Csu Health And Medical Center

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 manager, the laboratory failed to achieve satisfactory performance scores for the American Proficiency Institute (API) PT for TSH for two out of three PT events, (event 3 in 2023 and event 2 in 2024). See D2099. D2099 ENDOCRINOLOGY CFR(s): 493.843(b) 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 attain an overall testing event score of at least 80 percent is unsatisfactory performance. This STANDARD is not met as evidenced by: Based on a routine desk review of the CMS-155 report for Proficiency Testing (PT), and email communication with the laboratory manager, the laboratory failed to achieve a satisfactory score for TSH for event 3 in 2023 and event 2 in 2024. Findings include: 1. A review of the CMS-155 Individual Laboratory Profile on July 17, 2024, at 10:23 AM, revealed the API PT results for TSH testing scores for event 3 in 2023 was 0%, and 60% for event 2 in 2024. 2. An email with the laboratory's manager on July 17, 2024, at 01:58 PM, confirmed the laboratory failed to achieve satisfactory test performance for TSH. -- 2 of 2 --

Summary Statement of Deficiencies 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 record review and an interview with the Technical Supervisor (TS), the laboratory failed to assess the competency of and establish policies or procedures to evaluate the competency of TS, General Supervisor (GS), and Clinical Consultant (CC) roles, since the last survey on 02/14/2022. The laboratory performs approximately 83,400 tests annually. Findings include: 1. A review of the laboratory's competency records revealed that the laboratory did not have any documented evaluations of TS, GS, or CC competencies, since the last survey on 02/14/2022. 2. A review of the laboratory's manuals revealed that the laboratory did not have an approved policy or procedure to evaluate TS, GS, or CC competencies, since the last survey on 02/14/2022. 3. An interview with the TS on 03/11/2024, at 2 p.m., confirmed that the laboratory did not assess the competency of and establish an approved policy or procedure to evaluate TS, GS, or CC competencies, since the last survey on 02/14/2022. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test 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 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 -- 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 manager, the laboratory failed to achieve satisfactory performance scores for the American Proficiency Institute (API) PT for Total Bilirubin for two out of three PT events, (event 2 in 2023 and event 3 in 2023), and Sodium for two out of three PT events, (event 1 in 2023 and event 3 in 2023). 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 manager, the laboratory failed to achieve a satisfactory score for Total Bilirubin for event 2 in 2023 and event 3 in 2023 and failed to achieve a satisfactory score for Sodium for event 1 in 2023 and event 3 in 2023. Findings: 1. A review of the CMS-155 Individual Laboratory Profile on 12/27/2023, at 10:30 AM, revealed the API PT results for Total Bilirubin testing scores for event 2 in 2023 was 20%, and 0% for event 3 in 2023. 2. A review of the CMS-155 Individual Laboratory Profile on 12 /27/2023, at 10:30 AM, revealed the API PT results for Sodium testing scores for event 1 in 2023 was 20%, and 0% for event 3 in 2023. 3. An email with the laboratory manager on 12/28/2023, at 09:16 AM, confirmed the laboratory failed to achieve satisfactory test performance for Total Bilirubin, and Sodium. -- 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 laboratory manager confirmation, the laboratory failed to achieve successful PT performance in 2 of 3 consecutive testing events in the specialty of microbiology in 2017 and 2018. See D2055. D2055 PARASITOLOGY CFR(s): 493.829(e) Failure to achieve an overall testing event score of satisfactory performance for 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 (PT) scores and laboratory manager confirmation, the laboratory failed to achieve satisfactory performance for the the analyte of parasitology in the specialty of Microbiology in 2 of 3 consecutive PT events. Findings include: Parasitology 3rd Event of 2017: 60% 1st Event of 2018: 60% -- 2 of 2 --