Advanced Dermatology Pc

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on the lack of training and competency documentation of fungal culture testing person, the laboratory failed to perform training and competency. Confirmed on an interview with general supervisor on 6/24/2022 about 11am. D5291 GENERAL LABORATORY SYSTEMS QUALITY ASSESSMENT CFR(s): 493.1239(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 general laboratory systems requirements specified at 493.1231 through 493.1236. This STANDARD is not met as evidenced by: Based on review of the Quality Assessment (QA) policy, the laboratory failed to establish frequency of QA policy and perform QA review. FINDINGS: 1. 2020 and 2021 annual QA review documentation was not available for review. 2. 2020 and 2021 annual QA review not performed confirmed with an interview with general supervisor on 6/24/3022 about 11:30am. D6021 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(5) 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 -- 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 a lack of the training/competency documentation and annual QA documentation, the laboratory director failed to ensure that the laboratory's QA program was maintained for all phases of laboratory testing. Refer to: D5209 and D5291 -- 2 of 2 --

Summary Statement of Deficiencies D5209 PERSONNEL COMPETENCY ASSESSMENT POLICIES CFR(s): 493.1235 As specified in the personnel requirements in subpart M, the laboratory must establish and follow written policies and procedures to assess employee and, if applicable, consultant competency. This STANDARD is not met as evidenced by: Based on surveyor's review of laboratory records and an interview with the practice manager, the laboratory failed to establish a comprehensive written policy and procedure that includes the six required components that assess testing personnel's competency, twice annually during the first year of testing and annually thereafter. The six required components are: 1. direct observation of routine patient test performance, including preparation. specimen handling and testing; 2. monitoring the recording and reporting of test results; 3. review of intermediate results of worksheets, quality control records, proficiency testing results, and preventive maintenance records; 4. direct observation of performance of instrument maintenance and function checks; 5. assessment of test performance through testing previously analyzed specimens, internal blind testing samples or external proficiency testing samples; and, 6. assessment of problem solving skills. 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. 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 -- (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)