Grace Health Clinic Laboratory

Summary Statement of Deficiencies D0000 Based on an on-site recertification survey conducted on January 13, 2026, deficiencies were cited for Grace Health Clinic Laboratory located in Aurora, Colorado. 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 a review of the American Proficiency Institute (API) proficiency test results for 2024 and 2025, and an interview with the laboratory director during the survey, the laboratory failed to perform and document any evaluation of unsatisfactory scores and the

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 director, the laboratory failed to achieve satisfactory performance scores for the American Proficiency Institute (API) PT for Chloride for two out of three PT events, (event 3 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 director, the laboratory failed to achieve a satisfactory score for Chloride for event 3 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 Chloride testing scores for event 3 in 2023 was 0%, and 40% for event 1 in 2024. 2. An email with the laboratory director on 4/11/2024, at 10:21 AM, confirmed the laboratory failed to achieve satisfactory test performance for Chloride. -- 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 Chloride for two of three events, Event 3 of 2019 and Event 2 of 2020, 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 Chloride in two of three events, resulting in unsuccessful performance. The findings include: 1. During a review on 7-29-20, the CMS-153 Unsuccessful Proficiency Testing Report included Grace Health Clinic Laboratory with unsatisfactory proficiency testing scores for Chloride. 2. During a review on 7-29-20 of the CMS-155 report, the Chloride score for event 3 of 2019 was 60%. 3. During a review on 7-29-20 of the CMS-155 report, the Chloride score for event 2 of 2020 was 40%.4. On 7-30-20 at 10:00 am, the laboratory director stated that there were issues with obtaining parts and service for the chemistry analyzer. -- 2 of 2 --

Summary Statement of Deficiencies D6076 LABORATORY DIRECTOR CFR(s): 493.1441 The laboratory must have a director who meets the qualification requirements of 493. 1443 of this subpart and provides overall management and direction in accordance with 493.1445 of this subpart. This CONDITION is not met as evidenced by: Based on the deficiencies cited under the Laboratory Director's responsibilities and continued unsuccessful performance in proficiency testing, the laboratory director failed to provide overall management and direction for the laboratory. Refer to D6079. D6079 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(a)(b) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, record and report test results promptly, accurately and proficiently, and for assuring compliance with the applicable regulations. (a) The laboratory director, if qualified, may perform the duties of the technical supervisor, clinical consultant, general supervisor, and testing personnel, or delegate these responsibilities to personnel meeting the qualifications under 493.1447, 493.1453, 493.1459, and 493.1487 respectively. (b) If the laboratory director reapportions performance of his or her responsibilities, he or she remains responsible for ensuring that all duties are properly performed. This STANDARD is not met as evidenced by: Based on proficiency testing (PT) review and the laboratory's PT results, the 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 -- laboratory failed to achieve satisfactory performance in the specialty of Chemistry for the analyte of Total Calcium and has sustained a subsequent occurrence of unsuccessful participation in PT. Findings include: a. Scores on the last 4 PT testing events: Analyte Year Event Score Total Calcium 2017 1 20% Total Calcium 2017 2 0% Total Calcium 2017 3 0% Total Calcium 2018 1 0% -- 2 of 2 --