National Office
Private Bag 92071
Auckland Mail Centre
AUCKLAND 1142
New Zealand
Telephone: 09 523 5758
Facsimile: 09 523 5754
19th June 2019
Sabelina Smith
Email:
[FYI request #10365 email]
Dear Sabelina
RE: OIA - Response
I am writing to respond to your request for release of information under the Official Information Act.
You have requested that New Zealand Blood Service (NZBS) provide information on the ‘
policy,
process and procedures in place for when contacting clients that had an anomaly/condition
identified on their blood during their annual check-ups. Could you please include copy of process,
policies and procedures for ‘cancer referral’.
Potential donors are required to complete a Donor Questionnaire on each and every occasion they
attend to donate blood. A copy of the questionnaire is freely available on the NZBS website
(https://www.nzblood.co.nz/give-blood/donating/the-donation-process/donor-health-
questionnaire/). We undertake a number of tests on the donation. The questionnaire identifies the
nature of these tests and identifies that they ‘wil be notified if any important abnormalities are
found’. In consenting to donate, the donor agrees to this. Any important abnormalities identified
during testing are reviewed by a member of the NZBS medical team who wil then notify the donor
by letter. The content of the letter is determined by the nature of the findings.
NZBS undertakes annual testing of apheresis donors. Donors undergo a specific consent process
before they donate by apheresis for the first time. Copies of the Apheresis Donor Information sheet
(111I00801) and Consent form (111F03802) are provided. These notify the donor of this additional
testing and identify that they wil be informed about any significant abnormalities that might be found
with these tests.
A member of the NZBS medical team reviews the results of the annual monitoring tests against a
set of agreed Guidelines. These are contained in document number 111G08703 (copy provided).
Where appropriate, standard letter templates are used to inform the donor of the results.
NZBS always sends letters directly to the donor. Information is only provided to a general
practitioner, or other registered health care practitioner, with the specific written consent of the
donor. Where appropriate, a request to do this wil be included in the letter informing the donor of
the results.
You have requested information on systems relating to ‘cancer referral’. The blood donor
questionnaire specifically asks donors if they have ever had cancer. In common with other
international blood services, NZBS does not al ow individuals to donate if they have been
diagnosed with a form of cancer. The rules used to determine eligibility for this are contained in a
set of documents called the Collection Standards. A copy of the information relating to the rules on
cancer is provided (107D002c09 - cancer). The donor is informed when they attend to donate, or
contact us via our call centre, if a history of cancer wil prevent them from donating.
Occasionally, though infrequently, the results of the tests performed at the time of donation wil
suggest the possibility that the donor has a form of cancer or other serious disease. When this
occurs, the donor is notified using the systems identified above. The responsibility for management
of the findings and onward referral for specialist care is the responsibility of the donor’s general
practitioner.
Yours sincerely
Sam Cliffe
Chief Executive Officer
New Zealand Blood Service
Attachments: 111I00801
111F03802
111G08703
107D002c09 - cancer
NATIONAL
111I00801
APHERESIS DONOR INFORMATION SHEET
Thank you for volunteering to become an Apheresis Donor. This sheet is intended to inform
you about the reasons for apheresis Donation, the practical procedures involved and the
potential risks of undergoing apheresis. After reading this sheet, we will ask you to sign a
consent form to undergo this procedure for the first time.
WHAT ARE THE ADVANTAGES OF APHERESIS DONATION?
As a blood donor you will be aware that you normally donate about 450mls of whole blood at each
donation. You may also be aware that,
after donation, each unit is separated into the various
components of blood, including:
•
red blood cells, which carry oxygen around the body
•
platelet cells, which help the blood to clot; and
•
plasma, the liquid part of blood which contains all of the clotting, immune and other proteins.
Each of these components is used separately to treat patients with a variety of disorders and much of
the plasma collected is sent to Australia for manufacture into blood products for New Zealand patients.
The amount of blood that can be donated is limited by the loss of red blood cells because donors
become anaemic if we remove too much blood. Plasma and platelets lost by blood donation are much
more easily replaced by the donor than red blood cells and much larger quantities of these
components can be donated safely if the red blood cells can be returned to the donor. This is what
happens in an apheresis donation.
