Pocahontas Memorial Hospital

Summary Statement of Deficiencies D0000 A routine recertification survey was conducted at Pocahontas Memorial Hospital on May 21 and 22, 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. 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 record review, lack of documentation, and interview the laboratory failed to verify the accuracy of c-reactive protein (CRP) and direct antiglobin testing (DAT) not included in subpart I twice annually in 2023. Findings: 1. Review of 2022, 2023, and 2024 proficiency testing (PT) records revealed no commercial PT documented for CRP and DAT testing in 2023. 2. No documentation of the twice annual verification of CRP and DAT testing could be located for 2023. 3. An interview with the general supervisor, 5/21/24 at 12:15 PM, confirmed the lack of alternate verification of CRP and DAT testing twice annually in 2023 and that the two tests were not enrolled in commercial PT for 2023. D5411 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(a) Test systems must be selected by the laboratory. The testing must be performed following the manufacturer's instructions and in a manner that provides test results within the laboratory's stated performance specifications for each test system as determined under 493.1253. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 6 -- This STANDARD is not met as evidenced by: Based on record review, observation, lack of documentation, and interview the laboratory failed to determine the mean normal patient prothrombin time (MNPT) for one of two new lots (lot 564643) of Innovin prothrombin time (PT) reagent and verify the accuracy of the INR calculation before putting the lot into use for patient testing. Findings: 1. Review of Sysmex CA-660 coagulation analyzer records for the verification of new Dade Innovin reagent lot 564643 (expiry 1/12/26) revealed no documentation of the manual verification of the INR calculation or the determined MNPT. 2. Observation of the coagulation analyzer set up menu, 5/22/24 at 9:45 AM, identified the current ISI in use for lot 564643 to be accurate per Dade Innovin lot specific product insert. 3. An interview with the technical consultant (TC), 5/22/24 at 9:55 AM, confirmed the lack of documentation for the verification of required performance specifications for lot 564643 of Dade Innovin. D5421 ESTABLISHMENT AND VERIFICATION OF PERFORMANCE CFR(s): 493.1253(b)(1) Each laboratory that introduces an unmodified, FDA-cleared or approved test system must do the following before reporting patient test results: (1)(i) Demonstrate that it can obtain performance specifications comparable to those established by the manufacturer for the following performance characteristics: (1)(i)(A) Accuracy. (1)(i) (B) Precision. (1)(i)(C) Reportable range of test results for the test system. (1)(ii) Verify that the manufacturer's reference intervals (normal values) are appropriate for the laboratory's patient population. This STANDARD is not met as evidenced by: Based on record review, observation, and interview the laboratory failed to ensure that the Vitros 7600 chemistry analyzer or the HMS Medhost laboratory information system (LIS), had set detection limits to identify patient results falling outside the verified analytical measuring ranges (AMRs) for 60 of 60 chemistry analytes. Findings: 1. Review of the Vitros 7600 chemistry analyzer validation records (analyzer put into use 9/25/23) revealed established upper and lower AMRs for 60 of 60 analytes tested. 2. During an observation in the laboratory, 5/22/24 at 4:00 PM, the state surveyor and general supervisor (GS) chose 4 chemistry analytes to review and identified no programmed AMRs in the VItros 7600 analyzer or the LIS for 4 of 4 analytes (Lactate, AST, ALT, CK). 3. During an interview on 5/22/24 at 4:03 PM, the GS confirmed the findings, stating the instrument installer/service representative did not program the AMRs into the Vitros 7600 and the facility information technology (IT) staff did not program the AMRs into the LIS before the Vitros 7600 was put into use on 9/25/23. 4. An interview with the IT staff of the hospital, 5/22/24 at 4:15 PM, confirmed the IT staff had not programmed the upper and lower AMRs in the LIS system for 60 of 60 analytes. D5469 CONTROL PROCEDURES CFR(s): 493.1256(d)(10)(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-- Establish or verify the criteria for acceptability of all control materials. (i) When control materials providing quantitative results are used, statistical parameters (for -- 2 of 6 -- example, mean and standard deviation) for each batch and lot number of control materials must be defined and available. (ii) The laboratory may use the stated value of a commercially assayed control material provided the stated value is for the methodology and instrumentation employed by the laboratory and is verified by the laboratory. (iii) Statistical parameters for unassayed control materials must be established over time by the laboratory through concurrent testing of control materials having previously determined statistical parameters. (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 verify the (ii) manufacturer stated reference range, mean, and standard deviation for lot 02222 (expiry 9/10/25) external quality control (QC) used for the Innovance DDimer assay before putting into use for patient testing on the CA-660 coagulation analyzer. Findings: 1. Review of 2023 and 2024 external QC records for DDimer testing identified lot 02222 (expiry 9/10/25) contained level 1 575511 and level 2 575611 as the current lot of external QC in use. 2. No documentation of the verification of the reference range, mean, and standard deviation values stated by the manufacturer for DDimer testing on the CA-660 could be located for lot 02222 (level 1 575511 and level 2 575611). 