Reflex, Confirmatory and Add-on Testing

1. Reflex, Confirmatory and Add-on Testing September 20,

2. Reflex or Confirmatory Testing Definition: Additional laboratory testing included in the original test request by reference to specific follow-up testing, e.g. “Urinalysis w/Culture Reflex” as opposed to “Urinalysis” ordered as a standalone test.  The decision to perform the reflex or confirmatory test is based upon the results of the initial test and application of a predetermined local or national practice guideline, approved protocol or legal requirement. • Example: A Urinalysis with elevated WBCs signals the potential for bacterial infection and a confirmatory Urine Culture is ordered on the same specimen as a reflex test.  Depending on the laboratory standard operating procedure, LIS and nature of the reflexed or confirmatory test one or more of the following may be generated: a new accession number, new test codes and additional charges.. • Compliance: The initial test request received in the laboratory is adequate to demonstrate an order for both the initial and the additional testing for CLIA compliance and CMS auditing purposes. • EHR/LIS Implications: The EHR must be capable of receiving the additional test result or test report transmission from the laboratory (as a new OBR/OBX, additional OBX on an existing OBR or new accession) and associate it with the original test request for the specimen.

3. Add-on Testing Definition: Additional laboratory testing is requested by an authorized provider (as defined by CLIA and state law) on an existing specimen after the original test request has been submitted to the laboratory.  The decision to request additional testing is individual provider driven and based on any number of factors not limited to a test result. • Example: A physician orders a Complete Blood Count and Basic Metabolic Panel on an outpatient who presented in the office with symptoms of fatigue and a low-grade fever following a camping trip to Wisconsin.  After consultation with an infectious disease physician later in the day, he calls the laboratory and requests the addition of a Lyme’s Disease Antibody test to the specimens already in the laboratory. • Compliance:CLIA requires the laboratory to obtain a written or electronic test request for the add-on testing from the authorized provider for its records. If the test request is verbal the laboratory must document its efforts to receive a written or electronic test request within 30 days. [42CFR493.1241(b)] • EHR/LIS Implications: The EHR must be capable of receiving the additional test result or test report transmission from the laboratory (as a new OBR/OBX or new accession) and associate it with the original test request for the specimen.  To address compliance, it is also desirable that the LIS receive an electronic order for the add-on testing from an authorized provider, however, the test request may be provided and retained by other means (paper, fax, etc.).

4. Reflex/Confirmatory testing recommendations • Reflex or Confirmatory testing may be represented in the result transaction as 1) one or more additional OBXs as part of an existing OBR or 2) one or more additional OBR/OBX(s) 3) a new accession. • In the event method two or three is used (one or more additional OBR/OBX(s), or a new accession), then the new OBR(s) must be referenced to the original OBR (using the parent-child relationship via the unique identifier in OBR-2 or using OBR-2/OBR-4 if OBR-2 is not unique ) with the same date specimen was collected or obtained. (OBR-7 in new OBR must be the same as the referenced original OBR-7)