HOW DOES APHERESIS WORK? Blood is removed from a vein and mixed with a substance called citrate to stop it clotting while in the
blood collection set. It is then processed in the collection set to separate the red blood cells from the
plasma and platelets. The components that are required are kept in the collection set and the red
blood cells are returned to the donor. This process allows 2-3 times the usual volume of plasma and
up to 12 times the usual number of platelets to be removed at a single donation, without making the
donor anaemic.
WHAT ARE THE POSSIBLE PROBLEMS OR RISKS OF APHERESIS DONATION?
•
Some of the minor problems seen occasionally in normal donations may also occur from time to
time with apheresis donations. Many of these relate to the use of a needle to puncture the vein of
the donor and include pain, bruising, infection or minor damage to the nerves in the skin.
Dizziness and fainting can also occur occasionally. These potential problems are no more
common, and some may be less common with apheresis donations, than with ordinary whole blood
donations.
•
Apheresis donations take longer than normal donations and usually require:
•
1-2 hours for platelet apheresis
•
35-45 minutes for plasmapheresis
•
Tingling in the fingers and around the mouth can occur when the red blood cells are returned to the
donor. This is due to the infusion of citrate (which is mixed with the blood in the collection set to
prevent clotting) with the red blood cells. Citrate is used as a fuel by the body and is rapidly
removed from the blood stream, making this a very brief phenomenon. It can generally be
overcome by slowing the rate of return of the red blood cells or by having a drink containing
calcium.
_________________________________________________________________________________
Prepared by: CAG Effective Date: 16/8/01 Page 1 of 2
Authorised by: Peter Flanagan File name:111I00801
QA Approved by: Lorraine Rimmer Previous ID: NA
NATIONAL
111I00801
APHERESIS DONOR INFORMATION SHEET
•
Despite the use of citrate, it is possible that the blood may clot while out of the body, preventing its
return. However, this is very uncommon and the volume of blood that can be lost in this way is no
more than that of a normal whole blood donation.
•
Rare theoretical risks include the possibility that air might be introduced into the donor’s blood
stream but modern apheresis machines include alarms to prevent this and donors are monitored
very closely during the procedure.
•
All the tubing, needles, and bowls used in this process are sterile and disposable. A new blood
collection set is used for each donation, avoiding any problems of contamination.
IS THE DONATION TESTED IN THE USUAL WAY? The usual tests performed on normal blood donations will be performed, including screening tests for
HIV (the AIDS Virus), Hepatitis B, Hepatitis C, HTLV and Syphilis.
Apheresis donors have a number of other monitoring blood tests performed occasionally to ensure
that the levels of proteins in their blood and their blood counts remain normal.
Donors will be informed about any significant abnormalities that might be found with these tests.
OTHER IMPORTANT INFORMATION
We will normally conduct a brief physical check up before your first donation to ensure that there are
no obvious problems with your health that might lead to difficulties during apheresis donation.
The products collected by apheresis may be used for transfusion to patients; for processing into blood
components used by patients; for teaching; or for other laboratory uses.
Should you suffer any adverse effect as a result of undergoing apheresis you will be eligible for
compensation in the same way that normal donors are.
If you have any concerns or questions about this procedure you may discuss them at any time with the
nurse who will be carrying out the apheresis procedures or with a transfusion medicine specialist.
_________________________________________________________________________________
Prepared by: CAG Effective Date: 16/8/01 Page 2 of 2
Authorised by: Peter Flanagan File name:111I00801
QA Approved by: Lorraine Rimmer Previous ID: NA
NATIONAL
111F03802
CONSENT FOR APHERESIS PROCEDURE
I ___________________________ have given an apheresis information sheet to the donor and have
provided an explanation in relation to the donation of plasma/platelets/white cells
(delete whichever is not applicable) by apheresis.
This information included:
• The nature and the purpose of the apheresis procedure
• The practical procedures involved
• The possible side effects and risks of this procedure
I have also offered the donor the opportunity to ask questions and where the questions have been
asked, I have answered them appropriately and to the best of my ability.
