143/2008 Sb.
DECREE
of 15 November 2004. April 2008
on the determination of detailed requirements to ensure the quality and safety of
human blood and its components (the Decree on human blood)
Change: 351/2010 Sb.
Change: 96/2014 Sb.
The Ministry of health shall, pursuant to section 114 para. 1 of law No.
378/2007 Coll., on pharmaceuticals and on amendments to some related laws
(law on medicinal products), hereinafter referred to as the "Act"):
PART THE FIRST
THE DECREE ON HUMAN BLOOD
§ 1
The subject of the edit
This Decree incorporates the relevant provisions of the European Communities ^ 1)
and lays down more specific requirements for the
and the subscription and the procedures to be performed) in connection with the collection, testing,
processing, storage and distribution of human blood and its components,
blood products and raw materials from human blood and its components for
the production of medicinal products (hereinafter referred to as "raw materials for further production"), dispersing blood
products, the importation of blood products and raw materials for further production from
a country which is a Member State of the European Communities (hereinafter referred to as
"import"), and their export to the country which is a Member State of the European
Community (hereinafter referred to as "export"),
(b)) the quality system and good manufacturing practice in the provision of activities
According to subparagraph (a)),
(c) the assessment of the eligibility of blood donors) and its components (hereinafter referred to as "donor")
and donor selection,
(d)) of the blood quality and safety of products and raw materials for further
the production,
e) manufacturing authorisation for blood products and raw materials for further production,
(f)) hemovigilanci and traceability.
§ 2
Basic concepts
For the purposes of this Ordinance, means the
and blood and its component) full of human blood and blood component, in particular
erythrocytes, thrombocytes, granulocytes, plasma, obtained from the donor and
processed for transfusion or further manufacture as a raw material for various
methods, such as centrifugation or filtration,
(b)) rotations of the place temporary or mobile mobile spaces, which are
outside the device, blood transfusion services, which are under his
control and are used for blood and its components,
(c)) traceability traceability of each individual unit
blood or its components, obtained from the donor to its final destination without
regardless of whether it is a recipient of a blood product manufacturer
medicinal or other final destination including the write-down, and also
in the opposite direction,
d) dismissal of blood or its components process that allows them to
approval and transfer from the sandbox for the purpose for which they are
intended for the use of the systems and procedures that will ensure that the final product
meets the requirements for release,
(e) distribution of the supply of blood products) to other devices of blood
services and blood banks or raw materials for further production manufacturers
medicinal products, including transportation; the distribution does not include issue
blood products for transfusion under section 67 para. 1 of the law on
Pharmaceuticals,
f) quality system organizational structure, responsibilities, procedures, processes,
and resources for implementing quality management, and quality management means the
coordinated activities for the management and control of the Organization at all
levels with regard to quality,
g) quality assurance of all activities from the collection to distribution, which
to ensure that blood and its components at all stages of production to the quality of the
required for the intended use,
(h)) to create a validation a documented and objective evidence that the
pre-defined requirements for a specific procedure or process can be
consistently fulfilled; part of the validation of the qualification, which is
Verify that the personnel, premises, equipment, or material provided
the expected results,
I) specifications, description of the criteria that must be met in order to
achieved the required standard of quality and safety, and
standard means the requirements that serve as a basis for comparison,
j) Apheresis method which gets one or more blood components
by machine processing of whole blood, with the remaining blood components are
returned to the donor during the process or at the end of the process.
§ 3
The system of quality and good manufacturing practice
(Section 67, paragraph 4 and 5 of the Act)
(1) the requirements for a quality system in blood transfusion services, and the device in the blood
the Bank, including requirements for good manufacturing practice are set out in
Annex No 1 of this order. These requirements are applied to the extent
that corresponds to the activities of the transfusion service or device, blood banks.
The requirements set out in annex 1 of this order applies for the blood, her
folder, transfusion products and raw materials for further production that came from
abroad.
(2) prior to the initiation of new activities and when you change activities, which may
influence the quality and safety of blood transfusion medicine and raw materials for
another production, the proposed changes to procedures or practices shall be validated. Additionally,
verifies that the requirements are achieved and demonstrates
that the transfusion product or raw material for the next production, which have
be released, meet the requirements on quality and safety.
§ 4
Procedures to be performed in connection with the collection
(Section 67, paragraph 4, of the Act)
(1) prior to any collection of blood or blood components donor designated for
the processing of the blood products or raw materials for further production
(hereinafter referred to as "subscription"), shall be carried out
and an interview in which) are provided to prospective donors information and
are obtained from him his identification information referred to in annex No. 2
This public notice and information about his State of health, and
(b) to assess the eligibility of a potential donor) and a selection of the donor to receive
so that, in the context of the available data preclude damage to the health of the donor and
damage to the health of the recipient of the medicinal product, which is supposed to be from the subscription
manufactured.
(2) the interview and the assessment referred to in paragraph 1 shall be carried out according to the requirements
laid down in annexes 2 and 3 of this Decree.
(3) each time the subscription is done by examination of diagnostic specimens
obtained from the donor (hereinafter referred to as "samples from the donor") including
and examination of available stamps) infection
1. the human immunodeficiency virus types 1 and 2 (hereinafter referred to as "HIV 1 and 2")
method of determination of antibodies and p24 antigen,
2. hepatitis B virus (hereinafter referred to as "HBV"), and this method of measurement
surface antigen,
3. hepatitis C virus ("HCV"), and this method of measurement
antibodies, and
4. the syphilis, and this method of determination of antibodies
b blood group) of the AB0 and RhD, character screening
screening irregular antibody direct antiglobulin, taking
independently verifies the result of blood groups in the Abo system; This
the examination shall not be conducted for raw materials for further production, unless such
examination by the processor required
c) according to the epidemiological situation for more imunohaematological examination and
further examination of the signs of infection by blood transfusion product specifications
or raw materials for further production.
(4) the Examination referred to in paragraph 3 (b). and) shall be carried out and evaluated according
Annex No. 3 part C of this Ordinance. Subscriptions and products originating from
the donor, which has been identified in accordance with annex 3, part C, repeatedly
reactive result one examination, is excluded from therapeutic use.
(5) in the case of autologous blood or its components examination
implemented and evaluated according to paragraph 3, for each series of subscriptions for
planned treatment performance. Autologous collection means blood or its
components collected from an individual and intended solely for subsequent transfusions
the same person or other human use in the same person.
(6) serious medical findings recorded in connection with the collection of blood or
donors shall be notified of its constituents.
§ 5
Dispensing of blood products and blood derivatives
(§ 4 paragraph 7, section 24, paragraph 3, and article 67, paragraph 4, and 11 of the law)
(1) the dispensing of blood products, and blood products is carried out
the conditions listed in Appendix 1, points 1 to 5 of this order.
(2) the blood transfusion products are issued on the basis of the request referred to in
requisition ^ 2).
(3) documentation that guides issued by the transfusion medicine, contains
and the name and address of the issuing) device or a blood transfusion services
the Bank,
(b) the health care facility) identification of Subscriber transfusion
the product, if this is not the same medical equipment, such as
issuing,
(c) the identification number and the name) of a blood product and the information referred to in
Annex No 1 (1). 7.1.4. subparagraph (a). a), b), c), (e)), and (h)) of this order,
(d)), the quantities of blood transfusion medicine and data to characterize the
the content of the active ingredient,
(e) the date of issue of blood product), and any requirements on
transport,
(f) the date of execution and the result) předtransfuzního examination, if
done, and the signature of the employee who made the examination
g) name or name, last name, and the number that uniquely identifies the
the treated person for which the transfusion medicine issues.
(4) a doctor who is an applicant for the issue of a blood product, the
provides information about the
and the blood transfusion medicine in the range) the specifications provided for in annex No. 1
paragraph. 5.1.3. the Decree,
(b) traceability requirements),
c) notification procedure of serious adverse reaction, serious adverse
or suspected event, including information about which data and
How to be provided to the issuing of transfusion device
services or the blood bank.
(5) the Transfusion Medicine blood bank or device returned by transfusion
the service can be reissued if
and it is in the original) as packaged for sale,
(b)) is not exposed to adverse effects on its quality, safety and
efficiency,
(c)) was considered to be appropriate by the qualified person ^ 3), found
a satisfactory and has been re-released on the basis of its recorded consent.
§ 6
Quality and safety of blood products
(Section 67, paragraph 2 and 4 of the Act)
(1) the minimum requirements for the quality and safety of the basic blood
the products are laid down in annex 4 of this Ordinance.
(2) before the start of the distribution and supply of a blood product that
It is not included among the basic transfusion products in annex 4 of this
the Decree, proceed in accordance with § 3 (1). 2 of this order including authentication,
that this transfusion medicine meets the requirements for the quality, safety and
It has a healing effect as set out in its specification.
§ 7
Conditions of storage of blood products
(Section 67, paragraph 4, of the Act)
The basic conditions of the storage of blood products are laid down in
Annex No 4 in part B of this order. These storage conditions and time
usability for blood products collected, processed and
stored procedure in the device-specific transfusion services shall be
so that the data characterizing the transfusion product pursuant to its
the specifications have been met throughout the period of application of blood transfusion
of the product.
§ 8
The traceability of
(Section 24, paragraph 2, and article 67, paragraph 4 and 5 of the Act)
(1) ensuring traceability Records shall include
transfusion device) services
1. identification of the transfusion service device; in the case of the Czech equipment
transfusion services, at least the identification code,
2. identification of the donor, according to annex 2 of part B, point 1 of this order,
3. identification of each unit of blood, its components, blood transfusion
medicine and raw materials for further production,
4. date of collection, indicating the day, month and year,
5. identification of medical devices manufacturers, research institutes,
receiving blood, its folder, transfusion medicine or
raw material for the next production (hereinafter referred to as "Subscriber"), or consequential
dealing with them, if they were not released in their own health care
the device,
(b)) at the Subscriber
1. identification of the supplier,
2. identification of each unit of blood, its components, blood transfusion
medicine and raw materials for further production,
3. identify the recipient to whom it was administered, of transfusion medicine
4. If the unit is not used for transfusion, data on
subsequent disposition of it,
5. date of transfusion or other disposition of blood, its components,
the blood transfusion product or raw material for further production, IE. year,
month, day,
6. batch number, if it is stated.
(2) if it is a unit of blood, its components, of a blood product or
raw materials for further production, which is supplied from abroad, or is
granted to foreign countries, shall ensure the traceability of at least
of paragraph 1.
§ 9
Monitoring of serious adverse reactions and events
(Section 24, paragraph 3, and article 67, paragraph 4, and 7 of the law)
(1) the procedures for monitoring adverse reactions in the recipient or
suspicion of them are introduced in accordance with § 24 para. 3 of the law on pharmaceuticals,
to include the reactions that are observed during and after transfusion
transfusion and are related to the administration of a blood product. Also how to
for the monitoring of adverse reactions in donors or suspected
are introduced to include reaction during and after the donation process
it. These procedures shall include the transfer of information equipment of transfusion
the service, which has produced products, and blood transfusion or blood banks,
that transfusion products.
