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 billing mechanism is in place, (2) documentation of HIC and HIPAA approvals have been provided, and (3) the study has been approved by Lab Medicine.

Procedures for initiating studies

A. Obtain Checklist

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

1. 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).
2. Once t-account number and HIC approval have been obtained, submit study details and request research pricing on page 2 of the Request for Laboratory Services or Specimens form.
   Note:  Research pricing is not available for send-out tests.
   
3. Obtain Blue T-account Requisitions from the Laboratory Medicine Research Coordinator.  Use to submit individual patient samples for testing that will be charged to a T-account. Enter the T-account number prominently at the top left.
4. Use a Special Study Protocol form with T-account at the top instead of the Blue T-account Requisition for pre-aliquoted samples (human or non-human) brought to the lab for batch testing. Contact the individual laboratory for details.

C. Forms: It is important to begin early. To initiate a study:

1. Download the Request for Laboratory Services or Specimens form for all studies. Fill out and submit to the Laboratory Medicine departmental research coordinator by fax or email (see instructions on the form). Include a copy of your HIC approval letter for human studies.
2. Download the Use of Excess Clinical Samples for Research (HIPAA) form to obtain excess clinical specimens and submit to HIC. Provide a copy of this form, signed by HIC, to Laboratory Medicine.  Studies cannot begin until this form is received, since HIPAA Tracking may be required (see below).
3. Meet with the individual clinical laboratory coordinator to discuss the logistics of your study. The laboratory will contact you after you have submitted the forms above.
   Note: Laboratory participation 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.