MANUAL OF OPERATIONS

FOR RBC

Place and date of publication:

Islamabad, September 2016

This publication has been developed and produced with the technical support of the

German Federal Government through the Health Sector Support Programme

implemented by Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ) GmbH

in cooperation with GFA Consulting Group.

CONTENTS

ABBREVIATIONS .............................................................................................................................. i

OBJECTIVE OF THIS MANUAL OF OPERATIONS ......................................................................... 1

FOR THE BEST USE OF THIS MANUAL ......................................................................................... 2

1. THE VERSATILE ENVIRONMENT OF BT ................................................................................ 3

1.1 As a System: Legal and Regulatory Environment ............................................................... 3

2. ROLES AND RESPONSIBILITIES OF BTS, OF RBCS, OF HBBS ............................................ 5

2.1 BTS is a Coordinator and a Reference ............................................................................... 5

2.2 RBCs are Providers, HBBs are Users ................................................................................. 6

3. SOME PRINCIPLES OF MANAGEMENT ................................................................................ 11

OPERATING CHAPTERS .............................................................................................................. 19

4. ADMINISTRATIVE OPERATIONS ........................................................................................... 19

4.1 General presentation of the OM ........................................................................................ 19

4.2 Mandatory First Elements of the OM ................................................................................. 21

5. TECHNICAL OPERATIONS .................................................................................................... 33

5.1 Reminder on Standards and Guidelines ........................................................................... 33

5.2 Blood Donor Sensitization, Motivation and Management .................................................. 36

5.3 Blood Collection (Fixed Site and Mobile Teams) ............................................................... 41

5.4 Laboratory Screening (Biological Qualification of Donations) ............................................ 48

5.5 Blood Components Preparation and QC ........................................................................... 52

5.6 Blood Components Storage, Transport and Stock Management ....................................... 56

5.7 Blood Components Storage Equipment ............................................................................ 57

5.8 Blood Components Labelling and Distribution to HBBs ..................................................... 80

6. TRANSVERSAL/CROSS CUTTING OPERATIONS ................................................................ 83

6.1 Traceability/Haemovigilance, Call Back and Returns ........................................................ 83

6.2 Quality System-Related Operations: which data for what? ................................................ 88

6.3 Risk Management ............................................................................................................. 90

6.4 Biosafety ........................................................................................................................... 97

6.5 MIS, Record Keeping, Data System: Which Data for what Type of Action? ...................... 98

6.6 Reporting Operations ...................................................................................................... 101

ANNEXES..................................................................................................................................... 105

ANNEX 1: TEMPLATE OF LOCAL PROTOCOLS/MOUs .......................................................... 107

ANNEX 2: DEFINITIONS IN HAEMOVIGILANCE ...................................................................... 115

i

ABBREVIATIONS

ARE: Adverse Reactions and events; also SARE: Serious ARE

BTA: Blood Transfusion Authority

BC: Blood Centre

BCCE Blood Cold Chain Equipment

BDC, DC: Blood Donation centre, Donation Centre (Drop in Donation Centre)

BDO: Blood donors Organization

BE: Blood Establishment (the gathering of RBCs and HBBs)

BT: Blood Transfusion

BTA: Blood Transfusion Authority

BTS: Blood Transfusion System

CAPA: Corrective and Preventive Actions

EQAS: External Quality Assessment.

FFP: Fresh Frozen Plasma

GP: Good Practices

GMP: Good Manufacturing Practices

GLP: Good Laboratory Practices

HBB: Hospital Blood Bank

Hb: Haemoglobin

Ht: Haematocrit

IEC: Information, Education, Communication

IH: Immuno-Haematology

MIS: Management Information System

OM: Manual of Operations (Operations Manual)

PC: Platelet Concentrate

PHD: Provincial Health Department

QA: Quality Assurance

QC: Quality Control

QMS: Quality management System

RBC: Regional Blood Centre

RBCC: Red Blood Cell Concentrate

SBTP: Safe Blood Transfusion Project

TTIs: Transfusion Transmitted Infections

VNRBD: Voluntary Non Remunerated Blood Donors

i i

PREFACE

Effective management of resources and operations of a regional blood centre is a challenging task

under the newly reformed system. This system demands collection of blood from voluntary blood

donors, selection of donors under certain eligibility criteria with screening of blood for 5 essential

parameters to prevent transfusion transmissible infections (Hepatitis B, C and HIV, Syphilis and

Malaria) and processing of blood into components. Effective management of blood inventory is a pre-

requisite for adequate supply of blood and blood components to all affiliated hospital blood banks as

per their demands. Moreover, ensuring traceability/haemovigilance, quality assurance and quality

management, biosafety and information management with record keeping are overarching elements

in the effective management of these centres. These management tasks can be cumbersome until

step wise approach is adopted for dealing with all matters within and outside the facility. The main

purpose of having operational manual is to run the operations smoothly and effectively for improving

the overall quality of services in these centres.

This document ‘Operational Manual for RBC’ briefly describes the diverse and versatile environment

of blood transfusion sector with a special focus on legal-regulatory framework and the functional

differentiation of regional blood centre and hospital blood banks as providers and users respectively

under the system reform. Later in the subsequent chapters, it provides important operational aspects

and it also gives details on basics management skills like how to delegate, to prepare job

descriptions, to develop organograms and to implement them. This manual concentrates on three

main operating chapters (1) administrative operations, (2) technical operations and (3)

transverse/crosscutting operations. All chapters include detailed explanations and illustrations, giving

reference to previously developed documents such as functional briefs for RBC and HBBs, Standards

and Guidelines, SOPs, Business plan, etc.

This manual will provide managers with the tools to build their own operational manual and will

support them in policy development and in understanding the legal status of the RBC, financing and

budgeting, maintenance operations, record keeping, implementation of SOPs and quality control

guidelines to ensure quality services, etc. The programme appreciates technical input, expertise and

guidance received from Phillippe Conte, a short term international expert, who has guided the GIZ

team and developed this document during his mission to Pakistan.

Prof. Hasan Abbas Zaheer

National Coordinator

Safe Blood Transfusion Programme

Government of Pakistan

1

OBJECTIVE OF THIS MANUAL OF OPERATIONS

BT activities are generating a mass of documentation and of data that are sometimes difficult

to handle and to transform into information usable for action and decision making: they need

to be organized according to some priorities and reflections.

Within the BE (Blood Establishment), a hierarchy of management levels must exist

(definition of 3 levels with the 3 levels of competencies). Jobs descriptions describe

what is expected from each level. So, which kind of data is to be used and managed in

priority by which level? This OM will address only the first and second level of

hierarchy.

Hierarchy and its management means delegation of activities, thus the only academic

and technical “pedigree” is not sufficient: reliability and reproducibility is crucial, as well as critical approach on data, to determine links and feed-backs between each level,

particularly in cases that are situated at the limit between two levels of hierarchy. This

OM will try to help solving these situations.

The manager role (at each level) may mainly be considered as limited to delegating and

demanding: this has to be examined more in depth to obtain acceptable results.

A BE is a public enterprise “living” in two kinds of environment: the internal one (the most easy to consider as it is immediately available and hierarchized, but not limited to

technical aspects), and the external one, which is very versatile (see Chapter 1). This

OM will try to bring tools to ease the management of various operations to be

conducted by managers.

Objective of an OM is ordinarily to describe tasks and “how to” in order that a new

employee is able to realize them without a long training period. In this Manual we shall

not go till process description and procedure redaction, as most of them have been

already described as templates and flow charts in the SOP Manual1 and in the various

documents produced by the project. On the same way, Functional briefs have been

published for RBCs and HBBs2 and in this OM, references will be made to these

documents, as well as to the already published Business Plan3 and Standards and

Guidelines4 .

1 Standard Operating Procedures for Blood Bank Processes in Pakistan, SBTP, 2013

2 Functional brief for RBC, Functional brief for HBB, SBTP, 2011

3 Business Plan for Blood Centres in Pakistan, SBTP, 2011

4 Standards and Guidelines for Blood Banks and Transfusion Services, SBTP, 2013, Guidelines for Quality Control, NACP, 2007

Each OM is specific to a given BE. Like SOP, it has to be conceived by and for

people who will have to implement it, as and when the Quality system is developing.

It is why, rather than a template, the present document is only pretending to provide

future Managers tools to build it, and not to create a “ready to use” Manual.

2

FOR THE BEST USE OF THIS MANUAL

Those text areas in Orange design data, SOPs or texts that are needed by

Managers and already existing in other documents

Those text areas design processes, SOPs, or other texts to be designed and

written as they are currently missing out to be completed in existing

documentation

Those text areas design synthetic, important things to keep in mind for the

Manager

Those text areas are directly excerpts from official or published documents

NEEDED

SOP on...

CONCLUSION

EXCERPT

3

1. THE VERSATILE ENVIRONMENT OF BT

1.1 As a System: Legal and Regulatory Environment

BTS is made of various entities the role of which is clearly delimited and specified:

1. Policy makers: Government and its structures

(under Health Minister):

Secretary Health

Chief Planning Officer

Blood Transfusion Authority (BTA)

2. Funding Structures: Provincial Finance

Department, in relation with Finance Department

of Health Department.

According to PC1, funds that shall ensure funding of

the BTS are supposed to be provided by

Government. Procedures are extensively described in Official Manuals.5

3. Controlling Structures: BTA

BTA is a relatively new structure, established by all the Provinces where an Act has been

published. These Acts are mainly describing operations of Registering, Controlling and

Licensing of BEs as well as mechanism of Inspections.

4. Comments

The legislative framework in Pakistan is evolving towards more completion and precision on

roles and responsibilities of respective BEs6 and Hospitals Blood Banks It is expected that

this framework will progressively be extended to other structures dealing with BT (such as

NGOs and BDOs or Private for profit structures currently running the same activity).

Currently the only Programme addressing, as a network, the whole BT activity using

exclusively VNRBD as donors and based on RBCs that are Public Establishments is the

SBTP. Other observed structures are more the result of extension to several provinces of a

single structure, or individual initiatives the action of which is geographically limited, even if

some of them show a quite important volume of activity. Currently there is no exhaustive

quantitative mapping of BT related types of activity at national level, nor at Province level.

The Federal BT Act 2013 is still a draft, but represents the first advance on this clear

definition of roles and responsibilities and on Quality and Haemovigilance Policy.

5. Position of Establishments composing the BTS

This position in Administrative and legal landscape shall be as follows to benefit from the

best management flexibility:

5 See « Tools for Budget Management », SBTP, 2015

6 For more details, see “Functional brief on BTA”, SBTP, 2013

SPECIFIC LEGAL BASIS

Sindh BT Act 1997

Punjab BT Ordinance 1999

KPK BT Act 1999

ICT BT Ordinance 2002

AJK BT Act 2003

Balochistan BT Act 2004

Federal BT Act 2013 (draft)

Public Establishment

Autonomous Management

Self-Accountancy

Delegation of Financial Powers for the Manager

4

2. As a RBC, Part of a Public System, RBC is a Medico-technical

Enterprise

1. On technical side, it must be balanced regarding Input (Blood donations) and Output

(Blood Components)

a) That means having a good knowledge of Blood Donors and of their environment in

order to obtain as many as possible Blood Donors, who could be really Volunteers,

Non Remunerated, and Regular donors. RBC has to develop social marketing tools

in place to address persons and population with an adapted language, and, once

these Blood donors are obtained, collect them properly and manage them in order

to obtain regular Donors (see Chapter in Operational Chapters)

b) Distribution aspects are totally linked to Donation income aspects, and reflect the

income of Blood. But this must not be the way of functioning, as it is the knowledge

and follow up of Blood components stock that must lead Blood Collection activity

(see in Operational Chapters).

2. On Budget and Finance side, it must be balanced regarding Expenditure and income

a) Recurrent Expenditure is performed on a daily base, and has to be followed strictly,

as budget are limited to a ceiling, and must stay inside forecast limits.

b) Recurrent Income is linked to level of activity on one hand, and to ways of financing

on the other hand. Indicators have to be put in place to follow up the general

balance and also more specific indicators (see Operational Chapters and Tools for

Budget Management).

c) In fact, it is necessary to follow up 5 types of Budget to be able to manage properly

the RBC (see Tools for Budget Management): Fixed Assets budget, Recurrent

Budget, Stocks Budget, Cash Budget and Analytical Accountancy budget.

d) All these Budgets must be inter-linked through MIS on an automated way, in order

to facilitate management.

3. As a Discipline, BT is a Cross Cutting Discipline

In fact, in order to be able to perform on a professional way its activities and fulfil its mission,

the BTS and its RBCs must use at a good level several disciplines that are all related to its

activities:

Communication and IEC techniques, all linked to a good knowledge of Marketing.

Social Science and Psychology applied to Public relations

Epidemiology, Hygiene, Bacteriology and prevention of Infectious diseases

Haematology and more precisely Immuno-Haematology

Virology, mainly applied to Hepatitis B and C, HIV/AIDS, HTLV, Dengue Fever, Crimea-

Congo Virus, etc.

Bacteriology, mainly directed on Syphilis

Parasitology regarding mainly Malaria

Quality Assurance, Quality Control and Quality Systems

IT systems use

Clinical Haematology, Oncology and Transfusion Medicine

Management of HR, and of Various budgets,

5

Knowledge of Administrations way of functioning

RBC Policy and Strategy definition and follow up.

4. Consequences for RBC and HBB Managers

Given the multiplicity of operations and of skills that are required, it is highly recommended

that the RBC Manager has a very good notion of leadership inside and outside a RBC.

He/she must also have good skills in organization of so various tasks, and must be

supported by a good team of Heads of Departments.

Following Introducing chapters advices will better introduce the Manager into the roles and

responsibilities of RBCs, and to classical Management principles, to integrate Operating

Chapters into a Quality System approach.

2. ROLES AND RESPONSIBILITIES OF BTS, OF RBCS, OF HBBS

2.1 BTS is a Coordinator and a Reference

1. Co-ordination

Blood Transfusion System (or Service, when it is all centralized) is in fact a network of

several institutions in charge of complementary tasks, in order to put into practice the

National Policy.

Policy proposal, dissemination, and Directives for implementation: this may address

Legal and Regulatory domains, as well as Standardization and Clerical Operations,

such as harmonization of IT systems of various BEs.

Strategy proposal and Guidelines for implementation, both on the technical and

administrative sides.

Conducting coordination actions in collaboration with Public Authority to better

organize Transfusion Regions, and to solve inter-institutional problems.

Creation of specific Working Groups in charge for questions that need reflection, such

as implementation of routine Leukocyte-poor RBCCs, or Pathogens inactivation in

Plasma, but also to develop administrative subjects such as specific MOUs with

Hospitals or other structures.

Establishment of common Policy and Strategy towards Blood donation and BDOs

(Communication Strategy, General Volunteering Policy, Terms of Reference,

conditions of common work, etc.)

Providing the platform for negotiations with Staff on practical problems of career,

salaries, working organization and conditions, etc.)

2. Reference

BTS role is to bring to the entire network tools and knowledge to ensure best practices and

best technical and scientific knowledge are obtained everywhere in the country, and allow

homogeneity of Quality of service.

This needs for instance:

Organization of a continuous training programme in all the domains concerned by BT

(even regarding equipment and maintenance subjects)

6

Organization of Internal Quality Control, either through development and

establishment of a National Reference Laboratory, or through identification of and

sub-contracting to Reference Laboratories or Institutions that could play this role.

Organization of an EQAS through subscription to International Laboratories, Result

dissemination and Workshop organization for improvement.

Qualification of new equipment when the RBCs have not the financial means to

proceed to these operations.

Organization of Pilot projects such as Plasma Pathogens inactivation, or Routine

Leukocyte-poor production, in a “Pilot Centre”, before introducing this new method to all the RBCs.

Diffusion of updates of the IT centralized system.

Organization of National Conferences to maintain contact between actors of the

system, share experiences and observations

3. Reporting

All these activities shall be the object of an Annual Activity report, in order to show and share

the dynamism of the whole network, and provide a basis for discussion with Public Authority

and Stakeholders.

2.2 RBCs are Providers, HBBs are Users7

7 Ref : Legislative reforms of the blood transfusion system in Pakistan: Letter to the Editor,

Transfusion Medicine, 2014, 24, 117–119; H. A. Zaheer & U.Waheed, SBT, GoP

« The reforms include the formulation of a National Blood Policy and Strategic Framework (2008–2012), establishment of Blood Transfusion Programmes at the National and Provincial levels and

the creation of a new infrastructure which will, in the first phase, develop 13 Regional Blood

Centres as ‘production units’ and 78 Hospital Blood Banks as consumption units »

H. A. Zaheer & U.Waheed, SBTP, GoP

LEGAL: THE SAFE BLOOD TRANSFUSION ACT, 2013

5. Functions and Responsibilities of Blood Centres:

b) Every blood centre may perform processes related to blood donation promotion,

collection, testing, processing, storage, transport, distribution of human blood and

blood components, according to the license issued.

o) Blood and blood components will be distributed to hospitals, based on hospital blood

banks requests, in accordance with provisions set up by a written contract.

7

1. The licensed RBC is responsible for:

FIRST ESSENTIAL OBJECTIVE:

REGIONAL ORGANISATION

SECOND ESSENTIAL OBJECTIVE: SPLITTING PRODUCERS AND USERS

THIRD ESSENTIAL OBJECTIVE: ESTABLISHMENT OF A WRITTEN

CONTRACT BETWEEN PRODUCER AND USERS

CONSEQUENCES

Fig 1: Regional Organization of BT

Fig 2: Producers and users

8

Recruitment, collection of blood from VNRBD

exclusively, and management of donors

Production and distribution of all Blood

Components to all the HBBs of its catchment

area, and providing evidence for their

compliance to Standards and Guidelines.

Ensuring that its part of the Haemovigilance

and traceability procedures, records and

notifications are performed according to

corresponding Guidelines

2. It is not in charge for issuance to patients, which is

the role of the HBBs. In their turn, HBBs are no

more authorized to collect Blood from Donors.

This implies some « cultural and traditional » fundamental changes, as:

Plenty of hospitals are maintaining a HBB (generally part of the General

Laboratory) that is in fact a Blood Collecting, testing and Blood Components

Issuing Establishment, using mostly “familiar or replacement Blood Donors”. This practice has demonstrated since time that it is not ensuring the maximum safety

and it has also been demonstrated that working conditions do not ensure

compliance with Guidelines (IBTA already reports on several withdrawn licenses in

relation to those practices8). It is the objective of the present Reform to end that

practice.

But Hospitals are places where Blood donors may be most easily encountered, as

use of Blood Components is needed there, and it may be easily made a call for

“replacement of Blood” as people are immediately sensitised. That is why, despite

a RBC has a specific Department at its place for collecting Donors, it is sometimes

far (in distance or in time) from Hospitals and it is generally necessary to develop

inside (or immediately in the vicinity), premises for Blood Donors call, medical

examination, blood collection and Donor management. Such structures could be

called Blood Donation Centres (BDCs), and work in close collaboration with local

BDOs.

8 IBTA_Annual_Report_2013_14

REFERENCES:

SBTP Functional Brief for RBCs

Functional Brief MIS for BT Services

SBTP Standards and Guidelines for Blood Banks and Transfusion Services

SOP for BT Service

Haemovigilance guidelines

The Safe Blood Transfusion Act, 2013

9

If it is not possible to develop such structures, and if the RBC is not too far (e.g. in

the same City) a RBC shuttle could be usefully organized to pick up Donors and

bring them to the RBC, and to ensure their back transportation.

3. RBC shall ensure this service in routine, and not in emergency, for logical reasons

mainly linked to geographical and time constraints and to types of blood components

requests from Hospitals:

a) It is unrealistic to demand to a RBC to provide Platelet Concentrates (PCs) in

emergency when the time needed to prepare, control, and transport (how many

time for how many Km?) a significant quantity, is largely exhausting the time left

clinically by an haemorrhage. This leads generally to wastage of a Component that

would have been useful for other patients. Use of Platelets is generally a matter of

therapeutic protocol that can be largely planned in advance (see Guidelines for

ACUB) through a smooth relationship between prescribers and RBCs Responsible

Persons. Some needs for specific PCs (HLA immunisation for instance) need

specific choice of Blood Donors, and Platelet Apheresis technics, which cannot be

performed in emergency (but which have to be developed by the RBCs that serve

University hospitals and Hospitals treating Cancer and Leukaemia patients for

instance). Dengue Fever areas must also be considered as priority areas for the

development of Platelet Apheresis Departments in RBCs for those reasons.

b) It is unrealistic to demand from RBCs, for the same reasons of time and real

efficiency, the provision of Leukocyte-poor RBCCs, which needs either filtration or

centrifugation, thus opening of the primary blood bag, and cannot be used after

Fig 3: Possible organization of RBCs

10

more than 6H storage. Same remark can be made regarding Washed RBCs,

adding to this that it is a rare indication. So, the HBBs will have to adapt their

equipment to this question.

c) Units that are designed for BT Safety operations, which are HBBs, best do

requests for specific phenotypes in immunized patients. That is common sense, as

it is easy to request and obtain quickly more blood samples if needed, and to issue

blood components the cross-match of which is negative.

d) In general, emergency BT cannot be treated by the RBC, as those operations,

multiplied by the number of attached Hospitals, will quickly appear not feasible as

they will lead to multiply the number of vehicles and drivers without responding

properly to situations that may frequently be simultaneous. This will be non-cost-

effective and inefficient. So, emergency is very often used as a pretext to bypass

Laws and Regulations, through creating “exceptions” that further are contributing to a complete disorganization of the system.

