Manchin Clinic

Summary Statement of Deficiencies D0000 An offsite proficiency testing (PT) desk review was conducted for Manchin Clinic on October 6, 2025, by the West Virginia Office of Laboratory Services. The laboratory PT evaluations were reviewed for successful participation and compliance with the CLIA regulations under 42 CFR 493, Requirements for Laboratories. 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 and laboratory PT evaluations from the American Proficiency Institute (API), the laboratory failed to perform successfully in two consecutive testing events in 2025 for the analyte #0785 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 -- hematocrit, resulting in an initial occurrence of unsuccessful participation. Refer to D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of CASPER 155D proficiency testing (PT) report and laboratory PT evaluations from the American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance for the analyte #0785 hematocrit in two consecutive testing events in 2025, resulting in an initial occurrence of unsuccessful participation in PT. Findings: 1. Review of CASPER 155D PT report revealed the following unsatisfactory scores for for analyte #0785 hematocrit: 60% 2025 event 1 0% 2025 event 2 2. Review of 2025 API Hematology PT evaluation reports for testing events 1 and 2, confirmed the unsatisfactory scores and unsuccessful performance for analyte #0785 hematocrit in two consecutive testing events and the resulting occurrence of unsuccessful participation. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An offsite proficiency testing (PT) desk review was conducted for Manchin Clinic on July 24, 2025, by the West Virginia Office of Laboratory Services. The laboratory PT evaluations were reviewed for successful participation and compliance with the CLIA regulations under 42 CFR 493, Requirements for Laboratories. The identified unsuccessful participation 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 and PT evaluations from American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance for chemistry analytes #0305 total bilirubin in two of three 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 -- consecutive events and #0355 chloride and #0475 sodium in two consecutive testing events, resulting in an initial occurrence of unsuccessful participation in PT. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of CASPER 155D proficiency testing (PT) report and laboratory PT evaluations from American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance for the analyte #0305 total bilirubin in two of three consecutive PT events in 2024 and 2025, and analytes #0355 chloride #0475 sodium in two consecutive events in 2025, resulting in an initial occurrence of unsuccessful participation in PT. Findings: 1. Review of CASPER 155D PT report revealed the following unsatisfactory scores for analyte #0305 total bilirubin: 40% 2024 event 3 0% 2025 event 2 2. Review of CASPER 155D PT report revealed the following unsatisfactory scores for analyte #0355 chloride: 0% 2025 event 1 0% 2025 event 2 3. Review of CASPER 155D PT report revealed the following unsatisfactory scores for analyte #0475 sodium: 0% 2025 event 1 0% 2025 event 2 4. Review of 2024 and 2025 API Chemistry Core PT evaluation reports confirmed the unsatisfactory scores for analyte #0305 total bilirubin in two of three consecutive PT events and analytes #0355 chloride and #0475 sodium in two consecutive PT events. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted at Manchin Clinic on February 14, 2024, by the West Virginia Office of Laboratory Services. The laboratory was assessed for compliance with the Federal Clinical Laboratory Improvement Amendments (CLIA) regulations under 42 CFR 493. Specific deficiencies cited are explained below. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to attain satisfactory scores for the chemistry analyte #0255 ALT in the 2nd proficiency testing (PT) event of 2023 and the chemistry analytes #0305 total bilirubin and #0345 total calcium in the 3rd proficiency testing (PT) event of 2023. Findings: 1. Review of CASPER 155D report identified the following usatisfactory analyte score in the 2023 2nd PT event: #0255 ALT 20% 2. Review of CASPER 155D report identified the following unsatisfactory analyte scores in the 2023 3rd PT event: #0305 total bilirubin 20% #0345 total calcium 0% 3. Review of American Proficiency Institute (API) records confirmed the unsatisfactory scores for the analytes in the 2nd and 3rd PT event of 2023. 4. An exit interview with the technical consultant and testing personnel, 2/14/24 at 3:00 PM, confirmed the findings. D2098 ENDOCRINOLOGY CFR(s): 493.843(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. 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 record review and interview, the laboratory failed to attain a satisfactory score for the endocrinology analyte #0585 TSH in the 2nd proficiency testing (PT) event of 2023. Findings: 1. Review of CASPER 155D report identified the following unsatisfactory analyte score in the 2023 2nd PT event: #0585 TSH 40% 2. Review of American Proficiency Institute (API) PT records confirmed the unsatisfactory score of 40% for analyte #0585 TSH in the 2nd event of 2023. 