______________________
_____________________
_______________________
Signature
Designation
Date
Donor Consent
If there is anything that you don’t understand about the explanation or
If you want more information please ask before signing this form
I _____________________________ have received, read and understood the information provided in
relation to the apheresis procedure. I have been given the opportunity to ask questions and my
questions have been satisfactorily answered.
I consent to the apheresis procedure and a medical assessment.
I consent to the administration of citrate and calcium and any alternative procedures or treatment that
may be required during the course of the donation.
I consent to a blood sample being taken for HLA/HPA typing and for my name to be placed on a list of
donors available to be cal ed for specific platelet collection. (
Delete if not applicable)
_________________________________
__________________________________
Donor Signature
Date
Author: Maree Clarkin
Effective Date: 13/06/2011
Page 1 of 2
Authoriser: Peter Flanagan
Previous ID: 107F03801
QA Approver: Meredith Smith
Refer to document(s): 107M095
NATIONAL
111F03802
CONSENT FOR APHERESIS PROCEDURE
_________________________________
Donor ID Number
Author: Maree Clarkin
Effective Date: 13/06/2011
Page 2 of 2
Authoriser: Peter Flanagan
Previous ID: 107F03801
QA Approver: Meredith Smith
Refer to document(s): 107M095
NATIONAL
111G08703
GUIDELINES FOR MEDICAL REVIEW OF
ANNUAL APHERESIS BLOOD TESTS
REASON FOR ISSUE:
Removed a document that has been merged (DCR5078) and corrected eProgesa
references (DCR10843). Included reference to 111P165.
1.
DESCRIPTION
Annual blood tests are a requirement for apheresis donors to continue donating. These
test results have to be reviewed by a medical officer or transfusion medicine specialist.
These guidelines are to assist that review and provide some consistency between
reviewers and sites.
2.
SCOPE
A number of factors affect the parameters measured, including gender, age, ethnicity,
environment (e.g. altitude), timing of the sample, exercise as well as variations in analytical
methods and technique. Normal ranges provided by laboratories may not have been
developed for the population group of the donor being reviewed. As a result of this
variation, these guidelines are intended only to assist medical officers and transfusion
medicine specialists, not replace sound clinical assessment.
3.
RELATED DOCUMENTS
107M095 Apheresis Donors – Consent and Assessment
107M121 Selection of Donors for Hyperimmune Plasma and Cyroprecipitate
111F112 Letters to Apheresis Donor
111P165 Policy for Collection and Transfusion of Plasma Fresh Frozen Apheresis
Leucocyte Depleted Low IgA
4.
REFERENCE RANGES
Medical laboratories generally provide normal ranges that include 95% of the population.
They are calculated from the arithmetic mean ± 2 standard deviations (SD). These ranges
are referred to as the reference ranges. The acceptable limits include 99% of the
population and are calculated from the arithmetic mean ± 3 SD. To derive the acceptable
limits (mean ± 3SD), assuming a Gaussian distribution, calculate 1SD (the difference
between the higher and lower ranges divided by 4) and add to the higher range and
subtract from the lower. This may be necessary for each age and gender specific range. It
is recommended that the laboratory performing the tests send the reviewing MO/TMS a full
set of reference ranges for all tests concerned so that the necessary acceptable limits can
be calculated.
5.
PROCEDURE - GENERAL PRINCIPLES
5.1
A single value outside the reference range (2SD) but within acceptable limits (3SD)
This should prompt a review of the donor history and, if appropriate, follow-up tests (eg
blood film or ferritin). Suspension or withdrawal is not necessary in the majority of cases.
5.2
Two consecutive values of the same test parameter or 2 concurrent different
parameters falling outside the reference range (2SD) but within acceptable limits
(3SD)
This should prompt a review of the donor history and, if appropriate, follow-up tests (eg
blood film or ferritin). If the finding cannot be explained by physiological variation, the donor
should in most cases be suspended for 3 months. A standard letter should be used to
communicate abnormal test results and should include a copy of the test results.
