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Research Procurement

When a patient has been scheduled for a surgical procedure or a biopsy during which specimens will be collected for research, the research team or designated clinical staff should initiate the "Request & Certification for Research Procurement of Human Biological Materials"(NIH 2803-1) form and obtain the signature of the principal investigator/assistant investigator (PI/AI). For in-patients, the form is placed in the in-patient chart. For out-patients, the form can be sent to the PACU on the day of and prior to the procedure taking place. We know there will be times when proactive planning will not work and a patient is taken to the procedure area without the required form NIH-2803-1. You can bring the completed form to the PACU or the Operating Room Front Desk and the staff will make sure it is delivered to the right hands. Research material will not be released unless the "Request & Certification for Research Procurement of Human Biological Materials" (Medical Records form NIH-2803-1) is complete and signed. Refer to Medical Administrative Series M01-2 for more details.

If the specimen is time-sensitive, the research team should call the resident before the procedure takes place to coordinate quick release. If a critical research specimen requires prompt transport to the lab, the pathologist can be notified prospectively to make appropriate arrangements.

Most specimens removed during a surgical procedure must be reviewed grossly by an NCI pathologist before being released for research to ensure that sufficient diagnostic material required for the clinical care of the patient has been submitted for clinical pathology evaluation. This includes any specimens that are divided in the Operating Room, but does not include the following exceptions:

Protocol-driven needle core biopsies or other small biopsies.
Samples transported to other CLIA-certified labs for division and test reporting of clinical results (e.g., bone marrow biopsies, muscle biopsies, ocular specimens, if they are sent to a CLIA-certified lab that issues a diagnostic report).
Samples which are transported to areas for division by LP Pathologists outside the operating room (e.g., TIL specimens, UOB nephrectomy and prostate specimens, lymph node biopsies divided by Hematopathology).

The operating room (OR) team will call the Hot Seat resident or pathologists' assistant (page 102-10332) to review the specimen in either the surgical suite or frozen section room. Shortly thereafter, the OR staff will notify the person designated on Form NIH 2803-1 when the specimen is procured and/or ready for release and give the location for pick-up.

If the Hot Seat resident is not available, the intra-operative consult resident (page: 102-10375) will serve as a back-up in emergency situations and the on-call resident will assist after-hours and on holidays (NIH pager operator: 496-1211).

The OR should also tell the pathologist and research team the OR suite number and phone number from which it can be obtained, if necessary.
If the research team arrives before the pathologist, please be patient and do not take the specimen until the pathologist reviews and releases it.
In some cases, the pathologist will review the specimen in the OR, but most research specimens will exit the operating room suite via the Frozen Section Laboratory (Room 10/2C533) and be reviewed in this location.
SOP for OR Procurements

Exempt samples most likely will not be passed through the Frozen Section Lab, since the lab is locked when not in use.
While the OR is staffed until 11:00 PM Monday thru Friday, the doors do lock after 6:00 PM. If you are picking up a specimen after 6:00 PM, please use the phone located outside the PACU to call the Main OR number (301-496-5646) to advise them of your arrival.

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