Altus Waxahachie, Lp

Summary Statement of Deficiencies D0000 Based on a proficiency testing desk review survey performed on 05/01/2025, 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 American Proficiency Institute (API) Proficiency Testing Performance Evaluation, 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 3 -- laboratory failed to achieve satisfactory performance (80% or greater) for two of three consecutive testing events for 2024 and 2025 (2024 Event 2 and 2025 Event 1) for the analytes RBC and HCT, resulting in an initial unsuccessful performance. Refer to D2130. Key: RBC - Red Blood Cell HCT - Hematocrit D2130 HEMATOLOGY CFR(s): 493.851(f) (f) Failure to achieve satisfactory performance for the same analyte in two consecutive 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 American Proficiency Institute (API) Proficiency Testing Performance Evaluation, the laboratory failed to achieve satisfactory performance (80% or greater) for two of three consecutive testing events in 2024 and 2025 (2024 Event 2 and 2025 Event 1) for the analytes RBC and HCT. Findings include: 1. Review of the CASPER Report 155 Individual Laboratory Profile determined the laboratory received the following unsatisfactory performances for the analyte RBC for two of three consecutive testing events: 2024 Event 2: 0% 2025 Event 1: 0% Further review of the CASPER Report 155 Individual Laboratory Profile determined the laboratory received the following unsatisfactory performances for the analyte HCT for two of three consecutive testing events: 2024 Event 2: 0% 2025 Event 1: 20% 2. Review of the API Performance Evaluation Report determined the laboratory received the following unsatisfactory performances for the analyte RBC for two of three consecutive testing events: 2024 Event 2: 0% 2025 Event 1: 0% Further review of the API Performance Evaluation Report determined the laboratory received the following unsatisfactory performances for the analyte HCT for two of three consecutive testing events: 2024 Event 2: 0% 2025 Event 1: 20% Key: RBC - Red Blood Cell HCT - Hematocrit 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 American Proficiency Institute (API) Proficiency Testing Performance Evaluation, the laboratory director failed ensure successful participation in an HHS approved proficiency testing program for the analytes RBC and HCT for two of three consecutive testing events in 2024 and 2025 (2024 Event 2 and 2025 Event 1). Refer to D6016. Key: RBC - Red Blood Cell HCT - Hematocrit 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 -- 2 of 3 -- 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 American Proficiency Institute (API) Proficiency Testing Performance Evaluation, the laboratory director failed to ensure successful participation in an HHS approved proficiency testing program for the analytes RBC and HCT for two of three consecutive testing events in 2024 and 2025 (2024 Event 2 and 2025 Event 1). Refer to D2130. Key:RBC - Red Blood Cell HCT - Hematocrit -- 3 of 3 --

Summary Statement of Deficiencies D0000 Laboratory representatives were present at the entrance conference. The survey process was discussed. An opportunity for questions and comments was given. The exit conference was held with the laboratory representatives. The laboratory was found to be in substantial compliance for the specialties/subspecialties for which it was surveyed. The standard level deficiencies cited were discussed. The process for submitting the corrections was explained. CMS form 2567 will be emailed from the Texas Health and Human Services Commission, Health Facility Compliance Arlington Group. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the

Summary Statement of Deficiencies D0000 An entrance conference was held with the laboratory director. The survey process was discussed and survey forms were provided. An opportunity for questions and comments was given. Noted deficiencies and plans of correction were discussed with the laboratory representatives at the exit conference. The laboratory director was given an opportunity to provide evidence of compliance with the noted deficiencies, and no such evidence was provided prior to survey exit. The facility was found to be NOT in compliance with the CLIA conditions for specialties/subspecialties surveyed for 42 CFR 493.1409 Technical Consultant 493.1421 Testing Personnel (moderate complexity) Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the