Summary:
Summary Statement of Deficiencies D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to establish and follow a written procedure for specimen labeling requirements. Findings are as follows: 1. The laboratory performed Mohs Micrographic Surgery testing as confirmed by the Histotechnician (HT) during a tour of the laboratory at 10:05 a.m on 05/08/19. 2. During the tour of the laboratory, patient tissue specimens were observed in small plastic boxes and accompanied by Mohs maps. The specimen box and associated Mohs map were placed together on separate shelves of the pending processing cabinet. 3. Three of three tissue specimen boxes were labeled with the patient's room number. Patient identifiers were not found on the specimen boxes. The associated Mohs maps included patient identifiers. The room numbers were not included on the Mohs maps. 4. The Mohs Micrographic Surgery procedure located in the Lab Manual did not include criteria for patient tissue specimen labeling. 5. In an interview at 10:15 a.m. on 05/08/19, the HT confirmed the above finding and stated criteria was not present on the specimen boxes to correlate the patient specimen to the Mohs map. D5603 HISTOPATHOLOGY CFR(s): 493.1273(b)(f) 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 -- (b) The laboratory must retain stained slides, specimen blocks, and tissue remnants as specified in 493.1105. The remnants of tissue specimens must be maintained in a manner that ensures proper preservation of the tissue specimens until the portions submitted for microscopic examination have been examined and a diagnosis made by an individual qualified under 493.1449(b), (l), or (m). (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: . Based on observation, document review, and interview with laboratory personnel, the laboratory failed to retain all slides created from each Mohs Micrographic Surgery procedure. Findings are as follows: 1. The laboratory performed Mohs Micrographic Surgery testing as confirmed by the Histotechnician (HT) during a tour of the laboratory at 10:05 a.m on 05/08/19. 2. Documentation in the electronic Mohs log indicated five patient slides were retained for patient B tested on 01/08/19. The laboratory produced three patient slides for review and was unable to provide additional slides upon request. 3. The Interpretation of Mohs Slides procedure, located in the Lab Manual, indicated duplicate Mohs Micrographic Surgery patient slides were discarded. 4. In an interview at 12:00 p.m. on 05/08/19, the Laboratory Director confirmed the above finding and explained that the missing slides had been discarded. -- 2 of 2 --