Irene Dines M.L.T.Manager of the Lookback Traceback program

Canadian Blood ServicesCentral Ontario Region

Toronto Site

AgendaOverview of CBS

The LB/TB program

External networking

Questions

Canadian Blood Services

Lookback Traceback

Who are we, what do we do??

Central Ontario Blood Centre67 College Street, Toronto

Mission Statement

Canadian Blood Services:

Operates Canada’s blood supply in a manner that gains the trust, commitment and confidence of all Canadians by providing a safe, secure, cost-effective, affordable and accessible supply of quality blood, blood products and their alternatives.

Lookback Traceback , contained within the MSRA ,assists with the provision of ‘safe’ blood.

Testing

Currently all blood donations are tested for the following:•ABO/Rh, antibody screening,•HBsAg, HTLV-I/II, Anti HCV, HCV –RNA, HIV-RNA, Anti HBcore Selected clinics-WNV-RNA, Anti-CMV

• Testing is both manual and automated• NOTE: CBS has 3 testing sites in

Canada..Halifax, Toronto, Calgary.

• All donations collected have the samples shipped to one of these locations for testing, results are sent electronically to the production / distribution sites

CBS Customer / Client Services

Ways to ensure the safety of the blood supply• General public awareness and ongoing, available education regarding blood donation

and transfusion• Health screening of donor, verbal, visual, questionnaire- donor must meet very strict

criteria• “State of the art testing”, current methods, continual QC of tests, mandatory training

and re-certification of staff performing tests• Post donation information system to retrieve products immediately upon receipt of

information making that donors product not suitable for transfusion• Internal and External Audits- we follow strict rules and guidelines set up Health

Canada and are audited to ensure we follow them• Lookback/Traceback program for donor/recipient follow up.

Lookback

A lookback is the process of identifying previous donations of a donor who currently is testing positive for a transmissible disease marker,including testing done at outside laboratories-ie PHL

Limitations

• Incomplete donor records( pre 1980 is scattered)• Hospital records limited• Not always able to identify the treating physician• Recipient is not able to be found- moved, died and therefore unable to be tested to

determine if indeed donor was infectious at the time of that donation.• Recipient might refuse to be tested

Traceback

• A traceback is the process of identifying the donors of products that have been transfused to a patient, who now is testing positive for a transmissible disease.

Limitations

Limiting factors in Traceback investigation are:• Incomplete records ( prior to 1980- scattered)• Unable to establish transfusion history of the recipient• Unable to locate the donor- moved, died etc• Donor Unwilling to be tested- fear factor

Compensation

• There is financial compensation available, for any recipient who has been infected with a transmissible disease if it is determined to have occurred as a result of the blood transfusion.

• Hep B, HIV compensation is handled through KPMG organization, or private legal case to CRC

• HCV compensation is handled through either OHCAP( provincial) or LNP(federal)• OHCAP= Ontario Hepatitis C Assistance Program= if transfusion happened prior to

1986 and post 1990• LNP=Litigation Notification Program= if transfusion happened between 1986-1990.• Pre 86 Post 90 Federal compensation program- as of September 2007 there has

been an agreement between this program and CBS to provide information regarding possible traceback information on a claimant. The information in our files is consolidated into a report sent back to the Fund Administrator.( indicating that a Pos donor was identified, or that all the donors are negative, or that the case is inconclusive- some donors unable to locate etc)

Limitations of the Compensation Programs

• Lengthy , time consuming process

• Recipient must attempt to obtain their own transfusion records from the Hospital records department

• Recipient must submit a test result to indicate positive status

• Other risk factors are considered before trace back is begun.

• (i.e. IV drug history, tattoos, Incarceration, )

External Networking

Canadian Liver Foundation

• Canadian Liver Foundation provides counseling and guidance in regards to questions from the general public or infected individual

• Contact Info: Canadian Liver Foundation

2235 Sheppard Ave East, Suite 1500

Toronto Ontario

416-491-3353

1-800-563-5483

www.liver.ca

email: clf@liver.ca

How PHL can help CBS

• HIV,HCV,HBV, are all reportable diseases. Any testing facility MUST report to PHL a confirmed positive transmissible disease test.

