St Mary's Medical Center Himg Campus

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted at St. Mary's Medical Center HIMG Campus on June 24, 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 laboratory policies and procedures, testing personnel (TP) competency records, lack of documentation, interview with the general supervisor (GS), and exit interview with the laboratory director (LD) and administrative team, the laboratory failed to document the assessment of problem solving skills for 8 of 8 TP for initial, six month, and annual competency assessments (CA) in 2024 and 2025. Findings: 1. Review of laboratory policies identified "Personnel Competency and Assessment" stating "All documentation for training, proficiency testing participation, QC verification, and evaluation of critical documentation will be maintained in the Technical Personnel Individual Folders in the supervisor's office." 2. Review of the 11 CAs performed in 2024- 4 initial CAs (TP5, TP6, TP7, TP8) three semiannual CAs (TP4, TP5, TP6, TP8) four annual CAs (TP1, TP2, TP3, TP4)- revealed no documented assessment of problem solving skills. 3. Review of the two CAs performed in 2025 (one semi annual for TP7 and one annual for TP8) revealed no documented assessment of problem solving skills. 4. During an interview with the GS /TP8, 6/24/25 at approximately 10:00 AM, the GS agreed that no documentation for 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 assessment of problem solving skills could be located for the CAs performed in 2024 and 2025. 5. An exit phone interview, 6/24/25 at approximately 5:15 PM, with the LD and the laboratory administration team 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: Based on review of laboratory policies and procedures, performance verification records for the Beckman chemistry analyzers, validation records of the CERNER laboratory information system (LIS), CERNER LIS patient reports, interview with the general supervisor (GS), and exit interview with the laboratory director and administration team, the laboratory failed to ensure accurate reference intervals were available on the test report for one of 45 chemistry analytes from March 2025 thru date of survey. Findings: 1. Review of performance verification records for two Beckman DxC 700 AU analyzers and one Beckman Dxi 600 analyzer (put in use December 2023) and the CERNER LIS validation records (put into use March 2025) revealed reference intervals for all 45 analytes were validated. 2. Review of "Chemistry Procedure Manual" revealed written policies for all 45 analytes that included reference intervals. 3. Review of CERNER patient reports from date of survey (MRN 00039632, MRN 01020290, MRN 33024940) compared with the written policy reference intervals for each analyte revealed an inaccurate reference interval for one of 45 chemistry analytes (creatinine). The CERNER patient reports state the following reference interval for creatinine: 0.70-1.30 for the two reports for male patients (69 years old and 68 years old) 0.60-1.20 stated for the female patient (67 years old) The approved policy for creatinine states the following reference interval for creatinine: 0.70-1.30 for female patients >1 year old to 150 years old 0.60- 1.20 for male patients >1 year old to 150 years old 4. During an interview with the GS, 6/24/25 at approximately 2:30 PM, the GS stated that the reference interval discrepancy for creatinine was possibly a transcription error in the policy. 5. An exit phone interview with the LD and administration team, 6/24/25 at 5:15 PM, confirmed the finding. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced, on site, routine recertification survey was performed at St Mary's Medical Center HIMG Campus on June 13, 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. D3039 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(5) Quality system assessment records. Retain all laboratory quality system assessment records for at least 2 years. 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 retain the documentation of the Quality Assurance (QA) checklists developed to monitor the QA program of the laboratory for 2022 thru the date of survey. Findings: 1. Review of P&P identified "Quality Assurance Program" that states a QA checklist was developed to monitor the program and the completion of the checklists will be performed by the general supervisor and laboratory director. 2. No completed QA Checklists from January 2022 thru the date of survey could be located. 3. An interview with the general supervisor, 6 /13/23 at approximately 11:41 AM, confirmed the lack of completed QA checklists. 4. An exit interview with the administration and general supervisor, 6/13/23 at approximately 3:00 PM, confirmed the findings. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of 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 -- collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on written policies and procedures (P&P), a tour of the laboratory, and interview the laboratory failed to ensure that positive patient identification is maintained throughout the testing process in Hematology for 7 of 11 manual differential slides reviewed. Findings: 1. Review of P&P identified "Preparation of a Blood Smear" that states each slide prepared for a manual differential or slide review must be labeled with patient's name, date of birth, and date the slide is made. 2. During a laboratory tour at approximately 1:15 PM, 11 recent blood smear slides were examined: 5 slides had only the patient's name and date of birth, 2 slides had only the patient name. 3. An interview with the general supervisor, on 6/13/23 at approximately 1:20 PM, confirmed the lack of proper identification on the blood smear slides. 