(2) the notification of serious adverse reactions, serious adverse events
or suspected patterns shall apply the notification referred to in the annex No 5
part A of this Ordinance. This notice provides the National Institute for
drug control (hereinafter referred to as "the Institute") medical devices serving
blood transfusion, blood bank transfusion services or facilities (hereinafter referred to as
"indicating device") that a serious adverse reaction, severe
adverse event suspected or found.
(3) the report on the outcome of the investigation reported serious adverse reactions,
serious adverse events suspected or under paragraph 2 shall
provides pursuant to § 24 para. 3 of the Law Institute of the models referred to in
Annex No 5 (B) of this order. This message provides the Institute's blood
Bank or device that has a service of blood available handouts
for an investigation, the necessary laboratory tests and ensures the investigation.
(4) If a serious adverse reaction, serious adverse event or
suspicion on them with blood, its components, the blood transfusion with or
raw material for another production, supplied from abroad, the system
the notification referred to in paragraphs 1 to 3.
(5) for the submission of reports of serious adverse reactions and
the events that occurred during the calendar year, shall apply patterns
the report referred to in annex 6 of this Ordinance. Annual report on serious
adverse reactions and events provide the Institute of blood transfusion device
services and blood banks, to 30. April of the following year. In the device
transfusion services and blood bank issued by transfusion
products, creates the conditions for obtaining feedback on submissions
issued by the blood of the recipient, where appropriate, as with the blood transfusion
the product was loaded, if it is not used for the recipient, and to obtain
information about any serious adverse reactions and events which have
the link with the issued the blood transfusion medicine. Transfusion device services
and the blood bank to be classified in the report referred to in annex 6, point 1.2. and
point 2. This order data on serious adverse reactions and events
which were the subject of their investigation and the report referred to in paragraph 3.
§ 10
To suspected contamination of the blood product and raw material
or an intermediate product for the next production of the originator of the communicable diseases
(Section 67, paragraph 4, of the Act)
(1) in the event that the
and) were detected in donor reactive test results on repeatedly
signs of infection HIV 1 and 2, HBV and HCV, or other findings or clinical
symptoms in relation to these infections, or
(b)), the recipient has developed the transfusional infection referred to in point (a)),
that is associated with a suspected transmission of infection from a donor
equipment of transfusion services that pass the blood products or
raw material for the next production in accordance with Annex 1, point 7.2.1. of this order,
secure within 7 working days from the ascertainment of the facts referred to in
(a)), and (b)) the suspension of the use of all blood products and
raw materials for further production, whose shelf life is that
come from the risk of donations under section 67 para. 4 (b). h) of the Act, and
inform their customers. For risk subscriptions shall be all
subscriptions to blood donor made in 6 months period before the last collection, for
which were the results of the examination referred to in section 4, paragraph 4. 3 (b). a) points 1, 2 and
3 of this order.
(2) laboratory verification of the symptoms of infection, HIV 1 and 2, HBV and HCV in donors
within the reference laboratory for AIDS and reference
laboratory for viral hepatitis, when you repeatedly reactive
the results of the examination for characteristics of the infections listed or disputed
findings. In the case of confirmation of the award referred to in paragraph 1 (b). a) and b)
transfusion service provision without delay download suspended
blood products and raw materials for further production.
(3) If the donor is found to be a disease transmissible spongiform
encephalopathies or suspected transfusion services downloaded from the device
distribution of all transfusion products whose shelf life
in progress, and the raw materials for further production originating from any subscription
the same donor in the past and inform their customers.
(4) in the case of autologous blood transfusion product with unsatisfactory results
pursuant to section 4, paragraph 4. 3 (b). and it is a condition of this order), its release also
the written consent of a physician, transfusion medicine the autologous
requests for treatment.
§ 11
Application for a permit for the manufacture of blood products and raw materials for further
the production of
(Section 67, paragraph 2, of the Act)
(1) an application for a permit for the manufacture of blood products and raw materials for the
other production includes
and) name or name, last name, place of business and identification number,
If it was assigned to, a natural person applying for a permit; If the
This authorisation is sought a legal person, its commercial name, where appropriate,
name, address, delivery address, and identification number, if
allocated,
(b)), the name or names and surnames of the statutory representative of the persons referred to in
(a)),
(c)), the name or name, last name, education, and practice, the person responsible for
the professional activity of blood services, equipment
(d)), the name or name, last name, education, and practice of qualified persons and
their contact details,
(e)) the kind and range of production including quality control testing,
to be carried out,
(f)) list of blood products that will be produced,
g) addresses of all places of production and quality control, including the designation of the place
the production of blood products and raw materials for further production, which are
produced in the place of production,
h) the identification of the natural person or legal entity which, in the
the basis of the Treaty, will take over part of the production or quality control, to the extent
data referred to in point (a)), and
I) phone, fax and e-mail to the requestor.
(2) Furthermore, the request contains
and a description of the quality system), which in particular includes the
1. scheme of the internal arrangement, including the functions of responsible persons and their
hierarchy,
2. the basic document on the place of production,
3. number of staff and basic information about the level of their education and experience,
4. hygiene provisions
5. Description of the facilities and equipment and
6. the list of written procedures, including procedures for obtaining blood donors and
of its constituents, and reviews of donors, for processing, inspection, storage,
the transport, supply, distribution, and downloading of blood and its components,
blood products and raw materials for further production, for the treatment of
materials that may affect product quality and safety, including records for the
reporting and recording of serious adverse reactions and
events,
(b)) report documenting the creation of prerequisites for compliance with the requirements
referred to in § 24 para. 2 and 3 and section 67 para. 3, 4, 6 and 7 of the Act and in section 4 to
9 of this order, to the extent that it relates to the subject of the intended
activities,
(c)) the current extract from the commercial register, not older than 3 months, if
the person making the request is registered in the commercial register, or
proof of trade permissions, or the instrument of incorporation or
the statute issued by the competent authority of the Czech Republic or another Member
the State, which must not be older at the time of submission of the application for more than 30 days,
d) proof of the right to use the premises, buildings, rooms for the production of
blood products and raw materials for further production including equipment,
e) demonstrate that the requirements are met, a qualified person in accordance with §
67 para. 6 of the Act,
(f)) list of blood banks, which the applicant for an authorisation to supply, and
g) proof of payment of the administrative fee for filing an application and proof of
the implementation of cost recovery for the assessment of the application.
(3) the permit shall be subject to the changes referred to in the request for authorisation to
the production of blood products and raw materials for further production, or in the
application for authorisation of the changes that are listed in paragraph 1 (b). a), (d)),
(e)), g) and (h)).
(4) a request to allow changes to the data referred to in the request for authorisation to
the production of blood products and raw materials for further production includes data
referred to in paragraphs 1 and 2, in which the change occurs, and
the changes, for which authorization is sought, shall be indicated.
(5) in the devices blood transfusion service is carried out checks on compliance with
the law on pharmaceuticals and of this order and the particulars given in the application for at least
once every 2 years.
§ 12
The supply of a blood plasma product or for the production of blood derivatives
abroad and their supply from abroad
(Section 24, paragraph 4, 7 and 8 of the Act)
(1) an application for the issue of the consent of the Ministry of health to distribute the
between the Czech Republic and a Member State of the European communities,
import and export of blood and plasma products for the production of blood
derivatives in accordance with § 24 para. 4 of the Act contains
and) name or name, last name, place of business and identification number,
If it was assigned to, a natural person applying for consent; If the
This agreement calls for a legal entity, its business name, if applicable
name, address, delivery address, and identification number, if
allocated,
b) subitem of the combined nomenclature and the common customs tariff
her name, indicating that blood and its components referred to in annex I directly
of the applicable legislation of the European Union governing customs statistical
^ nomenclature 9), which are subject of the application,
(c) the quantity in net mass) or litres, including the size of the packaging,
(d) the proposed period of validity),
(e) the name of the country of origin) for blood products and plasma for production
blood derivatives, with respect to imports; the name of the State, which is the place of destination,
in the case of export,
f) identification of vendor and manufacturer of blood products and
plasma for the production of blood derivatives within the scope of the data referred to in point (a)),
g) blood products and plasma enumeration for the production of blood derivatives
According to the title of annex 4 of this Ordinance.
(2) the request under paragraph 1 shall be accompanied
and) an extract from the commercial register, or officially certified copy of provisioning
of the Charter, the person who asks for your consent,
(b)) to allow production or distribution with permission to distribute
blood plasma products, where appropriate, for the production of blood derivatives,
(c)) Declaration of compliance with requirements equivalent to the requirements of the Act and this
the Ordinance, in the case of imports,
d) a statement that the distribution, import or export of blood products and
plasma for the production of blood derivatives will be implemented only from donations
blood or plasma from voluntary unpaid donors ^ 7).
(3) information about the importation or exportation of blood products and
plasma for the production of blood products provided by the Ministry of
health care in accordance with § 24 para. 7 of the law containing the information listed in
paragraph 1 (b). a) to (c)), and (g)). This information shall be provided in any
in a way that is demonstrable.
(4) information on the distribution, import or export to an urgent
urgent need for blood transfusion medicine provided by the Ministry of
health care in accordance with § 24 para. the law contains
and) identification of the natural or legal person, that information
provides, in the range of the data referred to in paragraph 1 (b). and)
(b) the health care facility and) identification of his place of work, for which the
There was a need to ensure transfusion medicine for urgent emergency
the need for, and also internal data for the identification of the beneficiary also,
(c) the identity of the manufacturer of a blood product) and
(d)) the data referred to in paragraph 1 (b). (c)), e), (f) and (g))).
PART TWO
Amendment to Decree No 411/2004 Coll., laying down good manufacturing
practice, good distribution practices and detailed conditions enabling the production and
distribution of medicinal products, including medicated feedingstuffs, veterinary autogenních
vaccines, changes issued by authorised laboratories
(Decree on the manufacture and distribution of medicinal products)
section 13 of the
Part four of the Decree No 411/2004 Coll., laying down good manufacturing
practice, good distribution practices and detailed conditions enabling the production and
distribution of medicinal products, including medicated feedingstuffs, veterinary autogenních
vaccines, changes issued by authorised laboratories
(Decree on the manufacture and distribution of medicinal products), is hereby repealed.
PART THREE
The EFFECTIVENESS of the
§ 14
This Decree shall take effect on the date of its publication.
Minister:
Mudr. Julínek, MBA in r.
Annex 1
THE SYSTEM OF QUALITY AND GOOD MANUFACTURING PRACTICE
1. General principles
1.1.
The quality system
1. The quality system includes quality management, quality assurance,
good manufacturing practice and continued improvement of quality, employees,
premises, instruments and equipment, on the materials used, particularly when
subscriptions, processing and quality checks on documentation, procurement,
processing, storage, distribution, quality control, download blood and
its components, blood products and other raw materials for the production of
circulation, management of contractual relations and in cases of disagreement and on internal inspection,
where appropriate, external and internal audit.
