Mission and Goals:
The mission of the Tissue Procurement and Processing Facility is to facilitate cancer and biomedical research by ensuring that the highest quality tissue samples are obtained to answer research questions while securing clinically diagnostic tissue and surgical margins.
The mission of the Tissue Procurement and Processing Facility (TPPF) is achieved by:
- Conferring with research teams about procurement and stabilization of tissue samples for their research.
- A pathologist or pathologists' assistant is available to assist the research team with the procurement and stabilization of research tissue and to retain tissue for clinical anatomic pathology diagnosis.
- Employing standard operating procedures in accordance with industry best practices.
- Investigating and implementing best-practice solutions for tissue stabilization, storage, and tracking.
Accreditation and Certification
The Laboratory of Pathology's clinical sections are accredited by the College of American Pathologists (CAP) and the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). LP is certified pursuant to the Clinical Laboratory Improvement Amendments (CLIA) by the Center for Medicare and Medicaid Services (CMS), and adheres to any federal, state or local laws that have jurisdiction on LP’s functions. LP adheres to statutes that govern the Department of Health and Human Services, the National Institutes of Health, and the Clinical Center. Documentation is available to anyone who requests the information.
Tissue Procurement & Processing Facility CAP accreditation certificate
The Tissue Procurement and Processing Facility (TPPF), supports both the clinical and research missions of the Laboratory of Pathology within the National Cancer Institute (NCI).
The TPPF supports the researchers of the National Institutes of Health (NIH) by collecting and distributing high-quality tissue samples through procurements and biobanking. Researchers must complete a Tissue Research Committee (TRC) form and have IRB approval or exemption to access tissue from procurements or tissue from the LP tissue banks. With proper approval, TPPF services are available to all members within the NIH.
Samples from the tissue bank are for research purposes only and may not be used for clinical diagnosis. Samples are de-identified during the collection process (except for tissue requested from autopsy cases). Clinical information relating to the patient, other than age, sex, race, and primary diagnosis, is not collected.
In support of the clinical team, a pathologist, pathology resident or pathologists' assistant is directly involved with procurements to ensure surgical margins are protected and to secure adequate diagnostic tissues.
Tissue Procurement
The TPPF staff will meet directly with the PI/research team to develop a custom protocol for tissue collection and processing.
A CRIS Research Tissue Procurement Request must be placed prior to the procurement. This form verifies enrollment in a specific protocol and serves as a record of transfer for the biospecimen. The specimen procured must be documented on this form, and the form must be signed by a TPPF staff member and a member of the research team before the biospecimen can be released from LP.
The Hot-Seat Resident or PA works with the research team to obtain samples.
Tissue will be procured under clean and/or sterile conditions.
Once the tissue is collected and passed to the research team, it is the researcher’s responsibility to freeze/stabilize the tissue per the method detailed in their individual protocol.
Tissues may be collected from a variety of anatomic sites.
Surgical tissues available for procurement include: normal, diseased/benign, malignant.
Biospecimen Banking
Normal Frozen Tissue Bank
The TPPF staff collects and stores normal (non tumor) tissues (not needed for diagnosis) for current and future research projects.
Specimens are collected under clean conditions
Samples are collected one of two ways: placed in a nunc tube and frozen in liquid nitrogen or placed in an OCT block and frozen.
The samples are stored in a -80 C freezer for long term storage.
When placed into the normal tissue bank, samples and data are de-identified.
Sample code numbers are used to maintain patient confidentiality. The data is logged into Lab Matrix and given a generic Lab Matrix code.
Documented information includes: tissue type, age, sex, race, primary diagnosis.
De-identified specimens are not traceable. The pathology report, including final diagnosis cannot be obtained.
Formalin Fixed Paraffin Embedded
Excess tumor and normal tissue (not needed for diagnosis) from surgical cases and autopsy are collected and placed into the Laboratory of Pathology's Formalin Fixed Paraffin Embedded (FFPE) Tissue Bank.
Samples are given a generic accession number XX- for surgical specimens and XA- for autopsy.
These samples have been in formalin fixative for at least 24 hours prior to processing.
Surgical samples are de-identified. Only the following information is documented: tissue type, age, sex, race, primary diagnosis, and time in formalin. The pathology report and final diagnosis cannot be obtained.
Autopsy samples do not have to be de-identified. Any information can be given to the researcher with proper documentation from IRB.
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).
- 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.
The TPPF is comprised of a dedicated team who are committed to fulfilling the mission of the department. To contact an individual member, click on the links below.
Chief, Laboratory of Pathology
Kenneth Aldape, MD
Deputy Chief, Laboratory of Pathology
Frederic Barr, MD, PhD
Medical Director, TPPF
David E. Kleiner, MD, PhD
Clinical Manager
Joseph Chinquee, DHSc, MBA, MT(ASCP)DLM
Informatics Consultant
Jason Levine, MD, PhD
Technical Laboratory Manager
John Sipes
Pathologists’ Assistant
Nicole Hufnagel
Pathologists’ Assistant
Sarah Young
Deputy Clinical Manager and Histology Supervisor
Vice
Archivist, Tissue Resource
Vice
To view the organizational structure of the TPPF, click on the following link:
Resources available for the research team:
- Rapid turn around time from procurement to stabilization
- 24 hour on-call pathologist for procurements
- Close proximity to the NIH clinical center's main operating room
- Liquid nitrogen, canisters (for snap freezing), specimen containers (Nunc tubes, sterile cups, and conical tubes)
- Sterile conditions (biological safety cabinet)
- -80 C freezer available for brief overnight storage
- Technical expertise
- The protection of human subjects standards
- Specimen processing and stabilization techniques
- Identification, labeling, tracking and transportation standards
Tissue Procurement and Biobanking Materials:
- Labguard Class II, Type 2A Biological Safety Cabinet
- Liquid nitrogen tank and small flasks
- -80 Thermo Fisher freezer model #992
- Cryomolds
- OCT
- Nunc tubes
- Surgical tools (scapels, forceps, rulers, gloves, etc)
- 70% alcohol
- CRIS research form
- Freeze bath (2-methylbutane)
- PC access (Lab Matrix/CRIS)
- 10% buffered formalin
- Tissue cassettes
Inventory
- Normal Frozen Tissue Bank
- Walter Reed Tissues
- Formalin Fixed Paraffin Embedded Normal and Tumor Tissue Bank
Forms
Tissue Resource Committee (TRC) - Tissue Request Form
Tissue Procurement Form - NIH 2803
New Protocol form
Related Sites and Info
- NIH website
- NCI website
- NCI Office of Biorepositories and Biospecimen Research
- International Society for biological and Environmental Repositories (ISBER)