3. An interview with the general supervisor, 5/22/24 at 10:00 AM, confirmed the lack of verification for the lot of DDimer QC currently in use for patient testing. D5559 IMMUNOHEMATOLOGY CFR(s): 493.1271(e)(f) (e) Investigation of transfusion reactions. (e)(1) According to its established procedures, the laboratory that performs compatibility testing, or issues blood or blood products, must promptly investigate all transfusion reactions occurring in facilities for which it has investigational responsibility and make recommendations to the medical staff regarding improvements in transfusion procedures. (e)(2) The laboratory must document, as applicable, that all necessary remedial actions are taken to prevent recurrences of transfusion reactions and that all policies and procedures are reviewed to assure they are adequate to ensure the safety of individuals being transfused. (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 policies and procedures (P&P), record review, lack of documentation, and interview the laboratory director (LD) failed to ensure the complete testing procedure and investigation were performed for two of two transfusion reactions identified by the facility between January 2023 thru date of survey (DOS). Findings: 1. Review of Immunohematology P&P identified facility policies stating the criteria for identification of transfusion reactions by nursing staff and to immediately stop the transfusion and notify the laboratory. Laboratory Immunohematology P&P state the testing to be performed for a suspected transfusion reaction and the responsibility of LD to review the transfusion reaction workup. 2. Review of laboratory transfusion records (January 2023 thru DOS) identified two transfusion reactions (Patient A on 9 /24/23 and Patient B on 10/20/23). 3. Review of the 9/24/23 transfusion reaction records for patient A revealed documentation for transfusions of packed red blood cells (PRBCs) and platelets as follows: PRBC, unit# W202323253983, transfusion -- 3 of 6 -- complete on 9/24 at 1710 PRBC, unit# W203523735903, transfusion complete on 9 /24 at 1930 Platelets, unit# W203523854913, transfusion complete on 9/25 at 0013 The laboratory was notified on 9/25 at 0130 that a possible transfusion reaction had occurred and a transfusion reaction workup was initiated. The laboratory collected post transfusion specimens on 9/25 at 0200. The empty bags from the two transfused PRBCs were returned to the laboratory for testing. No documentation that the platelet unit bag was returned to the laboratory for testing in accordance with the P&P could be located. 4. Review of the 10/20/23 transfusion reaction records for patient B revealed documentation for transfusions of PRBCs as follows: PRBC, unit# W202723570636, transfusion complete 10/20 at 1435 PRBC, unit # W203523744666, transfusion complete 10/20 at 1700 The laboratory was notified on 10/20 at 1800 that a possible transfusion reaction had occurred and a transfusion reaction workup was initiated. The laboratory collected post transfusion specimens on 10/20 at 1815. No documentation that the laboratory director had reviewed the transfusion reaction workup or confirmed whether a transfusion reaction occurred could be located. 5. An interview with the general supervisor, 5/22/24 at 10:45 AM, confirmed the lack of documentation in the performance, review, and assessment of two of two possible transfusion reactions. D5801 TEST REPORT CFR(s): 493.1291(a) The laboratory must have an adequate manual or electronic system(s) in place to ensure test results and other patient-specific data are accurately and reliably sent from the point of data entry (whether interfaced or entered manually) to final report destination, in a timely manner. This includes the following: (a)(1) Results reported from calculated data. (a)(2) Results and patient-specific data electronically reported to network or interfaced systems. (a)(3) Manually transcribed or electronically transmitted results and patient-specific information reported directly or upon receipt from outside referral laboratories, satellite or point-of-care testing locations. This STANDARD is not met as evidenced by: Based on observation, policies and procedures (P&P), review of patient records, and interview the laboratory failed to establish an adequate system to ensure that (a)(1) the absolute number and percentage of white blood cells (WBCs) calculated when performing a manual differential are accurately transcribed and resulted into the patient final CBC test report. Findings: 1. On 5/22/24 at 1:15 PM, the state surveyor observed testing personnel (TP1) perform a manual differential on patient A. TP1 entered the WBC values from the manual differential into a spreadsheet for calculating the absolute number and percentages of WBCs. TP1 stated that the LIS does not calculate absolute values or percentages of WBCs when a manual differential is performed and that TP must use the spreadsheet to calculate these values and manually enter the results in the HMS Medhost LIS. 2. No P&P for calculating the absolute number and percentage of WBCs and entering the results of a manual differential cell count into the EMR could be located. 3.. Review of 5 patient manual differential CBC results (November 2023 thru date of survey) identified 5 of the 5 records listed percentages and absolute numbers of each type of WBC that did not correlate to the manual differential cell count. 4. An interview with the general supervisor, 5/22/24 at 1:30 PM, confirmed the inaccurate WBC percentages and absolute numbers for the 5 patient CBC manual differential results in the electronic health record and the lack of a P&P to establish the process of data entry. -- 4 of 6 -- D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 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 record review, lack of documentation, and interview the laboratory director (LD) failed to ensure that 1 of 7 laboratory testing personnel (TP) were assessed for annual competency in Immunohematology testing in 2023. Findings: 1. Review of 2023 CA for TP revealed no documentation of a completed Immunohematology competency assessment for TP4 in 2023. 2. An interview with the LD, 5/21/24 at 1:00 PM, confirmed the lack of a documented CA for TP4 in 2023 for Immunohematology. D6091 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(iii) The laboratory director must ensure all proficiency testing reports received are reviewed by the appropriate staff to evaluate the laboratory's performance and to identify any problems that require

