Appalachian Labs Of Wv

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted at Appalachian Labs of WV on May 13, 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 a review of policies and procedures, laboratory testing personnel records, lack of documentation, an interview with the general supervisor (GS), and an exit interview with the laboratory team, the laboratory failed to document the annual competency assessment (CA) for three of three testing personnel (TP) in LC/MS toxicology testing for 2023 and/or 2024. Findings: 1. Review of policies identified "Competency Evaluations" stating "testing personnel competencies are done every 6 months for the first year, thereafter on an annual basis." 2. Review of 2022, 2023, 2024, and 2025 TP records identified the following documented annual CA for the performance of LCMS testing: TP1 annual 4/8/2022, annual 5/19/2025 (no 2023 or 2024 CA) TP2 initial 7/17/2022, semi-annual 11/17/2022, 7/16/2023 (no 2024 CA) TP3 semi-annual 5/15/2022, annual 11/15/2022 (no 2023 or 2024 CA) 3. During an interview 5/13/2025 at approximately 8:30 AM, the GS stated the documentation for the missing competency assessments for 2023 and 2024 could not be located. 4. An exit interview with the laboratory team, 3/15/25 at 3:15 PM, confirmed the lack of documented competency assessments for the TP. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE 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 -- CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on a review of College of American Pathologists (CAP) proficiency testing (PT) records, LCMS Sciex analyzer records, lack of documentation, and an exit interview with the technical supervisor (TS) and laboratory team, the laboratory failed to document the evaluation of ungraded PT results for one of one LCMS toxicology event of 2025. Findings: 1. Review of CAP 2025 UDC-A evaluation report revealed no results graded for analytes MDA and MDMA in toxicology confirmation testing. CAP coded the analytes as {42} no response received. 2. Review of raw data from the LCMS Sciex analyzer for 2025 UDC-A identified a result for both MDA and MDMA analytes on the PT specimens. 3. No

