1
Appendix 4
to the list of some orders
of the Minister of Health Care
of the Republic of Kazakhstan,
wherein changes and amendments
are introduced
Approved by the order
of the acting Minister
of Health Care
of the Republic of Kazakhstan
No. 666 dated November 6, 2009
Regulations on medical examination of a donor prior to donation of blood
and its components
1. General Provisions
1. These Regulations on medical examination of a donor prior to donation of
blood and its components (hereinafter the “Regulations”) have been developed in
accordance with paragraph 1 of Article 166 of the Code of the Republic of
Kazakhstan dated 18 September 2009 “On Health of People and Healthcare System”
(hereinafter the “Code”) and determine the procedure of medical examination of the
donor before donation of blood and its components in medical organizations that
perform banking of blood and its components (hereinafter the “Blood Service
Organizations”).
2. In these Regulations the following concepts are used:
1) voluntary non-remunerated donation of blood and its components means a
donation of allogenic blood and its components made without receipt of cash
consideration, with the exception of guarantees provided to the donor pursuant to
Article 167 of the Code;
2) targeted donation of blood and its components means a donation of
allogenic blood and its components intended for specific patients and made without
receipt of cash consideration, with the exception of guarantees provided to donor
pursuant to Article 167 of the Code;
3) autologous donation of blood and its components means a donation of blood
and its components that are taken from one person and intended exclusively for
subsequent autologous transfusion to the same person;
4) completed (full) donation means an exfusion of whole blood with the
achieved target volume ± 10%;
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5) incomplete (not full) donation (underdrawal) means an insufficient exfusion
of whole blood in view of forced termination of the procedure without achievement
of the target volume but with the accomplishment of the exfusion in the amount of
200 ml and more;
6) failed donation (puncture) means a failed vein puncture and the exfusion of
whole blood in the amount up to 200 ml.
3. The procedure of medical examination of the donor prior to donation of
blood and its components includes the following stages:
1) reception and registration of the donor;
2) medical examination of the donor.
4. A donor is a person, who had attained the age of eighteen, passed an
appropriate medical examination and has no contradiction, voluntarily willing to
donate blood and its components for medical purposes.
5. Persons aged above 60 years, who makes blood donation for the first time in
their lives, as well as persons aged above 65 years shall be admitted for the donation
of blood and its components according to the opinion of the physician, conducting
the medical examination.
6. According to the frequency and number of blood and its component
donations, donors shall be subdivided into the following categories:
A primary donor is a person who donates blood and its components for the
very first time in the life;
A repeated donor is a person who has previously donated blood and its
components in the same Blood Service Organization;
A regular donor is a person who regularly donates blood and (or) its
components.
Regularity shall imply the frequency of blood donation equal to three or more
times per year, of blood plasma and cells donation – twelve or more times per year,
of red blood cells by the means of red blood cells exchange - donation two and more
times per year.
7. Donation of blood and its components is divided into the following types:
1) according to the type of donation:
donation of blood;
donation of plasma, including immune plasma;
donation of blood cells;
2) according to the motivation of donation:
non-remunerated (voluntary non-remunerated donation, targeted donation and
autologous donation);
donation of blood on the payment basis.
3) according to the result of the procedure of whole blood donation:
completed (full);
incomplete (not full);
failed (puncture).
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2. Reception and registration of donor
8. The reception of the donor in Blood Service Organizations shall be made on
the basis of identification documents or military service card for compulsory-duty
servicemen.
9. After presentation of the documents envisaged by paragraph 6 of these
Regulations, the donor shall be given a questionnaire for the donor of blood and its
components in accordance with Appendix 1 to these Regulations, which he or she
shall fill in independently or with the participation of a medical registrar, and a
datasheet in accordance with Appendix 2 to these Regulations.
This paragraph shall not apply to donors of hematopoietic stem cells
(hereinafter the “HSC”) of peripheral blood.
10. Reconciliation of the donor’s data, with the exception of the donors of
peripheral blood HSC, shall be made with electronic databases of donors and persons
ineligible to donate, after which the passport part of electronic or paper-based donor’s
card shall be filled in with an indication on verification of the information about the
donor.
