Summary:
Summary Statement of Deficiencies D3009 FACILITIES CFR(s): 493.1101(c) The laboratory must be in compliance with applicable Federal, State, and local laboratory requirements. This STANDARD is not met as evidenced by: Based on review of the CLIA and Maryland State licensing database and interview with the histo technician (HT) and supervisor, the laboratory failed to complete the application process for updating the identity of the current laboratory director (LD) as required in the Code of Maryland Regulations COMAR10.10.07.01 Permitted POL [Physician Office Laboratory] and POCL [Point-of-Care Laboratory]- Director and Associate Director. B. Standards. (6) Changes in Employment or Service. A director shall notify the OHCQ [Office of Health Care Quality] within 30 days of any change in the director's service or employment as a laboratory director. Findings: 1. During the survey at 11:45 AM, the HT confirmed that the LD listed on the CLIA certificate and Maryland State licensing database left in August 2023. 2. During the survey on 06 /20/2024 at 12:45 PM, the HT and supervisor confirmed that the laboratory had not submitted an application to OHCQ update the identity of the qualified LD for the CLIA and Maryland State license. The laboratory failed to be in compliance with the applicable Maryland State laboratory requirements. 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: 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 -- Based on review of the policy and procedure manuals and interview with the histo technician (HT), the laboratory failed to have all the policies and procedures approved by the current laboratory director (LD). Findings: 1. Review of the policy and procedure manuals showed that they were signed by the LD listed on the CLIA certificate. When interviewed the HT stated that the LD had left in August 2023. The acting LD is listed on the "Laboratory Personnel Report CLIA" but the appropriate documents have not been submitted to the Office of Health Care Quality to make the changes. Refer to Tag D3009 for details. 2. During the survey on 06/20/2024 at 11:30 AM, the HT confirmed that the policy and procedure manuals were not signed by the current laboratory director. D5787 TEST RECORDS CFR(s): 493.1283(a) The laboratory must maintain an information or record system that includes the following: (a)(1) The positive identification of the specimen. (a)(2) The date and time of specimen receipt into the laboratory. (a)(3) The condition and disposition of specimens that do not meet the laboratory's criteria for specimen acceptability. (a)(4) The records and dates of all specimen testing, including the identity of the personnel who performed the test(s). This STANDARD is not met as evidenced by: Based on review of the Mohs maps and interview with the histo technician (HT), the laboratory's record system failed to identify the HT who performed the staining and slide preparation of each stage of the procedure. Findings: 1. According to the HT that was interviewed on 06/20/24 at 10:45 AM, whenever there are two HT's working the same day they both initial the "Histo" section of the Mohs map in case they perform staining of one of the stages. Moh's map #24-106 was pulled for review. The procedure was performed on 04/04/24 and there were two initials documented on the "Histo" section and two stages were performed before the margins were clear. The records failed to identify which HT performed the stage one or stage two staining. 2. During the survey on 06/20/2024 at 11:15 AM, the HT confirmed that the Mohs maps failed to identify which HT performed the staining and slide preparation for each stage of the testing. -- 2 of 2 --