Southeast Colorado Hospital District

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 Antibody Detection for two out of three proficiency testing events, (event 3 in 2024 and event 1 in 2025), see D2172. D2172 UNEXPECTED ANTIBODY DETECTION CFR(s): 493.861(e) (e) Failure to achieve an overall testing event score of satisfactory for 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 routine desk review of the CMS-155 report for proficiency testing (PT) performance, review of PT evaluation reports from the PT provider, American Proficiency Institute (API), the laboratory failed to achieve a satisfactory score for Antibody Detection PT in two out of three testing events, Event 3 in 2024, and Event 1 in 2025. Findings include: 1. A review of the CMS-155 report for PT performance on August 5, 2025, at approximately 11:24 AM, revealed the API PT results for the Antibody Detection analyte was 0% in Event 3 of 2024, and was 80% for event 1 of 2025. 2. A review of the PT evaluation report from the PT provider, API, on August 5, 2025, at approximately 11:28 AM, revealed the API PT results for the Antibody Detection analyte was 0% in Event 3 of 2024, and was 80% for event 1 of 2025. -- 2 of 2 --

Summary Statement of Deficiencies D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based upon direct observation, and an interview with General Supervisor #1 (GS #1), revealed that the laboratory had not ensured its biological safety cabinet (BSC) was functioning properly since August 16,2023. The laboratory performs approximately 1,187 microbiology tests annually. Findings include: 1. Based upon direct observation of the laboratory's BSC maintenance record, at approximately 1:30 PM on February 1, 2024, the laboratory had not ensured the BSC was functioning properly since the facility's BSC failed its certification on August 16, 2023. 2. Based on an interview with GS #1, at approximately 1:30 PM on February 1, 2024, confirmed that the laboratory had not ensured the BSC was functioning properly since the facility's BSC failed its certification on August 16, 2023. D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on direct observation of the laboratory, and an interview with general supervisor #1 (GS #1), the laboratory failed to follow its written policy and procedure 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 labeling aliquoted serum specimens in the blood bank refrigerator. The laboratory conducts approximately 166 immunohematology tests annually. Findings include: 1. Based on a direct observation of the laboratory's blood bank refrigerator at approximately 1:45 PM on February 1, 2024, revealed three unlabeled test tubes containing patient serum aliquots used for blood bank testing. 2. The laboratory's policy and procedure for aliquoting patient specimens states the aliquot must contain two unique patient identifiers. 3. Based on an interview with GS #1, at approximately 1:45 PM on February 1, 2024, confirmed that the laboratory was not following its policy for labeling patient aliquots for testing in the blood bank refrigerator and discarded the unlabeled specimens. D5507 BACTERIOLOGY CFR(s): 493.1261(b)(c) (b) For antimicrobial susceptibility tests, the laboratory must check each batch of media and each lot number and shipment of antimicrobial agent(s) before, or concurrent with, initial use, using approved control organisms. (b)(1) Each day tests are performed, the laboratory must use the appropriate control organism(s) to check the procedure. (b)(2) The laboratory's zone sizes or minimum inhibitory concentration for control organisms must be within established limits before reporting patient results. (c) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on an onsite records review, and an interview with general supervisor #1 (GS #1), the laboratory failed to perform and document quality control reactions of each new shipment of their CHROMagar orientation media as required by the manufacturer since July 2022. The laboratory conducts approximately 397 cultures annually. Findings include: 1. Based on a records review, the laboratory failed to perform and document quality control reactions of each new shipment of their CHROMagar orientation media as required by manufacturer since July 2022. 2. Based on an interview with GS #1, at approximately 1:15 PM on February 1, 2024, confirmed that the laboratory failed to perform and document quality control reactions of each new shipment of their CHROMagar orientation media as required by the manufacturer since July 2022. -- 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: Based on a routine desk review of the CMS-155 report for proficiency testing performance and an interview with the laboratory manager, the laboratory failed to achieve satisfactory performance scores for compatibility testing for two out of three events in 2022. Event 1 and Event 2). See D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) Failure to achieve an overall testing event score of satisfactory for two consecutive 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 events or two out of three consecutive testing events is unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of proficiency testing scores from the American Proficiency Institute (API) and an interview with the laboratory manager, the laboratory failed to achieve a score of 100% for compatibility testing for Events 1 and 2 in 2022. Findings: 1. A review of the CMS-155 Individual Laboratory Profile on 9/25/2022, at 1:00 PM, revealed the compatibility testing scores for 2022 Event 1 and 2 were both 80%. 2. An interview with laboratory manager on 09/23/2022, at 2:50 PM, confirmed two consective unsuccessful proficiency scores for compatibility testing due to clerical and laboratory errors. -- 2 of 2 --