11. The registration of the donor, with the exception of donors of peripheral
blood HSC, shall be made in accordance with primary medical documents, on the
basis of which the electronic database of donors shall be formed.
12. After donation of blood and its components, the primary donor, with the
exception of donors of peripheral blood HSC, shall be given a donor certificate in
accordance with the form included in Appendix 3 to these Regulations. A duplicate
instead of a lost donor certificate shall be issued on the basis of a written application
of the donor.
13. A donor, with the exception of donors of peripheral blood HSC, suspended
from donation shall be given a certificate in accordance with the form approved by
the competent authority;
Sources of data for taking decision about the capability to perform the donor’s
function shall be the following:
1) electronic databases of donors and persons ineligible to donate blood and its
components;
2) questionnaire for the donor of blood and its components;
3) preliminary laboratory examination;
4) medical examination.
14. The formation electronic databases of persons ineligible to donate, shall be
made with the use of information received from AIDS Prevention and Control
Centers (hereinafter the “AIDS Center”), tuberculosis hospitals (early treatment
clinics), narcological hospitals (early treatment clinics), dermatovenerologic hospitals
(early treatment clinics), psychiatric hospitals (early treatment clinics), territorial
subdivisions of the state body in the sphere of sanitary and epidemiological safety of
people within the respective territories, and according to the results of blood induced
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infections examination of persons, who applied for the donation of blood and its
components to a Blood Service Organization.
15. Provision of the Blood Service Organizations with information about
persons with HIV in the republic with subsequent updating of information about new
identified persons shall be made by AIDS Centers of regions, Almaty and Astana
cities, respectively.
3. Procedure of medical examination of the donor
16. Before filling in the questionnaire, the donor shall be provided with
information in accordance with Appendices 2 and 7 to these Regulations.
17. Before each donation of blood and its components, the preliminary
determination of the donor’s hemoglobin (hematocrit) level, ALT level shall be
made, and before each donation of HSC peripheral blood the preliminary
determination of the composition of peripheral blood (hemoglobin (hematocrit), red
blood cells, white blood cells, and platelets) shall also be made.
For the plasma donor, before each donation, the count of total protein in blood
serum shall be made additionally.
For the platelets donor, before each donation, the count of platelets shall be
made additionally.
In case of blood components banking with the use of automatic separators,
before each donation, blood coagulation time shall be determined additionally.
18. Donors of peripheral blood HSC shall pass the initial examination for
infectious markers of human immunodeficiency virus (hereinafter the “HIV”), viral
hepatitis B (hereinafter the “VHB”), viral hepatitis C (hereinafter the “VHC”),
syphilis, cytomegalovirus infection, and toxoplasmaosis in the medical organization
referring for the donation.
The examination of the HSC donor for arthropod-borne infection markers shall
be conducted in accordance with the requirements of paragraphs 18 and 19 of
Appendix 3 to the Regulations on quality control of donated blood and its
components approved by the Order of the acting Minister of Health Care of the
Republic of Kazakhstan dated 10 November 2009 No. 684 “Regulations of quality
control of donated blood and its components” (entered into the Register of state
registration of laws and regulations No. 5930).
Laboratory analyses shall be conducted by the methods registered in the
Republic of Kazakhstan including dry chemistry, with the use of the equipment
registered in the Republic of Kazakhstan in accordance with the Regulations on state
registration, re-registration and making amendments to registration file of drugs,
medical articles, and medical devices, approved by the Order of the Minister of
Healthcare of the Republic of Kazakhstan on 18 November 2009 No. 735 “On
approval of the Regulations on state registration, re-registration and making
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amendments to registration file of drugs, medical articles, and medical devices”
(entered into the Register of state registration of laws and regulations No. 5935).
19. Sampling of donor’s blood for testing for blood induced infections shall be
made during the donation of blood and its components.
20. Medical examination of the donor, rejection or admission, and
determination of the type of blood and its components shall be made by the
transfusiologist or physician of the Blood Service Organization (hereinafter the
“physician”).
21. Medical examination of the donor shall include:
1) previous laboratory tests data analysis;
2) analysis of the questionnaire for the donor of blood and its components,
history taking and confidential interview with the donor to identify any risk factors
(the information from the questionnaire shall be supplemented with answers of the
donor received during the interview);
3) assessment of the general condition as of the current date by means of
interview and certain methods of medical examination (measurement of temperature,
height and weight of body, blood pressure, eurhythmy and pulse rate).