• When PHL rec’s notification of a ‘pos’ , they obtain information from the patient• The patient is also asked if they were ever a blood donor or have rec’d blood

transfusion in the past at any time. NOTE: The patient should also be asked if they perhaps had a previous surname at the time.

• If the patient responds, yes, or ‘possibly’,that they have been a donor or recipient of blood product then PHL notifies CBS, using a Report of Infectious Disease. This is forwarded to the local CBS site

• The information required must include WHERE transfusion took place- name of hospital and town of hospital, and/or WHERE blood donation took place.. Town, clinic name, at least the province they were living in at the time. CBS will forward onward to other CBS sites as needed.

Canadian Blood Services

ENHANCED LOOKBACK OUTCOMES ON COMPLETED INVESTIGATIONS

From: 1985-01-01 To: 2007-11-30

HIV HTLV HCV HBV

Total Cases 717 386 10521 296

# % # % # % # %

Initiated through Centre Screening 430 60.0% 370 95.9% 6108 58.1% 230 77.7%

Initiated through Traceback 67 9.3% 4 1.0% 751 7.1% 9 3.0%

Initiated through Other* 219 30.5% 12 3.1% 2721 25.9% 57 19.3%

Initiated through SSP** 1 0.1% 0 0.0% 941 8.9% 0 0.0%

Cases Open 10 1.4% 7 1.8% 288 2.7% 29 9.8%

Cases Completed 707 98.6% 379 98.2% 10233 97.3% 267 90.2%

First-time Donors 259 36.6% 194 51.2% 4091 40.0% 126 47.2%

Repeated Donors 400 56.6% 146 38.5% 4336 42.4% 59 22.1%

Not available 46 6.5% 36 9.5% 1704 16.7% 79 29.6%

Total # of Recipients Afftected*** 1559 217.4% 685 177.5% 26171 248.8% 324 109.5%

Recipients (+) 251 35.0% 28 7.3% 5758 54.7% 27 9.1%

Recipients (-) 373 52.0% 162 42.0% 2031 19.3% 76 25.7%

Recipients Not Found; Status Unknown 935 130.4% 495 128.2% 18382 174.7% 221 74.7%

*Information provided by donor, donor's physician, Public Health

**Stored Sample Project

***Estimated total # of transfused components = total # number of recipients affected

Canadian Blood Services

ANNUAL TRACEBACK OUTCOMES ON COMPLETED INVESTIGATIONS

From: 1985-01-01 To: 2007-11-30

HIV HTLV HCV HBV

Total Cases 547 29 15430 488

# % # % # % # %

Cases Open 10 1.8% 0 0.0% 898 5.8% 25 5.1%

Cases Completed 537 98.2% 29 100.0% 14532 94.2% 463 94.9%

Outcome of Completed Cases:                

Closed 134 24.5% 4 13.8% 3667 23.8% 149 30.5%

Positive 194 35.5% 14 48.3% 4825 31.3% 57 11.7%

Negative 101 18.5% 6 20.7% 2312 15.0% 133 27.3%

Withdrawn 63 62.4% 3 50.0% 2553 110.4% 81 60.9%

Not Investigated 45 44.6% 2 33.3% 1171 50.6% 42 31.6%

Closed: Case completed with no positive donors found, but some donors not assessed (either not found, deceased, refused testing or other).

Positive: At least one donor subsequently tested positive for the specific marker.

Negative: All donors subsequently tested and cleared negative for the specific marker.

Withdrawn: Case withdrawn at the discretion of the Medical Office, usually due to evidence suggesting the infection is not transfusion related.

Not Investigated: Donors/donations related to the transfusion were not investigated, usually because no documentation or records were available either from the hospital or at the Centre.

Questions?

Due Diligence

• As a Health Care professional, it is all of our responsibility to use the current available resources, pass along pertinent information, handle sensitive information with respect ,all the while utilizing the utmost of our abilities and training to achieve the best outcome for the Canadian public.

Thank you