Author: Richard Charlewood
Effective Date: 18/10/2013
Page 1 of 4
Authoriser: Peter Flanagan
Copy No:
Previous ID: 111G08702
QA Approver: Meredith Smith
Copyholder ID:
Manual(s): Clinicians’
link to page 7 link to page 7 link to page 9 link to page 7 link to page 9
NATIONAL
111G08703
GUIDELINES FOR MEDICAL REVIEW OF
ANNUAL APHERESIS BLOOD TESTS
5.3
A third consecutive value outside the reference range but within acceptable limits
If this is not explained by physiological variation, it would normally lead to withdrawal of the
donor. A standard letter should be used to communicate abnormal test results and should
include a copy of the test results.
5.4
Any parameter outside the acceptable limits (3SD)
These values are likely to be of significance. Review the donor history. Consider follow-up
tests (eg blood film review, or ferritin if abnormal haematological parameter). A MO/TMS
with experience in apheresis may accept the donor if the abnormality can be explained by
physiological variation (e.g. exercise). If the abnormality is felt to be significant, the donor
may need to be contacted for an urgent repeat sample. Permission must be obtained
before contacting the donor’s family doctor. A standard letter should be used to
communicate abnormal test results and should include a copy of the test results.
5.5
Unacceptable progressive change in a parameter value
MOs/TMSs with experience in apheresis may be concerned about the rate or degree of
change in a parameter even when it remains within normal limits (eg a fall in Hb from 150g/l
to 115g/l may give rise to concern). It is difficult to cover all such eventualities in guidelines
and decisions in such cases should be guided by clinical judgement.
6.
PROCEDURE – SPECIFIC TESTS
6.1
Haemoglobin
Donors must meet the minimum haemoglobin to donate as specified in the NZBS Collection
Standards. Other than this requirement, assessment is as outlined in secti
on 5.
6.2
Platelets
Platelet counts are measured to determine suitability to donate platelets, as outlined in
107M095 – Apheresis Donors – Consent and Assessment.
Counts below the reference range should be assessed as outlined in secti
on 5.
Because elevated counts may represent a transient acute inflammatory reaction, levels
above the reference range should be assessed as for IgG (section
6.7). Consider checking
a ferritin level for persistently elevated platelet counts as iron deficiency frequently provokes
a thrombocytosis.
6.3
Other FBC results (e.g. MCV)
As most laboratories provide a Full Blood Count and not just haemoglobin and platelet
values, abnormalities of other parameters may be discovered. These should only be
actioned if regarded as clinically significant and requiring referral to the donor’s family
doctor. The laboratory’s haematologist can be consulted for advice on such parameters.
6.4
Albumin
A raised albumin is caused by prolonged venous stasis or dehydration and does not require
any follow-up.
Assessment of a low albumin is as outlined in secti
on 5.
6.5
Total Protein
Albumin makes up more than half of a normal total protein level. Accordingly, only globulin
portion of the total protein level should be assessed. This should be assessed as for IgG
(section
6.7).
Page 2 of 4
link to page 9 link to page 7 link to page 9
NATIONAL
111G08703
GUIDELINES FOR MEDICAL REVIEW OF
ANNUAL APHERESIS BLOOD TESTS
6.6
IgM
IgM is not a requirement for annual testing (see secti
on 7).
6.7
IgG
Levels below the reference range should be assessed as outlined in secti
on 5.
Raised levels may represent a transient acute inflammatory reaction. Accordingly, a donor
with raised IgG outside the acceptable limits range (i.e. >3SD) should:
• On the first occasion, have IgG and serum protein electrophoresis tested in 3 months
time. A monoclonal band requires referral to a haematologist and a permanent deferral.
• On the second consecutive occasion, be considered for a 3 month suspension with
retesting before being accepted for apheresis.
• On the third consecutive occasion, be considered for deferral of the donor and referral
to the donor’s family doctor.
As immunoglobulin levels may fluctuate with intercurrent infections, action should only be
taken for consecutive results.
6.8
IgA
IgA is not a requirement for annual testing (see secti
on 7). It is useful to identify IgA
deficient donors (IgA below the level of detection) on the first set of annual tests in order to
provide components for patients with anti-IgA antibodies. See 111P165 for more details.