22. At suspicion on presence or identification of factors of any risk behavior of
the potential donor that lead to introduction of hemotransmissive infections as well
as in the presence of signs of other diseases, the scope of medical examination shall
be extended at the discretion of the physician, who is in charge of the admission to
the donation and additional methods of physical (inspection of skin cover and visible
mucosae, auscultation, percussion, palpation), laboratory tests or specialized medical
consultations shall be assigned.
23. When conducting medical examination, the guidance shall be taken of the
standards of laboratory analyses values in accordance with Appendix 4 to these
Regulations and the criteria of permanent and temporary rejection to donate blood
and its components, pursuant to Appendices 5 and 6 to these Regulations.
24. In case of abnormality of laboratory analyses values, the donor shall be
rejecter to donate blood and its components in accordance with periods envisaged in
Appendix 6 to these Regulations.
25. In the presence of contraindication, the donor shall receive the explanation
of the reason of rejection to donate blood and its components and recommendation to
pass additional examination in respective medical organizations.
26. The reason of rejection shall be registered in electronic databases of donors
and persons ineligible to donate blood, in the donor’s card, with the exception of
donors of peripheral blood HSC.
27. In the absence of contraindication to donation, the type and amount of the
donation of blood and its components, with the exception of donors of peripheral
blood HSC, shall be determined, at that the guidance shall be taken of the following
criteria:
1) needs of medical organizations for blood components;
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2) voluntary informed consent of the donor for the donation of blood and its
components;
3) minimum intervals between different types of donations of blood and its
components, determined in accordance with Appendix 8 to these Regulations;
4) maximum permissible amounts of donations of blood and its components,
that are as follows:
For blood:
In case of donors with the weight above 50 kg and height above 150 cm,
withdrawal of whole blood in the volume of 450 milliliters ( hereinafter the “ml”) ±
10% shall be made, in addition to this 30-35 ml of blood shall be taken for laboratory
analyses and for storage as the donor’s blood sample after the donation;
In case of donors with the weight below 50 kg and the height below 150 cm,
withdrawal of smaller volume of blood shall be made on the basis of 4-6 ml for one
kilogram of body weight, but not more than 13 % from the total circulating blood
volume (hereinafter the “CBV”), which makes up normally 6.5-7 % from the body
weight;
For plasma:
In case of donors with the weight above 50 kg and height above 150 cm,
withdrawal of plasma in the volume of 600-800 ml, but nto more than 16% of the
CBV, shall be made;
Donors with the weight below 50 kg and the height below 150 cm shall not be
admitted to the donation of plasma;
28. Additional medical examination of regular donors of blood and its
components shall be made at least oncea year, and of donors of peripheral blood HSC
before the donation:
1) photofluorographic examinations of thoracic organs;
2) electrocardiogram of donors aged above 40 years.
29. Control laboratory tests of regular donors of plasma and blood cells shall
be made at least every four months, and of donors of blood at least every year and
shall include:
1) the content of peripheral blood (hemoglobin (hematocrit), red blood cells,
white blood cells, platelets, sedimentation rate of red blood cells and leukogram);
2) total protein and protein fractions;
3) clinical urine analysis.
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Appendix 1
to the Regulations of medical examination of a donor
prior to donation of blood and its components
Form
Questionnaire for donor of blood and its components
Thank you for your desire to help patients requiring donated blood!
Please give straightforward answers to the following questions (for answers use
‘yes’ or ‘no’).
Your straightforward answers to the following questions are necessary to
ensure your safety as a donor and the safety of a patient, who will receive your blood.
Name, first name, patronymic (if any) of the donor_______________________
____________________________________________________________________
_________
Date of birth ____________ Sex____________E-mail __________
Home address (actual and
registered)____________________________________________________________
____________________________________________________________________
Home phone
number____________________________________________________________
Mobile phone
number___________________________________________________________
Business phone
number______________________________________________________________
Place of
employment__________________________________________________________
______
Item
No.
1.
2.
3.
4.
5.
6.
7.