3. An exit interview with the technical consultant and testing personnel, 2/14/24 at 3:00 PM, confirmed the findings. D5425 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(3) The laboratory must determine the test system's calibration procedures and control procedures based upon the performance specifications verified or established under paragraph (b)(1) or (b)(2) of this section. This STANDARD is not met as evidenced by: Based on review of written policies and procedures (P&P), quality control (QC) records, lack of documentation, and interview the laboratory failed to follow the established process for the verification of parameters for new lots of assayed quality control material in Chemistry and Hematology. Findings: 1. Review of P&P identified a Quality Control and Assessment Procedure for a Change in Lot stating for assayed controls each level is evaluated at least 5 times, results are compared to the product insert established ranges, filed, and retained. 2. Review of QC records (1/25/23 thru 12 /18/23) for the Act Diff 2 revealed no documentation for the validation of 6 of 6 new lots of QC material. 3. Review of QC records (5/2/23 thru 12/30/23) for the VItros XT 3400 revealed no documentation for the validation of 2 of 2 new lots of QC material. 4. During an interview 2/14/24 at 9:30 AM, the laboratory testing personnel (TP1) confirmed that no validation for new lots of QC occurred. 5. An exit interview with the technical consultant and TP1, 2/14/24 at 3:00 PM, confirmed the findings. D6015 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4) 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)(4) Ensure that the laboratory is enrolled in an HHS approved proficiency testing program for the testing performed. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview the laboratory director failed to ensure the laboratory was enrolled in an approved proficiency testing program in the specialty of chemistry for the first event of 2023. Findings: 1. Review of CASPER 155D report and 2023 American Proficiency Institute PT records revealed no enrollment for the analytes in Chemistry for the 1st event of 2023. 2. No documentation of alternative assessment for the chemistry analytes could be located. -- 2 of 3 -- 3. An interview with the testing personnel, 2/14/24 at 11:15 AM, confirmed the lack of enrollment and evaluation for the chemistry analytes. 4. An exit interview with the technical consultant and testing personnel, 2/14/24 at 3:00 PM, confirmed the findings. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced, on site, recertification survey was conducted at Manchin Clinic on December 14, 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. D2121 HEMATOLOGY CFR(s): 493.851(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to attain at least an 80% for the analytes 0785 HCT and 0815 Platelets in one of two Hematology 2021 proficiency testing (PT) events. Findings: 1. Review of American Proficiency Institute (API) PT records identified the following unsatisfactory analyte performances in the 2021 Hematology 1st event: 40% for analyte 0785 HCT 60% for analyte 0815 Platelets 2. During the exit interview, 12/14/2021 at approximately 1:00 PM, the technical consultant 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 D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on a review of the laboratory American Proficiency Institute (API) proficiency testing (PT) records and an interview with Technical Consultant 1 (TC1), the laboratory failed to attain a score of at least 80 percent for the analyte Total Bilirubin in the 3rd Chemistry Core 2019 testing event. Findings: 1. A review of API PT records identified an unsatisfactory performance of 40 percent for the analyte Total Bilirubin in the Chemistry Core 2019 3rd testing event. 2. An interview with TC1, on 10/22/19 at approximately 11:15 AM, confirmed the findings. 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) 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 -- 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 that had an expired NIST calibration. The certificate of calibration for the NIST certified Thomas 9337T07 thermometer expired 10/18. 2. The room temperature reagents and supplies were located in a separate storage area from the lab. This storage area was not being monitored and documented for temperature and humidity conditions. 3. An interview with TP1, on 10/22/19 at approximately 11:38 AM, confirmed the findings. 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: Based on a review of laboratory Quality Control (QC) records, calibration records, and an interview with Testing Personnel 1 (TP1), the laboratory failed to perform and document calibration verification for the Sodium, Potassium, and Chloride analytes in chemistry testing. Findings: 1. A review of calibration records for 2018 and 2019 established that no calibration verification of Sodium, Potassium, and Chloride analytes had been performed and documented on the Vitros 350 chemistry analyzer. The calibration of Sodium, Potassium, and Chloride analytes utilizes only two levels of calibration materials. 2. A review of QC records identified the laboratory ran 2 levels of Quality Control materials once each day of testing on the Vitros 350 chemistry analyzer. 3. An interview with TP1, on 10/22/19 at approximately 11:30 AM, confirmed that the laboratory had not performed or documented calibration verification for the Sodium, Potassium, and Chloride analyte testing on the Vitros 350. -- 2 of 2 --