6.9
Specific antibody quantitation
The levels of these specific antibodies determine whether or not a donor’s plasma is
suitable for hyperimmune immunoglobulin production (see 107M121 Testing for
Hyperimmune plasma). Donors should not be deferred on the basis of a fall in these levels.
6.10 Fibrinogen
Fibrinogen is measured to determine the suitability of making cryoprecipitate from the
donor’s plasma, as outlined in 107M095 – Apheresis Donors – Consent and Assessment.
Levels below the reference range should be assessed as outlined in section 5. Because
elevated levels may represent a transient acute inflammatory reaction, levels above the
reference range should be assessed as for IgG and IgM.
7.
RESULTS OF TESTS OTHER THAN THOSE MANDATED
Requesting tests other than those required for annual checks on plasmapheresis and
plateletpheresis donors or for testing for hyperimmune plasma, as specified in the
respective national SOPs, must be actively discouraged. Similarly, laboratories reporting
results of tests that have not been requested must be asked to only report what has been
requested.
Results of tests other than those mandated should only be actioned if regarded as clinically
significant and requiring referral to the donor’s family doctor. Examples of such tests are
IgA and IgM levels.
8.
WHOLE BLOOD DONATION
Provided the abnormality identified on annual testing does not reveal an abnormality
precluding the donor from donating whole blood, a donor who is no longer able to make
apheresis donations can give whole blood. An example of an abnormality where the donor
could donate whole blood is a low IgG level. An example of an abnormality where the donor
would be permanently deferred from all types of donation is a monoclonal paraprotein.
Page 3 of 4
NATIONAL
111G08703
GUIDELINES FOR MEDICAL REVIEW OF
ANNUAL APHERESIS BLOOD TESTS
9.
REFERENCES
• Gesinde M. Guidelines on managing apheresis donors MPD/DSD/CS/013/02. Sept
2003. National Blood Service (UK) Internal Document.
• European Directorate for the Quality of Medicines and Healthcare of the Council of
Europe (EDQM). The guide to the preparation, use and quality assurance of blood
components. 14th edition. Council of Europe; 2008.
Page 4 of 4
NATIONAL
107D002c09
A-Z GUIDELINES (C)
POST DONATION WITHDRAWAL
eProgesa
DONOR EVENT
CODE
EXPLANATION &
Allows
CLARIFICATION
ACTION
Issue of
Withdraw
Notify
CSL Action
Previous
Components
Clinician
Required
Donation
CANCER
M07P These specific malignancies rarely Successful treatment of basal cell
Yes
From date of
No
No
metastasise. But treatment carries carcinoma (rodent ulcer),
diagnosis
drug and infection risks.
squamous cell carcinoma of the
See also: CYTOTOXIC DRUGS
skin and carcinoma in situ of
cervix (also known as CIN-III or
CIS), accept. If on treatment,
awaiting treatment or not yet
discharged from medical care,
defer for 2 years
M00X Risk of transmission by blood.
Solid tumours including
Yes
From date of
No
No
melanoma: accept if successfully
diagnosis
treated and clear of disease for at
least 5 years. Otherwise defer
permanently.
M00X Risk of transmission by blood.
Haematological malignancies
Yes
From date of
No
No
including leukaemias,
diagnosis
lymphomas, myelomas,
Monoclonal Gammopathy Of
Uncertain Significance (MGUS):
defer permanently
M03N This is a pre-malignant condition
Precancerous conditions (e.g.
Yes
From date of
No
No
cervical dysplasia CIN-1 and CIN-
diagnosis
II) on treatment or under
investigation, defer for 1 year
M00Y See also AWAITING RESULTS OF If in doubt about nature of tumour,
Yes
From date of
-
-
TESTS
refer to MO
onset of
symptoms
Author: Karen Martin
Effective Date: 23/10/2018
Page 1 of 1
Authoriser: Peter Flanagan
Copy No:
Previous ID: 107D002c08
QA Approver: Meredith Smith
Copyholder ID:
Manual(s): NZBS Collection Standards
Document Outline
