Agenda

1. Irene DinesManager of the Lookback Traceback ProgramCanadian Blood ServicesCentral Ontario Region Toronto SiteMarch 2011

2. Agenda • Introduction to CBS – who we are , what we do • Overview of Transmissible Disease Markers currently tested for • Lookback Program- over view, scenario depicting the process, limitations of process, statistics • Traceback Program- overview , scenario depicting the process, limitations of process, statistics • Financial compensation programs for Hep C • Statistical reporting to Health Canada • Future of LBTB program at CBS

3. Corporate Strategy WHO IS CBS??? We are a company who have a PLAN!!! 5yr Strategy Plan By 2015 to be a leader and trusted partner in advancing patient care and influencing policy in transfusion and transplantation , and related areas by leveraging our organizational capabilities and national scope. Stewardship Continually earn the right to serve( a stewards of Canada’s blood supply) through our commitment to safety, performance improvement, responsible and accountable financial management and business management. This is achieved by: • “ CBS improves patient outcomes by maximizing accessibility to life saving and sustaining products and services. • Meet Patient needs by delivering enhanced products and services quickly and effectively • Develop Partnerships with customers and stakeholders through understanding and engagement.

4. TD markers which are involved in the LBTB program • HIV • HCV • HBV • HTLV (LB on cellular components only) • WNV( seasonal testing and selected clinics) • Chagas (testing performed on selected study donors, and donors who answer yes to the risk questions)

5. Lookback A lookback is the process of identifying previous donations of a donor who currently is testing positive for a transmissible disease marker, Tesing performed internally or externally, (i.e., PHL) Automatically initiated on each Repeat Reactive Confirmed blood donation. External testing results usually only include RR antigen testing, however if proof of blood donor status, a LB is initiated.

6. Scenario: Lookback Steps in the process • Donor presents at our local Perm Clinic. Meets all donation criteria and donates a bag of WB. Samples for testing are collected • The WB goes to the Production lab, where RCC, PTL and a Plasma unit are made from that one donation. The samples go to the Testing Lab( Toronto ,Calgary) • The donation tests POSITIVE for HCV. Repeat Testing shows POSITIVE for HCV. Sample is sent for confirmation testing. • The RCC, PTL and plasma units are quarantined for destruction. • Once confirmatory testing is performed, the results are sent to the testing lab, who in turn notifies LBTB. When the confirmatory test results are entered into out computer system, the computer applies a ‘lookback event’ . • In the Lookback department, the results are received, The donor is called up in the computer and there is a review of the donor file to see if the donor has had previous donations. • IF NO - the lookback event is closed, the donor will have had a permanent deferral placed on his file, he would have rec’d a letter from our medical office telling him of his positive status and asking him to no longer donate (Obviously no LB is initiated.) • IF YES- previous donations on file…… all the donation are investigated.- this can involve a manual paper search of donation records, if the donor has donated long ago. ( depending on the marker, we can go back as far as entire donation history) • For each donation, it is determined what products were made, then determined which hospital received these products • Notification letter sent to hospital which asks to identify the recipient of a particular platelet product.

7. Scenario cont…. Hospital involvement: • Lookback letter sent to the hospital blood bank, along with an acknowledgement section, which the hospital must fill out and return to CBS within 2 weeks (this indicates to us that they will make attempts to notify the recipient if possible). • Hospital begins searching it’s sources for the recipient of the product. Usually looks for a physician who has treated the patient, and contacts that physician requesting recipient notification. This can vary depending on how each hospital is set up. Some hospitals have Transfusion Safety committee’s, who do the searching and notifications, others have the blood bank do the notifications. • Response back to CBS regarding the outcome (this is what we use when gathering statistics for Health Canada or it influences our donation criteria or supports policy change)

8. Outcomes Possible Outcomes are • product NOT transfused/discarded in hospital( or returned to CBS as indate or outdate) • unable to identify recipient( lack of records, or old records, or gaps in records, ) • recipient deceased as per hospital records • identified recipient but no physician listed, recipient NOT notified • identified recipient, physician listed , physician notified outcomes= patient deceased, patient not located, patient notified and testing was requested( or possibly requested and patient refused), once test results are available they are shared with CBS. All the above info is sent back to CBS, hopefully within 6 months of initial notification. At times, if recipient was not notified by hospital. CBS has made attempt to notify , depending on the case outcome already established (i.e., other positive recipients have been identified, or if recipient was young when treated, we have a chance to find them using a tracing agency)

9. Limitations Limitations of LOOKBACK • Incomplete donor records at CBS (pre 1980 is scattered) • Limited Hospital records • Limited Hospital time and resources to perform notification process • Unable to identify the treating physician( who ultimately is responsible for recipient notification ) • Recipient can not be found (i.e., moved, died, etc.). Therefore recipient is unable to be tested to determine if indeed the donor was infectious at the time of that donation and this impacts the speed and access to treatments if necessary • Recipient might refuse to be tested • Blood bank staff do not place enough emphasis on the value of this process( perhaps do not understand the LB process) • Physicians might feel uncomfortable trying to locate a recipient /patient they have not seen for years….but who’s role is it? • Inconsistent in how recipients are located- how hard do we really try?

