South Routt Medical Center

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 provider. 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: 42 C.F.R. 493.803 Condition: Successful Participation [proficiency testing]; 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 routine desk review of the CMS-155 report for proficiency testing performance and review of proficiency testing evaluation reports from the 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 provider, American Proficiency Institute, the laboratory failed to achieve satisfactory performance scores for the American Proficiency Institute proficiency testing for Erythrocyte count, and Hematocrit for two consecutive proficiency testing events, (event 3 in 2024 and event 1 in 2025), see D2130. D2130 HEMATOLOGY CFR(s): 493.851(f) (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 a routine desk review of the CMS-155 report for Proficiency Testing (PT) performance, and review of PT evaluation reports from the PT provider, American Proficiency Institute (API), the laboratory failed to achieve a satisfactory score for two consecutive PT events for the analytes: Erythrocyte count (RBC), and Hematocrit (HCT) for event 3 in 2024 and event 1 in 2025. Findings include: 1. A review of the CMS-155 report for PT performance on May 19, 2025, at 3:19 PM, revealed the API PT results for the analyte: RBC was 20% for event 3 in 2024, and 60% for event 1 in 2025; and for the analyte HCT was 20% for event 3 in 2024, and 40% for event 1 in 2025. 2. A review of the PT evaluation reports from the PT provider, API, on May 28, 2025, at 10:22 AM, confirmed that the laboratory failed to achieve satisfactory PT scores for two consecutive events for the following analytes: RBC and HCT, for event 3 in 2024 and event 1 in 2025. -- 2 of 2 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and procedures manual, a record review, and an interview with testing personnel #3 (TP #3), the laboratory failed to write a policy or procedure for, or perform competency assessment for the position of clinical consultant (CC), and technical consultant (TC) for one out of one CC, and for one out of one of TC listed on the CMS-209 form since the laboratory's last survey on 8/12/2021. Findings include: 1. A review of the laboratory's policies and procedures manual, the laboratory failed to have a written policy or procedure to assess the competency of the CC or TC. 2. A review of personnel records revealed the laboratory failed to perform competency assessment for the position of clinical consultant on one out of one CC listed on the CMS-209 form. 3. A review of personnel records revealed the laboratory failed to perform competency assessment for the position of technical consultant on one out of one TC listed on the CMS-209 form. 4. Based on an interview with TP #3, on February 15, 2024, at approximately 9:45 PM, confirmed the laboratory failed to have a written policy or procedure for, or performed competency assessments for the position of CC and TC at the laboratory. D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. 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 review of the laboratory's policies and procedures manual, and an interview with testing personnel #3 (TP #3), the laboratory director (LD) failed to ensure that the laboratory's policies and procedures manual for quality assurance, chemistry, hematology, and microbiology had been approved, signed, and dated by the current LD before use since the laboratory's last survey on 8/12/2021. The laboratory conducts a total of approximately 192 tests annually. Findings include: 1. A review of the laboratory's policies and procedures manual for quality assurance, chemistry, hematology, and microbiology revealed that the current LD had not approved, signed, or dated the laboratory's policies and procedures prior to their use in the laboratory. 2. Based on an interview with TP #3 on February 15, 2024, at approximately 09:30 AM, confirmed that the current LD had not reviewed, signed, and dated the laboratory's policies and procedures manual for quality assurance, chemistry, hematology, and microbiology prior to their use in the laboratory. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on an onsite records review, and an interview with testing personnel #3 (TP #3) the laboratory failed to document instrument maintenance for their Beckman Coulter DxH 500 hematology analyzer as specified by the manufacturer since 2022. The laboratory performs approximately 192 hematology tests annually. Findings include: 1. Based on an onsite records review, it was revealed that the laboratory failed to document the instrument maintenance for their Beckman Coulter DxH 500 hematology analyzer as specified by the manufacturer since 2022. 2. Based on an interview with TP #3, on February 15, 2024, at approximately 10:45 AM, confirmed that the laboratory failed to document the instrument maintenance for their Beckman Coulter DxH 500 hematology analyzer as specified by the manufacturer since 2022. -- 2 of 2 --

Summary Statement of Deficiencies 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. This STANDARD is not met as evidenced by: Based on the review of the quality assessment (QA) plan, personnel competency assessment records and staff interview, the laboratory failed to follow their written policy in 2019 and 2020 to assess competency of all testing personnel who perform complete blood count (CBC) testing using the Beckman Coulter DxH 520 and approximately 70 patients are tested annually. Findings include: a. The QA plan states competency will be performed twice in the first year of employment and annually thereafter and will be documented. b. No documentation existed to show that competency was assessed for 3 of 3 established testing personnel in 2019 or 2020. c. Staff confirmed the laboratory failed to follow their QA plan and Federal regulation and did not evaluate testing personnel for competency in 2019 and 2020. 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 --