Naz Medical Center

Summary Statement of Deficiencies D0000 The recertification survey was performed on 06/17/2024. The laboratory was found in compliance with standard-level deficiencies cited. The findings were reviewed with the chemotherapy nurse at the conclusion of the survey. 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 a review of records and interview with the chemotherapy nurse, the laboratory failed to ensure patient test reports included a unique patient identifier for two of four test reports reviewed. Findings include: (1) On 06/17/2024 at 10:00 am, the chemotherapy nurse stated the laboratory performed microscopic interpretations of peripheral smears and bone marrow aspirations; (2) A review of the following patient reports identified that unique patient identifiers were not included: (a) Two patient bone marrow reports resulted on 01/3/2024 (3) The findings were reviewed with the chemotherapy nurse, who stated on 06/17/2024 at 10:00 am, the laboratory failed to ensure all patient test reports included a unique patient identifier. 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 D0000 The recertification survey was performed on 07/18/2022. The laboratory was found in compliance with a standard-level deficiency cited. The findings were reviewed with the laboratory director at the conclusion of the survey. 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 a review of records and interview with the laboratory director, the laboratory failed to ensure patient test reports included either the patient's name and identification number, or a unique patient identifier and identification number for five of five reports reviewed. Findings include: (1) A review of five patient test reports for bone marrow aspirations and biopsy slide interpretations revealed the reports did not include a second unique identifier (only the patient's first and last name were on the reports) for patient reports dated 08/19/2021, 09/08/2021, 02/10/2022, 04/19/2022, and 05/19/2022: (2) The reports were reviewed with the laboratory director who stated on 07/18/2022 at 02:20 pm, the reports did not include a second unique identifier. 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 D0000 The laboratory was found to be in compliance with standard-level deficiencies cited. The findings were reviewed with the laboratory director at the conclusion of the survey. D5311 SPECIMEN SUBMISSION, HANDLING, AND REFERRAL CFR(s): 493.1242(a) The laboratory must establish and follow written policies and procedures for each of the following, if applicable: (1) Patient preparation. (2) Specimen collection. (3) Specimen labeling, including patient name or unique patient identifier and, when appropriate, specimen source. (4) Specimen storage and preservation. (5) Conditions for specimen transportation. (6) Specimen processing. (7) Specimen acceptability and rejection. (8) Specimen referral. This STANDARD is not met as evidenced by: Based on a review of records, written policies and procedures, observation of slides, and interview with the laboratory director, the laboratory failed to follow its written procedure for labeling patient test slides to ensure positive identification. Findings include: (1) At the beginning of the survey, the laboratory director stated the laboratory performed microscopic interpretations of peripheral smears and bone marrow aspirates stained with Wright's stain; (2) The surveyor reviewed the laboratory's written procedure for labeling patient slides which stated, "Collect and label specimens with a permanent marker with patient's full name and date of birth"; (3) The surveyor then observed 26 peripheral slides from 6 patients which were stored in slide boxes, each labeled with the "succession number" assigned to patient specimens by the laboratory director. The surveyor identified inside the slide box labeled with the succession number for Patient #5, 1 unlabeled smear slide; (4) The laboratory director explained the slides were extra peripheral smears from Patient #5 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 -- which were stained with Wright stain, and stated they had not been labeled as required in the procedure. NOTE: D5311 was cited on the recertification survey performed on 7 /18/16. -- 2 of 2 --