Sheffield Teaching Hospitals Foundation Trust Rachel Cutting Principal Embryologist / Quality Manager The Jessop Wing, Centre for Reproductive Medicine

Sheffield Teaching Hospitals Foundation Trust

Rachel Cutting

Principal Embryologist / Quality Manager

The Jessop Wing, Centre for Reproductive Medicine and Fertility

QC/QA in clinical embryology

Future recommendations for assisted reproduction laboratories


• All IVF procedures should be undertaken within an effective quality management framework


Overview

• Definitions :QA/QC

• Quality management

• Monitoring the laboratory

• Monitoring performance

• The benefits

• Future recommendations


Quality - What Do We Want To Achieve?

• Positive team approach

• Minimise risk

• Consistency

• Reproducibility

• Evidence


What Is Quality?

• High grade

• Superiority

• Excellence

• In an IVF setting, best practice, patient care


What is quality?

• Quality is a process of meeting the needs and expectations of patients and health service staff(WHO 2000)

• Quality is the degree to which care services influence the probability of optimal patient outcomes(American Medical Association, 1991)


Definitions

• Quality Control– a system for verifying and maintaining a desired level

of quality in each product or process by careful planning, use of proper equipment, continued inspection, and corrective action as required

– (checks individual tasks done correctly)

• Quality Assurance– a program for the systematic monitoring and

evaluation of the various aspects of a project, service, or facility to ensure that standards of quality are being met (including QC)

– (relates to the way in which a task is done)


How do we achieve this?


The clinic


Quality Management System

• QMS– Involves the whole organisation– Quality manual– Quality objectives– Quality policy– Includes QA and QC


Developing A System

• ISO– International Organization for Standardisation


How It Works?

• It is not a fixed set of rules

• It is a flexible system that can be adapted to guarantee quality

• ISO 9001:2008 helps you to continually improve and meet customer satisfaction

• Based on a quality management system

• Involves everyone!!


The Quality Manual

• Introduction to the clinic

• Management Structure

• Quality Policy

• Resources

• Patient journey – planning, design, development

• Measurement, analysis and improvement


Document Control

• Agreed on a header for all documents

– Title– Author– Issue Number– Issue date– Review date


SOPs

• What are you doing?

• How do you to it?

• How do you record it?

• What do you do with the information?


The Laboratory


Quality Control

• Measuring specific equipment

• Continuous vs ‘spot checks’

Which equipment?• Incubators• Fridges• Heated stages





Validation: Incubator thermal mappingMixture of 6 different culture dishes on each

shelf in incubator• Thermocouple in medium in each dish• Continually monitored by data logger

– Over 24 hours– Opening and shutting doors under normal working

conditions– Door left open for 10 minutes– Simulate a power failure.




Environmental Monitoring

• VOC measurements– Very sensitive (above 0.5- ppm would – be toxic)

• Microbiological testing


Consumables

• Use CE marked products where possible

• Batch record to enable full traceability

• New batches use a Sperm Survival Test (SST) (risk assess what you need to test)


Recording Batch Numbers

• Paper records• Spreadsheet• Computer database

– ACUbase & Ideas both use a template setting to identify which products are used within (eg IVF) cycle.

– RI IVF Witness, introducing a system based on start of use date & using a barcode scanner


• Accuracy– Overlap of some products, different media

batches used by different patients on same day, have to keep entries up-to-date

• Efficiency– Very time consuming, easier if suppliers will

minimise changes in batches• Retrieval

– In 10 years time will you be able to find out which patients had ET catheter batch A444247?

Problems


SST

• Bioassay for quality control testing• Performed over 4 days at room

temperature to assess sperm survival• Used to test cytotoxicity of new products

and new batch numbers.• Inexpensive, convenient• Detects problems before they are

introduced to the lab Critchlow et al 1989


SST

• Control tube

• Tube with small sample of the test material

• Room temperature

• For most consumables assess motility every 24 hours

• For the test to be valid the motility of the control sample after 4 days should be >70%


Sperm Survival Index

Survival index = %progressive motility of test

%progressive motility of control

• Items with a SSI of <0.85 considered to be potentially cytotoxic

• Items >0.85 considered to be OK to use


Training

• Recognised training programme

• Properly supervised

• ACE, ESHRE

• CPD


SOP Review

• Each member of the team checks another one

• Juniors to check seniors against SOPs

• Identifies non conformances / deviations

• Discussed at lab meetings


Quality Assurance

• External QA

• Internal QA


External QA

NEQAS

• Comprehensive external quality assessment

• Promotes best practice• Ensure that the results of investigations

are reliable and comparable wherever they are produced.


Semen analysis

• 4 distributions a year

• Motility

• Concentrations

• Morphology

• 1 member of the team nominated to forward results, use the samples for internal QA


Embryo Grading

• NEQAS / ACE

• 4 per annum

• Day 2, 3 and 5 for assessment

• Interpretive questions


Audit


The Whole Picture!

• Key performance indicators

• Define limits

Parameter Value to trigger action

Implantation rates <18%

Clinical Pregnancy rate <28%

Biochemical rate >10%

Fertilisation rates <60%

Cleavage rates <85%

Damage rate >15%


Audit

• Embryo transfer operators

• ICSI damage rates

• Cryosurvival per operator


Embryo transfer audit per operator and embryologist(biochemical rate, +ve sac at scan rate, ectopic rate per embryo transfer)

0

5

10

15

20

25

30

35

40

E1 E2 E3 E4 O1 O2 O3 O4 O5 O6

Operator

%

bio

sac seen

ectopic


Future recommendations

• Formal assessment

• Certification

• Accreditation


Lab specific

• ISO 15189

• Extension of 9001

• More for diagnostic or testing laboratories– Viral screening– Serology– PGD


Standards


Conclusions

• QA / QC is a reality

• Not an expensive additional burden

• Ensures reproducibility and consistency

• Picks up potential problems before they affect your program

• Benefits to the whole team


Documents

Sheffield Teaching Hospitals Foundation Trust Rachel Cutting Principal Embryologist / Quality Manager The Jessop Wing, Centre for Reproductive Medicine