Clinch Memorial Hospital

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on March 20, 2024. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following condition deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 CFR 493.1403 Condition: Moderate Complex Laboratory Director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of the American Proficiency Institute (API) reports, the laboratory Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- failed to successfully participate in proficiency testing (PT) in 3 events for PCO2 Blood Gas (PCO2) resulting in the non-initial unsuccessful participation for PCO2. Refer to D 2096 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 CMS CASPER 155 report and review of API PT reports, the laboratory failed to demonstrate satisfactory performance in 3 testing events for PCO2 resulting in the non-initial unsuccessful participation for PCO2. Findings: 1. A review of Casper Report 155 disclosed the laboratory failed PCO2 on the following: 2022 Event 2 Score 40% 2022 Event 3 Score 60% 2023 Event 1 Score 20% 2. A review of the laboratory's API Reports confirmed the laboratory failed PCO2 with the aforementioned scores. D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on review of the CMS CASPER 155 report and review of the API reports, the laboratory director failed to provide overall management and direction for successful participation in PT. The laboratory director failed to ensure PT samples were tested as required. Refer to D6016 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on review of the CMS CASPER Report 155 and the API 2022 & 2023 PT evaluation reports, the laboratory director failed to ensure successful PT participation in 3 consecutive testing events. Refer to D 2096 -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on Sept. 21, 2023. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following condition deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6076 - 42 CFR 493.1441 Condition: Laboratory Director D2016 SUCCESSFUL PARTICIPATION CFR(s): 493.803(a)(b)(c) (a) Each laboratory performing nonwaived testing must successfully participate in a proficiency testing program approved by CMS, if applicable, as described in subpart I of this part for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. (b) Except as specified in paragraph (c) of this section, if a laboratory fails to participate successfully in proficiency testing for a given specialty, subspecialty, analyte or test, as defined in this section, or fails to take remedial action when an individual fails gynecologic cytology, CMS imposes sanctions, as specified in subpart R of this part. (c) If a laboratory fails to perform successfully in a CMS- approved proficiency testing program, for the initial unsuccessful performance, CMS may direct the laboratory to undertake training of its personnel or to obtain technical assistance, or both, rather than imposing alternative or principle sanctions except when one or more of the following conditions exists: (1) There is immediate jeopardy to patient health and safety. (2) The laboratory fails to provide CMS or a CMS agent with satisfactory evidence that it has taken steps to correct the problem identified by the unsuccessful proficiency testing performance. (3) The laboratory has a poor compliance history. This CONDITION is not met as evidenced by: Based on review of the CASPER 155 report and review of the American Proficiency Institute (API) reports, the laboratory failed to maintain satisfactory 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 -- testing (PT) participation for Compatability Testing in 2023 event 2, resulting in an initial unsuccessful participation for Compatability Testing. Refer to D 2173 D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the Centers for Medicare and Medicaid (CMS) CASPER 155 report and review of American Proficiency Institute (API) reports, the laboratory failed to maintain satisfactory participation in testing event ( 2nd event of 2023), resulting in an initial unsuccessful participation for compatibility testing. Findings: 1. A review of Casper Report 155 revealed the laboratory failed compatibility testing on the following: 2023 Event 2 Score 80% 2. A review of the laboratory's API Reports confirmed the laboratory failed compatibility testing with the aforementioned score. 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 CMS CASPER 155 report and review of American Proficiency Institute (API) reports, the laboratory director failed to provide overall management and direction for proficiency testing performance. The laboratory director failed to ensure proficiency testing samples were tested as required. Refer to D6089 D6089 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(4)(i) The laboratory director must ensure the proficiency testing samples are tested as required under subpart H of this part. This STANDARD is not met as evidenced by: Based on review of the CMS CASPER Report 155 and the American Proficiency Institute (API) PT evaluation reports, the laboratory director failed to ensure successful proficiency testing performance in Compatibility Testing for 2023 event 2 resulting in the initial unsuccessful participation for Compatibility Testing. Findings: 1. A review of Casper Report 155 revealed the laboratory failed compatibility testing on the following: 2023 Event 2 Score 80% 2. A review of the laboratory's API Reports confirmed the laboratory failed compatibility testing with the aforementioned score. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A proficiency testing desk review was completed on January 31, 2023. At the time of the review, the laboratory was not in compliance with the Clinical Laboratory Improvement Amendments of 1988, 42 CFR 493.1 through 42 CFR 493.1780. The following condition deficiencies were cited: D2016 - 42 CFR 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 CFR 493.1403 Condition: Moderate Complex Laboratory Director 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 proficiency testing review using the Centers for Medicare and Medicaid (CMS) Casper Reports 153 and 155 and review of the American Proficiency Institute 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 -- (API) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory participation in two consecutive events (2nd and 3rd events of 2022) resulting in the initial unsuccessful particpation for partial pressure carbon dioxide (PC02). Refer to D 2096 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 proficiency testing review using the Centers for Medicare and Medicaid (CMS) Casper Reports 153 and 155 and review of the American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory failed to maintain satisfactory participation in two consecutive events (2nd and 3rd events of 2022) resulting in the initial unsuccessful particpation for partial pressure carbon dioxide (PC02). Findings : 1. Review of Casper Reports 153 and 155 disclosed the laboratory failed PC02 : - 2022 event 2 with a score of 40% - 2022 event 3 with a score of 60%. 2. Review of the laboratory's proficiency testing reports from API confirmed the laboratory failed PC02 on Events 2 and 3 of 2022 resulting in the initial unsuccessful participation.. 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 proficiency testing review using the Centers for Medicare and Medicaid (CMS) Casper Reports 153 and 155 and review of the American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory director failed to ensure the lab maintained satisfactory participation in two consecutive events (2nd and 3rd events of 2022) resulting in the initial unsuccessful particpation for partial pressure carbon dioxide (PC02). Refer to D 2096 D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on proficiency testing review using the Centers for Medicare and Medicaid -- 2 of 3 -- (CMS) Casper Reports 153 and 155 and review of the American Proficiency Institute (API) proficiency testing (PT) reports, the laboratory director failed to ensure the lab maintained satisfactory participation in two consecutive events (2nd and 3rd events of 2022) resulting in the initial unsuccessful particpation for partial pressure carbon dioxide (PC02). Refer to D 2096 -- 3 of 3 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) Recertification survey was completed on May 18, 2021. Condition and Standard Citations were found. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2173 COMPATIBILITY TESTING CFR(s): 493.863(a) Failure to attain an overall testing event score of at least 100 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API) Proficiency Testing (PT) documents and staff interview, the laboratory failed to score 100% for the Immunohematology Blood Bank Compatability Testing for the third event of 2020. Findings: 1 Review of the API PT results for the third event for 2020 for Blood Bank Compability Testing, the laboratory reported sample SER-11 as Not Compatible, the expected result was Compatible. The performance was determined to be unacceptable and the score received was 80%. The laboratory failed to attain an overall testing event score of at least 100 %. 2 Interview with laboratory manager, on May 18, 2021, at approximately 3 pm in the manager's office confirmed that the laboratory failed to attain an overall testing of at least 100 % for Blood Bank Compability Testing for event 3 in 2020. D5026 IMMUNOHEMATOLOGY CFR(s): 493.1217 If the laboratory provides services in the specialty of Immunohematology, the laboratory must meet the requirements specified in 493.1230 through 493.1256, 493. 1271, and 493.1281 through 493.1299. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- This CONDITION is not met as evidenced by: Based on review of the American Proficiency Institute (API) Proficiency Testing (PT) documents for Immunohematology, for the year 2020, the laboratory failed to receive a minimum score of 100% for the third event, for Compatibility Testing. The laboratory received an unsuccessful score of 80%. Refer: D2173 D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b) The technical consultant is responsible for-- (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. This STANDARD is not met as evidenced by: Based on review of the Competency Assessment Documents from 2020, and staff interview, the blood gas lab failed to evaluate competency using the required six criteria for all blood gas testing personnel and assure that the staff maintained their competency. Findings: 1. Review of the Competency Assessment Documents from 2020, the blood gas lab participated in a skills fair, the documents presented did not evaluate the personnel using the six required criteria to determine competency. 2. Interview with the lab manager, and staff #2 on the Blood Gas 209 CMS form, on May 18, 2021 at approximately 3:30pm in the lab manager's office confirmed that the Competency Assessment was a check sheet from a skills fair at the hospital. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Clinical Laboratory Improvement Amendments (CLIA) recertification survey was completed on February 20, 2019. The laboratory was not in compliance with applicable CLIA requirements found at 42 CFR 493.1 through 42 CFR 493.1780. The following deficiencies were cited: D2094 ROUTINE CHEMISTRY CFR(s): 493.841(e) (1) For any unsatisfactory analyte or test performance or testing event for reasons other than a failure to participate, the laboratory must undertake appropriate training and employ the technical assistance necessary to correct problems associated with a proficiency testing failure. (2) For any unacceptable analyte or testing event score, remedial action must be taken and documented, and the documentation must be maintained by the laboratory for two years from the date of participation in the proficiency testing event. This STANDARD is not met as evidenced by: Based on review of the American Proficiency Institute (API), proficiency testing provider, Performance Evaluations the laboratory failed to document