Pathology Clinical Research Testing

Testing services provided by the former Pathology Clinical Laboratory Research Core changed effective January 16, 2015. Please refer to the Tests and Prices list for more information.

Overview

Mass General Pathology Service Support for Research Testing 

MGH Pathology Service Policy Concerning testing of research specimens in the Clinical Pathology Core laboratories [Gray 5].

This memo is generated in relationship to the closure of the CLR in January 2015 and is meant to provide some guidance during the transition period. The MGH Pathology Service supports research testing in the context of our patient care services and in compliance with Medicare and Research billing regulations. The follow guidelines apply to research testing conducted by the Clinical Pathology Core laboratories [Gray 5]. These guidelines have been designed to ensure the safety of human subjects, not interfere with patient care testing and to be fully compliant with all CLIA and billing regulatory requirements.

General Principles:

  1. Only testing related to safety and/or relevant to subject well being [e.g., tests validated and approved for clinical use] is supported.
  2. Only testing performed in-house is supported. Specimens that must be sent out to outside reference laboratories will not be accepted. 
  3. Only human specimens are accepted for testing. The laboratory does not support testing of animal specimens. Please contact the Center for Comparative Medicine Veterinary Clinical Pathology Laboratory for animal testing services.

Specific requirements:

  1. Specimens must be submitted using purple research laboratory requisitions that require subject identifiers [including MRN] and the research sundry fund or grant fund number to which billing will be billed. Note that billing will meet the definition of patient care testing and is not subject to indirect cost recovery from the fund charged [indirect cost recovery is in the research price which is billed]. The research price represents a discount based on the clinical price; this discount is calculated each year but typically represents about 15% of the clinical rate [discounted 85%].
  2. Research subjects must be registered in EPIC.
  3. Specimens submitted must comply with laboratory requirements with respect to specimen type, specimen container and processing.
  4. No batched specimen submissions are accepted. Investigators can request recommendations for external research laboratories that provide support for batch testing.
  5. No send out tests are supported. Investigators can request support from laboratory directors for setting up individual accounts with external reference laboratories that have centralized specimen pick up at MGH. 
    • No residual specimen can be returned and no “discard” specimens can be obtained directly from the laboratory. The labor will not be available to aliquot tubes for storage or banking. Discarded specimens can be obtained from the Crimson program and consented research specimens can be obtained from the Partners Biobank

Frequently Asked Questions - Research Support by MGH Clinical Pathology Core Laboratories

1.       What tests will be supported in MGH Clinical Pathology Core Labs.?

  • Only safety tests
  • No batch submissions
  • No send out tests [ie only tests performed in-house]
  • Only specimens that comply with acceptable specimen types – see lab handbook
  • No animal specimens

2.       Where do I find out what tests are supported?

3.       Where can I find out the prices of supported tests?

4.       Where can I get testing done for tests that are not supported?

  • There are several options for tests that are not supported by the MGH Clinical Pathology Core Labs. The following are some examples of available options:

5.       How do I submit specimens for testing?

  • Research requisition which lists supported tests – check boxes
  • Requires ordering physician code
  • Requires MRN of subject
  • Subject must be registered in EPIC

6.       How do I get results?

  • MGH Results go to CAS [only safety tests are supported]
  • MGH Critical values are called to the ordering physician and escalated to Pathology Resident if necessary
  • Results from reference labs depend on how the investigator sets up the account
  • Results from LabCorp for Catalyst investigators are web-accessible

7.       What is the process for billing and payment?

  • Tests are automatically charged to the research fund number provided by the investigator on the research requisition
  • Tests hit the sundry fund at full clinical cost the same month in which specimens are received
  • Research discounting appears as a credit on the following month’s fund statement

8.       Who do I contact to resolve issues?

a.       For billing issues – David Rasmussen drasmussen@partners.org

9.       Can the unused specimen volume be returned?

  • No

10.    Can the laboratory prepare aliquots for return to the investigator of to be shipped out to other laboratories for testing?

  • No

11.    Can I get discarded clinical specimens from the laboratory?

12.    Can I submit animal specimens?

 

Services

Please open this PDF file for a list of cinical research tests that are supported by the Clinical Pathology Core laboratories on Gray 5. The Mass General Pathology Service now supports research testing only in the context of patient care services.

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