The Tissue Issue: How to Effectively Navigate the Pathology Review Process and Tissue Request Forms

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The Tissue IssueHow to Effectively Navigate the
Pathology Review Process and Tissue Request Forms

• Rebecca Baergen, MD
• Department of Pathology and Laboratory Medicine

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Pathology Review

• What is it?
• Why is it necessary?
• When do I need it?
• How do I get it done?
• ..ASAP

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What is Pathology?

• Study of the nature underlying disease, the
  structural and morphologic changes in tissue and
  cells due to disease and the consequences of
  these changes.

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Pathology

• Gross and microscopic examination and evaluation
  of tissue for
• Diagnosis
• Staging
• Prognosis
• Therapeutic monitoring

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Pathology Review?

• What is it?
• Why is it necessary?
• When do I need it?
• How do I get it done?
• ..ASAP

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What is Pathology Review

• Review of the protocol and associated paperwork
  to evaluate tissue requirements to ensure
  feasibility while ensuring good patient care.

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Why is Pathology Review Necessary

• To ensure feasibility of a study
• Is there sufficient tissue in the stated
  procedure, organ, etc to do the study requested
• Can the studies requested be performed on the
  amount and type of tissue requested
• Is Pathology technical support required
• If so, are resources available (personnel and
  financial)

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Why is Pathology Review Necessary?

• To ensure good patient care.
• For Pathology that means ensuring that
  sufficient, intact, specimens are available to
  provide needed information on
• diagnosis,
• prognosis,
• staging,
• margins,
• therapeutic monitoring
• Other

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When is Pathology Review Necessary?

• Tissue from patients at NYPH-WMC is being used in
  the research study
• Sent to outside institution
• Storage
• Testing
• Pathology Review is NOT required
• When study involves only routine pathologic
  examination or review of Pathology Reports
• When study involves tissue from patients outside
  this institution
• When study is closed to patient accrual and no
  additional tissue will be requested

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Tissue Submission Policy

• As per JCHO, all human tissue removed during a
  diagnostic or therapeutic procedure must be
  submitted to Pathology, with two exceptions
• Tissues which are specifically designated as
  surgical waste by the institutions Medical Board
• Placentas from normal deliveries.
• Specimens must be sent intact to Pathology and
  may not be incised, opened, or damaged in any
  way. Tissue may not be removed from the specimen
  before receipt in Pathology

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Definition of Human Tissue

• Includes
• Placentas
• Umbilical cord and cord blood
• Bone marrow aspirates
• Cytology specimens
• Excludes
• Fluids such as blood, urine, CSF and amniotic
  fluid at the time of membrane rupture prior to or
  during labor
• Surgical waste as defined by the Medical Board

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Surgical Waste

• SPECIFICALLY defined by the medical board as
• Subcutaneous tissue removed to facilitate wound
  closure
• Tissues significantly altered or diluted by the
  procedure such as
• Lens phakoemulsifications
• Vitrectomy specimens
• Liposuction specimens

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• Any research study using tissue, as previously
  defined, that does not fit within the narrow
  definitions of surgical waste must be submitted
  for Pathology Review.

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What kind of tissue is available?

• Fresh tissue at the time of surgery
• Previously frozen, stored tissue
• Slides from formalin-fixed, paraffin-embedded
  tissue blocks
• Blocks may NOT be obtained
• NYS law requires Pathology to retain original
  diagnostic slides and tissue blocks for a minimum
  of 20 years for possible future diagnostic,
  prognostic studies or therapeutic monitoring
• Release is always at the discretion of Pathology

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Fresh Tissue

• All specimens are to be submitted to Pathology
  after removal
• After initial evaluation, fresh tissue may be
  removed from the specimen and released to the
  investigatorby Pathology
• Technical work may be done by Pathology or
  investigator
• Freezing
• Storage
• Embedding and cutting sections

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Slides

• Slides may be cut from formalin-fixed,
  paraffin-embedded tissue block
• Routine stain (HE)
• Special stains (trichrome, PAS, etc)
• Immunohistochemical stains
• Unstained

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Tissue Blocks

• Diagnostic tissue blocks can not be released from
  Pathology
• If study requires tissue blocks there are several
  possible solutions
• Often unstained slides may be used in lieu of
  blocks, please inquire
• If sufficient fresh tissue is available, tissue
  blocks may be prepared by investigator or outside
  lab etc
• If patients can be identified prior to surgery,
  and sufficient tissue is available, an additional
  prospective tissue block may be prepared
• Must be in collaboration with Pathology and a
  specific Pathologist
• Blocks will be separate and in addition to those
  submitted for diagnostic purposes
• If appropriate, cores from the block may be sent
  for purposes of creating a tissue microarray

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• The amount of tissue released is ALWAYS at the
  discretion of Pathology. Therefore, in individual
  cases, the amount of tissue requested may not be
  available.

