Blood safety has been accorded a high priority by WHO and is an issue of

concern to many developed and developing Member Countries. Recognizing the

importance of blood safety, the theme of World Health Day 2000 was devoted to this

subject with a thought-provoking slogan,

“Safe blood starts with me: blood saves life”.

The availability and safety of blood depends on multiple steps in the

transfusion chain. This starts with a healthy and motivated population, retention of

voluntary non-remunerated donors, processing and testing of all donated blood,

availability of blood and blood products, rational use of blood and its components and

post-transfusion monitoring of the patient. At every step, any lowering of quality

would reflect adversely on the final product. To ensure quality in blood transfusion

services, WHO initiated a quality management project in 2001. One of the important

areas identified under this project is capacity building in the quality management of

blood transfusion services in which emphasis is laid on ensuring consistency in

performing various activities so that the safety and quality of blood is guaranteed.

The performance of any procedure will yield desired quality results only if

standard operating procedures (SOPs) are followed. Realizing that most blood banks

in the countries of the South-East Asia Region may not have the capacity to write

their own SOPs, WHO has developed model SOPs for various procedures that are

commonly performed in blood transfusion services. Individual blood banks need to

adapt these and develop their own blood bank-specific SOPs based on the

infrastructure available, test procedures to be followed and availability of reagents.

I am sure the blood banks will find this model SOPs useful to help them in

achieving their objective of continuously providing adequate, safe and quality blood.

Preface

There has been growing awareness about quality in blood transfusion services with

the objective of releasing only those blood products and blood which fulfill the desired

standards in terms of safety and efficacy. Consistency is the hallmark of quality and

can be achieved only through the use of standard operating procedures (SOP) by all

staff engaged in blood centers at all times. Use of SOPs has also become essential

for licensing and accreditation.

Each blood bank has to develop its own set of SOPs matching their requirement and

resources. SOP need to be developed for all critical procedures. There is now an

international unanimity on the framework of SOPs. Each SOP must have the

following components:

Each SOP must be given a unique identity number along with the revision number, if

any. Information about the procedure, location where the SOPs will be used, its

function and distribution list; date from which it will be effective and signatures of the

author(s) and the person from top management who can authorize the use of SOP

from the effective date must precede the technical details.

The technical contents of SOP should include the following:

Scope and application

Responsibility

References for technical content, if any

Materials required to perform the procedure

Various steps of procedure

Interpretation criteria

Quality assurance

Documentation

Prior to their use, the SOPs must be validated to demonstrate their utility in the

Setting of the respective blood bank. Realizing that in the countries of the South-East

Asia Region, the capacity to develop their own SOPs is currently limited, we have

Developed “model” SOPs for some of the important procedures that are followed in

blood banks. These are intended to act as a guide and help all blood banks in writing

and validating their own SOPs. We are hopeful that these will act not only as models

for development of SOPs but shall also stimulate blood transfusion services in using

SOPs for various procedures and strengthening their quality systems