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 facility personnel, the laboratory's test requisition failed to identify the specific tests performed by the laboratory. Findings include: 1. The laboratory performs patient testing in the sub- specialty of Toxicology, with an approximate annual test volume of 7,439. 2. The laboratory's test requisition presented for review during the survey conducted on June 19, 2018 included two test types, Screening Services and Confirmation. The laboratory only performs the Screening Services. The Screening Services portion of the test requisition included a screening panel that included the following analytes: AMP, BAR, BNZ, COC, ETH, MTD, OPI, OXY, SOMA, TCA and THC. 3. Review of patient test requisition and corresponding test report for patient #180612001 tested on 6/12/2018 indicated a screening panel was ordered, but the patient's test report only included test results for AMP, BAR, MTD, OPI and Fentanyl. The laboratory director 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 -- stated that at the time the sample was tested the laboratory was only performing testing for amphetamines, barbiturates, Fentanyl, methadone and opiates. 4. The facility personnel confirmed that the specific analytes tested by the laboratory were not selected on the test requisition for the patient testing indicated above. -- 2 of 2 --