The Decree On Human Blood

Original Language Title: vyhláška o lidské krvi

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Read the untranslated law here: https://portal.gov.cz/app/zakony/download?idBiblio=67013&nr=143~2F2008~20Sb.&ft=txt

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.