4. An exit interview with the administration and general supervisor, 6/13 /23 at approximately 3:00 PM, confirmed the findings. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (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. (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 (d)(2) perform external quality control (QC) for the Cepheid GeneXpert CT/NG testing system as established by the current Individualized Quality Control Plan (IQCP) for 5 of 5 months in 2023. Findings: 1. Review of P&P identified an IQCP for performance of external quality control on the Cepheid GeneXpert stating the established frequency as once a month and each new lot or shipment. 2. Review of QC records for January 2023 thru May 2023 revealed no documentation of the external QC being performed in the 5 months of GeneXpert CT/NG testing. 3. An interview with the general supervisor, on 6/13/23 at approximately 2:00 PM, confirmed the lack of external QC for the CT/NG testing system. 4. An exit interview with the administration and the general supervisor, 6/13/23 at approximately 3:00 PM, confirmed the findings. D5781

Summary Statement of Deficiencies D0000 An announced, on site, recertification survey was conducted at St Mary's Medical Center HIMG Campus on July 21, 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. The specific deficiencies 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 record review and interview the laboratory failed to assess and document the competency of 1 (TP1) of 7 laboratory testing personnel for 2020. Findings: 1. Review of personnel competencies revealed no annual testing personnel competency for TP1 for 2020. 2. An exit interview with the general supervisor, administrative laboratory director, and vice president, on 7/21/21 at approximately 12:45 PM, confirmed the findings. 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. 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 policies and procedures (P&P) and interview the laboratory failed to establish the criteria for Hematology peripheral smear to be (8) referred for review. Findings: 1. Review of P&P identified a lack of defined criteria for referral of a peripheral smear. 2. An exit interview with the general supervisor, administrative laboratory director, and vice president, on 7/21/21 at approximately 12:45 PM, confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on Proficiency Testing (PT) record review and interview with Testing Personnel 1 (TP1), the laboratory failed to verify accuracy 2 times a year for tests that are not included in Subpart I. Findings: 1. A review of PT records from 2018 and 2019 established that the laboratory had not performed commercial PT, or utilized other methods, to verify accuracy on the analyte Urine Protein twice a year. 2. An interview with TP1, on 07/08/19 at approximately 2:00 PM, confirmed that no testing of Urine Protein to establish and maintain accuracy had occurred. 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 upon a review of Proficiency Testing (PT) records and an interview with Testing Personnel 1 (TP1), the Laboratory Director (LD) had not signed the attestation statements for numerous PT events. Findings: 1. A review of PT records revealed that the 2019 1st Testing events in Mycology, Hematology, and Chemistry Core had attestation statements signed by the testing personnel, but not signed by 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 3 -- LD. 2. An interview with TP1, on 7/8/19 at approximately 2:45 PM, confirmed that the attestation statements were not signed by the LD. 3. An interview with TP1, on 7/8 /19 at approximately 2:47 PM, confirmed that there was no written delegation of the responsibility for signing the attestation statement from the LD. 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 Proficiency Testing (PT) record review and interview with Testing Personnel 1 (TP1), the laboratory failed to verify the accuracy twice a year for tests that are not included in Subpart I. Findings: 1. A review of PT records from 2018 and 2019 established that the laboratory had not performed commercial PT, or utilized other methods, to verify accuracy on the analyte Urine Protein twice a year. 2. An interview with TP1, on 07/08/19 at approximately 2:00 PM, confirmed that no testing of Urine Protein to establish and maintain accuracy had occurred. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based upon a review of the laboratories written policies and procedures, the Quality Control (QC) logs, and an interview with Testing Personnel 1 (TP1), the actual testing procedure for the Quality Control (QC) of the Cepheid has been modified from the written QC procedure. Findings: 1. 1. The Individual Quality Control Plan (IQCP) for the Cepheid GeneXpert states that external controls (both positive and negative) are to be ran "with each new lot or shipment and every 30 days thereafter for the life of the lot/shipment." 