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DR.AMANI MUTHAKANI
THE POST-ANALYTICAL PHASE OF
HISTOPATHOLOGY PRACTICE
INTRODUCTION:
 Storage And Retention
 Ownership of Tissue Material
 Role Of The Institution Review Board
 Informed Consent In Research
 Need For Law
Storage And Retention
 Two Things:Space,Proper conditions of storage
 Space-
• In general –A period of 10-20yrs is considered as lower limit guideline for storage and retention.
• In INDIA-They preserve specimen,blocks,slides for 10yrs & 25yrs in cancer referral center.
• College of American pathologists & joint commission on Accreditation of Health Care
Organization(USA)
a)10yrs-paraffin blocks,wet tissues,histologyslides,cytology smears
b) 7days-peripheral smear
• Royal college of pathologists(UK)
a)Permanently-Paraffin blocks
b)10yrs-Histology slides,smears
c)4wks-wet tissues
 Proper conditions of storage
I. Museum specimens & left over gross specimens are stored in 10% neutral buffered
formalin.
ratio-1:20
This buffered formalin maintains the solution at neutral/slightly alkaline Ph
WHEN TO REPLACE FOMALIN:
a)When Ph turns acidic(LITMUS PAPER TEST)
b)When paraformaldehyde precipitation is observed at bottom of the
container
c)When solution shows discolouration
II.Paraffin blocks & slides should be stored below 27°C (or) at room temperature
in humidity free conditions with adequate pest control.
III.Stained slides should be kept away from direct light to preserve the intensity
& quality of stains for a longer duration.
IV.Unstained slides should be kept in absolutely dry conditions to prevent
hydrolysis & adequate preservation of protiens.
V. Storage under refrigeration at 4°C has also been suggested as it was shown to
produce improved quality of staining,However it is neither proven nor in
practice.
Ownership/custodianship Of Tissue
Material
 Ownership rights-patient,surgeon,pathologist,institution.
 The patient may ask for tissue material to transferred to other pathology
laboratories for additional testing or consultation.
 The pathologist may need the tissue material for rechecking the diagnosis and
for further research purpose.
 The parent care providing institution may claim its rights over tissue material
particularly in the event of conflict.
 There is no established law to issue of ownership/custodianship of tissue
material.
 It is yet to be determined the ultimate authority and control over the fate of
excised tissue or biospecimens.
 Ownership-Includes the property rights,where the owner usually
possesses the right to use,sell,transfer,exchange or destroy his
property & to prohibit others from doing so.
 Custodianship-Involves charge and control of property within specified
legal guidelines.In general practice, it comes upon Pathology
departments under the ultimate binding of the parent institution.
Role of Institution Review board(IRB)
 Decision making regarding use of human tissue specimens is usually the
responsibility of IRB.
 IRB also known as institutional Ethics committee who are designated by Indian
Council for Research in India.
 It categorizes the research praposals according to the risk involved in the
research
1)Exemption from review
2)Expedited review
3)Full review
Informed consent in Research
 It is important to obtain an informed conset.
 Experts are now attempting to formulate an acceptable for consent.
 ONE TIME CONSENT-It covers all prospects of future research.
Also known as BLANKET CONSENT.
 RECONSENT-Consent has to be taken for every subsequent use of clinical
material.
 TIERED CONSENT-Which provides participants with a list of choices to which
they may decide to consent for.
Need For Law

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THE POST-ANALYTICAL PHASE OF HISTOPATHOLOGY PRACTICE.pptx

  • 1. DR.AMANI MUTHAKANI THE POST-ANALYTICAL PHASE OF HISTOPATHOLOGY PRACTICE
  • 2. INTRODUCTION:  Storage And Retention  Ownership of Tissue Material  Role Of The Institution Review Board  Informed Consent In Research  Need For Law
  • 3. Storage And Retention  Two Things:Space,Proper conditions of storage  Space- • In general –A period of 10-20yrs is considered as lower limit guideline for storage and retention. • In INDIA-They preserve specimen,blocks,slides for 10yrs & 25yrs in cancer referral center. • College of American pathologists & joint commission on Accreditation of Health Care Organization(USA) a)10yrs-paraffin blocks,wet tissues,histologyslides,cytology smears b) 7days-peripheral smear • Royal college of pathologists(UK) a)Permanently-Paraffin blocks b)10yrs-Histology slides,smears c)4wks-wet tissues
  • 4.  Proper conditions of storage I. Museum specimens & left over gross specimens are stored in 10% neutral buffered formalin. ratio-1:20 This buffered formalin maintains the solution at neutral/slightly alkaline Ph WHEN TO REPLACE FOMALIN: a)When Ph turns acidic(LITMUS PAPER TEST) b)When paraformaldehyde precipitation is observed at bottom of the container c)When solution shows discolouration
  • 5. II.Paraffin blocks & slides should be stored below 27°C (or) at room temperature in humidity free conditions with adequate pest control. III.Stained slides should be kept away from direct light to preserve the intensity & quality of stains for a longer duration. IV.Unstained slides should be kept in absolutely dry conditions to prevent hydrolysis & adequate preservation of protiens. V. Storage under refrigeration at 4°C has also been suggested as it was shown to produce improved quality of staining,However it is neither proven nor in practice.
  • 6. Ownership/custodianship Of Tissue Material  Ownership rights-patient,surgeon,pathologist,institution.  The patient may ask for tissue material to transferred to other pathology laboratories for additional testing or consultation.  The pathologist may need the tissue material for rechecking the diagnosis and for further research purpose.  The parent care providing institution may claim its rights over tissue material particularly in the event of conflict.  There is no established law to issue of ownership/custodianship of tissue material.  It is yet to be determined the ultimate authority and control over the fate of excised tissue or biospecimens.
  • 7.  Ownership-Includes the property rights,where the owner usually possesses the right to use,sell,transfer,exchange or destroy his property & to prohibit others from doing so.  Custodianship-Involves charge and control of property within specified legal guidelines.In general practice, it comes upon Pathology departments under the ultimate binding of the parent institution.
  • 8. Role of Institution Review board(IRB)  Decision making regarding use of human tissue specimens is usually the responsibility of IRB.  IRB also known as institutional Ethics committee who are designated by Indian Council for Research in India.  It categorizes the research praposals according to the risk involved in the research 1)Exemption from review 2)Expedited review 3)Full review
  • 9. Informed consent in Research  It is important to obtain an informed conset.  Experts are now attempting to formulate an acceptable for consent.  ONE TIME CONSENT-It covers all prospects of future research. Also known as BLANKET CONSENT.  RECONSENT-Consent has to be taken for every subsequent use of clinical material.  TIERED CONSENT-Which provides participants with a list of choices to which they may decide to consent for.