L E A D I N G
I N N O V A T I O N
S A V I N G
L I V E S
Quality Approach to Investigate Donor ABO/Rh Discrepancies
J Fiorillo and B Jett
New York Blood Center, Quality and Regulatory Affairs Department
INTRODUCTION
RESULTS
When a donor’s ABO/RH does not match historical typing, a laboratory
investigation is initiated. Many discrepancies can be attributed to test system
limitations and red cell antigen sub-groups or variants. Once serological
reasons are ruled out, the focus shifts to the collection process to determine if
there was a mix up in paper-work, specimens, data entry, or labels.
Our facility used a 2-pronged approach, retesting 9 products collected before
and after the index case and then interviewing staff involved. Interviews with
staff rarely provided useful information because it was difficult for them to
recall details for a particular collection event several days afterwards.
Our goal was to establish a new approach for prompt, tailored investigations
that would resolve the case quickly and yield useful information for process
improvement.
While the facility has many process control points in place to prevent matching
errors, they do still occur occasionally. We identified 4 main types of missmatches that occur:
Switch Type
Test Results
Point of Failure
1) Computer Record
Bag = Tube
Registration - visit attached to
wrong donor’s record
Bag and Tube ≠ Historical
2) Donor, paperwork
Bag = Tube
Bag and Tube ≠ Historical
3) Test Tube
OBJECTIVES
CONCLUSIONS
Tube ≠ Historical
To improve the effectiveness and efficiency of investigation and resolution of
blood donor typing discrepancies by:
4) Blood Bag
Bag ≠ Tube
• Identifying possible/probable points of failure for each type of miss-match
Bag ≠ Bag Label
• Developing a tool for guided investigation and follow up of typing
discrepancies
MATERIALS AND METHODS
The BECS flags records when the current donation blood type does not match
historical. Deviations are entered into our Quality (QMS) software to track
investigation, RCA and CAPAs.
ACKNOWLEDGEMENTS
Thanks to NYBC Collections and Core Operations Departments for
collaboration in analyzing our processes and development of this tool.
Bedside – side by side donors,
pick up wrong label or wrong
bag
Tube = Historical
• Describing the most common types of miss-matches that occur in our facility
While a tailored approach to the ABO discrepant investigations is an
improvement, mix-ups that involve donors with the same ABO and RH type
may continue to go undetected. To achieve the next level of safety, Donor
Centers may consider assigning alerts in their BECS system to detect
discrepancies in extended historical phenotype compared to testing done on
the current donation.
Bedside - donors switch beds
but leave paperwork and/or
supplies behind
Bedside – side by side donors,
pick up wrong label or wrong
tube
Bag = Historical
Use of a logic tree to facilitate investigations based on most probable cause
has reduced non-value added retesting and provided for faster resolution of
these cases.
By identifying most probable point of failures, we can target staff interviews to
gather timely information that helps resolve the case and leads to process
improvement.
In addition, we found that retesting 9 units collected before and after the index
case is not useful for resolving AOB/Rh discrepancies. Instead, we adopted a
time based approach (+/- 30 minutes from start bleed time) to identify units that
could have been implicated in the mix up.
Data from the QMS were reviewed and analyzed by a cross-functional working
group that included the labs, collections and quality. A review of 2 years data
led to “most probable” scenarios given our particular work environment,
processes, and process controls.
This allowed us to develop tailored investigational pathways to eliminate
unnecessary investigation steps and speed up resolution.
Scenario
Computer Record Mix-up
Data entry errors may result in a donation assigned to the wrong donor’s file. Although the test tube, segment and label
all match, the donor historical type does not. Investigation does not identify any other donation suspected to be involved
in the mix up. Search is for first time donor typing as O + collected around the same time, or historic A- donor typing as
O+. Retesting of tubes and segments will not yield any new information.
Donor Paperwork Mix -up
Errors involving registration/health history forms occur when two donors switch beds leaving behind labeled tubes and
bag, or forms. Although the test tube, segment and label all match, the donor historical type does not. If both individuals
involved are returning donors, BECS will identify them both. If a corresponding donor is not found, the mix up could have
been with a first time (A-) donor who is typing as O+ collected around the same time, or historic A- donor whose
collection was incomplete with no testing done. Retesting of tubes and segments will not yield any new information.
Test Tube Mix-up
Sample tubes errors occur when sample tubes of two donors collected in close proximity of each other were switched
and filled with blood. The donation ID number of the tubes does not match with that on the bag and form. The segment
testing will match the historical type. The test tube and the bag label do not match historical. These mix-ups are usually
between donors being bled at the same time and in close proximity. Retesting of tubes and segments for all donations
that occurred +/- 30 minutes of the index donation may identify a corresponding discrepancy.
Blood Bag Label Mix-up
The container bag number errors occur when donation number labels on the product bags between two donors are
switched. The ABO/Rh of the test tube and bag label match historical, but segment testing does not match the label.
These mix-ups are usually between donors being bled at the same time and in close proximity. Retesting of tubes and
segments for all donations that occurred +/- 30 minutes of the index donation may identify a corresponding discrepancy.
Donor
Hist
Type
Test
Tube
Bag
Seg
Bag
Label
#1
O+
A-
A-
A-
Outcomes/Follow-up
RETURNING DONORS are detected by BECS.
Contact the donor on file to determine if she/he actually donated on the day/location in
question. If no, suspect that the wrong donor was selected at registration. Depending on
what other records are available, it may be difficult to determine who the real donor was.
#1
O+
A-
A-
A-
RETURNING DONORS are detected by BECS.
If the BECS does not detect a corresponding discrepant donation, suspect first time donors
typing as O+, and returning donors whose historical type is A-, but whose current donation
was not tested because the collection was incomplete.
#2
Unk
O+
O+
O+
FIRST TIME DONORS are NOT detected by BECS.
A-
RETURNING DONORS are detected by BECS.
If the BECS does not identify a corresponding discrepant donation, suspect that the mix-up
is with a first time donor or incomplete collection drawn within 30 minutes of the implicated
unit.
#1
O+
A-
O+
#2
Unk
O+
A-
O+
#1
O+
O+
A-
O+
#2
Unk
A-
O+
A-
FIRST TIME DONORS are detected when segment testing is performed at the Hospital.
Test first time donors and incomplete (returning) donations drawn within 30 minutes of the
implicated unit.
RETURNING DONORS and FIRST TIME DONORS are NOT detected by BECS.
They are detected when segment testing is performed at the Hospital.
Test all donations drawn within 30 minutes of the implicated unit.
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