Questions
1. General state of health and epidemiologic environment
Are you feeling well?
Did you have a rest last night?
Have you had any tooth extraction in the past 14 days?
Have you drunk alcohol during the past 48 hours?
Have you had any vaccinations in the past 12 months? If ‘yes’
please specify:
Have you sought medical attention in the past 6 months?
Have you had transfusion of donated blood or its components in
the past 12 months?
Answers
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8.
9.
10.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
23.
24.
25.
26.
Have you had any surgery (including cosmetological ones) in the
past 4 months?
Have you taken any medicinal drugs including aspirin or
antibiotics, or growth hormones in the past 2 weeks?
Have you had any intravenous or intramuscular injections in the
past 4 months?
Have you had acupuncture, tattoos, piercing in the past 4
months?
Have you ever had unmotivated temperature rise, weight loss,
faintness, night-sweat?
Have you suffered from malaria, tuberculosis, brucellosis,
syphilis?
Is your work or hobby associated with any danger to your life or
the life of others (motor vehicle driving, stay in high-altitude or
underwater environment, work with high voltage power lines and
Have you read and understood the information about AIDS (HIV
infection) and viral hepatitides?
Have you changed your surname? If ‘yes’ please specify the
previous surname?
2. Have you ever had grave diseases, such as:
Heart disease, high or low blood pressure?
Severe hypersensitivity, asthma?
Convulsions or nervous disorders?
Chronic diseases, such as diabetes or cancer?
3. Have you:
Travelled abroad in the past 3 years? Specify the country?
Have you ever donated blood as a donor?
Have you ever been rejected to donate blood?
4. Additionally for females:
Are you pregnant now or were you pregnant in the past 6
months?
Are you breastfeeding?
5. Additionally for self-assessment:
Have you ever made yourself injections of any medical drugs or
narcotic substances?
Have you ever accepted payment for sexual favors?
Over the past 12 months, have you had sexual relationship with
persons that:
are infected with HIV or hepatitis virus?
used narcotic substances intravenously?
receive or have received payment for sexual favors?
with other males? (for males).
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Have you ever suffered from sexually transmitted diseases?
Have you ever had contacts with a person suffering from
hepatitis (within family or at work)?
Was there a contact between blood of other person and your
mucosa or stab with an injection needle?
Note:
If over the past six months you had a reason to answer ‘yes’ to
one or more questions of this paragraph write ‘Yes’. If there is no
reason to answer ‘yes” to one or more questions of this paragraph
write ‘No’.
I confirm that I am donating blood or its components voluntarily, without any
compulsion and my blood or its components may be used for medical purposes.
I agree that my blood will be tested for HIV, syphilis, hepatitides B and C, and
other infections.
I have been warned that in case of positive results of tests for markers of the
above mentioned infections the information will be transferred to the respective
medical organizations for establishing diagnosis and making decision about
treatment.
I understand that the laboratory tests of my blood are conducted exclusively for
the safety of patients.
I declare that I have completely understood all questions in the questionnaire
and provided true answers thereto realizing the importance of that information for me
and for the health of patients.
I have been warned about the use of my personal data for the purpose of
creating the donors database and about the fact that processing of such data is made
with the use of automated information systems.
I agree to receive information mails with the aim of inviting to the participation
in donation via mobile communication or electronic mail.
I have been warned that in case of provision of inaccurate information I can be
made liable pursuant to the laws of the Republic of Kazakhstan.
I confirm that I have completely understood all above listed questions that have
been explained to me in ___________________ language by the physician
________________________
The donor’s signature _____________________
The physician’s signature __________________________ Date_________________
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Appendix 2
to the Regulations of medical examination of a donor
prior to donation of blood and its components
Information Sheet
Dear Donor!
Subject to satisfactory condition of your health, your donated blood can help
and even rescue the life of patients requiring blood transfusion. Although all blood
goes through the stringent tests in the center in order to exclude the presence of any
viruses, however, certain viruses such as HIV or hepatitis virus are not always
detectable at an early stage of infection. If you were exposed to the risk of
introduction of infection, then your blood may turn to be a disease carrier and make
harm to patients, who would receive it in the course of transfusion. That is why it is
very important to read this information carefully and give straightforward answers to
the question of the provided questionnaire and give to the utmost honest answers to
the questions of the physician, who will talk to you. You may rest assured that all the
information provided by you is confidential and will be used for the purpose of the
safety of blood transfusion only. Your blood tests results will be provided to you after
presentation of the identity document only. In case of positive result of the analysis
for presence of the virus, the respective medical organizations of the city will be also
informed. You may be invited for subsequent examination, which is extremely
important for your health.