Summary Statement of Deficiencies D0000 An unannounced, off site, proficiency testing (PT) desk review was conducted for Pocahontas Memorial Hospital on April 26, 2023, by the West Virginia Office of Laboratory Services. The laboratory PT 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 of CASPER 153D Unsuccessful PT report, CASPER 155D Individual Laboratory Profile Report, and evaluation reports from the American 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 -- Proficiency Institute (API), the laboratory failed to successfully participate in PT for the analyte #0045 Virology in 2 consecutive testing events. Findings: 1. Review of CASPER 153D Unsuccessful PT Report identified an unsuccessful perfromance for analyte #0045 Virology. 2. Review of CASPER 155D Individual Laboratory Profile Report identified the following unsatisfactory scores for analyte #0045 Virology: a. 0% event 3 2022 b. 0% event 1 2023 3. Review of API evaluation reports confirmed the 0% for analyte #0045 Virology in the 3rd event of 2022 and the 1st event of 2023. D2057 VIROLOGY CFR(s): 493.831(b) 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 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 review of proficiency testing (PT) records and interview, the laboratory failed to participate in 2 consecutive PT events resulting in a unsuccessful score of 0% for the analyte #0045 Virology. Findings: 1. API 3rd Event 2022 Virology 0% SARS- CoV-2 Antigen 2. API 1st Event 2023 Virology 0% SARS-CoV-2 Antigen 3. A phone call with the laboratory manager, 4/27/23 at approximately 8:15 AM, confirmed the failure to participate in the 2 consecutive events for Virology SARS- CoV-2 Antigen. D2061 VIROLOGY CFR(s): 493.831(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 proficiency testing (PT) records and interview, the laboratory failed to submit the PT results for the analyte #0045 Virology (SARS-CoV-2 antigen) within the timeframe for the 3rd Event of 2022 and the 1st Event of 2023. Findings: 1. Review of American Proficiency Institute (API) evaluations identified the following unsatisfactory scores: a. Virology (SARS-CoV-2) 0% for 2022 3rd event Failure to Participate b. Virology (SARS-CoV-2) 0% for 2023 3rd event Failure to Participate 2. A phone interview with the laboratory manager, 4/27/23 at approximately 8:15 AM, confirmed the failure to participate in the PT events. -- 2 of 2 --

Summary Statement of Deficiencies D6096 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(7) The laboratory director must ensure that all necessary remedial actions are taken and documented whenever significant deviations from the laboratory's established performance characteristics are identified. This STANDARD is not met as evidenced by: Based on record review, lack of documentation, and interview the laboratory director failed to establish an effective process to monitor and maintain the quality of laboratory services in the specialty of Microbiology to ensure accurate and reliable patient results. Findings: Refer to D5791 D6102 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(12) The laboratory director must ensure that prior to testing patients' specimens, all personnel have the appropriate education and experience, receive the appropriate training for the type and complexity of the services offered, and have demonstrated that they can perform all testing operations reliably to provide and report accurate results. This STANDARD is not met as evidenced by: Based on review of testing personnel (TP) competencies, lack of documentation, and interview the laboratory director failed to ensure TP received the appropriate training to establish and maintain competency to perform Microbiology testing proficiently. Refer to D5209 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 D0000 An announced, on site, routine recertification survey was conducted at Pocahontas Memorial Hospital on May 24 and May 25 2022, 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 are explained below. D2020 BACTERIOLOGY CFR(s): 493.823(a) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on record review and interview the laboratory failed to receive a satisfactory score of at least 80% in Bacteriology for 1 of 1 American Association of Bioanalyst (AAB) proficiency testing (PT) events in 2022. Findings: 1. Review of 2022 PT records revealed an unsatisfactory score of 64% for CMS analyte #0005 Bacteriology for the following incorrect results: Specimen #2 904-Streptococcus salivarius 0% Specimen #4 819-Micrococcus sp.; NOS 0% 2. An exit interview with the laboratory director and administration team, 5/25/22 at approximately 5:00 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. 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, lack of documentation, and interview the laboratory failed to document the competencies of 4 of 4 laboratory testing personnel (TP) in 2021 for each testing methodology used in the laboratory. Findings: 1. Review of TP records revealed 4 of 4 2021 competencies had only Immunohematology methodologies completed. 2. An interview with the laboratory director, 5/25/22 at approximately 1: 00 PM, 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 for Pocahontas Memorial Hospital on April 18, 2022, by the West Virginia Office of Laboratory Services. The laboratory PT evaluations with the American Association of Bioanalysts (AAB) 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 record review, the laboratory failed to successfully participate in proficiency testing (PT) for the analyte #0895-Compatibility Testing (Immunohematology) for 2 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 -- of 3 American Association of Bioanalysts (AAB) PT events in 2021 and 2022. Findings: 1. Review of PT evaluation reports from AAB for Q2 of 2021 and Q1 of 2022 identified the folllowing unsatisfactory scores for analyte #0895-Compatibility Testing (Immunohematology): Q2 event 2021 60% Q1 event 2022 80% 2. This is a repeat deficiency. 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 participate in proficiency testing (PT) for the analyte #0895-Compatibility Testing (Immunohematology) for 2 of 3 American Association of Bioanalysts (AAB) PT events in 2021 and 2022. Findings: 1. Review of PT evaluation reports from AAB for Q2 of 2021 and Q1 of 2022 identified the following unsatisfactory scores for analyte #0895 Compatibility Testing (Immunohematology): Q2 event 2021: 60% Q1 event 2022: 80% 2. This is a repeat deficiency. D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the American Association of Bioanalysts (AAB) proficiency testing (PT) evaluation scores for Pocahontas Memorial Hospital Laboratory, the laboratory director failed to ensure successful participation in a program approved by CMS for the analyte #0895-Compatibility Testing for 2 of 3 PT events in 2021 and 2022. Findings: 1. Review of PT evaluation reports from AAB for Q2 2021 and Q1 of 2022 identified the following unsatisfactory scores for analyte #0895-Compatibility Testing (Immunohematology): Q2 event 2021: 60% Q1 event 2022: 80% 2. This is a repeat deficiency. