Total Quality Management in Medical Laboratories

Total Quality Management in Medical Laboratories

Gift Ajay Sam

Sr. Demonstrator

TMIH, CMC

Quality?

• Philip B Crosby- Quality is free 1979- “The customer is the one you need to make successful. You have to learn what they need and give it to them”.

• Joseph M Juran (Father of Quality Management)-Juran's Quality Handbook -“Some products give little or no dissatisfaction; they do what the producer said they would do. Yet they are not salable because some competing product has features that provide greater customersatisfaction”.

Quality?

• David Gravin- 8 dimensions to quality-– Performance based

– Feature based

– Reliability

– Conformance

– Durability

– Serviceability

– Aesthetics

– Perceived quality

“THE DEGREE TO WHICH A SET OF INHERENT CHARACTERISTICS MEET REQUIREMENTS”.

ISO 9000; 2005

GET IT DONE!

Management?

How to get it done?

• Plan- Define course of action toward a measurable goal.

• Organize- How and How much

• Staff- Who does what

• Lead/ Direct- Do it

• Control- system functions in line with the plan

PLAN + ORGANIZE + STAFF + LEAD + CONTROL = CUSTOMER SATISFACTION

Quality Management

Quality Management System- Core

• Customer focus

• Top management initiation

• Involve all staff

• Process oriented approach

• System orientation

• Factual decision making

• Mutually beneficial supplier relationship

Key elements of Quality Management

• Documenting and Recording strategies

• Organizational structure (Organogram)

• Staff job descriptions and specific roles

• Equipment/ instruments

• Inventory management systems

• Statistical Process control

Quality Assurance and Quality Control

Quality Assurance Quality Control

Management strategy Error detection methodology

Everybody's businessArea specific activity performed by authorized staff only

The 7 common tools of Quality Management

• Cause and effect diagram

• Flow charts

• Checklist

• Control chart

• Scatter diagrams

• Pareto analysis

• Histograms

7 tools of QC- Cause & effect diagram

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1. Ishikawa diagram or fish bone diagram.2. Kaoru Ishikawa 1968.

7 tools of QC- Flow charts

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1. Describe a process.2. Arrows- flow of

direction.

Flow chart example

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7 tools of QC- Checklist

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7 tools of QC- Control charts

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1. Shewhart chart, 1920.2. Mean value in centre.3. Upper cut off limits &

lower cut off limits on either side of mean.

4. 68% of values b/w ±1SD; 95% of values b/w ±2SD; 99.7% values b/w ±3 SD.

7 tools of QC- Scatter diagrams

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1. Determine the correlation b/w events.

2. Shows if a relationship exists b/w 2 sets of data.

7 tools of QC- Pareto analysis

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1. Joseph M Juran, 1940.

2. VilfredoPareto- Italian Economist-80/20 principle.

3. 20% of work generate 80% benefit.

Other Advanced Quality Management strategies

LEAN 6 SIGMA

Toyota production system Motorola corp

Philosophy Metric

5s principle (Seiri, Seiton, SeisoSikethu, Shitsuke)

DMAIC

Eliminate waste (Waiting, Over production, Rejection, Motion, Processing, Inventory, Transport)

Variation minimization

LEAN 6 Sigma= Philosophy + Metric

International Standards Organization

• Merger b/w ISA (International Federation of National Standardizing Association, New York 1926) and UNSCC (United Nations Standards Coordinating Committee, 1944 London)

• ISO set up in 1947 by 67 technical committees

• Firstly called International Standards Coordinating Association by Americans and Britons.

• Later on called as ISO derived from the Greek meaning equal.

The Evolution of ISO standards1 ISO 1: Standard reference temperature for industrial length

measurement1951

2 ISO 31 (Now ISO 80000) document based on SI, ISO has set units and how to measure them

1955

3 ISO/ TC 104 Standard on freight containers 1968

4 ISO 9001 family of standards published 1995

5 ISO 14001 environmental management standards published 1996

6 ISO 17025 Standard for testing and calibrating laboratories 1999

7 ISO 15189 Medical laboratories requirement for quality and competence (From ISO 9001+ISO 17025)

2003

8 ISO/IEC 27001 Management system standard on information security

2005

9 ISO 26000 Guidance on social responsibility 2010

10 ISO 50001 energy management standard 2011

11 ISO 37001 Anti bribery management systems 2016

Medical Laboratory Accreditation

• A process by which an authoritative body gives formal recognition that an organization is competent to carry out specific tasks.

• E.g. Joint commission on accreditation of healthcare organizations (JAHO), National committee on quality assurance (NCQA), NABL, CAP.

