Haxtun Hospital District

Summary Statement of Deficiencies D0000 Based on an on-site recertification survey conducted on December 18, 2025, deficiencies were cited for Haxtun Hospital District in Haxtun, Colorado. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on surveyor review of 2024 and 2025 competency assessments, surveyor review of CMS 209 from, and interview with testing personnel 1, labeled as TP1 on the CMS 209, the technical supervisor failed to perform semiannual competency on one out of three high complexity testing personnel. Findings include: 1. Review of 2024 and 2025 competencies revealed no semiannual competency for testing personnel 1, labeled as TP1 on the CMS 209 form. 2. Interview with testing personnel 1, labeled as TP1 on the CMS 209, on December 18, 2025, at 11:41 confirmed the semiannual competency was not performed since the start of employment in March 2024. D6128 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) (b)(9) Thereafter, evaluations must be performed at least annually unless test methodology or instrumentation changes, in which case, prior to reporting patient test results, the individuals performance must be reevaluated to include the use of the new test methodology or instrumentation. 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 surveyor review of 2024 and 2025 competency assessments, surveyor review of CMS 209 form, and interview with testing personnel 1, labeled as TP1 on the CMS 209, the technical supervisor failed to perform competency assessment on one out of three high complexity testing personnel. Findings include: 1. Review of 2024 and 2025 competencies revealed no competency assessment performed in 2024 and 2025 for testing personnel 1, labeled as TP 1 on the CMS 209 form. 2. Interview with testing personnel 1, labeled as TP1 on the CMS 209, on December 18, 2025, at 11:41 confirmed the no annual competency was performed since the start of employment in March 2024. -- 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 (PT) performance and email communications with the laboratory manager, the laboratory failed to achieve satisfactory performance scores for the American Proficiency Institute (API) PT for PO2 Blood Gas for two out of three PT events, (event 2 in 2023 and event 1 in 2024). See D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) 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 -- 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 routine desk review of the CMS-155 report for Proficiency Testing (PT), American Proficiency Institute (API) reports, and email communication with the laboratory manager, the laboratory failed to achieve a satisfactory score for PO2 Blood Gas for event 2 in 2023 and event 1 in 2024. Findings: 1. A review of the CMS- 155 Individual Laboratory Profile on 4/10/2024, at 11:21 AM, revealed the API PT results for PO2 Blood Gas testing scores for event 2 in 2023 was 60%, and 60% for event 1 in 2024. 2. An email with the laboratory manager on 4/17/2024, at 12:02 PM, confirmed the laboratory failed to achieve satisfactory test performance for PO2 Blood Gas. -- 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 review of the laboratory's policies and procedures manual, and interviews with the laboratory director (LD), and testing personnel (TP) #1, the laboratory failed to assess the competency of, or establish a written policy or procedure for assessing the competency of personnel in the positions of Clinical Consultant (CC), Technical Consultant (TC), and General Supervisor (GS) since the laboratory's last survey on 7 /28/2021. The laboratory conducts a total of approximately 36,710 tests annually. Findings include: 1. A review of the laboratory's policies and procedures manual revealed that the laboratory failed to assess the competency of, or establish a written policy or procedure for assessing the competency for two out of two of the clinical consultants (CC), two out of two of the technical supervisors (TS) listed on the CMS- 209 Form, or for the general supervisor (GS) whose position was not filled at time of survey. The laboratory conducts a total of approximately 36,710 tests annually. 2. Based on an interview with the LD and TP #1, on November 1, 2023, at approximately 12:30 PM, and 1:00 PM, respectively, confirmed that the laboratory failed to assess the competency of or establish a written policy or procedure for assessing the competency of personnel in the positions of CC, TC, and GS. