings. D5801 TEST REPORT CFR(s): 493.1291(a) (a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on a review of Stratus laboratory information system (LIS) patient results, chromatograms from the AB Sciex 3200 LCMS toxicology analyzer, direct observation of test setup in the Stratus LIS, interview with the technical supervisor (TS1), and general supervisor (GS), the laboratory failed to ensure the cutoff values programmed into the Stratus LIS were correct for one of 11 analytes in the drug screening panel and one of 35 analytes in the drug confirmation testing panel. Findings: 1. Review of 5 final patient toxicology reports from the Stratus LIS system and the corresponding chromatograms from the AB Sciex 3200 LCMS analyzer identified the following: a. Patients 76331 and 78401 were both reported in the Stratus LIS as POSITIVE for benzodiazepine screening with a stated cutoff of 300 ng/mL. Review of chromatograms revealed both patient results were below 300 ng/mL (228.5 and 184.7, respectively). b. Patients 79076 and 86325 were both reported in the Stratus LIS as POSITIVE for buprenorphine confirmation with a stated cutoff of 50 ng /mL. Review of chromatograms revealed both patient results were below 50 ng/mL (34 and 33, respectively). 2. On a tour of the laboratory, 3/18/2025 at approximately 3: 00 PM, the GS accessed and reviewed the Stratus LIS test setup for benzodiazepine screen and buprenorphine confirmation. The cutoff for benzodiazepine on the drug screening panel was programmed at 100 ng/mL. Subsequently, patients 76331 and 78401 were reported as POSITIVE when the results obtained were negative according to the lab's established cutoff of 300 ng/mL. The cutoff for buprenorphine on the drug confirmation panel was programmed at 25 ng/mL. Subsequently, patients 79076 and 86325 were reported as POSITIVE when the results obtained were negative according to the lab's established cutoff of 50 ng/mL. 3. During an interview with TS1, 3/18/25 at 3:15 PM, TS1 stated the cutoffs programmed into the Stratus LIS were inaccurate according to the established cutoffs for the two analytes. 4. An exit interview with TS1 and GS, 3/18/25 at 5:35 PM, confirmed the findings. D5807 TEST REPORT CFR(s): 493.1291(d) (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: -- 3 of 4 -- Based on review of written policies and procedures, Stratus laboratory information system (LIS) final report, and interview with the technical supervisor (TS1) and the general supervisor (GS), the laboratory failed to ensure the reference intervals (cutoffs) provided to clients for interpretation of drug screen results were accurate for two of 35 confirmation analytes on the final report. Findings: 1. Review of the "Reference Ranges" in the "3200 Confirmation Test Procedure" stated cutoffs established during instrument validation for all 35 analytes tested in a confirmation toxicology panel on the AB Sciex 3200 analyzer. 2. Review of one Stratus LIS patient report (69876) identified a PCP cutoff of 50 ng/mL and 6-MAM cutoff as 20 ng/mL. The "3200 Confirmation Test Procedure" stated that both the PCP and 6-MAM cutoffs were 100 ng/mL. 3. During an interview with the TS1, 3/18/25 at approximately 11:00 AM, TS1 agreed the cutoffs for PCP and 6-MAM on the LIS final report differed from the cutoffs for PCP and 6-MAM in the written test procedure. 4. An exit interview with TS1 and GS, 3/18/25 at 5:35 PM, confirmed the findings. D5893 POSTANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1299(b)(c) (b) The postanalytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies D0000 An announced, on site, routine recertification survey was conducted for Mountaineer Family Medicine Lab on April 19, 2023, by the West Virginia Office of Laboratory Services. The laboratory was assessed for compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. D5781

Summary Statement of Deficiencies D0000 An announced, on site, recertification survey was conducted at Mountaineer Family Medicine Lab on April 27, 2021, by the West Virginia Office of Laboratory Services. The laboratory was surveyed for compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview the laboratory failed to (2) retain the documentation of proficiency testing (PT) remedial actions taken for an unsatisfactory score in 1 of 2 College of American Pathologists (CAP) testing events in 2020 for the API 3200 ABSCIEX LCMS toxicology confirmation testing. Findings: 1. Review of CAP PT 2020 evaluation scores identified an unsatisfactory score for DMPM-B 2020. 2. No documentation could be located for the remedial actions taken by the laboratory for the DMPM-B 2020 unsatisfactory score. 3. The technical supervisor confirmed the findings on 4/27/2021 at 12:15 PM. D3031 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- 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 record review, lack of documentation, and interview the laboratory failed to retain the API 3200 ABSCIEX LCMS analyzer quality control (QC), calibrations, maintenance, function checks, reagent storage, and environmental monitoring documentation records for 17 of 18 months reviewed. Findings: 1.Record review from September 2019 thru April 2021 identified no API 3200 ABSCIEX LCMS analytic systems records for 4 of 4 months in 2019, 12 of 12 months in 2020, and 1 of 2 months in 2021. Lack of documentation included: no QC data and review from patient testing days, calibration data and review from patient testing days, maintenance, function checks, temperature and humidity logs, and reagent use and storage monitoring. 2. The technical supervisor confirmed the findings on 4/27/2021 at 1:00 PM. D3037 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(4) Proficiency testing records. Retain all proficiency testing records for at least 2 years. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview the laboratory failed to retain all College of American Pathologists (CAP) proficiency testing (PT) records for 4 of 4 testing events in 2019 and 2020 for the API 3200 ABSCIEX LCMS toxicology analyzer. Findings: 1. Record review of CAP PT documentation for 2019 and 2020 revealed a lack of records for 2 of 2 events in 2019 and 2 of 2 events in 2020. Lack of documentation included: no original data results from the analyzer, signed attestation statements, laboratory review of submitted results, and

Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based upon a review of the written policies and procedures of the laboratory and an interview with Testing Personnel 1 (TP1), the laboratory failed to establish written policies and procedures for (7) specimen acceptability and rejection. Findings: 1. A review of written policies and procedures could not locate a written policy for specimen acceptability and rejection criteria. 2. An interview with TP1, on 8/28/19 at approximately 11:30 AM, confirmed there is no written policy/procedure for acceptability and rejection criteria of laboratory specimens. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) 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 -- The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)