Wvu Med Princeton Community Hospital Bluefield

Summary Statement of Deficiencies D0000 An off site, proficiency testing (PT) desk review was conducted for WVU Med Princeton Community Hospital Bluefield Location on August 26, 2024, by the West Virginia Office of Laboratory Services. The laboratory PT evaluations were reviewed for successful participation and compliance with the Federal Clinical Laboratory Improvement Amendments (CLIA) regulations under 42 CFR 493. 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, laboratory evaluations from the College of American Pathologists (CAP), and interview, 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 failed to achieve satisfactory performance for analyte #0505 BUN in the first two consecutive PT events of 2024, resulting in an intitial unsuccessful participation. Refer to D2096. 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 review of CASPER 155D proficiency testing (PT) report, laboratory evaluations from the College of American Pathologists (CAP), and interview, the laboratory failed to achieve satisfactory performance for analyte #0505 BUN in the first two consecutive PT events of 2024, resulting in an unsuccessful PT performance. Findings: 1. Review of CASPER 155D report revealed the following unsatisfactory scores for the analyte #0505 BUN: 60% 2024 event 1 60% 2024 event 2 2. Review of CAP laboratory evaluations confirmed the unsatisfactory scores of 60% for the analyte #0505 BUN in each of the two consecutive PT events of 2024. 3. An email exchange with the laboratory director, 8/23/24 at 5:00 PM, confirmed the two consecutive unsatisfactory scores for analyte #0505 BUN and the resulting unsuccessful PT performance. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted at WVU Med Princeton Community Hospital Bluefield on June 4-5, 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. D2025 BACTERIOLOGY CFR(s): 493.823(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 Group A Strep (GAS) proficiency testing (PT) results to College of American Pathologists (CAP) before the deadline for one of 3 events in 2023. Findings: 1. Review of CASPER 155D Report revealed an unsatisfactory score of 0% for bacteriology in PT event 2 of 2023. 2. Review of 2023 CAP PT records revealed the bacteriology 0% unsatisfactory score for event 2 2023 was due to the PT results for GAS testing not being submitted to the program within the specified timeframe. 3. An interview with the general supervisor, 6/4/24 at 10:50 AM, confirmed the findings. D2093 ROUTINE CHEMISTRY CFR(s): 493.841(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. 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 -- This STANDARD is not met as evidenced by: Based on record review and interview, the laboratory failed to submit the CK Isoenzyme (CK-MB) proficiency testing (PT) results to College of American Pathologists (CAP) before the deadline for one of 3 events in 2023. Findings: 1. Review of CASPER 155D Report revealed an unsatisfactory score of 0% for analyte #0395 CK Isoenzyme (CK-MB) in PT event 2 of 2023. 2. Review of 2023 CAP PT records revealed the 0% unsatisfactory score for event 2 2023 was due to the PT results for analyte #0395 not being submitted to the program within the specified timeframe. 3. An interview with the general supervisor, 6/4/24 at 10:50 AM, confirmed the findings. 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 policies and procedures (P&P), personnel record review, and interview the laboratory failed to ensure one of 9 testing personnel (TP) had a documented competency assessment (CA) evaluation for all test methodologies employed by the laboratory for patient testing in 2023. This is a repeat deficiency. Findings: 1. Review of laboratory general P&P revealed a process for assessing TP competency for all test methodologies at prescribed intervals. 2. Review of 2022 and 2023 TP competency assessment records identified the last retained annual CA for TP9 dated 1/7/2022. No documentation of an annual CA for TP9 in 2023 could be located. 3. An interview with the general supervisor, 6/4/24 at 9:15AM, confirmed the lack of CA for TP9 in 2023. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview the laboratory failed to evaluate two of two educational challenge events for College of American Pathologists (CAP) hematology proficiency testing (PT) in 2023. Findings: 1. Review of CAP hematology PT records identified two educational challenge events for virtual peripheral blood smear (VPBS-A and VPBS-B) in 2023. 2. Review of the 2023 CAP PT evaluation reports for VPBS-A and VPBS-B revealed laboratory testing personnel (TP) participated in the educational challenge events. No documentation that the results were reviewed or evaluated could be located for the two (VPBS-A and VPBS- B) events. 3. An interview with the general supervisor, 6/4/24 at 10:00 AM, confirmed the lack of documented evaluation of performance and review by the laboratory for VPBS-A and VPBS-B in 2023. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE -- 2 of 4 -- 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 record review, lack of documentation, and interview the laboratory failed to semiannually verify the accuracy of troponin and wet prep testing in 2023. Findings: 1. Review of 2022, 2023, and 2024 proficiency testing (PT) records revealed no commercial PT documented for troponin and wet prep testing in 2023. 2. No documentation of the alternative twice annual verification of troponin and wet prep testing could be located for 2023. 3. An interview with the general supervisor, 6/4/24 at 10:50 AM, confirmed the lack of alternate verification of troponin and wet prep testing twice annually in 2023 and that the two tests were not enrolled in commercial PT in 2023. