Marietta Memorial Hospital Of Tyler County Inc Dba

Summary Statement of Deficiencies D0000 A routine recertification survey for Marietta Memorial Hospital of Tyler County Inc DBA Sistersville General Hospital was completed on October 8, 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 are cited below. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) (d) 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. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on review of laboratory established quality control procedures, Microbiology quality control (QC) records, lack of documentation, interview with the general supervisor (GS), and exit interview with the laboratory administration team, the laboratory failed to (d)(2) follow the laboratory established QC protocol for the introduction of new lots and document the crosscheck verification of acceptability for four of four new reagent lots of C. diff Quik Chek test kits in 2025. Findings: 1. Review of quality control procedures identified policy 110866.2407, titled "New Reagent Lot Verification". The policy states that all reagents, kits, and new lots received are to be validated by crosschecking new lots with current lots using a 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 -- minimum of one known positive and one known negative sample. The policy lists which materials are suitable for verification testing and includes step-by -step instructions for performing and documenting the lot-to-lot crosscheck. 2. Review of Microbiology QC records for C. diff Quik Chek testing (January 2025 thru date of survey) identified four new lots of test kits (1123013, 0324004, 0125170, 0425010) put into use in 2025. 3. No documentation for the performance of the crosscheck verifications for the four new lots of C. diff Quik Chek reagents could be located. 4. During an interview, 10/8/25 at approximately 10:30 AM, the GS stated the documentation of the crosscheck verification for the four new lots of C. diff Quik Chek could not be located. 5. An exit interview with the laboratory administration team on 10/8/25 at 11:15 AM confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A routine, recertification survey was conducted at Marietta Memorial Hospital of Tyler County DBA Sistersville General Hospital on September 11 and September 12, 2023, 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. D3033 RETENTION REQUIREMENTS CFR(s): 493.1105(a)(3)(i) In addition, the laboratory must retain records of test system performance specifications that the laboratory establishes or verifies under 493.1253 for the period of time the laboratory uses the test system but no less than 2 years. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to retain the signed approval of the validation for the auto-verification system currently utilized in the chemistry department on the Roche Cobas 6000. Findings: 1. Review of the Roche Cobas 6000 records identified the testing used to establish the auto-verification system was completed 6/18/21. No analysis or approval of the raw data could be located. 2. An interview with the general supervisor, 9/12/23 at 11:00 AM, confirmed the lack of retention for the auto-verification analysis and approval of the auto- verification system on the Roche Cobas 6000. 3. An exit interview with the laboratory team, 9/12/23 at 2:30 PM, 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 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 -- 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 observation and interview, the laboratory failed to establish and follow an environmental monitoring process for the two storage rooms where Roche Cobas reagents and individual test kits are stored in 2023. Findings: 1. A tour of the laboratory, 9/12/23 at 12:30 PM, revealed no environmental monitoring for the two room temperature reagent storage rooms. Room temperature range identified on the outside of the reagent boxes 15-25 degrees Celsius. 2. An interview with the general supervisor, 9/12/23 at 12:35 PM, confirmed no environmental monitoring of the two storage rooms had been established and documented. 3. An exit interview with the laboratory team, 9/12/23 at 2:30 PM, confirmed the findings. 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. This STANDARD is not met as evidenced by: Based on record review and interview, 7 of 7 respiratory therapy testing personnel (TP) did not possess a current West Virginia Clinical Laboratory Practitioner (WV CLP) license. Findings: 1. WV State rule Clinical Laboratory Practitioner Licensure and Certification 64 CSR 57 states that a current license is required for any individual performing moderate complex testing. Respiratory therapists are exempt if they are only performing blood gases per section 1.6.c.3. of the CLP Rule. The current test menu for the respiratory therapy testing analyzer includes electrolytes in addition to blood gases. 