So, the only possible principle is a routine weekly (for instance) provision of a stock of all

Blood components by the RBC (together with the removal of all remaining components ) in

order to ensure an equal status of perishing dates, and prevent unused Components from

perishing. Volume of stocks (V) to renew is to be calculated according to a simple formula

for each category:

e) It is thus possible to propose a complement of the scheme proposed on Fig 4;

The only situation where Leukocyte-poor RBCCs could be prepared and

distributed by RBCs would be routine Leukocyte-poor RBC preparation in all

Blood Bags. Nothing goes against this, the only limit is the sustainable

budgeting of the cost of specific Blood bags and of the equipment for

preparation. In that case, all the RBCCs would be Leukocyte-poor, which would

be a considerable progress both in TTI prevention and in febrile reactions

prevention, with an impact at national level. Budgeting of such an action would

be a real sign of political willing.

V= Routine needs + Mean emergency consumption

Routine and emergency needs= from past year experience

Mean Emergency consumption has to be calculated every month and

adapted each month to reach an adequate satisfactory and reasonable

volume on a one-year period

11

3. SOME PRINCIPLES OF MANAGEMENT

THEORY.....

Classical managerial principles may be summarized as follows:

...AND PRACTICE:

Generally that is never realized, with the following result:

1. DO NOTHING

3. DON’T LET DO ANYTHING

2. MAKE DO EVERYTHING

12

Causes may generally be:

a) Insufficient competencies of the delegated person, or delegation to the

wrong person

b) Limitations of job descriptions:

c) Bypassing the hierarchy to « go directly to the Chief » because intermediate hierarchy is

said not to be decisional.

d) “My problem is emergent and that needs an immediate decision”. e) The Manager cannot psychologically delegate by lack of trust.

Organogram Development, Establishment and Implementation

1. An organogram is the result of:

a) Definition of needs: which competence is required for which post?

b) Call for Applications, defining roles and responsibilities of the post, job description,

and expected qualifications of the future post holder9

9 See Business Plan

TASK ABC

TASK EFG

WHO WILL DO THE TASK D? TASK

MAIN OBJECTIVE: THE RIGHT PERSON AT THE

RIGHT POST

13

c) Rational Choice among several applicants made by a consensus between the

Manager, the Human Resources Manager (or the Administration Manager), the

Head of the corresponding Department, and a representative of the Legal

Authority. Usually a pre-selection is performed and 2 or 3 applicants are selected

for interview

d) Interview/Negotiation to better approach the personalities and competencies of

applicants, followed by a motivated choice, officially communicated to applicants.

e) Final official and published appointment of the person to the post, with

establishment of an employment contract.

2. Regarding a RBC, the classical organogram is the following (Fig 5):10

a) Some explanations are to be brought on required qualifications mentioned in this

Organogram :

b) MD is generally

mandatory for the

position of General

Director, together with

Management

qualification or

experience.

c) General Director is a full-time post.

d) In each position mentioned in the organogram, MD is generally required. If a MD

cannot be recruited it is necessary to adapt the requirements. For instance,

Laboratory may be Headed by a Pharmacist, provided he/she has the Biological

needed competencies (see above definition of the requirements)

e) Regarding Quality Department, if a MD or a Pharmacist is available, he/she must

bring the evidence of a Qualification in the Quality domain. With this required

Qualification, it is also possible to recruit a Scientist, an Engineer or a qualified

person in the domain of Quality.

f) Regarding Processing/Blood Component Department (Distribution Department

may be merged to it), the Qualification of MD is only necessary when the RBC is

issuing Blood Components to patients, or realizing itself Blood Components

Injections) 11. A Pharmacist or a Production engineer may fit the job.

10 See also Business Plan and Functional Brief for RBC

11 That is not the case in the Pakistan Reform Programme, where RBC is only distributing Blood

Components to attached HBBs.

NEEDED LEGAL AND OPERATIONAL DOCUMENTATION

Legal framework for recruitment operations

Legal advertisements

Official SOP for recruitment

Applicants’ CVs

Contract template officially approved

14

LABOR ATO R Y

Q U ALITY DE PAR TM E N T

M D o r Pha rm a cis t

TTI

SCR E E N IN G

D ON OR

R E CR U ITM E N T

SE CTION

D O N O R

COLLE CTION

SE CTION

G E N E R AL D IR E CTOR

M D

M D

BLOOD D ON OR D E PAR TM E N T

M D

LABOR ATOR Y DE PAR TM E N T

M D

BLOO D CO M PO N E N T

D E PAR TM E N T

M D

D ISTR IBU TIO N

LABOR ATOR Y

AD M IN ISTR ATIO N

F IN AN CE

IH LAB

Fig 5: RBC ORGANOGRAM

15

g) The Administration and Finance Department is usually composed of following

sections:

Required Qualifications and job descriptions are described in the Business Plan. Being quite

specialized, these sections must be headed by specifically qualified persons, who will have

to adapt to particularities of the job.

It is of particular importance to appoint an efficient and very pragmatic and polyvalent

responsible person to the Maintenance sector, which is crucial for the sustainability

of the RBC

.

ADMINISTRATION

FINANCE

HR AND GENERAL

ADMINISTRATION

ACCOUNTING

AND FINANCE

MAINTENANCE IT

THE RBC MANAGER IS THE FIRST

RESPONSIBLE PERSON FOR A&F DEPARTMENT

Fig 6: Organogram of Administration and

Finance Department

EVERYTIME CALCULATE AND COMPARE COSTS OF

STAFF AND EQUIPMENT AMORTIZING VERSUS SUB-

CONTRACTING (VEHICLES...)

16

The IT Head being responsible for the maintenance and the

development of the MIS, it is also crucial to appoint a high level

practitioner to this responsibility.

3. Organogram

implementation: responsibility and

delegation

a) Notion of Responsible Person12

and of responsibility

Regarding Regulatory aspects and Inspections, the responsible person is the

person named on the BE licence: it is thus the Manager of the RBC13 .

In Pakistan14 ,

As regards Quality systems, the responsible person is in charge for 15:

12 See documents on Quality

13 Ref : Common European Standards and Criteria for the Inspection of Blood Establishments

(EUBIS) 14

Ref : The Safe Blood Transfusion Act, 2013, ICT Health Department., Islamabad, Pakistan 15 Ref: Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003

BUDGETS ARE GENERALLY NOT EXTENSIVE

TAKE CARE: NOT TOO MANY HIERARCHICAL

LEVELS IN THIS DEPARTMENT: HEADS MUST BE

OPERATIONAL AND NOT CREATING « A STATE

WITHIN THE STATE »

AN INDICATOR: % AF Dept/Global staff<20%

PRIORITY TO TECHNICAL POSITIONS!!

The responsible person shall possess a diploma, certificate or other evidence of formal qualifications in the field of medical or biological sciences awarded on completion of a university course of study or a course recognized as equivalent by the Pakistan Medical and Dental Council and shall have practical post-graduate experience in relevant areas for at least two years, in one or more blood centres which are authorized to undertake activities related to collection and/or testing of human blood and blood components, or to their preparation, storage, and distribution.

Where the responsible person is permanently or temporarily replaced, the blood centre shall provide immediately the name of the new responsible person and his date of commencement to the Authority.

Ensuring that every unit of blood or blood components has been collected and tested, whatever its intended purpose, and processed, stored, and distributed, when intended for Transfusion, in compliance with the laws in force in the Member State,

Providing information to the competent authority in the designation, authorisation, and accreditation or licensing procedures (...)

The implementation of the requirements of Articles 10, 11, 12, 13, 14 and 15 in the blood establishment*

* These articles are related to the establishment of a Quality system and to Haemovigilance activities, which

17

In Pakistan the responsible person « shall be accountable for ensuring that

every unit of blood or blood components has been collected and tested,

whatever its intended purpose, and processed, stored, and distributed, when

intended for transfusion, in compliance with the provisions of this Act, the rules,

and the regulations”16 .

That means the Manager (responsible person) has put in place all the needed

administrative and financial dispositions to reach that objective.

b) Notion of Delegation

The Manager delegates his/her authority and corresponding tasks to the Heads of

Departments, and they delegate in their turn their own authority and corresponding tasks to

the technical level. This means, from the delegated person, not only acceptation of the job

description, but also acceptation of the involvement of his/her own responsibility in execution

of tasks.

Consequences:

The Delegating person must check whether tasks are executed in compliance with the

Procedures and to the Quality system

The Delegated person must accept to carry on all the delegated tasks, and directly

make decisions incumbent to her own responsibility at his/her level of hierarchy.

Feedback is mandatory.

There must be a reciprocal review

of the overall functioning of the

delegation system in order to

prevent the dysfunctions evoked

on the beginning of this Chapter.

Of course, results must be

analysed and checked for conformity to objectives.

This also applies to the Manager, who is the main actor of the establishment and

implementation of the Quality System.

It is only through applying these principles that jobs descriptions may get some

functionality. Their smooth implementation is in fact the result of a clear negotiation

and of a reciprocal acceptation of roles and responsibilities inside the RBC.

A tool: Management meetings....

But also, Department meetings,

16 The Safe Blood Transfusion Act, 2013, ICT Health Department., Islamabad, Pakistan

EACH ONE MUST MAKE DECISIONS

AND TAKE RESPONSIBILITIES

AT HIS/HER OWN LEVEL OF AUTHORITY,

EVEN IN EMERGENCY

18

....provided they:

are organized at programmed dates and times

with a clear agenda,

do not prevent normal functioning

and allow decision making.

Another tool is personal periodical performance review, which is the opportunity to

examine, on a collaborative way, both successes and drawbacks in overall performance of

each person all along the Delegation chain.

19

OPERATING CHAPTERS

4. ADMINISTRATIVE OPERATIONS

4.1 General presentation of the OM

Operations Manual must first introduce the RBC to make it accessible to all

REGIONAL BLOOD CENTRE OF

.................................................

Postal

Address..............................................................................

Document

Reference

OPERATIONS MANUAL

CONTENTS

1- Mission 2- Legal 3- Location, Business hours 4- Staff, training and organogram 5- License and accreditation - Responsible person 6- Policy and Quality Commitment 7- Activities carried out

6.1. Blood donor recruitment and management

6.2. Blood collection

6.3. Blood processing

6.4. Blood Screening

20

Comments on the two first pages of this OM

a) As it may be observed, header and footer are to be reproduced on each page b) The document must have a reference, and page N° is also inserted c) In the footer are mandatory elements for Document management in a Quality

System. d) Contents are only an example, but may be modified according to local

circumstances e) All pages and chapters of the OM must have the same shape

REGIONAL BLOOD CENTRE OF.................................................

Postal Address...................................................................................

Land Phone.......................................Fax:...........................................

E-mail address....................................................................................

Document

Reference

OM 001

OPERATIONS MANUAL

CONTENTS (CONTINUED)

8- Financing and Budget operations

9- Maintenance operations

10-Traceability/Haemovigilance, call back and returns

11-Quality System-related operations: which data for what?

12- MIS, Data system: which data for what type of action?

Annexes

References

21

4.2 Mandatory First Elements of the OM

a) Mission: it must reflect the Policy of the RBC

The first element to represent the Policy of the RBC is the external aspect it

wants to give to the Population: that starts with the letterhead and the logotype.

It must represent the mission, and identify the whole programme as a whole

across the country for a good identification. This aspect has to be carefully

studied and validated, as it will be really the equivalent of a “Trade Mark”

Fig 7 represents the official Logotype of the SBTP, it has

then to be reproduced on all official papers of the RBC, as

an identifier.

That does not prevent the RBC from Provincial identification

with various types of logotypes that would be also referring

to safety of Blood and bearing an attractive message for

Blood donation.

This Policy is representing the Objectives of the RBC, which are not only limited

to simple implementation of the Law (passive, mandatory mission), but also a

commitment in volunteering in Quality progression and best Patient and

Population service.

Policy of the RBC must be written not only by the Manager, but also in collaboration with all

persons at their respective level, and must be a synthesis of all contributions.

Implementation of this Policy will be expressed in the Business Plan and in the Strategic

Plan(s) established to implement one or several aspects of the Business Plan (Fig 8).

Fig 7: Logotype of SBTP

POLICY

BUSINESS

PLAN

STRATEGIC

PLANS

Fig 8: Hierarchy of Policy, Business Plan

and Strategic Plan(s)

22

Mission description must also specify the catchment area of the RBC (Whole

Province or only some Districts), and the

attached Hospitals HBBs.

When a RBC is supplying Blood

Components to attached HBBs, it is

necessary to establish and sign MOUs

that shall precise practical conditions of

this service (see Introducing Chapter 2):

references of MOUs have to be reminded

in the OM.

b) Legal

The legal statute of the RBC must be explained. For instance, it must be

specified that the RBC is a Public Establishment and a legal entity, with

autonomous statute, functioning under Public self-accountancy rules, and that

the RBC Manager has delegation of Financial Powers to implement that Public

expenditure.

This Chapter must remind references to all legal texts that are constituting on

a direct or indirect way the legal framework of RBC activity:

o Federal or Provincial Act

o Ordinances

o Administrative and Financial texts that apply to the RBC.

o Provincial decisions for implementation

c) Location, working times

Full address and phone numbers, fax and e-mail addresses of the RBC and of its secondary

places if the RBC has some “satellite” Blood Donation Centres (BDCs).

A simple map of the City may be added to the address, in order to help persons who do

not know very well the District where is located the RBC.

Working times must be précised, as well as duty periods.

d) Staff, training and Organogram

Regarding external users:

i. In each activity, Qualification, Grade, Recruitment conditions and Number

of staff must be specified.

ii. Rhythm and topics of continuous training sessions has to be précised,

iii. A list of Departments and Heads is added, with direct phone numbers.

That is depending upon the physical organization of telephone inside the

RBC (through a unique phone N° and dispatch, or through a decentralized

dispatching system).

iv. This has also to be part of the Website (if any) toolbar headlines.

An example of such details is presented in Fig 9 17:

17 Blood transfusion manual Aberdeen 12th edition, 2013

SUPPORT DOCUMENTS:

Provincial decision on catchment area and attached HBBs

Texts of MOUs

23

24

25

Regarding Staff and internal environment (see Chapter 3 and Business

Plan)

i. Procedures have to be

developed to recruit right

persons for the considered

jobs, at each level.

ii. Evaluating staff performance

and problems in job

implementation is also part of

the OM. That has to be

developed from Jobs descriptions through procedures and indicators that

have to be specifically developed.

iii. Chapter 3 of the present document provides some basic notions in relation

to this part of the OM.

e) License and accreditation- Responsible person18

A per all Provincial Acts, a BE must be registered and Licensed, after due inspection by

BTA.

The OM will specify the N° and type of License, as Fig 10 is showing19:

Fig 10: RBC License model

18 See Business Plan for Blood Centres in Pakistan, SBTP, 2011, Chapter 2, p9

19 Functional Brief for BTA, SBTP 2013

DOCUMENTS NEEDED

Staff recruitment operations (see Chapter 3)

Job Descriptions

Working contracts

Employee Review document

26

It must specify: “Responsible person is (See Chapter 3 of present document):

f) Policy and Quality Commitment

This Policy (see above reflection on RBC Mission) must be a strong statement on several

aspects, as the RBC and its Staff and management must be really and practically

engaged into “client” satisfaction. That includes several aspects:

The first “client” is the population and more precisely Population of Blood Donors: RBC must have a specific approach on specific Blood Donor

satisfaction, in relation to expectations as a population and as individuals.

The second and end “client” is the Patient, but also his/her Medical and

Nursing environment, and it is needed to conduct a specific reflection on

technical and organizational Quality aspects to meet expectancies of

everybody within this environment

A third kind of “client” is “internal clients”, as Vein-to-Vein Chain is really a

chain of various processes, each of them being the “client “of the preceding

one, which is its provider. That chain needs also a Quality approach, Quality

Control being only the sanction of final results.

So, Policy and Quality Commitment statement must be a real commitment of

the Manager and of all Staff, and not only a declaration of intention without any

real substance.

Financing and Budget Operations

These operations are extensively described in a separate document

We just would remind here main minimal indicators that are useful in daily Management of

a RBC and must be part of the Manager’s keyboard, specifically during the first year of functioning of the RBC.

Some of these indicators may further be followed monthly or even yearly, but only when

activity is stabilized.

Name and surname

Title, grade, function in the RBC

Address, Phone N°, e-mail

INTEGRATION OF BUDGET OPERATIONS

INTO GENERAL MIS OF THE RBC

IS MANDATORY

27

0 INDICATORS FOLLOW UP INTEREST

1 Amount of amortizations Yearly Capacity of renewal and acquiring new equipment

2 Balance income/expenditure Monthly Knowing general Budget balance or deficit

3 Staff ratio Monthly Impact on Fixed Charges and sustainability

4 Result R=T-(FC+VC) Monthly Same as 2, more analytic

5 Calculation of Break event point Weekly Evaluation of profitability floor

6 Calculation of neutral point in terms of number of days:

Weekly Evaluation of starting date of profitability

7 Consumable security stocks Weekly Avoid consumable stock shortage

8 Dates of stock replenishment Weekly Same as 7, more pragmatic

9 Cash-flow schedule –

Bank reconciliation Monthly Avoid bank cash deficit and interests

10 Cost of Blood Components Monthly Approach the amount of expenditure budget needed and further pricing bases.

MAINTENANCE OPERATIONS

1. Who is in charge?

Practically, three kinds of assets are to be considered:

a) Non technically specialized assets, such as general Building maintenance, Stand-

by Generator, General Electricity, Water supply and plumbing, Telephone, Vehicles,

Donor beds, paintings, etc.: these assets can be maintained by trained polyvalent

Technicians.

b) “Semi-specialized” assets, such as Cold Chain, and Refrigerated centrifuges,:

same personnel or concerned Technicians could be able to maintain them provided

they have received an appropriate training.

c) Technically specialized assets, such as Laboratory automated machines, rotators-

mixers for blood bags, Sterile connecting devices, Haematology Analysers, Sealers,

Optical plasma separators, Copiers, etc.: such assets must be the object of

Maintenance contracts with providers and use of Guarantee periods.

MAINTENANCE OPERATIONS ARE CRUCIAL FOR A SMOOTH

RUNNING OF THE RBC,

AND ARE TOO OFTEN NEGLECTED

At the level of a RBC, and especially during the first year, it will be needed to decide

both:

on Maintenance Policy according to types of equipment on type of personnel to be recruited at first,

28

For instance, regarding a copy machine and printing needs, it would be more cost efficient to

contract with the Stationery supplier for both paper supply and machine rental or leasing,

and maintenance. That has to be calculated before deciding. Same approach may be used

regarding vehicles, if they are not too much specialized (for instance transport vehicle for

staff and Mobile Team equipment, equipped with a autonomous generator to provide

electricity to Blood Bags rotators and electric devices).

Another solution to be examined is the kind of Services that can be provided by Health

Department from its own Maintenance Department; regarding two first categories of assets:

that has to be submitted to a very pragmatic assessment in terms of delays of intervention,

documentation, reporting, record keeping and of cost/efficiency ratio.

Whatever the chosen Policy, starting a building is every time causing practical and daily

problems that have to be solved immediately.

It is generally more advisable to recruit a Bio-medical Engineer, or a high level Bio medical

Technician to ensure a real end efficient field service and integration into Quality System.

2. Organizational Chart

Fig 11: Maintenance Organizational Chart

Maintenance operations must be performed in collaboration with Technicians working

on the site of the Equipment (Fig 10)

3. What is Maintenance?

It is a gathering of operations performed with the final purpose of maintaining or resetting an

equipment in good condition and able to perform according to its performance and

operational qualification.

Manager (of the Blood Centre or of the Hospital) and Dept. managers

Quality Manager

and Dept Maintenance Dept BB Technicians

Maintenance operations

SOPs

Reporting

and

recording

29

It is part of the global concept of Security of functioning, which is itself part of the Product

Quality Assurance, so Maintenance, could even more adequately be part of Quality

Department instead of Administrative Department (Fig 11)

Fig 12: Relationship between Maintenance and Quality System

It addresses critical Equipment, which is Equipment without which the RBC could not

be able to fulfil its missions.

a) Maintenance starts in fact before the first breakdown:

Design of the Equipment, which

makes it able to be maintained or

repaired (Design Qualification

concept, Provider Qualification, allow

to choose equipment able to be

maintained)

Installation Qualification

procedures provide a good knowledge about the equipment

b) Two types of maintenance: Fig 13

QUALITY MANAGEMENT

FUNCTIONING SECURITY

NEEDED DATA

Design Qualification Document

Provider qualification results

Installation Qualification (SOPs and Results)

Acceptable level

of performance

Real Performance Repair

Interventions

Obtained results

Time

30

Normally, “on demand” repairs (Corrective Maintenance) should make the

equipment come back to its original status, but it is generally not the case, and

the most frequently observed result is represented by the dotted curve of Fig 12,

till the equipment is no more functioning on an acceptable way. Corrective

Maintenance, performed after failure or breakdown is an emergency

attitude, but does not ensure a real sustainability of the equipment.

Nevertheless, when a breakdown is occurring, analysis of its causes can be

useful to improve preventive maintenance or other procedures linked to the

equipment.

Of course, after a Corrective Maintenance Operation, a re-qualification of the

Equipment has to be performed and documented.

