Policies for Research Testing

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 HIC ONCORE and other tests to the patient’s insurance).

Blue Requisition required for individual patient samples

Failure to use the blue requisition may result in the patient being billed instead of the HIC ONCORE.

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.

Important

Research samples will not be accepted or spun, or research results released, until:

  • The HIC ONCORE is in place
  • Documentation of HIC and HIPAA approvals have been provided
  • The study has been approved by Lab Medicine