Oakcliff Medical Treatment Clinic

Summary Statement of Deficiencies D0000 Laboratory representatives were present at the entrance conference conducted 04/26 /2021. The survey process was discussed. An opportunity for questions and comments was given. The exit conference was held with the laboratory representatives on 04/26 /2021. 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 State Health and Human Services Commission, Health Facility Compliance Arlington Group. D5211 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(a) The laboratory must review and evaluate the results obtained on proficiency testing performed as specified in subpart H of this part. This STANDARD is not met as evidenced by: Based on review of laboratory policy, American Academy of Family Physicians (AAFP) proficiency testing(PT) records, and confirmed in interview, the laboratory failed to review and evaluate the results obtained on proficiency testing for 3 of 3 hematology events in 2020 (Events A, B, C). Findings: 1. Review of the laboratory's policy titled "Proficiency Testing (PT) Assessment Policy" revealed: "E. Evaluation of Survey ... 4. All proficiency testing results should be reviewed ... 9. The laboratory director or designee will review and sign all PT survey reports, evaluation forms, and

Summary Statement of Deficiencies D5791 ANALYTIC SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1289(a)(c) (a) The laboratory must establish and follow written policies and procedures for an ongoing mechanism to monitor, assess, and when indicated, correct problems identified in the analytic systems specified in 493.1251 through 493.1283. (c) The laboratory must document all analytic systems assessment activities. This STANDARD is not met as evidenced by: Based on review of quality assessment reports and interview, the laboratory failed to establish a written policy for ongoing mechanism to monitor, assess and correct problems identified in analytical systems. Findings were: a. At the time of the survey the laboratory failed to provide a Quality assessment policy documentation for Quality Control and problems in the analytical systems, for the analytes Hemoglobin, Hematocrit and Mean Corpuscle Volume a problem from January 2019 through May 2019 . b An interview with the technical Consultant on 07/17/2019 at 11:00 hrs in the office confirmed the above 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 --