Commonspirit Emergency & Urgent Care - Lakewood

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 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 -- performance and review of proficiency testing evaluation reports from the proficiency testing provider, American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance for Creatinine in two out of three consecutive testing events: Event 1 in 2025 and Event 3 in 2025. See D2096. D2096 ROUTINE CHEMISTRY 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 a review of the CMS-155 Individual Laboratory Profile report for proficiency testing (PT) performance and a review of the proficiency testing evaluation report provided by the American Proficiency Institute (API), the laboratory failed to achieve satisfactory performance for Creatinine in two out of three consecutive testing events: Event 1 in 2025 and Event 3 in 2025. Findings include: 1. A review of the CMS-155 Individual Laboratory Profile on 12/24/2025 at 11:30 AM, revealed the Creatinine proficiency testing score for event 1 in 2025 was 60%, and the score for event 3 in 2025 was 40%. 2. A review of the PT evaluation report from the provider, API, on 12/24/2025 at 12:00 PM revealed the Creatinine proficiency testing score for event 1 in 2025 was 60%, and the score for event 3 in 2025 was 40%. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on an on-site recertification survey conducted on April 30, 2025, deficiencies were cited for Commonspirit Emergency & Urgent Care - Lakewood in Lakewood, Colorado. 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 a review of the laboratory's personnel records, policies and procedures manual, and an interview with the laboratory's technical consultant #7 (TC7), the laboratory failed to perform and document the initial semi-annual competency evaluation for six (6) out of twenty-two (22) testing personnel (TP) since the laboratory's last survey was conducted on 8/19/2021. The laboratory performs approximately 15,290 tests annually. Findings include: 1. A review of the laboratory's personnel records revealed the laboratory failed to perform and document the initial semi-annual competency evaluation for 6 out of 22 TP listed on the CMS-209 form. 2. A review of the laboratory's policies and procedures manual revealed the laboratory was required to assess the initial semi-annual competency for TP within six-months of their initial competency assessment being completed. 3. An interview with the laboratory's TC7, on April 30, 2025, at approximately 10:45 AM, confirmed that the laboratory failed to perform and document the initial semi-annual competency assessment for 6 out of 22 TP listed on the CMS-209 form, and failed to follow the laboratory's policies and procedures to assess and document TP competency within six-months of their initial competency being completed. 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 D6063 LABORATORY TESTING PERSONNEL CFR(s): 493.1421 The laboratory must have a sufficient number of individuals who meet the qualification requirements of 493.1423, to perform the functions specified in 493. 1425 for the volume and complexity of tests performed. This CONDITION is not met as evidenced by: The laboratory failed to maintain a copy of the diploma or transcripts for completion of high school or higher academic achievement for 1 of 19 personnel who performed moderate complexity testing in 2017 and 2018 (Ref D6065). D6065 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1423(b)(1)(2)(3)(4)(i) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine or doctor of osteopathy licensed to practice medicine or osteopathy in the State in which the laboratory is located or have earned a doctoral, master's, or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; or (b)(2) Have earned an associate degree in a chemical, physical or biological science or medical laboratory technology from an accredited institution; or (b)(3) Be a high school graduate or equivalent and have successfully completed an official military medical laboratory procedures course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); or (b)(4)(i) Have earned a high school diploma or equivalent; and This STANDARD is not met as evidenced by: 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 -- Based on review of personnel records and staff confirmation, the laboratory failed to ensure that 1 of 19 testing personnel (#8 on Form CMS-209) was qualified to perform moderate complexity routine chemistry and hematology testing using the Abbott i- STAT, Sysmex x1000i and the Triage Meter since the testing personnel began employment in May 2017. The laboratory failed to maintain documentation that all testing personnel had earned at minimum a high school diploma or equivalent prior to testing patient specimens. -- 2 of 2 --