Summary:
Summary Statement of Deficiencies D5401 PROCEDURE MANUAL CFR(s): 493.1251(a) 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: Based on the Moh's laboratory's standard operating procedure (SOP) manual and interview with the newly hired Moh's technician, the laboratory failed to have an SOP that was specific for this laboratory. FINDINGS: 1. The policies and procedures in the SOP referred to the Sadick Aesthetic Surgery & Dermatology located at 58A 15th Street Manhattan New York 10011. 2. The cryostat, & microscope maintenance records, stain quality control records, temperature logs and slide verification documentation for 2019 through survey date was from the 58A 15th St. NY location. 3. The 6 patient reports reviewed were also from the 58A 15th location. a. reviewed the EMR patient logs for this location 911 Park Ave. NY, NY 10075 and found that Moh's procedures were not performed from 1/2019 through survey date. 4. The newly hired Moh's technician confirmed on January 26, 2022 at approximately 9:30 that the Moh's procedures were not performed at this current address in 2019, 2020 and 2021 and that the Moh's patients were referred to the 58A 15th office. D6031 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1407(e)(13) 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 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 -- director must-- (e)(13) Ensure that an approved procedure manual is available to all personnel responsible for any aspect of the testing process; This STANDARD is not met as evidenced by: Based on the Moh's laboratory's SOP manual and interview with the newly hired Moh's technician, the laboratory failed to have an SOP that was specific for this laboratory available to the Moh's staff. Refer to D5401. -- 2 of 2 --