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 policy and procedure manual review and staff interview, the laboratory director failed to sign, and date as approved, 12 of 18 standard operating and histopathology procedures reviewed. The findings were: 1. Review of 12 out of 18 histopathology and standard operating procedures failed to include the laboratory director's signature and date of approval. 2. Interview with the laboratory manager on 12/16/24 at 2:40 PM confirmed the laboratory director had not reviewed and approved each of the laboratory's policies and procedures. 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. This STANDARD is not met as evidenced by: Based on review of patient test reports and staff interview, the laboratory failed to 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 -- ensure the patient test report included the name and address of the laboratory location where the test was performed. The laboratory performed approximately 60 Mohs procedures annually. The findings were: 1. Review of the test report for patient #32275886 showed the name and address of the testing site was not included in the report. 2. Interview with the laboratory manager on 12/16/24 at 3:04 PM confirmed the patient test report failed to include the name and address of the location the test was performed. -- 2 of 2 --