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are -- 2 of 3 -- properly performed. This STANDARD is not met as evidenced by: Based on review of the American Association of Bioanalysts (AAB) proficiency testing (PT) evaluation reports, the laboratory director failed to ensure successful participation in PT for the analyte #0895-Compatibility Testing (Immunohematology) for 2 of 3 testing events in 2021 and 2022. Findings: 1. Refer to D2016 and D2181. 2. This is a repeat deficiency. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An unannounced, off site, proficiency testing (PT) desk review was conducted for Pocahontas Memorial Hospital on July 2, 2021, by the West Virginia Office of Laboratory Services. The laboratory PT evaluations with the American Association of Bioanalysts (AAB) 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 record review the laboratory failed to successfully participate in proficiency testing (PT) for the analyte #0895 Compatability Testing (Immunohematology) for 2 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 -- of 2 American Association of Bioanalysts (AAB) PT events in 2021. Findings: 1. Review of PT evaluation reports from AAB for Q1 and Q2 of 2021 identified the folllowing unsatisfactory scores for analyte #0895 Compatability Testing (Immunohematology): Q1 event 2021 80% Q2 event 2021 60% 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 participate in proficiency testing (PT) for the analyte #0895 Compatability Testing (Hematology) for 2 of 2 American Association of Bioanalysts (AAB) PT events in 2021. Findings: 1. Review of PT evaluation reports from AAB for Q1 and Q2 of 2021 identified the following unsatisfactory scores for analyte #0895 Compatability Testing (Immunohematology): Q1 event 2021 80% Q2 event 2021 60% D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on review of the American Association of Bioanalysts (AAB) proficiency testing (PT) evaluation scores for Pocahontas Memorial Hospital Laboratory, the laboratory director failed to ensure successful participation in a program approved by CMS for the analyte #0895 Compatability Testing for 2 of 2 PT events in 2021. Findings: 1. Review of PT evaluation reports from AAB for Q1 and Q2 of 2021 identified the following unsatisfactory scores for analyte #0895 Compatability Testing (Immunohematology): Q1 event 2021 80% Q2 event 2021 60% D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(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, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of the American Association of Bioanalysts (AAB) proficiency testing (PT) evaluation reports, the laboratory director failed to assure compliance with the regulation requiring successful participation in PT for the analyte #0895 Compatability Testing (Immunohematology) in 2 of 2 testing events of 2021. Findings: 1. Refer to D2016 2. Refer to D2181 -- 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 a review of the CLIA database CASPER Reports 155D and 153D and the proficiency testing (PT) records from the American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in proficiency testing for each analyte on their CLIA test menu. Findings: 1. Review of the CLIA database, via CASPER Report 153D for failed proficiency testing results, identified a PT failure of the laboratory for the analyte #0565 (T3 Uptake). 2. Review of the individual laboratory PT scores,via CASPER Report 155D, identified the following unsatisfactory scores for analyte #0565 (T3 Uptake): a. 0% for T3 Uptake 3rd event 2019 b. 0% for T3 Uptake 1st event 2020 3. Comparative evaluation scores from 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 -- AAB identified no analyte #0565 (T3 Uptake) enrolled or tested for the facility for the 3rd event 2019 and the 1st event 2020. D2107 ENDOCRINOLOGY CFR(s): 493.843(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 CLIA database CASPER Reports 155D and 153D and the proficiency testing (PT) records from the American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in proficiency testing for each analyte on their CLIA test menu. Findings: 1. Review of the CLIA database, via CASPER Report 153D for failed proficiency testing results, identified a PT failure of the laboratory for the analyte #0565 (T3 Uptake). 2. Review of the individual laboratory PT scores,via CASPER Report 155D, identified the following unsatisfactory scores for analyte #0565 (T3 Uptake): a. 0% for T3 Uptake 3rd event 2019 b. 0% for T3 Uptake 1st event 2020 3. Comparative evaluation scores from AAB identified no analyte #0565 (T3 Uptake) enrolled or tested for the facility for the 3rd event 2019 and the 1st event 2020. 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 Association of Bioanalysts (AAB), the laboratory director failed to provide overall management and direction in accordance with CLIA regulations. Findings: 1. Review of the CLIA database, via CASPER Report 153D for failed proficiency testing results, identified a PT failure of the laboratory for the analyte #0565 (T3 Uptake). 2. Review of the individual laboratory PT scores,via CASPER Report 155D, identified the following unsatisfactory scores for analyte #0565 (T3 Uptake): a. 0% for T3 Uptake 3rd event 2019 b. 0% for T3 Uptake 1st event 2020 3. Comparative evaluation scores from AAB identified no analyte #0565 (T3 Uptake) enrolled for the facility for the 3rd event 2019 and the 1st event 2020. 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 -- 2 of 3 -- 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 155D and 153D and the proficiency testing (PT) records from the American Association of Bioanalysts (AAB), the laboratory director failed to ensure satisfactory performance from the laboratory in proficiency testing (PT). Findings: 1. Review of the CLIA database, via CASPER Report 153D for failed proficiency testing results, identified a PT failure of the laboratory for the analyte #0565 (T3 Uptake). 2. Review of the individual laboratory PT scores,via CASPER Report 155D, identified the following unsatisfactory scores for analyte #0565 (T3 Uptake): a. 0% for T3 Uptake 3rd event 2019 b. 0% for T3 Uptake 1st event 2020 3. Comparative evaluation scores from AAB identified no analyte #0565 (T3 Uptake) enrolled for the facility for the 3rd event 2019 and the 1st event 2020. -- 3 of 3 --

