Msrc, Llc

Summary Statement of Deficiencies D0000 A routine recertification survey was completed at MSRC, LLC. on August 20, 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. 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 College of American Pathologists (CAP) proficiency testing (PT) evaluation reports, laboratory PT records, lack of documentation, and interview with the technical supervisor (TS), the laboratory failed to evaluate unacceptable scores for toxicology analytes in one of two UDS screening testing events and one of two DMPM confirmation testing events in 2024. Findings: 1. Review of four 2024 CAP PT evaluation reports (UDS-B, -C and DMPM-A,-B) revealed the following unacceptable scores: For UDS-C 2024 specimen UDS-11, laboratory reported a positive methamphetamine screening result that CAP graded as unacceptable. For DMPM-B 2024 specimen 06, laboratory reported a quantitative result for pregabalin that CAP graded as unacceptable. 2. Review of the laboratory PT records for 2024 revealed no documented evaluation of the two unacceptable analyte scores. 3. During an interview, 8/20/25 at 9:00 AM, the TS stated that no documented evaluation for the two unacceptable results could be located. 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 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 -- 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 the current laboratory test menu, College of American Pathologists (CAP) proficiency testing (PT) records, laboratory quality assessment (QA) documents, lack of documentation, and interview with the technical supervisor (TS), the laboratory failed to verify the accuracy for 8 of 8 toxicology analytes tested on the Biolis 24i screening panel from January 2025 thru date of survey. Findings: 1. Review of the current test menu on the Biolis 24i toxicology analyzer identified an 8 analyte screening panel ( buprenorphine, amphetamine, methamphetamine, benzodiazepine, cocaine metabolite, methadone, opiate, and oxycodone). 2. Review of CAP PT records for 2025 revealed the 8 analytes on the Biolis 24i screening panel were not enrolled in commercial PT. All 8 are unregulated analytes and not included in Subpart I. 3. Review of laboratory QA documents revealed no documentation that the laboratory performed an alternate accuracy verification from January 2025 thru date of survey for the 8 analytes. 4. During an interview, 8/20/25 at 10:00 AM, the TS stated no commercial PT or alternative verification for the 8 Biolis 24i analytes had taken place yet in 2025. 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. This STANDARD is not met as evidenced by: Based on review of toxicology policies and procedures, quality assessment (QA) documents, lack of documentation, and interview with the technical supervisor (TS), the laboratory failed to follow established policies for monitoring and correcting problems in the general laboratory systems from October 2024 thru date of survey. Findings: 1. Review of laboratory QA policies identified the following elements of the general laboratory systems to be monitored on a monthly basis and findings documented on the "MSRC Monthly Quality Assurance Monitor": investigation of unacceptable proficiency testing (PT) results and documentation alternative PT assessment was completed as needed. 2. Review of MSRC Monthly Quality Assurance Monitor (October 2024 thru date of survey) revealed no documentation that the performance of the general laboratory systems QA involving the investigation of unacceptable PT scores and the alternative PT assessment occurred. Refer to D5211 and D5217. 3. During an interview, 8/20/25 at 12:00 PM, the TS stated the general laboratory systems QA had not been performed since October 2024. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(g) (d)(10) Establish or verify the criteria for acceptability of all control materials. (d)(10) (i) When 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. (d)(10)(ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value -- 2 of 3 -- is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (d)(10)(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. This STANDARD is not met as evidenced by: Based on review of toxicology policies and procedures, quality control (QC) records for the Sciex LCMS analyzer, Main Panel Batch Run Forms, lack of documentation, and interview with the technical supervisor (TS), the laboratory failed to (d)(10)(ii) document the evaluation and verification of acceptability for two of two new lots of commercially assayed QC in 2025. Findings: 1. Review of "Analytic Procedure V 2.0" for LCMS testing identified the process for preparation, evaluation, and verification of acceptability for new lots of QC materials (QC Working Stock) from commercially prepared analytical reference standards (Cerilliant). 2. Review of QC records and Main Panel Batch Run Forms (January 2025 thru date of survey) revealed the following new lots of QC Working Stock and the date put into use: lot 29 June 25 put into use 3/3/2025 lot 01 Nov 25 put into use 6/2/2025 3. No documentation of the evaluation and verification of acceptability for the two new lots of QC material could be located. 4. During an interview, 8/20/2025 at 11:00 AM, the TS stated that no evaluation and verification of acceptability for the two new lots of QC materials could be located. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced, on site, routine recertification survey was conducted at MSRC, LLC on July 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 cited below. 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 record review, lack of documentation, and interview the laboratory failed to monitor and document the water quality and utilize NIST calibrated thermometer /hydrometers to ensure accurate and reliable test system operation. Findings: 1. No documentation of the water quality for January 2023 thru date of survey could be located. 2. The thermometer/hydrometer used to monitor the environmental conditions of the laboratory analyzers has a NIST calibration that expired 9/27/21. 