Dmb Medical

Summary Statement of Deficiencies D5417 TEST SYSTEMS, EQUIPMENT, INSTRUMENTS, REAGENT CFR(s): 493.1252(d) Reagents, solutions, culture media, control materials, calibration materials, and other supplies must not be used when they have exceeded their expiration date, have deteriorated, or are of substandard quality. This STANDARD is not met as evidenced by: Based on a direct observation of the Eosin Y Stain Solution and an interview with the Office Manager, it was determined that the laboratory failed to ensure that the Eosin Y Stain Solution reagent was not used past the manufacturer's expiration date. Findings include: 1. A direct observation of staining reagents used for Hematoxylin and Eosin (H&E) slide staining, at 10:45 AM on 10/24/2022, revealed that the Eosin Y Stain Solution with lot #1811624 had expired on 4/30/2022. The Eosin Y Stain Solution was used to stain approximately 1000 patient slides from 5/1/2022 - 10/24 /2022 2. In an interview with the Office Manager at approximately 10:50 AM on 10/24 /2022, it was confirmed that the expired Eosin Y Stain Solution was used for patient testing from 5/1/2022 - 10/24/2022. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --

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 test records reviewed, test reports reviewed, specimen slide review and interview with the laboratory manager, the laboratory failed to include the specimen case number on the test report for Mohs frozen section test reports and failed to include the biopsy slide number on the formalin fixed paraffin embedded (FFPE) histopathology specimens report for 15 of 15 reports reviewed. The laboratory reported approximately 3370 histopathology test results per year. Findings include: 1. A. Test records reviewed for Mohs frozen section histopathology cases included the case numbers: J18-18, J18-64, J19-20, J19-103, and J19-104 on the Mohs surgical map and the slides from the frozen section included the case numbers on the slide as the unique identification of the specimens. Specimens J19-103 and J19- 104 were from the same patient. B. Test records for skin biopsies included the patient's name and slide number in the laboratory specimen log book. 2. Specimen slides reviewed included the patient's name and case number for frozen sections and the patient's name and slide number for the FFPE slides. 3. Test reports reviewed failed to include the case number in the surgical pathology reports for frozen section cases and failed to include the slide number on skin biopsy histopathology reports. 4. In an interview conducted on 01/22/2020 at approximately 4:40 P.M. staff confirmed the test reports 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 -- did not include the case number for frozen section or the slide number for shave or punch biopsy histopathology as positive identification of the specimen reported. -- 2 of 2 --

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 patient test reports review, laboratory test log review, patient slide review, and interview with staff, the laboratory failed to include the slide number used for making the reported diagnosis on the test report. Findings include: 1. Patient test reports for histopathology specimens reviewed form the laboratory electronic medical record failed to include the slide number for each specimen reported in the test report. 2. The laboratory log book review included the slide number for the specimen. The same patient was observed to have more than one specimen corresponding to more than one slide number taken on the same day for one patient. (Example: on 04/20 /2018 patient [Date of Birth] 09/17/1978 had 3 specimens biopsied form the suprapubic skin, the neck, and the scalp. The slide numbers 811, 810, and 809 were assigned. The slide numbers were not included in the test report for each of the biopsy locations. 3. In an interview with staff on 01/24/2018 at approximately 4:15 P.M. the laboratory manager confirmed the electronic test report failed to include the specimen slide number. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --