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 patient test requisitions and interview with the technical supervisor, the laboratory's test requisition failed to include the address of the authorized person requesting the test. Findings include: 1. The laboratory performs patient testing under the sub-specialties of Routine Chemistry and Toxicology, with an approximate annual test volume of 592,800. The laboratory receives specimens from seven different locations. 2. The laboratory's test requisition presented for review during the survey conducted on December 10, 2019 failed to include the address of the authorized person requesting the test. 3. The technical supervisor confirmed that the test requisitions reviewed during the survey failed to include the address of the authorized person requesting the test. 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 --