Quality systems in ART

T.Mardesic

Prague, Czech RepublicAntalya 2011

WHY QUALITY MANAGEMENT ?

QM is needed to ensure consistency and reproducibility of all methods and competence in all duties performed by the personell

Today every ART laboratory in EU is obliged to implement a QM system to establish and maintain a strict QC and QA

• Do we need QM in ART and why ?

• Levels of QM

• Existing systems for QM

• Benefits ( and drawbacks? )

of QM systems

Quality management in reproductive medicine

• The number of unvoluntary childless couples seeking for help in specialized clinics is worlwide increasing.

• Patient expectations: treatment according to the state of the art and real chance for success (delivery of – one - healthy child)

• Quality=competent, intensive individualized care with personal involvement before treatment, during the treatment process and after the treatment.

Quality Control (QC) – routine monitoring of all important operational aspects directly or indirectly involved with performing IVF

( verifying CO2 content and temperature in incubators and working places using an independent instrument, intra- and interobserver variability using internal and external controls)

Quality Assurance ( QA ) – evaluation of protocols and establishing a means of identifying problems

( to proof that QM is working )

In daily routine usually quality considers only medico-technological

aspects of services (therapeutical results)

„pregnancy rates“

Quality means much more!

• Medico-technological aspects (PR)

• Psychological und ethical aspects

• Organisatory and economical aspects

• Fulfillment of quality expectations from the patient´s perspective

Quality in Medicine means integration of:

• Doctors and patient´s points of view

• Insurance companies points of view

• Clinic´s managements points of view

• Points of view of all other participants taking part in medical services

Beginning of the 21st century in reproductive medicine in Europe

Quality control becomes a key feature !

• guidelines

• international QM standards

• laws ( national level, EU level )

Human Reproducttion vol.15 no.10 pp2241-2246, 2000

ESHRE guidelines for good practice in IVF laboratoriesLuca Gianarolli, Michael Plachot, Roelof van Kooij, Safaa Al-Hasani, Karin Dawson, Anick DeVos, M.Cristina Magli, Jaqueline Mandelbaum, Jaqueline Selva and Wouter van Inzen (Comitee of the Special Interest Group on Embriology)

Whenever a formal recognition is desired – official standards such as developed and released by International Organization for Standardization should be implemented

QM system ISO – an international standard since its first publication in 1987

• EN ISO 9001 certification• EN ISO 170 25 accreditation• EN ISO 151 89 accreditation

Certification

The whole clinic– Third party inspection and verification that a product,

process or service conforms to specific requirements (valid for a defined, limited period)

BUT– Does not ensure that the laboratory achieves the

highest level of care for patients

Consultation Stimulation + OPU IVF lab Embryotransfer..

Accreditation

Accreditation (method): a procedure by which an authoritative body gives formal recognition that a body or person is competent to carry out specific tasks

Consultation Stimulation + OPU IVF lab Embryotransfer...

ISO requirements

Responsibility of management

Management of resources

Management of processes

Analysis and quality improvement

• The basis for a documentation of any functioning QM system is a manual describing the QM processes in IVF clinic

Shows that the system is operating

Infertility consultations

Urology

OP UrologyAnesthesia

Gynaecology

OP

IVF lab

Defines Who? What? and When?

External QM manual

QM-review

EN/ISO 9001 : 2000

Level 1: QM Manuals

Levels 3: SOP ´s (job instructions)

Level 4: Results and other documentation

Level 2: Procedures

Defines approach and responsibility, outlines the structure of documentation

Answers how

EN ISO/IEC 17025 : 2000

QM manual

Medicalprocesses

Manuals and supporting processes according to ISO 9001 : 2000

Control manuals

5-zisk ejakulátu4-operační sál

3-urologická ambulance

2 –operační sál

1-gynekologická ambulance

10-ET

9-AH

8-kultivace

7-ICSI

6-odběr oocytů

38-externí zisk kryokonzervovaného materiálu

37-transportní centra 15-zpracování

po MESA14-zpracování ejakulátu

13-PGD

12-příprava roztoků

11-kryokonzervace

23-k katetru po ET

17-striktní morfologie

16-akrozomální reakce

21-k-urologická a

20-k-zisk ejakulá

19-k při punkci

18-k před punkcí, ET, gynekologie

29-hodnocení vzorků28-hodnocení

dle

26-k-intra-inter

35-kalibrace příst34-hodnocení

kvality33-kontrola metodik

31-měření pH a osmolality

30-měření teplot

25-kontrola hladiny kapalnéh24-kontrola

šarží

39 - External manual for SOP

recepce

Marketing a rozvaha

Vrchní sestra

Plánování investic a vnitřní komunikace

personalistika

Nákup a hospodářství se spotřebním materiálem

Ambulance pro léčbu strility

Pořadač se zákony, normami vyhláškami atd.

SeznamInterních formulářů

Vykazování účtů

Vnitřní komunikace

Urologická ambulance

Operační sál a stacionář

anestezie

Všeobecná gynekologická ambulanceambulance a poradna pro těhotné

Lékař na operačním sále

IVF laboratoř

hygiena

Ochrana dat

bezpečnost

Externí manuál

Manuál QM-review

QM systems in IVF lab

establishing a strict discipline of routines and procedures QC and QA is mandatory

Indicators of quality

• Objective• Relevant to the laboratory• Measure a broad range of specific events or

aspects of treatment reflecting the quality of care

Treshold values for each of the indicators must be given with clearly defined corrective actions

Monitoring of final outcome

• PR/started cycle, OPU, ET / age groups• Cumulative PR/egg retrieval• % of eSET• % of single pregnancies• % multiple pregnancies• % ectopic pregnancies• % spontaneous abortions

Law in reproductive medicine-national level-

(influencing the availability of services)

Countries with liberal situation:• Spain, Belgium, Denmark, Czech Republic

Countries with restrictive situation:• Italy, Germany, (Poland)

crossborder reproductive care

Law in reproductive medicine- EU level-

DIRECTIVE 2004/23/EC OF THE EUROPEAN PARLIAMENT AND OF THE

COUNCIL of 31 March 2004 on setting standards of quality and safety for the donation, procurement, testing, processing, preservation, storage and distribution of human tissues and cells

EUTCD is NOT concerned with increasing „performance“ (succes rates)It aims at increasing quality through mandatory implementation of a quality

management system

• Foresees common standards of safety and quality of human tissues and cells intended for human application

• Requirements were laid down by the „mother“ Directive 2004/23/EC and subsequent two Technical Directives 2006/17/EC and 2006/86/EC.

EU Tissues and Cells Directive EC/2004/23

• Influence on the level of individual clinics (better QM, increased PR?, more safety X expensive (more people, more expensive technology) • Influence on the national level (system of audits

and accreditation• International level (international inspections,

international cooperation – coding etc..)

Benefits and drawbacks of QMBenefits Drawbacks

For patients: consistency, reproducibility and highest quality of all diagnostic and therapeutic procedures

Increased workload for managementTime consumingNot always easy to motivate all the staff ! (increased competence, but also responsibility)

For health insurance companies: highest quality care for their clients

For IVF lab: troubleshooting, maintenance of equipment and milieu improved and standardized

For IVF clinic management:Optimalization of working processesActive risk managementPowerful mechanism for internal and external controls and decision making (saving costs)

QM is expensive:Councelling companyDirect investmentsAudits

Documented improvement of PR ! Not easy to explain to our patients !