Summary Statement of Deficiencies D0000 An announced, on-site, recertification survey was conducted at Pocahontas Memorial Hospital on March 17, 2020, by the West Virginia Office of Laboratory Services. The laboratory was surveyed to assess compliance with the Federal Clinical Laboratory Improvement Amendments (CLIA) regulations under 42 CFR 493. Specific deficiencies are explained below. 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 a review of the blood bank patient logs, gel and tube method quality control (QC) logs, and an interview with the general supervisor (GS), the laboratory failed to document QC for immunohematology testing performed. Findings: 1. Review of the immunohematology patient testing log for January and February 2020, identified a total of 15 days of patient testing or retyping of received units (1/2/20, 1/9/20, 1/12 /20, 1/17/20, 1/23/20, 1/24/20, 1/26/20, 1/29/20, 1/30/20, 2/4/20, 2/6/20, 2/8/20, 2/13 /20, 2/17/20, 2/28/20). 2. Comparison of patient testing to QC records, for both gel and tube testing, in immunohematology identified 7 of the 15 days patient testing or retyping of units was performed that no QC was documented (1/2/20, 1/12/20, 1/17 /20, 1/23/20, 1/29/20, 2/6/20, 2/28/20). 3. During an interview with the GS, on 3/17 /2020 at approximately 2:00 PM, the GS stated that no documentation of QC for the 7 days could be located. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed 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 4 -- laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on a review of laboratory written policies and procedures (P&P) and an interview with the technical supervisor (TS), the laboratory failed to establish a system that ensures all testing personnel (TP) are aware of and follow the written P&P for laboratory processes. Findings: 1. A review of written P&Ps identified an effective date of 4/24/2018, signed into use by the laboratory director (LD). The written P&P manual had a LD review date of 8/31/2019. 2. A review of written P&P manual identified no documentation of TP having read the current P&Ps for the laboratory that were put into use 4/24/2018. 3. During an interview with the TS, on 3/18/2020 at approximately 10:30 AM, the TS stated that there was no documentation of TP having read the written P&P and no other system to ensure TP are aware of, and following, the laboratory written P&P. D5413 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(b) The laboratory must define criteria for those conditions that are essential for proper 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 a tour of the laboratory, a review of maintenance logs, a review of manufacturer instructions, and an interview with the technical supervisor (TS), the laboratory failed to monitor and document (1) water quality. Findings: 1. A tour of the laboratory identified the Millipore H2O water system that is used as a source for microbiology and coagulation testing. 2. A review of 2019 and 2020 maintenance logs for the Millipore H2O system identified a column labeled "Bacteria Count" that had not been documented as performed for 14 of the 14 months reviewed. 3. A review of the Millipore H2O manufacturer instructions identified a recommended "periodic testing for bacteria count" of the water quality. 4. During an interview with the TS, on 3/18/2020 at approximately 8:00 AM, the TS stated that no bacteria count was currently being performed or documented on the maintenance logs and that a written policy and procedure for determining the criteria for performing the bacteria count would be created for the water system. D5431 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(2) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document function checks as defined by the manufacturer and with at least the frequency specified by the manufacturer. Function checks must be within the manufacturer's established limits before patient testing is conducted. -- 2 of 4 -- This STANDARD is not met as evidenced by: Based on a review of laboratory maintenance logs for the Sysmex hematology analyzer, the manufacturue instructions, and an interview with the technical supervisor (TS), the laboratory failed to document the daily background check for the analyzer. Findings: 1. A review of the January 2020 and February 2020 maintenance logs for the Sysmex hematology analyzer revealed no documentation for the daily background check performed on the Sysmex in 2 of 2 monthly maintenance logs. 2. A review of the manufacturer instructions for the Sysmex hematology analyzer states a passing background check is to be performed daily before running quality control and patient testing. 3. During an interview with TS, on 3/18/2020 at approximately 8:00 AM, the TS stated that there was no place to document the Sysmex background check on the current maintenance log and corrected the form on site. D5437 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(a) Unless otherwise specified in this subpart, for each applicable test system the laboratory must perform and document calibration procedures-- (1) Following the manufacturer's test system instructions, using calibration materials provided or specified, and with at least the frequency recommended by the manufacturer; (2) Using the criteria verified or established by the laboratory as specified in 493.1253(b) (3)-- (2)(i) Using calibration materials appropriate for the test system and, if possible, traceable to a reference method or reference material of known value; and (2)(ii) Including the number, type, and concentration of calibration materials, as well as acceptable limits for and the frequency of calibration; and (3) Whenever calibration verification fails to meet the laboratory's acceptable limits for calibration verification. This STANDARD is not met as evidenced by: Based on a tour of the laboratory and an interview with the technical supervisor (TS), the laboratory failed to calibrate the MLA pipettes used in Immunohematology as required by the manufacturer. Findings: 1. A tour of the Immunohematology laboratory identified 7 MLA pipettes and 1 Fisherbrand Elite Adjustable Volume Pipette. 