2. The quality system shall ensure that all critical processes that can
directly or indirectly affect the quality, specified in appropriate instructions and
carried out in accordance with the standards and specifications laid down in this
the annex. The quality system is checked at regular intervals and
reviewing the effectiveness of corrective measures, including the adoption of
If it is deemed necessary.
1.2.
-Quality assurance
1. Quality assurance quality assurance function is created.
The employee to ensure that activity is involved in all matters
related to the quality and review and approve any documents
relating to the quality; It is equipped with adequate powers to an independent
the performance of this function.
2. All procedures, premises, instruments and equipment, which could
influence the quality and safety of blood, its components, blood
products and raw materials for further production, including quality control procedures,
before the introduction of validated and are repeatedly validated at intervals
laid down in accordance with the nature of the validation.
2. the staff and ORGANIZATION
1. the staff are available in sufficient numbers to be able to
carry out activities associated with the collection, testing, processing,
storage and distribution of blood and its components, blood products and
raw materials for further production, have appropriate training and practice, are
trained and assessed as competent to perform the tasks which are
instructed to.
2. Employees have the current work description clearly defining their tasks
and responsibility.
3. employees undergo initial and continuing training, adequate
their specific tasks. About training records are kept. Training
the programs also include good manufacturing practice.
4. The content of the training programmes are regularly assessed and support
employees are regularly evaluated.
5. Are there written safety and hygiene guidance
the activities to be carried out and which are included in the training of
employees.
6. Set out the organizational scheme, including the relationship of control and
subordination.
3. the premises
3.1.
The General principles of
1. the premises, including surfaces, are designed, sited, designed,
operated and maintained to suit the activities to be
perform and allow that the work was carried out in a logical sequence, it was
to minimise the risk of errors, the threat to the health of donors, employees and was
secure the quality and safety of blood and its components, blood
products and raw materials for further production. Requirements for spaces
apply, and mobile sampling locations.
2. In separate, separated by spaces, shall be carried out
and a confidential interview with the donor) and the assessment of the eligibility of donors for the collection,
b) subscriptions to blood or its components from donors,
(c) sampling and processing) of its constituents,
(d)) the storage of blood and its components released, their marking and
layoffs,
e) storage and dispensing of blood products released for treatment
use,
f) storage of the raw material released for the continued production,
g) laboratory activities.
Access to individual space to authorized personnel.
3.2.
Space for the collection
Sampling shall be carried out in the area designated for the safe removal of the blood or
its constituents from donors, appropriately equipped for the initial treatment
donors, for which adverse reaction or injury in connection with the
your donation or subscription.
3.3.
Space for storage
1. in the areas of storage ensures safe and separate
storage in such a way as to ensure the quality and safety of
of blood, its components, blood products and raw materials for the next
production, and that could cause errors and mix-ups. During storage are
physically separated units of blood or its components, taken in
the specific criteria. The requirement for a secure and separate storage of the
also apply to the various types of materials, including the materials delivered and
nepřevzatých and materials have not yet released.
2. prior to the dismissal of blood, its components or supplied materials including
reagent reagents for their use, acceptance, or rejection of, the
ensure separate storage for the period during which the redundancies
It is expected.
3. In case of failure of the device for storage or delivery failure
electrical energy is introduced replacement scheme.
4. Storage conditions are tracked and recorded, if these
conditions affect the quality.
3.4.
Space for waste disposal
The space for the safe disposal of waste, disposable one
use after contact with blood or its components, released the blood or
its components or disorder of blood transfusion medicine and raw materials for
For more production.
4. apparatus, equipment and MATERIALS
1. For the purpose of the use of instruments, equipment, and medical devices
(hereinafter referred to as "equipment") shall be carried out their calibration and qualification,
While the procedure is validated by their use. Equipment is maintained so as to
meet the planned purpose of use. Guidelines for the treatment of
a device for cleaning, maintenance, validation and calibration, include
also, the instructions of the manufacturer of the device. Their calibration, qualification and
validation of records are kept.
2. the device is selected so as to minimise the risk to the health
donors, employees and the quality of the blood and its components, blood
products and raw materials for further production and not to compromise their
safety.
3. selection and specifications, in particular diagnostic medical
in vitro, laboratory reagents and bags for subscriptions and
processing of blood and its components (hereinafter referred to as "materials"), including
dealing with them will be determined in the context of the documentation referred to in paragraph 1. 5.
Use only materials from approved suppliers
meet the requirements documentation. Materials and equipment, if they are
medical devices or diagnostic medical devices
in vitro, meet the requirements for the relevant medical devices and
they bear the CE marking. The absence of such materials and equipment available,
They shall apply to other, which verifies that correspond to equivalent standards.
This also applies in the case of materials used when taking in countries that
not a Member State of the European communities. Critical materials are
for use in transfusion services are released by an authorised device
by the employee.
4. When using the computer systems are regularly checks for software
hardware and backup systems to ensure reliability of the system,
in particular, if the include data input, processing and output
information that will be used for the transmission of messages, automatic control
or the documentation. The system shall be validated prior to use and keep it
a validated state. The hardware and software that protects against unauthorized
use or unauthorised changes. The backup procedure will avoid the loss of
or damage data during the expected or unexpected outages or
failure of the system functionality.
5. DOCUMENTATION
5.1.
Documents
1. Are developed, maintained and updated documents, in particular
standard operating procedures, instructions, specifications, materials,
specifications blood products and raw materials for further production, training
and methodological guide that describes and sets out how to be carried out
specific procedures and processes and ensure a quality system. These documents
are approved and checked by a qualified person.
2. all significant changes to the documents referred to in section 5.1.1. are
carried out without delay, are reviewed, detailing the date of the approval and
the validity of, and signed by a competent employee.
3. Specification of a blood product and raw material specifications for more
the production includes
and the name of the product) and its description,
(b) qualitative or quantitative) data on the composition and content of
packaging,
(c) the creation and) data on the characteristics of the product that are essential for the
quality, safety and efficacy, including information about the subscription and the materials
intended for the production,
(d) the data on the packaging), the pattern of labelling and also for blood transfusion of pattern
information provided by the doctor, who asks for his extradition,
e) information on the conditions of storage and transport, and of the time of application,
f) data relating to inspections of quality including the procedures for sampling and
the frequency of checks, the results of the checks, the criteria for their evaluation and
variation of quantifiable data,
g) information about the correct use, therapeutic indications, contraindications,
warnings and side effects in the case of transfusion medicine and the data
the purpose of the use, in the case of raw material for the next production.
5.2.
Records
1. the records may be handwritten or transferred to another medium such as
microfilm or documented in a computer system, and the
ensure readability throughout the period of their retention.
2. the records are controlled and are maintained to allow backward
finding the course and conditions, procedures, processes and ensure the system
quality, including reverse reconstruction of evaluation and decision.
3. the records are safe from unauthorized access,
unauthorized changes to data, loss, damage and replenishment. Are
procedures in place for dealing with non-compliance data.
4. The collected personal and health information of donors or
the recipient is treated so as to prevent unauthorised disclosure of
information about them. Are converted to anonymous data, if they have
access and persons other than employees, and healthcare professionals
to ensure the operation for which the data required are anonymous.
5. Part of the records is to report on the activities of transfusion services at the device
the past year involving
and the number of donors), and it
1. the total number of donors, with the exclude first time donors, who in the period
donated blood repeatedly, in the total number of donors indicate just once,
2. total number of recurring donors,
3. the total number of prvodárců,
(b)) the total numbers of individual types of subscriptions and the sum of all subscriptions,
(c)) the updated list of blood banks, transfusion services that
in the reference period of the supply,
(d)) the total number of unused full subscriptions,
(e)) the number of each type of subscription,
(f) the quantities produced and distributed), blood products and
raw materials for further production, whose name is given in annex No 4 section
And,
g) incidence and prevalence indicators on individual infections transmissible
the total number of transfusions and recurring donors, or prvodárců,
(h)) the number of packages downloaded blood products or raw materials for further
the production,
I) the number of reported serious adverse reactions and events.
The information in subparagraphs (a) (b)), d) and (e)) shall be reported separately for each of the types
subscriptions, in particular the collection of whole blood or plasma exchange or subscription
cytaferézou. The information in subparagraph (f)) shall be shown separately in the relevant
units for whole blood, red blood cells, platelets, plasma, and any
other types of products, whose name is indicated. Report on operations under the
the past year in electronic form shall be forwarded to the Ministry of health
until 31 December 2006. January of the following year in a manner allowing remote access.
5.3.
The development, management and preservation of documentation
and Documents shall be drawn up) for all procedures, processes and systems
order to operate standard and authenticated manner. Documents
provides everything that can directly or indirectly affect the safety of the donor,
employees, the quality and safety of blood and its components, blood
products and raw materials for further production. Demonstrate compliance with records
These documents, the law on pharmaceuticals and this order.
(b)) documents and records that the carry-over § 24 para. 2 of the law on
pharmaceuticals are kept for 15 years.
6. the collection and EXAMINATION of SAMPLES FROM the DONOR
6.1.
Eligibility of donors
1. Interview with the donor and the donor's eligibility assessment, leads to
ensure confidentiality.
2. Interview with the donor, the donor eligibility assessment performed by an authorized
a health professional to ensure that the records showing their
implementation, confirms by signing the records about the suitability of the donor and the final
an assessment of its eligibility to donate.
3. for the implementation of procedures for eligibility assessment and the selection of donors, donations and
the procedures that are associated with the collection, corresponds to the doctor.
6.2.
Donation of blood and its components
1. the procedure for the collection of blood and its components is designed have been verified and
safely recorded donor identification data, the binding between donor and
removed blood or its components or blood samples from the donor.
2. systems of sterile blood bags used in blood collection and its
folders, their processing, have the CE marking or to authenticate and are
collected to meet the equivalent standards, even in the case that
blood and its components are removed in the countries which are not Member State
Of the European communities. Records are kept so that the batch number
the used blood bag was traceable to each blood sampling or
the folder transfuznímu product or raw material for further production.
3. the collection and processing is carried out in a closed system, without breaking his
integrity, with the exception of injection at the opening of the subscription, or in any other
validated and equally safe procedure, which reduces to the minimum the risk of
microbial contamination.
4. For the collection of laboratory samples shall be taken from the donor and prior to the examination
will be stored under conditions that are appropriate for their examination.
5. the labelling of records, blood bags and laboratory samples,
the subscription number is designed to avoid any risk of error
When identifying or confusion.
6. After the collection of the blood and its components are treated in a manner that preserves
their quality during storage and transport temperature that corresponds to the
needs further processing.
7. Storage and transport conditions for blood, its components and for the samples
from the donor are validated.
8. the systems set up for the donation, procurement, and processing of blood and its
components, including record keeping, are put in place so that they are coherent.
6.3.
Laboratory examination of samples from donors
1. Before each operating a series of laboratory tests shall be carried out
operational validation procedure and reagents to be used
for the examination.
