Biomedical scientists: Extended roles in Austria
Professor Claudia Wilfing

Professor Claudia Wilfing, above right, qualified in 1970 as a Laboratory Technologist in Vienna, worked at the University clinic in Vienna and then as a volunteer for 3 years in Kenya. She has been a researcher for nearly 20 years in the Boltzmann Institute for experimental and clinical traumatology, and now works as a quality supervisor for the Vienna Health Insurance Fund.

From 1988-1992 she was a board member of IAMLT (International Association of Medical Laboratory Technologists)and acted as president of the Austrian Biomedical Scientists Association from 1991 - 2001.

Extended roles in Austria

1 Study-Administrator / Site co-ordinator
(in USA: Study-Nurse)
Co-ordinator of Clinical Trials in health institutions

2 Quality Supervisor
Vienna District Health Insurance Fund

3 Professional and training matters of health professions
Federal Ministry of Health and Women

Extended role: Site Co-ordinator
Co-ordinator of Clinical Trials in health institutions

Post graduate training organised by Claudia Wilfing with contribution from Öst. MTA Verband and Arbeiterkammer Wien

Training
48 hours theory – 1 week
3 hours - multiple choice examination (4 weeks later)
40 hours minimum - practical training on selected
sites in hospitals and university clinics

Players in clinical trials
Sponsor
Monitor
Investigator
Legal-authorities
Hospital authorities
Hospital co-workers
PATIENT/PROBAND

Site Co-ordinator undertakes complex and diverse tasks
Support of the investigator

CRF´s (case report forms)
“Get it down on paper. If it is not documented, it did not happen”

Keeping terms
Source data verification
Archiving

All according to ICH guidelines

1 Pre-Study Phase

• Invest. Brochure
• Preliminary discussion
• Investig. Meeting
• Submission to EC
• Study-material
• Study-medication

2 Study Phase

• Start-up Meeting
• Screening
• Recruitment of patients
• Medication
• Care for patients
• Data documentation
• Meetings with Monitor

3 After-Study Phase

• Close-out visit
• Report to Ethics
• Committee and
• Hospital authorities
• Archiving

Extended role: Quality Supervisor
Vienna Health Insurance Fund

Defining of quality standards for:

• Clinical Chemistry Laboratories
• Histological and Cytological Laboratories
• Physical Medicine and Rehabilitation (PMR) Institutes

Basis:
Contract between Vienna Health Insurance Fund and medical institutes or medical practises

Each contract includes guidelines for quality criteria depending on the field and subject area

Quality Criteria: (excluded Health and Safety at work control)
Structure: Qualification of the employees acc. to the law regulations, team training barrier free facilities, opening hours,
medical equipment (state of the art)

Processes: Methods (state of the art), data management, QM, practice leaflet, patients complaints procedure

Results: Evaluation of contentment (measurement questionnaires)

Consequences, if quality criteria are not fulfilled:

• Cancellation of the contract - depending on the contract
• Fee Deduction
• Invitation to the Insurance Fund head quarters for an amicable personal discussion in presence of one of the Insurance's legal experts

Collaborator in task forces of the Austrian Health Insurance Fund
(in co-operation with the General Medical Council

Reform of the public medical check-up system
Standards for quality improvement for general practitioner and specialists

Extended role: Professional and training matters
Federal Ministry of Health and Women

Expert in professional and training matters of health professions
Austrian Federal Ministry of Health and Women

Structure of the department:
Head: a pedagoge
Deputy: a lawyer
2 Experts:
1 Nurse
1 Lab Technologist = Gabriele Dorninger

• The seven MTD
• Lab Technologists
• Radiological technologists
• Dieticians and nutrition consultants
• Physiotherapists
• Occupational therapists
• Speech therapists and logopedists
• Orthoptists
• Medical Technical Specialists
• Midwifes
• Cardiotechnicians
• Medical Masseurs

Tasks of Gabriele Dorninger

• Define and control principles of medical professions
• Collect different opinions of experts and comment them
• Preparation of laws
• Work out guidelines for training and curricula
• Prepare letters and information for the minister and other leading
• Discussion with representatives of the counties
• Expert evidences for Lab. Techs coming from European and non-European countries for admittance in Austria
• Workshops for quality-assurance in non-medical professions. Overlappings and delimitation
• Surveillance and evaluation of different projects
• Continuing training and lifelong learning officials