Overview

The Pathology Service performs clinical tests to support research at the MGH. Testing can be performed on both animal and human specimens using patient or subject identifiers. This page is designed to help clinical research coordinators understand what is needed to have the Pathology laboratories perform testing on research samples. We also answer the most frequently asked questions here, such as how to get pricing, what to do if the patient's insurance is billed incorrectly, and how to acquire laboratory certification. If you have additional questions about setting up a study, you may contact our Customer Service Coordinator at 617-724-1140. For test results, you can use our 4-LABS hotline (617-724-LABS).

• What do I need to do to send a research sample for testing?
• Setting up a research study
• Tips for Completing the Research Requisition
• Research rates for commonly requested tests
• Frequently Asked Questions

What do I need to do to submit a research sample for testing? [Back to top]

1. The first thing you will need is a special billing number, which you received when your study was approved.
   
   
2. Submit a Research Services Request Form to our Customer Service Coordinator. (See "Setting Up a Research Study," below.)
   
   
3. To send in a sample for testing, you will need the new Research Requisition (Req #70280) and ziplock specimen transport bags (#83836), both available from Standard Register.

 

Setting Up an Animal or Human Research Study [Back to top]

If you are a researcher requesting laboratory tests for animal or human specimens, first collect the following information:

1. Subject type (animal or human)
2. Research ID numbers and/or subject naming
3. Research contact person (include contact's fax, phone, and email)
4. Principal Investigator
5. Report delivery location - building and room
6. The Special Billing number that you received from Research Administration
7. Approximate number of research subjects being tested for duration of study
8. Test(s) being ordered

Then fill out the below form completely and email it to our Customer Service Coordinator, who will then provide you with a set of ARES or HRES numbers that you can use on the research requisition.

• Pathology Research Services Request Form (Word document)

 

Tips for Completing the New Research Requisition [Back to top]

• New Requisitions - The new research requisition went into effect on January 29, 2005 with the intent of improving the accurate capture and subsequent billing of research-related testing for pathology and electrocardiograms. Failure to use the correct research requisition may result in delays in testing.

• Use your Special Billing Number - As part of PACE, each research project with IRB approval has a special billing number of seven digits that must be used to order research-related testing. You should have received your special billing number previously from Research Administration. The seven-digit number consists of "9" plus your six-digit Peoplesoft Fund number (it does not include the "1200" portion of your account number). Using the incorrect billing number may result in inaccurate billing to patients.
  
  
• Use Provider ID and full name
  
• Write legibly
  
• Include your phone number so we can contact you if we have questions
  
  
  

 

How much will the tests cost? [Back to top]

• Visit this page to get the research rates for commonly requested tests
• For other tests, please send us an email with the tests for which you need pricing.

 

Frequently Asked Questions [Back to top]

How do I find out what my special billing number is?
You should have received this number when your study was approved. If you do not have this number, you will need to contact Research Administration.

Are there limits on the number of samples that I can send?
If you are planning to send a large number of specimens, you will need to contact the director of the laboratory that performs the assay to schedule the testing so that it does not affect routine testing.

What can I do to obtain timely results?
The turnaround times for research specimens are the same as for clinical specimens. The best way to minimize delays is to follow our tips for completing reqs above.

Will the labs freeze/centrifuge specimens for me?
Unfortunately, no. Because of the volume of specimens that the Pathology labs process, they cannot process and freeze samples for research storage. The labs process only what will be tested.

How do I see the results?
The results are available via a paper report that is delivered to the mailing address (or addresses) associated with the provider ID that you put on the requisition. If you used the patient's name and medical record number, the results are also available in CAS. You can also call our 4-LABS hotline for test results.

What are the differences between CLIA, CAP, and JCAHO certificates?
The Clinical Laboratory Improvement Amendment (CLIA) of 1988 was implemented to improve quality and reduce errors. This amendment, which is administered by the Department of Health and Human Services, requires certification for any laboratory performing tests for diagnosis, prevention, treatment, and monitoring. Labs obtain this certification from CMS or from accreditation programs with deemed status (CAP, JCAHO). In the case of the MGH Pathology Laboratories, we use JCAHO, not CAP. Compliance with regulations is required to receive federal payments and payments from most other payors. We provide research staff with certificates of compliance with CLIA ("CLIA certificates"), and documentation of accreditation with JCAHO.

How do I obtain a copy of the lab's CAP certificate?
We are not accredited by the College of American Pathologists.

How do I obtain a copy of the lab's CLIA or JCAHO certificates?
Complete our Document Release Form and email it to Dom Misiano.

How do I obtain the laboratory's reference ranges?
The reference ranges for the Pathology laboratories are available online.

How do I obtain the lab director's CV?
Please contact the director who is listed on your CLIA certificate.

Can I use the CLIA certificate from a previous study for my new study?
The Pathology labs use many different CLIA certificates. Using the incorrect certificate can jeopardize your study and put the hospital at legal risk. If the new study requires different tests, please resubmit our document release form.

My patient or 3rd-party payor was incorrectly charged...what do I do?
Please contact Patricia Noonan (617-726-7983) in Patient Accounting Customer Service.

How do I request labs using subject and code numbers instead of names?
Complete and send in the form above, and we will provide you with appropriate ARES (animal research) or HRES (human research) code numbers.

 

For other questions about laboratory testing, please contact MGH 4Labs Customer Support at 617-724-1140. For additional information about clinical research, visit the MGH Clinical Research Handbook.