Summary:
Summary Statement of Deficiencies 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 (Mohs maps) and interview with the Director of Training and Compliance (DTC), the laboratory failed to include the address of the location where MOHS microscopic slide examinations were performed on patient test reports from 05/20/2024 to the date of the survey. Findings include: 1. On the day of survey, 10/23/2024 at 09:20 am, review of 2 of 2 patient test reports (Mohs maps) revealed the laboratory failed to ensure the addition of the address of the laboratory where MOHS microscopic slides were examined from 05/20/2024 until 10/11/2024. 2. The DTC confirmed the above findings on 10/23/2024 at 09:20 am. D6094 LABORATORY DIRECTOR RESPONSIBILITIES CFR(s): 493.1445(e)(5) The laboratory director must ensure that the quality assessment programs are established and maintained to assure the quality of laboratory services provided and to identify failures in quality as they occur. 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 laboratory QA records and interview with the Director of Training and Compliance (DTC), the laboratory director (LD) failed to ensure quality assessment (QA) programs were maintained to assure the quality of laboratory services and to identify failures in the quality as they occur from June 2024 to October 2024. Findings include: 1. On the day of survey 10/23/2024 at 9:18 am, review of the Monthly QA Assurance Checklists revealed that the LD failed to provide checklists for 5 out of 6 months in 2024: - June 2024 - July 2024 - August 2024 - September 2024 - October 2024 2. The laboratory performed 200 MOHS microscopic examinations in 2024 (CMS 116 annual volume) 3. The DTC confirmed the findings above on, 10/23/2024 at 9:18 am. -- 2 of 2 --