Quality and Risk Management in the IVF Laboratory

Author: David Mortimer; Sharon T. Mortimer  

Publisher: Cambridge University Press‎

Publication year: 2007

E-ISBN: 9780511839931

P-ISBN(Paperback): 9780521049900

Subject: R714.1 physiological normal pregnancy (pregnancy)

Keyword: 计划生育与卫生

Language: ENG

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Quality and Risk Management in the IVF Laboratory

Description

This essential survival guide for successfully managing the modern-day IVF clinic condenses a wealth of expertise and experience from the authors in troubleshooting and implementing quality management in the IVF laboratory. With high-profile media coverage of mistakes at IVF clinics, and escalating regulatory scrutiny, there is increasing pressure for professional accreditation. Modern accreditation schemes, which are largely based on the principles of ISO 9001 and related standards, require Quality Systems. Yet quality management beyond basic assay quality control is often poorly understood by biomedical scientists outside clinical chemistry laboratories. Quality and risk management are thus becoming hot topics for those working in IVF clinics and this book brings together, for the first time in one place, the basics of these essential aspects of laboratory management. The focus on taking a holistic approach to 'prophylactic management' - prevention rather than cure - will be welcomed by all scientists working in IVF.

Chapter

The European Tissues and Cells Directive

A generic accreditation process

Self-assessment

External assessment

Assessment results and recommendations

Afterwards

The need to use your own processes

3 Quality and quality management

What is quality?

Quality management

Terminology

An example of quality in action

Going beyond QC and QA: the quality cycle

Continual quality improvement: the ultimate goal

Total quality management

Implementing TQM

Leadership

Education and training

Using tools and techniques

Involvement and commitment

Teamwork

Measurement and feedback

An ongoing process

Why does TQM fail?

Resistance to change

The toxic workplace

Quality itself is not the goal

4 What is risk?

Identifying “high risk” IVF laboratories

Staffing issues

Resource issues

Organizational issues

Risk management issues

Disaster planning

Tools for risk management

5 Process and systems

Systems analysis

Process mapping

IVF laboratory systems

Process mapping tools

Flowcharts

Top–down process maps

Swim lanes

IDEF0

Building a process map

Breaking down “silos”

Process control and process analysis

Identifying controlling factors

Knowing “why,” not just “how”

Tools vs. solutions

Who needs to understand all this?

The benefits of process mapping

6 Making it work

Methods design and selection

“Third party” services

Standard operating procedures or SOPs

An example of “good” and “poor” versions of an SOP

The “big nightmare”: did we use the right sperm?

Process control

Control charts

Implementing and validating methods

Reference materials vs. calibrators

Uncertainty of measurement

How accurate do we need to be?

Document control

External quality assurance

7 Quality and risk management tools

Inspection

Audit

Failure Modes and Effects Analysis

Root cause analysis

Using Root Cause Analysis

Conclusions

8 What’s gone wrong? Troubleshooting

Having to be reactive

Troubleshooting

Troubleshooting a process

Troubleshooting an incident

9 Risk management: being proactive

“Why bother with that? It’s never happened here!”

Can we eliminate risk?

Risk elimination

Risk avoidance

Risk reduction or risk minimization

Risk transfer

Risk acceptance or risk retention

How do we manage risk?

Risk reduction

Taking responsibility

The benefits of risk management

Developing a risk management program

Illustrative examples of risk management in the IVF lab

Off-site collection of sperm samples

Disposal of frozen embryos

Parallel processing of sperm samples

Labeling OPU tubes

Temperature control during oocyte retrieval

Packaging systems for cryobanking gametes and embryos

Protecting IVF laboratory staff from unfair litigation

Conclusion

10 How are we doing? Benchmarking

Sentinel indicators and adverse events

How to choose indicators

Operational and performance indicators

Program Performance Indicators

Laboratory performance indicators

Efficiency

Best practice

Laboratory operations

Financial

Reference populations

Honesty in reporting results

Illustrations of benchmarking

Internal benchmarking

Competitive benchmarking

Functional (generic) benchmarking

11 Specifying systems

Selecting methods, devices, equipment, etc.

Can semen analysis be standardized?

Reactive oxygen species and sperm preparation methods

Tomcat catheters

Cryo buffers: the move from PBS to HEPES

Practical examples

What sort of embryology work station is best?

Choosing a CO2 incubator

Choosing a culture medium

When/why do you need to use culture oil?

Creating a quality IVF lab

12 Human resources: finding (and keeping) the right staff

Who makes a good embryologist?

Training: the importance of teaching “why,” not just “how”

Why other people should be trying to steal your staff (and why they will be unsuccessful)

Different types of reward

Development of a career path

Delegation

Other considerations

13 The well-run lab

What does it take?

How do we get there?

Is it all worth it?

14 References and recommended reading

Index

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