Webster Memorial Hospital, Inc

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted at Webster Memorial Hospital, Inc., on February 27 and February 28, 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. 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, 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)

Summary Statement of Deficiencies D0000 An unnannounced, off site, proficiency testing (PT) desk review was conducted for Webster Memorial Hospital on September 23, 2022, by the West Virginia Office of Laboratory Services. The laboratory PT evaluations with the American Proficiency Institute were compared with the CMS CASPER 153D Unsuccessful PT Report. The following deficiencies were identified: 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 record review the laboratory failed to successfully participate in proficiency testing (PT) for the analyte #0895 Compatibility Testing (Immunohematology) for 2 out of 3 consecutive testing events in 2021 and 2022. Findings: 1. Review of 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 2 -- laboratory (PT) evaluations with the American Proficiency Institute (API) identified the following unsatisfactory scores for analyte #0895 Compatibility Testing: 3rd Event 2021- 0% 2nd Event 2022- 80% 2. Review of the CMS CASPER 155D Individual Laboratory Profile PT Report confirmed the unsuccessful participation. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for 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 record review the laboratory failed to successfully perform in proficiency testing (PT) for the analyte #0895 Compatibility Testing (Immunohematology) for 2 out of 3 consecutive testing events in 2021 and 2022. Findings: 1. Review of the laboratory (PT) evaluations with the American Proficiency Institute (API) identified the following unsatisfactory scores for analyte #0895 Compatibility Testing: 3rd Event 2021- 0% 2nd Event 2022- 80% 2. Review of the CMS CASPER 155D Individual Laboratory Profile PT Report confirmed the unsuccessful performance for the analyte #0895 Compatibility Testing. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced, on site, routine recertification survey was conducted at Webster Memorial Hospital Inc on February 8 and 9, 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. 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, lack of documentation, and interview the laboratory failed to (5) document and maintain the examination and interpretation of all proficiency testing (PT) results and the attestation statements signed by the laboratory director (LD) for 2021. Findings: 1. Review of American Proficiency Testing (API) PT records for 2021 revealed a lack of documentation for the interpretation of all specimen results for ABO/RH, Compatibility, and Crossmatch in 3 of 3 Immunohematology events. 2. Review of API PT records for 2021 identified no LD signature on the attestation statements for 5 of 17 PT events: 3rd event Chemistry Core, 3rd event Microbiology, 2nd event Chemistry Miscellaneous, 3rd 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 5 -- Hematology, 3rd event Immunohematology/Immunology. 3. An interview with the general supervisor and the technical consultant, on 2/8/22 at approximately 10:20 AM, confirmed the findings. D2081 GENERAL IMMUNOLOGY CFR(s): 493.837(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 results for the American Proficicncy Institute (API) proficiency testing (PT) 2021 3rd Immunology event before the deadline. Findings: 1. Review of API records identiifed an unsatisfactory score of 0% for analyte #0215 Infectious Mono and HIV. 2. An interview with the technical consultant, on 2/8/22 at approximately 11:30 AM, confirmed the results were not submitted before the API deadline for grading. D2159 ABO GROUP AND D(RHO) TYPING CFR(s): 493.859(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 results of American Proficiency Institute (API) Immunohematology 2021 3rd proficiency testing (PT) event before the deadline. Findings: 1. Review of API records identified an unsatisfactory score of 0% for the analyte #0860 ABO/RH. 2. Review of API records revealed a documented self-evaluation of results by the labratory. 3. An interview with the general supervisor, on 2/8/22 at approximately 11:20 AM, confirmed the results were not submitted for the event before the deadline. D2169 UNEXPECTED ANTIBODY DETECTION CFR(s): 493.861(c) 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 American Proficiency Institute (API) proficiency testing (PT) results for the 2021 3rd Immunohematology event before the deadline. Findings: 1. Review of API records identified an unsatisfactory score of 0% for analyte #0855 Antibody Detection. 2. Review of API records revealed a documented self-evaluation of results by the laboratory. 3. An interview with the general supervisor, 2/8/22 at approximately 11:20 AM, confirmed the results had not been submitted to API before the deadline. -- 2 of 5 -- D2178 COMPATIBILITY TESTING CFR(s): 493.863(c) 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 American Proficiency Institute (API) proficiency testing (PT) results for the 2021 3rd Immunohematology event before the deadline. Findings: 1. Review of API records identified an unsatisfactory score of 0% for analyte #0895 Compatibility Testing. 2. Review of API records revealed a documented self-evaluation of results by the laboratory. 3. An interview with the general supervisor, 2/8/22 at approximately 11:20 AM, confirmed the results had not been submitted to API before the deadline. 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 policies and procedures (P&P), record review, lack of documentation, and interview the laboratory failed to perform and document the annual competency for 1 of 7 laboratory testing personnel (TP) for 2020 and 2021. Findings: 1. Review of P&P identified a process for documenting the competency of laboratory testing personnel. 2. Review of personnel records identified a lack of documentation for the annual competency of TP1 for 2020 and 2021. 3. An interview with the general supervisor, 2/8/22 at approximately 10:00 AM, confirmed the findings. 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, 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)

