QMS in ART how why and who ms pope

QUALITY CONTROL & QUALITY ASSURANCE The terms “quality assurance” and “quality control” are often used interchangeably to refer to ways of ensuring the quality of a service or product.

Quality Management Systems (QMS)

in ART - How, Why & Who?

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HOW?

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Quality Management Standards are based on eight

quality management principles

QUALITY CONTROL & QUALITY ASSURANCE

The terms “quality assurance” and “quality control”

are often used interchangeably to refer to ways of

ensuring the quality of a service or product

The terms, however, have different meanings

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QUALITY ASSURANCE &

QUALITY CONTROL

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Determine which factors may affect the ART services, both the processes involved in delivering the services and the outcomes

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QUALITY in A.R.T

Clear idea of the variables

Set the K ey P erformance I ndicators

 EPU needles & ET catheters

 Drugs used in Ovarian Stim

 Any item used in IVF

TEMPERATURE • Control at every phase

of culturing

pH • Gas environment

SAFETY

• Culturing conditions maintained

• Culture medium storage

QUALITY CONTROL MEASURES:

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• Incubators, microscopes, refrigerators

• Fluids containing gametes / embryos

• LN2 loss from tanks – integrity of tanks

• Oxygen displacement alarms

LN 2 levels

• Emergency power – generators / UPS

• Battery power to alarms

Emergency backup

• Test response systems regularly

• Trigger alarms

Alarm systems

• Culture medium - EQA

• Disposables – Lot Nos (dishes, tubes, gloves)

• Air filter function

Air Purity - VOC

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QUALITY CONTROL - EXAMPLE

Oocyte Temperature Process Map

Oocyte aspirated

to test tube

Test tube in heating block prior

to ID

Oocyte transfer to culture dish

Oocyte in dish on warm stage

Oocyte dish transferred

to incubator

Oocyte inseminated

on m/scope stage

Oocyte cultured in incubator

to D1

Fertilization check on m/

scope stage

Oocyte culture in incubator D2

Cleavage check on m/scope stage

D3 – embryo moved to blastocyst medium

Embryo moved to

CM in new dish

Embryo moved to

ET dish

Embryo loaded into catheter

Embryo transferred into uterus

Blastocyst vitrified

Oocyte in

follicle

Embryo in LN2 Tank

AUDIT

PROCESS

RISK

Legend:

QUALITY ASSURANCE MEASURES:

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• Competency of embryologist

• Competency of clinician

Oocyte numbers

• Timing of egg retrieval

Oocyte Maturation rates

• Culturing conditions

• Sperm preparation – ICSI option

Fertilisation rates

• Competency of ICSI skills

ICSI Lysis rate

• Embryo transfer technique

• Temperature & pH control

• VOC / contaminant levels

 Develop process to identify

 Determine and implement the

action necessary to address the

issue

 Record action taken and results

 Review these actions to ensure

the matter is satisfactorily

Decreases in

 Fertilisation rates

 Pregnancy rates (+βhCG; clinical)

 Live birth rates

 No of eggs retrieved

 Increased miscarriage rates

 Blastocyst development

 Utilisation rates

 Frozen embryo survival

 Revenue per cycle

PARAMETERS (Q.C & Q.A.)

BENEFITS of QMS –

Identification & Review of Critical

Parameters (Q.C & Q A.)

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QUALITY ASSURANCE - RESOURCES

Determine the resources necessary

to achieve the ART clinic objectives

/ KPIs

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1 Staff required to deliver service

QUALITY ASSURANCE - RESOURCES

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Team Player

Attention to detail

Technical capabilities

Empathy towards patients

& staff; customer focussed Good communication skills

cycle –

1 embryologist per 150 - 200 cycles RESOURCES – STAFFING REQUIREMENTS

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2 Physical resources required to

deliver service

QUALITY ASSURANCE - RESOURCES

Buildings; equipment; environs (e.g ample space & equipment to

undertake cases; air-conditioning; emergency back-up)

Validate equipment to ensure suitability

Introduce calibration and maintenance processes to ensure

ongoing reliability & safety of equipment

Determine the:

 Criteria necessary for success (embryotoxicity)

 Outline procedures to verify purchased products meet the

QUALITY ASSURANCE - RESOURCES

Example: OVARIAN HYPERSTIMULATION MEDICATION

Ensure Consistency in

all the variables – all medications & batch nos

drugs may be exposed to conditions beyond recommended storage (e.g extreme heat)

manufacturing standards – risks associated with infectious agents (CJD) or noncompliance with international GMP; safety to patient

additional costs may be incurred for a replacement cycle

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QUALITY ASSURANCE - RESOURCES

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0 10 20 30 40 50 60 70 80 90 100

Individual Embryologist Fertilisation Rates

Fertilisation Rate: 1 S D Average 1 S D.

