Summary:
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 review of laboratory test reports and interview with the facility personnel, the laboratory failed to indicate the name and address of where the testing was performed. Findings include: 1. Two out of two test reports reviewed (1ViCh-03/31 /2017) and (1SeBe-06/14/2017) failed to indicate the facility name and address of where the semen analysis testing was performed. 2. The only facility name and address on the test reports indicated Seattle Sperm Bank with a address listed in Seattle, WA. 3. The facility personnel acknowledged that the name and address of the testing location was not indicated on the test reports. 4. The total annual test volume under the specialty of Hematology is 2,653. 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 --