Preventive Maintenance is aimed to reduce probability of failure or

degradation of an equipment:

o Lower emergent repairs frequency

o Easier management

o Easier repairs operations planning

o Avoids dysfunction periods before breakdown

o Avoids losses of products due to brutal breakdown

o It may be systematic or conditional

Systematic: periodic inspections and planned operations

Conditional: provoked by a predetermined parameter that reveals the status of

the equipment. Such an approach prevents from systematically taking down into

parts (that could be more dangerous than useful) and permits a continuous follow

up of beginning problems. This feature is part of equipment specifications.

c) Documentation and linked operations

In addition to Qualification documentation and Inventory list (see Tools for Budget

Management), several documents must be created and properly registered and stored for

each element of Equipment:

User’s Manual supplied by Provider when installing the equipment. Log book of the equipment, where following information is mentioned (Table 2):

31

Table 2: Example of Log sheet (Log Book)

Related SOPs have to be established in

reciprocal collaboration by maintenance

Department, AQ Department and

Technicians working on the Equipment.

Spare parts and tools must be specifically

stored and a specific Inventory file has to be

created

ITEM DESIGNATION Place of use

Inventory N°

(barcode)

Accounting N°

Item

name

Trade

mark

Type Serial

N°

Provider

Date of

Installation

Unit

Price

Installation Qualification

Date

Result Signature of provider

Signature AQ

Operational Qualification

Date Result Signature AQ

Maintenance operations

Date Nature of operation Recommendation Signature

Log Book must be created by AQ Department in collaboration with Maintenance

Team, and related SOPs must be established and validated.

LINK WITH MIS MUST BE ESTABLISHED

NEED FOR

A SPECIFIC WORKSHOP

TOOLS WITH RELATED INVENTORY LIST

32

d) Reporting (feedback) and recording must be made to and kept at:

Maintenance Department, for follow up and update of any operation related to the

Equipment

Laboratory or Department user of the Equipment, as it is the main and daily user

of the Equipment

AQ Department, to look for improvements and integration into the whole Quality

Strategy of the RBC.

e) As a conclusion to this Chapter:

Maintenance operations must follow several SOPs and use several forms. An indicative (not

exhaustive) list is provided below, as an example for Blood Cold Chain Maintenance:

RECORD KEEPING IS CAPITAL:

TO DETERMINE WHETHER OR NOT THE EQUIPMENT HAS CONSISTENTLY PERFORMED ACCORDING TO SPECIFICATIONS.

TO SELECT FUTURE EQUIPMENT

APPROPRIATE PREVENTIVE MAINTENANCE IS A SOURCE OF

QUALITY PRODUCTS COST SAVINGS

Monthly alarm and battery checks

Preventive maintenance of blood bank refrigerators

Preventive maintenance of blood bank freezers

Preventive maintenance of platelet agitators

Preventive maintenance of plasma thawers

Weekly maintenance of transport boxes

Maintenance of generator

Defrosting and cleaning a blood bank freezer

33

5. TECHNICAL OPERATIONS

5.1 Reminder on Standards and Guidelines20

Standards are Policy Documents

Those documents are establishing the objective of the Government, for a general direction of

work.

1. At Country or at Province level, these Objectives will be

established regarding Quality: National Standards are

representing Objectives of the Country/Province in terms of Quality requirements. They

will address 5 domains.

2. Domains addressed.

a) As regards Blood Components, it is the role of BTA to establish their Quality and

composition requirements in order to ensure a uniform level of Quality all over the

Country/Province. This will create the reference against which the Inspection function

will determine the licensing or not of the BT facility. Of course, those Blood

Components will be the object of Qualification Operations, to be evidenced by the BT

Facility through its Quality Control operations.

b) As regards Human Resources, it is crucial that the BTA establishes the

Qualification requirements for the Responsible Person of a Blood Facility and for the

Intermediate and Technical levels of Management. As far as Law is requiring

qualified persons, their documented Curriculum has to be established and included

into the Documentation of the Facility.

c) Premises have to be qualified in relation to BT Facility activities, as they have to

be appropriate in terms of surfaces dedicated to each of technical activities and

equipment, and also in terms of appropriateness of the pathways related to Blood

Donors, to Blood bags and to samples. Biosafety conditions must be created by

Premises organization, as it must permit to avoid any risk of contamination or

biohazard. Of course, safety and permanence of Electricity and water supply, as well

as appropriate temperature working conditions for the equipment must be ensured.

d) Equipment Standards have to be fixed at least regarding critical equipment: Its

Qualification operations (Design, Installation, Operational/Functional Qualification

operations, as well as Calibration Operations) have to be appropriately documented.

Of course, the Maintenance and re-Qualification operations after repairs/re-

installation have to be documented. BTA’s role is to fix the list of critical equipment,

the Standards to be reached by each critical equipment, and the type of operations

related to Qualification/calibration Operations. Qualification operations have also to

be extended to the providers.

e) Reagents Standards have also to be determined for all Biologic screening tests

related to Blood donors and to Patient Transfusion safety. Qualification Operations

have also to be determined for those reagents and their providers, as well as Quality

Control operations specific for Laboratories

20 Standards and Guidelines for Blood Banks and Transfusion Services, SBTP, 2013

THE “WHAT?”

34

3. It is part of the role of BTA to inspect BT Facilities to get on a documented way

evidence that Standards are met (or not) and to make subsequent decisions.21 (See

Inspection Section).

Guidelines are Strategy Documents

1. Process Description Documents are describing in general how

various operations from the Vein of the Donor to the final use of

Blood Components by Transfusion (or by disposal) are to be

executed. In fact, those texts are National Guidelines (or Good

practices: GMP, GLP, other). They are elaborated by Experts of the

Profession, through recommendations and proposals, but the role of

BTA is to transform them into Regulations.

2. National Guidelines will address the description of Key

Processes and the Documentation used and generated by those processes. This will

regard both RBCs and HBBs.

Those processes are very often made of several Procedures (FIG 14):

Fig 14: Several Procedures are constitutive of a Process, to reach a Result.

3. That is a general description, as each of the Blood Facilities will have to establish

on a documented way the local way of working (Procedures, or SOP) for each

Process.

This way of working may differ according to the type of equipment, reagents, and more

generally local working conditions.

4. Procedures (SOPs) and the whole Processes have to be validated to ensure on a

documented way that they allow to obtain the expected result.

5. It is the role of BTA to establish, through the Guidelines, validation operations related

to Procedures and to the whole Processes, and to inspect them.

21 Functional Brief Blood Transfusion Authority, SBTP, 2013

THE

“WHO?

HOW?

WHEN?

WHERE?”

P1 P2 P3 P4 RESULT

PROCESS

35

Fig 15 provides an example of description of key processes of a RBC to be described and

transcribed into Regulations (together with the corresponding documentation)

NATIONAL STANDARDS AND NATIONAL GUIDELINES ARE PART OF THE

RBC DOCUMENTATION

THEY MUST BE AVAILABLE IN ALL DEPARTMENTS,

AS A REFERENCE FOR SOP REDACTION

AND SUPPORT OF PRACTICAL DAILY WORK

Guidelines and

documentation

Guidelines and

documentation

Quality Control

RECALLS AND

RETURNS

H

E

M

O

V

I

G

I

L

A

N

C

STANDAR

Fig 15: Representation of a RBC’s Key Processes, showing the domain

of impact of Standards, Guidelines and of Quality Control

36

5.2 Blood Donor Sensitization, Motivation and Management

The number of obtained Blood donations is the only significant indicator of the success of

sensitization and motivation methods of the RBC.

All this activity is then oriented to the ways and means to obtain Blood donors (VNRBD) in a

sufficient and regular quantity.

Sensitization and Motivation

1. General Population sensitization

This objective may be reached through use of several tools that are directed towards

following axes:

Knowledge of the General population on

Health in general and Blood donation in

particular: this is the objective of KAP studies

already initiated by SBTP 22

From these results, elaboration of messages

to be broadcast through TV and Radio

Channels, together with targeted written

Press, for awareness campaigns.

It is sometimes interesting to provoke the

interest of a Leader of any kind (religious, TV

star or of a well-known and appreciated sportsman), to create some “identification”, to be the support of messages. Political leaders as well as religious leaders would be

more usefully “used” to give practical example of Blood donation, or to express the need for the whole population.

Anyway, these actions must be evaluated, in order to select “what is working best”. Regarding the same approach, it is necessary to choose a logotype and colours (for

vehicles and Buildings) that could express best what is (in the Population’s mind) best representing the action of donating Blood, and will provoke in people’s mind an immediate and distinctive identification. That will help to realize posters, t-shirts, caps

and other materials useful to create and contribute to identification.

General sensitization must not be only limited to the Annual Blood Donor Day, all the

“World days” created by WHO (Women, Child, HIV/AIDS, Malaria, Genetic diseases,

Cancer, etc.) have to be used to include a message on Blood need and donation.

2. Targeted Population sensitization and motivation

Social Marketing techniques must be used to identify more precisely what are the

messages to send according to each particular populations the RBC will address:

Rural and traditional population, Universities,

Schools in general, large enterprises, Public

Administrations, etc. as their cultures are

different and they are not sensitive to the same

arguments, or to the same kind of information.

22 Creation of an enabling environment for Voluntary Blood Donation, SBTP, 2012

DATA NEEDED

KAP Studies Evaluation of messages Evaluation of sensitization

campaigns Evaluation of TV spots,

articles and interviews Study on Logo and general

looking.

NEEDED DATA

Results of Marketing study Planning of Information

meetings Evaluation of meetings

-

37

The approach in such cases will more be organized around meetings to provide

information on Blood, Needs for Blood (practical examples), both qualitative and

quantitative, as Population is very often ignorant about basic notions on the subject.

Those meetings must be the opportunity to discuss and interchange with people, and

to provide them tools for their own reflection. Sometimes, motivation must be more

oriented on emotion than on information, according to type of attendance.

Blood and related questions are very often a difficult matter, linked to so many

symbols and beliefs, that such an approach must be very carefully prepared, at the

same time it must bring a usable information.

All meetings must be conducted by specifically trained persons, able to respond to

any of the questions asked. The most legitimate is the Medical Doctor, responsible

of the Blood Donors Department, and that is part of his/her job.

Each meeting must finish with a call for Blood donation intentions, and if possible,

written inscription on a list. This is the first evaluation on results of the meeting.

All meetings must generate a report and an evaluation. This evaluation must also be

realized with participants, to get a direct and immediate feedback, and improve

organization and contents.

A simple evaluation tool could be as follows (Fig 15). Questions must call for simple

responses, and may be of course modified, such as:” have you learnt from this session?”, or “do you think that session was useful?”

Fig 16: An example of evaluation form to be used after an informative meeting

3. Immediate sensitization

It is the sensitization and motivation speech made just at the time and during a Mobile team

already organized in a particular place (University, Village, etc.).

It shall normally play just the role of a reminder, but in fact it is very useful as it may address

more persons than those who have been met at the information meeting, or they have

forgotten the date and time of the Blood collection session...

LOGOTYPE, NAME,

ADRESS OF RBC

38

It must be organized in advance with the responsible persons of the site, at the same time as

is planned the Mobile team. It is a good thing if these persons are participants to this

sensitization session, and actively contributing to the Mobile Team organization and

realization.

Direct evaluation of this type of sensitization is obtained with VNRBD participation to the

Collection session.

4. Emergency calls

This kind of sensitization is different from other ones, as it is addressing Population in case

of shortage of stock, during the first phases of a disaster, or more frequently, when Blood

Components stocks is under security limit at some critic periods of the year.

They use Public media to a large extent, and also street calls with specific equipment such

as megaphones and sound equipment.

A strong organization has to be put in place, to be able to transport and collect large

amounts of population within a short period of time.

5. Interest and limits of existing Blood Donors Organizations (BDOs)

a) Around 62 BDOs already exist in Pakistan23 and are working since several years

in this field. They are mostly in fact Blood Banks, mostly not for profit Organizations,

collecting Blood from a percentage between VNRBD and replacement, or “family

donors” which is ranging from 10% to 50%, and realizing all the activities of a Blood Centre, till issuing of Blood components to patients (mainly Thalassemia patients, or

anaemic, or Oncology patients, and even to Hospitals). Origin of their funds is shared

between Donators, and cost recovery, and sometimes the Government is

contributing financially to their services. Some of them are issuing Blood

Components free of charge to patients.

b) Volume and quality of their activity is not very well know, but is certainly significant. It

is important to realize such a quantitative and qualitative mapping of their

activity, as they are potentially a good source of Donors.

c) Their number is per se an indication on their individualism and unwilling to

network themselves. That could also be an obstacle to the development of VNRBD

by RBCs, as they are already picking up the existing potential VNRBD population.

The main risk is thus to face a situation of competition.

d) Strategy to adopt could then be to develop a collaborative strategy, which could

be an alliance of their strengths (existing Blood collection activities and Blood donor

files) and of strengths of the future RBCs, through provision of technical quality in

Blood Collection, Screening and Processing. Such a strategy has to be negotiated

and could be the object of MOUs between the RBC and various BDOs of the

Province.

Management of Blood Donors

Two categories of Blood donors are existing in Pakistan

23 Inventory of Blood Donor Organizations of Pakistan, SBTP, 2012

39

1. “Replacement” Blood Donors, or Family Donors

They are not the objective of the RBC, but they do exist and represent from 50% to 100% of

current donors in the country, according to places and establishments. Of course this is not

contributing to BT safety, and the objective is to substitute this population with a VNRBD

population.

As RBCs do not have any VNRBD in their files at the very beginning of their activity, it could

be proposed to establish a particular strategy, consisting of:

Regulations enforcing interdiction made to HBBs about collecting Blood from these

Donors.

Establishing a specific organization of the RBC (see Introductive Chapter 2, Fig

3), including either BDCs (or drop-in Blood collection Centres) located in Hospitals or

at immediate vicinity of the Hospitals, or shuttles to transport “replacement” Blood

Donors to the RBC fixed site.

Development of a very personalized communication strategy towards those

Donors, and trying to engage them into a regular donation process. Such a strategy

has revealed to be successful in some countries (France, Laos), and has to be tried

in Pakistan. The approach is to calculate that, if 30 000 Blood donations are obtained

from 30 000 persons who never give more Blood, the same result can be obtained

from 10 000 donating Blood 3 times per year, or 6 000 donating 5 times per year.

The latter means a 25% yield in this strategy, which is successful by 40% in Laos.

2. VNRBD Management elements

a) Constituting the related database with all administrative information on the Donor.

Updating it regularly, as persons are very often moving and change their details very

often.

b) Individual management of the Donor (fixed site)

Updating his/her details at each donation

Organizing an appointment for the next donation,

and writing it on a flyer to give to the Donor.

Call back the donor the day before his/her

scheduled donation day (just to confirm) and fixing

another date in case of temporary non-availability.

c) Management of Donors (Mobile Collection

sessions)

Local management is crucial, and could be the

starting point for creation of local BDOs, without

ambiguity in relation to other activities of current “BDOs”. The persons belonging to this Organization will have to liaise with IEC Department of RBC, to organize Blood

Collection sessions in their area of action, and to organize the venue and local

NOT UPDATING A DATA BASE IS SOURCE OF

DEFINITIVE LOSS OF DONORS

SOPs

Entering data and validation

Updating data Daily management

and reconvening

Data base on local

BDOs and features

40

NEEDED DOCUMENTATION:

Post – donation: result remittance and counselling SOP

Decisional flowcharts for each marker

Monthly report on this activity

preparation for RBC Mobile Teams. Those “new BDOs” will ideally be constituted by VNRBDs themselves.

It is of particular importance to create and maintain a Data base on those

Organizations.

Individual Management of VNRBDs is the same as in fixed site, and data on the

VNRBD are to be entered the same way into the main Donor data base.

3. Counselling of Blood donors (both “Replacement” and VNRBD)

a) Pre-donation Counselling is mandatory

It is important to inform the candidate Donor that his blood will be submitted to

Biological screening, particularly TTI screening, in the interest of the patient. That

measure was introduced initially with respect to VIH/AIDS Infection (due to window

period), and is still an internationally recommended procedure. It is important to

emphasize that this screening is also potentially an opportunity for the donor to know

his/her personal situation towards the TTIs that are specifically screened by RBC.

Medical confidentiality has to be reminded, as well as treatment and remittance of

results.

Regarding RBC, several documents must be prepared and used:

General information on Blood

Donation Conditions (in Urdu

and English), to be affixed on RBC

entrance, and waiting room of

Blood Donors. This document

must have a place for each Blood

Donor to confirm he/she has read

and understood the document, and

to specify remittance conditions of

results.

This document will be reviewed

by the Medical Officer of the RBC during the Medical Interview (see

hereunder), and that will provide opportunity for the Blood Donor to receive

answers to his/her questions.

A specific document is to be remitted to the donor, in relation to his/her

definitive agreeing on further use of his/her donation (self-deferral

document): it will be signed and remitted to the RBC team after donation.

Specific Training, Documents and SOPs 24 must be developed a,d added to

existing ones.

b) Post donation Counselling is also mandatory

In any case, it must ensure the

best conditions of

confidentiality

If every marker is negative,

results may be sent by postage,

24 Standard Operating Procedures for Blood Bank Processes in Pakistan, SBTP, 2013

NEEDS:

Counselling specific training

Pre-Donation Counselling (BTS/SOP/WP/03)

Blood donor Educational Material, in SOPS, Annex 3.

Self-deferral document

Pre - donation counselling SOP (BTS/SOP/WP/03)

Monthly report on this activity -

41

or kept at donor’s disposition, according to conditions of remittance previously determined with the Donor during the pre-donation Counselling interview.

If one marker is positive, it is necessary to have a direct interview with the

Donor, and to determine what will be the kind of follow up, according to the type

of Marker that has been discovered. In general, the first attitude is to collect a

new blood sample for confirmation.

Decisional organograms, as well as related validated SOPs, have to be

developed in collaboration with other specialized Departments according to type of

marker discovered.

Evaluation of this strategy must be performed monthly

General Evaluation

Evaluation and analysis of this result (are they men, women, VNRBD, relatives, in what

proportion?) has to be performed to examine what are the most efficient strategies, and what

is the type of problems to be solved to improve results.

5.3 Blood Collection (Fixed Site and Mobile Teams)

This aspect has been abundantly treated in several documents produced by the SBTP, and

most of related SOPs are available as examples, to be rewritten and adapted according to

local working conditions25. National Standards and Guidelines26 also create national

regulatory environment to run this activity.

We shall only summarize here main aspects that are needed for a consistent management.

Fixed Site

This site must be the example and the “vitrine” of Quality Management of the RBC, regarding several aspects:

1. Conditions for both a friendly and professional donor reception

Fig 18: Reception of

Donors

25 Standard Operating Procedures for Blood Bank Processes in Pakistan, SBTP, 2013

26 Standards and Guidelines for Blood Banks and Transfusion Services, SBTP, 2013

OVERALL INDICATOR OF THOSE ACTIVITIES IS:

NUMBER OF CANDIDATE DONORS, PRESENTED AT FIXED AND MOBILE

SITES

SOPs

DONOR RECEPTION: BTS/SOP/WP/01

DONOR RECEPTION ANNEX 1 : REGISTRATION FORM

42

2. Donor register must ensure on a definitive way the link between Donor (Unique ID

N°) and his/her successive donations (each of them also with unique ID N°)

That is well described in MIS description, as there must be distinct files containing:

Donor’s ID N° and his/her donations (for traceability). It is highly advisable that ISBT 128 Barcode is used routinely, as a progress in really and more complete

identification of the Donation.

Donor’s administrative file (for management) Donor’s medical file (confidential)

3. Conditions for a confidential Medical interview

Room must be Closed, and properly equipped (Fig 16)

SOP/WP/01

SOP/TP/02a

SOP/TP/02b

4. Equipment must ensure:

o Proper installation of the Donor and easy surveillance

o Adequate equipment for Blood collection and good ergonomics

SOPs

DONOR HISTORY QUESTIONNAIRE FORM (ANNEX 4 ) DONOR PHYSICAL EXAMINATION FORM (ANNEX 2 ) PHYSICAL EXAMINATION (BTS/SOP/WP/05) HAEMOGLOBIN SCREENING BY CuSO4 METHOD

(BTS/SOP/TP/02a) HAEMOGLOBIN SCREENING BY HAEMOGLOBINOMETER

(BTS/SOP/TP/02b)

Fig 17: Haemocue

Fig 18: An example of Donation room

43

Separate space for adverse reactions must be available, and it is advised that chairs

or beds for Blood collection be equipped with rolls, to move them to this space and

ensure some isolation of the donor from other ones.

SOPs are available for all of collection operations:

Reporting of ARE shall be not only regarding those that need hospitalization: all ARE will be

reported on a specific register. That is of particular importance, especially as the RBC will

have very often at the beginning of its activity, to deal with first time donators, and such

events may have a very negative impact on other donors, or on

their relatives.

It is also important to explore the causes of those ARE, which may

sometimes be linked to technical aspects of Blood Collection.

