TOTAL QUALITY MANAGEMENTIN BLOOD TRANSFUSION

SERVICES

Prof. Neelam Marwaha M.D; F.A.M.S; F.I.S.H.T.M.

Head, Department of Transfusion MedicinePostgraduate Institute of Medical Education and Research, Chandigarh

QUALITY – A CHALLENGE IN BTS

Blood is covered under the definition of ‘Drug’ under Sec. 3(b) of Drugs & Cosmetics Act

Quality of the end product cannot be tested as each unit is a batch

in itself

Blood Banks need Quality management system to ensure that blood and blood products are safe for transfusion

WHY QUALITY IN BTS

Quality is about consistently producing products that are fit for their purpose

Safe• Free from infection risk• Free from other

contamination• Correctly labelled• “In date”

Effective• Contain required bioactive

substances• Give clinical benefit

Lower risk of transfusion-associated morbidity or mortality

• Fewer adverse transfusion reactions

• Fewer transfusion-transmitted infections

Increased confidence in the BTS

Impossible to ignore when Bad

Invisible when Good

Methods

Personnel

PROCESS INPUT

Environment

Equipment, reagents

OUTPUT

FACTORS AFFECTING QUALITY

TOTAL QUALITY MANAGEMENT

TQM functions on the premise that the quality of products and processes is the responsibility of everyone who is involved with the creation or consumption of the products or services offered by an organization.

In other words, TQM capitalizes on the involvement of management, workforce, suppliers, and even customers, in order to meet or exceed customer expectations

KEY ELEMENTS OF TQM

Organizational Management Facility, Quality Standards A Documentation System

Process Management Human Resource Management External Services and Supplies

Quality Control Equipment Management Managing Nonconformances

WHY TQM Blood transfusions today are safer than

ever before, yet there are increasing number of complaints and controversies.

This is likely due to the general public and governments having a low tolerance for risk in this area.

Transfusion Medicine is an evolving field with continuous questions on risks and benefits; management is thus becoming more complex.

OBJECTIVE OF TQM

“Do the right things right the first time and everytime” or“ Achieve total client satisfaction through quality products and services and Endeavour towards continuous improvements”

PRINCIPLES OF TQM

Choice must be made by the top management, only then it will be translated to the whole organization

Inspection of the process is as important as the inspection of the product

Preventing variability is the key to producing high quality

Quality is a journey of continuous improvements, it is not a destination

National Standards for Quality in BTS

DOCUMENT PYRAMID

Level 1Policy

Level 2Process

Level 3Procedure (SOP)

Level 4Forms, records, labels

What will be done

How it happens

How to do it

What was done

QUALITY POLICY

Covers all BTS activities

Is communicated and understood within BTSIs periodically reviewedIs appropriate

Includes commitment to

Identify needs of blood donors and recipientsContinually improve QSComply with regulatory and accreditation requirements

QUALITY PLANNING

Mission Statement should be clear Establish quality goals Identify all activities required to meet

regulations and accreditation standards Develop operational processes for blood

product preparation and issue Develop process controls Develop validation protocols

ORGANOGRAM

The blood bank should have a written dated and signed organogram (organisational structure), clearly defining the reporting structures and hierarchies of the management and staff

The organogram should be displayed at a place where it can be viewed by the staff

PROCESS MANAGEMENT

A process approach is important because a desired result is achieved more efficiently when activities and related resources are managed as a process

A process flow chart should be prepared with inputs, outputs and control points

Identify process owners,i.e. persons who actually perform the job

Communicate effectively and rapidly Validate the process.In BTS this is essential since it is

not feasible to inspect each product

GENERIC FLOW – BLOOD COLLECTION

• Motivation• Education• Counsellin

g• Retention

• Medical• Physical• Hb testing• Interview• Consent

• Identification• Labelling• Arm disinfection

• Proper

mixing/volume

• Refreshment• Reactions• Observation• Gratitude

Donor selection

Donor recruitment Phlebotomy Post donation

care

Motivator MOIC Nurse MOIC / Nurse

Thank the donor Management

Deferralregistry

Donor selection

Phlebotomy

Post donation counseling

Adverse effectsdonation

Deferral

• Donor Identification• Labeling of bag / tubes• Arm disinfection• Proper mixing / volume

Actual process flow in blood collection

YesFitNo

SuccessfulYes No

QUALITY INDICATORS

Important tool of quality Management Assess efficiency of key points in the process

Blood collection

Donor reactions

Failed collections

Clots in bloodPlatelet

aggregates

Component preparation

Percentage of blood

separated into components

Nonconforming components

DOCUMENT CONTROL SYSTEM

A document control system to ensure that documents are

written in a standardized format

approved prior to implementation

available at point of use

reviewed at least once every two years

identified with current revision status

indexed, filed , stored and disposed in a controlled manner

obsolete documents are destroyed

Operational techniques and activities used to monitor and eliminate causes of unsatisfactory performance

