Download Serious Adverse Reaction Report Form Human Tissues and Cells

Please send completed form to:
Health Care Services Standards Directorate
Biovigilance
SLH - OPD (Level 1), St. Luke’s Square,
G'Mangia, PTA 1010 – MALTA
Tel: +356 2595 3326 Fax: +356 2595 3327
Email: [email protected]
URL: www.healthstandards.gov.mt
SERIOUS ADVERSE REACTION REPORT FORM
HUMAN TISSUES AND CELLS
Rapid Notification for Serious Adverse Reactions
For office use only
Reference Number:
Tissue/Cell Establishment
Address
Report identification
(unique identification number given at
reporting site)
Reporting date (yyyy/mm/dd)
Date and place of procurement.
yyyy/mm/dd
Date and place of human application
yyyy/mm/dd
Individual affected
Unique donation Identification Number
Donor sex
Recipient sex
Donor age/DOB
Recipient age/DOB
Date of onset of suspected adverse
reaction
yyyy/mm/dd
Recipient
Donor
Male
Female
Type of tissues and cells involved in the reaction
Pericardium
Arterial vessels
Other Cardiovascular tissues including
heart valves and other tissues
Ocular tissues (including cornea and
scleras)
Bone
Tendons
Meniscus
Skin
Cornea
Sclera
Type of suspected
serious adverse
reaction
Ocular limbal stem cells
Amnion
Bone marrow
Peripheral blood stem cells
Cord blood
Donor lymphocyte infusions
Other stem cells
Stem cell lines
Other
Explanation
All data collected is processed in accordance with the Human Blood and Transplants Act 2006 (Act IV 2006) and the
Data Protection Act 2001. Data is required for administrative purposes in the interest of Public Health
1
(Brief description of
reaction including
treatment and outcome)
Infection - Donor
Infection – Tissue/cells
Hypersensitivity
Malignancy
Failure
Toxicity
Mismatch
Undue Risk
Genetic Abnormality
Other Transmission
Other
Clinical outcome (if
known)
Imputability level
NA
0
Unexpected* primary infections possibly transferred from the donor to
recipient (e.g. viral,
bacterial, parasitic, fungal, prion)
Transmitted infection (viral, bacterial, parasitic, fungal, prion) possibly
due to contamination
or cross-contamination by an infectious agent on the procured
tissues, cells or associated
materials from procurement to clinical application
Hypersensitivity reactions, including allergy, anaphylactoid reactions
or anaphylaxis
Malignant disease possibly transferred by the tissue/cells (whatever
the origin, donor or process)
Unexpectedly delayed or absent engraftment, graft failure (including
mechanical failure)
Toxic effects from tissues and cells or associated materials
Unexpected immunological reactions due to tissue/cell mismatch
Aborted procedure involving unnecessary exposure to risk e.g. wrong
tissue supplied, discovered after patient is anaesthetised and the
surgical procedure has begun.
Suspected transmission of genetic
Suspected transmission of other (non-infectious) illness
Other
Complete
Minor
Serious
Death
Unknown
recovery
sequelae
sequelae
Definition
Not assessable
Excluded
Unlikely
1
Possible
2
Likely, probable
3
Definite, certain
Explanation
When there is insufficient data for imputability
assessment.
When there is conclusive evidence beyond
reasonable doubt for attributing the adverse
reaction to alternative causes.
When the evidence is clearly in favour of
attributing the adverse reaction to causes other
than the quality/safety of tissues/cells.
When the evidence is indeterminate for
attributing adverse reaction either to the
quality/safety of tissues/cells or to alternative
causes.
When the evidence is clearly in favour of
attributing the adverse reaction to the
quality/safety of tissues/cells.
When there is conclusive evidence beyond
reasonable doubt for attributing the adverse
reaction to the quality/safety of tissues/cells.
Reporter’s Name
Title
Signature
Email address
Telephone number
Supply of report forms required
Yes
No
All data collected is processed in accordance with the Human Blood and Transplants Act 2006 (Act IV 2006) and the
Data Protection Act 2001. Data is required for administrative purposes in the interest of Public Health
2