Summary:
Summary Statement of Deficiencies D0000 Based on an on-site recertification certification survey conducted on 7/20/2026, deficiencies were cited for Sunrise Monfort Family Clinic in Evans, Colorado. 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 surveyor review of proficiency testing (PT) records and an interview with the technical consultant (TC), the laboratory failed to achieve successful PT performance for total bilirubin, resulting in unsuccessful performance in 2 of 3 consecutive events. Refer to D2096. D2096 ROUTINE CHEMISTRY Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- CFR(s): 493.841(f) (f) 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 surveyor review of proficiency testing (PT) records and an interview with the technical consultant (TC), the laboratory failed to achieve successful PT performance for total bilirubin, resulting in unsuccessful performance in 2 of 3 consecutive events. The findings include: 1. Surveyor review of the laboratory's PT records revealed that the laboratory received a failing score of 20% for total bilirubin in Event 3 of 2025. 2. Further record review revealed that the laboratory received a failing score of 0% for total bilirubin in Event 2 of 2026. 3. By failing Event 3 of 2025 and Event 2 of 2026, the laboratory demonstrated unsuccessful PT performance for total bilirubin in 2 out of 3 consecutive events. 4. During an interview on July 20 at 11: 45 AM, the TC confirmed the failing scores and the unsuccessful PT performance for total bilirubin. 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 surveyor review of laboratory policies, personnel records, and an interview with the technical consultant (TC), the laboratory failed to establish a policy for and failed to perform competency assessments for 2 of 2 required consultant positions (the TC and the Clinical Consultant [CC]) for 3 of 3 years reviewed (2024, 2025, and 2026). The findings include: 1. Surveyor review of the laboratory's policies and procedures manual revealed that no policy existed outlining the requirements or procedures for performing competency assessments for the TC and CC. 2. Surveyor review of the personnel records for the TC and CC showed a lack of any documented competency assessments for the years 2024, 2025, and 2026. 3. During an interview on July 20 at 11:30 AM, the TC confirmed that the laboratory did not have a policy for these competency assessments and that no competency assessments were performed for the TC or the CC in 2024, 2025, or 2026. D5221 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(d) All proficiency testing evaluation and verification activities must be documented. This STANDARD is not met as evidenced by: Based on surveyor review of proficiency testing (PT) records and an interview with the technical consultant (TC), the laboratory failed to perform and document