11. Traceback A traceback is the process of identifying, locating and testing the donors of products that have been transfused to a patient, who now is testing positive for a transmissible disease to determine if potential for transmission of disease. Request to initiate a TB comes from external sources, (i.e., Physician, Public Health, Legal Representative, etc.) “Claimant” must be ‘positive’ (antibody) for the infectious marker in question (and provide positive test results)

12. Scenario: Traceback Steps in the process -NOTE: not much hospital involvement, only to provide transfusion history • Individual- CLAIMANT- comes forward with request for a Traceback, providing positive test results for the marker in question and provides info regarding blood transfusion history. ( sometimes this is only from memory and can be hospitalization memory only) • CBS creates a request to the hospital , asking for full transfusion history, in a blood bank records search. • Hospital performs the search based on the NAME & DOB provided. Outcomes of the search are sent back to CBS. Some hospitals, if they don’t find anything in Blood bank records and the suggested tx was from 80’s , they will get a search of the Hospital general records, to see if patient was ever admitted . • At times, the hospital sends copies of Blood bank records, other times a full list of transfused products are sent. • Note: if the patient was NOT TRANSFUSED, the hospital indicates this and sends the request form back to CBS.

13. Scenario cont….. • CBS compiles a list of all products transfused, and searches current donor computer bank for donor info. This can become a manual paper search, if the donor info is not found in our computer, or if the transfusion was PRIOR to our computer data collection (per 1985ish). • Once the correct donor is identified, the donor records are reviewed and assessed to determine if there is a ‘clearing donation’ on file. (Clearing donation = a donation which has a negative test result for the marker in question, 3 months or more AFTER the TB claimant’s transfusion date). If so, that donor is associated with the case but not implicated. • If there is no ‘clearing’ donation on file, the donor is set a letter to his last known address. • This letter explains the TB process in general and indicates his association with the case, and requests he go for testing and provide the test results. 2 OPTIONS OPTION ONE: This donor is encouraged to come to CBS to donate , if eligible, when ever possible. (or donate samples only for testing) This hopefully gets the donor back into donating again,( he was obviously lapsed) and we can obtain the ‘clearing’ test result the next day and if he is POS, we will know right away and close the case. OPTION TWO: the donor can go to his doctor , bring the letter and the doc will request testing.( consent form to allow doc office to share the test results). This requires generally many follow up phone calls to finally get the test results and takes months.- very labour intensive for CBS

14. Scenario cont….. • Once all donors have been investigated regardless of outcomes , the case can be closed. • If we identify a positive donor, we initiate a LOOKBACK on that donor, and close the case. • Letter of outcome sent to ‘claimant’ in most cases. • If Hep C case, and there is a positive or inconclusive, the claimant CAN submit claim for financial compensation to the provincial or federal government. TRACEBACK OUTCOMES: • All donors NEGATIVE • POSITIVE donor Identified • Closed Inconclusive – all donors searched, no positive found, but not all donors negative. • Withdrawn- due to poor memory of claimant as to location or dates of possible transfusion

15. Limitations Limitations of Traceback investigation are: • Claimant neglects to inform us of previous names • Incomplete records (prior to 1980 is scattered) • Unable to establish transfusion/hospitalization history of the recipient( patient poor memory as to location or date of tx) • Limited hospital records • Limited hospital time and resources to assist with transfusion history/ records • Unable to locate the donor - moved, died, changed name etc. • Donor has no ‘family doc’ who he can go see and get testing ordered. • Donor unwilling to be tested - fear factor

17. Hep B, HIV compensation is handled through Canadian Blood Agency Investigations can be done via private legal case to CRC (costly to individual and not necessary - claimant can contact CBS LBTB directly to request a TB) HCV compensation is handled through either OHCAP (provincial) or LNP (federal specific time frame) or PrePost (for federal specific timeframe) OHCAP (Ontario Hepatitis C Assistance Program): if transfusion happened prior to 1986 and post 1990 PROVINCIAL (MCAP) LNP (Litigation Notification Program): if transfusion happened between 1986-1990. FEDERAL Program for HCV Pre86Post90HCV Federal compensation program for all provinces for this timeframe CompensationThere 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. Limitations of Compensation Programs • Lengthy , time consuming process- can take 1-2yrs for FA to process and complete the claim. • Recipient must attempt to obtain their own transfusion records from the Hospital records department first , to prove hospitalization • Recipient must submit a test result to indicate positive status- difficult if claimant is deceased and legal rep is putting in claim. • Other risk factors are considered before trace back is begun.-role of FA • (i.e. IV drug history, tattoos, Incarceration,)

18. Reporting • Data is collected from the LB and TB cases, and reported to Health Canada. # cases initiated, and outcomes, • Other data gathered as needed to perform studies ,be used in research papers, which can be used to influence policy and donor selection criteria.

19. Future of CBS LBTB • CBS is in the process of consolidating all LBTB functions into ONE site, located within the South Central Ontario Region- BRAMPTON. Currently there are 11 CBS sites who perform the LB and TB process. • Summary letter of investigation outcome for Traceback is being considered. Currently some sites provide this , other sites do not. The letter will be sent to the claimant directly upon request. And is done so for all Federal Compensation claims. • Potential changes/standardization to the ‘notification to CBS form’ (currently many versions of the form are in use and is causing some confusion) – potential for this form to be located on websites such as www.transfusionmedicine.com or www.blood.ca and be available to use electronically-

20. Thank you