Irene Dines
Manager of the Lookback Traceback Program
Canadian Blood Services
Central Ontario Region
Toronto Site
March 2011
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
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.
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)
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.
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.
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)
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)
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?
ENHANCED LOOKBACK OUTCOMES ON COMPLETED INVESTIGATIONS
From: 1981-01-01 To: 2010-12-31
Total Cases
#
HIV
HTLV
HCV
HBV
745
416
11130
524
%
#
%
#
#
%
446
59.9%
400
96.2%
6311
56.7%
439
83.8%
68
9.1%
4
1.0%
838
7.5%
11
2.1%
Initiated through Other*
230
30.9%
12
2.9%
3040
27.3%
74
14.1%
Initiated through SSP**
1
0.1%
0
0.0%
941
8.5%
0
0.0%
Cases Open
1
0.1%
1
0.2%
80
0.7%
17
3.2%
Cases Completed
744
99.9%
415
99.8%
11050
99.3%
507
96.8%
First-time Donors
277
37.2%
222
53.5%
4447
40.2%
308
60.7%
Repeated Donors
421
56.6%
154
37.1%
4736
42.9%
94
18.5%
46
6.2%
36
8.7%
1765
16.0%
103
20.3%
Initiated through Centre Screening
Initiated through Traceback
Not available
Total # of Recipients Afftected***
%
1642
694
28180
419
Recipients (+)
262
26
6292
29
Recipients (-)
392
165
2196
110
Recipients Not Found; Status Unknown
988
503
19692
280
***Estimated total # of transfused components = total # number of recipients affected
**** Donor status not available due to notification from external source (ie. Public Health Laboratory) or from a site where donations were suspected, but
no donations were found. The Lookback case initiated and closed.
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)
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.
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
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
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
TRACEBACK OUTCOMES ON COMPLETED INVESTIGATIONS
From: 1985-01-01 To: 2010-12-31
Total Cases
HIV
HTLV
HCV
HBV
572
30
16475
542
#
Cases Open
%
#
%
#
%
#
%
6
1.0%
0
0.0%
212
1.3%
9
1.7%
566
99.0%
30
100.0%
16263
98.7%
533
98.3%
Closed
142
24.8%
5
16.7%
4547
27.6%
192
35.4%
Positive
196
34.3%
14
46.7%
5246
31.8%
63
11.6%
Negative
118
20.6%
6
20.0%
2734
16.6%
152
28.0%
Withdrawn
63
11.0%
3
10.0%
2588
15.7%
83
15.3%
Not Investigated
47
8.2%
2
6.7%
1148
7.0%
43
7.9%
Cases Completed
Outcome of Completed Cases:
Negative:
Withdrawn:
Not Investigated:
All donors subsequently tested and cleared negative for the specific marker.
Case withdrawn at the discretion of the Medical Office, usually due to evidence suggesting
the infection is not transfusion related.
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.
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
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
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,)
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.
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-
Thank you