2. There shall be a clearly defined procedures for resolving discrepancies, with
order to ensure that blood and its components, which in case of serological
the screening examination repeatedly reactive results on viral
of infection referred to in § 4, paragraph 4. 3 (b). and) of this order, are excluded from the
therapeutic use and be stored separately in a dedicated
space for this purpose. In the case of confirmed positive results,
ensure that the appropriate measures pursuant to section 10 of this Ordinance.
3. use only reagents, whose suitability and verification for
laboratory examination of samples from the donor are documented in the records.
4. The quality of laboratory investigations are periodically examines the participation in
eligibility verification system within the laboratory examination
provided samples and evaluating results.
5. Examination of the donor, according to the specific situation extends, for example,
repeated blood group donor who donates blood or its
the folder for the first time.
7. the processing of
1. processing includes any procedure that is carried out between the collection of
blood or its components and the development of a blood product or raw material
for the continued production, including the release of a blood product for
distribution, supply and release of the raw materials for further production.
2. the processing of blood and its components is carried out using validated
procedures, including measures to avoid the risk of contamination and
Microbial growth in the manufactured blood components, blood
products and raw materials for further production.
3. Equipment and materials are used in the processing of blood or its
ingredients in accordance with validated procedures.
7.1.
Labelling
1. the Packaging of all units in all stages of the production marks the data
enabling them to be uniquely identified. Sign clearly
distinguish released released units of blood and blood components.
2. The labelling system collected blood, its components, intermediate,
blood products, raw materials for further production and samples is introduced
so, to be perfectly identified by their type and content and have been met
requirements on their marking and traceability.
3. provide for the designation of autologous blood and its components at all stages of
the production.
4. each transfusion medicine against dismissal is indicated by a label on the
which States:
and the identification number of a blood product), which includes
installation identification code assigned by the Institute of blood transfusion services,
the last two digits of the year of the subscription, registration number, the type of subscription
transfusion medicine and in the split of the part,
(b) the name of a blood product)
(c) the name and address of the device), transfusion services, the final transfusion
product is released,
(d) the quantity of a blood product;) This means the volume or weight of the
of, or the content of the active ingredient, expressed as the number of cells,
e) name, composition and volume of the used protisrážlivého solution, or
added solution,
f) temperature, and other conditions required for the storage of
transfusion medicine,
g) date of collection,
h) the expiry date and, in the case of the shelf life of a blood
of the 48 hours whether or not the exact time
I) blood group Abo system (A, B, 0, AB)
j D) character the Rh system [RhD positive, RhD negative], and other characters
If determined,
k) for plasma for clinical use matching the results of the
examination of the donor. 7.2.,
l) for blood product produced from autologous collection, clear
autologous donation and name, surname, and the identification number of the person
that is also the recipient of the blood transfusion and donor of the product; in the case of
transfusion medicine is unsatisfactory in any examination under section 10, paragraph 1.
4 of this order, give notice "does not meet within the prescribed
the tests ".
The information referred to in subparagraph (a). a), b), (g)) and i) on the label of a blood
They also indicate the product barcode. Raw material for the next production is
before the release of the label on which the marks are given according to the data
the request processor, at a minimum, however, the information referred to in subparagraph (a). and)
(c)), f) and (g)).
7.2.
The release of blood and its components
1. Is there a reliable system to ensure that it is not relased
a unit of blood or its components if they do not meet all of the mandatory
the requirements laid down by the law on pharmaceuticals. It is confirmed that before the
the release has been verified that all the records are available, including
medical records, production records, records on the examination, the results of the
examination, and that there is evidence of fulfilment of all the conditions and criteria referred to in
blood transfusion services, devices, documents, including the appearance and markings
the final product is in conformity with the specifications of a blood product
or raw materials for further production.
2. in the batch of plasma for clinical use to evaluate compliant
the results of the examination of the donor, particularly to HIV 1 and 2,
HBV and HCV using a sample collected from the donor after the expiry of at least
such a time interval during which occurs in healthy persons, in
If infected, to change the outcome of the examinations of negative
on the positive. This interval is at least 6 months shall be carried out
the tests referred to in section 4, paragraph 4. 3 (b). and) point 1 to 3 of this order. In
where is the service used, validated method of blood transfusion
inactivation of pathogens in the plasma, which was allowed by the Institute pursuant to § 67
paragraph. 2 of the Act, the repeated examination of the donor does not.
3. the records of which are established formal release
all blood products and packaging materials for further production
qualified person in ^ 3).
4. Before release, blood and its components shall be kept administratively and
physically separate from released blood products and released
raw materials for other uses.
5. in the event that the transfusion product or raw material for the next production
When you release fails due to the unsatisfactory outcome of the
examination of the infection in the donor, proceed according to section 10 and annex No. 3 part
(C) of this order, and donor records, according to the results of the tests as soon as
updated.
6. in the event that, during the period of application of transfusion medicine
changes the criteria for their quality or safety shall be assessed by a qualified
person ^ 3), whether the application of those criteria may unduly
affect the safety and effectiveness of treatment his transfusion
products which have not yet been used. If needed, download
the number of transfusion products and carry out the necessary measures
to exclude them from medicinal use. The qualified person shall record the
the conclusions of the assessment, the reasons for them, the follow-up and the measures adopted
measures.
8. storage and distribution, import and export
1. the procedures for storage and distribution are validated to ensure
the quality of the blood, its components, blood products or raw materials for
the continued production during the whole period of storage and eliminate the confusion.
During the storage, distribution and transportation is provided the integrity of the packaging,
protection from pollution, damage and confusion. Monitors compliance with the
the shelf life of blood products and raw materials for further production and
the conditions laid down for storage.
2. all activities in warehousing, distribution, import and export, including
reception and transportation are defined by written procedures and specifications and
are records kept of them.
3. Autologous blood, its components and blood products, as well as
subscriptions and preparations intended for specific purposes shall be stored,
carry, deliver and receive separately.
4. in the context of equipment quality transfusion service during storage
and distribution of raw materials for further production including distribution abroad, and
from abroad, it also ensures compliance with the requirements of good manufacturing
practice for medicinal products ^ 4).
5. When receiving blood products or blood derivatives are
controls the appearance and integrity of the packaging, completeness and conformity of the delivered
documentation with the information on the label, blood products or blood
derivatives, including the provision of storage conditions during transport.
6. On imports and exports shall apply requirements equivalent to those
of this annex.
9. QUALITY CONTROL
1. Carry out the quality control, which checks the fulfilment of
requirements on quality and safety in the undertaken activities. Checks
in particular, the quality
and examination of the samples from the donor) during each donation in accordance with § 4 para. 3 and 4
of this order,
(b) checking final products) at least to the extent of annex 4, part B,
of this order; control volume or weight, the active ingredients,
unwanted components and indicators of the effect, security and stability, according to the
laid down specifications, with regard to the final product that is not listed in the
Annex No. 4 in part A of this order,
(c) the checks referred to in point 2) to be carried out as necessary for intermediates in the
during production,
(d) checks on the effectiveness of disinfection) places venepunkce prior to the collection of blood and
of its constituents,
e) microbiological checks of blood products in order to control
the process of collection and processing,
f) microbiological checks of surfaces in areas where there are handled with the
bags, subscriptions and products in bags without packaging by
at random,
g) checks the supplied materials for subscriptions, processing and control
quality according to the specifications of the material; shall be carried out prior to the inclusion
material to use in the transfusion service device.
During the checks referred to in point (a). b) to (e)) uses a random selection
samples and controls shall be carried out for the purpose of statistical process control,
2. the checks referred to in point 1 (b). (b)) shall be carried out so as to enable the
statistical process control of production of each type of blood
products, including the process of storage during the period of application of the
blood transfusion medicine.
3. in the quality control laboratory is progressing well. 6.3.
section 1., 3. and 4 a (1). 7. point 3., if possible.
4. the procedure for obtaining and maintaining the sample shall be validated. Ensures that
quality control sample reflect the properties that are the subject of
checks.
For the examination of characteristics of infectious diseases must keep installations
transfusion service sample from the donor to each donation of blood or its
folder. If the sample is not used up to the examination when doubts about the
quality and safety of blood transfusion medicine and raw materials for the next
the production referred to in annex No. 3 part (C) of this order, shall be kept for a period of
at least 1 year after the expiry date of a blood product;
raw materials for further production, the sample is kept for a minimum period of 2 years from
their delivery for the next production.
10. The MANAGEMENT of CONTRACTUAL RELATIONS
Tasks performed externally shall be laid down in a specific written agreement
It defines the responsibilities of each party, in particular compliance with the law on pharmaceuticals
and the person who has to perform tasks and its agreement with checks
carried out by the Institute and the entrusted employee device transfusion
the service defines the manner in which the qualified person ^ 3)
transfusion services to discharge his responsibilities.
11. DISAGREEMENTS
11.1. derogations
Blood transfusion products, where it is found that deviate from the
the required standards set out in annex 4 of this order, the
be released for transfusion only in exceptional cases, and it is
recorded the agreement of the prescribing physician and qualified person ^ 3)
the blood establishment.
11.2.
Complaints
All complaints and other information, including serious adverse reactions
or serious adverse events that could indicate that they have been
issued defective blood products or delivered defective raw material
for the continued production, shall be documented and examined the causes of that failure
they caused. If necessary, blood, its components and transfusion
preparations to withdraw from circulation, and carry out remedial action to the situation
not repeated.
11.3.
Withdrawal from circulation
1. monitoring of blood, its components, blood products and raw materials for the
another production, which can endanger the recipient, shall be carried out according to the procedure
comprising also a predetermined limits of each step of the procedure.
Shall be assessed and, where possible, also performs the retrieval and download
of blood, its components, blood products and raw materials for further production
from earlier donations the donor, which is identified as
possible originator of the threat to the recipient. In the case of possible threats to the recipient,
to provide information to subscribers of the blood products or raw materials
for the continued production, donors or recipients.
2. In case of withdrawal of blood, its components, blood products and
raw materials for further production from circulation shall be determined by personnel authorised to assess the
the necessity of withdrawal, who will initiate and coordinate the necessary steps leading to the
their withdrawal.
3. effective procedure shall be accurate, effective, verifiable download
blood, blood components and blood products from circulation, which include
description of the responsibilities and the steps that will be taken, including the notification information
to download the Institute. Information about the need for raw materials for download more
the production will be transmitted to its customers and the Institute.
4. in the case that subsequently discovers that it was not properly carried out some
examinations referred to in section 4, paragraph 4. 3 of this order, equipment service, transfusion
that pass the transfusion-related products or raw materials for
another production, shall inform their customers and ensure their
the withdrawal from use.
11.4.
Corrective and preventive action
1. Establish a system for the provision of corrective and preventive actions
for blood, its components, transfusion products and raw material for the next
the production, which do not conform to the requirements on quality and safety.
2. the data tracked in transfusion device services are analysed with a view to
identify variances that could be the reason for remedial or
preventive measures.
3. all errors, accidents, complaints, complaints, serious adverse
reactions and serious adverse events should be documented and examined with a view to
identify system problems to be remedied.