1 • Oocyte retrieval nos

2 • Fertilisation rates

3 • ICSI Lysis rates

4 • Pregnancy rates

5 • Thaw survival rates

6 • Live birth rates

Q.A MEASURES - COMPETENCY:

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• Record, investigate, corrective action

• Preventative action, review

Accidents

• Record, investigate, corrective action

• Preventative action, review

Infections

• Record, investigate, corrective action

• Preventative action, review

Adverse Outcomes

• Record, investigate, corrective action

• Preventative action, review

HR

• Record, investigate, corrective action

• Preventative action, review

Multiple Pregnancy

Root Cause Analysis

RELEVANCE of QMS –

Data Monitoring – Adverse Outcomes /

Incidents

5 Whys?

Monitor conformity of service delivery and outcomes

 Benchmark internally & externally

 “Gold Standard” pregnancy rates

 Comparison to international data

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Q.A MEASURES – BENCHMARKING:

Gold Standard – Good Prognosis Group:

 Women aged 25 – 35 yrs

 1 st cycle of IVF

 Normal semen parameters

 ET

 Normal AMH

 ~10 or more oocytes collected

 Good quality embryos for selection

 Excess embryos to freeze / vitrify

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QMS REVIEW TOPICS:

5. Audit schedule &

results

WHY?

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QUALITY BENEFITS of QMS –

ADVANTAGE TO THE BUSINESS

QUALITY ADVANTAGES:

 Setting Objectives – planning

for the future

(e.g introducing a new service or

technology)

 Consistency in procedures – ability to assess outcomes by controlling variables

(e.g auditing)

 Defining protocols – agreeing to best practice

(e.g document control)

 Training – clear procedures

ensuring all staff are trained

embryologists)

 Identify risks & implement mitigation strategies

(e.g minimising errors)

 Competency – ensuring staff are competent following training & in the future (e.g minimum no of procedures)

identify the needs of customers –

internal & external; address

expectations; retain staff)

data to continually implement improvements)

 Identification & review of critical parameters (Q.C &

Q.A.) (e.g Fert.; Preg.;

Miscarriage; Live Birth rates)

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COMMERCIAL BENEFITS of QMS –

ADVANTAGE TO THE BUSINESS

BUSINESS ADVANTAGES:

 Assess the market – SWOT;

offering new services or

technology)

 Set Objectives / Goals – Clinical & Financial – budget for Cap Exp

 Manage expenses and suppliers

 Minimise waste through

medium)

 Identify risks & implement

additional expense)

 Manage resources – stock &

stock; stock rotation; rostering staff)

 Plan & prepare for growth in

advance (e.g employ & train

additional staff to deploy with

increase)

 Negotiate contracts with suppliers (both costs & services)

 Identify and monitor financial

consumable costs / cycle; staffing costs / cycle; EBITDA margin)

minimising complaints & free cycles; min expense to patient

SWOT – Strengths; Weaknesses; Opportunities; Threats PESTLE – Political; Economic; Sociological; Technology; Legal; Environment

WHO?

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Incidents relating to safety;

Implementation of best practice

REGULATORY BODIES:

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ASRM – Society for Assisted Reproductive Technology (SART) Guidelines & Data monitoring

the use of ART in clinical practice and research 2007 (Under review)

incident)

requirements (air quality) similar to EU

REGULATORY BODIES:

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DONATED GAMETES & EMBRYOS

 Rights of children to know genetic parents Vs anonymity

 Sibling / half sibling – consanguinity issues

 Donor coercion - vulnerability

 Rights of donors

 Trading in biological material – altruistic Vs commercial donation

 Safety of reproductive material

transfer)

 Legal issues of birth registration and property

 Cultural issues & acceptance

REGULATORY BODIES:

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SURROGACY

REGULATORY BODIES:

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SEX SELECTION – FAMILY BALANCING

 Cultural desire for specific sex of child

 Societal & religious opinions towards sex selection

 Sex selection for genetic disease

ROLE of REGULATORY BODIES:

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1 SAFETY – Minimising risks of:

 Infection

 Adverse obstetrical outcomes

 Multiple pregnancy – health of babies

 OHSS

 Medication issues

 Identification & witnessing errors

 Legal disputes over parentage

 Accidents or errors

 Inappropriate equipment or consumables

 Untrained / inexperienced staff

 Offspring unable to track genetic origins

 Social unrest

ROLE of REGULATORY BODIES:

ROLE of REGULATORY BODIES:

ROLE of REGULATORY BODIES:

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4 CUSTOMER FOCUS – Ensure:

 Treatments meet patient expectations

 Patients are fully informed of outcomes & potential

issues

 Information relating to outcomes is reported to

regulatory bodies

 Society has a role in determining options for care

 Financial constraints are addressed – value of

government funding (health economics)

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SUMMARY

Quality Management Systems – Relevance in ART clinical outcomes

Questions?

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