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 4 -- This STANDARD is not met as evidenced by: Based on an onsite records review, and interview with Testing Personnel (TP) #1, the laboratory director failed to review and evaluate results obtained on American Proficiency Institute (API) proficiency testing (PT) performed in the laboratory. Findings include: 1. Based on an onsite records review, the laboratory director failed to review or evaluate results obtained on API PT performed by the laboratory for the following events: 2023, Chemistry Core, Event 2 2023, Chemistry Miscellaneous, Event 2 2023, Hematology/Coagulation, Event 1 2023, Hematology/Coagulation, Event 2 2023, Microbiology, Event 1 2023, Microbiology, Event 2 2023, Immunology /Immunohematology, Event 1 2023, Immunology/Immunohematology, Event 2 2022, Chemistry Core, Event 3 2022, Hematology/Coagulation, Event 2 2022, Hematology /Coagulation, Event 3 2022, Immunology/Immunohematology, Event 2 2022, Immunology/Immunohematology, Event 3 2. Based on an interview with TP #1, on November 1, 2023 at approximately 1:00 PM, confirmed that the laboratory director did not review or evaluate results obtained on API PT for the following events: 2023, Chemistry Core, Event 2 2023, Chemistry Miscellaneous, Event 2 2023, Hematology /Coagulation, Event 1 2023, Hematology/Coagulation, Event 2 2023, Microbiology, Event 1 2023, Microbiology, Event 2 2023, Immunology/Immunohematology, Event 1 2023, Immunology/Immunohematology, Event 2 2022, Chemistry Core, Event 3 2022, Hematology/Coagulation, Event 2 2022, Hematology/Coagulation, Event 3 2022, Immunology/Immunohematology, Event 2 2022, Immunology /Immunohematology, Event 3 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. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures manual, and interviews with the laboratory director (LD), and testing personnel (TP) #1, the laboratory director failed to ensure that the laboratory's policies and procedures manual for quality assurance, blood bank, chemistry, toxicology, hematology, and microbiology had been approved, signed, and dated by the current LD before use since the laboratory's last survey on 7/28/2021. The laboratory conducts a total of approximately 36,710 tests annually. Findings include: 1. A review of the laboratory's policies and procedures manual for quality assurance, blood bank, chemistry, toxicology, hematology, and microbiology revealed that Clinical Consultant (CC) #2 had approved, signed, and dated the laboratory's policies and procedures prior to their use in the laboratory. 2. Based on an interview with the LD and TP #1, on November 1, 2023, at approximately 12:30 PM, and 1:00 PM, respectively, confirmed that CC #2 approved, signed, and dated the laboratory's policies and procedures manual for quality assurance, blood bank, chemistry, toxicology, hematology, and microbiology, and was not approved, signed, or dated by the LD prior to their use in the laboratory. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) Unless CMS Approves a procedure, specified in Appendix C of the State Operations -- 2 of 4 -- Manual (CMS Pub. 7), that provides equivalent quality testing, the laboratory must-- (d)(1) Perform control procedures as defined in this section unless otherwise specified in the additional specialty and subspecialty requirements at 493.1261 through 493.1278. (d)(2) For each test system, perform control procedures using the number and frequency specified by the manufacturer or established by the laboratory when they meet or exceed the requirements in paragraph (d)(3) of this section. (g) The laboratory must document all control procedures performed. This STANDARD is not met as evidenced by: Based on an onsite records review of the laboratory's individualized quality control plan (IQCP) risk assessment (RA) for Siemens Dimension EXL 200, Abbott i-STAT, Alere D-Dimer, Siemens DCA Vantage, and MedTOX ER platforms, and an interview with the laboratory director (LD) and testing personnel (TP) #1, revealed that the laboratory director did not reevaluate the RA to account for personnel changes in the laboratory since the laboratory was last surveyed on 7/28/2021. The laboratory performs approximately 36,710 tests annually. Findings include: 1. Based on an onsite records review of the laboratory's IQCP RA, it was revealed that the laboratory director did not perform a reevaluation of the RA for the above-named test systems to account for changes in personnel performing testing. 2. Based on an interview with the LD, and TP #1 on November 1, 2023, at approximately 12:15 PM, confirmed that the RA has not been reevaluated for the above-named test systems to account for changes in laboratory personnel. D5775 COMPARISON OF TEST RESULTS CFR(s): 493.1281(a)(c) (a) If a laboratory performs the same test using different methodologies or instruments, or performs the same test at multiple testing sites, the laboratory must have a system that twice a year evaluates and defines the relationship between test results using the different methodologies, instruments, or testing sites. (c) The laboratory must document all test result comparison activities. This STANDARD is not met as evidenced by: Based on an onsite records review, a review of the laboratory's policies and procedures manual, and an interview with Testing Personnel (TP) #1, the laboratory failed to compare, or establish a policy or procedure to compare their Beckman Coulter DxH 520 Hematology analyzers at least semiannually since the laboratory's last survey on 7/28/2021. The laboratory conducts approximately 8,500 hematology tests annually. Findings include: 1. Based on an onsite records review, the laboratory failed to compare two out of two Beckman Coulter DxH 520 Hematology analyzers at least semiannually. 