Summary:
Summary Statement of Deficiencies D0000 A recertification survey conducted on 05/06/2024 found the SKIN PATHOLOGY CENTER INC clinical laboratory not in compliance with 42 CFR Part 493, Requirements for Laboratories. D3001 FACILITIES CFR(s): 493.1101(a)(1) The laboratory must be constructed, arranged, and maintained to ensure the space, ventilation, and utilities necessary for conducting all phases of the testing process. This STANDARD is not met as evidenced by: Based on observation, lack of records and interview, the laboratory failed to monitor the Xylene and Formaldehyde exposure limits for 34 out of 34 months reviewed (2021 (July to December), 2022, 2023 and 2024 (January to April)). Findings include: -During the arrival of the surveyor on site on 05/06/2024 at 10:30 AM, the surveyor noted a strong odor for a chemical product. During the permanence of the surveyor onsite for 3 hours, she could sense the permanence of the strong chemical odor. - Review of procedure manual signed by the laboratory director on 10/16/2023, revealed that the laboratory failed to include a policy to implement the staff monitoring of the exposure to Xylene and Formaldehyde used in the laboratory. - Review of specimen policy revealed that the specimens are received in a 10% formalin bottle. Review of Sakura VIP tissue processor procedure revealed that the laboratory used the 10 % Formalin solution in the first two stations for tissue dehydration and Xylene in the ninth and ten station for clearing. Review of the Hematoxylin and Eosin stain process revealed that the laboratory used Xylene. - Review of Safety Data Sheet for: a) 10% Neutral Buffered Formalin revealed that the OSHA Permissible Limits (PELS) was 0.75 ppm (parts per million). b) Xylene revealed that the OSHA PEL was 100 ppm. During an interview on 05/06/2024 at 12: 30 PM, the laboratory consultant confirmed that the laboratory failed to effectively monitor the Xylene and Formaldehyde exposure. 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 -- 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)