3 of the 8 pipettes had documentation of calibration performed on 4/23/2018. There was no documentation on the other 5. a. 25 ul MLA (2) b. 10 ul MLA c. 100 ul MLA calibration done 4/23/18 due 10/2018 d. 400 ul MLA calibration done 4/23/18 due 10/2018 e. 300 ul MLA f. 50 ul MLA calibration done 4/23/18 due 10/2018 g. Fisherbrand Elite 0.5-5 ml 2. The manufacturer instructions state calibrations should be performed every 6-12 months depending on frequency of use. 3. During an interview with the TS, on 3/18/2020 at approximately 9:30 AM, the TS stated that no calibration of the laboratory pipettes had occurred in 2019 and that the pipettes would be calibrated and a system established to ensure the calibration of the pipettes occurs on the required basis. D5507 BACTERIOLOGY CFR(s): 493.1261(b)(c) (b) For antimicrobial susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antimicrobial agent(s) before, or concurrent with, initial use, using approved control organisms. (b)(1) Each day tests are performed, the laboratory must use the appropriate control organism(s) to check the procedure. (b)(2) The laboratory's zone sizes or minimum inhibitory concentration -- 3 of 4 -- for control organisms must be within established limits before reporting patient results. (c) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on a review of laboratory quality control (QC) records and an interview with the technical supervisor (TS), the laboratory failed to document the lot number and shipment of antimicrobial agents before use. Findings: 1. A review of microbiology QC records, from January 2019 thru February 2020, identified no documentation of specific lot numbers and shipments for Catalase, Coagulase, Oxidase, Bacitracin, Optochin agents in 14 of the 14 QC documentation records. 2. During an interview with the TS, on 3/17/2020 at approximately 1:30 pm, the TS stated there was no documentation of the lot numbers and shipments for QC records and that a new form will be created and put into use with documentation of the lot numbers and shipments. This was corrected on site. 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 a review of written policies and procedures (P&P), a review of temperature charts and maintenance logs for Immunohematology, and an interview with the general supervisor (GS), the laboratory failed to follow established P&P regarding blood bank unit inspection while in storage. Findings: 1. A review of written P&P identified a Blood Bank Lab policy effective 4/24/2018, that states "Unit Inspection Each day all units of blood in the blood bank will be examined for the following: Hemolysis, Turbidity, Broken bags/leaks, Expiration dates". 2. A review of 2019 and 2020 temperature charts and maintenance logs for Immunohematology identified no documentation of this daily unit check. 3. During an interview with the GS, on 3/18 /2020 at approximately 10:00 AM, the GS stated that there was no documentation of the daily checks of units in blood bank and a form will be created to document the criteria and completion of daily checks on blood bank units stored in the laboratory. -- 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 proficiency testing records from the American Association of Bioanalysts (AAB), the laboratory failed to successfully participate in proficiency testing (PT) for each analyte on the CLIA test menu. Findings: 1. Review of the CLIA database, via CASPER report 153D for failed proficiency testing results, identified a PT failure for the laboratory for analyte #0765 (Blood Cell Identification or White Blood Cell Differential). 2. Review of the idividual laboratory PT report scores, via CASPER report 155D, and comparative evaluation scores from AAB identified 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 -- following unsatisfactory scores for White Blood Cell Differential: a. 44% for Hematology with Differential E 2nd event 2019 b. 72% for Hematology with Differential E 3rd event 2019 D2131 HEMATOLOGY CFR(s): 493.851(g) Failure to achieve an overall testing event score of satisfactory performance 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 review of the proficiency testing (PT) records from the American Association of Bioanalysts (AAB), the laboratory produced unsatisfactory results for the same analyte in hematology, analyte #0765 Cell ID or WBC Diff, in two consectutive testing events. Findings: 1. Review of the individual laboratory PT report scores (Casper Report 155D) and comparative evaluation scores from AAB identified the following unsatisfactory scores for analyte #0765 White Blood Cell Differential: a. 44% for Hematology with Differential E 2nd test event 2019 b.72% for Hematology with Differential E 3rd test 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 proficiency testing (PT) records, the laboratory director failed to provide overall management and direction in accordance with CLIA regulations. Findings: 1. Review of American Association of Bioanalysts (AAB) PT evaluation scores, CASPER Report 155D, and CASPER Report 153D demonstrated unsatisfactory scores for analyte #0765 (Cell ID or WBC Diff) in two consecutive testing events. a. 44% for Hematology with Diff E 2nd testing event 2019 b. 72% for Hematology with Diff E 3rd testing event 2019 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. -- 2 of 3 -- This STANDARD is not met as evidenced by: Based on review of American Association of Bioanalysts (AAB) proficiency testing (PT) records, the laboratory director failed to ensure satisfactory performance from the laboratory in proficiency testing. Findings: 1. Review of American Association of Bioanalysts (AAB) PT evaluation scores, CASPER Report 155D, and CASPER Report 153D demonstrated unsatisfactory scores for analyte #0765 (Cell ID or WBC Diff) in two consecutive testing events. a. 44% for Hematology with Diff E 2nd testing event 2019 b. 72% for Hematology with Diff E 3rd testing event 2019 -- 3 of 3 --

Summary Statement of Deficiencies D5439 CALIBRATION AND CALIBRATION VERIFICATION CFR(s): 493.1255(b) Unless otherwise specified in this subpart, for each applicable test system the laboratory must do the following: Perform and document calibration verification procedure - (b)(1) Following the manufacturer's calibration verification instructions; (b)(2) Using the criteria verified or established by the laboratory under 493.1253(b)(3) -- (b)(2)(i) Including the number, type, and concentration of the materials, as well as acceptable limits for calibration verification; and (b)(2)(ii) Including at least a minimal (or zero) value, a mid-point value, and a maximum value near the upper limit of the range to verify the laboratory's reportable range of test results for the test system; and (b)(3) At least once every 6 months and whenever any of the following occur: (b)(3)(i) A complete change of reagents for a procedure is introduced, unless the laboratory can demonstrate that changing reagent lot numbers does not affect the range used to report patient test results, and control values are not adversely affected by reagent lot number changes. (b)(3)(ii) There is major preventive maintenance or replacement of critical parts that may influence test performance. (b)(3)(iii) Control materials