2. Review of TP records identified no current WV CLP license for 7 of 7 TP. 3. An interview with the respiratory therapy supervisor, 9/11/23 at 1:30 PM, confirmed the lack of a current WV CLP license for the 7 TP. 4. An exit interview with the laboratory team, 9/12/23 at 2:30 PM, confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced, on site, routine recertification survey was conducted at Marietta Memorial Hospital of Tyler County on August 31 and September 1, 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. 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 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, a lack of documentation, and interview the laboratory failed to retain all required documentation for 4 of 9 American Proficiency Institute (API) 2021 proficiency testing (PT) events. Findings: 1. Review of API Hematology /Coagulation 2021 PT records revealed a lack of documentation for the examination and testing of PT specimens in 2 of 2 events. a. 1st event 2021 Hematology /Coagulation- no original test data of testing performed for any PT specimens, no signed attestation statement by the laboratory director b. 2nd event 2021 Hematology /Coagulation- no original test data of testing performed for following specimens: Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- ISED CAD-03, ISED CAD-04, FOB-03, WST-03, WST-04, BCI-06, BCI-07, BCI- 08, BCI-09, BCI-10, DIF-02, VA-02, VKP-02. 2. Review of API Microbiology 2021 PT records revealed a lack of documentation for the examination and testing of PT specimens in 1 of 2 events. a. 1st event 2021 Microbiology- no original test data of testing performed for following specimens: CDF-01, CDF-02, CDF-03, CDF-04, CDF-05. 3. Review of API Immunology/Immunohematology 2021 PT records revealed a lack of documentation for the examination and testing of PT specimens in 1 of 2 events. a. 1st event 2021 Immunohematology- no original test data of testing performed for DAT-01, DAT-02 b. 1st event 2021 Immunology- no original test data of testing performed for HPY-01, HPY-02, HS-01, HS-02, RF-01, RF-02, RF-03, RF- 04, RF-05 4. An interview with the general supervisor, 8/31/21 at approximately 2:30 PM, confirmed the findings. D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to attain a satisfactory score for 1 of 3 2020 proficiency testing (PT) events in Compatibility Testing for the American Proficiency Institute (API) commercial PT program. Findings: 1. Review of the API PT records for 2020 identified an unsatisfactory performance of 80% for Immunohematology Compatibility Testing 1st event 2020. Sample SER-01 reported as Compatible Sample SER-01 expected result Not Compatible 2. An interview with the general supervisor, 8/31/21 at approximately 1:00 PM, confirmed the findings. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to document the performance of monthly maintenance and verify the accurate ISI and Reference time on the Stago Compact Max analyzer maintenance logs. Findings: 1. Review of Stago Compact Max maintenance logs (January 2020 thru August 2021) identified no monthly maintenance (replacement of O Ring and syringe tip) for 15 of 20 months reviewed. a. January 2020 thru December 2020- no documented monthly maintenance January, February, March, April, May, July, August, September, October b. January 2021 thru August 2021- no documented monthly maintenance January, February, April, May, June, August 2. Review of Stago Compact Max maintenance logs for June 2021 thru August 2021 revealed the daily check of ISI and Reference time had not been changed to reflect the current lot of reagent in use for 3 of 3 months reviewed. a. Lot 257658 was put into use 6-16-21. The manufacturer product insert (PI) specified an ISI of 1.25 and a mean reference time of 12.8. b. June, July, and -- 2 of 4 -- August maintenance logs had the daily ISI and reference time checked as verified. The data for the ISI and reference time on the maintenance logs were not reflective of the PI information. 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 perform and document quality control (QC) procedures for DDimer testing as established by the laboratory in the policy and procedure (P&P) for Coagulation testing. Findings: 1. Review of P&P 110866.3219 Stago Readiness Performed identified that 2 levels of QC are to be ran every 8 hours for DDimer testing. 2. Review of QC records for April 2021 identified 26 of 30 days DDimer QC was not documented as performed every 8 hours. 