Lance H Brown Md Pllc

Summary Statement of Deficiencies D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) The laboratory director is responsible for the overall operation and administration of the laboratory, including the employment of personnel who are competent to perform test procedures, and record and report test results promptly, accurate, and proficiently and for assuring compliance with the applicable regulations. (e) The laboratory director must-- (e)(5) Ensure that quality assessment programs are established and maintained to assure the quality of laboratory services provided. This STANDARD is not met as evidenced by: Based on review of the laboratory's Quality Assessment (QA) documentation for year 2022, the laboratory director failed to perform QA review quarterly as per laboratory's QA policy for year 2022. Confirmed in an interview with the histotech on 10/11/2022 about 12pm. The laboratory director failed to perform QA for all phases for the general laboratory system. 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 D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on surveyor's observation of the laboratory's testing area and an interview with the histotech, the laboratory used testing materials beyond manufacturer's expiration date. FINDINGS: Surveyor observed one Gallon bottle of Eosin lot # G156-19 expiration date 7/7/19 and one Gallon bottle of Hematoxylin lot # 069759 expiration date 4/1/2020. In-date container of Eosin and an in-date container of Hematoxylin were not available for use. Approximately 32 Mohs patient biopsy specimens were processed and test results released using the expired stain reagents. D5429 MAINTENANCE AND FUNCTION CHECKS CFR(s): 493.1254(a)(1) For unmodified manufacturer's equipment, instruments, or test systems, the laboratory must perform and document maintenance as defined by the manufacturer and with at least the frequency specified by the manufacturer. This STANDARD is not met as evidenced by: Based on surveyor review of laboratory equipment maintenance records and interview with the histotech, the laboratory failed to follow their established laboratory equipment maintenance policy and the manufacturer maintenance requirement, which require the laboratory to perform an annual preventative maintenance for the Microscope and for the Cryostat used for the histopathology slide reading. 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 -- FINDINGS: The laboratory equipment maintenance policy and the manufacturer of the Microscope and the Cryostat require annual preventive maintenance of the Microscope and the Cryostat used for the histopathology slide reading. The records of preventive maintenance were not available at the time of the survey for the Microscope and for the Cryostat for calendar year 2019. Approximately 16 patient slides were read and reported for Mohs surgery during this time frame. -- 2 of 2 --