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Human Cells, Tissues and Organs for Transplantation - Error or Accident Investigation Preliminary Report Form (FRM-0172)
Introduction
The Cells, Tissues and Organs (CTO) Regulations require that suspected errors or accidents (E/A) identified after distribution of CTO and that could lead to a serious adverse reaction involving the transmission of an infectious disease or disease agent, must be reported to Health Canada within 24 hours after the start of the investigation. Establishments are given the option to report errors or accidents as defined above, by using Health Canada's form FRM-0172.
Supersedes: March 4, 2011
Date issued: November 6, 2012
Date of implementation: November 6, 2012
Disclaimer
This document does not constitute part of the Food and Drugs Act (Act) or it’s associated Regulations and in the event of any inconsistency or conflict between that Act or Regulations and this document, the Act or the Regulations take precedence. This document is an administrative document that is intended to facilitate compliance by the regulated party with the Act, the Regulations and the applicable administrative policies.
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(PDF Version - 54 K)FRM-0172 Version Oct. 2012
A) Information Related to the Source Establishment Reporting to Health Canada
A.1 Name of the Source Establishment:
A.2 Name/Title of the person reporting:
A.3 Establishment Registration Number:
A.4 Address of Source Establishment (street, city, province/state, postal code):
A.5 Phone Number:
A.6 Fax Number:
A.7 Contact Person:
A.8 Email address:
A.9. Actual Date of E/A Occurrence (yyyy/mm/dd):
A.10 Date E/A reported to Source Establishment (yyyy/mm/dd) :
A.11 Date E/A Awareness Date (yyyy/mm/dd):
A.12 Date Investigation initiated by Source Establishment (yyyy/mm/dd):
A.13 All implicated CTO, in Source Establishment's possession, have been quarantined:
- Yes
- No
If No, please explain:
A.14 Required notifications have been issued to all other implicated establishments:
- Yes - Please complete Part D.4
- No
If No, please explain:
A.15 Date of Preliminary Report (yyyy/mm/dd):
A.16 Signature/Title of Person Submitting the Report:
B) Information Related to the Establishment that Originally Reported the Errors or Accidents to the Source Establishment (if applicable)
B.1 Name of reporting Establishment:
- Not applicable, suspected E/A discovered by source establishment
B.2 Type of establishment who reported the E/A to the Source Establishment:
- Importer
- Another Source Establishment
- Distributor
- Transplant Establishment
- Other (explain)
B.3 Address of reporting Establishment (street, city, province/state, postal code):
B.4 Name/Title of the person who reported the E/A to Source Establishment:
B.5 Phone Number:
B.6 Fax Number:
B.7 Contact Person:
B.8 Email address:
B.9 Date of E/A Occurrence (yyyy/mm/dd):
B.10 E/A Awareness Date (yyyy/mm/dd):
C) Information Related to Cells, Tissues and Organs
C.1 Description of implicated CTO:
C.2 Description of other CTO recovered from same donor(s):
C.3 CTO Donor Identification Code(s):
C.4 Product number, product barcode, if applicable:
C.5 Lot number(s), if applicable:
C.6 Expiry Date(s) of implicated cells, tissues and organs (yyyy/mm/dd):
C.7 Was the product labelled as sterile?
- Yes
- No
C.8 A copy of the original report is attached?
- Yes
- No
If No, please explain:
D) Investigation Description
D.1 Detailed description of the investigation:
D.2 Name(s) of any suspected transmissible disease(s) or disease agents(s):
D.3 Corrective actions taken to date:
D.4 List other establishments involved and date they were notified:
D.5 Additional Information:
Note: An update describing any new information is required to be submitted within 15 days after the start of the investigation and every 15 days after, until the final report is submitted. A final report describing the results of the investigation, final disposition of implicated CTO, reason for disposition, and any corrective actions taken, must be submitted upon completion of the investigation
| Location of Source Establishment | Submit Report to: |
|---|---|
Canadian provinces: Newfoundland, New Brunswick, Nova Scotia, Prince Edward Island United States: Connecticut, Delaware, Maine, Maryland, Massachusetts, New Hampshire, New Jersey, Rhode Island, Vermont Middle East: Bahrain, Cyprus, Iran, Israel, Jordan, Kuwait, Lebanon, Oman, Qatar, Saudi Arabia, Syria, Turkey, United Arab Emirates, West Bank and Gaza Strip, Yemen |
Inspectorate Program, Atlantic Region |
Canadian provinces: Quebec United States: District of Columbia, Florida, Georgia, New York, North Carolina, Pennsylvania, South Carolina, West Virginia All islands in the Caribbean Central America: Belize, Costa Rica, Panama, El Salvador, Guatemala, Honduras, Nicaragua, Panama Scandinavia & Baltic States: Denmark, Estonia, Finland, Latvia, Lithuania, Norway, Sweden Central Europe: Austria, Belgium, France, Germany, Liechtenstein, Luxembourg, Netherlands, Switzerland |
Inspectorate Program, Quebec Region |
Canadian provinces: Ontario, Nunavut Territory United States: Alabama, Illinois, Indiana, Kentucky, Michigan, Mississippi, Ohio, Tennessee, Wisconsin Northern Europe: Iceland, Ireland, United Kingdom (England, Scotland, Wales, Northern Ireland) Eastern Europe: Albania, Bosnia and Herzegovina, Bulgaria, Croatia, Czech Republic, Hungary, Poland, Romania, Serbia, Slovak Republic, Slovenia Southern Europe: Greece, Holy See, Italy, Malta, Monaco, Portugal, San Marino, Spain All countries in South America |
Inspectorate Program, Ontario Region |
Canadian provinces: Manitoba, Saskatchewan United States: Arkansas, Iowa, Kansas, Louisiana, Minnesota, Missouri, Nebraska, North Dakota, Oklahoma, South Dakota, Texas All countries in Africa Mexico |
Inspectorate Program, Manitoba and Saskatchewan Region |
Canadian provinces: Alberta, British Columbia, Northwest Territories, Yukon Territory United States: Alaska, Arizona, California, Colorado, Hawaii, Idaho, Montana, Nevada, New Mexico, Oregon, Utah, Washington, Wyoming Australia New Zealand All islands in the South Pacific All countries in Asia |
Inspectorate Program, Alberta & British Columbia Region |