reflect an unusual trend or shift, or are outside of the laboratory's acceptable limits, and other means of assessing and correcting unacceptable control values fail to identify and correct the problem. (b)(3)(iv) The laboratory's established schedule for verifying the reportable range for patient test results requires more frequent calibration verification. This STANDARD is not met as evidenced by: Based on review of the laboratory's calibration/calibration verification records and interview with the Laboratory Manager(LM)/General Supervisor #1 (GS1), the laboratory failed to perform and document calibration verification every 6 months for Alanine Aminotransferase, Albumin, Alcohol-Ethanol, Alkaline Phosphotase, Ammonia, Amylase, Aspartate Aminotransferase, Bilirubin Direct, Brain Natriuretic Peptide, Blood Urea Nitrogen, C-Reactive Protein, Calcium, Chloride, Cholesterol, 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 -- Creatine Kinase MB, Creatine Kinase Total, Creatinine, Digoxin, Dilantin, Ferritin, Folic Acid, Glucose, Hemoglobin A1C, High Density Lipoprotein, Iron, Lactate, Lactate Dehydrogenase, Lipase, Magnesium, Micro-albumin, Neonatal Bilirubin, Phosphorus, Potassium, Total Protein, Salicylate, Sodium, Tegretol, Total Thyroxine, Total Billirubin, Triglycerides, FreeTriiodothyronine, Free Thyroxine, Troponin, Gentamycin, Vancomycin, Thyroid Stimulating Hormone, T3, Uric Acid, and Vitamin D performed on the Vitros 5600. Record review was from June 2016 to April 2018. The findings include:. 1. Review of the Vitros 5600 calibration/calibration verification records from June 2016 to April 2018 identified no calibration verification for Alanine Aminotransferase, Albumin, Alcohol-Ethanol, Alkaline Phosphotase, Ammonia, Amylase, Aspartate Aminotransferase, Bilirubin Direct, Brain Natriuretic Peptide, Blood Urea Nitrogen, C-Reactive Protein, Calcium, Chloride, Cholesterol, Creatine Kinase MB, Creatine Kinase Total, Creatinine, Digoxin, Dilantin, Ferritin, Folic Acid, Glucose, Hemoglobin A1C, High Density Lipoprotein, Iron, Lactate, Lactate Dehydrogenase, Lipase, Magnesium, Micro- albumin, Neonatal Bilirubin, Phosphorus, Potassium, Total Protein, Salicylate, Sodium, Tegretol, Total Thyroxine, Total Billirubin, Triglycerides, FreeTriiodothyronine, Free Thyroxine, Troponin, Gentamycin, Vancomycin, Thyroid Stimulating Hormone, T3, Uric Acid, and Vitamin D performed on the Vitros 5600. from June 2016 to April 2018. 2. On 4/25/18 at approximately 8:30AM, the LM/GS1 confirmed the findings. The LM/GS1 stated calibration verification was performed when the Vitros 5600 was installed in April 2016 but not since then. 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 review of the laboratory's quality control records, "Procedure-by patient listing for HCG", and interview with the General Supervisor #2, for the Sure-Vue Qualitative Serum HCG test, the laboratory failed to perform and document a positive and negative control for 177 of 179 days of patient testing. Record review was June 2016 to April 2018. The findings include: 1. Review of quality control records for the Sure-Vue Qualitative Serum HCG test identified documentation of quality control for 6/13/16, 8/1/16, 9/12/16, 10/12/16, 10/24/16, 2/13/17, 4/19/17, 5/17/17, 6/24/17, 7/17 /17, 10/17/17, 10/24/17 and 1/18/18. 2. Review of the laboratory's "Pregnancy Test - Qualitative Log Sheet" identified patient testing was performed on the following days: 6/5/16, 6/13/16, 6/21/16, 6/28/16, 6/29/18, 6/30/16, 7/7/16, 7/15/17, 7/19/16, 7/21/16, 7/26/16, 7/30/16, 8/3/16, 8/6/16, 8/15/16, 8/17/16, 8/18/16, 8/21/16, 8/22/16, 8/22/16, 8/24/16, 8/25/16, 8/30/16, 8/31/16, 9/2/16, 9/3/16, 9/6/16, 6/7/16, 9/20/16, 9/23/16, 9 /24/16, 9/29/16, 10/4/16, 10/6/16, 10/9/16, 10/11/16, 10/14/16, 10/19/16, 10/21/16, 10 /25/16, 10/29/16, 11/2/16, 11/10/16, 11/14/16, 11/16/16, 11/17/16, 11/18/16, 11/21 /16, 11/22/16, 11/23/16, 11/28/16, 11/30/16, 12/1/16, 12/2/16, 12/6/16, 12/13/16, 12 /15/16, 12/16/16, 12/18/16, 12/21/16, 12/22/16, 12/25/16, 12/27/16, 12/30/16, 12/31 /16, 1/5/17, 1/6/17, 1/8/17, 1/11/17, 1/15/17, 1/16/17. 1/17/16, 1/20/16, 1/22/17, 1/23 /17, 1/24/17, 1/28/17, 1/31/17, 2/2/17, 2/3/17, 2/5/17, 2/7/17, 2/18/17, 2/19/17, 2/20 /17, 2/23/17, 2/24/17, 2/26/17, 3/1/17, 3/2/17, 3/6/17, 3/7/17, 3/14/17, 3/16/17, 3/20 -- 2 of 5 -- /17, 3/31/17, 4/1/17, 4/3/17, 4/7/17, 4/10/17, 4/12/17, 4/13/17, 4/18/17, 4/20/17, 4/23 /17, 5/4/17, 5/6/17. 5/9/17, 5/16/17, 5/17/17, 5/20/17, 5/29/17, 6/1/17, 6/2/17, 6/5/17, 6 /11/17, 7/5/17, 7/6/17, 7/7/17, 7/18/17, 7/20/17, 7/22/17, 7/23/17, 7/25/17, 7/26/17, 8 /15/17, 8/28/17, 8/30/17, 9/5/17, 9/15/17, 9/18/17, 9/21/17, 9/22/17, 9/25/17, 9/26/17, 9/28/17, 10/13/17, 10/23/17, 10/24/17, 10/25/17, 10/30/17, 11/8/17, 11/11/17, 11/16 /17, 12/4/17, 12/5/17, 12/8/17, 12/9/17, 12/16/17, 12/20/17, 12/28/17, 1/2/18, 1/5/18, 1 /6/18, 1/9/18, 1/15/18, 1/20/18, 1/27/18, 1/29/18, 1/31/18, 2/4/18, 2/6/18, 2/10/18, 2/11 /18, 2/12/18, 2/14/18, 2/17/18, 2/19/18, 2/21/18, 2/22/18, 2/23/18, 2/24/18, 2/26/18, 3 /2/18, 3/12/18, 3/13/18, 3/21/18, 3/22/18, 3/26/18, 4/20/18 and 4/21/18. 3. On 4/24/18 at approximately 2:38 PM, GS2 stated they run a positive and negative control when they receive each kit and not each day of patient testing. D5477 CONTROL PROCEDURES CFR(s): 493.1256(e)(4)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (4) Before, or concurrent with the initial use-- (e)(4)(i) Check each batch of media for sterility if sterility is required for testing; (e)(4)(ii) Check each batch of media for its ability to support growth and, as appropriate, select or inhibit specific organisms or produce a biochemical response; and (e)(4)(iii) Document the physical characteristics of the media when compromised and report any deterioration in the media to the manufacturer. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: A. Based on review of the laboratory's policy and procedure manual, media log sheets and interview with the General Supervisor #2 (GS2), the laboratory failed to check each lot number and shipment of Signal Blood Culture System Bottles for sterility and ability to support growth from June 2016 to April 2018. The findings include: 1. Review of the laboratory's policy and procedure manual identified no quality control plan for the Signal Blood Culture System Bottles. 2. Review of the laboratory's quality control records identified a lack of documentation demonstrating the laboratory checked each lot number and shipment of Signal Blood Culture System Bottles for sterility and ability to support growth from June 2016 to current. 