Dear Donor!
If your desire is to pass the HIV test please address to the AIDS Prevention and
Control Center or to your local physician but do not donate blood. At any stage you
can inform the personnel on your desire to refuse donation of blood or on the fact that
your blood cannot be transfused to patients.
The duration of registration and blood donation procedure is 30 minutes on
average. Before the blood donation you will be offered tea with sugar-containing
confectioneries.
At all stages of preliminary examination and blood collection, disposable
expendable materials are used.
We appreciate your willingness to donate blood for people who require it!
Recommendations for the donor after blood donation:
Item What should be done after the completion of blood What should not be done
No.
donation
after blood donation
1.
After removal of the needle from your vein and
Abstain from smoking and
application of dressing the arm should be bended
drinking alcohol during 2
and held in that position for about 5-10 minutes
hours
2.
Plentiful drinking and rest for at least 10 minutes
Abstain from activity
within the premises of the Blood Center is
requiring material
recommended as well as drinking larger volume of physical effort during 8
liquid than usual during the next 24 hours after
hours
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3.
blood donation
If you feel sick, immediately report to any medical
officer of the Center and do not leave the Blood
Center without permission of medical personnel
You should not lift heavy
loads and take actions
associated with physical
effort with your arm, from
which blood was taken,
during 12 hours
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Front face
Appendix 3
to the Regulations of medical examination of a donor
prior to donation of blood and its components
Form
Donor Certificate
Reverse side
Republic of Kazakhstan
Ministry of Healthcare and
Social Development
Donor
Certificate________________
__
(issuing authority)
Name
________________________
__
First name
________________________
__
Patronymic
________________________
__
Identity card No.
______________
Date of issue
_______________
Blood group
Rhesus factor
Manager _______________
(signature)
Donation Donation type Authorized
Note
date Blood Plasma signature
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Appendix 4
to the Regulations of medical examination of a donor
prior to donation of blood and its components
Item
Test items
No.
1.
Hemoglobin
Laboratory normal ranges
Ranges
Men - not less than 120
gram/liter (hereinafter the
“g/l”),
Women - not less than 110 g/l
Men – 0.40-0.48
Women – 0.36-0.42
Men - (4.0-5.5)х1012/liter
Women -(3.7-4.7)х1012/liter
2.
Hematocrit
3.
Red blood
cells count
4.
ESR
5.
Platelets count
6.
While blood
cells count **
7.
Reticulocytes
8.
Total protein
of blood serum
Protein
Albumen 53.9-62.1 %
fractions of
Globulins 46.1-37.9 %:
blood serum:
a1 – globulins -2.7-5.1 %
a2 – globulins – 7.4-10.2 %
b – globulins – 11.7-15.3 %
g – globulins – 15.6-21.4 %
Bleeding time 2-5 minutes
Blood clotting 5-10 minutes
time
9.
10
11
Study methods*
Colorimetric methods,
automatic analyzers
Centrifugal methods
Count in automatic
analyzer or Goryaev
chamber
Men not more than 10
Panchenkov
millimeter per hour (hereinafter micromethod,
“mm/h”)
automatic analyzers
Women not more than 15 mm/h
Not less than 160х109/liter
Count in Goryaev
chamber, count in
stained smear of blood,
count in automatic
analyzer
9
(4 - 9) х 10 /liter
Count in automatic
counter or Goryaev
chamber
2-10 %
Count in stained
smear, automatic
hematologic analyzers
Not less than 65 g/l
Biuret method
Electrophoretic
method
Duke method
Lee-White method
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Appendix 5
to the Regulations of medical examination of a donor
prior to donation of blood and its components
Criteria for permanent rejection to donate blood and its components
Item No.
Description
1.