12. INTERNAL INSPECTIONS, audits and improvement
1. All stages of the activity they are classified in a system of internal inspection and
audits in order to monitor and evaluate the quality system. Internal
inspection and audit shall be carried out regularly in accordance with approved procedures.
It is carried out by trained and competent persons in a self-employed capacity
to the subject matter of the inspection.
2. all internal inspection and audit results shall be documented. In a timely and
an effective way to implement corrective and preventive actions.
Annex 2
PART AND
The information provided to prospective donors of blood or its components
Each prospective donors of blood or its components is provided
and the lesson of the necessity of blood), about the process of donating blood and its components
(hereinafter referred to as "donation"), about the ingredients coming from donations of whole blood and
from donations Apheresis and about significant benefits of voluntary unpaid
donation for patients in the form of precise, for the general public
user-friendly educational materials,
b) information about the reasons for which the required examination of the donor,
medical history, medical history, testing of donations and the importance of
informed consent,
(c)) in the allogeneic donations, information on the reasons for exclusion procedures,
temporary and permanent exclusion; the information shall state the reasons for which
donors do not donate blood or its components if it could
be a risk for the recipient or the donor's health was at risk;
the allogeneic collection means the donation of blood or its components to one person,
intended for transfusion to another person, or intended for use as raw material
for the continued production,
(d)) for autologous donations, the information about it, why would a subscription did not
take place because of the health risk,
e) information about the protection of personal data, and how to avoid
unauthorized disclosure of the identity of the donor, of information concerning the donor's health,
výsledkcích examinations, information provided by the donor and
details about the possible exclusion of the donor,
(f) specific information on procedures) alogenního or autologous collection
and the associated risks; for autologous donations, information about
the possibility that the autologous transfusion products may not be sufficient to
cover the requirements for the transfusion,
g) information about the fact that donors may change their mind before proceeding to the
collection, or about the possibility of resignation or exclusion procedures at any time during the
the subscription process without hindrance and discomfort,
h) lessons about why it is important that donors inform the blood transfusion
the device of any subsequent event that may call into question the appropriateness of the
one of the previous subscriptions for Administration of transfusion,
as well as information about the responsibility of the device) transfusion services to inform
donor in an appropriate manner, if some of the results of the examination of
significant for his health,
j) information about the reasons for that are not used and excludes autologous
blood transfusion products, including information about how it is cannot be used for
other patients,
allogeneic transplantations) at the information about the results of the tests
revealed indicators of HIV 1 and 2, HBV, HCV or other infectious agents,
portable blood, will lead to the exclusion of the donor and the depreciation taken
units,
l) an indication of the fact that the donor may at any time to ask questions.
PART (B)
Information that donors give blood transfusion service every time
subscription
1. The information provided by the donor include
a) data that uniquely identifies the donor (name or name, last name,
social security number, address), contact information, and
(b)), health information and medical history of the donor on the basis of personal
an interview with the official responsible for the medical professional, which shall be recorded in
the questionnaire of the donor; the data contain important factors that can help
to identify and exclude people whose collection could pose a
a health risk to others, such as the possibility of transmitting diseases, or
bringing the disproportionate health risks for the donor itself
2. The donor's signature confirms that the
and read the provided information materials) and understood,
(b)) had the opportunity to ask questions,
(c)) got satisfactory answers to all the questions raised,
(d)) gave informed consent to carry out sampling and lab
the examination,
e) in the case of autologous donations was informed that collected blood and its
the folder may not be sufficient for the intended transfusion needs and
(f) the information provided by it) are true.
3. A record of the interview with the donor confirms by signature of the donor and the designated
health professional conducting the interview with the donor, and the assessment of
eligibility of donors to donate.
Annex 3
SELECTION CRITERIA FOR DONORS OF BLOOD AND ITS COMPONENTS
PART AND
1. the criteria for the acceptance of donors of blood and its components for autologous donations
do not apply the criteria of this annex, with the exception of part B
(4).
In exceptional circumstances, be made to individual subscriptions and for
donors who do not meet the criteria of this annex, are enabled and
documented by authorized medical professional equipment of transfusion
the service. For these exceptions to the principles of the quality system and in particular
documentation requirements and the provisions of annex 1, paragraph 1. 11.1 this
the Decree.
1.1. Age and body weight of donors
------------------------------------ -----------------------------------------------------
Age 18 to 65 years
-------------------- -----------------------------------------------------
For the first time with the consent of the donor of the blood transfusion service, device doctor
age over 60 years
------------------- ----------------------------------------------------
Over 65 years old, exceptionally; with the consent of a physician, transfusion device
services
------------------------------------ -----------------------------------------------------
Body weight > = 50 kg for donors of whole blood or its components, Apheresis;
------------------------------------ -----------------------------------------------------
1.2. Haemoglobin in the blood donor
-------------------------------------------------- -----------------------------------
Hemoglobin in women in men in allogeneic donors of whole krvea
> = 125 g/l > = 135 g/l of cellular blood components, if not
stated otherwise
-------------------------------------------------- -----------------------------------
1.3. The value of protein in the blood donor
------------------------------ ------------------------------------------------------------
Protein > = 60 g/l for donations of plasma by Apheresis is done at least once a year
analysis of protein
------------------------------ ------------------------------------------------------------
1.4. platelet Values in donor's blood
------------------------------ ------------------------------------------------------------
Platelets, platelet count higher for platelet apheresis donors
than or equal to 150 x 109/l
------------------------------ ------------------------------------------------------------
2. the frequency of donations and the maximum amount of blood and its subscribed folders
2.1.
Donations of whole blood
1. standard subscription is 450 ml with a tolerance of 10% without
protisrážlivého solution; donors should not be removed while a subscription read more
than 13% of the calculated blood volume.
2. The minimum interval between two successive subscriptions is 8 weeks,
While the total number of standard subscriptions made during 12
months is no more than 5 men and 4 women.
3. In paediatric autologous donations must be removed no more than 10.5 ml of blood
on 1 kg of body weight of the donor.
2.2.
Instrument subscriptions of erythrocytes
(hereinafter referred to as "erytrocytaferéza")
1. For simple erytrocytaferézu the same restrictions apply as when
standard whole blood donations. When subscribing to two units of red cells
the technique of erytrocytaferézy is the minimum interval between two double
erytrocytaferézami or double erytrocytaferézou and the following
the standard collection of whole blood for at least 6 months.
2. The minimum interval between the standard collection and subsequent double
erytrocytaferézou is 3 months. The total amount of red cells collected in the
during the 12 months corresponds to the maximum amount that is in the
standard whole blood donations. After the collection should be the haemoglobin in
the donor greater than 110 g/l.
2.3.
Plasma subscriptions
1. the quantities of the plasma removed during one of the subscription without protisrážlivého
the solution is not more than 650 ml if not administered intravenously replacement
the solution. The amount of plasma collected in one week is not more than 1.5 liter.
The total volume of plasma without protisrážlivého solution taken within 12
months is not greater than 25 litres.
2. The minimum interval between the collection of plasma and subsequent standard
the collection of whole blood or platelets is 48 hours. The minimum interval between
the standard collection of whole blood and plasma collection is 4 weeks
the failure of the return of red blood cells for the collection of plasma is considered as
the standard collection of whole blood. The minimum interval between two device
plasma donations is 14 days.
2.4.
Instrument platelet subscriptions
1. The total number of donations made during the 12 months is up to 24.
2. the minimum interval between two donations of blood platelets, or between the collection of
the platelets and the standard collection of whole blood or plasma collection is 48
hours. The minimum interval between the standard collection of whole blood and taking over
the platelets is 4 weeks. If there is a failure to return when sampling red cell
platelets, this subscription is assessed as a standard collection of whole blood.
2.5.
Subscriptions to multiple blood components
The total volume of collected blood without protisrážlivého solution folder
does not exceed 13% of the calculated blood volume of the donor, if it is not given
intravenous replacement solution. The total collected quantity of each
components do not exceed the quantities set for the various species of subscriptions.
2.6.
Sampling policy
The volume of blood samples for laboratory tests carried out during any of the
types of subscription does not exceed 30 ml.
PART (B)
Deferral criteria for donors of blood and its components
Details marked with an asterisk are not honored when sampling, which is carried out
solely for the purpose of processing the plasma for the production of blood derivatives.
1. permanent deferral criteria for donors of allogeneic donations
----------------------------------- --------------------------------------------------------------
Cardiovascular disease potential donors with severe cardiovascular disease
current or past, with the exception of the completely cleaned
congenital anomalies
----------------------------------- --------------------------------------------------------------
Central nervous system disease serious disease of central nervous system in the history of
System
----------------------------------- --------------------------------------------------------------
Abnormal bleeding tendency of potential donors, who reported a history of coagulopathy
----------------------------------- --------------------------------------------------------------
Recurring events with the exception of a sudden loss of seizures in childhood or with výjimkoupřípadů, when
consciousness or convulsions in the history of at least three years have elapsed after the last administration anticonvulsants
----------------------------------- --------------------------------------------------------------
Diseases of potential donors are serious probíhajícímchronickým or
gastrointestinal, recurrent disease
Genitourinary, immune,
respiratory disease or
haematological, metabolic or
Renal
----------------------------------- ------------------------------------------------------------------
Diabetes is a potential donor being treated with insulin
----------------------------------- ------------------------------------------------------------------
Infectious disease hepatitis B in addition to the people with a negative test result on the
surface antigen of HBV (hereinafter referred to as "HBsAg"), which is
demonstrated immunity
hepatitis C
infection of the human immunodeficiency virus types 1 and 2
infection of human T cell lymfotropním virus type I and II (
"HTLV I and II")
babesiosis *
kala azar (visceral leishmaniasis) *
trypanosomiasis cruzi (Chagas disease) *
----------------------------------- ------------------------------------------------------------------
Malignant diseases besides cancer in situ, with full recovery
----------------------------------- ------------------------------------------------------------------
Portable spongiform encephalopathy persons with a family history that is runs the risk of developing
(hereinafter referred to as the "TSE"), (eg. Creutzfeldt-TSE, or persons who had cornea or graft
Jakob disease, variant hard mater, and or have been treated in the past, the active
Creutzfeldt-Jakob disease) products prepared from human hypofýz; stay in a large
Britain and France in the years 1980-1996 for more than 6
months; administration of transfusions before 1996 abroad
----------------------------------- ------------------------------------------------------------------
Use drugs intravenously or any intravenous or intramuscular use
nepředepsaného drug in the history of intramuscular administration, including hormones or
anabolic steroids
----------------------------------- ------------------------------------------------------------------
Recipients xenotransplantátu
----------------------------------- ------------------------------------------------------------------
Persons whose sexual behavior sexual behavior is exhibiting increased risk
getting serious infectious diseases that may be
transmitted by blood
----------------------------------- ------------------------------------------------------------------
2. temporary deferral criteria for donors of allogeneic donations are used
the period of the exclusion of the donor of the samples referred to in paragraph 1. 2.1 to 2.4.
2.1.