5. Cleanliness and Proper waste management

Cleanliness has to be managed on a way

that ensures on a permanent way that

Collection room is clean and offers an

attractive feeling. That does not mean a

continuous aspersion of water and Chlorinated

solutions, the effect of which could be worse

than initial damage, and disturbing for technical

work and Donors. It is necessary to train

Fig 19: Example of Blood

collection equipment

1. Inspection of Blood Bags and Labelling (SOP/WP/06)

2. Preparation of Venepuncture Site (SOP/WP/07)

3. Phlebotomy and Collection of whole Blood Donation (SOP/WP/08)

4. Collection of Blood Components through Aphaeresis (SOP/WP/09)

5. Collection of Blood Samples (SOP/WP/10)

6. Post-Donation Care/Refreshment (SOP/WP/11)

7. Management of Adverse Effects (SOP/WP/12)

8. Documentation of Adverse Effects (SOP/WP/13)

1. Annex 1. Post Donation Care

ROOT CAUSE

ANALYSIS

NEEDED

Waste Management Policy

Organization

Cleaning personnel training

SOPs

Provision of appropriate waste containers

44

specifically Cleaning Workers on a way of discrete but efficient technics of cleaning.

Waste management must be the object of a specific Policy, Strategy and SOPs in

order to eliminate used materials on a safe way.

Fig 20 shows the principles of a simple basic Policy that could serve for starting the RBC

Policy on Waste Management, and adaptation of primary containers to collection of those

waste items. “Special” being Chemical, Drug and Radio-elements, the RBC is not concerned

as far as it does not run an Irradiator.

Fig 20: Principles of Waste collection in the RBC

Mobile Teams

It is generally difficult, in Mobile teams, to benefit from the same good conditions as in fixed

sites.

Even if SOPs and general technical dispositions are the same, and have to be respected on

the same way, local working conditions will impose adaptations of the SOPs.

On another hand, when a RBC is running on a stabilized and steady way, Mobile Teams are

the source of 80% of Blood provision to te RBC, and a too much important variation between

SOPs, could lead to major deviations in Quality of obtained Blood Components.

1. Planning and organization matters

a) Monthly Planning is quite easy to organize, in collaboration with BDOs, or with local

counterparts, according to the situation. All their personal data must be recorded for an

easy contact.

A specific file has to be established and updated for each

Collection session place: practical problems such as

venue address, electric plugging, water source, size and

number of rooms (both for Collection, medical interview,

refreshment and donor post donation care have to be

agreed, planned and forecast in advance.

Transportation time needed to reach the place of Collection must also be calculated, with

some added interval of time in case of transport incident.

Time for staff arrival must take that into account

All that information must be collected, recorded and updated if any change is occurring.

45

b) Time of intervention: it is a basic principle that the Mobile Team must be ready to

start the Collection session exactly on the time fixed for it.

This means that all Equipment must be installed and Staff ready to work at that time.

c) Preparation of Technical equipment and

consumable

A check list must be established and the

corresponding SOP must be developed.

That check list will include at minimum:

Number of beds and sometimes pillows

(according to the model),

Related Consultation paper for beds

Rotators-mixers for blood collection (same number as Beds)

Tube sealer(s)

Electric wiring corresponding to number of beds

Transport boxes in number sufficient for the scheduled number of blood bags

Medical equipment and consumable

Boxes of Blood bags, and other medical supplies (cotton strips, disinfection solutions,

drugs for donor care)

Sample tubes in suitable quantity

Bar code labels in quantity, with specific allocation of numbers series to that Session.

Needed stationery and computers

Foldable tables and chairs if not locally available

Refreshment, food for donors if not locally available.

Such an apparatus cannot be prepared seriously at the time of departure for the Mobile

team place. It has to be prepared and ready the day before if the Mobile team is planned on

a morning, and on the morning if it is planned on the afternoon.

Very often, the vehicle has to be adapted on such a way that pieces of equipment do not

fall on each other during the transport.

Specific SOP has to be established for that specific activity.

2. If there is no electricity locally available, it would be strongly advised to bring an

autonomous source of electricity (mobile generator, or charged batteries for rotators

and computers).

This is not useless, as according to modern Standards, Blood components must uniformly

Comply. Lack of electricity will induce deviations in that Quality (for instance due to lack of

anticoagulant mixing, or manual records in Mobile Teams and re-transcriptions into the MIS

at the RBC, which are sources of errors).

Realization and Evaluation

Realization sheet is needed to record the results both of Mobile and fixed Collection

sessions. It must be added to ARE reactions record.

In the case of fixed site, it may be a daily realization sheet.

DOCUMENTATION NEEDED

Mobile team file

Check list

Related SOPs

Realization sheet

46

It will be added to and archived with the Blood Collection session file.

Contents of realization sheet: an example is shown in Table 3.

1. Consumable used

This information is necessary for Administration Department and persons in charge for

Stocks Budget management.

Barcode Labels N° of start and end of the Session are capital for the sequence of Numbers

once introduced into the MIS.

2. Compilation of Quantitative results of the session in terms of blood Donation

This compilation will help Managers to analyse both quantitative results and profile of

Donors.

MAIN INDICATORS AFTER BLOOD COLLECTION:

TYPE AND QUANTITY OF CANDIDATE DONORS

TYPE AND QUANTITY OF ACCEPTED DONORS

TYPE AND QUANTITY OF ACCEPTED FIRST TIME DONORS

NUMBER AND TYPE OF ARE

NUMBER OF BAGS FOR TESTING/PROCESSING

47

Table 3: Example of realization sheet

DATE TIME TIME NAME OF BLOOD COLLECTION SESSION

ITEMS STOCKS

Start End Results of Session

Bags Candidate Donors Categories Number

Tubes VNRBD Male

Hemocue

or CuSO4

VNRBD Female

Medical Replacement Male

Roll paper/beds Replacement Female

Stationery Total accepted donors VNRBD Male

Food VNRBD Female

Drinks Replacement Male

Barcode labels N° N° Replacement Female

1st Time donors accepted VNRBD Male

VNRBD Female

Replacement Male

Replacement Female

OTHER INFORMATION Deferred donors for Hb VNRBD Male

VNRBD Female

Replacement Male

Replacement Female

Deferred donors for other reasons

VNRBD Male

VNRBD Female

Replacement Male

Replacement Female

Donations not achieved VNRBD Male

(see ARE report for reasons) VNRBD Female

Replacement Male

Replacement Female

48

5.4 Laboratory Screening (Biological Qualification of Donations)

Reference to National Standards

RBC must comply with National Standards and

Guidelines. Biological screening of collected blood

must refer to National Standards27 ,28 , and most of the

SOPs related to this activity have also been published

and shall be adapted to local working conditions.29

We shall not repeat recommendations and SOPs,

already largely developed in those Manuals, simply remind the main SOPs related to this

activity (Fig 21).

Qualification and validation of techniques and Reagents are described in the Standards and

Guidelines Manual, as well as in Laboratory Quality Control Guidelines.

It is crucial to establish a contractual agreement with the provider of automated

machines of TTI testing, in order to obtain the best maintenance performances for the best

reproducibility and reliability, which is difficult sometimes during the guarantee period, and

even more after that period. That is part of Provider Qualification operations (se Tools for

Budget Management). It is why it is so important to choose equipment that would be

“open”, both in relation to Reagents (to maintain a good competition level) and in relation to MIS (to avoid absolutely manual re-transcriptions of results).

Importance of the Link to MIS

1. In Immuno-Haematology

Manual methods are generally privileged, as it is not yet very clear that automated machines

are able to date to provide a better service. Two main concerns must be addressed:

a) Reproducibility of techniques and repeatability of Technicians

Reproducibility is the certainty of obtaining the same results with the same technical

conditions. Repeatability is the capacity of a Technician to obtain every time the

same results in the same working conditions. Personal influence is determinant in

interpretation of weak results, and standardization must be obtained not only through

training, but also through a careful follow up of personal performance. It is of

particular importance that standardization of Manual techniques is obtained, through

for instance appreciation of results by a “scoring method” and its manual registering.

27 Standards and Guidelines for Blood Banks and Transfusion Services, SBTP, 2013

28 Guidelines_for_Quality_Control, National AIDS Control programme, 2007

29 Standard Operating Procedures for Blood Bank Processes in Pakistan, SBTP, 2013

NEEDED:

Qualification and validation reports

Contractual agreement on machines maintenance

49

Fig 21: Reminder of main SOPs in Screening Laboratory

TTI SCREENING

1. Reception of Blood Samples (SOP/WP/14)

2. HBs AG Testing by ELISA Method (SOP/TP/15a)

3. HBs AG Testing by Rapid Kit Method (SOP/TP/15b)

4. HCV Antibody Testing by ELISA Method (SOP/TP/16a)

5. HCV Antibody Testing by rapid Kit Method (SOP/TP/16b)

6. HIV Antibody Testing by ELISA Method (SOP/TP/17a)

7. HIV Antibody Testing by Rapid Kit Method (SOP/TP/17b)

8. Syphilis Testing by RPR (SOP/TP/18a)

9. Syphilis Testing by ICT-TP (SOP/TP/18b)

10. Syphilis Testing by TPHA (SOP/TP/18c)

11. Malarial Parasite Testing by Slide Method (SOP/TP/19b)

IMMUNO-HEAMATOLOGY

1. ABO Grouping and RhD Typing by Test Tube (SOP/TP/21a-23a)

2. ABO Grouping and RhD Typing by Microtest Plate (SOP/TP/21b-23b)

3. Identification of Weak ABO Type (SOP/TP/22)

4. Identification of Weak Rh Type (SOP/TP/24)

5. Red Cell Antibody Screening (SOP/TP/25-26a)

6. Cross Match: Saline/Bovine-Albumin/IAT (SOP/TP/26b)

ANNEXES

Annex 1. Red Cell Suspension Procedure

Annex 2. Reading and Grading Tube Agglutination

Annex 3. Interpretation of Agglutination Reaction

Annex 4. Preparation of 6% Bovine Albumin

Annex 5. Preparation of Check Cells

Annex 6. ABO Discrepancies Chart

50

Interpretation of results is crucial in Antibody screening and Weak Antigens determination,

as well as use and interpretation of control cells or antisera.

In the case of discrepant results, the specific MIS of the Laboratory shall be able to refuse

such results, according to a decisional organogram decided by the Head of Department.

b) Manually entering results into the IT System is in fact a re-transcription,

subject to mistakes by lack of attention or mistyping.

It is of particular importance to organize this entry as a real “double-blind” and to let the

System accept or not entries after checking.

2. In TTI screening

Roughly two types of automated machines systems are existing: some are “closed” systems,

accepting only reagents of the same trade mark, others are “open, accepting any

reagent (see Tools for Budget Management).

That is a choice to be made by Managers, according to easiness of reagents procurement,

and type of funding of the facility.

Whatever the chosen equipment, its choice must be driven by the type of MIS and it is

crucial to obtain the best compatibility, if possible allowing direct entry of data from the

machine into the system, the only interface being the data analysis interface and

not an IT interface, which generally provokes

problems of responsibility assigning between IT

provider and Machine provider.

3. A working sheet must be conceived and used both

for results inscription per N° of sample, and

analysis/interpretation of those results. It must be

signed by the Head of Laboratory Department.

Identification and what to do with positive TTI Tests

1. Importance

a) For the Donor

If the screening test result is positive, it is important for the donor to be informed and

to get a real diagnosis of his/her case, and to get a medical follow up for an

adapted treatment (see Counselling).

b) For the RBC, it is of particular importance to get confirmation of the reality of the

case, and to have a clear behaviour regarding the donor. A test which is positive

must anyway generate a Blockade of the Blood Donation in the Quarantine. It must

be confirmed both on primary sample and bag (to avoid possible crosses) and if

confirmed, on a new sample.

2. Several decisional flowcharts exist, according to countries and technical laboratory

capacities. We only provide here a general decisional flowchart, which may be

complemented by other ones according to local capacities and cases (HBs, HCV, HIV,

etc.) (Fig 22).

NEEDED:

Working sheet as results

of the Laboratory

screening and IH tests

51

Fig 22: Decisional organogram on a TTI positive test confirmation

52

c) Such cases, which are not rare, must be completely identified and classified. That

is linked not only to the actual decision to

be made regarding both the Donor and the

Unit of Blood, but also to global

organization of the RBC on those issues.

Frozen Serum samples must be archived for

a long period (to be determined by National

Standards and Guidelines) in a freezer allowing

a temperature less than -40°C.

IT Archive on first and confirmatory results

must be stored 30 years. MIS system must display decision made and eliminate the Blood

Donor definitely if confirmatory tests and decisional organogram have decided.

Specific SOPs must be developed and established.

External Quality Assessment or Quality Assurance (EQAS)

This assessment is mandatory for any RBC, in order to get an external view from an

internationally recognized and ISO Certified Assessment Organization.

It will help the RBC Laboratory Department to progressively adopt International level of

working, through receiving samples of sera that are of difficult diagnosis, and obtaining

results from an external laboratory on their own samples.

That could be associated with external audits by this organism, in order to provide objective

evidence of quality of performed analyses, and thus, progress in certification acceptance.

Several organizations exist across the world (http://www.nrl.gov.au, http://www.qcnet.com,

http://www.bnms.org.uk, etc.): the pragmatic attitude is to realize a kind of tender to analyse

the cost efficiency of proposals (including financial), as it is subscription to be budgeted.

Such a Service should be organized through the National Network of RBCs, in order to

minimize costs and develop homogeneity of the BTS under building.

As a conclusion

5.5 Blood Components Preparation and QC

NEEDED DOCUMENTATION:

COMPLEMENTS TO ADD

STANDARDS AND GUIDELINES

SOPs (ALREADY EXISTING AND COMPLEMENTARY)

DAILY SCREENING RESULTS (working sheet)

CONFIRMATORY TESTS RESULTS

MAIN INDICATORS ARE:

NUMBER OF BLOOD BAGS AVAILABLE FOR PROCESSING

BLOOD GROUP FREQUENCIES

PREVALENCE OF POSITIVE MARKERS, PER MARKE

EQAS RESULTS

BLOOD COMPONENTS MUST COMPLY WITH STANDARDS

AND BE PREPARED ACCORDING TO GUIDELINES

53

Related SOPs are the following3031,and Guidelines are specifying general, but also

technical conditions for Components production. (See also Fig 15)

‘

Quarantine

1. It is a very important and crucial step of the working chain, as no Blood Donation

can be extracted from it if not Biologically qualified.

That must not be a symbolic disposition, as it must benefit from a specific space of storage

(separate refrigerator, which must be physically closed to any person, the key remaining

safe guarded by the authorized person of the

Department or of the section).

A quarantine must be organized both for Blood

and RBCC, and for FFP, as the latter must be

prepared within the 6 following hours of donation.

It means that screening tests will be performed at the same time as Processing of Blood

bags is performed, to respect this Standard.

Specific SOPs must be elaborated in relation to management of Quarantine.

2. It must ensure proper storage conditions (see chapters on Standards and Storage).

Premises

Premises shall be properly separated from other rooms, in order to protect both persons and

products. Special gowns and cap shall be worn. If possible a positive pressure system shall

be installed, to prevent premises from external contamination.

A SOP shall be established on this specific aspect.

Equipment: Qualification Operations

Those operations are described in relation to

centrifuges in the Guidelines already published.

30 Standard Operating Procedures for Blood Bank Processes in Pakistan, SBTP, 2013

31 Standards and Guidelines for Blood Banks and Transfusion Services, SBTP, 2013

EXISTING SOPs

1. Preparation of Red Blood Cells Concentrate (SOP/WP/27)

2. Preparation of Fresh Frozen Plasma/Cryoprecipitate (SOP/WP/28)

3. Preparation of Platelets (SOP/WP/29)

4. Labeling of Blood Bags and Blood Components (SOP/WP/30)

ANNEXES

Annex 1. Formula for Calculating RCF

AT THE END OF THE DAY,

QUARANTINE MUST BE EMPTY

(EXCEPT BLOCKED BAGS FOR

SCREENING REASONS

NEEDED:

- Complete documentation

and Qualification processes

and results of equipment

54

This has to be integrated into a larger Qualification and Quality Assurance Policy, which is

described in the Chapter on Quality system.

The objective is to ensure that when a centrifuge is supposed to provide 3 500rpm, this

rotation speed is really obtained. That has to be checked also for each piece of Critical

Equipment (centrifuges, refrigerators, freezers, platelet rotators, Laminar flow hoods,

sealers, optical plasma separators, filters, etc.). Those operations must be documented,

and both documents and results shared with and kept inside Maintenance and Quality

Departments, as well as inside Processing Department. .

Processes: Validation Operations

For example, preparation of a PC is a process, including several operations of centrifugation,

separation, sealing, storage. This process is a succession

of several SOPs (see Chapter on Standards and

Guidelines), and it is supposed to give a result conform to

Standards of PCs.

It may be interesting to study separately each procedure

before aggregating them into the same process, at the beginning of Department running, as

the global result may not be helpful to understand from where is the defect coming, if any.

Validation operations must be documented, and this documentation must provide the

evidence that processes are successful. Results must be archived and kept the same way

as Qualification operations.

It is thus clear that the number of SOPs has to be increased in this Department, in order to

completely fit its needs.

Cleanliness and Biosafety

(See Chapter on Risk management and Biosafety)

Quality Control of Blood Components

This operation is the final step, ensuring that Blood components are conform to National

Standards. It is this aspect BTA will control, and if there are problems observed, BTA is

entitled to inspect Processes and SOPs.

For instance, International Standards and QC results for a RBCC should be as follows:

NEEDED:

- Complete documentation

on Validation processes and

results

55

Parameter to be checked Requirements Control frequency *

Volume 280±50 mL 1% of all units

Haematocrit

0.65-0.75 4 units Once a month

Haemoglobin/unit Minimum 45 g 4 units Once a month

Haemolysis after storage Below 0,8% of erythrocyte mass 4 units Once a month

(*)What is specified in this column is the “minimum” quality control sampling amount and control frequency.

If the blood service unit implements statistical process control to minimize the deviation risk in the process,

sampling amount and control frequency can be changed, provided that they are not less than the ones

specified here.

Fig 23: International Standards and Quality Control of a RBCC

Quality control has to be performed on freshly prepared Components by Quality Department.

Specific SOPs must be established and validated, and results must be recorded and kept at

Quality Department, Production Department.

Worksheet to be Established Daily

We present here an example of worksheet to be used daily by Processing Department staff,

and which must be the object of a SOP (Table 4). Of course it is only a proposal and may be

amended according to local working conditions. It is more practical to establish such a sheet

for each Blood collection session, as for Realization sheets of blood Collection Department.

Of course, a SOP must be realized for the use of this sheet.

It shall be stored at controlled temperatures between +2C and +6C.

Storage time varies according to the type of anticoagulant/ protective

solution used;

o If CPD is used, 21 days.

o If CPDA-1 is used, 35 days.

Handling systems, which can guarantee that the temperature will not

exceed +10 °C during maximum 24 hours of transfer time, are used.

56

Table 4: A proposal for a working sheet for Processing Department.

As a Result:

5.6 Blood Components Storage, Transport and Stock Management

Storage and Transport of Blood components is mainly linked to Blood Cold Chain Equipment

(BCCE), and indirectly to equipment dedicated to some other components that need

controlled Temperature, such as PCs. This aspect is generally too much neglected by Staff

and Management, despite it is in fact an essential part of the Quality of service the RBC

must provide, and places where this Equipment is located are the most strategic places of

the RBC.

BLOOD COMPONENT PROCESSING SHEET

RBC NAME COLLECTION SESSION DATE QC SAMPLES

(AQ DEPT)

NUMBER SEQUENCE

PRESENT RBC Prepared FFP Prepared Platelet

prepared Other

00001 Tick Tick

00002

00056

TOTAL 57 56 56 23

REMARKS

NUMBER AND TYPE OF BLOOD COMPONENTS CONFORM TO STANDARDS AND READY FOR LABELLING. FREQUENCY: DAILY

PERCENTAGE OF NON-CONFORMITY FOR EACH COMPONENT (FREQUENCY: MONTHLY)

57

Blood Components Storage Equipment

1. Reminder on Standards and Guidelines

Standards and Guidelines already published 32describe general recommendations on those

operations. Published SOPs 33 describe mainly operations related to handling of Blood

Components, but not to the related equipment

It is of particular importance that the RBC develops a document in relation to its own

Policy on BCC itself, as BCCE is part of Critical Equipment of the RBC, and those

aspects are too often neglected. That document will include, at minimum:

a) Qualification operations

Installation qualification

i. Definition: Action taken to ensure that equipment

and ancillary systems are properly installed, meet

manufacturers' specifications and design

intentions, operate appropriately in the intended

range of use. It is generally described in the

installation manuals or user’s guides and includes recommendations on equipment assembly, place

of use, environment conditions, interrelations with

other equipment, installation diagrams,…

32 Standards and Guidelines for Blood Banks and Transfusion Services, SBTP, 2013

33 Standard Operating Procedures for Blood Bank Processes in Pakistan, SBTP, 2013

EXISTING SOPS

1. Storage of Red Cell Concentrates (SOP/WP/31)

2. Storage of Fresh Frozen Plasma/Cryoprecipitate

(SOP/WP/32)

Storage of Platelets (SOP/WP/33)

WARNING

All of the texts presented

in a Blue cartridge era

subject to establishment

and validation of a specific

SOP

1. When receiving an equipment: verify carefully whether the equipment (part after part) is conform to purchase order and has not suffered from transport. If any problem is observed: notify immediately.

2. Installation operations should be performed in the presence of the supplier or its representative

3. Check that guarantee card, operating manual and other supplies, such as spare parts, temperature charts, pens, batteries and keys have been included. They should be inside the packing case or the equipment itself. Most manufacturers include a list of contents.

4. Follow installation recommendations made in each chapter of the present guide regarding each part of equipment, and install the Equipment.

5. Proceed to administrative registering of the equipment (Serial N°, trade mark, type…) and spare parts to start its registering into the inventory list.