2. Based on a review of the laboratory's policies and procedures manual, the laboratory failed to establish a policy or procedure to compare two out of two Beckman Coulter DxH 520 Hematology analyzers at least semiannually. 3. Based on an interview with TP #1 on November 1, 2023, at approximately 2:30 PM, confirmed that the laboratory failed to compare and establish a policy or procedure to compare two out of two Beckman Coulter DxH 520 Hematology analyzers at least semiannually. D6141 GENERAL SUPERVISOR CFR(s): 493.1459 -- 3 of 4 -- The laboratory must have one or more general supervisors who are qualified under 493.1461 of this subpart to provide general supervision in accordance with 493.1463 of this subpart. This CONDITION is not met as evidenced by: Based on the deficiencies cited herein, the laboratory failed to hire a qualified General Supervisor to provide day-to-day supervision of the laboratory, of testing personnel, and reporting of test results since the last survey of the laboratory was conducted on 7 /28/2021 (Refer to D6142). D6142 GENERAL SUPERVISOR QUALIFICATIONS CFR(s): 493.1461 The laboratory must have one or more general supervisors who, under the direction of the laboratory director and supervision of the technical supervisor, provides day-to- day supervision of testing personnel and reporting of test results. In the absence of the director and technical supervisor, the general supervisor must be responsible for the proper performance of all laboratory procedures and reporting of test results. This STANDARD is not met as evidenced by: Based on an onsite review of CMS Form-209 provided and signed by the Laboratory Director (LD), an interview with testing personnel (TP) #1, and the LD, the laboratory failed to hire a General Supervisor (GS) who provides day-to-day supervision of testing personnel and reporting of test results since the last survey of the laboratory was conducted on 7/28/2021. The laboratory performs approximately 36,710 tests annually. Findings include: 1. Based on an onsite review of CMS Form-209 provided and signed by the LD, the laboratory failed to hire one or more GS who provides day- to-day supervision of testing personnel and reporting of test results. 2. An interview with TP #1 and the LD on November 1, 2023 at approximately 12:00 PM, confirmed that the laboratory failed to hire one or more GS who provides day-to-day supervision of testing personnel and reporting of test results. -- 4 of 4 --

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, Event 3 in 2021 and Event 2 in 2022. 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 a review of the CMS-155 proficiency testing scores report 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 3 in 2021, and Event 2 in 2022. Findings: 1. A review of the CMS-155 Individual Laboratory Profile on 10/20/2022, at 11:45 AM, revealed the proficiency testing compatibility testing score for 2021 Event 3 was 80%, and the testing scores for Event 2 in 2022 was 80%. 2. An interview with laboratory manager on 10/20/2022, at 11:20 AM, confirmed two consecutive unsuccessful proficiency scores for compatibility testing. -- 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 routine desk audit of CMS-153 and 155 reports of proficiency testing performance and interview, the laboratory failed to achieve satisfactory performance for pH Blood Gas for two consecutive events (2021 event 2 and 3), resulting in unsuccessful proficiency testing performance. See D2096." D2096 ROUTINE CHEMISTRY CFR(s): 493.841(f) Failure to achieve satisfactory performance for the same analyte or test in two 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 -- 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 proficiency testing scores and interview, the laboratory failed to achieve a score of 80 percent for pH of Blood Gas in the specialty of routine chemistry in two consecutive events in 2021, resulting in unsuccessful performance. The findings include: 1. During a review on October 26, 2021 of the CMS-153 Unsuccessful Proficiency Testing Report included Haxtun Hospital District with unsatisfactory proficiency testing scores for pH of Blood Gas. 2. During a review on October 26, 2021 of the CMS-155 report, the American Proficiency Institute (API) pH of Blood Gas score for event 2 of 2021 was 60%. 3. During a review on October 26, 2021 of the CMS-155 report, the American Proficiency Institute (API) pH of Blood Gas score for event 3 of 2021 was 60%.4. On October 27, 2021 , the laboratory manager stated that the laboratory was aware of the unsatisfactory proficiency test results and had performed the investigation and