• India NABL authoritative body for testing and calibrating laboratories.

Accreditation vs Certification

Certification Accreditation

A procedure by which a third

party* gives a written

assurance that a product,

process or service confirms to

specific requirements.

*Third party- A person or a body that is

recognized to be independent of the

laboratory or parent organization.

A procedure by which an

authoritative body gives

formal recognition that a body

or a person is competent to

carry out specific tasks

(ISO/IEC guide 2).

eg. ISO 9000eg. ISO 15189; 2012, ISO

17043; 2010.

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Accreditation- Why?

Acceptance of test results within & beyond borders.

Greater control of laboratory process.

Customer satisfaction. & Brand value.

Customer can easily find an

accredited laboratory

Accreditation- How?

• NABL embraces the ISO 15189 Medical laboratories- requirements for quality and competence.

• Accreditation given based on laboratories capability to perform tests and provide reliable results.

• Assessment based on the ISO 15189; 2012 standard.

Requirements for accreditation

• Create a policy document (Quality Manual).

• Appoint a Quality Manager.

• Establish the Quality Management system

• Appoint a technical manager.

• Process breakdown & QI identification.

• Monitor quality indicators and undertake appropriate CA/PA.

• Documentation.

• Audits

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• Quality manual:– Satisfy every clause mentioned in the standard

(ISO 15189).

– Greatest document of the QMS (Level 1).

– Describes laboratory policies, organization structure, job descriptions and personnel interrelations.

Note:

“Every lab policies traceable to its QM”.

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• Quality Manager:

– Head of the QMS.

– Reports directly to the lab director.

– Keeps the laboratory audit fit.

– Monitors process and continuously improves them various lab processes.

– Involved in educating and training staff.

• Education- change the way people think.

• Training- change the way personnel work.

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• Quality Management system

– Quality: The degree to which a set of inherent characteristics fulfils requirements.

– Management: Plan, organize, staff, lead and control.

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• Technical Manager:

– Usually a senior technical person.

– Appointed by HOD.

– Technical workload management and work distribution among existing staff.

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• Quality indicators:

– “It measures how well an organization meets the needs and requirements of users and the quality of all operational processes”.

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• Establishing QI & continual improvement:

– Lab process broken down to its components and micro components.

– Identify the common failures or errors that occur frequently.

– Log the most common errors and the reason behind the errors.

– Appoint a person to ensure the log is maintained and updated regularly.

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• Establishing QI & continual improvement:

– Tabulate and identify the major causes for the errors.

– Present the data with recommended corrective measures.

– Implement the CA and measure the rate of success of the corrective action.

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• Properties of QI’s:

– Measurable in terms of numbers.

– Benchmarks should be predefined.

– Results should be subjected to statistical analysis.

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Pre analytical

• Sample collection

• Routing to appropriate location

• Registration into LIS

Analytical

• QC

• Sample processing

• Result genera ration

Post analytical

• Result validation

• Result transfer.

Lab work breakdown structure and QI identification

Sample rejection.Sample missingDouble poke

QC failure.Unscheduled Downtime.

Human error.Software crash

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Documentation

Indicators for good documentation:

• Approved, reviewed and updated regularly.

• Concise, legible, accurate and traceable.

• Amendments & revision are identifiable.

• Current version is available at points of use.

• Follows change control procedure.

• Obsolete documents separated, identified and retained for defined amount of time.

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Documents of the QMS

Quality Manual

QSP/ SOP

Forms, checklist, Records.

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Document classification in QMS

Internal documents External documents Records

Documents

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• Internal documents:

– Documents/ reference material created by the laboratory for use within the laboratory.

– It is subject to the change control procedures created by the laboratory.

– It is approved by appropriate personal before release for use by the laboratory personnel.

– E.g. SOP, QM, QSP.

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• External documents:

– Maintained by the laboratory for reference purposes.

– Created by a third party and is formally published for use.

– Not subject to the change control procedure of the laboratory.

– E.g. ISO 15189; 2012 standard, published book.

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Records

• Proof/ evidence of activity.

• They have a defined retention period.

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Other activities

• Quality Control– Goal to identify errors before they impact the real

test.

– Also called as repeatability testing or precision.

• Proficiency testing– Ensure the laboratory tests are accurate.

• Calibration– All equipment's and instruments are produce

accurate results.

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Conclusion

• All Quality management efforts should be primarily directed toward provision of the best possible service at the lowest possible price.

• “Quality is Marketing redefined”.

Healthcare

Total Quality Management in Medical Laboratories