Pathology Clinical Research Testing
Clinical Research Testing
Kent Lewandrowski, MD
Clinical Research Testing – CID
Explore This Lab
Mass General Pathology Service Support for Research Testing
Mass General Pathology Service Policy Concerning testing of research specimens in the Clinical Pathology Core laboratories [Gray 5].
The Mass General 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.
- Only testing related to safety and/or relevant to subject well being [e.g., tests validated and approved for clinical use] is supported
- Only testing performed in-house is supported. Specimens that must be sent out to outside reference laboratories will not be accepted
- 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
If you are planning a research study and would like to submit the details for review, please use the following link:
- Research subjects must be registered in EPIC. HOVs that are created must be associated with the Epic study code. MRNs must be used as the subject identifiers in most cases.
- Specimens submitted must comply with laboratory requirements with respect to specimen type, specimen container and processing
- No batched specimen submissions are accepted. Investigators can request recommendations for external research laboratories that provide support for batch testing
- 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%]
- 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 Mass General
- 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 Mass General Brigham Biobank
Frequently Asked Questions
1. What tests will be supported in MGH Clinical Pathology Core Labs?
Only safety tests
No batch submissions
No send out tests [i.e. only tests performed in-house]
Only specimens that comply with acceptable specimen types – see lab handbook
No animal specimens
2. Where can I find out the prices of supported tests?
- For research pricing, please email firstname.lastname@example.org
Research finance - budget builder (http://mghresearch.partners.org/)
3. Where can I get testing done for tests that are not supported?
There are several options for tests that are not supported by the Mass General Clinical Pathology Core Labs. The following are some examples of available options:
The CRC can send specimens to Quest Diagnostics. CRC Website: https://tcrc.mgh.harvard.edu/tcrc_services/laboratory_services
Many of the high complexity tests can be performed by the BRAC laboratory at BWH. BRAC website: https://www.brighamandwomens.org/research/cores-and-resources/brigham-research-assay-core/brac-lab-overview
Large volume testing needs may be supported by the BWH clinical trials laboratory. Contact: Petr Jarolim email@example.com
Related support is also provided by a number of Mass General Brigham Core Facilities: https://www.massgeneral.org/research/researchers-laboratories/hospital-wide-programs
4. How do I submit specimens for testing?
Requires MRN of subject
- Requires ordering physician code
Subject must be registered in EPIC
- Requested tests must be linked in Epic by HOV.
5. How do I get results?
Mass General Results go to Epic [only safety tests are supported]
Mass General Critical values are called to the ordering physician and escalated to Pathology Resident if necessary
6. 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 are charged to 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
7. Who do I contact to resolve issues?
For billing issues, contact firstname.lastname@example.org
8. Can the unused specimen volume be returned?
9. Can the laboratory prepare aliquots for return to the investigator of to be shipped out to other laboratories for testing?
Not directly. Only through Mass General Brigham programs which requires IRB approval in all cases
Consented specimens: http://personalizedmedicine.partners.org/Biobank/Banked-Consented-Samples/Default.aspx
Non-consented specimens: http://crimson-core.partners.org/
11. Can I submit animal specimens?
No. Animal specimens can be tested by the Center of Comparative Medicine