Summary Statement of Deficiencies D0000 An unannounced, off site proficiency testing (PT) desk review was conducted at Webster County Memorial Hospital on March 19, 2021, by the West Virginia Office of Laboratory Services. The laboratory proficiency testing evaluations with the American Proficiency Institute (API) were reviewed for compliance with the Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. Specific deficiencies are 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 a review of CASPER 153D Unsuccessful PT Report, CASPER 155D Individual Laboratory Profile Report, and the Failures Summary report from 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 -- American Proficiency Institute (API), the laboratory failed to successfully participate in proficiency testing (PT) for the analyte # 0325 pO2 for 2 of the last 3 testing events. Findings: 1. Review of CASPER 153D Unsuccessful PT Report identified an unsuccessful performance for the analyte # 0325. 2. Review of CASPER 155D Individual Laboratory Profile Report revealed the following unsatisfactory scores for analyte # 0325 pO2: 2nd event 2020- 40% 1st event 2021- 60% 3. Review of API Failures Summary Report confirmed the unsuccessful score of 40% for analyte # 0325 pO2 for the 2nd event 2020 and a score of 60% for pO2 for the 1st event 2021. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 a review of the individual laboratory proficiency testing (PT) scores (CASPER Report 153D) and the American Proficiency Institute (API) laboratory evaluation scores, the laboratory received unsuccessful scores for the analyte # 0365 pO2 in 2 of 3 consecutive testing events resulting in an unsatisfactory performance. Findings: 1. Review of the individual laboratory PT report scores (CASPER report 155D) and comparative evaluation scores from API demonstrated the following unsatisfactory analyte performance for analyte # 0365 pO2 in 2 of 3 consecutive testing events: 2nd event 2020- 40% 1st event 2021- 60% 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 American Proficiency Institute (API) proficiency testing (PT) records and the CASPER 155D Individual Laboratory Profile report for Webster County Memorial Hospital, the laboratory director failed to ensure successful participation in a program approved by CMS for the analyte # 0325 pO2 (2nd event 2020 and 1st event 2021). The findings include: 1. pO2 Event 2 (2020) - 40% Event 1 (2021)- 60% 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 -- 2 of 3 -- 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 American Proficiency Institute (API) proficiency testing (PT) records and the CASPER 155D Individual Laboratory Profile report for Webster County Memorial Hospital, the laboratory director failed to assure compliance with the regulation requiring successful participation in PT testing (see D2016) for the analyte # 0325 pO2 (2nd event 2020 and 1st event 2021). The findings include: 1. pO2 Event 2 (2020) - 40% Event 1 (2021) - 60% -- 3 of 3 --