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How do I get it done?

• For ALL research studies using human tissue the
  following must be submitted for Pathology Review
• Completed Pathology Research Form/Tissue Section
• Contact information
• Submit to Pathology Administrative Office C-302,
  Box 69

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New Protocols

• Completed protocol application
• including tissue section
• Copy of the informed consent
• if applicable
• Contact information

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Continuing Reviews

• Copy of the original protocol application or most
  recent revision
• Consent form
• if applicable
• Continuing review form
• Completed Pathology Research Form/Human Tissue
  Section
• Contact information

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Other

• Studies that do not fulfill criteria for human
  subjects research but that use human tissue
• Documentation that study fits criteria for non
  human subjects research
• Completed Pathology Research Form/Human Tissue
  Section
• Contact information

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Procedure

• Submit paperwork to Pathology Admin Office
• Paperwork is reviewed
• Revisions may be requested
• Approval of Tissue Section/Form
• Signature of chairman of Pathology and Laboratory
  Medicine, Dr. Knowles
• Return of paperwork to investigator
• Submission of paperwork to IRB (if applicable)
• After by the IRB, a copy of the approval letter
  and the tissue section must be submitted to the
  Pathology Administrative Office at C-302, Box 69
  before any tissue is released
• Pathology Review usually takes at least 3 days
  but may take up to a week or longer

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Paperwork

• Is human tissue being used?
• Will only diagnostic tissue be used or will extra
  tissue be taken for research?
• Brief summary
• Exceptions to tissue submission policy
• Tissue request form

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Brief Summary

• What tissue is being requested?
• Organ/site lung, breast, prostate, etc
• Procedure endoscopic biopsy, resection, etc
• Amount of tissue requested
• Potential diagnoses if possible
• What type of tissue is being requested?
• Fresh, frozen, slides from paraffin embedded, etc
• What will be done with the tissue?
• Testing done immunohistochemistry, PCR etc
• Will testing be done by NYPH-WMC Pathology, by
  the investigator or by an outside lab
• Please indicate specific tests, antibodies etc.
• Storage tissue bank, etc
• Tissue/slides sent out to central lab or other
  outside institution
• For banking purposes, testing etc?

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Exceptions to Tissue Submission Policy

• Examples
• Tissue taken solely for research purposes
• Patient must give consent
• Additional tissue (beyond what is taken for
  diagnosis) is taken for research purposes
• Patient must give consent
• Tissue that fulfills the criteria for human
  tissue but that does not initially go to
  Pathology
• Bone marrow aspirates (but not bone marrow
  biopsies)
• Umbilical cords, umbilical cord blood
• Tissue that might be considered surgical waste
  but that does not meet criteria for surgical
  waste as defined previously
• Case by case basis

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Paperwork for Exceptions

• Must request exception in Tissue Section
• Must explain justification for exception
• Must obtain additional signature of chairman of
  Pathology

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Technical and Professional Work

• Technical work may be done by Pathology
• Includes freezing, stoage, processing, cutting,
  staining, etc
• Additional form required for billing purposes
  available at the Pathology web site.
• Professional work may be done by Pathology
• Interpretation of slides, selection of blocks etc
• Either requires a Pathologist as co-investigator
  or a fee for professional work

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Specific Issues
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Fetal Tissue

• If fetal tissue is requested, as per Department
  of Pathology and Laboratory Medicine Policy,
  additional paperwork is required
• If gestational age is 12 weeks or greater, tissue
  can only be released is permission has been
  obtained for an autopsy (Form 41160)
• Form is usually submitted with the Surgical
  Pathology Requisition at the time of surgery

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Small Biopsies

• Endoscopic biopsies from the GI tract,
  transbronchial biopsies, needle biopsies and many
  other types of small biopsies from various sites,
  the specimens are small and the entire specimen
  is submitted for diagnostic purposes
• There is NO left over or additional tissue
• If these types of biopsies are required the
  investigator MUST obtain biopsies in ADDITION to
  those taken for diagnostic purposes
• Specific consent must be obtained from the
  patient to obtain these additional biopsies
• An exception to the tissue submission policy must
  also be requested

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To Conclude.

• Pathology review is required to ensure good
  patient care and to facilitate procurement of
  tissue by researchers
• Pathology review requires complete information on
  the study
• Whether tissue is released and the amount of
  tissue released is always at the discretion of
  Pathology to ensure patient care and to comply
  with state regulations