East Carroll Parish Hospital

Summary Statement of Deficiencies D0000 An offsite PT Desk Review survey was performed on August 23, 2022. East Carroll Parish Hospital, 19D0673263, was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803 CONDITION: Successful Participation 42 CFR 493.1403 CONDITION: Laboratory Director, Moderate Complexity 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 proficiency testing results from the CMS-153D, CMS-155D and American Association of Bioanalysts (AAB), the laboratory failed to achieve a score of at least 80% for total bilirubin (tBili) in two of three consecutive events, resulting 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 -- in initial unsuccessful performance as evidenced by: 1. The laboratory failed to achieve satisfactory performance for Lithium in three consecutive events resulting in a non-intial unsuccessful performance. Refer to D2118. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two consecutive testing events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on a review of proficiency testing results from the CMS-153, CMS-155D and American Association of Bioanalysts (AAB), the laboratory failed to achieve a score of at least 80% for total bilirubin (tBili) in two of three consecutive events, resulting in initial unsuccessful performance. Findings are: 1. Review of American Association of Bioanalysts (AAB) proficiency testing results and CMS Report 0153D and 0155D revealed the laboratory received unsatisfactory performance for the following two events resulting in the first unsuccessful participation for total bilirubin (tBili): Event 3 of 2021 received a score of 40% Event 1 of 2022 received a score of 100% Event 2 of 2022 received a score of 40% 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 record review and interview with personnel, the Laboratory Director failed to provide overall management and direction for the laboratory. 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-153D and CMS-155D reports and the College of American Pathologists (CAP) proficiency testing records, the laboratory director failed to ensure that proficiency testing samples are satisfactory as required. Findings: 1. The laboratory failed to achieve satisfactory performance for Lithium in three consecutive events resulting in a non-intial unsuccessful performance. Refer to D2118. -- 2 of 2 --

Summary Statement of Deficiencies D0000 A Recertification survey was performed at East Carroll Patish Hospital, CLIA ID # 19D0673263, on May 24, 2021 through May 26, 2021 East Carroll Parish Hospital was found not in compliance with the following CONDITION LEVEL DEFICIENCIES: 42 CFR 493.803 CONDITION: Successful Participation 42 CFR 493.807 CONDITION: Reinstatement of laboratories performing nonwaived testing 42 CFR 493.1403 CONDITION: Laboratories Performing Moderate Complexity Testing, 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 proficiency testing results from the CASPER 155D report, Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- American Proficiency Institute (API) and College of American Pathologists (CAP), the laboratory failed to successfully participate in proficiency testing events for three (3) of five (5) events reviewed. Findings: 1. The laboratory failed to achieve a score of at least 80% for pCO2 in three (3) of five (5) consecutive events reviewed, resulting in a non-initial unsuccessful performance for the 2019 and 2020: a) API 2019 Chemistry Core 2nd event pCO2 score received 60% b) API 2020 Chemistry Core 1st event pCO2 score received 60% c) CAP AQ-C 2020 Crit Care/Aqueous Blood Gas for pCO2 score received 60% D2017 REINSTATEMENT OF NONWAIVED LABORATORIES CFR(s): 493.807(a)(b) (a) If a laboratory's certificate is suspended or limited or its Medicare or Medicaid approval is cancelled or its Medicare or Medicaid payments are suspended because it fails to participate successfully in proficiency testing for one or more specialties, subspecialties, analyte or test, or voluntarily withdraws its certification under CLIA for the failed specialty, subspecialty, or analyte, the laboratory must then demonstrate sustained satisfactory performance on two consecutive proficiency testing events, one of which may be on site, before CMS will consider it for reinstatement for certification and Medicare or Medicaid approval in that specialty, subspecialty, analyte or test. (b) The cancellation period for Medicare and Medicaid approval or period for suspension of Medicare or Medicaid payments or suspension or limitation of certification under CLIA for the failed specialty, subspecialty, or analyte or test is for a period of not less than six months from the date of cancellation, limitation or suspension of the CLIA certificate. This CONDITION is not met as evidenced by: Based on review of proficiency testing (PT) results from the CASPER 155D report, American Proficiency Institute (API) and College of American Pathologists (CAP), the laboratory failed to achieve satisfactory performance for pCO2 in three (3) of five (5) consecutive testing events resulting in non-initial unsuccessful participation for 2019 and 2020. Findings: 1. Review of the CASPER 155D , American Proficiency Institute (API) and College of American Pathologists (CAP) proficiency testing reports revealed the laboratory received the following scores of less than 80% for pCO2 for the following three (3) of five (5) consecutive testing events: a) API 2019 Chemistry Core 2nd event: 60% b) API 2020 Chemistry Core 1st event: 60% c) CAP AQ-C 2020 Crit Care/Aqueous Blood Gas: 60% 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 proficiency testing results from the CASPER 155D report, proficiency test records and interview with personnel, the laboratory failed to achieve a score of at least 80% for pCO2 in three (3) of five (5) consecutive events reviewed, resulting in a non-initial unsuccessful performance for 2019 and 2020. Findings: 1. Review of the CASPER 155D report and the laboratory's American Proficiency -- 2 of 3 -- Institute (API) and College of American Pathologists (CAP) proficiency test records from 2019 and 2020 for pCO2 revealed the laboratory received the following scores in three (3) of five (5) events reveiwed, resulting in a non-intial unsuccessful performance: a) API 2019 Chemistry Core 2nd event pCO2 score received 60% b) API 2020 Chemistry Core 1st event pCO2 score received 60% c) CAP AQ-C 2020 Crit Care/Aqueous Blood Gas for pCO2 score received 60% 2. Further review of the laboratory's proficiency test records revealed the laboratory did have