Internal QC (for precision) indicates reproducibility of results

Control Charts, Run Charts

External QC (for accuracy) is also equivalent to Proficiency Testing ( Interlaboratory comparisons)

Proficiency testing is meaningful if handling and testing of PT samples is same as those for patient and donor specimens

Quality Assurance - defined as overall program that ensures that the final results reported by the laboratory are correct

QUALITY CONTROL AND QUALITY ASSURANCE

ACCURACY AND PRECISION Accuracy: is the degree of closeness of measurements of

quantity to actual (true) value.

Precision: also called reproducibility or repeatability, is the degree to which repeated measurements under unchanged conditions show the same results.

Two types of precision: intra-assay precision and inter-assay precision

Accuracy: is the degree of closeness of measurements of quantity to actual (true) value.

Precision: also called reproducibility or repeatability, is the degree to which repeated measurements under unchanged conditions show the same results.

Two types of precision: intra-assay precision and inter-assay precision

QA at All Levels from Vein-Vein

Recruitment

Selection

Collection

Processing

Gp & TTI Testing

Requesting for Tx

Pre Tx Testing

Issue

Administration

Hemovigilance

QUALITY IN Tx PRACTICEQUALITY IN BLOOD SUPPLY

Labelling & Storage

Through ensuring quality at each CCP

HUMAN RESOURCE MANAGEMENT

Choose right people for the right place Encourage teamwork

Improves

communication

Makes workplace more

enjoyable

Improves productivity

Helps in problem solvingDefine responsibility

TRAINING

Orientation; processes,procedures,documents

In service refresher training

Workshops, CMEs, seminars

Higher courses; PG degree, diploma

Periodic review of training curriculum

National and international fellowships and

conferences

COMPETENCY ASSESSMENT

Informal

Direct observation of activities

Review of work reports

Materials, supplies and services

used as inputs to a process

are considered “critical” as they affect

the quality of products and services being produced

Ref: AABB Technical Manual, 15th Edition

Examples

Critical Supplies Critical Services

Blood Centres - Equipment - Consumbles * Blood Bags * Kits * Reagents

Blood Centres - Testing - Storage - Equipment Maintenance

Patients - Blood / Components

Patients - Issue of blood / components

NON CONFORMING SUPPLY

Initiate corrective action Contact supplier Withold payment Request for replacement Demonstrate evaluation if necessary Repeat quality test on new supply If acceptable release payment

CONTINUOUS IMPROVEMENT

Identification of problems Nonconforming

products and services Customer complaints QC records Proficiency testing Audits

Analysis of causes Process flow charting

may help to identify problem-prone areas

The cause-and-effect diagram or fish-bone diagram to arrive at a root cause

Pareto chart where causes are arranged in decreasing order of frequency

ROOT CAUSE ANALYSIS OF FAILED TEST RUN

CAPA

Corrective Action

Eliminate

detectednonconformity

Preventive Action

Preventnonconformity

occurrence

EXAMPLE OF CAPA

Remedial action Discard unit, decontaminate centrifuge

Corrective action Find out the cause if unit was over collected Calibrate the centrifuge (speed) / biomixer (vol)

Preventive action AMC of equipment Checking volume before centrifugation

Event: Rupture of whole blood unit during centrifugation

POOR QUALITY HAS HIGH COSTS

Tangible Costs

Errors Repeat tests Equipment failures Wastage Delays Serious adverse events Litigations

Intangible Costs Breach of trust with

treating clinicians and the patients

Low morale of staff

Low market value

ASSESSMENT OF BTS

Audit A systematic independent examination and review to determine

whether actual activities and results comply with planned arrangements.

Internal Audit Audits are formally planned and organized and are carried out

by Quality Manager or designated personnel Audits are not done by sections for their own activities.

External Audit Performed by a licensing/ accrediting agency or inspections

by those not affiliated with that BTS

Total QualityManagementQuality

Assurance

QualityManagement Quality

Control

Evolution of the Concept of Quality

APPRECIATION

Words of praise for a task well done Recording good performance in review reports Letter of appreciation Generous in giving grading in ACRs Recommending for awards Giving positions of responsibility Creating special awards at CMEs,conference

TO CONCLUDETotal

• Made up of whole,• Entire organization

Quality• Degree of excellence

a product or service provider conform to

Management

• Manner of planning, controlling and directing an organization

TQM is the art of managing the whole to achieve excellence

Thank You

Your Attitude determines your Altitude Stephen Covey