Summary:
Summary Statement of Deficiencies D0000 An announced CLIA recertification survey was conducted at Skin Cancer Surgery Center on May 18, 2018 by the Virginia Department of Health's Office of Licensure and Certification. The laboratory was surveyed under 42 CFR part 493 CLIA Requirements. Specific deficiencies cited are as follows: 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 a tour, review of the policy and procedure manual, and an interview, the laboratory failed to follow their written policy to label all histopathology staining reagents for fifteen (15) of fifteen (15) containers in the slide preparation area on 5/18 /18. Findings include: 1. During a tour of the laboratory on 5/18/18 at approximately 11:00 AM, the inspector noted twelve (12) stain reagent containers being utilized to prepare Hematoxylin and Eosin (H & E) MOHS slides. Twelve (12) of the twelve (12) reagent containers were not labeled. The inspector noted three (3) bulk containers with staining reagents were also unlabeled and inquired pertaining to the identification of the reagents. The Histotechnologist stated "I get the staining reagents from another office lab. I do not have the reagent lot numbers or expiration dates onsite." 2. Review of the policy and procedure manual revealed a Materials Reagents policy that stated "All reagents are to be labeled with reagent name, expiration date/discard date, and storage requirements". Review of the policy and procedure manual revealed a Quality Assurance (QA) policy that stated "Discard reagents that are unlabeled or those whose expiration date has passed". 3. In an interview with the laboratory coordinator at Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- approximately 1 PM, it was confirmed that the laboratory did not follow their written Materials Reagent and QA policies for labeling of the histopathology reagents. 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)