Summary:
Summary Statement of Deficiencies D0000 A CLIA validation survey was performed on May 30, 2018 . The following deficiency was found: 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 patient reports and an interview with the technical supervisor (TS), the laboratory failed to include all required components on the facility's result reports. Findings include: 1. Review of two (2) in-house test reports revealed the lab failed to include the disclaimer "This test was developed and its performance characteristics determined by Nexus Pain Center. It has not been cleared or approved by the U.S. Food and Drug Administration". 2. Interview with the TS (CMS 209 form) on 5/30/18 in the breakroom at approximately 2 PM, confirmed the reports did not contain the required disclaimer. 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 --