3. An exit interview with the technical supervisor, 7/19/23 at approximately 2:00 PM, confirmed that no documentation of water quality could be located for 2023 and the environmental conditions were being monitored from a thermometer/hydrometer with an expired NIST calibration. D5437 CALIBRATION AND CALIBRATION VERIFICATION 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 -- CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on written policies and procedures, record review, and interview the laboratory failed to (2) follow the calibration procedures established in the validation of the Sciex toxicology analyzer in October 2022. Findings: 1. Review of the validation binder for the Sciex identified a calibration policy stating each analyte will have a low calibrator that is 75% of the established cutoff. 2. Review of June 2023 calibration records for 4 of the 36 analytes (buprenorphine, fentanyl, hydrocodone, oxycodone) revealed the following: buprenorphine cutoff for positive result 25, lowest calibration point 80 fentanyl cutoff for a positive result 10, lowest calibration point 80 hydrocodone cutoff for a positive result 50, lowest calibration point 80 oxycodone cutoff for a positive result 50, lowest calibration point 80 3. An exit interview with the technical supervisor, 7/19/23 at approximately 2:00 PM, confirmed that the calibration for the analytes did not meet the established criteria of the validation of the Sciex analyzer. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic 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 at MSRC, LLC on August 18, 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 cited are as follows: D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: 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 -- Based on record review, lack of documentation, and interview the laboratory failed to perform and document calibration verification every 6 months for 10 of 10 analytes on the Biolis 24i analyzer for 2020 and 2021. Findings: 1. Review of 2020 and 2021 calibration records revealed all 10 analytes are calibrated with 2 levels of calibrator material at least weekly. 2. No documentation was found that calibration verification was performed on the 10 Biolis 24i analytes from February 2020 thru the date of the survey. 3. The laboratory director and the technical consultant confirmed during the exit interview on 8/18/21 at 12:00 PM that the calibration verification procedures had not been performed or documented. 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 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 review of policies and procedures (P&P), lack of documentation, record review, and interview the laboratory failed to establish the criteria for the acceptance of quality control values for 10 of 10 analytes tested on the Biolis 24i analyzer. Findings: 1. Review of P&P revealed a lack of specified acceptable ranges for quality control (QC) materials for amphetamines, methamphetamine, cocaine, benzodiazepine, buprenorphine, opiates, oxycodone, methadone, creatinine, and PH testing on the Biolis 24i analyzer. 2. Review of quality control records (April 2021 thru July 2021) identified: runs of 2 levels of QC for amphetamines, methamphetamine, cocaine, benzodiazepine, buprenorphine, opiates, oxycodone, and methadone and runs of 3 levels of QC for creatinine and PH on days of patient testing. 3. The laboratory director and technical supervisor confirmed during the exit interview, on 8/18/21 at 12:00 PM, that there was no documented acceptable ranges for the acceptance of QC on the Biolis 24i analyzer. -- 2 of 2 --

Summary Statement of Deficiencies 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 written laboratory policies and procedures and an interview with the technical supervisor (TS1), the laboratory failed to establish written policies and procedures to assess employee competency and initial training of testing personnel. Findings: 1. A review of written laboratory policies and procedures could not locate a written policy or procedure for assessing employee competency or initial training of testing personnel. 2. A review of written policies and procedures identified an employee assessment form for initial training and employee competency that contains all six of the required elements. 3. An interview with TS, on 1/22/2020 at approximately 9:40 AM, 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. This STANDARD is not met as evidenced by: Based on review of the laboratory written policies and procedures and an interview with the technical supervisor (TS1), the laboratory failed to establish a written policy Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- and procedure for monitoring, assessing, and correcting problems of the general laboratory systems. Findings: 1. No written policy or procedure for the Quality Assessment (QA) of the general laboratory systems could be located. This includes the monitoring and assessment of confidentiality, specimen identification and integrity, complaint investigations, communications, personnel competency, and proficiency testing evaluation. 2. An interview with TS1, on 01/22/2020 at approximately 10:30 AM, confirmed that no written policy or procedure for the QA of the general laboratory systems could be located. 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 on a review of written laboratory policies and procedures and an interview with the technical supervisor (TS1), the laboratory failed to establish a written policy or procedure for (8) specimen referral. Findings: 1. A review of written laboratory policies and procedures identified that no written policy or procedure for specimen referral could be located. 2. An interview with TS1, on 01/22/2020 at approximately 10:00 AM, confirmed that no written policy or procedure for specimen referral to QLabs for confirmation testing could be located. 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 laboratory written policies and procedures and an interview with the technical supervisor (TS1), the laboratory failed to establish a written policy or procedure for monitoring, assessing, and correcting problems identified in the preanalytic systems. Findings: 1. No written policy or procedure for the Quality Assessment (QA) of preanalytic systems could be located. QA of preanalytic systems includes test requests and specimen submission, specimen handling, and specimen referral. 2. An interview with TS1, on 01/22/2020 at approximately 10:30 AM, confirmed that no written policy or procedure for the QA of preanalytic systems could be located. 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, -- 2 of 6 -- 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)