Infection
After the infectious disease, which is not mentioned in this paragraph shall
potential donors will exclude from the subscriptions of at least two weeks after the date of full
Clinical recovery.
---------------------------- ----------------------------------------------------------------------
Brucellosis * 2 years after the date of the complete healing
---------------------------- ----------------------------------------------------------------------
Osteomyelitis 2 years after confirmation of cure
---------------------------- ----------------------------------------------------------------------
Q fever * 2 years after the date of confirmed cured
---------------------------- ----------------------------------------------------------------------
Syphilis 1 year after the date of confirmed cured
---------------------------- ----------------------------------------------------------------------
Toxoplasmosis * 6 months after the date of the clinical healing
---------------------------- ----------------------------------------------------------------------
Tuberculosis, 2 years after the date of confirmed cured
---------------------------- ----------------------------------------------------------------------
Rheumatic fever 2 years after the date of the disappearance of the symptoms, if there is no evidence of chronic
heart disease
---------------------------- ----------------------------------------------------------------------
Fever > 38th. (C) 2 weeks after the date of the disappearance of the symptoms
---------------------------- ----------------------------------------------------------------------
Diseases like the flu 2 weeks after the disappearance of symptoms
---------------------------- ----------------------------------------------------------------------
Malaria *
---------------------------- ----------------------------------------------------------------------
-a person who lived 3 years after his return from last visit to any endemic area for
in the area of malaria during provided that person remains symptom free;
the first five years of life may be reduced to 4 months if the result on each sampling
immunological or molecular genomic test is negative
---------------------------- ----------------------------------------------------------------------
-people with a history of malaria in 3 years after their treatment, and in the absence of symptoms. After the adoption of the only
in the event that is the result of immunological or molecular genomic
negative tests
---------------------------- ----------------------------------------------------------------------
-visitors of the endemic 6 months after leaving the endemic area, if it is not the result of
areas without symptoms immunologic or molecular genomic test is negative
---------------------------- ----------------------------------------------------------------------
-persons with a history of 3 years after the disappearance of symptoms;
undiagnosed may be reduced to 4 months if it is výsledekimunologické or
febrilního disease during molecular genomic test is negative
visits or during the six
months after a visit to the endemic
area
---------------------------- ----------------------------------------------------------------------
West Nile virus 28 days after leaving an area where West Nile virus transmission occurs
fever to humans
---------------------------- ----------------------------------------------------------------------
2.2. the exposure of infectious diseases of the portable
transfusion
------------------------------------------- ---------------------------------------------------------
-Endoscopic examination, using the exclusion for 6 months or at 4 months, provided that the
flexible instruments, test result for hepatitis C amplification technique
-splashes of blood or mucous membrane injury of nucleic acids is negative
puncture needles
-administration of a blood product
-the transplantation of tissues or cells of human
of origin,
-major surgery,
-tattoo or body-piercing,
-Acupuncture unless performed
a qualified doctor and sterile
needles for single use,
-persons faced a tight contact with the person
with hepatitis B infection in the household.
------------------------------------------- ---------------------------------------------------------
The person whose conduct or activity is after their risk behavior are excluded for a period of
at risk get the infectious disease under the fixed and subject to availability
a disease that can be transmitted through the blood of appropriate tests
------------------------------------------- ---------------------------------------------------------
2.3. the Vaccination
------------------------------------------- ---------------------------------------------------------
Attenuated bacteria and viruses 4 weeks ago
------------------------------------------- ---------------------------------------------------------
Inactivated or killed viruses, bacteria, without exclusion, if the status of the donor matching
or rickettsiae
------------------------------------------- ---------------------------------------------------------
Toxoids without exclusion, if the status of the donor matching
------------------------------------------- ---------------------------------------------------------
Hepatitis A vaccine or without exclusion, if the status of the donor is suitable and if it is not
exposed to hepatitis B infection; in the case of hepatitis B vaccination,
It is possible to exclude at the discretion of the doctor
------------------------------------------- ---------------------------------------------------------
Rabies without exclusion, if the status of the donor is suitable and if it is not
exposed to infection; exclusion to one year, if the vaccination
done after exposure
------------------------------------------- ---------------------------------------------------------
Tick-borne encephalitis vaccine without the exclusion, if the status of the donor is suitable and if it is not
exposed to disease; the exclusion of the jedenrok, if the vaccination
done after exposure
------------------------------------------- ---------------------------------------------------------
2.4. Other reasons for the temporary exclusion of the donor
------------------------------------------- ---------------------------------------------------------
Pregnancy 6 months after delivery or termination, except in exceptional
circumstances, or at the discretion of the physician
------------------------------------------- ---------------------------------------------------------
Small surgery 1 week
------------------------------------------- ---------------------------------------------------------
Dental treatment dental treatment, or smaller dental health officer-exclusion
until the next day, while tooth extraction, root-filling and
similar treatment is considered to be a small surgery
------------------------------------------- ---------------------------------------------------------
Administration of the drug depends on the nature of the prescribed drugs, mode of action and the
the treatment of the disease; Typically, the exclusion for a period of at least two
biological half-lives
------------------------------------------- ---------------------------------------------------------
3. The exclusion of the donor in the specific epidemiological situations
------------------------------------------- ---------------------------------------------------------
The specific epidemiological situation of exclusion of the corresponding epidemiological situation in accordance with the instruction
(eg. the sharp increase in the number of working of the CZECH REPUBLIC
disease)
------------------------------------------- ---------------------------------------------------------
4. Deferral criteria for donors of autologous donations
------------------------------------------- ---------------------------------------------------------
Severe heart disease under clinical circumstances blood sampling
------------------------------------------- ---------------------------------------------------------
A person with a disease or having in people with hepatitis B or C in the history of the subscription can be
a history of autotransfuzi performed in agreement aid doctor
-hepatitis B with the exception of people sick in the case that the risk from the administration of allogeneic transfusion
with a negative result HBsAg tests, would exceed the subscription autologous blood and infected
where it is established that they are immune under the terms of § 10 para. 2
-hepatitis C
-HIV 1 and 2
-infection with HTLV I II
------------------------------------------- ---------------------------------------------------------
Ongoing bacterial infection
------------------------------------------- ---------------------------------------------------------
PART (C)
EVALUATION OF THE RESULTS OF THE LABORATORY EXAMINATIONS
1. the tests referred to in section 4, paragraph 4. 3 (b). and this order is carried out)
from a blood sample taken on the day of the donation of blood or its components. In
justified and documented cases it is possible to perform the longest subscription
7 days before the donation of blood or its components. In the case of negative
the result, the collected blood or its component be released for other uses.
In the case of reactive results, the sample is marked as "52.
reactive ".
2. In the case of "initially reactive" result, examination sample
repeated twice. In the case that both the results of the examination are
negative, interprets the total result as "negative" and removed
blood or component shall be released for other uses. In the case that
one or both of the results of the examination are reactive, mark
pattern, such as "repeatedly reactive."
3. repeatedly reactive Samples are sent immediately to konfirmačnímu
testing to the national reference laboratories for the infection in the State
Health Institute ^ 8). Confirmatory testing is performed on a sample of that
was used for the screening referred to in paragraph 1 and also includes
tests based on a different principle than this screening
examination.
4. in the case of a positive result of confirmation examination of the donor
permanently excluded from subscriptions, ensure that the records of the decommissioning of the donor and the lessons
on the significance of the identified donor Award for his health.
5. in the case of equivocal results of confirmation tests are the giver of discards
temporarily from donations. Screening and confirmatory testing is repeated for
use the sample taken at least 6 months.
6. in the case of negative test results of the samples taken in accordance with
point 3. other subscriptions will start blood or blood components donors after 6
months since the last sample.
Annex 4
PART AND
Basic types of blood products, requirements for its control and
the criteria of quality and safety
The requirements laid down in this section and with the requirements of the examination provided for in
section 4, paragraph 4. 3 and 4 and annex No 1 (1). 9 (1). (a). e) this order
constitute the minimum requirements for the quality and safety of blood
preparations.
For blood products for autologous use, the checks marked
an asterisk (*) non-binding.
For the need to wash the cellular blood components, shall implement a procedure, in which
separate plasma or medium for keeping cells from cell preparation
After centrifuging, add izotonická fluid and how to spin,
Department and replacing fluid repeats as needed.