6. Create the “life document/log book” of the equipment with its identification, SOP on running, surveillance and maintenance operations.

7. Check functional parameters of the equipment after 24H running. 8. Create installation report and fill it with all collected information. 9. Check the entire process to validate it.

58

ii. Practically what to do regarding BCCE?

Operational and performance qualification

i. Definition: Is the equipment (automatisms, data acquisition systems, recording

systems, regulation systems, alarms and securities) functioning on a reproducible

way within the limits of performance forecast by the user’s specifications, the provider’s documentation and the limits established by the standards? Additionally, is the equipment and the whole system working according to expectations?

ii. Practically:

Important remark: Re-qualification (see Maintenance Chapter)

b) Practically, what are terms of Guidelines meaning?

Space:

This means room(s) where the equipment will be located is (are) spacious enough to permit:

i. large doors opening without any obstacle;

ii. easy circulation for persons and carts to fill the equipment with blood bags or

to remove them;

iii. easy and conform to Standards electrical connection (avoiding wires running

on the floor…see electrical safety);

iv. space enough between equipment and wall or ceiling, and between pieces of

equipment, (Fig. 23):

v. This is particularly important to allow air circulation around the equipment to

prevent any problem to the condenser, and also to provide correct conditions

of cleaning and access for eventual repairs. It will also be useful to locate

properly any Voltage stabiliser if needed.

Put in place all the elements for measurement and documentation of its main characteristics and

follow them carefully within a defined period of time. This period of time should be determined

contractually with the supplier as the period for acceptance of the equipment. Add considerations

and documentation on the impact (negative or positive) of the new equipment on the functional

result of the system.

After a breakdown and repair, same operations of Qualification have to be implemented to

determine whether the repaired equipment recovered the same characteristics as before

the breakdown.

If not, a decision will have to be made on its further use.

59

To ease installation, some types of equipment come with rear protecting bars. Make

sure to attach these bars on the rear of the equipment as illustrated in Fig 24 before putting

the equipment in place.

Light

This means that, in addition to internal light of the equipment, the room must have the

same quality of light as in the laboratories and areas of preparation, to facilitate:

technical operations and create correct conditions to handle the Blood Products

with security

monitoring of any cleaning problem or water escape

cleaning, maintenance and repair operations

So, this light system must have the same emergency rescue system as the general building

(see Power security).

Any dysfunction of the light system must be signalled and repaired.

Safety

i. Unauthorized persons: only people who have to work in a laboratory or in the

Preparation Room are allowed to enter those rooms, for reasons of hygiene

(both for the visitors and the products), but also of disturbance and

overcrowding. It is thus necessary to establish, for each of the working locations

inside the Blood Centre, a list of the authorized persons, which could be

checked through different ways of dressing, or access badges, or any other

efficient mean.

Fig 23 : Space

Fig 24: Rear bars

60

ii. Animals, for evident reasons of hygiene and discipline; in some locations, the

presence of rats and/or mice should be detected and treated (risk for hygiene

and also of damage to the installations and equipment).

iii. Insects, particularly:

Mosquitos, not only to prevent Malaria transmission, but also to protect

some water places (water baths, plasma thawers…) from the risk of becoming “nurseries”

Flies, to prevent bacterial contamination of any of the places, instruments

and technical operations.

Ants, that may damage seriously electric installations

It is thus recommended to install mosquito nets, at all the windows and

doors of housing places, and watch for ants appearing

iv. Smoke, food…

Smoking, eating and drinking are strictly forbidden, and furthermore is the storing of food,

drinks and ice creams, for evident hygiene purpose (Fig 25)

This aspect must be checked regularly.

Easiness of cleaning and quality

Right Equipment at the right place

This aspect is linked to the whole conception and design of the Blood Centre, which must

ensure that the working pathway of Blood and Blood Components is both simple and logical.

1. Instruments (brooms, brushes, dusters, etc) must combine non-aggressiveness and cleaning efficiency for the surfaces, together with a size compatible with the surfaces to clean.

2. Products with demonstrated antibacterial and antiviral activity without damage for the internal surfaces of the equipment and for the Blood Bags: This must be evidenced through preliminary tests performed by qualified technicians. The equipment provider can advise on the definitive choice. It is important to check the quality of the local provider’s products as some fraudulent products may be proposed.

3. Cleaning procedures have to be validated. Do not project more dust than you are removing!!! And of course, do not flood the room with water !!!

4. Cleaning operations must be facilitated by the general disposition of the equipment (see above SPACE).

5. Cleaning instruments must be stored and maintained (renewed) in a separate room. 6. Ideally, a cleaning kit should be developed and distributed according to the use of rooms

At least, the BCCE pieces should be located in the following places:

1. Quarantine, back from collection sessions, waiting for Qualification, near the Laboratory for samples, and near Preparation Room

2. Labelling Operations Room, for Blood Products having received Biological and Preparation Qualification

3. Distribution Room, for Qualified and Labelled Blood Products ready to be distributed 4. Autologous Blood products, both under quarantine and qualified 5. A specific place should be assigned for Blood and plasma samples inside

Laboratories, and a different one for Reagents according to their storage temperature. Their location must be near or inside the using place to avoid useless moves from one room to another one.

61

When the number of BCCE pieces is not sufficient enough to allow such a repartition, it is

crucial to locate the equipment in a place easily accessible and controllable, and to clearly

indicate destination and type of Blood Components to minimize the risk of error.

Suitable Working temperature conditions

As the condenser is releasing heat, this warm air must receive a good ventilation not to

impair its function. The range of accepted room temperature is indicated in the Operating

Instructions Manual.

Practically:

Safe electric conditions

i. For Equipment itself

Fig 28 is summarizing most of situations

1. Do not install the equipment directly close to AC equipment (risk of water leaking), nor to water sources.

2. Do not install the equipment near a warming source (direct sunlight, or any other source of heat, which could be another condenser…) (see Fig 26).

3. Ensure a good ventilation of the room to make warm air circulate (fans…)

4. Generally the room receives an AC equipment to maintain an accurate temperature. This Equipment must be qualified, and regularly checked and maintained according to the same procedures as for the whole building.

Fig 26

1- Ensure equipment is working under the correct voltage 2- Voltage of the room must be carefully checked at various times in order to detect some

variations that could affect the functioning of the equipment (see stabilizers). 3- Avoid contact of the equipment with any metallic part 4- Locate equipment near a wall outlet (no extension) that fits with the Standards of the

provided plug. If necessary, install a suitable socket (with grounding) instead of trying to connect equipment into a wrong or damaged socket.

5- If several pieces of equipment have to be installed in the room, it is advisable to install a specific line with several outlets, or several outlets on the wall. Do not use multiple outlet socket extensions, that will cause:

- over consuming of electricity on the same socket and provoking its failure within a short term,

- Hazard of electric accident if located on the floor. 6- It is also necessary to check the equipment alarm battery connections, if the equipment

is equipped with. 7- Finally, ensure there is no water source near the equipment.

62

ii. Power supply of the room.

This security may be obtained through 2 main conceptions:

Whole building security, with a surge global security that interrupts power supply

above or under some preset levels of Voltage. It is generally connected with a switch

that provokes the start of a global emergency system (electricity generator). This

generator is also activated when the power supply is brutally interrupted for

any reason. This function has to be checked regularly (at least weekly) by the

Maintenance Team.

Instead of such a surge protection, a general stabilizer can be installed to ensure

inside the whole building a global energy stabilization. This solution is rarely

observed, for cost reasons. It can be sometimes negotiated with the Public

Electricity Supply.

Several generators, designed to ensure electrical rescue in some “strategic areas” of the Blood Centre or of the Hospital. This solution is the most often observed. Places

where BCCE is located are to consider as “Strategic areas”.

In such a case, it is necessary to stabilize individually Voltage, installing one

sufficient Voltage Stabilizer for each of the pieces of Equipment (see Voltage

stabilizers, and space).

iii. Voltage Stabilizers

Severe voltage fluctuations in the mains power supply may occur. Voltage fluctuations greater than 15% may damage electronic components of BCCE, notably compressors and

engines. The local Maintenance Head should advise if fluctuation exceeds 15%, thus

requiring a voltage regulator.

To choose a Voltage stabiliser:

Fig 28

63

Check potency in Watt (must be superior to the potency of all of connected

Equipment pieces)

Check output Voltage display (and request if possible the input Voltage display)

A voltage regulator (or stabiliser) will normally be connected between power source and the

cold chain equipment (Fig 29):

Never install Voltage stabilizers directly on the floor (risk of accident with water, and disturbs

cleaning operations)

iii. Stand by generators

The principle is that all blood bank refrigerators, freezers, cold rooms and freezer

rooms should be connected to a stand-by electricity generator, as well as the Rooms

and AC equipment of those rooms.

Main points to consider

Fig.31 Fig 29: proper installation of Voltage

Stabilizer

Stand-by generators are using petrol or diesel fuel: it ils better to choose diesel fuel (engines more robust and fuel cheaper), and an air cooling system.

Type and size are crucial : the needed total potency has to be calculated in KWA, and must even exceed the calculated result, to take into account needs for starting and running of various pieces of equipment and frequency of use of the generator.

Quality of the distributed power has to be carefully checked and monitored by specialized technicians , not only considering delivered Voltage and Potency , but also its Frequency (a wrong Frequency can damage electronic parts of all Equipment).

Location and Security 1. Avoid fire hazard : separate and specific building, permitting air circulation and easy

maintenance and repair 2. Fuel tank and lines in a specific, fire and theft-secured place, also avoiding spreading of fuel

spills. 3. Avoid noise disturbance as far as possible 4. Availability on the site of functional fire extinguishers adequate for fuel, engine and electrical

fires: it is necessary to check regularly their functionality.

64

Supply of rescue power to the whole building (one big generator), by connection

to main electricity supply unit, with automatic switching on (ideally) or manual

Advantages : global and automatic rescue, no interruption of the whole rythm of working provided the system is secured with UPS equipping the strategic equipment (computers, analyzers,…). BCCE has its own batteries for the alarms.

Possible problems : if a breakdown occurs (due to the switch or to the generator), there is no immediate solution.

o Needs a very careful maintenance and regular checking and alarm

exercises by specialized staff o Needs a strategy for alternative power supply (neighbouring

hospital or other organization close to the Blood Center ?) o Needs a strategy for blood alternative storage (neighbouring hospital ?

private structure with cold rooms ?) o Those strategies have to be designed at the same time the system ils

chosen Supply to strategic areas only (one or several smaller generators, generally

manually turned on).

Disadvantages : limited rescue, and disturbance in general organization of the Blood Centre. Strategic areas are BCC, Laboratories, and Preparation Department. Generally Administration and Blood Collection Department are « sacrificed ». The problem becomes the same as above if only one generator is rescuing the 3 areas, so it becomes necessary to buy more than one, which can become expensive.

Advantages : it is unlikely that 3 generators will fall into breakdown at the same time, so an alternative solution ils already existing.

It could be advised (if financially possible) to buy a 20KVA generator in addition to main one and to connect it to strategic areas….

The need for maintenance and regular checks is the same as for a global

power supply.

65

Two possible conceptions:

2. BCC Equipment: general aspects

a) Refrigeration cycle

Fig 30: Main elements of the Refrigeration cycle

Primary components of the refrigeration cycle are:

Compressor,

Condenser,

Evaporator (cooling unit)

Thermostat, that controls the cycle.

Refrigerant gas starts in a gaseous state, passing through a number of changes before it

returns to gaseous state. It is this cycle that enables cooling of the cabinet and maintenance

of the desired temperatures.

This technology applies equally to refrigerators and freezers.

b) Main elements

Refrigerant gas

Ensure it is CFC free (specifications from the provider). It is a liquid gas and there is oil in the compressor, so never lay the refrigerator horizontally

during its transport (always vertical), and if that occurred, let it for a minimum of 24H before putting in function.

A gas escape is rarely occurring, but in case of such an occurrence, identify a local reliable provider. Never let refrigerant spray on to your skin (risk of cold burn)

Replacing the refrigerant gas requires a trained refrigeration expert.

66

Compressor

Condenser

Evaporator

Thermostat

c) Temperature monitoring devices

Portable Thermometers

Fig 31: Portable thermometer

1. Compresses refrigerant vapour and pumps the heat-laden refrigerant gas to the condenser.

2. The most important part and the most expensive!! 3. Main cause of failure: Voltage fluctuations, so take care of that!!! 4. To be replaced only by a specialist

1. Releases heat from the refrigerant gas to the surrounding air. Easy to identify (usually made of steel or copper and normally painted black). Condenser pipes are kept together by wire fins (also helps to increase the cooling surface area of the condenser).

2. Essential for release of heat : clean it regularly (dust) and take care for ambiant temperature (see facilities)

1. Area that absorbs heat from the cabinet and its contents. 2. Evaporator rarely requires repair but needs to be kept clean: clean regularly the

refrigerator with an adequate product (see cleaning).

1. Inside temperature may rise due to limited capacity of insulation and/or door opening effect. Internal temperature is also maintained by the thermostat, which stops the compressor when the temperature is dropping too much.

2. So, please avoid too frequent or too long doors opening!!!

3. Only a qualified refrigeration technician should carry out any adjustment to the thermostat.

67

Built-in temperature display units

This must be the case for all refrigerators provided for RBCs and HBBs: a light-emitting

diode (LED) displays equipment’s temperature No need to open the cabinet

The display shows the maximum / minimum temperatures achieved

Some units permit to test the alarms

.

The Provider’s Operating Instructions Manual is to be followed carefully for starting properly

the equipment.

Temperature recorders / thermographs

1. Interests: Cheap, Ease of use, Transferability from one piece of equipment to

another. Can be calibrated and offer accurate results when used correctly.

2. Maximum/minimum thermometers are designed to record permanently maximum and

minimum temperature attained since the thermometer was set.

3. 2- Disadvantages: no electronic memory (data have to be captured manually),

fragile, can be misplaced, need to open the door of the refrigerator

4. Practically: it is every time useful to have at least one to rescue possible built-in

temperature displays breakdown.

Fig 32: Refrigerator

display

1. They provide a permanent record of temperatures achieved at any time in cold chain equipment. It comes with a paper chart on which temperature changes inside the equipment are recorded over a 24 hours or seven days period.

2. Can be provided separated from the piece of equipment or under a built-in form, the latter is generally the case; Allows permanent temperature recording and ability to be linked to a central monitoring system

3. Consequence: Needs chart paper and ink for pen, so, manage a permanent availability of those consumables (for instance, order 5 years stock in advance)

Fig 33: Thermograph

68

Records must be analysed daily (even several times a day) and kept carefully for a

proper follow-up and corrective actions.

Alarm systems

So, those alarms and their parameters must be verified at the time of installation, regularly

checked and organization in case of failure must be defined.

All the recordings of the alarms and of the actions made must be carefully kept and analysed

It is sometimes possible to connect them to a computer system and to centralize their

monitoring into the MIS (Fig 35):

c) Doors

They can be transparent or opaque, made with the same materials as the cabinet itself.

The important thing is to check periodically (according to a periodicity to define) proof of the

door seal:

Fig 34: represents an example of recording paper

(for more details, see Operating Instructions Manual).

1. Temperature alarms (warning light +continuous sound) if temperatures exceed the

set thermostat values. The alarm signal is pre-set to activate at a temperature that

allows proper action to be taken before the stored blood or blood products reach

undesirable temperatures.

2. Power failure alarms (warning light + continuous sound)

3. 3_ Door (when the door is open for too long) and cleaning alarms (when the cleaning

interval has been exceeded) : warning message and sound)

4. An alarm history is also available

69

In fact, a proof-ness defect can cause water condensation and further accumulation of ice

along the door seal, compromising a correct internal temperature and favouring bacterial

contamination.

d) Common installation and use matters

Levelling for refrigerators and freezers

If the unit is fitted with castors, once it is in its final location, the feet must be unscrewed to

immobilise it and stop it rolling away.

Unscrew the foot until it touches the floor and then screw the lock nut back up (Fig 37)

Fig.37

Safe starting

Fig 36 shows a simple checking method

This aspect is particularly important as, when getting older, door seals can turn dry and be less

flexible. It is the reason why the Blood Centre or the Hospital must ensure the availability of

replacement door seals suitable for the model in function.

Cabinet gaskets of refrigerators:

Most gaskets have magnets built into the vinyl to hold the door closed. If the door gasket does not

provide an airtight seal, the compressor works harder. It must counteract the warm air leakage

through the gasket, resulting in higher operating costs.

Check regularly and carefully the seal and the gasket and report on any observed malfunction.

After having complied with all the checking recommendations (see chapters above), Let the equipment operate for 24H before using it, and check the temperature display and then measure manually the temperature inside the cabinet, which must be between 2°C and 6°C. If not, call the provider.

70

Ice accumulation in cabinet insulation

BCCE: Specific Aspects

1. FFP Storage

a) Risk of breaking frozen plasma bags when handled

Apart from other common operations (see Refrigeration cycle and Main installation

operations), Plasma Blood bags must receive some particular attention regarding water

condensation and further freezing: when freezing, the atmospheric water will freeze at the

surface off the bags, and provoke a risk of sticking bags reciprocally to each other. This

is a cause of rupture of bags physical integrity and breaking when further handled and

transported. Fig 38 shows the situation and its potential risk:

Fig.38: FFP Bags not protected

A refrigerator or freezer may have an air leak in the seal. This allows moisture from the

atmosphere to enter and condense around the leaking point. Particularly in a freezer, ice build-ups

reduce insulating ability of the cabinet, thus causing the compressor to run harder. A cold spot or

condensation on the outside surface may indicate ice accumulation in a freezer before this

accumulation gets more important.

In a refrigerator, the leak will be signalled by a condensation spot along the seal or on the window.

To eliminate the unwanted ice, place the contents in an alternative freezer, cut the power supply

and allow it to warm up for a few days. Lightly packed fine fibreglass insulation is sometimes used

to plug the leak. This should be considered a very temporary measure since the equipment is no

longer suitable for freezing or storing blood products, and should be condemned.

The only solution is to replace the seal, provided it has been purchased at the time of BCCE

purchasing.

It is thus advisable to insert each blood bag individually into a cardboard or light plastic box in

order to isolate bags from each other and:

- avoid further sticking

- facilitate their classification and ordering inside freezer and the transport boxes, as the label of

the Unit of PFC could be easily readable by a scanner (Fig 39)

71

b) Defrosting

Freezers are often equipped with automatic defrosting function, which is activated at pre-set

times in a day (DT1 and DT2 parameters). Defrosting process lasts for approximately 30

minutes.

2. Walk in cold rooms

a) They are generally built at the same time as the Main Blood Centre is built, for

reasons of costing and importance of stock, avoiding multiplication of equipment.

Principles of functioning are the same, plus some alarms for personal security (possibility of

opening doors from the interior).

It is important to forecast specific warm clothes for the personnel.

b) Conception and location

Generally, it includes a freezing room at the same temperature as individual freezers.

This freezing room must be accessible only passing through the Positive Cold Room,

to avoid loss in negative temperature, and each of the doors must be doubled by

plastic sheets to avoid thermal exchanges:

Fig. 39 : protection of FFP bags from breaking

During defrosting process, equipment’s cooling system will be inactive and inside temperature will

rise. For that reason, defrosting time should be set at a time when the equipment is usually less

used. So, do not open for a too long time the freezer when defrosting, which will cause the

interruption of this operation.

Whenever the settings need to be changed, the manufacturer’s local Customer Service Centre or a specialized engineer must be contacted to make the change.

(Fig.

40)

72

Location inside the building: it must be close to the operations of Preparation and

Distribution to avoid too important moves of staff and Blood Products. Ideally, it could

include a place for labelling operations, thus ensuring a simple and logical

progression of production chain (Fig 42):

c) Important aspects

3. Transport boxes

a) Objective : A storage temperature maintained within limits

That means transport boxes must comply with several specifications

Secure confinement and robustness of the box and its sealing / closing

system, in order to:

resist to handling operations (sometimes very rough),

prevent unwanted opening (lockable) and subsequent content warming

Combination of:

+4°C -25°C

Shelves

Tables or shelves

Fig.41: Map of a Walking Cold Room

Fig.42: Wok progression

Quarantine Qualified La

be

lli

ng

Distribution

1. Ensure temperature is homogeneous inside the Cold Room: locate several thermometers or temperature registers at various places ( floor and upper shelves for instance) and check the temperature , to compare with the data from the recorder.

2. Perform same operations with a thermal probe inserted into a blood bag filled with Glycerol at 4% (same thermal conductivity as Blood) to approach the internal temperature of Blood.

3. Cleaning the cold Rooms is capital, to avoid development of mushrooms (no wooden shelves…) and oxidation of metal shelves

73

Sufficient size for transport of the needed quantity of blood bags: the provider can

advise on the type of box suitable for the needs of each Blood Bank.

Lightweight, as they will be manually handled

Maintaining temperature within limits of conservation of the component for the

duration of the transport: this has to be checked and is part of the Qualification of

the Box

This is obtained using specific devices as special cooling packs filled with a coolant solution that are themselves stored in a specific freezer to make them available for use. (Fig.43)

Take care: some of those packs have a lower freezing point than water, and must be used only for FFP transport but not for Red Blood Cells. This has to be checked and the SOP must precise this.