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on review of written policies and procedures (P&P), quality assurance (QA) records, and interview the laboratory failed to establish a process for the step by step performance that evaluates and defines the correlation of test results between the Hematology automatic differential and manual differential testing methodologies twice a year. Findings: 1. Review of hematology and QA P&P revealed no procedure for completing intra-lab comparison studies of testing personnel (TP) performance of manual differentials. No documentation that comparison studies were performed in 2022 or 2023 could be located. 2. Review of hematology and QA P&P revealed no procedure for completing comparison studies between the Beckman Coulter DxH560 automated differential and a manual differential. No documentation that comparison studies were performed between the two methodologies in 2022 or 2023 could be located. 3. An interview with the general supervisor, 6/5/24 at 9:30 AM, confirmed the lack of P&P and that no intra-lab TP comparison studies or comparison studies between the DxH650 and a manual differential were performed in 2022 and 2023. 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 primary source verification, record review, and interview, 8 of 8 respiratory therapy laboratory testing personnel (TP) did not possess a current WV Clinical -- 3 of 4 -- Laboratory Practitioner License and performed moderate complex patient testing (lactate) in 2024 (January thru date of survey). 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 moderately complex testing. 2. Review of WV licensure primary source verification for the respiratory therapy TP listed on the current CMS 209, identified 8 of 8 TP had no current WV license in 2024. 3. Review of two patient test results (DOS) released by respiratory therapy testing personnel from the ABL90 analyzer identified blood lactate results released. 4. An interview with respiratory therapy testing personnel (TP1 and TP2), 6/5/24 at 1:00 PM, confirmed that lactate was on the current test menu for the ABL90 in the respiratory therapy department and lactate testing testing was performed and released by respiratory therapy TP. -- 4 of 4 --

Summary Statement of Deficiencies D0000 An announced, on site, routine recertification survey was conducted at Princeton Community Hospital Bluefield Laboratory on June 27 and June 28, 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. 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. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to attain a satisfactory score of at least 80% for analyte #0555 HCG in one of three College of American Pathologists (CAP) proficiency testing (PT) events in 2021. Findings: 1. Review of CAP records identified a score of 60% for analyte #0555 HCG in the 3rd PT event of 2021. 2. An exit interview with the general supervisor and laboratory director, 6/27/22 at approximately 2:30 PM, confirmed the findings. 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 written policies and procedures (P&P), record review, lack 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 2 -- documentation, and interview the laboratory failed to: A) Assess 1 of 9 testing personnel (TP1) competency at the required intervals B) Document the assessment of releasing emergency requested blood bank products to the emergency room of 9 of 9 TP Findings: A) 1. Review of P&P identified a process of assessing TP competency after initial training, at the 6 month testing mark, and annually thereafter for all methodologies and methods utilized in the laboratory. 2. Review of the 9 TP competency assessment records revealed an initial training for TP1 signed and dated 2 /26/21. No other competency assessment documents could be located. B) 1. Review of the 9 TP competency assessment records revealed no documented evaluation of the process for the emergency release of blood bank products for all 9 TP. An exit interview with the general supervisor and laboratory director, 6/27/22 at approximately 2:30 PM, confirmed the findings. D6070 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1425(b)(1) Each individual performing moderate complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. This STANDARD is not met as evidenced by: Based on review of policies and procedures (P&P), record review, lack of documentation, and interview laboratory testing personnel (TP) failed to follow the established process for documentation of a peripheral scan slide review for 4 of 6 patient results as established in the parameters of result reporting for the hematology analyzer. Findings: 1. Review of P&P identified "HEM-1020.6" which states the WBC parameters that a Peripheral Scan can be performed by TP instead of a manual differential: Basophilia, Eosinophilia, Leukopenia, Lymphopenia, Neutropenia, Monocytosis, Leukocytosis, Lymphocytosis, Neutrophilia. A comment is to be documented on the patient results that a Peripheral Scan was performed and the automated results verified. 2. Review of analyzer printouts and EMR results for 6/24 /22 and 6/25/22 identified 6 hematology results that met the criteria for a Peripheral Scan. 4 of the 6 had no comment a Peripheral Scan was performed. 