Summary:
Summary Statement of Deficiencies D5305 TEST REQUEST CFR(s): 493.1241(c) The laboratory must ensure the test requisition solicits the following information: (1) The name and address or other suitable identifiers of the authorized person requesting the test and, if appropriate, the individual responsible for using the test results, or the name and address of the laboratory submitting the specimen, including, as applicable, a contact person to enable the reporting of imminently life threatening laboratory results or panic or alert values. (2) The patient's name or unique patient identifier. (3) The sex and age or date of birth of the patient. (4) The test(s) to be performed. (5) The source of the specimen, when appropriate. (6) The date and, if appropriate, time of specimen collection. (7) For Pap smears, the patient's last menstrual period, and indication of whether the patient had a previous abnormal report, treatment, or biopsy. (8) Any additional information relevant and necessary for a specific test to ensure accurate and timely testing and reporting of results, including interpretation, if applicable. This STANDARD is not met as evidenced by: Based on review of test requisitions and interviews with the Laboratory Director (LD) and histologist, the laboratory failed to include the address of the authorized person requesting Mohs surgery testing from 09/14/2021 to date of the survey. Findings include: 1. On the day of survey, 09/11/2023 at 02:58 pm, review of 3 of 3 patient test requisitions revealed that the test requisitions did not include the address of the authorized person requesting Mohs surgery testing from 09/14/2021 to 09/11/2023. 2. The LD and histologist confirmed the above findings on 09/11/2023 around 03:10 pm. D5805 TEST REPORT CFR(s): 493.1291(c) The test report must indicate the following: (c)(1) For positive patient identification, 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 -- 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 the review of patient test reports and interviews with the Laboratory Director (LD) and histologist, the laboratory failed to include the laboratory's address on patient test reports for Mohs micrographic surgery from 09/14/2021 to date of the survey. Findings include: 1. On the day of survey, 09/11/2023 at 02:58 pm, review of 3 of 3 patient Mohs test reports revealed that the final test reports did not include the laboratory's address from 09/14/2021 to 09/11/2023. 2. The LD and histologist confirmed the above findings on 09/11/2023 around 03:10 pm. -- 2 of 2 --