The cooling packs must not be in direct contact with Blood Cells as they could cause a thermal haemolysis: separation is obtained through special films (or thin polystyrene sheets): a proper supply of such films is to be organized when purchasing the cooling packs and the box itself, and they must be qualified at the same time as the boxes. This separation must be located under the cooling packs and above the Blood units (the cold is going down…see fig 43 hereunder)

Qualification of the box must include the verification of its “Cold life”: it must maintain internal Temperature between 2°C and 10°C for 24H under an external temperature of 43°Cwhen loaded with Blood bags an Cooling packs as described in the SOP. (This is an example, but could be a Standard).

Temperature Control inside the box is necessary for Qualification, but also at regular

intervals of time to be defined by users. The objective is to check whether temperature

arose above the limits or not, and if possible for how many time. For this control, it is

possible to use:

- Max/Min Thermometers (fragile, no indication of warming duration),

- Sticky labels (no indication of duration)

- Temperature data loggers (the best, needs an adequate computer software for registering and analysing)-

see Fig 44 an example:

74

b) For a proper use:

4. Platelet incubators/rotators

Platelet storage requirements are as follows:

An ambient temperature of between +20 °C and +24 °C.

Soft agitation to maintain Platelet viability (Fig 45)

a) Ambient temperature

Continuous and soft agitation

b) Electrical security

Store Boxes at requested temperature for the product to be transported: that means defining the use of the Boxes and thus where to store them: Blood from Collection places: ambient temperature (not too hot but not in the

cold) to bring them back to the Blood Centre Qualified RBC and FFP: ice packs in the specific freezer, boxes in the cold or

brought as close as possible to the ideal temperature with cooling packs or ice packs before use

Platelets: ambient temperature (25°C), no cooling. If possible, store them in a place where they can be apart from shocks, liquids

and dust Clean them before and after each transport (same instruments and products as for

the refrigerators) Identify clearly boxes and their content Do not use them for food and drink or other goods transport. As a remark and

according to local organization, it is strongly advised that the RBC would store and manage all Transport boxes in use in its Servicing area, no one being kept by the beneficiary Hospitals or Departments.

Packaging of Blood inside the Boxes must ensure minimal space is left inside to air ( to avoid warming)

Define transport conditions of Components: if this activity is subcontracted to another organisation, it is necessary to put in place a specific organization/contract in order not to exceed a total of 12H and to ensure traceability, and to respect the external organization’s requirements (aircrafts for instance).

Fig.45

It can be maintained through:

A proper AC system in the room (provided it is set up at the desired temperature, which has to be monitored).

When no AC, if the platelet agitator is equipped with an incubator and the related temperature and recording alarms. The cabinet must ensure an efficient insulation and the shelves must be non-oxydable

Amplitude and stroke rhythm per mm of the agitation (ideally 65 to 75) and the

amplitude of each stroke (ideally 3.6 to 4.0 cm) are the main factors to check and

control.

Ensure power is also stabilized before putting the agitator in function (Platelets are

also a critical Blood Product!)

75

c) Main aspects of utilisation

Various models exist, but main actions are every time as follows:

5. Plasma Thawers

a) Principle - main features

Specially designed water baths able to maintain a constant temperature at around

+37°C, and designed to agitate frozen products in order to enhance their

thawing. This agitation is provided by directing a stream of warm water onto the

frozen product. This stirring system will have to be qualified.

There are two main types of plasma thawers:

o “Wet” type: plasma packs are suspended from clamps and packed to be in

direct contact with water.

o “Dry” type: plasma packs are protected from direct contact with water by leak

proof containers (bladders) that come as part of the equipment. Warm water is

circulated around the bags.

Clean the agitator regularly (same instruments, products and precautions as for other devices)

Load the agitator with a number of Platelet concentrates that could be reasonably suitable for the size of the agitator (too much weight could provoke mechanical difficulties in the agitation movements

When platelet Concentrates are placed on the agitator, it must be switched on and the rotation movements must not be hindered (Fig 46)

Regularly check and record internal temperature of the agitator, or of the Room if the agitator has no incubator

Regularly check amplitude and stroke rhythm to detect possible mechanical problems

Fig.46: no extra weight

76

b) Practical consequences

Stock/Blood Components Inventory Management

Stock management is generally the main concern RBCs have to face, specifically in

countries where Blood donation is difficult to obtain and to develop, for various reasons.

This issue has several components, they may be classified under two main categories:

1. At level of the RBC, Stock management is a cycle (Fig 48) :

Whatever the type, it must:

1. Ensure defrosting of maximum packs of plasma from –30 °C to 0 ° within approximately 20 minutes.

2. It also must be able to handle all types of plasma packs, such as Apheresis packs. 3. It must be equipped with audio-visual alarms: for temperature and low water level. 4. An efficient water drainage system must ease cleaning of the bath

“Wet” type: Risk of bacterial contamination through direct water contact, need to put bags into sealed waterproof bags, so forecast a sufficient stock.

“Dry type”: seems better because operator’s hands and plasma packs remain dry. For both: - Detergent should never be added to water. - Water should be regularly tested for the presence of micro-organisms. Plasma

thawers should also be subjected to a rigorous schedule of cleaning and decontamination, including changing of the water

Fig 47: Plasma thawer with 3 isolated sections

and digital temperature control

BLOOD BLOOD

COMPONENTS

Fig

77

a) Knowledge of stocks: Useful precautions for management of Stock are provided

by General Guidelines, and mainly the ones that allow to get indicators :

That knowledge must include several aspects

that have yo be known on a daily base :

o Number and group repartition of RBCC,

with perishing dates

o Number and type of PCs (single units and

pools) with perishing dates

o Number of FFP and other Cryopreserved

components (perishing dates longer)

b) Knowledge of Blood collection capabilities in terms of dates, periods, location of

planned Sessions, known number of VNRBD according to previous experiences

c) Knowledge of existing Stocks outside the RBC (other RBCs or BDOs, Hospitals

when these stocks are known and monitored).

d) Knowledge of perishing dates, on a daily way: routine weekly (for instance) supply

to the HBBs together with withdrawal of non-used components, could avoid perishing

of numerous components that could be used elsewhere. Inside the RBC, distribution

of the “oldest” Bags must be a routine in order to organize a proper Stock rotation.

2. If Hospitals (which are the users) are included into this approach, stock

management has to take into account a more complex cycle: (Fig 49)

a) One of them is quite manageable: it is the HBB Stock, received from the RBC, but

situation may be more complicated when attached HBBs become numerous.

NEEDED:

Inventory sheets for all blood components

Blood Collection Department planning

Reports from Other BEs

BLOOD

DONATI

ON BLOOD

COMPONENT

HBB

STO

CK

HBB

STO

CK

HBB

STO

CK

HBB

STO

CK

HBB

STO

CK

HBB

STOCKS

CLINICAL

WARDS

Supp

Reque

Fig 49: Total cycle of Blood

Components demand

78

SOPs must be developed to obtain daily information on Blood Components stocks,

composition and outdating, and on feed back to Blood Collection Department.

A good tool would be interconnection of RBC with HBBs on

an electronic way, and with other RBCs inside the future

network of RBCs, to know in real time their stocks situation

and thus estimation of availability. Such an approach needs a

reliable and constant Internet network and MIS that are all

inter-connected.

b) The main parameter to monitor and to control is the demand coming from

Hospitals, This demand is made of:

Routine needs, which may be forecast on a quantitative way on basis of previous

month’s consumption.

Sometimes they may be the objects of Therapeutic protocols that can be decided in

collaboration with HBB and RBC, and treated on a routine way (Leukaemia

treatment, Thalassemia for instance)

Forecast able needs, such as programmed Orthopaedic, Cardiac and Digestive

surgery, which may be organized in advance and in collaboration.

It is important to get an estimation of those categories of needs, which are the most

numerically important for most of the RBCs. They will serve as a basis for the basic

calculation of the needs of each Hospital. 34

That could help to reduce the notion of Emergency to its real dimension and maintain

RBCs and HBBs staffs motivated for their management. That has to be calculated

from last 6 months experience and auditing, to calculate a percentage that could be

added to routine supply.

c) Particular and pragmatic actions must be developed to avoid over consuming of

Blood and Blood Components:

Collaborative work on ACUB and Rational use of Blood, particularly in Blood

consuming situations.

Approach on Alternative Solutions such as Intraoperative Blood Salvage, or Pre-

deposit donations, in some indications.

Study and audit of places where Blood Components are stored inside Clinical Wards,

are not used and come to outdating: it is known that it is where the Blood stocks are

very small, only maintained for the case of a possible emergency, that outdating is

the most important. This practice is estimated by some countries to be accountable

for 15 to 20% of the whole Cells Component available for Transfusion.

It is clear the those approaches may only give results in the mid-term , but it is only through

them that it will be possible to obtain a rational Blood supply strategy.

Particular situations

a) Breakdown of a refrigerator, or more important breakdown

A SOP must be established to move the components to another one,

34 See Business Plan for Blood Centres in Pakistan, SBTP, 2011, Strategy for the first year

NEEDED:

HBB stock reports Analysis of Hospitals

requests profiles

NEEDS:

SOPs TO

DEVELOP

79

and explaining the reasons of the choice. This has to be established for Quarantine,

Reagents, and Qualified Blood Components.

Breakdown of Electric supply may also occur for the whole RBC: it is then necessary to

determine in advance and to write a specific SOP regarding the external place to store Blood

Components (HBB? Other place in the nearest Hospital? Or any BCCE existing in the City?

It is then necessary to address such situations in advance, in order to give time enough to

achieve the needed repairs.

b) Specific emergencies such as Dengue and Crimean Congo Fevers: the only

solution is to increase production of Platelets, both from individual donations (and further

pooling) and Platelet Aphaeresis, Availability of 2

functional machines in RBCs would improve response

capacity, while it would help improving protocols of

Leukaemia therapy. Such a Strategy could also be

coordinated at National level, to avoid wastage.

c) National disasters (earthquakes) are situations where needs are not locally

immediate, as the only solution is to bring already qualified components to the

Reference Hospitals that are functioning, and that are assigned as being in charge for

first line referrals. The need occurs generally within the two or 3 following days, and

according to the type of needs, the best solution is a national coordination that has

information on all the stocks available in the country. Transport and logistic questions

are generally solved through collaboration with Security Forces of the country. National

Strategy is generally available on the site of Concerned Ministry.

As a Conclusion

NATIONAL DISASTER

POLICY AND

STRATEGY

MAIN INDICATORS:

RBC DAILY STOCK SHEET (Blood Groups, Outdating, Number) HBBs DAILY STOCK SHEETS (same information) KNOWN PROGRAMMED REQUESTS FROM WARDS DIAGRAM OF DAILY AND MONTHY DISTRIBUTION MAPPING OF QUANTITIES DISTRIBUTED, BY COMPONENTS Phone contacts with HBBs (morning and evening) on Stock situation) must be a Routine

80

5.8 Blood Components Labelling and Distribution to HBBs

Labelling

This operation is the crucial assignment of a unique N° and identification label to the final

obtained component that will be distributed on a non-nominal way to HBBs. It is the result of

confrontation between Blood Components prepared by the Production Department and their

Biological Qualification by the Laboratory Department.

1. The label itself may be of various made (Fig 50), but must comply with Standards

which must be determined by National Authorities35

a) Provision of such labels must be the result of a Public Tender specifying:

Physical properties of labels, particularly in

the case of freezing, high temperatures

and water contact.

Conformance to ISBT Standards

in relation to Barcoding

On demand printability through

specific devices

Compatibility with MIS System.

Qualification and certification of

the provider.

b) Disposition of labels on the Component bag is generally internationally specified

as represented on Fig 51.

In fact several labelling operations are performed during the working process of a Blood Bag:

The first one is the Unique ID N° assigned to the Donation (Bag and Sample Tubes)

at Collection time. It must use the ISBT 128 Barcode system.

The second one is the Production Department label affixture indicating the nature of

the Component.

The last one is the Blood group and other information affixture, commonly called

“Labelling”.

35 Guidelines for the Blood Transfusion Services in the UK 2005

Fig 50: Blood Components labels

SOP: LABELING OF BLOOD BAGS

AND BLOOD COMPONENTS

BTS/SOP/WP/30

NEEDED:

TENDER SPECIFICATIONS AND

RESULTS

RESULTS OF LABELS QUALIFICATION

81

2. Labelling operation itself is realized simply by calling the Donation ID N° from the

general MIS, and the MIS provides results and prints the label after validation.

Double check is recommended, as specified in SOPs.

It must have a direct link through the MIS, with ready to use Blood Components stock. An

Inventory Stock sheet has to be edited to ease

checking and handling.

3. That operation allows Blood

components to pass from Quarantine area

to Distribution stock, and it may be either

located under Processing Department or

under Distribution Department’s responsibility.

This has to be decided when building the

RBC’s organogram (See Chapter 3), as it is closely in relation with the following one, which

is distribution/dispatching of Blood Components.

NEEDED

LABELS’ STANDARDS-REGULATION

MORE SOPs (providing evidence of

Responsibility endorsement

PRECISION ON RBC ORGANOGRAM

AND FLOW CHART

INVENTORY STOCK SHEET

UPDATED DAILY

RBC

ID

BAG TRADE

MARK AND

COMPONE

NT

Fig 51: General Shape and

Disposition of a Blood Component Label

ID NUMBER

EXPIRY

DATE BLOO

D

82

Fig 52: cooling packs must be separated from

direct contact with Blood Components

It seems more logical that a continuous workflow would be established, under the

responsibility of one person, who has the responsibility of preparation and endorses

responsibility for final release of Blood Components. A SOP must be developed, to

ensure components are not released to stock unless authorized by the designated person.

That cannot be left to a simple clerical clerk.

The only case where Labelling could be under Distribution Department’s responsibility is when Distribution Department is also equipped with a Laboratory and Issues directly Blood

Components to patients and Hospitals. That is not the case in the future RBCs organization.

Distribution/Dispatching

1. Distribution and/or dispatching are based upon

terms decided by the establishment of MOUs

between RBCs and their attached HBBs.

These MOUs will define the quantities, Blood Groups and

types of Blood Components requested by HBBs, frequency

of requests from HBBs, supply frequency and financial

conditions for supplying, as well as legal framework of their

establishment36. As RBCs are not supposed to issue Blood

components directly to the HBBs, patient identification is not needed.

2. Practically, the RBC has to organize several steps:

a) Stock Cold Chain inside the RBC: must be clearly separated from other BCC

elements. In other terms, as Blood Components will be entered directly from

Quarantine to Distribution Area, physical pieces of the BCC must be different.

b) Request reception and recording is described in existing SOPs.

c) Packaging, dispatching and

preparation for

transportation are described

in a existing SOP. This

packaging and dispatching

operation must ensure that

Blood Components will not suffer from thermic damage, and thus must be performed in

a room equipped with AC.

Disposition of

Refrigerant/cooling packs inside the

transport boxes must avoid direct

contact between Blood

components and Cooling packs

(Fig 52) to prevent any Haemolysis

risk. Documentation is

described in existing SOP.

36 A separate document is available as a template (Annex 1 of this document). All related SOPs will

be annexes to the MOU.

NEEDED

Official MOU signed between RBC and HBB

Request form Distribution form Monthly invoice

1. RECEPTION AND DOCUMENTATION OF

REQUESTS FROM HBB (SOP/WP/34)

2. DISPATCHING AND TRANSPORTING

COMPONENTS (SOP/WP/35)

83

d) Transportation itself may be executed through

various transport ways, according to distance

and time of transportation..

This process has to be addressed very carefully as it is

involving various kinds of responsibility according to the

chosen type of transport.

By RBC itself: it is generally the best way as it

is involving only one type of responsibility, A

specific SOP has to be created, together with the

appropriate documentation regarding driver(s) and

vehicle

Subcontracting to a transport Company: that

could be a good solution to avoid recruitment and management of several drivers

and vehicles. It needs qualification of the Company, a service contract and

monitoring of execution.

By Public transportation or taxi: that has to be very carefully organized in

relation to type of vehicle, time for transport, eventual stops and conditions of

storage inside the vehicle. A contract must be signed and its execution monitored

and documented.

By plane, in some regions: it is necessary to conform to specific legislation and

requirements of the Company regarding transport of Human and biological products.

Blood components must be stored in an area the temperature of which cannot

become negative (animals area for instance). A specific contract must be signed with

the Company.

As a Conclusion

6. TRANSVERSAL/CROSS CUTTING OPERATIONS

6.1 Traceability/Haemovigilance, Call Back and Returns

1. Haemovigilance is a transversal activity that is part of the Quality System

It is shared between RBCs and HBBs, from the vein of the Donor to the final use of the

Blood Components, whatever its destination (Fig 53)

NEEDED:

SOP complement regarding separation of cooling packs from direct contact with Blood Components

SOP for transportation by RBC

Qualification, Contract, monitoring conditions and reporting if sub-contracted

MOUs REPORTS ON EXECUTION DISTRIBUTION SHEETS REALIZED LINKS WITH MIS FOR MONTHLY REPORTING ON

DISTRIBUTED BLOOD COMPONENTS

84

Haemovigilance uses a specific vocabulary, which is summarized in Annex 2

This activity (Fig 15) is directed in RBC towards several

aspects:

Regarding the Donor, any of ARE or SARE must be

documented and notified to Quality Department, for

further analysis and CAPA. That may encompass Near misses.

Regarding Blood Components, 2 kinds of general processes will be determined:

Regarding Traceability: Look back and trace back

Regarding problems of Blood Components conformance: Recalls and Returns

Notification form is

described in BTA FB

BTA

Fig 53; Cycle of information between RBC, Hospital and BTA

85

2. Organization elements for ARE AND SARE occurring to Blood Donors

1. This activity being part of the Quality System, its responsibility must be placed under

the Quality Department Head, with the Contribution of Blood Donor Department Head in

relation with all clinical aspects.

2. It is necessary that a Working Group would systematize the various ARE that may occur

to a Blood Donor, under the following classification, that could be used nationwide as a

reference and a tool for encoding IT files:

a) Local symptoms related to Phlebotomy

b) General symptoms (vasovagal reaction)

c) Reactions related to apheresis (local and general symptoms

d) Other reactions

3. A set of working documents must be developed:

a) Form of Investigation and Care of Blood Donation Related Adverse Reaction

b) Grading and imputability Form for Adverse Reactions in Blood Donor (see

Annex2)

c) Notification form

4. Development and establishment of SOPs related to the Workflow diagram, and to the

use of forms.

5. Definition and implementation of CAPA in the case of evidence of quality or medico-

technical problems having caused the ARE or SARE

86

3. Traceability

a) Whatever the objective (Trace back or Look back), conditions for traceability are

the same: the MIS must provide following elements:

b) Blood transfusion is a cycle of information, that must be as safe on the side of the

RBC as on the side of the Hospital: SOPs must be developed for several operations:

4. Call backs (Recalls): Active operation

A unique donation identification (donation number, ISBT 128) and link with

Donor’s contact details (unique ID N° of the donor)

Place and details of the BE where blood or blood component was collected

Date and donation number

Information on produced Blood Components and any additional data related to the

components, if necessary

Name of the BE where the blood component was sent, if different from the facility

where it had been manufactured;

Name of the TC and department which consumed the blood component and name of

the patient to whom the blood component unit was given and positive confirmation that

the unit was transfused to the intended patient

Date and time of blood component consumption

In the event that the blood component is not used for transfusion purposes, information

to determine its final destination.

Registering of a complaint about a product or a patient: notification form to be established and filled

Trace back SOP in order to identify the Blood component(s) and the donor(s) and corresponding results; new test from archive serum sample

Convoking the donor and review history and perform new tests (more sensitive if available)

Reporting form for Trace back results documentation Look back SOP in order to find out the Blood Component request, and the final

destination (from the RBC side: this destination must be the corresponding HBB, but may be another destination...)

a) Determination of the causes for launching a call back procedure (for instance observation of an infectious problem occurring in a Donor after Blood donation, even more if Platelets have been prepared and pooled with other PCs); A list of these causes must be prepared by the RBC and be the object of a Working Group with other RBCs.

b) A SOP must be developed to determine the workflow chart of the call back operation: tracing of all the Blood components prepared from the Donation, definition and use of a form for calling back Blood components, notification form to Management and to BTA

c) This procedure may be performed within the context of a return from Hospitals or HBBs.

87

5. Returns: passive Operation

This situation may occur in various cases:

On the side of the RBC, corresponding operations are to be performed:

In Conclusion

a) Non-conformance or defect of a blood component: Generally this is done during the reception process at HBB: it is mentioned on the

distribution sheet and the Blood component is not entered into the HBB’s stock. Back to RBC, stock is updated accordingly. Waste management process is

implemented.

b) SARE occurred in a patient during or after a Blood Component injection. Same procedure as for SARE management in patients, it is part of this process.

c) Blood Component (s) is (are) perished Two cases:

Perishing inside the HBB: no return accepted, waste management process to implement

Perishing inside Clinical wards: no return accepted, to be managed by HBB. d) Blood component was not used, but is not perished: Acceptation of the return

according to real storage conditions in HBB and in Clinical Wards.

MONTHLY REPORT ON ALL EVENTS AND REACTIONS IN DONORS WITH GRADING AND CAUSE ANALYSIS

MONTHLY REPORT ON TRACE BACK AND LOOK BACK INQUIRIES, WITH REASONS AND QUANTITATIVE DATA

MONTHLY REPORT ON RECALLS

MONTHLY REPORT ON RETURNS

88

6.2 Quality System-Related Operations: which data for what?

1. General management principle of Quality System is the following:

All precedent chapters recall data that are needed to implement the various processes of

a RBC, to reach preparation of Blood Components that could be conform to standards, and

more generally services compliant with Guidelines and responding to expectations of users.

