Complete Care Southlake

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. Standard level deficiencies were cited. D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) A written procedures manual for all tests, assays, and examinations performed by the laboratory must be available to, and followed by, laboratory personnel. Textbooks may supplement but not replace the laboratory's written procedures for testing or examining specimens. This STANDARD is not met as evidenced by: Based on review of the laboratory's policies, calibration verification records from 2023 for the Triage analyzer , review of patient test volumes, and staff interview, the laboratory failed to have documentation of performing calibration verification on the Triage analyzer every six months for two of two events in 2023. Findings include: 1. Review of the laboratory's policies "Laboratory Procedure Triage Cardiac Panel" and "Laboratory Procedure Triage D Dimer", approved by the laboratory director on 11/01 /2023 determined : "Verification of Linearity and Precision B. Verification Frequency When a new analyzer is put into use and every 6 months after this date." Tests performed on the Triage Cardiac Panel are: a) CK-MB (Creatinine Kinase - Myocardial Band) b) Troponin-I 2. The laboratory was asked to provide documentation of performing calibration verification for Cardiac Panel and D-Dimer cartridges on the Triage analyzer in 2023. No documentation was provided. 1. Review of patient test volumes for the Triage analyzer in 2023 revealed the following: a) Cardiac Panel: 207 tests b) D-Dimer: 89 tests 2. Technical Consultant-1 and Technical Consultant-2 (as listed on the CMS-209 form) confirmed the findings during an interview on 05/14/2024 at 1130 hours in the office. Key: CMS - Centers for Medicare and Medicaid Services 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 --

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 laboratory representatives. 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 representatives were 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 in COMPLIANCE with applicable Conditions of Participation in the CLIA program, and recertification is recommended. Note: The CMS-2567 (Statement of Deficiencies) is an official, legal document. All information must remain unchanged except for entering the