Braun Dermatology

Summary Statement of Deficiencies D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. This STANDARD is not met as evidenced by: Based on review of the written quality assurance (QA) procedure, review of the lab records, and interview with the testing personnel (TP), The laboratory director (LD) failed to ensure that QA procedures were performed for accurate and reliable patient testing. Findings: A. 1. The LD failed to document on the QA log that autoclave V298485 was out of service and the

Summary Statement of Deficiencies D5435 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(b)(2) For equipment, instruments, or test systems developed in-house, commercially available and modified by the laboratory, or maintenance and function check protocols are not provided by the manufacturer, the laboratory must: (i) Define a function check protocol that ensures equipment, instrument, and test system performance that is necessary for accurate and reliable test results and test result reporting. (ii) Perform and document the function checks, including background or baseline checks, specified in paragraph (b)(2)(i) of this section. Function checks must be within the laboratory's established limits before patient testing is conducted. This STANDARD is not met as evidenced by: A. Based on review of the written procedure manual and interview with the laboratory person, the laboratory failed to establish maintenance procedures for the autoclave to ensure accurate and reliable patient testing. Findings: 1. The laboratory has an autoclave where instruments used for patient procedures are sterilized. 2. The laboratory did not have written procedures nor documentation that showed the autoclave was checked for spore contamination. 3. The laboratory person stated that he was unsure if the autoclave was ever checked for spore contamination. 4. The laboratory person confirmed that written maintenance procedures were not available to ensure that contamination procedures were performed on the autoclave. B. Based on review of the written procedure manual and interview with the laboratory person, the laboratory failed to document all maintenance procedures preformed on the cryostat. Findings: 1. The laboratory written cryostat maintenance procedure states "after each frozen section is completed the blade is cleaned, moved to a new position, or replaced. 2. The laboratory did not document when the cryostat blade was replaced. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- 3. The laboratory person stated that there was no need to document this because the person performing the cutting should know when to change the blade. 4. The testing person confirmed that the cryostat blade changes were not documented. -- 2 of 2 --

Summary Statement of Deficiencies D2003 ENROLLMENT CFR(s): 493.801(a)(2)(ii) For those tests performed by the laboratory that are not included in subpart I of this part, a laboratory must establish and maintain the accuracy of its testing procedures, in accordance with 493.1236(c)(1) This STANDARD is not met as evidenced by: Based on record review and interview with staff, the histology laboratory did not follow written procedures for biannual peer review of MOHS cases. Findings: 1. The laboratorys written procedure instructs the laboratory to submit three MOHS cases for peer review, for each surgeon, twice a year; 2. In 2018 the laboratory did not perform biannual peer reviews of MOHS cases for each surgeon; 3. In 2019 the laboratory did not perform the first biannual peer review of MOHS cases for each surgeon; and 4. This was confirmed during interview with laboratory staff at approximately 14:00 hours. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD 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 5 -- Based on record review and interview, the histology laboratory did not follow its written procedures to document the return of slides referred for consult or followup to determine if slides were returned. Findings: 1. On January 24, 2018 slides were sent out for a second opinion, the slides were prepared from tissue obtained from patient #1 on January 8, 2018. The specimen log includes a space to record the return and date of slides that were sent out of the office. There was no return documentation for the return of these slides in the log; and 2. This was confirmed during interview with the laboratory director at approximately 15:00 hours on the day of survey. D5403 PROCEDURE MANUAL CFR(s): 493.1251(b) The procedure manual must include the following when applicable to the test procedure: (1) Requirements for patient preparation; specimen collection, labeling, storage, preservation, transportation, processing, and referral; and criteria for specimen acceptability and rejection as described in 493.1242. (2) Microscopic examination, including the detection of inadequately prepared slides. (3) Step-by-step performance of the procedure, including test calculations and interpretation of results. (4) Preparation of slides, solutions, calibrators, controls, reagents, stains, and other materials used in testing. (5) Calibration and calibration verification procedures. (6) The reportable range for test results for the test system as established or verified in 493.1253. (7) Control procedures. (8)