Infectious diseases: hepatitis B and C, HIV infection, syphilis, tuberculosis
(all forms), tularemia, epidemic typhus, leprosy, positive result of the test
for hepatitis B and C viral markers, HIV syphilis
2.
Use of injectable narcotics
3.
Parasitic diseases: echinococcosis, toxoplasmaosis, trypanosomiasis,
filariasis, Duinea-worm disease, leishmaniasis
4.
Subacute blood-induced spongiform encephalopathies (hereinafter the
“SBISE”): kuru, Creutzfeldt-Jacob disease, Gerstmann-Straussler
syndrome; persons with SBISE in the family anamnesis; amyotrophic
leukospongiosis
5.
Presence of information on treatment with human hypophysis drugs,
growth hormones in the medical history
6.
Cardiovascular diseases: hypertensive disease of the II-III grade; coronary
heart disease; atherosclerosis; aterosclerotic cardiosclerosis; obliterating
endarteritis; Takayasu's arteritis; recurrent trombophlebitis; endocarditises;
myocarditises; heart disease (congenital and acquired)
7.
Respiratory diseases with signs of respiratory compromise at the
decompensation stage
8.
Chronic liver diseases – hepatitides including such of toxic and unknown
etiology, liver cirrhosis
9.
Renal and urinoexcretory tracts diseases at the decompensation stage
10.
Endocrine system diseases in the presence of irreversible damage of
functions and metabolism, diabetes mellitus (insulin-dependent form)
11.
Organic diseases of the central nervous system
12.
Diffuse diseases of connective tissue
13.
Radiation disease
14.
Visual organs diseases: complete blindness
15.
Skin diseases: generalized psoriasis, vitiligo, deep mycosises
16.
Otolaryngological organs diseases: ozena, chronic severe pyoinflammatory
diseases
17.
Malignant neoplasmas and blood diseases
18.
Past surgeries with limb amputation; with amputation of parenchymal
and/or hollow organs or a part of organ (liver, kidney, lung, stomach)
19.
Acute and chronic osteomyelitis
20.
Organ transplantation
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21.
22.
23.
24.
25.
26.
27.
28.
29.
30.
31.
32.
33.
34.
35.
36.
37.
38.
39.
40.
41.
42.
43.
44.
45.
Total absence of the sense of hearing and speech
Confirmed information about anaphylaxis in the medical history
Autoimmune disease with the involvement of more than one organ
Established genetic diseases
Inherited and congenital pathologies including such of hemopoietic and
immune systems
Mental insanities and behavioral disorders
Oncological diseases including such in remission
Use of cytostatic and teratogenic drugs during pregnancy
Drug addiction, toxicomania, alcoholism in the medical history
Transfusion of blood and its components, operative interventions (including
abortions) in the past 12 months
Acupuncture treatment, making piercing and tattoos within 12 months
before childbirth
Permanent rejection to donate blood
Stillbirth
Child abandonment by mother
Anemia of pregnancy in the late pregnancy
Threatened miscarriage during the whole pregnancy period
Gestation period less than 38 weeks and more than 40 weeks of pregnancy
The second stage of uterine cake maturity
Presence of nonspecific infectious disease during the recent pregnancy
period in the medical history of the mother
The mother’s age above 40 years
The third birth and more
Multiple pregnancy
Over 4 hours duration of period without amniotic fluid
Cesarean section
Proven facts of risky behavior: provision of sexual services, promiscuity
Note:
Criteria of permanent rejection to donate blood envisaged in paragraphs 1, 2, 3,
4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, and 23, shall not apply
to autologous donors and donors of hematopoietic stem cells of peripheral blood. A
documented decision on admittance of such donors to donation shall be made by the
consulting physician of the recipient (autodonor);
Criteria of permanent rejection to donate blood envisaged in paragraphs 1, 24,
25, 26, 27, 28, 29, 30, 31, 32, 33, and 34, shall apply to donors of hematopoietic stem
cells of placental blood;
Criteria of permanent rejection to donate blood envisaged in paragraphs 35, 36,
37, 38, 39, 40, 41, 42, 43, and 44, associated with peculiarities of the course of
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gestation and labor are intended to improve the work of obstetric-gynecologic
personnel administering the medical assistance to a maternity patient and newborn
child and in case of need of the donation of hematopoietic stem cells of placental blood
shall not be taken into account.