---------------------------------- ----------------------------------- -------------------------------------------------
Quality control of transfusion medicine Acceptable quality measurement results
Checks shall be carried out
with sufficient frequency, in order to
zajišztěna statistical control
process
---------------------------------- ----------------------------------- -------------------------------------------------
Erythrocytes, stanovendle way of storage volume to
that means the Red dodrželyspecifikace for haemoglobin and haemolysis
from a single whole blood donation, from
which is a large proportion of the
plazmy ---------------------------------- -------------------------------------------------
hemoglobin of at least 45 g per unit
---------------------------------- -------------------------------------------------
hemolysis of less than 0, 8% erytrocytové mass at the end of
shelf life
---------------------------------- ----------------------------------- -------------------------------------------------
Red cells, buffy-coat panels required, the volume of stored stanovendle, so that the
that means the Red dodrželyspecifikace for haemoglobin and haemolysis
from a single whole blood donation, from
which is a large proportion of the
plasma and buffy coat, containing
a large proportion of platelets and leukocytes
from jednorky removed
---------------------------------- -------------------------------------------------
hemoglobin at least 43 g per unit
---------------------------------- -------------------------------------------------
contents leukocytes * less than 1, 2 x 109 per unit
---------------------------------- -------------------------------------------------
hemolysis of less than 0, 8% erytrocytové mass at the end of
shelf life
---------------------------------- ----------------------------------- -------------------------------------------------
Red deleukotizované, stanovendle way of storage volume to
that means the Red dodrželyspecifikace for haemoglobin and haemolysis
from a single whole blood donation, from
which is a large proportion of the
plasma and from which they are removed
leukocyty ---------------------------------- -------------------------------------------------
hemoglobin * nejméně40 g per unit
---------------------------------- -------------------------------------------------
contents leukocytes less than 1 x 106 per unit
---------------------------------- -------------------------------------------------
hemolysis of less than 0, 8% erytrocytové mass at the end of
shelf life
---------------------------------- ----------------------------------- -------------------------------------------------
Red blood cells resuspended, the volume of stored stanovendle, so that the
that means the Red dodrželyspecifikace for haemoglobin and haemolysis
from a single whole blood donation, from
which is a large proportion of the
plasma and is added to the solution, which
maintains the beneficial properties of cells
during storage (hereinafter referred to as
"resuspenzní roztok") ---------------------------------- -------------------------------------------------
hemoglobin at least than 45 g per unit
---------------------------------- -------------------------------------------------
hemolysis of less than 0, 8% erytrocytové mass at the end of
shelf life
---------------------------------- ----------------------------------- -------------------------------------------------
Red cells, buffy-coat panels required, the volume of stored stanovendle, so that the
resuspended, which means dodrželyspecifikace for hemoglobin and hemolysis
the red cells from a single
full of blood, from which it is removed
a large proportion of the plasma after centrifugation;
of the unit is removed
Buffy coat, containing a large proportion of
platelets and leukocytes and is added
resuspenzní roztok ---------------------------------- -------------------------------------------------
hemoglobin at least 43 g per unit
---------------------------------- -------------------------------------------------
contents leukocytes * less than 1, 2 x 109 per unit
---------------------------------- -------------------------------------------------
hemolysis of less than 0, 8% erytrocytové mass at the end of
shelf life
---------------------------------- ----------------------------------- -------------------------------------------------
The volume of red blood cells stored stanovendle, so that the
resuspended, dodrželyspecifikace for hemoglobin and
deleukotizované, hemolysis
that means the Red
from a single whole blood donation, from
which is a large proportion of the
plasma and from which they are removed
leukocytes, resuspenzní is added to the
roztok ---------------------------------- -------------------------------------------------
hemoglobin of less than 40 g per unit
---------------------------------- -------------------------------------------------
Leukocyte content less than 1 × 106 per unit
---------------------------------- -------------------------------------------------
hemolysis of less than 0, 8% erytrocytové mass at the end of
shelf life
---------------------------------- ----------------------------------- -------------------------------------------------
Red cells, Apheresis, the volume of stored stanovendle, so that the
that means the Red dodrželyspecifikace specifications for
from the abstraction of hemoglobin by Apheresis, and hemolysis
---------------------------------- -------------------------------------------------
hemoglobin of less than 40 g per unit
---------------------------------- -------------------------------------------------
hemolysis of less than 0, 8% erytrocytové mass at the end of
shelf life
---------------------------------- ----------------------------------- -------------------------------------------------
Whole blood, volume stanovendle the collection and storage,
which means the blood transfusion in order to comply with the specifications for haemoglobin and
the product of the corresponding unit of hemolysis
whole blood (annex No 3 part
(A). 2.1 této vyhlášky) ---------------------------------- -------------------------------------------------
hemoglobin of at least 45 g per unit
---------------------------------- -------------------------------------------------
hemolysis of less than 0, 8% erytrocytové mass at the end of
shelf life
---------------------------------- ----------------------------------- -------------------------------------------------
Platelets, Apheresis, which stanovendle the method of storage volume to
means a concentrated suspension of dodrželyspecifikace for pH
of blood platelets, obtained by Apheresis-----------------------------------------------------------------------------------
content aggregation is enabled in platelet content fluctuation
specified range, if it is in accordance
with the validated conditions of preparation and
the retention of
---------------------------------- -------------------------------------------------
pH 6.4-7.4 corrected for 22nd. (C) at the end of the period
the applicability of
---------------------------------- ----------------------------------- -------------------------------------------------
Platelets, Apheresis, the volume of stored stanovendle, so that the
deleukotizované, dodrželyspecifikace for pH
which means a concentrated
suspension of blood platelets, obtained by
Apheresis, from which they are removed
leukocyty ---------------------------------- -------------------------------------------------
content aggregation is enabled in platelet content fluctuation
specified range, if it is in accordance
with the validated conditions of preparation and
the retention of
---------------------------------- -------------------------------------------------
contents leukocytes less than 1 x 106 per unit
---------------------------------- -------------------------------------------------
pH 6.4-7.4 corrected for 22nd. (C) at the end of the period
the applicability of
---------------------------------- -------------------------------------------------
the volume of stored stanovendle, so that the
dodrželyspecifikace for pH
---------------------------------- ----------------------------------- -------------------------------------------------
Platelets from the standard subscription
mixed,
which means a concentrated
suspension of blood platelets, obtained by
processing of whole blood units and
by joining the platelets
of these units during separation
nebo po oddělení ---------------------------------- -------------------------------------------------
content aggregation is enabled in platelet content fluctuation
mixture vestanoveném range, if it is
in accordance with the terms and conditions by preparing and
the retention of
---------------------------------- -------------------------------------------------
contents of leukocytes to less than 0, 2 x 109 per unit sampling
When the method using plasma rich in
platelets, recovered,
less than 0.05 x 109 per unit sampling
When the method that uses the buffy coat
---------------------------------- -------------------------------------------------
pH 6.4-7.4 corrected for 22nd. (C) at the end of the period
the applicability of
---------------------------------- ----------------------------------- -------------------------------------------------
Platelets from the standard subscription, the volume of stored stanovendle, so that the
mixed, deleukotizované dodrželyspecifikace for pH
which means a concentrated
suspension of blood platelets, obtained by
processing of whole blood units and
by joining the platelets
of these units during separation
or after separation from which they are
odstraněny leukocyty ---------------------------------- -------------------------------------------------
content aggregation is enabled in platelet content fluctuation
mixture vestanoveném range, if it is
in accordance with the terms and conditions by preparing and
the retention of
---------------------------------- -------------------------------------------------
contents leukocytes less than 1 x 106 the mix
---------------------------------- -------------------------------------------------
pH 6.4-7.4 corrected for 22nd. (C) at the end of the period
the applicability of
---------------------------------- ----------------------------------- -------------------------------------------------
Platelets stored stanovendle volume so that the
of the individual standard subscription dodrželyspecifikace for pH
1. whole blood platelets
2. the Platelets from buffy-coat panels required,
which means a concentrated
suspension of blood platelets, obtained by
the processing of a single unit of full
krve ---------------------------------- -------------------------------------------------
content aggregation is enabled fluctuations in platelet content
from an individual subscription within a specified range,
If the phenomenon according to validated terms
training and retention
---------------------------------- -------------------------------------------------
contents of leukocytes to less than 0, 2 x 109 per unit (subscription upon
the method using plasma rich in
thrombocytes)
less than 0, 05 x 109 per unit (subscription upon
the method that uses the buffy coat)
---------------------------------- -------------------------------------------------
pH 6.4-7.4 corrected for 22nd. (C) at the end of the period
the applicability of
---------------------------------- ----------------------------------- -------------------------------------------------
Platelets from a single stanovendle method of storage volume to
standard subscription, dodrželyspecifikace for pH
deleukotizované
1. whole blood, platelets,
deleukotizované
2. the Platelets from buffy-coat panels required
deleukotizované,
which means a concentrated
suspension of blood platelets, obtained by
the processing of a single unit of full
blood, from which they are removed
leukocyty ---------------------------------- -------------------------------------------------
content aggregation is enabled fluctuations in platelet content
from an individual subscription within a specified range,
If the phenomenon according to validated terms
training and retention
---------------------------------- -------------------------------------------------
contents leukocytes less than 1 x 106 per unit
---------------------------------- -------------------------------------------------
pH 6.4-7.4 corrected for 22nd. (C) at the end of the period
the applicability of
---------------------------------- ----------------------------------- -------------------------------------------------
Fresh frozen plasma volume declared volume +/-10%
which means the supernatant
plasma separated from a whole blood donation
or plasma collected by Apheresis,
zmrazená a skladovaná ---------------------------------- -------------------------------------------------
factor VIIIc average (after freezing and thawing) is 70%
the value of fresh plasma unit collected or
more
---------------------------------- -------------------------------------------------
total protein g/l * nejméně50
---------------------------------- -------------------------------------------------
residual content of cells of red cells: less than 6.0 x 109/l
leucocytes: less than 0.1 x 109/l
platelets: less than 50 x 109/l
---------------------------------- ----------------------------------- -------------------------------------------------
Plasma without kryoproteinu, the volume of the declared volume +/-10%
that means a plasma component
prepared from a unit frozen
fresh plasma. Includes the share of
remaining after the removal of kryoproteinu
zmrazený a skladovaný ---------------------------------- -------------------------------------------------
residual content of cells of red cells: less than 6.0 x 109/l
leucocytes: less than 0.1 x 109/l
platelets: less than 50 x 109/l
---------------------------------- ----------------------------------- -------------------------------------------------
Kryoprotein, Fibrinogen content larger than or equal to 140 mg per unit
which means a plasma component
prepared from fresh-frozen
plasma proteins when
the melting of the frozen status and
subsequent re
nitride of protein in the small
objemu tekuté plazmy ---------------------------------- -------------------------------------------------
factor VIIIc content * greater or equal to 70 international units on
Unit
---------------------------------- ----------------------------------- -------------------------------------------------
Granulocytes, Apheresis, a volume of less than 500 ml
which means a concentrated
suspension of granulocytes obtained by
aferézou ---------------------------------- -------------------------------------------------
granulocyte content greater than 1 x 1010 granulocytes per unit
---------------------------------- ----------------------------------- -------------------------------------------------
The next transfusion preparations proceed under section 6 (1). 2 of this order and shall take into account the detailed guidelines for the
ensure the quality and safety of blood products, issued by the Council of Europe, ^ 5).
New transfusion products Announces zařízenítransfuzní services of the Institute.
A new transfusion products shall not be considered a standard transfusion products
Additionally modified basic production processes, in particular, by washing,
removing leukocytes, adjusting volume, etc.
---------------------------------- ----------------------------------- -------------------------------------------------
PART (B)
CONDITIONS OF STORAGE OF BLOOD PRODUCTS
1. storage in a liquid state
--------------------------- ---------------------------- -----------------------------------------------------
Transfusion medicine storage temperature maximum storage time
--------------------------- ---------------------------- -----------------------------------------------------
Red blood cells and whole blood + 2nd. (C) to + 6th. (C) 28 to 49 days according to processes used for collection,
(if used for transfusion processing and storage
as whole blood)
--------------------------- ---------------------------- -----------------------------------------------------
Thrombocytes + 20th. C to + 24 ° c 5 days; may be stored for 7 days, if it is done
bakteriálníkontaminace examination, or if the associated
with the procedure snižujícímriziko of this contamination
--------------------------- ---------------------------- -----------------------------------------------------
Granulocytes + 20th. C to + 24 ° c for 24 hours
--------------------------- ---------------------------- -----------------------------------------------------
2. storage procedure, which allows the extension of the period of application of the
of blood components by freezing ("freezing")
------------------------------ ----------------------------------------------------------------------------------------
Transfusion medicine the conditions and duration of storage
------------------------------ ----------------------------------------------------------------------------------------
Erythrocytes in 30 years according to processes used for collection, processing and storage
Platelets within 24 months according to processes used for collection, processing and storage
Plasma and kryoprecipitát to 36 months according to processes used for collection, processing and storage
------------------------------ ----------------------------------------------------------------------------------------
Erythrocytes and thrombocytes are thoroughly tested donors after thawing, govern the appropriate medium. After defrosting depends allowed time
storage on the method used.