2. Which kind of data to Plan?

They are data collected for realization of an objective: for instance increase of Blood

donations number:

Fig 54: general management principle

of Quality system DATA

KAP

STUDIE

S

SOCIAL

MARKETING

TYPE OF

MESSAGES

NEEDS

TECHNICAL

CAPACITY

STOCKS

LOGISTICS

BLOOD

COLLECTION

SESSIONS

PLAN

Fig 55: Data needed for Blood collection sessions planning

89

3. Which kind of data to Do?

An example may be found in technical processes such as laboratory screening, where the

Head of Laboratory needs:

Results of qualification of Laboratory Equipment and of its performances to be able to

use them for realization of analyses

Results of Qualification of reagents

Guidelines for Laboratory Procedures design

4. Which kind of data to Check?

“To check” is in fact representing the permanent monitoring that has to be performed in order

to objectively verify that the result is conform to what was expected.

The best example is the Quality Control of Blood Components and of Laboratory tests.

But this approach must be developed in all sectors of the RBC, hence the various indicators

that have been presented as conclusions of each Chapter of this Manual.

It is of particular importance to systematically record all data produced by the various sectors

of the RBC, and to regularly analyse and evaluate them in view of improvement.

The most important is, after validation of procedures, to put in all indicators of their

systematic respect.

5. Which kind of data to Act?

Acting is the action of taking into account the results of the evaluation of actions and to

integrate them to make a new plan for improvement or even for corrective actions.

So, needed data will be chosen according to the results of the initial plan.

That may occur in all sectors of the RBC

Most known example is the Blood donations quantitative evolution, and the number of Blood

components produced and distributed, which need analyses and new plans for increasing

and better managing stocks.

Results of maintenance of equipment, or of BCCE conditions of use, are also fundamental

for a good quality of Service.

6. A Quality System is pragmatically based on data, and those Data are both the

result of a reproducible way of working, the result of its monitoring, and the bases

for further developments.

So,

FIRST RESULT TO OBTAIN: RESPECTED PROCEDURES SECOND RESULT: WORKING ORGANIZATION THAT ENSURES

EXPECTED RESULTS

90

6.3 Risk Management

1. Definition-context

Establishing a QMS according to GMP and

sustaining its efficiency is only possible including all

blood banking and transfusion medicine practices.

Risk may occur in all of the steps such as donor

recruitment, blood collection, production, distribution

and the use of blood components to a certain extent.

Generally risk means the combination of the

probability of occurrence of harm and the severity of that harm. Quality risk

management is a significant element enabling a proactive approach to identify and control

the potential quality and safety problems in blood supply chain and assuring the

efficiency of QMS.

THIS CHAPTER DESCRIBES

GENERAL METHODOLOGY,

IT MAY BE APPLIED TO ANY

PROCESS OF THE RBC

Administrative/

Managerial

Procedures

Material

Management

Equipment

Management

Corrective/Preventiv

e Actions

Document Control

Validation

Deviation

Supplier Control

Premise Control

Change Control

Qualification

Management

Information

Technologies

Finance Management

Legal

Arrangements

Monitoring

Activities

Audits

Complaints

Haemovigilanc

e

Reporting

Recall

Hygiene

Management

Management

Review

Blood Collection

Blood

Component

Production

Testing

Storage

Distribution

HOSPITAL

S

DONOR

REQUEST

Donor

Screening

Figure 56. Operational management/support/monitoring processes of RBC

91

Quality risk management is composed of 3 main elements:

• Risk Assessment,

• Risk Control,

• Risk Review.

2. Quality risk assessment

It is a proactive approach that should be based on facts and figures and be related to the

donor or/and the protection of the patient, but addresses in fact all the domains of activity of

the RBC. Level of risk must be assessed to put in place safety measures accordingly

a) Risk Identification

Systematic use of information to identify potential sources of harm (hazards)

Identification and estimation of the risk can only be realized by the personnel performing the

tasks. Observing the workplace or

knowing the performed tasks

cannot be sufficient. For instance;

while identifying risks related to the

storage conditions of materials and samples in the laboratory, all factors should be

considered (such as: not to keep

hazardous materials above 40 cm., not

to overload shelves, accessibility of

shelves, access permits of authorized personnel, use of right materials, good definition of

chemical interactions, cleaning of the storage area, or storing food and beverage separately,

training of the personnel carrying reagents). The target group affected by the risk may be

differently depending on the risk; in addition to the personnel sometimes visitors may also be

affected. Staff of other units, cleaning personnel, donors or the relatives coming to the

transfusion centres, trainees and even the environment may be affected.

Risk Register

Register of risks shall be prepared

regardless of their size and significance by

the entire stakeholders that may be

Ris

k

Com

mu

nic

atio

n R

isk Ma

na

ge

me

nt

Tools

Risk Assessment

Risk Identification Risk Analysis Risk Evaluation

Risk Review

Review Events

Risk Control

Risk Reduction Risk Acceptance

Figure 57 Typical quality risk management

process

WHAT MIGHT GO WRONG?

BY WHOM?

Units that perform the activities causing the risk.

BY WHOM?

İnter-disciplinary team

92

affected. All the relevant records kept for the events and the measures taken shall be

reviewed. The relevant documents are examined whether awareness of risk is in the

documents.

Risk register means categorizing risks and monitor them accordingly. A possible list of risks

is a following

b) Risk Analysis

Probability and severity of the harm is analysed. Two questions to be asked to identify the

risk are as follows;

It is crucial that the risks analysis should include all the

Heads of Departments. The level of possible impact may be

different among various Departments. Therefore risk should

be identified according to its severity but the results may be

evaluated individually or commonly. The efficiency of communication between Heads of

Departments may increase the efficiency of risk analysis

Score grading of the probability of occurrence of the risk

PROBABILITY NUMERIC GRADING THE PROBABILITY OF OCCURRENCE

VERY LOW 1 Unlikely

LOW 2 Only in abnormal situations (once a year)

MEDIUM 3 Few (several times a year)

HIGH 4 Often (once a month)

VERY HIGH 5 Vey often during ordinary working conditions (once a week,

everyday)

• Risk for physical, chemical or microbiological contamination (products, equipment, materials and areas)

• Risks for incomplete or incorrect identification (products, equipment, materials, donors, customers, patients)

• Risk of losing traceability in the chain

• Risk of reducing donor motivation

• Risk regarding the availability of donors or products

• Risk of not being in compliance with (in- or external) required criteria

• Risk of damages of image (for the BE itself, for the blood supply, for health care)

What is the likelihood (probability) it will go wrong?

What are the consequences (in terms of severity)?

BY WHOM?

İnter-disciplinary team

93

Score grading of Severity of the Harm

RESULT NUMERIC GRADING THE SEVERITY

VERY LOW 1 No loss of work hour, no need for first aid

LOW 2 No loss of work day, no permanent impact, first-aid is necessary,

outpatient treatment

MEDIUM 3 Minor injury, inpatient treatment

SEVERE

(HIGH)

4 Serious injury, long-term treatment, occupational disease

VERY

SEVERE

(VERY HIGH)

5 Serious injury, long-term treatment, occupational disease, death,

permanent incapacity

Table 5: Probability of occurrence of the risk and identification of severity of associated harm

c) Risk Evaluation

Risks that are identified shall be evaluated through a risk

matrix.

L type matrix is given as an example. This matrix is

based on cause-effect relation. It is generally used to

identify emergency hazards that impose measures to be taken immediately

PROBABILITY /

SEVERITY

EXTREME

5

SEVERE

4

MODERATE

3

MINOR

2

UNLIKELY

1

VERY HIGH

5

INTOLERABLE

25

HIGH

20

HIGH

15

MEDIUM

10

LOW

5

HIGH

4

HIGH

20

HIGH

16

HIGH

12

MEDIUM

8

LOW

4

MEDIUM

3

HIGH

15

HIGH

12

MEDIUM

9

LOW

6

LOW

3

LOW

2

HIGH

10

MEDIUM

8

LOW

6

LOW

4

LOW

2

VERY LOW

1

MEDIUM

5

LOW

4

LOW

3

LOW

2

LOW

1

Table 6: risk matrix

BY WHOM?

İnter-disciplinary team

94

3. Quality Risk Control:

The purpose of risk control is to reduce the risk to an acceptable level. The amount of

effort used for risk control should be proportional to the significance of the risk.

Risk control might focus on following questions:

a) Risk Reduction

Risk reduction means actions taken to lessen the

probability of occurrence of harm and the severity of that

harm. The main principle would be to eliminate hazards

completely. If that it is not possible, following method/s

may be used to reduce risk exposure (acceptable level).

Replacement by less hazardous method, material, equipment, software, etc.

Redesigning the working method, process, equipment or software,

Isolating the hazard (Isolation)

All of the measures taken shall be documented. Validation will be performed in order to

check whether the measures are taken according to the severity of the risks.

b) Risk Acceptance

Risk acceptance is a decision to accept the risk and should

be recorded with its causes. It is the period of completing

measures taken to reduce risk; It covers the development of

working methods, sharing measures with the personnel

(communication), providing education and training, and

subsequent internal monitoring.

Risk acceptance can be a formal decision to accept the residual risk or it can be a passive

decision in which residual risks are yet specified. It is possible to propose a risk acceptability

table (Table 7):

RISK SEVERITY ACTION

Intolerable Risks

(25)

1. Is the risk above an acceptable level?

2. What can be done to reduce or eliminate risks?

3. What is the appropriate balance among benefits, risks and resources?

4. Are new risks introduced as a result of the identified risks being

controlled?

BY WHOM?

İnter-disciplinary team

BY WHOM?

Management

The activity should not be started before the identified risk is reduced to

an acceptable level. If there is an ongoing activity, it should be stopped

immediately. Provided that it is not possible to reduce the risk despite the

preventive actions the activity should be prevented. Decision and the

causes should be documented.

95

Crucial Risks

(15,16,20)

Medium Risks

(8,9,10,12)

Activities should be performed in order to reduce the identified risks.

Risk reduction measures may take some time. Additional control

processes should be developed and the results should be audited.

Activities should be recorded.

Tolerable Risks

(2,3,4,5,6)

Additional control processes may not be necessary to eliminate

identified risks. However, the current controls should be performed and

they should be audited. Activities should be recorded.

Unimportant Risks It is not necessary to plan control processes to eliminate identified risks and to keep the record of the realized activities.

Table 7: Acceptability level of the risk (scores are the scores of Table 6):

4. Risk review

Risk management is a permanent part of Quality Management

process. It is necessary to perform a regular monitoring to confirm

that the risk will not be repeated or s not increasing if it has been

accepted under some conditions.

The following questions must be answered to monitor the

outputs/results of the risk management process:

According to obtained and documented results, the risk evaluation plan shall be

updated/modified and documented. If the risk is still considered as unacceptable from the

results of the review, the cycle shall start again from the first steps of identification and

analysis. In case of a repetition despite all the measures, an emergency plan shall be

established and the risk shall be reviewed. It is crucial that the processes or equipment are

re-specified redefined and re-validated by the Responsible persons. Risk assessment cycle

shall then be repeated.

The activity should not be started before the identified risk is reduced

to an acceptable level. If there is an ongoing activity, it should be

stopped immediately. If the risk is related to the continuity of the

activity, immediate measures should be taken; control processes

should be established and documented. The reflections of the

preventive actions on the results should be monitored. In case of a

BY WHOM?

İnter-disciplinary team

1. Are the selected control measures (or preventive actions) completed as planned?

2. Are those measures appropriate and resulting according to their objective?

3. Is the considered risk exposure eliminated or reduced sufficiently?

BY WHOM?

İnter-disciplinary team,

Decision makers

According to the subject

96

5. Risk communication

Risk communication is the sharing of information about risk and risk management between

decision makers and other (internal or external people)

All data shall be collected in the scope of risk communication and shall be evaluated

analytically to provide explanation.

Type and content of communication may be different according to the type of interested

parties (technical, political...). Between BEs and Competent Authority, communication is

limited to the legal requirements.

6. Practically: Risk management process and risk evaluation plan

a) Responsibility: usually interdisciplinary teams

In BEs, this team is composed of Quality Department, Administrative and Finance

Department, IT Department, Technical Departments and Haemovigilance Department. They

are in charge of all the steps of the process including risk identification, analysis,

assessment and review.

The Responsible person shall be in charge of

coordination and effective functioning of the process,

and of decision making for risk acceptance and change

decision.

b) Tools may be different according to the type of

risk and its evaluation methods (statistical, or

qualitative)

Tools (preferably a QMS software integrated with the database) used in BEs shall be

supported by relevant SOPs to monitor and evaluate the effects of quality risk management

on efficiency of the QMS, to keep the records complete and timely, to eliminate the identified

risks or minimize to an acceptable level, to monitor the corrective/preventive actions.

c) Documentation of a regular risk management plan is as follows;

- Flow charts

- Check Sheets

- Process Mapping

- Cause and Effect Diagrams (Ishikawa diagram or fish bone diagram)

- Failure Mode Effects Analysis (FMEA) (see IEC 60812)

- Fault Tree Analysis (FTA) (see IEC 61025)

- Hazard Analysis and Critical Control Points (HACCP) –Ref 2

- Hazard Operability Analysis (HAZOP) (see IEC 61882)

SOPs to describe actions to be conducted for each risk or category of risk;

Building of forms for reporting results

97

6.4 Biosafety

1. Discard of non-conforming

components

a) Persons in charge: AQ

Head and Processing

/Distribution Department.

b) Existing Guidelines give

the general guidance for this operation, existing SOP is regarding mainly

HBBs. The RBC will also have to develop such SOP, in relation to possible returns

from HBBS. Process will in fact be the same as regarding Biohazards.

2. Biohazards

a) Definition

Components from donations that are repeatedly reactive in TTI screening tests, or

from donors whose records indicate their components should be destroyed because

they are on a high risk deferral registry or because of previous TTI test results are

classified as biohazards.

b) Their disposal is submitted both to National Regulation and to Technical

requirements which impose several types of processes, included under the generic

name of Waste management (see Chapter on Blood Collection)

c) Important documentation: it must ensure traceability and definition of

responsibilities of actors

d) Archive and Positive Serum samples

Such samples or even plasma bags may be kept for laboratory use: they must be

appropriately labelled to prevent from any use for ordinary laboratory use or therapeutic

purpose, and must be stored in a secure freezer or other storage unit that is clearly labelled

An inventory sheet of this freezer (or other storage unit) contents, mentioning identification,

type of product, reason for retention, and use will be maintained.

EXISTING DOCUMENTATION

Guidelines HANDLING RETURNED/EXPIRED BLOOD

COMPONENTS (BTS/SOP/WP/52)

SOPs will be developed:

To ensure that all components prepared from any donation can be traced To ensure that those Blood Components units are officially withdrawn from the

RBC Stock If destruction is sub-contracted to an agreed and qualified Company, a contract

must be signed between the RBC and the Company, fixing technical conditions of destruction and traceability. A certificate must be issued by the Company after each operation, mentioning the Units barcode N°.

98

3. General Hygiene measures

6.5 MIS, Record Keeping, Data System: Which Data for what Type of

Action?

MIS is in fact a system of data collection, keeping, organization and restitution according to

needs of users37. Provided appropriate data have been entered into the system, and design

is appropriate, it may be very useful to transform data into information for quick and accurate

decision making.

Some data are existing that are not the product of the RBC activity (Legal and Regulatory

data, general information and statistics for instance): they will be entered into the MIS only if

they can be the support of operations in the RBC.

MIS must integrate, too, on a functional way, primary accountancy data in order to

organize them according to Management needs.

Data must be hierarchized according to 2 levels at minimum in each Department.

1. Technical data: These data that are generated and used mainly at Technical level and

Head of Department levels

a) Legal and Regulatory environment documentation: mainly Standards and

Guidelines. But other kind of documentation will be useful, such as recent scientific

results, results of Working groups on particular subjects or other more advanced

Regulations and decisions. They will allow the constitution of a referential for the best

running of technical activities.

b) Technical SOPs, Processes organization, Documentation and reporting

supports that will be the way each Department will implement the abovementioned

Guidelines and referentials. They are fully part of the Quality Assurance System, and

the MIS must provide direct links to this system.

37 Functional Brief : MIS for Blood Transfusion Services, SBTP, 2012

a) They must be the result of a Risk assessment study, in order to evaluate:

What are the “dangerous” products and samples In which premises and areas they will be handled What is the type of staff who will have to work in those areas, and who will not?

b) From that study, establishment of a “Risk grading map” of the RBC using the table 6 model. This map will permit to establish appropriate protections of these areas, and related

SOPs including type of cleaning

c) Determination of the Personnel protection measures to be taken according to the areas, in addition to classical measures related to smoking, food and personal hygiene, specific gowns and use of gloves.

d) That will be part of the Operations Manual, and be the equivalent of an “Internal Regulation” of the RBC

99

c) Specific data for each Department and inside them for each general objective:

Table 8 summarizes some of this kind of data

2. Decisional and Managerial data: there are data to be managed in view of more

Strategic management of the RBC, and used mainly at Manager and Head of

Department level.

b) Those data are more made of indicators that have been decided as representative of

results of activities. They provide elements for decision making and will motivate

strategic decisions if needed

Most of them have been reminded as conclusions of each Chapter of this Manual (red text

zones). Some of decisions are to be made by Heads of Department as far as they are

technical decisions. Other ones are pertaining only to managerial level, as far as they have

financial consequences.

c) Those indicators are more “Macro” indicators, representative of the Whole RBC performance level. Table 9 is proposing some of them.

DEPARTMENTS, SECTORS TYPES OF DATA

(SYNTHETIC)

INTEREST

BLOOD DONOR

RECRUITMENT

KAP studies, Social MKT, , Sessions

data base

Evaluation of Blood donor recruitment

strategy and adaptation

BLOOD DONOR

MANAGEMENT

Personal information, Medical

information, satisfaction inquiries

Data base of Donors

BLOOD DONOR

COLLECTION

Realization sheets results, Quantitative indicator of activity

BLOOD DONOR

HAEMOVIGILANCE

ARE notifications, analysis and

assessment

Improvement of Donor collection and

selection conditions

QUARANTINE Stock Evaluation of screening and production

input

IH SCREENING Blood groups and IH results Blood Groups proportion

TTI SCREENING TTI results TTI results by Marker and other

repartition (age, VNRBD or not,..)

EQAS RESULTS Results Quality control of the Laboratory and

CAPA if needed

COMPONENT

PREPARATION

Realization sheets (daily) Daily and monthly production of

Components

QUALITY CONTROL Results Quality of Components and CAPA if

100

needed

LABELLING Daily entry into stock Calculation of daily stock

STORAGE CONDITIONS,

BCCE

Results of preventive maintenance Status of BCCE

STOCK MANAGEMENT Balance between requests and

distribution, Number of expiries,

Knowledge of other stocks

Alerts to be sent to Collection

Department if needed.

Analysis of expiry causes

Profile of needs

Other solutions to be proposed

DISTRIBUTION Realization sheets of operations Stock update after withdrawal of non-

used Components by HBB

TRANSPORTATION TO

HBB

Realization sheets of operations Assessment of possible problems

RECALLS Active operation on request of

Laboratory or Production

Interest of patients

RETURNS Result of operations Analysis of causes and CAPA

WASTE MANAGEMENT Number of units discarded Analysis of causes and CAPA

TRACEABILITY OF

COMPONENTS

Results of Trace back and Look Back

inquiries

Ability to trace Blood units and Donors

EQUIPMENT

MAINTENANCE

Log books examination Status of equipment

CONSUMABLE STOCKS Stock inventory sheets (weekly) Avoid shortages

RECURRENT

EXPENDITURE

Regular recurrent budget follow up Entry of primary data for all types of

budget management

RECURRENT INCOME Regular recurrent budget follow up Data for all types of Budget

management

CASH FLOW DATA Annual budget, Regular reconciliation Avoid Bank penalties

QUALITY INDICATORS Regular monitoring results Improvement of QS and QA.

Table 8: Types of data at technical level

101

DOMAIN OF ACTIVITY

INDICATOR INTEREST

BLOOD COLLECTION

N° of Blood donations Evaluation of blood donation strategy and realization, technical features, and CAPA

if needed % VNRBD

% 1st time donations

Haemovigilance Results

BLOOD PRODUCTION

N° and type of Components produced

QC statistics

Quality and quantity of production

SCREENING LABORATORY

Sero-prevalence of markers and population repartition (VNRBD,..)

Sero-prevalence evolution as a marker of VNRBD progression

STOCK Daily stock evolution Follow up of available stock and CAPA if needed

DISTRIBUTION Monthly statistics per HBB and total

Follow up of needs evolution (quantitative and qualitative)

MAINTENANCE Monthly maintenance reports Global status of the Equipment, evaluation of needs

BUDGET INDICATORS

10 Indicators (see that Chapter) Financial status of the RBC, decisions to make if needed

QUALITY SYSTEM QA indicatoors Follow up and progressive building of the Quality System

Table 9: Proposed Managerial indicators

6.6 Reporting Operations

Internal reports have been treated in each Chapter, we shall address here “external” ones.

1. Activity reporting

The objective of this reporting is for any external Organization, to make know with objective

evidence the various aspects of the RVC activity.

It may be divided into various narrative chapters such as:

Blood Collection activities and awareness making activities, with a narrative

presentation of results.