Summary Statement of Deficiencies D6120 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(7)(8) (7) The technical supervisor is responsible for identifying training needs and assuring that each individual performing tests receives regular in-service training and education appropriate for the type and complexity of the laboratory services performed; (8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on a review of testing personnel competency records, testing personnel qualifications and interviews with the laboratory director (LD) and general supervisor (GS), the laboratory failed (8) to have the competency of the testing personnel in Immunohematology assessed by a qualified individual. Findings: 1. A review of testing personnel competency records for 2018 and 2019, identified that the required annual Immunohematology competency for all 5 of the laboratory testing personnel in Immunohematology was documented and assessed in 2018 by the GS and not the technical supervisor of Immunohematology. 2. An interview with the LD and GS, on 12/10/19 at approximately 8:30 AM, confirmed these 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 D3000 FACILITY ADMINISTRATION CFR(s): 493.1100 Each laboratory that performs nonwaived testing must meet the applicable requirements under 493.1101 through 493.1105, unless HHS approves a procedure that provides equivalent quality testing as specified in Appendix C of the State Operations Manual (CMS Pub. 7). (a) Reporting of SARS-CoV-2 test results During the Public Health Emergency, as defined in 400.200 of this chapter, each laboratory that performs a test that is intended to detect SARS-CoV-2 or to diagnose a possible case of COVID-19 (hereinafter referred to as a "SARS-CoV-2 test") must report SARS-CoV-2 test results to the Secretary in such form and manner, and at such timing and frequency, as the Secretary may prescribe. This CONDITION is not met as evidenced by: Based on a tour of the laboratory, review of blood bank records, and interview with testing personnel, the laboratory failed to meet safety and requirements for transfusion services standards under Subpart J - Facility Management for Non-Waived Testing. Findings include: 1. Refer to cross-reference in D3011 2. Refer to cross-reference in D3015 D3011 FACILITIES CFR(s): 493.1101(d) Safety procedures must be established, accessible, and observed to ensure protection from physical, chemical, biochemical, and electrical hazards, and biohazardous materials. This STANDARD is not met as evidenced by: Based on a tour of the laboratory and interview with testing personnel, the laboratory 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 -- failed to provide safety and personal protective equipment for testing personnel for use during laboratory activities of potential blood and/or body fluid exposure. Findings include: 1. During the tour of the laboratory at approximately 10:30AM, no equipment for protecting testing personnel from splashes was found (no face shields, goggles, or countertop shields were available). 2. During the lab tour, testing personnel were wearing uniforms and fabric lab coats. However, no fluid resistant lab coats were found. 3. Interviews with testing personnel 1 (TP1) on 1/10/19 at approximately 11:10 AM and testing personnel 2 (TP2) and the assistant manager at approximately 2:25 PM confirmed the findings. D3015 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103 A facility that provides transfusion services must meet all of the requirements of this section and document all transfusion-related activities. This STANDARD is not met as evidenced by: Based on review of the blood bank patient and QC testing logs, the laboratory failed to document QC for blood bank testing performed on three separate occasions during the look-back period. Findings include: 1. Review of the Ortho Transfusion Service testing record from September 18, 2018 to January 3, 2019 identified that 26 patients were tested. 2. Comparison of dates of patient testing to quality control records in the Blood Bank Reagent QC Record binder identified three of the dates patient testing was performed that no QC was documented (11/4/18, 11/18/18, 12/23/18). 3. Patient testing was performed by the same testing personnel on all three dates that QC was not documented. 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 the laboratory's personnel records and interview with Testing Personnel (1) and Assistant Manager, the laboratory failed to document the assessment of employee competency. Findings: 1. The laboratory did have a system for recording personnel competency. However, the assistant manager was only able to produce competency records for one of the two employees requested; this competency was from 2017. No other records were found. 2. There was no written procedure or policy available that provided details on personnel competency assessment. 2. During interview with the assistant manager on 1/10/19 at approximately 1:10 PM, she stated that she had only been in the role of Assistant Manager since December 2018. The former Laboratory manager left her role suddenly in late September 2018. The competency records from the previous Laboratory manager were not found. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test -- 2 of 7 -- procedure: (1) Requirements for patient preparation; specimen collection, labeling, 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)

Summary Statement of Deficiencies No Tags No deficiency details available. 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 --