Can the ISO9000 quality assessment be applied to the practice of medical oncology?

S. Monfardini1, A. Jirillo1, M. Boscaro*,2, M. Galeazzo and O. Pitocchi3

1 Medical Oncology Unit, Padua University Hospital, Padova; 2 Education and Communication Office, Cancer Center of the Veneto Region; 3 OPT s.r.l., Milan, Italy

*E-mail: martina.boscaro@unipd.it

Increased safety in drug administration and continuous monitoring of the quality of clinical and research process is necessary in medical oncology, but to our knowledge no medical oncology unit in Europe has yet planned or achieved certification. In Europe, the quality accreditation system is mainly provided through ISO 9001/2000 VISION. From February 2002 to November 2002, we addressed a program to develop a management framework for the implementation of a specific quality system to retain effective management control according to ISO 9000 rules.

The Quality Management System (QMS) includes three accreditation components—besides improvement objectives—namely diagnosis and care for in-patients and out-patients, chemotherapy preparation and administration, and scientific planning.

The main improvement objectives were: reduction in the waiting time for chemotherapy administration to outpatients; decrease in the risk of errors in the administration of chemotherapy; improvement in the implementation and running of phase II–III trials; and increase in patient satisfaction. Counselling for the implementation of the quality system was provided by OPT s.r.l. directional consulting, whose activity was sponsored by a pharmaceutical company.

The QSM is guaranteed by assessment inspections, periodic meetings on quality, and corrective actions on non-conformity procedures.

Two site visits were made, with an external audit to check on other possible non-conformities of our quality system. The third-party registrar (Certiquality) assessed that our system was compliant with the ISO requests for the three above-mentioned aspects, which was followed by the Certification of the Medical Oncology Unit on 17 December 2002.

In conclusion, certification of a medical oncology unit is a goal that should be pursued to improve not only the level of clinical activity, but also the whole process of design, implementation and running of clinical trials. However, this can not be achieved without the investment of additional resources.

S. Monfardini1, A. Jirillo1, M. Boscaro2*, M. Galeazzo & O. Pitocchi3

1Medical Oncology Unit, Padua University Hospital, Padova; 2Education and Communication Office, Cancer Center of the Veneto Region, Via Gattamelata 64, I-35128 Padova, Italy; 3OPT s.r.l., Milan, Italy (*E-mail: martina.boscaro@unipd.it)





This Article
Full Text (PDF)
E-letters: Submit a response
Alert me when this article is cited
Alert me when E-letters are posted
Alert me if a correction is posted
Services
Email this article to a friend
Similar articles in this journal
Similar articles in PubMed
Alert me to new issues of the journal
Add to My Personal Archive
Download to citation manager
Search for citing articles in:
ISI Web of Science (1)
Disclaimer
Request Permissions
Google Scholar
Articles by Monfardini, S.
Articles by Pitocchi, O.
PubMed
PubMed Citation
Articles by Monfardini, S.
Articles by Pitocchi, O.