Rangely District Hospital

Summary Statement of Deficiencies D0000 Based on an on-site recertification survey conducted on June 03, 2025, deficiencies were cited for Rangely District Hospital in Rangely, Colorado. D5215 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(b)(2) The laboratory must verify the accuracy of any analyte, specialty or subspecialty assigned a proficiency testing score that does not reflect laboratory test performance (that is, when the proficiency testing program does not obtain the agreement required for scoring as specified in subpart I of this part, or the laboratory receives a zero score for nonparticipation, or late return or results). This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and procedures manual, proficiency testing (PT) records review, and an interview with general supervisor #2 (GS2), the laboratory failed to establish a written policy or procedure for, and failed to evaluate PT results that were not evaluated or scored by the PT provider since the laboratory's last survey on February 27, 2024. The laboratory performs approximately 63,335 tests annually. Findings include: 1. A review of the laboratory's policies and procedures manual revealed the laboratory failed to establish a written policy or procedure for evaluating PT scores that were not evaluated or scored by the PT provider since the last survey was conducted on February 27, 2024. 2. A review of the laboratory's PT records revealed the laboratory did not evaluate the accuracy of any analyte for which the PT provider did not evaluate or score since the last survey was conducted on February 27, 2024. 3. An interview with GS2 on June 03, 2025, at approximately 11: 00 AM, confirmed that the laboratory failed to establish a written policy or procedure for, and evaluate any PT scores that the PT provider did not evaluate or score since the laboratory's last survey was conducted on February 27, 2024. 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 --

Summary Statement of Deficiencies D3021 REQUIREMENTS FOR TRANSFUSION SERVICES CFR(s): 493.1103(c)(1) Blood and blood products storage and distribution. If a facility stores or maintains blood or blood products for transfusion outside of a monitored refrigerator, the facility must ensure the storage conditions, including temperature, are appropriate to prevent deterioration of the blood or blood product. This STANDARD is not met as evidenced by: Based on a review of the laboratory's policies and procedures manual, and an interview with general supervisor #2 (GS #2), the laboratory failed to establish a written policy or procedure to ensure the storage conditions of blood products are appropriate to prevent deterioration of the products during a failure of the laboratory's monitored refrigerator since the laboratory's last survey was conducted on 6/28/2021. The laboratory performs approximately 52 immunohematology tests annually. Findings include: 1. Based on a review of the laboratory's policies and procedures manual, the laboratory failed to establish a written policy or procedure to document and monitor the temperature of blood products to prevent the deterioration of blood products in case of a failure of their monitored refrigerator since the last survey was conducted on 6/28/2021. 2. An interview with GS #2 on February 27, 2024, at approximately 12:00 PM, confirmed that the laboratory failed to establish a written policy or procedure to document and monitor the temperature of blood products to prevent the deterioration of blood products in case of a failure of their monitored refrigerator. 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, 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 -- consultant competency. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies and procedures manual, and an interview with General Supervisor #2 (GS #2), 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 Supervisor (TS), and General Supervisor (GS) since the laboratory's last survey was conducted on 6/28 /2021. The laboratory conducts approximately 48,256 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 the CC, the TS, or for the GS listed on CMS Form-209 since the last survey was conducted on 6/28/2021. 2. Based on an interview with GS #2 on February 27, 2024, at approximately 11:15 AM, 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, TS, and GS. -- 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 review of Proficiency Testing (PT) scores and staff confirmation, the laboratory failed to successfully participate in PT in 2 of 3 consecutive testing events in the specialty of Endocrinology in the second and third event of 2017. Ref D2108. D2108 ENDOCRINOLOGY CFR(s): 493.843(g) Failure to achieve an overall testing event score of satisfactory performance for two consecutive testing events or two out of three consecutive testing events is 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 -- unsuccessful performance. This STANDARD is not met as evidenced by: Based on review of Proficiency Testing (PT) scores and staff confirmation, the laboratory failed to achieve satisfactory performance for the overall testing score in the specialty of Endocrinology in 2 of 3 consecutive PT events. Findings include: Endocrinology: 2nd Event of 2017: 66% 3rd Event of 2017: 73 % -- 2 of 2 --