Utswmc Mineral Metabolism Laboratory

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on 05/12/2025, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, and the College of American Pathologists (CAP) Original Evaluation form, the laboratory 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 -- failed to achieve satisfactory performance for three consecutive testing events for the analyte sodium, resulting in a non-initial unsuccessful performance. Refer to 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 proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, and the College of American Pathologists (CAP) Original Evaluation form, the laboratory failed to achieve satisfactory performance for three consecutive testing events in 2024 and 2025 for the analyte sodium. Findings include: 1. Review of the CASPER Report 155 Individual Laboratory Profile, the laboratory received the following unsatisfactory performances for three consecutive testing events for the analyte sodium: 2024 2nd event: 60% 2024 3rd event: 60% 2025 1st event: 60% 2. Review of the CAP Analyte Scorecard, the laboratory received the following unsatisfactory performances for three consecutive testing events for the analyte sodium: 2024 CAP Event 2: 60% 2024 CAP Event 3: 60% 2025 CAP Event 1: 60% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, and the College of American Pathologists (CAP) Original Evaluation form, the laboratory director failed to provide overall management and direction for the laboratory. Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) (e)(4)(i) The proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: Based on a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, and the College of American Pathologists (CAP) Original Evaluation form, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for the analyte sodium for three consecutive testing events in 2024 and 2025. Refer to D2096. -- 2 of 2 --

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on December 18, 2024, the laboratory was found to be out of compliance based on the following CONDITION LEVEL DEFICIENCIES: D2016 - 42 C.F.R. 493.803 Condition: Successful participation D6000 - 42 C.F.R. 493.1403 Condition: Laboratory Director, moderate complexity 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 proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, and the College of American Pathologists (CAP) Analyte Scorecard, the laboratory failed to 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 -- achieve satisfactory performance (80% or greater) for two consecutive testing events for 2024 (Events 2 and 3) for the analyte sodium, resulting in an initial unsuccessful performance. Refer to D2096. D2096 ROUTINE CHEMISTRY CFR(s): 493.841(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 proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, and the College of American Pathologists (CAP) Analyte Scorecard, the laboratory failed to achieve satisfactory performance (80% or greater) for two consecutive testing events in 2024 for the analyte sodium. Findings include: 1. Review of the CASPER Report 155 Individual Laboratory Profile, the laboratory received the following unsatisfactory performances for the analyte sodium for two consecutive testing events: 2024 2nd event: 60% 2024 3rd event: 60% 2. Review of the CAP Analyte Scorecard, the laboratory received the following unsatisfactory performances for the analyte sodium for two consecutive testing events: 2024 CAP Event 2: 60% 2024 CAP Event 3: 60% D6000 MODERATE COMPLEXITY LABORATORY DIRECTOR CFR(s): 493.1403 The laboratory must have a director who meets the qualification requirements of 493. 1405 of this subpart and provides overall management and direction in accordance with 493.1407 of this subpart. This CONDITION is not met as evidenced by: Based on a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the College of American Pathologists (CAP) Analyte Scorecard, the laboratory director failed ensure successful participation in an HHS approved proficiency testing program for the analyte sodium for two consecutive testing events in 2024 (Events 2 and 3). Refer to D6016. D6016 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(4)(i) 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, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(4)(i) Ensure that the proficiency testing samples are tested as required under Subpart H of this part; This STANDARD is not met as evidenced by: -- 2 of 3 -- Based on a proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile, and the College of American Pathologists (CAP) Analyte Scorecard, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for the analyte sodium for two consecutive testing events in 2024 (Events 2 and 3). Refer to D2096. -- 3 of 3 --

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 review of CMS 209 form, personnel records and confirmed in interview, the laboratory failed to ensure consultant competency procedures were established and followed for 1 of 2 Technical Supervisors (TS-1), 2 of 2 General Supervisors (GS-1) and Technical Consultants (TC-1) for 2018 and Testing Person (TP) #4 Findings included: 1. Review of the CMS 209 form listed TS-1/GS-1/TC-1 and TP #1 as supervisors/consultants for moderate and high complexity testing. Review of personnel records did not include competency assessments for TP #4. 2. During an interview on 07/15/2019 at 11:00 hrs, TS-1 and GS-1 are one in the same confirmed the above findings. D5783