3. An exit interview with the general supervisor and laboratory director, 6/27/22 at approximately 2:30 PM, confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An unannounced, off site, proficiency testing (PT) desk review was conducted for Princeton Community Hospital Bluefield on August 3, 2021, by the West Virginia Office of Laboratory Services. The laboratory PT evaluations with the College of American Pathologists (CAP) were reviewed for compliance with Federal Clinical Laboratory Improvement Amendment (CLIA) regulations under 42 CFR 493. The unsuccessful PT performance 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 review of the College of American Pathologists (CAP) proficiency testing (PT) records and the CLIA 155 Individual Laboratory Profile, Princeton Community 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 -- Hospital Bluefield laboratory failed to (c) successfully perform in a program approved by CMS for the analyte #0825 Fibrinogen for 2 of 2 consecutive testing events in 2021. Findings: #0825 Fibrinogen 1st event 2021- 0% 2nd event 2021- 0% 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 review of the College of American Pathologists (CAP) proficiency testing (PT) records and the CLIA 155 Individual Laboratory Profile, Princeton Community Hospital Bluefield laboratory failed to successfully perform in a program approved by CMS for the analyte #0825 Fibrinogen for 2 of 2 consecutive testing events in 2021. Findings: #0825 Fibrinogen 1st event 2021- 0% 2nd event 2021- 0% 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 College of American Pathologists (CAP) proficiency testing (PT) records and the CLIA 155 Individual Laboratory Profile, the Princeton Community Hospital Bluefield laboratory director failed to ensure successful participation in a program approved by CMS for the analyte #0825 Fibrinogen for 2 of 2 consecutive testing events in 2021. Findings: #0825 Fibrinogen 1st event 2021- 0% 2nd event 2021- 0% 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 College of American Pathologists (CAP) proficiency testing (PT) records and the CLIA 155 Individual Laboratory Profile, the Princeton Community Hospital Bluefield laboratory director failed to ensure compliance with the regulation requiring successfull participation in a program approved by CMS for -- 2 of 3 -- the analyte #0825 Fibrinogen for 2 of 2 consecutive testing events in 2021. Findings: #0825 Fibrinogen 1st event 2021- 0% 2nd event 2021- 0% -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced, on site, recertification survey was conducted at Princeton Community Hospital Bluefield on October 27 and October 28, 2020, 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. D2025 BACTERIOLOGY CFR(s): 493.823(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 a review of laboratory proficiency testing (PT) records from the College of American Pathologists (CAP) and an interview with the general supervisor (GS), the laboratory failed to return PT results to CAP within the timeframe specified for the CAP D6-B 2020 event. Findings: 1. Review of laboratory CAP PT records identified an unsatisfactory score of 0% for the CAP D6-B 2020 bacteriology event. 2. Review of laboratory PT records identified an investigation into the unsatisfactory score and documentation of the laboratory self-evaluation. 3. During an interview with the GS, on 10/27/2020 at approximately 8:45 AM, the GS stated the results were not returned in time to CAP because the delivery of the specimens was after the due date. D2123 HEMATOLOGY CFR(s): 493.851(c) Failure to participate in a testing event is unsatisfactory performance and results in a score of 0 for the testing event. Consideration may be given to those laboratories failing to participate in a testing event only if-- (1) Patient testing was suspended 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 -- during the time frame allotted for testing and reporting proficiency testing results; (2) The laboratory notifies the inspecting agency and the proficiency testing program within the time frame for submitting proficiency testing results of the suspension of patient testing and the circumstances associated with failure to perform tests on proficiency testing samples; and (3) The laboratory participated in the previous two proficiency testing events. This STANDARD is not met as evidenced by: Based on a review of the laboratory proficiency testing (PT) records from the College of American Pathologists (CAP) and an interview with the general supervisor (GS), the laboratory failed to return the results to the CAP VPBS-B 2020 testing event within the time frame required. Findings: 1. Review of CAP PT records identified a 0% unsatisfactory score for the VPBS-B 2020 virtual peripheral blood smear event. 2. The PT investigation identified a failure to participate in the VPBS-B 2020 virtual peripheral blood smear event within the specified time frame by CAP. 3. During an interview with the GS, on 10/27/2020 at approximately 9:00 AM, the GS stated that there were some issues during the transition of the laboratory and the event did not get performed in time. D5433 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(1) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must establish a maintenance protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. The laboratory must perform and document the maintenance activities specified in paragraph (b)(1)(i) of this section. This STANDARD is not met as evidenced by: Based on a review of laboratory preventative maintenance (PM) logs for August and September 2020 of the Sysmex XS-100i and the Sysmex EX-2100 analyzers, and an interview with the general supervisor (GS), the laboratory failed to document weekly and monthly maintenance of the hematology analyzers. Findings: 1. Review of August 2020 and September 2020 PM logs for the Sysmex XS-100i, identified no documentation of the weekly or monthly maintenance being performed for the months reviewed. 2. Review of August 2020 and September 2020 PM logs for the Sysmex XE-2100, identified no documentation of the weekly or monthly maintenance being performed for the months reviewed. 3. Review of the October 2020 PM logs (thru October 27th) for the Sysmex XS-100i and the Sysmex XE-2100, identified the documentation of the weekly and monthly maintenance of the analyzers for the month. 4. During an interview with the GS, on 10/27/2020 at approximately 3:30 PM, the GS stated she was aware of the weekly and monthly maintenance not being documented for the Sysmex XE-2100 and the Sysmex XS-100i hematology analyzers for August 2020 and September 2020. -- 2 of 2 --