Coplin Clinic Laboratory

Summary Statement of Deficiencies D0000 An off site, proficiency testing (PT) desk review was conducted for Coplin Clinic Laboratory on April 10, 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) under 42 CFR 493. The identified unsuccessful participation is the second occurrence involving three of three laboratory testing personnel and is 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 PT evaluations from American Proficiency Institute (API), signed API PT attestation 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 -- records, and the current personnel roster (CMS-209), the laboratory failed to achieve satisfactory performance for the analyte #0765 Blood Cell ID in three of 5 consecutive testing events and has sustained a subsequent occurrence of unsuccessful participation in PT involving three of three laboratory testing personnel. Refer to D2130. 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 CASPER 155D proficiency testing (PT) report, laboratory PT evaluations from American Proficiency Institute (API), signed API PT attestation records, and the current personnel roster (CMS-209), the laboratory failed to achieve satisfactory performance for the analyte #0765 Blood Cell ID in three of 5 consecutive testing events and has sustained a subsequent occurrence of unsuccessful participation in PT involving three of three laboratory testing personnel. Findings: 1. Review of CASPER 155D Report revealed the following unsatisfactory scores for #0765 Blood Cell ID. Signed API PT attestation records identified three of three testing personnel (TP) responsible for the testing events. 60% 2022 event 2 (performed by TP2) 60% 2023 event 1 (performed by TP3) 40% 2023 event 3 (performed by TP1) 2. Review of API PT evaluation reports confirmed the unsatisfactory scores and the second unsuccessful performance for analyte #0765 Blood Cell ID in three of 5 consecutive testing events. 3. Review of laboratory personnel roster (CMS-209), from recertification survey performed 4/9/2024, identified TP1, TP2, and TP3 as current testing personnel. 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 CASPER 155D proficiency testing (PT) report, laboratory PT evaluations from American Proficiency Institute (API), signed API PT attestation records, and the current personnel roster (CMS-209), the laboratory director failed to ensure deficient practices leading to the initial unsuccessful participation in PT for the analyte #0765 Blood Cell ID were corrected, resulting in a subsequent occurrence of unsuccessful participation in three of 5 consecutive testing events involving three of three laboratory testing personnel. Refer to D6019. D6019 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(iv) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently -- 2 of 3 -- and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(iv) Ensure that an approved

Summary Statement of Deficiencies D0000 A routine recertification survey was performed at Coplin Clinic Laboratory on April 9, 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. 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 record review and interview the laboratory failed to achieve satisfactory performance for Fecal Occult Blood and Urine Sediment testing in two out of three consecutive proficiency testing events of 2023. Findings: 1. Review of American Proficiency Institute (API) records identified the following unsatisfactory scores: Fecal Occult Blood:50% 2023 1st event, 50% 2023 3rd event Urine Sediment: 50% 2023 1st event, 50% 2023 3rd event 2. An interview with the technical consultant, 4/9 /24 at 9:30 AM, confirmed the unsatisfactory scores and unsuccessful performance of Fecal Occult Blood and Urine Sediment proficiency testing in two of three consecutive testing events. 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 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 -- 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 Coplin Clinic Laboratory on May 4, 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 record rveiew, the laboratory failed to successfully participate in proficiency testing (PT) for the analyte #0765 Cell ID for two of the last 3 American Proficiency 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 -- Institute (API) testing events. Findings: 1. Review of CASPER 155D Individual Laboratory Profile Report identified the following unsatisfactory scores for analyte #0765 Cell ID: 60% event 2 2022 60% event 1 2023 2. Review of PT evaluation reports from API confirmed the unsuccessful participation for analyte #0765 Cell ID in two of the last 3 PT events. 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 record review and interview the laboratory failed to perform successfully in proficiency testing (PT) for the analyte #0765 Cell ID for two of the last 3 American Proficiency Institute (API) testing events in 2022 and 2023. Findings: 1. Review of CASPER 155D Individual Laboratory Profile Report identified the following unsatisfactory scores for analyte #0765 Cell ID: 60% event 2 2022 60% event 1 2023 2. Review of PT evaluation reports from API confirmed the unsatisfactory performance scores for analyte #0765 Cell ID in 2nd event 2022 and 1st event 2023. 3. An interview with the clinical laboratory director, 5/5/23 at approximately 8:00 AM, confirmed the unsuccessful performance for analyte #0765 Cell ID in two of the last 3 PT events. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An unannounced, off site, proficiency testing (PT) desk review was conducted for Coplin Clinic Laboratory on July 27, 2022, by the West Virginia Office of Laboratory Services. The laboratory PT evaluations from 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 review of American Proficiency Institute (API) evaluations and the CLIA 155D report for Coplin Clinic Laboratory, the laboratory failed to successfully 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 -- participate in a program approved by CMS for the analyte #0435 LDH Total in two consecutive testing events. Findings: 1. LDH Total #0435 1st Event 2022- 0% 2nd Event 2022- 0% 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 the CLIA 155D report and the failures summary report from the American Proficiency Institute (API) proficiency testing (PT) evaluations, the laboratory failed to achieve satisfactory performance for the analyte #0435 LDH Total in two consecutive testing events of 2022. Findings: 1. Review of 155D revealed the following for #0435 LDH Total: 1st Event 2022- 0% 2nd Event 2022- 0% 2. Review of API failures summary report confirmed the unsuccessful performance and unsatisfactory analyte scores for #0435 LDH Total. -- 2 of 2 --

