Blood (Quality and Safety) (Amendment) Regulations, 2017

L.N. 362 of 2017

HUMAN BLOOD AND TRANSPLANTS ACT

(CAP. 483)

Blood (Quality and Safety) (Amendment) Regulations, 2017

IN EXERCISE of the powers conferred by article 16 of the

Human Blood and Transplants Act, the Minister responsible for

Health, after consultation with the Licensing Authority, has made the

following regulations

The title of these regulations is the Blood (Quality and Citation.

Safety) (Amendment) Regulations, 2017, and these regulations shall

be read and construed as one with the Blood (Quality and Safety) S.L. 483.02

Regulations, hereinafter referred to as "the principal regulations".

Sub-regulation (2) of regulation 1 of the principal Amends

regulation 1 of

regulations shall be substituted as follows

the principal

regulations

"(2)

These regulations transpose

(a) the European Parliament and Council

Directive 2002/98/ EC of the of 27th January, 2003 setting

standards of quality and safety for the collection, testing,

processing, storage and distribution of human blood and

blood components;

(b)

Commission Directive 2004/33/EC of the

22 nd March, 2004 implementing Directive 2002/98/EC of

the European Parliament and of the Council as regards

certain technical requirements for blood and blood

components;

(c) Commission Directive 2004/33/EC of the

22 nd

March,

implementing

2005/62/EC

implementing Directive 2002/98/EC of the European

Parliament and of the Council as regards Community

Standards and specifications relating to a quality system

for blood establishments;

(d) Commission Directive 2014/110/EU of 17th

December 2014 amending Directive 2004/33 /EC as

regards temporary deferral criteria for donors of allogeneic

blood donations; and

(e) Commission Directive (EU) 2016/1214 of 25

July 2016 amending Directive 2005/62/EC as regards

quality system standards and specifications for blood

establishments.".

Regulation 2 of the principal regulations shall be amended

as follows

(a)

immediately after the definition "blood product",

there shall be added the following new definition

" "computerised system" means a system including

the input of data, electronic processing and the output of

information to be used either for reporting, automatic

control or documentation";

(b)

immediately after the definition "distribution" there

shall be added the following new definition

" "good practice" means all elements in established

practice that collectively will lead to final blood or blood

components

that

consistently

meet

predefined

specifications and compliance with defined regulations";

(c)

immediately after the definition "inspection" there

shall be added the following new definitions

" "mobile site" means a temporary or movable

place used for the collection of blood and blood

components which is in a location outside of but under the

control of the blood establishment;

"processing" means any step in the preparation of a

blood component that is carried out between the collection

of blood and the issuing of a blood component;

"qualification" as part of validation, means the

action of verifying that any personnel, premises,

equipment or material works correctly and delivers the

expected results";

(d)

immediately after the definition "qualified health

professional" there shall be added the following new

definitions

" "quality assurance" means all the activities from

blood collection to distribution made with the object of

ensuring that blood and blood components are of the

quality required for their intended use;

"quality control" means part of a quality system

focussed on fulfilling quality requirements;

"quality management" means the co-ordinated

activities to direct and control an organisation with regard

to quality at all levels within the blood establishment;

"quality system" means the organisational

structure, responsibilities, procedures, processes, and

resources for implementing quality management;

"quarantine" means the physical isolation of blood

components or incoming materials/reagents over a variable

period of time while awaiting acceptance, issuance or

rejection of the blood components or incoming materials/

reagents;"and

(e)

immediately after the definition "serious adverse

reaction" there shall be added the following new definitions

" "specification" means a description of the criteria

that must be fulfilled in order to achieve the required

quality standard;

"standard" means the requirements that serve as the

basis for comparison;

"trace-back" means the process of investigating a

report of a suspected transfusion-associated adverse

reaction in a recipient in order to identify a potentially

implicated donor;

"validation" means the establishment of

documented and objective evidence that the pre-defined

requirements for a specific procedure or process can be

consistently fulfilled;

"written procedures" means controlled documents

that describe how specified operations are to be carried

out;".

Immediately

after

regulation

of

the

principal Adds new

regulation 10 to

the principal

regulations.

regulations there shall be added the following new regulation

(1)

A quality system for blood

establishments laid down in the Annexes to Directive

2005/62/EC implementing Directive 2002/98/EC of

the European Parliament and the Council as regards

Community Standards and specifications relating to a

quality system for Blood Establishments shall be

established and maintained, taking into account, where

relevant for blood establishments, the detailed

principles and guidelines of good manufacturing

practice, as referred to in the first sub-paragraph of

Article 47 of Directive 2001/83/EC, and the Good

Practice Guidelines in the Guide to the preparation,

use and quality assurance of blood components,

Appendix to Recommendation No. R (95)15 of the

Committee of Minsters on the preparation, use and

quality assurance of blood components adopted on 12

October 1995 jointly developed by the Commission

and the European Directorate for the Quality of

Medicines and Healthcare of the Council of Europe

and published by the Council of Europe.

(2) Any blood or labile blood products

imported from third countries and intended for the use

or distribution in the Community must also adhere to

the Quality system as specified in Commission

Directive (EU) 2016/1214 of 25 July 2016 amending

Directive 2005/62/EC as regards quality system

standards and specifications for blood establishments,

even in the stages prior to importation.".

5. In item 1.1 of Schedule VI of the principal regulations the

word "doors" shall be substituted by the word "donors".

€0.36