Osmond General Hospital

Summary Statement of Deficiencies D0000 The following deficiencies are a result of a desk review of proficiency testing scores obtained from the national database and verified with the proficiency testing company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found to be out of compliance: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6076 - 42 C.F.R. 493.1441 Condition: Laboratories performing high 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 a desk review of proficiency testing (PT) records from the Certification and 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 -- Survey Provider Enhanced Reporting (CASPER) 0155 report and American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) 2024 and 2025 records, the laboratory did not successfully participate in a proficiency testing program approved by HHS, for each specialty, subspecialty, and analyte or test in which the laboratory is certified under CLIA. The laboratory failed to successfully participate in the specialty of Routine Chemistry for the analyte Partial Pressure of carbon dioxide (pCO2) blood gas. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) (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 proficiency testing desk review of CASPER 0155 report and AAB-MLE proficiency testing 2024 event 2 and 2025 event 1 records, the laboratory failed to achieve an overall satisfactory performance (80% or better) for the same analyte in two of three consecutive testing events in specialty of Routine Chemistry for the analyte Partial Pressure of carbon dioxide (pCO2) blood gas. Findings include: 1. Review of the CASPER 0155 report revealed the following results: Analyte Partial Pressure of carbon dioxide (pCO2) blood gas 2024 Event 2: The laboratory received an unsatisfactory score of 60%. Analyte Partial Pressure of carbon dioxide (pCO2) blood gas 2025 Event 1: The laboratory received an unsatisfactory score of 60%. 2. A review of the AAB-MLE 2024 and 2025 proficiency testing records confirmed the laboratory received the above results. 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 proficiency testing desk review of CASPER 0155 report and American Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) 2024 and 2025 records, the laboratory director failed to provide overall management and direction of the laboratory services. 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) (e)(4)(i) 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 desk review of CASPER 0155 report and American -- 2 of 3 -- Association of Bioanalysts Medical Laboratory Evaluation (AAB-MLE) 2024 and 2025 records, the laboratory director failed to ensure proficiency testing samples were tested as required. The laboratory director failed to ensure successful participation in an HHS approved proficiency testing program. Refer to D2096. -- 3 of 3 --

Summary Statement of Deficiencies D2006 TESTING OF PROFICIENCY TESTING SAMPLES CFR(s): 493.801(b) The laboratory must examine or test, as applicable, the proficiency testing samples it receives from the proficiency testing program in the same manner as it tests patient specimens. This testing must be conducted in conformance with paragraph (b)(4) of this section. If the laboratory's patient specimen testing procedures would normally require reflex, distributive, or confirmatory testing at another laboratory, the laboratory should test the proficiency testing sample as it would a patient specimen up until the point it would refer a patient specimen to a second laboratory for any form of further testing. This STANDARD is not met as evidenced by: Based on surveyor review of the laboratory's 2023 and 2024 American Association of Bioanalysts - Medical Laboratory Evaluation (AAB-MLE) proficiency testing (PT) records, lack of genital culture procedure, and interview with the laboratory manager, revealed the laboratory failed to perform proficiency testing in the same manner as it tests patient specimens for microbiology genital culture proficiency testing event 1- 2023. 1. Surveyor review of bacteriology worksheet for genital culture event 1 - 2023 revealed the laboratory performed a genital culture gram stain and set up the culture on 2/13/2023. 2. On 7/30/2024 at 1:12 PM interview with the laboratory manager confirmed the laboratory did not have a procedure for genital cultures. Laboratory manager indicated genital cultures are sent out for testing. 3. On 7/30/2024 at 1:12 PM interview with the laboratory manager confirmed the laboratory did not perform genital culture PT event 1 - 2023 the same manner as it tests genital culture patient specimens. D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(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 2 -- For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: Based on review of laboratory's maintenance procedure, blood bank centrifuge maintenance reports, and interview with the laboratory manager, the laboratory failed to follow procedures for performing centrifuge speed check on the blood bank centrifuge from 9/21/2022 - 7/30/2024. 1. Review of the laboratory's maintenance procedure for centrifuges indicate "Quarterly taching - Check speed (RPM) by tachometer." 2. Review of the blood bank centrifuge maintenance reports revealed the laboratory performed a speed check on the blood bank centrifuge on 9/21/2022, 9/11 /2023, and 3/8/2024 from 9/21/2022 - 7/30/2024. 3. On 7/30/2024 at 1:12 PM interview with the laboratory manager confirmed that the laboratory did not follow quarterly taching on the blood bank centrifuge as indicated on the laboratory's maintenance procedure. -- 2 of 2 --

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: The laboratory failed to achieve satisfactory scores for the chemistry analyte ALT for the second event 2018 and first event 2019 (see D2088). This results in the unsuccessful performance in proficiency testing for this analyte. D2088 ROUTINE CHEMISTRY CFR(s): 493.841(b) Failure to attain an overall testing event score of at least 80 percent is unsatisfactory performance. 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 STANDARD is not met as evidenced by: Based on desk review of proficiency testing for 2018 and 2019, this laboratory had unsatisfactory performance for the analyte ALT for the second event 2018 (score 0%) and the first event 2019 (score 60%). -- 2 of 2 --