------------------------------ ----------------------------------------------------------------------------------------
Annex 5
PART AND
NOTIFICATION
1. the model notification of serious adverse reactions or suspected
-----------------------------------------------------------------------------
Stating that the equipment referred to in § 9 para. 2 of this order, including the contact person
-----------------------------------------------------------------------------
Identification of the notification
-----------------------------------------------------------------------------
Reporting date (year/month/day)
-----------------------------------------------------------------------------
Date of transfusion (year/month/day)
-----------------------------------------------------------------------------
Age and sex of recipient
-----------------------------------------------------------------------------
Date of serious adverse reaction (year/month/day)
-----------------------------------------------------------------------------
Serious adverse reaction refers to:
-whole blood
-red blood cells
-platelets
-plasma
-named other blood products
-donor human blood or its components
-----------------------------------------------------------------------------
The type of serious adverse reaction:
-immune haemolysis due to Abo incompatibility
-immune haemolysis due to other aloprotilátce
-haemolysis from other than immune causes
-transfusion-transmitted bacterial infection
-Anaphylaxis/hypersensivita
-acute lung damage in connection with transfusions
— transfusion-transmitted viral infection-HBV
— transfusion-transmitted viral infection-HCV
— transfusion-transmitted viral infection-HIV 1 and 2
-other of transfusion transmitted virus infection
-parasitic infection of transfusion-transmitted malaria-
-other specified parasitic infection transmitted through transfusions
-transfusional purpura
-the disease of Graft versus host disease
-other of serious adverse reactions
the degree of přisuzovatelnosti1)
-----------------------------------------------------------------------------
1) Degree of imputability is filled with serious adverse
the reaction in a recipient and NP, 0, 1, 2, or 3, with
It's the
NP
(unable to assess) if there are insufficient
data for imputability assessment,
0
(excluded or unlikely to occur), if any
compelling evidence beyond a reasonable doubt, that the side
the reaction stems from other causes, or if the evidence clearly
suggest that adverse reaction stems from other causes,
1
(maybe) if there is no clear evidence suggesting that the
adverse reaction results
from transfusion of human blood or its components, or from other
the causes,
2
(probable), if the evidence clearly indicates that the adverse
the reaction stems from the
from transfusion of human blood or its components,
3
(sure), if there is compelling evidence beyond a reasonable
doubt that the adverse reaction results
from transfusion of human blood or its components.
2. the model notification of serious adverse events or suspected
----------------------------------------------------------------------------- ---------------------------------
Stating that the equipment referred to in § 9 para. 2 of this order, including the contact person
----------------------------------------------------------------------------- ---------------------------------
Identification of the notification
----------------------------------------------------------------------------- ---------------------------------
Reporting date (year/month/day)
----------------------------------------------------------------------------- ---------------------------------
Date of serious adverse events (year/month/day)
----------------------------------------------------------------------------- ---------------------------------
details
A serious adverse event, which can be
without prejudice to the quality and safety of blood and its
folders in the context of:
----------------------------------------------------------------------------- ---------------------------------
glitch error failure the other named
of the device of man
----------------------------------------------------------------------------- ---------------------------------
-the collection of whole blood
-by Apheresis
-examination referred to in section 4, paragraph 4. 3
-the processing of
-storage
-distribution
-materials
-the other named
----------------------------------------------------------------------------- ---------------------------------
PART (B)
MESSAGE
1. report on the outcome of the investigation, the Pattern of serious adverse reaction or suspected.
-----------------------------------------------------------------------------
Stating that the equipment referred to in § 9 para. 3 of this order, including the contact person
-----------------------------------------------------------------------------
Identification of the notification
-----------------------------------------------------------------------------
Confirmation date (year/month/day)
-----------------------------------------------------------------------------
Date of serious adverse reaction (year/month/day)
-----------------------------------------------------------------------------
Confirmation of serious adverse reaction – yes/no
-----------------------------------------------------------------------------
The degree of přisuzovatelnosti1)
-----------------------------------------------------------------------------
Change the type of serious adverse reaction – yes/no
-If Yes, please specify:-----------.
-----------------------------------------------------------------------------
Clinical conclusion (if known):
-complete recovery
-light effects
-serious consequences
-death
-----------------------------------------------------------------------------
1) grade shall be determined by the degree of imputability to the NP, 0, 1, 2, or 3 for the serious
adverse reactions in the recipient as defined in annex 5, part a.
in a footnote to table 1.
2. the report on the outcome of the investigation of serious adverse events or suspected
-----------------------------------------------------------------------------
Stating that the equipment referred to in § 9 para. 3 of this order, including the contact person
-----------------------------------------------------------------------------
Identification of the notification
-----------------------------------------------------------------------------
Confirmation date (year/month/day)
-----------------------------------------------------------------------------
Date of serious adverse events (year/month/day)
-----------------------------------------------------------------------------
Root cause analysis (details)
-----------------------------------------------------------------------------
Measures taken to remedy (details)
-----------------------------------------------------------------------------
Annex 6
ANNUAL REPORT
1. The pattern of annual reports of serious adverse reactions
1.1. the summary data presented in a separate table for whole blood,
red cells, platelets, plasma, and for an additional type of transfusion medicine.
-------------------------------------------------------------------------------
Stating that the equipment referred to in § 9 para. 4 of this order
-------------------------------------------------------------------------------
The notification period 1. January 1-31. December (year)
-------------------------------------------------------------------------------
Product type (whole blood or red blood cells or platelets or plasma or
Another referred to the type of product)
-------------------------------------------------------------------------------
The number of issued blood products packaging
-------------------------------------------------------------------------------
The number of recipients who have been awarded by the transfusion medicine transfusion is lodged
-------------------------------------------------------------------------------
The number of issued blood preparations namely packaging
referred to, where the size of the package is given in the relevant quantitative
units, which was brought by the recipients of transfusions
-------------------------------------------------------------------------------
2.1 information on serious adverse reactions by type of reaction and the degree of
imputability; shall be shown in a separate table for whole blood,
red cells, platelets, plasma, and for an additional type of transfusion medicine
------------------------------------------------------------------------------------------------------
Stating that the equipment referred to in § 9 para. 4
------------------------------------------------------------------------------------------------------
The notification period 1. January 1-31. December (year)
------------------------------------------------------------------------------------------------------
Product type (whole blood or red blood cells or platelets or plasma or other that type
product)
------------------------------------------------------------------------------------------------------
Total
The type of serious adverse reaction, the notified number of serious adverse reactions
the number of (according to the degree of přisuzovatelnosti1) after
just confirmation
the "total")
The number of deaths
of the total
of the notified
the number of (
"the death")
------------------------------------------------------------------------------------------------------
You cannot grade grade grade grade
assess 00 1 2 3
------------------------------------------------------------------------------------------------------
Immune due to incompatibility of the Total
hemolýza AB0 ------------------------------------------------------------
The death of a
-----------------------------------------------------------------------------------------
due to other aloprotilátce Total
------------------------------------------------------------
The death of a
------------------------------------------------------------------------------------------------------
Immune haemolysis from other than Total
příčin ------------------------------------------------------------
The death of a
------------------------------------------------------------------------------------------------------
A bacterial infection transmitted a total of
transfuzí ------------------------------------------------------------
The death of a
------------------------------------------------------------------------------------------------------
Anaphylaxis/hypersensitivity in total
The death of a
------------------------------------------------------------------------------------------------------
Acute lung damage in the context of a total
s transfuzí ------------------------------------------------------------
The death of a
------------------------------------------------------------------------------------------------------
HBV Viral Total
infekce ------------------------------------------------------------
transferred to the Death
transfusion
---------------------------------------------------------------- -------------------------
HCV Total
------------------------------------------------------------
The death of a
---------------------------------------------------------------- -------------------------
HIV 1 and 2 total
------------------------------------------------------------
The death of a
---------------------------------------------------------------- -------------------------
The other enumerated a total of
------------------------------------------------------------
The death of a
------------------------------------------------------------------------------------------------------
Parasitic Malaria Total
infekce ------------------------------------------------------------
transferred to the Death
transfusion
---------------------------------------------------------------- -------------------------
The other enumerated a total of
------------------------------------------------------------
The death of a
------------------------------------------------------------------------------------------------------
Transfusional purpura Total
------------------------------------- -----------------------
The death of a
------------------------------------------------------------------------------------------------------
The disease out of a total of Graft versus host disease
------------------------------------------------------------
The death of a
------------------------------------------------------------------------------------------------------
The other named severe Total
nežádoucí reakce ------------------------------------------------------------
The death of a
------------------------------------------------------------------------------------------------------
The degree of imputability level shall be determined by the degree of NP, 0, 1, 2
or 3 for serious adverse reactions in the recipient according to the
the definitions listed in annex 5 section, and in the note to table 1.
2. the model of the annual report on serious adverse events
----------------------------------------------------- -----------------------------------------------
Stating that the equipment referred to in § 9 para. 4 of this order
----------------------------------------------------- -----------------------------------------------
The notification period 1. January 1-31. December (year)
----------------------------------------------------- -----------------------------------------------
The total number of units of blood and blood components, processed
named in the relevant quantitative units
----------------------------------------------------- -----------------------------------------------
details
----------------------------------------------------- -----------------------------------------------
A serious adverse event, which is the total number of
prejudice to the quality and safety of
blood and its components due to
derogation in relation to:
----------------------------------------------------- -----------------------------------------------
glitch selháníchyba other
of zařízeníčlověka namely
----------------------------------------------------- ----------------------------------------------- uvedené
-the collection of whole blood
-by Apheresis
-examination referred to in section 4, paragraph 4. 3
-the processing of
-storage
-distribution
-materials
-the other named
----------------------------------------------------- -----------------------------------------------
Annex 7
cancelled
1) directive of the European Parliament and of the Council 2002/98/EC of 27 June 2002. January
2003 setting standards of quality and safety for the collection,
testing, processing, storage and distribution of human blood and blood
components and amending směrnic200e 2001/83/EC.
Commission Directive 2004/33/EC of 22 December 2004. March 2004 implementing
Directive of the European Parliament and of the Council 2002/98/EC as regards certain
technical requirements for blood and blood components.
Commission Directive 2005/61/EC of 30 March 2004. September 2005, implementing the
Directive of the European Parliament and of the Council 2002/98/EC, as regards the requirements
traceability and reporting of serious adverse reactions and events.
Commission Directive 2005/62/EC of 30 March 2004. September 2005, implementing the
Directive of the European Parliament and of the Council 2002/98/EC, as regards the standards
and community specifications relating to a quality system for
blood establishments.
2) Decree No. 54/2008 Coll., about how the prescription of medicinal products,
information to be entered on the medical prescription and the rules of use
medical prescriptions.
3) § 67 para. 6 of law No 378/2007 Coll., on pharmaceuticals and on changes
some related laws.
4) § 67 para. 5 of law No 378/2007 Sb.
5) instruction for the preparation, use and quality assurance of blood components
(Guide to the preparation, use and quality assurance of blood
in the current version of components) published by the Council of Europe.
6) Act No. 13/1993 Coll., the Customs Act, as amended.
7) article 2, paragraph 1 of the guideline on the preparation, use and quality assurance of
blood components (Guide to the preparation, use and quality assurance of
blood components), as amended.
8) § 74 para. 1 Act No. 258/2000 Coll., on the protection of public health, in
amended by Act No. 320/2002 Coll.
9) Annex I to Council Regulation (EEC) No 2658/87 of 23 July. July 1987 on
the tariff statistical nomenclature and on the common customs tariff, in the
as amended.