Manchin Clinic South Llc

Summary Statement of Deficiencies D5807 TEST REPORT CFR(s): 493.1291(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: Based on review of 50 September 2024 and October 2024 patient final test reports obtained from the Orchard laboratory information system (LIS) and interview with testing personnel (TP1), the laboratory failed to ensure the reference intervals for 6 of 20 complete blood count (CBC) parameters analyzed were included on patient test reports from September 2024 (date LIS and DxH 500 put into use) thru date of survey. Findings: 1. Review of 19 patient CBC test reports from the LIS (September 2024) revealed no stated reference intervals for 6 of 20 parameters listed on a final report: neutrophil %, eosinophil %, basophil %, # neutrophil, # eosinophil, # basophil. 2. Review of 31 patient CBC reports from the LIS (October 2024) revealed no stated reference intervals for 6 of 20 parameters listed on a final report: neutrophil %, eosinophil %, basophil %, # neutrophil, # eosinophil, # basophil. 3. During an interview on 11/6/24 at 9:30 AM, TP1 stated the DxH 500 and Orchard LIS were put into use September 3, 2024. TP1 stated Orchard had been contacted about the lack of reference intervals on the final patient test report but the issue has not been resolved. 4. An exit interview with TP1, 11/6/24 at 12:00 PM, confirmed the lack of reference intervals for the 6 CBC parameters on patient final test reports from the Orchard LIS. D6064 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(a) Each individual performing moderte complexity testing must possess a current license issued by the State in which the laboratory is located, if such licensing is required. 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 review of primary source verification (West Virginia state licensure primary source verification portal) and interview with testing personnel (TP1), one of two laboratory testing personnel (TP2) failed to possess a current West Virginia laboratory license as required by the West Virginia 64 CSR 57 Clinical Laboratory Practitioner and Licensure Certification rule. Findings: 1. On site, the state surveyor identified 6 of 20 days in September 2024 that patient complete blood count (CBC) results were released without QC being performed and acceptable: 9/9, 9/10, 9/11, 9/12, 9/13, 9 /16. Refer to D6025. 2. During an interview with TP1, 11/6/24 at 11:05 AM, TP1 stated that an individual (TP2) from a different facility performed all CBC testing between 9/9 and 9/16. The laboratory was unable to provide a valid state laboratory license for TP2. 3. A review of the WV state licensure primary source verification portal confirmed TP2 did not have a current laboratory testing license (POCT 13059, expired 10/1/2022). -- 2 of 2 --

Summary Statement of Deficiencies D0000 A routine recertification survey was performed at Manchin Clinic South LLC on March 22, 2024, by the West Virginia Office of Laboratory Services. The laboratory was assessed for compliance with the Federal Clinical Laboratory Improvement Amendments (CLIA) under 42 CFR 493. Specific deficiencies cited are explained below. 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 record review and interview the laboratory director (LD) and testing personnel (TP) failed to sign the attestation statement for 2 of 3 hematology proficiency testing (PT) events in 2023. Findings: 1. Review of 2023 American Proficiency Institute (API) PT records revealed no attestation statement signed by the LD and TP for the 1st and 3rd hematology testing event in 2023. 2. An exit interview with the LD, technical consultant, and TP, 3/22/24 at 3:30 PM, confirmed the findings. D2015 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b)(5)(6) (5) The laboratory must document the handling, preparation, processing, examination, and each step in the testing and reporting of results for all proficiency testing samples. The laboratory must maintain a copy of all records, including a copy of the proficiency testing program report forms used by the laboratory to record proficiency testing results including the attestation statement provided by the PT program, signed Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- by the analyst and the laboratory director, documenting that proficiency testing samples were tested in the same manner as patient specimens, for a minimum of two years from the date of the proficiency testing event. (6) PT is required for only the test system, assay, or examination used as the primary method for patient testing during the PT event. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory filed to maintain a copy of proficiency testing (PT) records for 2 of 3 testing events in 2023. Findings: 1. Review of American Proficiency Institute (API) PT records revealed no records for the processing and examination of PT samples for the 1st and 3rd hematology testing events of 2023. 2. An exit interview with the laboratory director, technical consultant, and testing personnel, 3/22/24 at 3:30 PM, confirmed the findings. D2128 HEMATOLOGY CFR(s): 493.851(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 document and retain the

Summary Statement of Deficiencies D0000 An announced, on site, routine recertification survey was conducted at Manchin Clinic South on May 12, 2022, 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. D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to submit the proficiency testing (PT) results for 1 of 3 American Proficiency Institute (API) 2021 events before the deadline. Findings: 1. Review of API records identified an unsatisfactory performance of 0% for the 2nd Hematology testing event of 2021. 2. Review of API records revealed a self evaluation of results by the laboratory. 3. An interview with the technical consultant, on 5/12/22 at approximately 9:45 AM, confirmed the PT results had not been submitted in time. D5781

Summary Statement of Deficiencies D2127 HEMATOLOGY CFR(s): 493.851(d) Failure to return proficiency testing results to the proficiency testing program within the time frame specified by the program is unsatisfactory performance and results in a score of 0 for the testing event. This STANDARD is not met as evidenced by: Based on review of the laboratory American Proficiency Institute (API) proficiency testing (PT) records and an interview with the technical consultant (TC) and testing personnel (TP), the laboratory failed to return PT results within the specified time frame resulting in a score of 0 for the 2019 API Hematology/Coagulation 3rd testing event. Findings: 1. A review of 2018 and 2019 API PT records identified a testing event score of 0 for the 2019 3rd Hematology/Coagulation testing event. 2. A review of the 2019 3rd Hematology/Coagulation testing event PT records identified the laboratory failed to submit the testing results within the specified time frame of API. A documented self-analysis of the laboratory results for the testing event was performed by the TC. 3. An interview with the TC and TP, on 02/05/2020 at approximately 9:30 AM, confirmed the findings. D5437 CALIBRATION AND CALIBRATION VERIFICATION 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) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- 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 a review of written laboratory policies and procedures, calibration records, quality control (QC) records, and an interview with the technical consultant (TC) and testing personnel (TP), the laboratory failed to document and perform calibration of the ACT2 DIFF analyzer at the frequency specified by the manufacturer. Findings: 1. A review of written laboratory policies and procedures identified the frequency of calibration for the ACT2 DIFF as every 6 months, as a step in the process of resolving QC issues, and after major maintenance. 2. A review of 2018 calibration records revealed calibration of the ACT2 DIFF analyzer was documented on 02/07/2018. No documentation of calibration being performed on the ACT2 DIFF analyzer every 6 months in 2018 could be located. 3. A review of 2019 calibration records revealed calibrations performed on the ACT2 DIFF on 03/27/2019 and 12/27/2019. This is a 9 month span between calibrations in 2019. 4. A review of 2018 and 2019 QC records for the ACT2 DIFF analyzer identified numerous QC issues for January, February, and March of 2019. All three levels of QC exhibited data points out of range and