Blood safety activities, presenting various tests and screening, and their results

Preparation of Blood Components, with figures and evolution

Distribution activities, showing the progress in needs meeting and eventual stocks

problems..

Quality features and successes

A quick and very synthetic result of Budget execution.

102

2. Following table (Table 10) may be the support of this report. MIS must be able to

provide it as it is presented.

GOVERNMENTOF

BLOODTRANSFUSIONAUTHORITY

PERIOD:

DESIGNATIONOFTHEBLOODCENTRE:NAME

ADDRESS

TEL

DONORMANAGEMENTDEPARTMENT N %

VOLUNTARYNONREMUNERATEDDONORS #DIV/0!

FAMILIAR/REPLACEMENTDONORS #DIV/0!

PAIDDONORS #DIV/0!

NUMBEROFDONORSPRESENTEDATTHECOLLECTIONSESSIONS: 0 #DIV/0!

FIRSTTIMEDONORS #DIV/0!

MEDICALSELECTIONOFDONORS

NUMBEROFDONORSDEFERREDAFTERINTERVIEW(1) #DIV/0!

NUMBEROFDONORSDEFERREDFORLOWHbCONTROL #DIV/0!

TOTALDONORSDEFERRED 0 #DIV/0!

DONORSADMITTEDTODONATION 0 #DIV/0!

DONATIONSNOTACHIEVEDFORFAINTING #DIV/0!

DONATIONSNOTACHIEVEDFOROTHERREASONS #DIV/0! REASONS:

TOTAL 0 #DIV/0!

BLOODBAGSAVAILABLEFORSCREENINGANDPROCESSING 0 #DIV/0!

RESULTSOFBIOLOGICALSCREENING

Positive HIV1/2 #DIV/0!

tests HBS #DIV/0!

for: HCV #DIV/0!

Syphilis #DIV/0!

Malaria #DIV/0!

TOTALPOSITIVETESTS 0 #DIV/0!

BLOODBAGSAVAILABLEFORPROCESSING 0 #DIV/0!

PROBLEMSOFPROCESSING #DIV/0!

UNITSOFBLOODPRODUCTSRELEASEDTOSTOCK

WHOLEBLOOD #DIV/0!

REDBLOODCELLCONCENTRATE #DIV/0!

PLATELETCONCENTRATE

FRESHFROZENPLASMA

OTHER,PLEASESPECIFY

DISTRIBUTIONACTIVITIES ENDPREVIOUSMONTHSTOCK PERIODDISTRIBUTION STOCKENDOFPERIOD OUTDATED

WHOLEBLOOD

REDBLOODCELLCONCENTRATE

PLATELETCONCENTRATE

FRESHFROZENPLASMA

OTHER,PLEASESPECIFY

DETAILOFDISTRIBUTION HBB1 HBB2 HBB3 HBB4 HBB5 HBB6

WHOLEBLOOD

REDBLOODCELLCONCENTRATE

PLATELETCONCENTRATE

FRESHFROZENPLASMA

OTHER,PLEASESPECIFY

ACTIVITYREPORTFORBLOODCENTRES

Table 10: Example of Activity report

103

3. Activity report must also include comments and a discussion, including calculation

of trends and a forecast for following fiscal year, as well as a mid term strategy

This Activity report is very important, as it will be the support for further negotiations and

approaches: it must be strongly documented an not only be a “communication tool”, even if it has to be shaped and presented as such.

2. Regulatory reporting and relations with BTA

a) Site master file: this file is part of the folder to be

presented to the BTA for Licensing.

The existing document is in fact a summary of information

made for BTA, but it does not encompass the real Site

Master File that a RBC must provide (as any Human Components Manufacturing Company)

to provide evidence of Quality. In fact, on the side of the BTA, this information will be

collected, recorded and kept

b) Haemovigilance notifications (see that Chapter)

c) General Activity Report: the above mentioned activity report may be used as a

complement to the official Quarterly activity report due to the BTA, as requested data

are the same 38.

d) Any report requested by BTA: the MIS should be able to provide data within a short

interval of time.

3. Financial and budget reporting to Government

Government is supposed to fund whole or part of the RBC funds, and it is mandatory to

provide a report on use of Funds. That report will serve as a basis for next Fiscal Year

38 Functional Brief for BTA, SBTP, 2013

REFERENCE:

-Compiled Licensing

and inspection data

This Site master file must include:

Blood collection, as well as Plasma collection, Leuko-aphaeresis, Platelet Aphaeresis, and type of donors (see above Activity Report)

Detailed Distribution activities (in terms of Component type) per HBB (see activity report above)

Detail on Human resources, in terms of place of work, grade, curriculum, position, number inside each Department. That is normally already studied through the Analytical Accountancy Budget Management (see “Tools for Budget Management”).

Detail on Premises and facilities in terms of surfaces allocated to each Department, and inside each Department to which activity. That repartition is the same as already studied in relation to Analytical Accountancy Budget (see “Tools for Budget Management”).

Detail on equipment of each Department (Type of Equipment and number): this needs to have established an appropriate inventory list (see Tools for Budget Management).

MIS must have already integrated and organized those data in order to provide them easily to BTA.

104

Budget justification and show to Government Administration that the RBC Manager is

conscious and responsible person.

Normally the RBC shall provide following reports:

First year(s) of functioning will be crucial for new RBCs sustainability, it is thus very

important that such reporting and reflection be at least conducted on a quarterly

basis during that period.

Fixed assets Budget and Inventory list, with Amortization forecast Recurrent Budget execution (expenditure and income) and Result. This must

include a comment on Calculation of Break event point (mainly in the first year on functioning), and possible forecast. Consumable stock variations are included into this result.

Cash Budget execution and reconciliation during the year, with comments on eventual difficulties that could have provoked Bank or Treasurer problems and penalties.

Costing study results, as it is crucial for the government to know how much credits it will have to forecast on following year, and that will mainly determine the needed Budget volume.

A complete analysis of Budget and Financial situation, together with proposals for following fiscal exercises.

ANNEXES

ANNEX 1 Template of Local Protocols/MOUs

b/w RBCs and HBBs

107

ANNEX 1: TEMPLATE OF LOCAL PROTOCOLS/MOUs BETWEEN RBCs

AND HBBs

Introduction

This template is prepared to be adapted at any local situation, but in a way that could be

immediately officially published by Provincial Authorities.

It is using the following bases of working:

1. Creation of a RBC, the terms of Reference of which are defined by a Provincial Act,

organizing network of 6 attached HBBs around one RBC.

2. Splitting of respective functions of RBC and HBBs, in order to eliminate duplication

regarding Blood Donors collection, and re-orientation of HBBs activities towards the

patients’ care. 3. Eventuality of use by the RBC of a place inside the Hospital’s area (and may be donor

related previous equipment of the HBB), to organize and collect Blood from VNRBD and

other potential donors, as well as realizing IEC actions to sensitize potential Blood

donors.

4. Both Hospital and RBC are legal entities and have delegation of Financial Powers.

The Protocols to be signed between RBCs and HBBs must include the following

minimal dispositions in application of the Law N°.....and of its Implementing

Regulation (art. )

General Dispositions

1. PARTIES

This protocol is signed between:

____________________HBB (hereafter named “HBB”, as defined in the Law N° ... and related Implementing Regulation) located at _____________, License N°.........,

represented by ..........................., Responsible Person as described in the Law and

related Guidelines.

And The Regional Blood Centre located at _______________ in _____________

(hereafter named “RBC” as defined in the Law N°.... and related Implementing

Regulation), license N°.............. , Represented by ..........................., Responsible

Person as described in the Law and related Guidelines.

who commit themselves and reciprocally to a faithful and transparent implementation.

A copy of this protocol is submitted to the approval of the BTA of the Province of the HBB,

who will transmit back to the parties the protocol, once approved.

2. TERMINOLOGY

Blood and Blood Components denomination will be the Official Denomination as specified in

the National Standards on Blood Products. They exclude any other denomination.

108

3. VALIDITY OF THE PROTOCOL

This protocol and its attachments (if any) may be developed or amended in the future

according to related changes to the Law, Regulations or Guidelines with mutual agreement

between the HBB and the RBC.

Scientific or technical evolution that may occur will also be a reason for amending the

present protocol.

For this reason, the Provincial BTA of the HBB through regular formal Inspections will

perform monitoring of implementation of the present protocol. A yearly meeting involving the

abovementioned BTA, the RBC and the HBB will permit to share the results of this

monitoring, to list the matters and problems arising, and to propose solutions.

In such conditions, the present Protocol will be updated every year if needed, within the

framework of the Law N°.... and its implementing Regulations.

4. SUBJECT

The subject of the present protocol is to address and mutually organize the relationships

between the RBC and the HBB on the following subjects:

Subjects that are specified as not being in the scope of the Law in reference will not be

addressed by this protocol.

Organization of Blood/plasma donation by the RBC inside the Hospital place of the

HBB, according to dispositions of the Law and its Implementing Regulation.

Organization of the requests by HBB and of supply by RBC of Blood and Blood

components: the various following procedures are described in the corresponding

Guidelines:

o Request organization and use of official forms

o Modalities of transport of Blood and Blood components by the RBC

o Modalities of acceptance by the HBB, organization of returns of non-conforming

components

o Modalities of storage of blood components in the HBB

o Modalities of traceability

Autologous donation and transfusion protocols

Each of those subjects is specified in the sub-protocols as follows.

109

Sub Protocol on Blood and Apheresis Donation Place for the RBC

Inside the hospital of..............

CHAPTER 1- PREMISES

Article 1- The RBC and the Hospital (as denominated above) agree for the rental of a place

suitable for the organization of blood donations.

Article 2- This place is, according to the BTA Inspection results; conform to the National

Standards related to premises of Blood donation.

The RBC and the Hospital/HBB conclude here an agreement on a monthly rental price

of: ..................

If it is not conform, the RBC and the Hospital/HBB conclude here an agreement on a

monthly rental price of: ..................

The RBC will take into account by itself the costs of civil works related to the upgrading

of the premises to National Standards.

In both cases, the rental price cannot excess the normal rental price of working

premises in the considered City.

Article 3- The premises maintenance, electricity, gas, water supply, land phone and security

costs will be:

At charge of the Hospital, and invoiced back to the RBC together with justifying

documents

At charge of RBC 39

Article 4- If it is not possible to find any suitable place inside the Hospital’s compound, the RBC will have to find a donation site at a walking distance from the Hospital. The RBC must

make know its address and details, and put inside the Hospital all the information to attract

Blood and Apheresis Donors, together with a contact person.

The Hospital/HBB has the duty to close to any donation its previous donation premises and

to send all the family and relative donors to the RBC donation site.

Article 5- The BTA will inspect regularly the implementation of the present dispositions, and

take note of any difficulty in its execution.

CHAPTER 2- EQUIPMENT

Article 6- An inventory list of the previous donation equipment of the HBB is established,

according to the model given in the Implementing Regulation. This inventory list must reflect

the amortized and residual value of the equipment. It is annexed to the present protocol.

Article 7- The RBC may buy this equipment at its residual value, if it is still conform to

Standards, and suitable with is working organization: the RBC will establish a list of the

equipment it will buy. This list is an annex to the present protocol.

39 Please choose one alternate

110

Article 8- The RBC and the Hospital agree for the cession of the total of equipment at the

price of: .............

CHAPTER 3- CONSUMABLE

Article 9- If any consumable such as donation Blood bags and consumable with a suitable

validity date is available, the HBB must prepare an Inventory list.

Article 10- The RBC and the Hospital/HBB agree for the cession of this consumable for the

global sum of..............

CHAPTER 4- GENERAL FUNCTIONING

Article 11- The Hospital and its HBB are committed to facilitate all daily aspects of the RBC

Donation site. Regular Inspections will be performed by the BTA and any difficulty will be the

subject of a coordination meeting to find out acceptable solution(s).

Sub Protocol on Demand and Supply of Blood and Blood Components

CHAPTER 1- STANDARDS AND GUIDELINES COMPLIANCE

Article 1- The RBC and the HBB must conform to National Standards on Blood Cold Chain.

Their respective licensing is depending partly on that aspect. The present protocol cannot

enter into force if they do not comply, and a BTA Inspection report must ensure that aspect.

Any non-compliance from both sides must be corrected without any delay. The Qualification

report of the related equipment is an Annex of this protocol.

Article 2- RBC Supplied Blood components must be conform to National Standards. A

procedure of returns for non-conformance is elaborated according to the National

Guidelines, and is an Annex of this protocol.

Article 3- Both RBC and HBB must comply with Traceability Guidelines. The traceability

procedure is an Annex to this protocol, which cannot enter into force without it. The BTA is in

charge for inspecting this aspect and reporting accordingly.

CHAPTER 2- GENERAL ORGANIZATION

Article 4- Blood Components are supplied in routine by the RBC to the HBB, according to a

weekly rhythm. Each 5 days 40 the RBC will ensure the supply of the agreed blood

components, according to the National Guidelines. The remaining Blood components units

will be withdrawn from the actual stock. This operation will be duly documented according to

the Guidelines. A monthly report of those operations will be produced in double by the RBC

and the HBB, and be submitted to the BTA, together with the quantitative data (see art.8 of

this Chapter).

Article 5- HBB’s Responsible person is responsible for his/her stock management. This management will be reflected in its quarterly activity report, as specified in the corresponding

BTA Guideline and Implementing Regulation.

40 Dates to be decided on common agreement

111

Article 6- the RBC will accept no emergency request, unless a real notion of emergency is

validated by Haemovigilance Coordinators. The HBB will use its own stock first, and then

request for an adaptation of its stock, which will be done the day after. An Inspection by the

BTA will be organized the day after this supply, to check about reality of the emergency

situation, and the compliance with ACUB Guidelines. A report on this Inspection will be

established, and be the support of a coordination meeting.

Article 7- The HBB responsible Person is in charge of centralizing the clinical wards needs

both on quantitative and qualitative aspects. He/she will establish this needs on a forecasting

way to formulate the requests, which would not be foreseen by the present protocol. He will

communicate his/her conclusions to the responsible person of the RBC, and to the BTA.

This is particularly regarding Apheresis Platelets and Autologous protocols.

CHAPTER 3- QUANTITATIVE AND QUALITATIVE DISPOSITIONS

Article 8- Weekly supply planning is established as follows41:

BLOOD

COMPONENTS

BLOOD GROUPS

A+ ANEG O+ ONEG B+ BNEG AB+ ABNEG

RBC CONCENTRATE

FFP

CRYOPRECIPITATE

PLATELETS, RANDOM

PLATELETS, APHERESIS

The quantities used for each component will be monitored both by RBC and HBB, and

annexed to the monthly report. (See Art.4 of this chapter).

Article 9- Platelets will be provided routinely on the basis of random platelets concentrates

by the RBC, according to the above specified quantities and modalities.

Article 10- Apheresis Platelets supply: as they are generally used for specific indications,

ACUB Guidelines will be used to establish the needs.

The HBB responsible person will coordinate with the Clinical prescriber 15 days in advance

on the Transfusion protocol.

He/she will inform the RBC responsible person accordingly and send the corresponding

request, according to Guidelines, to the RBC.

Apheresis Platelet Concentrates will be supplied separately from routine supply.

41 According to the documented past 6 months consumption, which includes also the emergency

requests, according to the Implementing Regulation of the Law.

112

CHAPTER 4- FINANCIAL DISPOSITIONS

Article 11- The mutually agreed cost of the Blood components distributed by the RBC is the

following, in accordance with the Communiqué published in Official Gazette.

Blood Components are VAT, taxes, duties, stocks and funds exempted. They cannot be the

objects of any price decrease for those reasons.

Article 12- The RBC will invoice every month the sum corresponding to the following

distributed components.

A list of Unit costs shall be annexed to each invoice. These Unit costs shall be calculated

according to data from Analytical Accountancy of the RBC.

BLOOD

COMPONENTS

UNIT COST QUANTITY

RBC CONCENTRATE

FFP

CRYOPRECIPITATE

PLATELETS, RANDOM

PLATELETS, APHERESIS

113

The HBB will pay under 45 days latest. In any case of difficulty, the BTA shall be informed

and a consensus will have to be found. In the event of a change for bank account, RBC shall

notify TC in written.

Article 13- Any dispute will be submitted to the BTA for solving and finding a consensus.

SIGNED BY SIGNED BY

__________________________ __________________________

__________________________ __________________________

Director for the Hospital BB Director of the RBC

RBC NAME INVOICE

TO HBB....................

BLOOD

COMPONENTS

BLOOD GROUPS

A+ ANEG O+ ONEG B+ BNEG AB+ ABNEG

RBC CONCENTRATE

Price

FFP

CRYOPRECIPITATE

PLATELETS, RANDOM

PLATELETS, APHERESIS

SUBTOTAL

GRAND TOTAL

ANNEX 2 Template of Local Protocols/MOUs

b/w RBCs and HBBs

115

ANNEX 2: DEFINITIONS IN HAEMOVIGILANCE

1. Serious adverse event: general definition and subgroups.

It is described as a condition that occurs associated with the collecting, processing, storage

or distribution of blood and blood components that might through the transfusion of affected

blood and blood components lead to death or is life-threatening, results in permanent or

prominent disability or incapacity or results in, or prolongs hospitalization. It can result as

non-conformance, an error, or an incident, in any step of the transfusion chain. For example:

error in ABO typing, mislabelling of blood components or blood samples, problem with

refrigerators temperature. Generally it occurs due to acting incompliantly with SOPs.

Serious event-free transfusion mistakes

Sub-group of serious adverse events. Defined as any mistake that has not caused an

adverse effect on the recipient despite transfusion of a wrong, non-compliant or insufficient

component. For example: transfusion of ABO-compatible component without cross-matching

or transfusion of a component without irradiation despite it had been requested

Mistaken transfusion

Transfusion of blood and blood components that fail to comply with transfusion compliance

requirements for the patient or that had actually been prepared for another patient. That

includes transfusion mistakes and deviations from SOPs or hospital policies which in turn

cause the transfusion error. It may lead to an adverse reaction but it may also result in no

reaction (serious event-free transfusion mistakes)

Near miss

May be defined as a deviation that is discovered prior any transfusion of the blood

component, and for this reason will not harm the health of the recipient. It means

identification prior to transfusion of faults such as erroneous blood typing, failure to detect

erythrocyte antibody, delivery and release of wrong, non-compliant or insufficient component

which could have led to adverse events if the transfusion had occurred. Despite being a

transfusion fault they do not cause any serious adverse events but notification of events

“prevented at last minute” is still important, as it helps determination of weak points during clinic transfusion practice. Therefore Haemovigilance system makes notification of near

misses” mandatory.

2. Adverse reaction

Unexpected and undesired effects developed by donors during the blood donation or by

patient in association with the transfusion of blood or blood component. This condition may

be, but not necessarily, a result of adverse event.

CAPA directed to aforesaid non-compliances (either SARE or events prevented from

happening at the last minute) shall be developed by the concerned unit. While making root

cause analysis of SARE, they might be classified as: originating from product, medical

device, or personnel. Any causes which cannot be covered under one of these three groups

might be classified as “other causes” but need to be explained.

In case a possible role of a device in an adverse reaction or event is suspected when the

reason of an experienced non-compliance is searched for then, manufacturer or

representative firm should be informed at the same time with the authorized body and CAPA

116

be determined according to given directives. Cause and effect relation does not need to be

definitely proven at the time of reporting. Additionally, any other Health institutes that use the

same device shall be warned. In case the cause is originating from personnel, activities have

to be described so as to protect individuals from being accused and a system which

promotes volunteer reporting must be developed.

3. Tracing

Trace-back

Process of investigation aiming to identify the Donor who has donated a Blood Component

that is likely to cause the reaction in case a transfusion-related reaction developed by the

recipient is suspected.

Look-back

Process of investigation to determine current destination of Blood Components (transfused

patients, production, disposal or stock) derived from that donor, following identification of a

the Donor non-conformance which poses a threat on transfusion safety.

4. Recall

Refers to the process of withdrawal, by the manufacturer, of not yet used Blood Components

that have a potential risk if a quality non-conformance causing a threat on transfusion safety

is identified.

5. Return

Refers to the process of returning by the user to the manufacturer, of not yet used Blood

Components which have a potential risk in case a non-conformance which poses a threat on

transfusion safety is identified.

6. Imputability

Likelihood that ARE or SARE suffered by the Donor is related to Blood donation, and by the

recipient is related to the transfusion;

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Evidence-based imputability degree

Level of

Probability Description

Not Assessable When there is insufficient data for causality assessment.

0

None When it is definitely proven that serious adverse effect in question has

been caused by a reason other than transfusion/blood donation

Unlikely

When it is quite likely –despite lack of definite evidence- that the

reason of serious adverse effect is related to causes other than

transfusion blood and blood components/blood donation.

1 Possible

When the evidence is not sufficient to attribute serious adverse effect

either to transfusion of blood and blood components/blood donation

or to alternative causes.

2 Probable

When the evidence is clearly in favour of attributing the serious

adverse effect to transfusion of blood and blood components/blood

donation.

3 Certain

When there is conclusive evidence without doubts (*) for attributing

the serious adverse effect to transfusion of blood and blood

components/blood donation.

Safe Blood Transfusion Programme Pakistan

Ministry of National Health Services, Regulation & Coordination, Government of Pakistan

H. No. 4-B, Street No. 17, Sector F-8/3, Islamabad, Pakistan

Tel: +92 (51) 9263236-7, Fax: +92 (51) 9263238

E-Mail: info@sbtp.gov.pk, Website: www.sbtp.gov.pk