Department of Pathology
  Brigham and Women's Hospital
  A teaching Affliate of Harvard Medical School
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Department of Pathology Reference Testing Policy
Ordering sendout tests through BWH Department of Pathology

Introduction

A reference laboratory formulary has been established for all reference laboratory tests (“sendout tests”, “sendouts”) that can be ordered by BWH clinicians. The formulary has been set up by the Advanced Laboratory Diagnostics Review Committee in collaboration with experts in individual clinical areas. It includes the status of all tests that can be ordered through the BWH Laboratory, including the approved reference lab for sendout testing.

Sendout test requests fall into one of the four following categories, each to be handled in a different manner:

1. Unrestricted Unrestricted sendouts will be automatically sent to a predetermined CLIA certified reference lab upon specimen receipt in the BWH Clinical Laboratories Lab Control.
2. Restricted Restricted sendouts will be sent to a predetermined CLIA certified reference lab upon specimen receipt in the BWH Clinical Laboratories Lab Control provided specific prerequisites are met. All complex genetic and other expensive tests fall into this category.
3. Unauthorized Unauthorized sendouts were deemed not appropriate for BWH patients when reviewed by the Advanced Laboratory Diagnostics Review Committee and will not be sent to a reference lab. These include but are not limited to Research Use Only (RUO) and Investigational Use Only (IUO) tests. Physicians ordering these tests will be notified that the testing will not be performed. An alternative unrestricted or restricted test may be offered and the order will be modified accordingly if the ordering clinician agrees with the change. If there is no alternative approved test, the order will be canceled and the sample will be discarded.
4. Undefined Undefined sendouts will not be sent to a reference lab, except in the case of medical emergency or irreplaceable specimen, which must be indicated on the requisition. Undefined sendouts include tests that are not registered in BICS/LMR, have no assigned reference laboratory, sample requirements, and/or charge code and tests where the clinician is requesting an alternative lab other than the one for which the test is defined.

 

Physicians ordering non-emergency undefined sendouts will be asked to submit a written proposal justifying the importance of this test for BWH patient care. This proposal will be reviewed by the Advanced Laboratory Diagnostics Review Committee which will classify the test as unrestricted, restricted, or unauthorized.

 

Undefined sendouts will be classified as a medical emergency test request if the test is urgently needed for a medical care decision and/or the specimen is irreplaceable. This includes specimens collected from a procedure that cannot be repeated without jeopardizing the patient’s safety (i.e. a surgical specimen). Emergency tests will be handled as exceptions and, after a real-time discussion between the lab, the clinical service and the Committee members, will be sent out once, upon receipt in Lab Control. Any subsequent requests for the same test will require that the test has been added to the formulary with the full Committee review and approval process.

 

An updated list of  Unrestricted and Restricted sendout tests can be found at http://bwhpathology.partners.org/labmanual.aspx, which includes (1) the test name used by the reference laboratory, (2) the approved reference laboratory, (3) specimen/fluid type, (4) test category as described above, (5) the type of restriction if the test falls into the Restricted category and (6) additional information, such as whether or not the reference laboratory is billing BWH or directly billing the patient.

 

Procedure

 

Physicians who wish to request a sendout test should follow this procedure:

 

1.      Consult the online catalog of defined sendout tests and predetermined reference laboratories at http://bwhpathology.partners.org/labmanual.aspx,

 

2.      If the test is Unrestricted, then the sample may be submitted as any other in-house lab test.

 

3.         If the test is Restricted, it will be listed as such under the test name at http://bwhpathology.partners.org/labmanual.aspx. If the restriction includes an approval by a member of the Advanced Laboratory Diagnostic Review Committee, contact the clinician specified on the website.

 

a.          If the testing is approved submit the sample and indicate on the requisition that pre-approval has been received.

 

b.         If the testing is not approved, do not collect a sample and do not request the test.

 

4.      If the test is Unauthorized, do not collect a sample and do not request the test.

 

5.      If the test is not listed, then it falls into the Undefined category.  Do not collect a sample unless it is a medical emergency, in which case the appropriate Medical Director should be notified prior to specimen collection and submission and the emergent nature of the test request should be indicated on the requisition.

 

6.      If you plan to order such test in the future, complete and submit the “ New Test Request Form” to the Reference Testing Coordinator.  You will be contacted by a member of the Advanced Laboratory Diagnostics Review Committee who will work with you to better understand the need for this test, and present the data to the Committee for review. You will be notified about the Committee’s decision in a timely manner.

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