3. On 4/24 /18 at approximately 12:45 PM, GS2 stated that they were keeping the certificates and not checking for sterility or the ability to support growth for the Signal Blood Culture System Bottles. B. Based on review of the laboratory's policy and procedure manual, media log sheets and interview with the General Supervisor #2 (GS2), the laboratory failed to check each lot number and shipment of Chocolate agar for sterility for 14 of 14 lots/shipments from June 2016 to April 2018. The findings include: 1. Review of the laboratory's policy and procedure manual identified no quality control plan for the Chocolate agar. 2. Review of the laboratory's quality control records identified a lack of documentation demonstrating the laboratory checked each lot number and shipment of Chocolate agar for sterility for 14 of 14 lots/shipments from June 2016 to current. 3. On 4/24/18 at approximately 12:45 PM, GS2 stated that they were keeping the certificates and only checking for ability to support growth for the Chocolate agar. C. Based on review of the laboratory's policy and procedure manual, media log sheets and interview with the General Supervisor #2 (GS2), the laboratory failed to check each lot number and shipment of Triple Soy Agar (TSA) for sterility for 15 of 15 lots /shipments from June 2016 to April 2018. The findings include: 1. Review of the laboratory's policy and procedure manual identified no quality control plan for the TSA. 2. Review of the laboratory's quality control records identified a lack of documentation demonstrating the laboratory checked each lot number and shipment of -- 3 of 5 -- TSA for sterility for 15 of 15 lots/shipments from June 2016 to current. 3. On 4/24/18 at approximately 12:45 PM, GS2 stated that they were keeping the certificates and only checking for ability to support growth for the TSA. D. Based on review of the laboratory's policy and procedure manual, media log sheets and interview with the General Supervisor #2 (GS2), the laboratory failed to check each lot number and shipment of Sheep Blood/MacConkey Bi-plate Agar for sterility for 16 of 16 lots /shipments from June 2016 to April 2018. The findings include: 1. Review of the laboratory's policy and procedure manual identified no quality control plan for the Sheep Blood/MacConkey Agar. 2. Review of the laboratory's quality control records identified a lack of documentation demonstrating the laboratory checked each lot number and shipment of Sheep Blood/MacConkey Agar for sterility for 16 of 16 lots /shipments from June 2016 to current. 3. On 4/24/18 at approximately 12:45 PM, GS2 stated that they were keeping the certificates and only checking for ability to support growth for the Sheep Blood/MacConkey Agar. E. Based on review of the laboratory's policy and procedure manual, media log sheets and interview with the General Supervisor #2 (GS2), the laboratory failed to check each lot number and shipment of MacConkey Agar for sterility for 15 of 15 lots/shipments from June 2016 to April 2018. The findings include: 1. Review of the laboratory's policy and procedure manual identified no quality control plan for the MacConkey agar. 2. Review of the laboratory's quality control records identified a lack of documentation demonstrating the laboratory checked each lot number and shipment of MacConkey for sterility for 15 of 15 lots/shipments from June 2016 to current. 3. On 4/24/18 at approximately 12: 45 PM, GS2 stated that they were keeping the certificates and only checking for ability to support growth for the MacConkey Agar. D5507 BACTERIOLOGY CFR(s): 493.1261(b)(c) (b) For antimicrobial susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antimicrobial agent(s) before, or concurrent with, initial use, using approved control organisms. (b)(1) Each day tests are performed, the laboratory must use the appropriate control organism(s) to check the procedure. (b)(2) The laboratory's zone sizes or minimum inhibitory concentration for control organisms must be within established limits before reporting patient results. (c) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on review of the laboratory's media quality control records, patient records and interview with General Supervisor #2 (GS2), the laboratory failed to perform quality control for 12 of 12 days of patient testing for identification and susceptibility performed on the Dade Behring AutoScan-4. Record review was from March 2018 to April 2018. The findings include: 1. Review of the laboratory's quality control records for the Dade Behring AutoScan-4 identified a positive and negative control organism was performed on the following days: 3/3/18, 3/17/18, 3/23/18, 4/6/18, 4/13/18 and 4 /20/18. 2. Review of the laboratory's patient records for the AutoScan-4 identified patients were analyzed on 3/17/18, 3/19/18, 3/21/18, 3/24/18, 3/25/18, 3/28/18, 4/1 /18, 4/4/18, 4/5/18, 4/8/18, 4/18/18, and 4/19/18. 2. On 4/24/18 at approximately 1:15 PM, GS2 confirmed the findings. GS2 stated they are performing quality control on Dade Behring AutoScan-4 for each of their panels when a new lot/shipment is received and every Friday. -- 4 of 5 -- 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: A. Based on direct observation of the laboratory's Thermo Scientific Ultra Freezer where Fresh Frozen Plasma is stored, Thermo Scientific Ultra Freezer temperature log sheets and interview with the General Supervisor #1 (GS1), the laboratory failed to monitor the Thermo Scientific Ultra Freezer on a continuous basis for 694 of 694 days between 6/1/16 and 4/24/18. The findings include: 1. Direct observation of the laboratory's Thermo Scientific Ultra Freezer identified a lack of a continuous monitor of the freezer's temperature. 2. Review of the laboratory's Thermo Scientific Ultra Freezer log sheet identified the laboratory was recording the temperature of the freezer every hour since 5/27/16. 3. On 4/24/18 at approximately 11:05 AM, GS1 confirmed the findings. B. Based on review of the laboratory's Blood Bank alarm check records and interview with the General Supervisor #1 (GS1), the laboratory failed to perform and document the alarm check for the Thermo Scientific Ultra Freezer from 6/2016 to 4/2018. The findings include: 1. Review of the laboratory's Blood Bank alarm check records identified a lack of alarm checks for the Thermo Scientific Ultra Freezer from 6/2016 to 4/2018. 2. At approximately 11:05 AM, GS1 stated the freezer had an alarm but it was not regularly tested. -- 5 of 5 --