3. An interview with the laboratory supervisor, 9/1/21 at approximately 10:00 AM, confirmed the findings. D5555 IMMUNOHEMATOLOGY CFR(s): 493.1271(c)(f) (c) Blood and blood products storage. Blood and Blood products must be stored under appropriate conditions that include an adequate temperature alarm system that is regularly inspected. (c)(1) An audible alarm system must monitor proper blood and blood product storage temperature over a 24-hour period. (c)(2) Inspections of the alarm system must be documented. (f) Documentation. The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview the laboratory failed to (c)(2) perform and document temperature alarm checks for the storage of blood products from January 2020 thru the date of survey. Findings: 1. Review of temperature logs and inventory checks for the blood bank refrigerator identified no documentation of the performance of temperature alarm checks for the storage of blood products from January 2020 thru the date of survey. 2. An interview with the blood bank supervisor, 9/1/21 at approximately 1:00 PM, confirmed the findings. D6013 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(3)(ii) 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 -- 3 of 4 -- and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(3) Ensure that-- (e)(3)(ii) Verification procedures used are adequate to determine the accuracy, precision, and other pertinent performance characteristics of the method; This STANDARD is not met as evidenced by: Based on record review the laboratory director failed to (e)(3)(ii) sign the method validation data summary of the Stago Compact Max analyzer. Findings: 1. Review of the method validation data for the Stago Compact Max revealed the laboratory implemented the methodology in October 2017. 2. Review of the method validation summary identified no laboratory director signature. D6072 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(3) Each individual performing moderate complexity testing must adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory testing personnel failed to document and perform quality control (QC) and maintenance as specified in written policies and procedures. Findings: 1. Review of maintenance records for the Stago Compact Max from January 2020 thru the date of survey identified a lack of documentation for the required monthly maintenance. Refer to D5429 2. Review of maintenance records for the Stago Compact Max for June 2021 thru the date of survey identified a failure to verify the correct ISI and mean reference time for the specific lot of reagent in use. Refer to D5429 3. Review of QC records for April 2021 identified a failure to perform and document DDimer QC every 8 hours as stated in the policy and procedure for DDimer testing. Refer to D5445 4. Reiew of blood product storage logs revealed no documentation of routine storage alarm verification. Refer to D5555 -- 4 of 4 --

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 a review of the CLIA database CASPER Reports 155D and 153D and the proficiency testing (PT) records from the American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for the analyte APTT in 2 consecutive testing events, resulting in an unsuccessful performance for that analyte. Findings: 1. A review of the CLIA database, via CASPER Report 153D for unsuccessful and unsatisfactory PT results, identified a PT failure of the laboratory for the analyte #0835 (APTT). 2. A review of the individual laboratory PT scores, via CASPER Report 155D, identified the following unsatisfactory scores for analyte 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 -- #0835 (APTT): a. 40% for APTT 2nd event 2020 b. 0% for APTT 3rd event 2020 3. Comparative evaluation scores from API identified a score of 40% for analyte #0835 (APTT) for the 2nd API 2020 testing event and a score of 0% (failure to participate) for the 3rd API 2020 testing event. D2130 HEMATOLOGY CFR(s): 493.851(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 a review of the CLIA database CASPER Reports 153D and 155D and the proficiency testing (PT) records from the American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing for the analyte APTT in 2 consecutive testing events, resulting in an unsuccessful performance for the analyte APTT. Findings: 1. A review of the CLIA database, via CASPER Report 153D for unsuccessful and unsatisfactory PT results, identified a PT failure of the laboratory for the analyte #0835 (APTT). 2. A review of the individual laboratory PT scores, via CASPER Report 155D, identified the following unsatisfactory scores for analyte #0835 (APTT): a. 40% for APTT 2nd event 2020 b. 0% for APTT 3rd event 2020 3. Comparative evaluation scores from API identified a score of 40% for analyte #0835 (APTT) for the 2nd API 2020 testing event and a score of 0% (failure to participate) for the 3rd API 2020 testing event. 