Quality systems in ART T.Mardesic Prague, Czech Republic Antalya 2011.
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Transcript of Quality systems in ART T.Mardesic Prague, Czech Republic Antalya 2011.
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 !