17
Appendix 6
to the Regulations of medical examination of a donor
prior to donation of blood and its components
Criteria of temporary rejection to donate blood and its components
Item
No.
1.
2.
3.
4.
5.
6.
7.
8.
9.
Description
Temporary
rejection period
1. Transmissible infections contamination factors:
Transfusion of blood and its components (exception –
ambustial convalescents and persons immunized against
Rh factor)
Operative interventions including abortions,
appendectomy, cholecystectomy, genital system organs
and ambulatory surgery
Contact of allogenic blood with mucosa or stab with an
injection needle
Administration of allogenic stem cells
Transplantation of cornea, pachymeninx
Acupuncture, tattoo, and piercing
Household contact with patients suffering from
hepatitides B, C (to be established according to the
donor’s statement)
Household contact with patients suffering from
infectious jaundice (to be established according to the
donor’s statement)
Stay over 4 months in the countries with tropical and
subtropical climate that are endemic with respect to
blood induced diseases (Asia, Africa, South and Central
America)
10.
Tooth extraction
11.
Unproved facts of risky behavior: provision of sexual
services, promiscuity
12 months
4 months
4 months
4 months
4 months
4 months
6 months
35 days
after 4 months
admission to
donation subject to
the availability of
negative
preliminary test for
malaria
Subject to absence
of complications 10 days subject to
absence of
complications (due
to risk of incidental
bacteremia)
4 months
18
12
13
14
Period of temporary disqualification of donor in case of
unproved primary positive results of tests for VHB,
VHC, syphilis, HIV markers
Period of temporary rejection of the donor in case of
determination of the increased activity of ALT
Period of temporary rejection of donor in case of
deviation of the results of clinical laboratory tests
6 months with
subsequent followup examination
1 month with
subsequent followup examination
1 month with
subsequent followup examination
2. Past diseases and vaccinations
15.
Malaria
16.
Brucellosis (proved by laboratory test methods)
17.
Typhoid fever
18.
Quinsy
19.
Influenza, acute respiratory viral infection
20.
Infectious diseases falling outside of the scope of
permanent rejection criteria
Acute and chronic inflammatory diseases in the
exacerbation phase irrespective of localization
21.
22.
Acute glomerulonephritis
23.
Allergic diseases in the exacerbation phase
4 months after
complete clinical
and laboratorial
recovery
2 years after
complete clinical
and laboratorial
recovery
1 year after
complete clinical
and laboratorial
recovery subject to
absence of apparent
functional
disorders
1 month after
recovery
2 weeks after
recovery subject to
satisfactory state of
health
6 months after
recovery
1 month after
recovery or reversal
of acute period
5 years after
complete proven
recovery
2 months after
reversal of acute
period
19
24.
Vegetovascular dystonia
25.
Q-fever
26.
Pregnancy, childbirth, and lactation
27.
Immunization with killed vaccines (hepatitis B,
pertussis, paratyphoids, influenza, anatoxins, tetanus,
diphtheria and others).
Immunization with live vaccines (brucellosis, plague,
tularemia, tuberculosis, measles, rubella, epidemic
parotiditis, live attenuated typhoid vaccine, live
attenuated cholera vaccine, poliomyelitis and others).
Immunization against hydrophobia, tick-borne
encephalitis
28.
29.
30.
31.
32.
33.
34.
35.
36.
37.
38.
39.
1 month after
treatment
2 years с after
complete clinical
recovery
1 year after
childbirth
2 weeks
4 weeks
1 year after contact
with the source of
infection
2 weeks
Mantoux test (in the absence of apparent inflammatory
events on the spot of injection)
3. Rejection by the physician due to general state of health and other
factors
Alcohol ingestion
48 hours
Antibiotic intake
2 weeks after
termination of
medication
Analgesic, salicylates intake
3 days after
termination of
medication
Pulse rate below 50 and above 100 beats per minute,
48 hours
arrhythmia
Systolic pressure above 180 millimeters of mercury
48 hours
(hereinafter the “mm Hg”) or below 100 mm Hg
Diastolic pressure above 100 mm Hg or below 60 mm
48 hours
Hg
Body temperature above 38°С
2 weeks
Night work before donation of blood
24 hours
4. Disqualification from donation in epidemiological situations
Epidemiological situations (for example, outbreak of
Disqualification
occurrence)
pursuant to
epidemiological
situation to be
determined by the
20
competent authority
in the area of
healthcare
Note:
Subject to the existence of other donor’s diseases and symptoms, which are not
included in this list, the issue about the donation shall be considered by the physician
conducting the medical examination, when necessary after the consultation with the
respective specialized doctor.
