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 procedure manual review, and staff interview, the laboratory director failed to sign, and date as approved, the laboratory's standard operating procedure and histopathology manuals. The findings were: 1. Review of the histopathology and standard operating procedure manuals failed to include the laboratory director's signature and date of approval. 2. Interview with the laboratory's compliance officer and laboratory director on 11/18/24 at 11:41 AM confirmed the laboratory director had not reviewed and approved the procedure manuals. 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 for 3 of 3 patient test reports reviewed (#13296547, #13334064, #12960445). The laboratory performed approximately 150 histopathology and cytology procedures per year. The findings were: 1. Review of the test reports for patient #13296547, #13334064, and #12960445 showed the specimens were collected at the Cheyenne Veterans Affairs Medical Center and contained all of the required information except for the name and address of the laboratory location where the test was performed. 2. Interview with the laboratory's compliance officer and laboratory director on 11/18/24 at 11:41 AM confirmed the patient test reports failed to include the correct name and address of the location the test was performed. -- 2 of 2 --