2. A review of the Cepheid QC logs identified instances where the documentation of external controls exceeded thirty days for CT/NG, FLU, and MRSA testing. a. For CT/NG testing external controls were ran 2/27/18, 6/26/18, 8/4/18, 10/4 /18, 2/21/19, and 4/19/19. All of the intervals between QC testing exceeded 30 days. b. For MRSA testing external controls were ran 2/21/19. c. For FLU testing external controls were ran 3/13/18 and 4/29/18 exceeding 30 days. External QC was not ran again until 1/23/19 greatly exceeding the 30 day interval. 3. An interview with TP1, on 7/8/19 at approximately 1200 noon, confirmed that external QC is "only performed on new lot/new shipment per the Cepheid sales representative." 4. No approval of the QC procedural change by the laboratory director could be located. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(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-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through -- 2 of 3 -- 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. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based upon review of Quality Control (QC) logs, written laboratory procedures and policies, and an interview with testing personnel the laboratory was not following the QC procedure for the Cepheid GeneXpert testing system. Findings: 1. The Individual Quality Control Plan (IQCP) for the Cepheid GeneXpert states that external controls (both positive and negative) are to be ran "with each new lot or shipment and every 30 days thereafter for the life of the lot/shipment." 2. A review of the Cepheid QC logs identified instances where the documentation of external controls exceeded thirty days for CT/NG, FLU, and MRSA testing. a. For CT/NG testing external controls were ran 2/27/18, 6/26/18, 8/4/18, 10/4/18, 2/21/19, and 4/19/19. All of the intervals between QC testing exceeded 30 days. b. For MRSA testing external controls were ran 2/21 /19. c. For FLU testing external controls were ran 3/13/18 and 4/29/18 exceeding 30 days. External QC was not ran again until 1/23/19 greatly exceeding the 30 day interval. 3. An interview with TP1, on 7/8/19 at approximately 1200 noon, confirmed that external QC is "only performed on new lot/new shipment per the Cepheid sales representative." D5821 TEST REPORT CFR(s): 493.1291(k) When errors in the reported patient test results are detected, the laboratory must do the following: (k)(1) Promptly notify the authorized person ordering the test and, if applicable, the individual using the test results of reporting errors. (k)(2) Issue corrected reports promptly to the authorized person ordering the test and, if applicable, the individual using the test results. (k)(3) Maintain duplicates of the original report, as well as the corrected report. This STANDARD is not met as evidenced by: Based upon a review of the written policies and procedures and an interview with Testing Personnel (TP1), no established system for identifying and maintaining corrected reports could be located. Findings: 1. No written policy or procedure regarding corrected reports could be located. 2. An interview with TP1, on 7/8/19 at approximately 3:30 PM, confirmed that there was no policy in place to identify and maintain corrected laboratory reports. -- 3 of 3 --

Summary Statement of Deficiencies 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 the proficiency testing records from the American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for each analyte on the CLIA test menu. Findings: 1. Review of the CLIA database, via CASPER report 153D for failed proficiency testing results, found a PT failure for the laboratory for analyte #0265 (albumin). 2. Review of the individual laboratory PT report scores (CASPER report 155D) and comparative evaluation scores from API demonstrated the following unsatisfactory scores for albumin: a. 20% for 3rd event 2018 b. 60% for 1st event 2019 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 -- 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 review of the proficiency testing records from the American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for each analyte on the CLIA test menu. Findings: 1. Review of the CLIA database, via CASPER report 153D for failed proficiency testing results, found a PT failure for the laboratory for analyte #0265 (albumin). 2. Review of the individual laboratory PT report scores (CASPER report 155D) and comparative evaluation scores from API demonstrated the following unsatisfactory scores for albumin: a. 20% for 3rd event 2018 b. 60% for 1st event 2019 D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the proficiency testing records, the laboratory director failed to provide overall management and direction in accordance with the regulations. Findings: 1. Refer to citation at D6004 for details. D6004 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(a)(b) 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. (a) The laboratory director, if qualified, may perform the duties of the technical consultant, clinical consultant, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications of 493.1409, 493.1415, and 493.1421, respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on review of the proficiency testing records, the laboratory director failed to ensure satisfactory performance of proficiency testing for each analyte. Findings: 1. Review of the individual laboratory PT report scores (CASPER report 155D) and comparative evaluation scores from API demonstrated the following unsatisfactory scores for albumin: a. 20% for 3rd event 2018 b. 60% for 1st event 2019 -- 2 of 2 --