21
Appendix 7
to the Regulations of medical examination of a donor
prior to donation of blood and its components
Information to be provided to the donor
Before donation of blood and its components, the donor shall be informed with
regard to the following issues:
1. About the procedure of donation of blood and its components, and the
necessity to use blood components for treatment of patients.
2. About the purposes of laboratory tests of donors, the importance of
acquirement of reliable medical history data, and the significance of the voluntary
informed consent of the donor for donation of blood and its components.
3. About eventual temporary adverse reactions associated with the donation of
blood and its components.
4. About the right of the donor to refuse donation of blood and its components
before the procedure or at any time in the course of the procedure, which will not
entail any negative consequences for the donor.
5. About the guarantee of the confidentiality of the donor’s personal data and
his or her right to receive information on the results of tests.
6. About the fact that the detection of HIV antibodies and markers of viral
hepatitides B and C and other blood induced infections will result in permanent
rejection from donation, destruction of banked blood and its components and
compulsory transfer of that information to the respective healthcare organizations.
7. About the need to limit physical activity and psychoemotional stress
associated with dangerous types of activity during 24 hours after the donation of
blood and its components.
8. About the infections transmitted with blood and its components.
9. About clinical features and routes of HIV infection.
22
Appendix 8
to the Regulations of medical examination of a donor
prior to donation of blood and its components
Minimum intervals between different types of donation of blood and its
components
Plateletpheresis
One-fold red blood
cells exchange
Two-foldred blood
cells exchange
1.
Donation of whole
blood
60 days 30 days
30 days
30 days
60 days
90 days
2.
One-fold
plasmapheresis
7 days
7 days
7 days
7 days
7 days
7 days
3.
Two-fold
plasmapheresis or
hardware
plasmapheresis
14 days 14 days
14 days
14 days
14 days
14 days
4.
Plateletpheresis
14 days 14 days
14 days
14 days
14 days
14 days
5.
One-fold red blood cells
60 days 30 days
exchange
30 days
30 days
60 days
90 days
6.
120
days
for men
180
60 days
days
for
women
60 days
120 days 120 days
for men for men
180 days 180 days
for
for
women women
Item
No.
Initial procedure
Two-fold red blood
cells exchange
One-fold
plasmapheresis
Two-fold
plasmapheresis or
hardware
plasmapheresis
Donation of whole
blood
Subsequent procedure
60 days
23
Note:
In case of donations of plasma (including immune plasma) banking of plasma
in the volume not more than 20 liters per year taking into account anticoagulant shall
be made. After each 20 serial donations of plasma or platelets, the donor shall be
given rest for one month.
In case of donations of red blood cells by the method of apheresis, banking of
red blood cells during the year shall be made in the volume identical to the loss of red
blood cells in case of donation of whole blood for the similar period.
The interval between procedures may be shortened in exceptional
circumstances (in the absence of a donor with required blood group) at the discretion
of physician conducting the medical examination of the donor.
A plasmapheresis procedure with failed rinseback of red blood cells to the
donor shall be equated, with respect to intervals between different types of donations
of blood and its components, to the donation of whole blood.
Low doses blood banking shall be made not more than 3 times a week in the
volume of 10-30 milliliters of whole blood.
Maximum frequency of blood donation:
For male donors: 6 doses in the volume of 450 milliliters (hereinafter the “ml”)
± 10% per year;
For female donors: 4 doses in the volume of 450 milliliter (hereinafter the
“ml”) ± 10% per year.
The frequency and number of donations of peripheral blood HSC shall be
determined in accordance with the initial level of CD34+ in peripheral blood in the
amount of 20 cells in microliter and higher level of CD34+ cells in the finished
product not less than 2х106 per one kilogram of the recipient’s body weight.