Summary:
Summary Statement of Deficiencies D5407 PROCEDURE MANUAL CFR(s): 493.1251(d) Procedures and changes in procedures must be approved, signed, and dated by the current laboratory director before use. This STANDARD is not met as evidenced by: Based on review of the laboratory procedure manual for Mohs testing presented for review during the survey and interview with the facility personnel, the laboratory failed to have the procedure manual approved, signed, and dated by the current laboratory director before use. Findings include: 1. The laboratory began Mohs testing in the sub-specialty of histopathology on 11/14/2019, with an approximate annual test volume of 600. 2. The Mohs procedure manual presented for review during the survey conducted on 01/18/2022 was not approved, signed and dated by the laboratory director before use. 3. The facility personnel acknowledged that the procedure manual was not approved, signed and dated by the laboratory director before use. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, either the patient's name and identification number, or a unique patient identifier and identification number. (c)(2) The name and address of the laboratory location where the test was performed. (c)(3) The test report date. (c)(4) The test performed. (c)(5) Specimen source, when appropriate. (c)(6) The test result and, if applicable, the units of measurement or interpretation, or both. (c)(7) Any information regarding the condition and disposition of specimens that do not meet the laboratory's criteria for acceptability. 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 -- This STANDARD is not met as evidenced by: Based on review of the laboratory's Mohs test reports and interview with the facility personnel, the Mohs test report for one patient failed to include a unique identification number and the test result. Findings include: 1. The laboratory reads and interprets slides in conjunction with the Mohs procedure in the sub-specialty of histopathology with an approximate annual test volume of 600. 2. It is the practice of the laboratory to maintain the Mohs test reports (Mohs operative report and Mohs map) in an electronic record system. Each Mohs case is given a unique accession number which is listed on the operative report, map and slide(s). 3. One out of four operative test reports (PWM20-019) reviewed during the survey failed to include the unique accession number. 4. One out of four operative test reports (PWM20-019) reviewed during the survey failed to include the final test result. 5. The facility personnel confirmed that the Mohs operative report for the patient indicated above failed to include the unique accession number and the final test result. -- 2 of 2 --