www.meditex-­‐so,ware.com  

MedITEX  –  Medical  IT  Experts  

IVF  So,ware  

 

CRITEX  GmbH      „CREATIVE  IT  EXPERTS“  

Headquarter    in  Regensburg,  Germany  Distributors:  Russia,  Serbia,  Italy,  Canada,  Romania,  etc.  

Founded  in  the  year  2000  for  individual  So>ware  Development  and  IT  ConsulDng    Specialized  on  IT  soluDons  for  doctors,  hospitals  and  laboratories  

   

References:  

   

Partner  Network:  

   

Member  of:  

Who  we  are?  

MedITEX  is  the  name  of  our  product´s  for  the  medical  branch.  

e.g.  MedITEX  –  IVF    Electronic  documentaEon  for  IVF    MedITEX  –  Scheduler    Managing  appointments  and  paEent  scheduling  

Product  website:    hRp://www.meditex-­‐so>ware.com  

In  Germany  our  IVF  product  has  the  name:  

What  is  MedITEX?  

§  It keeps yourself occupied with documentation…

§  It increases administration overhead…

§ Only relevant for certifications (SOPs…)

§  For driving lots of meaningless statistical evaluations…

Really?

What is data management good for?

Data management is an essential part of quality management

§ Streamline lab and clinical procedures

§ Reach high and sustainable success rates

§ Create individual approaches

§ Deal with professional regulations and obligations

§  Lower administration overhead

§ Prerequisite for establishing excellence models

What is data management good for?

§  „We don’t have time...“

„We don’t have time not to “

§  „Use intuition and common sense...“

„Collect and analyze data “

§  „Poor quality results from people...“

„Defects come from processes “

§  „Quality costs money...“

„Quality saves money “

Quality thinking!

§ Everyone in our organization is responsible for quality and for identifying and solving problems

§ Quality must always be seen and rated from the viewpoint of the customer, where the customer may be external or internal

§ Excellence relates to results – their effectiveness and reliability

Foundation for quality

§ Structural Quality – Staff, devices, material, building structure

§ Process Quality – Diagnostic and therapeutic procedures, activities, interaction of

teams

§ Result Quality – Precision, reliability and reproducibility of procedures and

measurements, significance of values, success rates, patient experience

Quality system essentials

§ Definition of essential data to be documented –  Legal obligations (Germany: IVF register) – Key variables (results, QM, administration, research etc.)

§ Data entry – Use of electronic databases recommended – Entry with least possible delay – Dedicate resources (personnel, time)

§ Validation – Data quantity (completeness) and quality (integrity, plausibility)

§ Retrieval and evaluation – Definition of essential / recurring queries – Suitable tools – Output formats (diagrams, tabs, statistical analysis)

Data management: How to?

§  e.g. German IVF-register – Non-profit organization for quality assurance in human

reproductive medicine

– Collects and evaluates treatment-related ART data

– Anynomized results are published annually

– Participation of IVF centers is due to the Medical Association's professional code of conduct binding

–  Treatment data have to be submitted electronically via DIR´s proprietary DIR-DLL standard

– Defined field list for obligatory data, plausibility checks and checks for prospective data entry

– Certified software for data collection: •  DIR Pro (supplied by DIR) •  RecDate ADVANCE

Defining data: Professional obligations

Androlab

Therapy

Cryolab Pregnancy and children Endolab Consultation/ Examination

Administration

Anamnesis Man

Examination Woman

Examination Man

Diagnosis Man

Diagnosis Woman

Planning Couple Therapy

Couple Pregnancy and birth

Cryobank Gyn / Andro

Children

Patient data Woman

Patient data Man

Anamnesis Woman

Andrology

Endocrinology Woman / Man

Woman Man Couple Children Woman or man

Defining data: Functional areas

Pregnancy Delivery Embryos Oocytes

Sperm

Maturity of eggs Semen quality and preparation Fertilization Culture conditions Cleavage

Method of transfer Number transferred Luteal support

Abortion Ectopic pr. Malformations

Etiology Paternal age

Maternal age Ovarian reserve Etiology Stimulation: •  Protocol •  Strengths •  Gonadotropins

(type, dosage) •  GnRH A / Ant •  Monitoring

Defining data: Endpoint considerations

§ E.g. fertilization rates

– Sperm preparation –  Insemination procedure –  Timeline – Preparation media – Culture media – Plasticware

(vials, tips, dishes)

–  Incubating conditions (gas, temperature)

–  Lab conditions (temperature, light) – Quality of semen and eggs – Performance of lab staff

Defining data: Detailing

§  Improve clinical performance – Monitor processes, main output factors (THBR, COS, OHSS)

§ Streamline operations – Workflow, patient administration, office services

– Data interchange (internal / external)

§ Ensure conformity (EU-guidelines, registers) – Certified documentation, plausibility checks

§  Improve patients’ satisfaction – Better clinical outcomes, individualized approaches

Benefits from data management

§  In 2007, CRITEX developed a modern software platform for IT-based clinical documentation in Fertility

§  The program conforms to the applicable professional and legal regulations

– Opportunity to document therapy cycles and export data according to German IVF-Register (DIR)

– Complies with EU guideline “Tissue & Cells”

§ Allows comprehensive evaluations

§  Includes individual options – Customizable presets, optional data fields, add-ons

§ Built-in data checks – Plausibility & integrity of data

MedITEX IVF

§ Germany – 90 out of 120 ART centers use RecDate

§ Russia – Operation of the national Registry “RAHR” – 80 out of 100 ART centers use MedITEX

§ International – Installations in 15 countries – Translation in 7 different languages

Widespread usage

The software

Billing software

LASER-Microscope

Scanner

Additional data fields

Evaluations and charts

Endolab Material

Letters and reports

Organizer

NIS

Workflow Management

My RecDate

Add-on

Add-on

Add-on

Taylor-made functionality

Statistics

Reports

Graphics

Customizeable output

Development

Support

by local hero

Conformity

Partnership

   Michael  Schindler      CEO                  E-­‐Mail:  michael.schindler@critex.de    Tel:  +49  941  5  99  39  33  9  

   post  address:    CRITEX  GmbH        member  of  Stobäusplatz  4  93047  Regensburg  Germany  

 Fax:  +49  941  5  99  39  33  3    

   

   product  website:  hDp://www.meditex-­‐so,ware.com  

 

Thank  You!