San Antonio Metroplitan Health District Lrn Lab

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 company. The facility was found to be out of compliance with the conditions of the CLIA program. The following CONDITION LEVEL DEFICIENCIES were found: D2016 - 42 C.F.R. 493.803 Condition: Successful participation [proficiency testing] D6000 - 42 C.F.R. 493.1403 Condition: Laboratories performing moderate complexity testing; laboratory director 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: 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 -- Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and College of American Pathologist's proficiency reports, the laboratory failed to achieve satisfactory performance in two of two testing events for the analyte of gram stain in the subspecialty of bacteriology (refer to D2028) resulting in an initial unsuccessful performance. D2028 BACTERIOLOGY CFR(s): 493.823(e) (e) Failure to achieve an overall testing event score of satisfactory performance 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 proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the College of American Pathologist's proficiency reports (2025 event 3) and 2026 (event 1), the laboratory failed to achieve satisfactory performance for two of two events for the analyte of gram stain in the subspecialty of bacteriology. The findings included: 1. A review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile report, the laboratory received the following unsatisfactory performances for gram stain in the subspecialty of bacteriology on two of two events: 2025 Event 3 70% 2026 Event 1 70% 2. A review of the College of American Pathologist's proficiency testing reports from 2025 and 2026 confirmed the findings. 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 proficiency testing desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the College of American Pathologist's proficiency testing reports from 2025 (Event 3) and 2026 (Event 1), the laboratory director failed to provide overall management and direction of the laboratory services resulting in an initial proficiency testing failure for the analyte gram stain in the subspecialty of bacteriology (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 proficiency desk review of the Certification and Survey Provider Enhanced Reporting (CASPER) Report 155 Individual Laboratory Profile and the College of -- 2 of 3 -- American Pathologist's proficiency testing reports from 2025 (Event 3) and 2026 (Event 1), the laboratory director failed to ensure successful participation in a HHS approved proficiency testing program for the analyte of gram stain in the subspecialty of bacteriology for two of two events in 2025 and 2026, resulting in an initial unsuccessful performance (refer to D2028). -- 3 of 3 --

Summary Statement of Deficiencies D0000 Noted deficiency and plans of correction were discussed with the laboratory representative(s) at the exit conference. The facility was found to be in compliance with applicable Conditions in the CLIA program, and recertification is recommended. D6127 TECHNICAL SUPERVISOR RESPONSIBILITIES CFR(s): 493.1451(b)(9) The technical supervisor is responsible for evaluating and documenting the performance of individuals responsible for high complexity testing at least semiannually during the first year the individual tests patient specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's submitted Form CMS 209, review of the laboratory's personnel records, and staff interview, it was revealed the laboratory failed to have documentation of the technical supervisor performing twice annual competency assessments for 1 of 1 testing personnel. The findings include: 1. A review of the laboratory's submitted Form CMS 209 revealed the laboratory identified 1 testing personnel. Testing personnel number 1 started in October 2021. 2. A review of the laboratory's personnel records revealed the laboratory had documentation of a competency assessment being performed on testing personnel number 1 in April 2022. There was no documentation of another competency being performed. 3. The laboratory was asked to provide documentation of a second competency assessment being performed by October 2022. No documentation was provided. 4. An interview with the technical supervisor on 03/29/2023 at 1005 hours in the break room revealed he was unable to find the second competency assessment for testing personnel number 1. This confirmed the findings. 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 --