Spanish Peaks Regional Health Center

Summary Statement of Deficiencies 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 the general supervisor (GS), 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 6/21/2019. The laboratory performs approximately 133,927 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 6/21/2019. 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 6/21/2019. 3. An interview with the GS on February 13, 2024, at approximately 11:15 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 6/21/25019. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test 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 -- procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)

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 Compatibility Testing for two out of three PT events, (event 2 in 2022 and event 1 in 2023). See D2181. D2181 COMPATIBILITY TESTING CFR(s): 493.863(e) 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 an overall testing event score of satisfactory for 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 Proficiency Testing (PT) scores report from the American Proficiency Institute (API) and email communication with the laboratory director, the laboratory failed to achieve a score of 100% for Compatibility Testing for event 2 in 2022, and event 1 in 2023. Findings: 1. A review of the CMS-155 Individual Laboratory Profile on 10/13/2023, at 11:15 AM, revealed the Compatibility Testing score for PT event 2 in 2022 was 80%, and the testing scores for event 1 in 2023 was 80%. 2. An email communication with laboratory director on 10/13/2023, at 11:50 AM, confirmed two out of three unsuccessful PT scores for Compatibility Testing. -- 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 proficiency test desk review of the CMS-155 report for proficiency testing performance and an interview with the laboratory director, the laboratory failed to achieve satisfactory performance scores for PO2 Blood Gas for two consecutive events (Event 3 in 2021 and Event 1 in 2022). 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 a review of proficiency testing scores from the American Proficiency Institute (API) and email communicatin with the laboratory director, the laboratory failed to achieve a satisfactory score of at least 80% for PO2 Blood Gas testing performed on Event 3 in 2021 and Event 1 in 2022. Findings include: 1. A review of the proficiency testing scores from API and the CMS-155 Individual Laboratory Profile on 10/07/2022, at 3:00 PM, revealed the PO2 Blood Gas testing scores for Event 3 in 2021 was 60% and Event 1 in 2022 was 20%. 2. An email communication with the laboratory director on 10/12/2022, at 4:20 PM, confirmed two consecutive unsuccessful proficiency scores for PO2 Blood Gas testing due to laboratory errors. -- 2 of 2 --