Summary:
Summary Statement of Deficiencies D0000 This statement of deficiencies was generated as a result of the on-site CLIA initial survey conducted at your facility on February 1, 2018. The findings and conclusions of any investigation by the Division of Public and Behavioral Health shall not be construed as prohibiting any criminal or civil investigations, actions or other claims for relief that may be available to any party under applicable federal, state or local laws. 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 random audit of five patient Mohs histopathology laboratory tests from 12 /07/17 through 2/01/18, a review of the director approved policy and procedure manual and an interview with the clinic manager, the laboratory failed to follow the established procedure for the labeling of patent histopathology slides. Findings include: 1. The laboratory failed to follow the director approved policy and procedure manual for the labeling of patient histopathology slides which states that "slides are labeled with number, full patient name, location, diagnosis, date, patient number and physician initials". 2. The histopathology slides that were reviewed during the random audit of five patients between 12/07/17 through 2/01/18 found the slides were labeled with patient full name, the patient date of birth, the date that the test was performed, the site of the specimen and the number of the slide. There was no indication of the diagnosis, the patient number or physician's initials. This was confirmed by the clinic manager on February 1, 2018 at approximately 3:30 PM. The laboratory performs approximately 200 patient histopathology tests annually. 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 --