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 a review of the CLIA database CASPER Reports 155D and 153D and the proficiency testing (PT) records from the American Proficiency Institute (API), the laboratory director failed to provide overall management and direction in accordance with CLIA guidelines. Findings: 1. A review of the CLIA database, via CASPER Report 153D for unsuccessful and unsatisfactory PT results, identified a PT failure of the laboratory for the analyte #0835 (APTT). 2. A review of the individual laboratory PT scores, via CASPER Report 155D, identified the following unsatisfactory scores for analyte #0835 (APTT): a. 40% for APTT 2nd event 2020 b. 0% for APTT 3rd event 2020 3. Comparative evaluation scores from API identified a score of 40% for analyte #0835 (APTT) for the 2nd API 2020 testing event and a score of 0% (failure to participate) for the 3rd API 2020 testing event. 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 -- 2 of 3 -- 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 a review of the CLIA database CASPER Reports 153D and 155D and the proficiency testing (PT) records from the American Proficiency Institute (API), the laboratory director failed to ensure satisfactory performance from the laboratory in PT. Findings: 1. A review of the CLIA database, via CASPER Report 153D for unsuccessful and unsatisfactory PT results, identified a PT failure of the laboratory for the analyte #0835 (APTT). 2. A review of the individual laboratory PT scores, via CASPER Report 155D, identified the following unsatisfactory scores for analyte #0835 (APTT): a. 40% for APTT 2nd event 2020 b. 0% for APTT 3rd event 2020 3. Comparative evaluation scores from API identified a score of 40% for analyte #0835 (APTT) for the 2nd API 2020 testing event and a score of 0% (failure to participate) for the 3rd API 2020 testing event. -- 3 of 3 --

Summary Statement of Deficiencies 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 a review of the laboratory Proficiency Testing (PT) records and an interview with the General Supervisor (GS), the laboratory director failed to sign the vendor's proficiency testing attestation statement for 2 of 3 Chemistry Core 2018 events and 1 of 3 Hematology/Coagulation 2018 events. Findings: 1. A review of 2018 PT Chemistry Core records identified the laboratory director (LD) did not sign the vendor's proficiency testing attestation statement for 2018 Chemistry Core 2nd testing event and 2018 Chemistry Core 3rd event. 2. A review of 2018 PT Hematology /Coagulation records identified the LD did not sign the vendor's proficiency testing attestation statement for 2018 Hematology/Coagulation 3rd testing event. 3. An interview with GS, on 8/26/19 at approximately 10:30 AM, 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. 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 a review of the laboratory Proficiency Testing (PT) records and an interview with Testing Personnel 1 (TP1) the laboratory failed to take and document remedial action for 1 of 2 Hematology/Coagulation testing events of 2019. Findings: 1. Review of the API PT records identified an unacceptable grade for specimen BCI-05 in the Blood Cell Identification part of the 2019 Hematology/Coagulation 1st Testing event. 2. Review of the API PT records identified no documentation of remedial action taken for 2019 Hematology/Coagulation 1st testing event 2019. 3. An interview with TP1, on 8/26/19 at approximately 1030 AM, confirmed the findings. D5449 CONTROL PROCEDURES CFR(s): 493.1256(d)(3)(ii)(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-- At least once a day patient specimens are assayed or examined perform the following for-- Each qualitative procedure, include a negative and positive control material; (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on a review of the laboratory Quality Control (QC) records, patient testing records, written policies and procedures, and an interview with the General Supervisor (GS) the laboratory failed to perform an external negative and positive control for the serum HCG qualitative test. Findings: 1. Review of the laboratory QC and patient testing records from 2018 and 2019 for serum HCG qualitative testing revealed that patient testing occurred on 7/23/19, 7/26/19, 6/30/19, 3/22/19, and 1/28/19 with no external QC documented. 2. The written policy and procedure for serum HCG qualitative testing states "a positive and negative control is run on each kit each day of testing, every 30 days, and when a new lot is in use." 3. An interview with GS, on 8/27 /19 at approximately 9:00 AM, confirmed that no external QC was documented for the specified dates of testing. -- 2 of 2 --