Christine D Brown, Md, Pa

Summary Statement of Deficiencies D0000 The laboratory was found to be in substantial compliance with CLIA regulations 42 CFR Part 493. No deficiencies were cited. 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 An entrance conference was held with the laboratory representative. 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 representative 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 NOT in compliance with the CLIA conditions for specialties /subspecialties surveyed for 42 CFR 494.1230 General Laboratory Systems 493.1250 Analytic Systems 493.1441 Laboratory Director, (high complexity) 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 The histotechnician was at the entrance conference conducted 01/03/2019. The survey process was discussed. An opportunity for questions and comments was given. Exit conference was held with the histotechnician on 01/03/2019. 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 Department of State Health Services, Health Facility Compliance Arlington Group. D5217 EVALUATION OF PROFICIENCY TESTING PERFORMANCE CFR(s): 493.1236(c)(1) At least twice annually, the laboratory must verify the accuracy of any test or procedure it performs that is not included in subpart I of this part. This STANDARD is not met as evidenced by: Based on review of the laboratory's policy, laboratory records and confirmed in interview, the laboratory failed to verify the accuracy of KOH (not regulated) test at least twice annually in 2017 and 2018. Findings: 1. Review of the laboratory's procedure manual did not include procedures for the KOH test and did not include procedure for verifying twice annual accuracy. The laboratory was unable to provide documentation of twice annual verification of accuracy for KOH test in 2017 and 2018. 2. According to records, the laboratory's annual patient test volume was 135 KOH's. 3. During an interview on 01/03/2019 at 11:00 am, the histotechnician confirmed the laboratory failed to perform twice annual verification of KOH. Key words: KOH - potassium hydroxide D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 7 -- 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: I. Based on direct observation, review of the laboratory's procedure manual, patient Mohs slides, and confirmed in interview, the laboratory failed to follow its own written policy for labeling Mohs slides for 1 of 12 sets of slides reviewed from 08 /2018 through 12/2018 (random sampling). Findings: 1. Review of the laboratory's Mohs Surgery-Histopathology policy stated "3.4.8 ...Slides are labeled with number, full patient name and date." 2. A random review of Mohs slides from 08/2018-12 /2018 revealed: Patient 18133 slide was labeled with only the patient last name. It was not labeled with patient ID and full name. The laboratory failed to follow its own written policy for the proper labeling of Mohs slides.