Wray Community District Hospital

Summary Statement of Deficiencies D0000 Based on an on-site recertification survey conducted on December 16, 2025, deficiencies were cited for Wray Community District Hospital in Wray, Colorado. D2000 ENROLLMENT AND TESTING OF SAMPLES CFR(s): 493.801 Each laboratory must enroll in a proficiency testing (PT) program that meets the criteria in subpart I of this part and is approved by HHS. The laboratory must enroll in an approved program or programs for each of the specialties and subspecialties for which it seeks certification. The laboratory must test the samples in the same manner as patients' specimens. For laboratories subject to 42 CFR part 493 published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the rules of this subpart are effective on September 1, 1992. For all other laboratories, the rules of this subpart are effective January 1, 1994. This CONDITION is not met as evidenced by: Based on the surveyor review of 2024 and 2025 Proficiency Testing (PT) documents and an interview with the technical consultant 1 (labeled as TC1 on the CMS 209), the laboratory failed to enroll in a PT program for both HCG (serum-quantitative) and HCG (serum-qualitative). Findings include: 1. A review of the laboratory PT documents revealed that the laboratory performed HCG (serum- quantitative) in 2024 Event 1, HCG (serum-qualitative) in 2024 Event 2, HCG (serum- qualitative) in 2024 Event 3, HCG (serum-quantitative) in 2025 Event 1, HCG (serum-quantitative) in 2025 Event 2, and HCG (serum-qualitative) in 2025 Event 3. 2. An interview with technical consultant 1 (labeled as TC1 on the CMS 209), on December 16, 2025, at 2: 41 PM confirmed that the laboratory performed either HCG (serum-qualitative) or HCG (serum-quantitative) in PT events reviewed, despite offering both. D5445 CONTROL PROCEDURES CFR(s): 493.1256(d)(1)(2)(g) 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 -- (d) Unless CMS Approves a procedure, specified in Appendix C of the State Operations 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. (d)(3) At least once each day patient specimens are assayed or examined perform the following for: This STANDARD is not met as evidenced by: Based on the surveyor review of the laboratory quality control documents and an interview with the general supervisor, the laboratory failed to perform Quality Control (QC) at least once each day patient specimens are tested with Cepheid GeneXpert Xpert Xpress MVP test. The laboratory has performed 219 Cepheid GeneXpert Xpert Xpress MVP tests since the start of the test in 2024. Findings include: 1. A review of the QC documents for Cepheid GeneXpert Xpert Xpress MVP test revealed that the laboratory performs QC once monthly. 2. An interview with the general supervisor on December 16, 2025, at 4:35 PM revealed that the laboratory performs QC once monthly for Cepheid GeneXpert Xpert Xpress MVP test. D6046 TECHNICAL CONSULTANT RESPONSIBILITIES CFR(s): 493.1413(b)(8) (b)(8) Evaluating the competency of all testing personnel and assuring that the staff maintain their competency to perform test procedures and report test results promptly, accurately and proficiently. The procedures for evaluation of the competency of the staff must include, but are not limited to-- This STANDARD is not met as evidenced by: Based on the surveyor review of the laboratory competency documents and an interview with the technical consultant 1 (labeled TC1 on the CMS 209) and technical consultant 2 (labeled TC2 on the CMS 209), the laboratory failed to maintain documentation on five out of five testing personnel competencies in 2024. Findings include: 1. A review of the laboratory competency documents revealed that the laboratory did not have documentation for competencies in 2024. 2. An interview with technical consultant 1 (labeled TC1 on the CMS 209) and technical consultant 2 (labeled TC2 on the CMS 209) on December 16, 2025, at 02:54 PM confirmed that the laboratory did not have documentation for five out of five testing personnel competencies in 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 performance and email communications with the laboratory administrative director, the laboratory failed to achieve satisfactory performance scores for the American Proficiency Institute proficiency testing for Total Bilirubin for two consecutive PT events, (event 2 in 2024 and event 3 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), and email communication with the laboratory manager, the laboratory failed to achieve a satisfactory score for Total Bilirubin for event 2 in 2024 and event 3 in 2024. Findings include: 1. A review of the CMS-155 Individual Laboratory Profile on October 24, 2024, at 09:25 AM, revealed the API PT results for Total Bilirubin testing scores for event 2 in 2024 was 60%, and 40% for event 3 in 2024. 2. An email with the laboratory's administrative director on November 12, 2024, at 01:48 PM, confirmed the laboratory failed to achieve satisfactory test performance for Total Bilirubin for event 2 in 2024, and event 3 in 2024. -- 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 interview with General Supervisor #1 (GS #1), revealed that the laboratory had not ensured its biological safety cabinet (BSC) was functioning properly since the last survey was conducted on 11/13/2020. The laboratory performs approximately 967 microbiology tests annually. Findings include: 1. Based upon direct observation of the laboratory's BSC maintenance record, at approximately 1:30 PM on January 12, 2024, the laboratory had not ensured the BSC was functioning properly since the facility last had it certified on 8/25/2016. 2. Based on an interview with GS #1, at approximately 2:00 PM on January 12, 2024, confirmed that the laboratory had not ensured the BSC was functioning properly since the facility last had it certified on 8/25/2016. 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 General Supervisor #1 (GS #1) the laboratory failed to establish and follow written policies or procedures to assess the competency of personnel in the positions 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 -- of Clinical Consultant (CC), Technical Supervisor (TS) and General Supervisor (GS) since the laboratory's last survey on 11/13/2020. The laboratory conducts a total of approximately 70,473 tests annually in the specialties of microbiology, diagnostic immunology, chemistry, hematology, and immunohematology. Findings include: 1. A review of the laboratory's policies and procedures manual revealed that the laboratory failed to establish and follow written policies or procedures to assess the competency of one out one of the clinical consultants (CC), one out of one of the technical supervisors (TS) and, two out of two of the general supervisors (GS) listed on the CMS-209 Form since the last survey was conducted on 11/13/2020. 2. Based on an interview with GS #1 at approximately 11:00 AM, on January 12, 2024, confirmed that the laboratory failed to establish and follow written policies or procedures to assess the competency of personnel in the positions of CC, TC, and GS since the last survey was conducted on 11/13/2020. -- 2 of 2 --