Department of Laboratory Medicine Policies and Procedures for
Research Studies involving YNHH Clinical Laboratories

Research to further medical knowledge, and thereby improve the prevention and treatment of disease, is an important part of Yale New Haven Hospital’s mission. In order to facilitate the interactions between the Clinical Laboratories and researchers who seek the Clinical Laboratories’ services, the policies and procedures governing research are listed in brief on this web page.

Types of research studies

The hospital laboratories may be asked to participate in research studies in several ways: 1) perform laboratory tests on patient samples, on animal samples, or on other materials, such as solutions or devices; 2) “spin and save” samples for research studies; 3) provide excess clinical samples (with or without patient identifiers) to researchers; or 4) provide test result data. Note: all human studies require HIC approval.

PLEASE NOTE: Research samples will not be accepted or spun, or research results released, until
(1) the T-account is in place, (2) documentation of HIC and HIPAA approvals have been provided, and (3) the study has been approved by Lab Medicine.

Allow 2 weeks for pricing only requests and 3-4 weeks for approval of research studies. Laboratory participation is not guaranteed, but will depend on both study requirements and laboratory resources. A Clinical Laboratory Manager may contact you to determine feasibility or work out the study logistics.

Procedures for initiating studies (also see checklist)

A. Billing instructions. Billing mechanisms must be in place BEFORE requesting laboratory services.

Set up a research T-account so your grant will be billed instead of the patient. Fill out the T-account Billing Request form and submit it to Christy Bishop (see instructions on the form).

B.  Human studies

To obtain clinical laboratory tests or services for human research studies, submit the Request for Human Subjects Research form. The T-account number, the HIC number and HIC approval letter must be provided.  

If excess clinical samples are requested, submit an additional form, the Excess Clinical Samples (HIPAA) form.  An HIC signature is required if the samples will have identifiers or codes of any kind.

For individual patient samples submitted for testing, obtain Blue T-account Requisitions from the Laboratory Medicine Research Coordinator.  Use to submit individual patient samples charged to a T-account. Enter the T-account number prominently at the top left.

For pre-aliquoted samples brought to the lab for batch testing, obtain a Special Study Protocol form instead of the Blue T-account Requisition. Contact the individual laboratory for details.

C. Non human studies:

To obtain clinical laboratory tests for non-human research studies, obtain a T-account as above and submit the Request for Non-Human Research form. Primate samples are not accepted.

D. Pricing only:  

To aid in preparation of budgets, a pricing estimate can be requested using the Request for Pricing Only form.  This estimate is based on handling and testing that is identical to a routine clinical sample.  Any deviation from the routine will incur additional charges.

Forms described in B or C above must be submitted and approved before sample submission and testing can begin.  Prices are valid for the current fiscal year only.

E. Phlebotomy only:

Obtain a T-account, PTAEO number, and HIC approval, and submit Request for Phlebotomy Only form to patricia.gelineau@ynhh.org.  Arrangements for specimen pickup and drawstation location must be made in advance. The phlebotomists will not centrifuge, deliver or mail specimens.

Billing will be done quarterly at a minimum. If the PTAEO changes, it is the responsibility of the researcher to notify patricia.gelineau@ynhh.org in advance of the change.

Phlebotomy service for research studies is not guaranteed, but will depend on both study requirements and laboratory resources.

PLEASE NOTE

Separate samples required
Separate samples must be submitted for research and for routine clinical testing. It is not possible to bill individual tests performed on one sample to different accounts (i.e. some tests to a T-account, and other tests to the patient’s insurance).

Blue T-account Requisition required for individual patient samples
Failure to use the blue requisition may result in the patient being billed instead of the T-account.

Research testing is confined to weekdays during the day shift
Please remember that the Clinical Laboratories’ first responsibility is patient care. Since staffing is limited on evenings and weekends, research testing can usually only be accommodated on weekdays during the day shift. Exceptions require pre-approval.

Changes in study requirements
If test or specimen requirements change during the course of your study, the individual clinical laboratory coordinator must be notified and must determine whether these changes can be accommodated. If work increases, the charge may also increase.

Storage of research samples
Storage space in the clinical laboratories is limited.
Research samples should be picked up within 24-48 hours.

HIPAA Tracking
Excess clinical samples taken for use in research need to be recorded by the researcher in a HIPAA Tracking book when two conditions are met: 1) the samples have identifiers; and 2) the patient has not given prior informed consent. The Clinical Laboratories are required to keep this information on file for 6 years.

CAP and CLIA Licenses
If needed, copies of the clinical laboratories CAP and CLIA licenses can be obtained by sending an email with fax information to the Research Coordinator.