Summary Statement of Deficiencies D0000 An announced, on site, routine recertification survey was conducted at the Coplin Clinic Laboratory on May 4, 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. D5793 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(b)(c) (b) The analytic systems quality assessment must include a review of the effectiveness of

Summary Statement of Deficiencies 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 a review of the laboratory American Proficiency Institute (API) proficiency testing (PT) records and an interview with the general supervisor (GS), the laboratory received an unsatisfactory performance score of 60 percent in Microbiology 1st event of 2018. Findings: 1. A review of API PT records identified an unsatisfactory performance of 60 percent in Bacteriology for the 1st Microbiology event of 2018. 2 of the 5 samples for Group A Strep Antigen had unacceptable answers by the laboratory. a. Sample ST-04 was reported by the laboratory as Negative for Group A Strep Antigen. The expected result was Positive. This was an unacceptable performance for Sample ST-04. b. Sample ST-05 was reported by the laboratory as Negative for Group A Strep Antigen. The expected result was Positive. This was an unacceptable performance for sample ST-05. 2. A review of API PT records identified an investigation into the 60 percent unsatisfactory performance for Group A Strep Antigen in the 1st API Microbiology 2018 testing event. 3. An interview with GS, on 2 /18/2020 at approximately 10:50 AM, confirmed the findings. D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: 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 -- Based on a review of laboratory American Proficiency Institute (API) proficiency testing (PT) records and an interview with the general supervisor (GS), the laboratory failed to attain a score of at least 80 percent for each analyte in the 2019 API Routine Chemistry 1st testing event. Findings: 1. A review of the 2019 API PT records identified an overall successful score of 96 percent for the 2019 API 1st testing event in Routine Chemistry. 2. A review of the 2019 API PT records identified an unsatisfactory performance score of 40 percent for the analyte Total Cholesterol. 3 of 5 specimens had unacceptable responses for Total Cholesterol. a. Specimen CH-01 was reported as 176. The expected value was 253-310. b. Specimen CH-05 was reported as 208. The expected value was 92-114. c. Specimen CH-04 was reported as 59. The expected value was 42-52. 3. A review of the 2019 API 1st testing event in Routine Chemistry identified an investigation into the unsatisfactory analyte performance of Total Cholesterol. 4. An interview with GS, on 2/12/2020 at approximately 10:50 AM, confirmed the findings. -- 2 of 2 --

Summary Statement of Deficiencies D2087 ROUTINE CHEMISTRY CFR(s): 493.841(a) Failure to attain a score of at least 80 percent of acceptable responses for each analyte in each testing event is unsatisfactory analyte performance for the testing event. This STANDARD is not met as evidenced by: Based on review of the laboratory's American Proficiency Institute (API) proficiency testing (PT) records and interview with the Technical Consultant #1 (TC1), the laboratory failed to achieve satisfactory performance for the analyte of Sodium for 2017 Chemistry-Core-2nd Event. The findings include: 1. Review of the API proficiency testing records identified the result for 2017 Chemistry-Core-2nd Event Sodium was 60%. 2. On 2/21/18 at approximately 1:30 PM, TC1 confirmed the findings. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --