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 the review of patient reports and interview with office personnel, the laboratory failed to disclose the name of the laboratory on the patient's report. Findings include: a. Five out of five randomly selected patient reports (spanning April 18, 2016 to March 18, 2018) reviewed lacked the disclosure of the name of the laboratory. b. On August 3, 2018 at 11:20 A.M., office personnel affirmed that the above patient reports did not contain the name of the laboratory performing 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 --