Total Quality Management in blood transfusion services
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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
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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
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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
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Impossible to ignore when Bad
Invisible when Good
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Methods
Personnel
PROCESS INPUT
Environment
Equipment, reagents
OUTPUT
FACTORS AFFECTING QUALITY
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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
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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
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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.
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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”
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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
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National Standards for Quality in BTS
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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COMPETENCY ASSESSMENT
Informal
Direct observation of activities
Review of work reports
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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
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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
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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
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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
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ROOT CAUSE ANALYSIS OF FAILED TEST RUN
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CAPA
Corrective Action
Eliminate
detectednonconformity
Preventive Action
Preventnonconformity
occurrence
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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
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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
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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
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Total QualityManagementQuality
Assurance
QualityManagement Quality
Control
Evolution of the Concept of Quality
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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
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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
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Thank You
Your Attitude determines your Altitude Stephen Covey