Summary Statement of Deficiencies D0000 An off site, proficiency testing (PT) desk review was conducted for Appalachian Labs of WV on August 26, 2024, by the West Virginia Office of Laboratory Services. The laboratory PT evaluations were reviewed for successful participation and compliance with the Federal Clinical Laboratory Improvement Amendments (CLIA) under 42 CFR 493. The identified unsuccessful participation in PT is an initial occurrence and explained below. D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of CASPER 155D proficiency testing (PT) report, laboratory evaluations from the College of American Pathologists (CAP), and interview, the 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 -- laboratory failed to achieve satisfactory performance for the analyte #0635 Carbamazapine in two consecutive testing events resulting in unsuccessful participation for the specialty of #0605 Toxicology for the first two PT events in 2024. Refer to D2110 and D2111. D2110 TOXICOLOGY CFR(s): 493.845(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of CASPER 155D proficiency testing (PT) report, laboratory PT evaluations from the College of American Pathologists (CAP), and interview, the laboratory failed to achieve satisfactory performance for the specialty of #0605 Toxicology in two consecutive testing events in 2024. Findings: 1. Review of CASPER 155D Report revealed the following unsatisfactory performance for the #0605 Toxicology specialty: 66% 2024 event 1 66% 2024 event 2 2. CAP laboratory evaluations confirmed the unsatisfactory performance for #0605 Toxicology due to 0% failure to participate scores for the analyte #0635 Carbamazepine in two consecutive PT events. 3. The technical supervisor, via telephone interview 8/23/24 at 9:30 AM, confirmed the unsatisfactory performance for #0605 Toxicology and stated the #0635 Carbamazepine 0% scores was due to not removing the analyte from the CAP menu. D2111 TOXICOLOGY CFR(s): 493.845(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on review of CASPER 155D proficiency testing (PT) report, laboratory PT evaluations from the College of American Pathologists (CAP), and interview, the laboratory failed to successfully participate in two consecutive testing events for the analyte #0635 Carbamazapine in 2024. Findings: 1. Review of CASPER 155D Report revealed the following unsatisfactory scores for the analyte #0635 Carbamazepine: 0% 2024 event 1 0% 2024 event 2 2. CAP laboratory evaluations confirmed the 0% failure to participate scores for the analyte #0635 Carbamazepine in two consecutive PT events. 3. The technical supervisor, via telephone interview 8/23/24 at 9:30 AM, confirmed the failure to participate and stated that the #0635 Carbamazepine 0% scores was due to not removing the analyte from the CAP menu when the laboratory ceased testing. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced, on site, routine recertification survey was conducted at Appalachian Labs of WV on July 25, 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 cited are explained below. 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. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview the laboratory failed to verify the accuracy of 46 of the 88 analytes tested on the Sciex toxicology analyzers (two 4500 analyzers and two 5500 analyzers) in 2022 and 2023. Findings: 1. Review of proficiency testing (PT) documents (January thru December 2022 and January thru date of survey 2023) revealed 46 analytes that are not included in Subpart I and not enrolled in commercial PT. 2. No documentation of the verification of accuracy for the 46 analytes on the Sciex analyzers could be located for the timeframe reviewed. 3. An exit interview with the technical supervisor and laboratory administration, 7/25/23 at approximately 5:00 PM, confirmed the lack of accuracy verification for the 46 analytes. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When 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 -- control materials providing quantitative results are used, statistical parameters (for example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview the laboratory failed to document the verification of new lots of external quality control (QC) for the Abacus- 5 hematology analyzer and the validation of the established statistical parameters for new lots of external QC on the Sciex 4500 and 5500 analyzers before being put into use for patient testing. Findings; 1. No policy or procedure could be located for the following: a) verifying manufacturer's established values for assayed hematology QC b) validating statistical parameters for unassayed, in house prepared toxicology QC 2. No documentation of the verification of the manufacturer established limits for new lots of assayed QC for the Abacus-5 hematology analyzer could be located. 3. No documentation could be located that new lots of in house prepared toxicology QC for the Sciex analyzers recovered the established statistical parameters for each analyte before being put into use. 4. An exit interview with the technical supervisors and laboratory management, 7/25/23 at approximately 5:00 PM, confirmed no policy or procedure for the validation and verification of new lots of QC and no documentation of the processes could be located. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on written policies and procedures (P&P), record review, lack of documentation, and interview the laboratory failed to establish a system to evaluate the comparison of test results between instruments. Findings: 1. Review of P&P revealed a lack of an established process to compare test results derived from the same methodology but performed on different analyzers. 2. Review of analyzer records identified testing performed between 2 of 4 Sciex analyzers in 2022 and 2023. No documentation of the evaluation of the data and the acceptability criteria for the comparison could be located. 3. No documentation of the comparison of test results and criteria for acceptability between the two CLC 720i analyzers for 2023 could be located. 4. An exit interview with technical supervisor 1 and technical supervisor 2, 7 /25/23 at approximately 5:00 PM, confirmed the laboratory had no P&P in place for performing and evaluating comparison testing among analyzers performing the same methodology of testing. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced, on site, recertification survey was conducted at Appalachian Labs of WV on July 20, 2021, by the West Virginia Office of Laboratory Services. The laboratory was surveyed to assess compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of records and interview the laboratory failed to evaluate the unsuccessful results of 1 of 3 College of American Pathologists (CAP) 2020 proficiency testing (PT) events and 1 of 2 CAP 2021 PT events. Findings: 1. Review of CAP records for 2020 UDC-D revealed no evaluation of the unacceptable results for the following analytes: hydromorphone, EDDP, oxycodone. 2. Review of CAP records for 2021 UDC-A revealed no evaluation of the unacceptable results for the following analytes: morphine, amphetamines, buprenorphine, norbuprenorphine, THC, phenobarbital, benzoylecgonine, hydromorphone. 3. An interview with the technical supervisor, on 7/20/21 at approximately 12:00 PM, confirmed the findings. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and, when indicated, correct problems identified in the general laboratory systems requirements specified at 493.1231 through 493.1236. 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 -- This STANDARD is not met as evidenced by: Based on review of policies and procedures (P&P) and interview the laboratory failed to establish a written P&P for the quality assessment (QA) of the general laboratory systems for LCMS/MS testing, which includes the monitoring and assessment of confidentiality, specimen identification and integrity, complaint investigations, communications, personnel competency, and proficiency testing evaluation. Findings: 1. No written P&P for QA of general laboratory systems for LCMS/MS testing could be located. 2. An interview with the technical supervisor, 7/20/21 at approximately 9: 15 AM, confirmed the findings. D5391 PREANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1249(a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the preanalytic systems specified at 493.1241 through 493.1242. This STANDARD is not met as evidenced by: Based on a review of policies and procedures (P&P),and interview the laboratory failed to establish a written P&P for the quality assessment (QA) of the preanalytic system for the LCMS/MS testing, which includes test request and specimen submission, handling, and referral. Findings: 1. No written P&P could be located for the QA of the LCMS/MS preanalytic systems. 2. An interview with the technical supervisor, on 7/20/21 at approximately 9:15 AM, confirmed the findings. 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) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

Summary Statement of Deficiencies D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper storage of reagents and specimens, accurate and reliable test system operation, and test result reporting. The criteria must be consistent with the manufacturer's instructions, if provided. These conditions must be monitored and documented and, if applicable, include the following: (1) Water quality. (2) Temperature. (3) Humidity. (4) Protection of equipment and instruments from fluctuations and interruptions in electrical current that adversely affect patient test results and test reports. This STANDARD is not met as evidenced by: Based on a tour of the laboratory and an interview with Testing Personnel 1 (TP1), the laboratory failed to accurately monitor the conditions (2) temperature and (3) humidity essential for proper storage of reagents and test system operation. Findings: 1. The room temperature and humidity of the laboratory were being monitored and documented from a thermometer/hydrometer that had an expired NIST calibration. The NIST certified calibration of the Control Company 4095 thermometer/hydrometer (SN 140202060) expired 3/21/2016. 2. The temperature of the freezer, used to store patient specimens, was being monitored and documented from a thermometer that had an expired NIST calibration. The NIST certified calibration of the Control Company 4227 thermometer (SN 140090585) expired 2/3/2016. 3. The temperature of the two refrigerators, used to store reagents and quality control materials, were being monitored and documented from thermometers that had expired NIST calibrations. The NIST certified calibrations of the Control Company 4227 thermometers (SN 140524828 and SN 140571239) expired 8/4/2016 and 8/26/2016. 4. An interview with TP1, on 11/19/19 at approximately 11:45 AM, 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 --