Inspectors are the backbone of JACIE; without them, there is no accreditation process. Becoming an inspector is a wonderful way to contribute to maintaining global quality standards. As the number of JACIE applications has increased, we are constantly looking for new inspectors to join our ranks. At the moment, we are particularly keen to hear of German, French and Spanish speaking Clinicians and Quality Managers.
Each month, you will have the opportunity to meet with one of our JACIE Inspector who will share his/her experience.
Read our interview with Hans Vrielink, MD, PhD
Apheresis- and Transfusion Medicine Specialist
Senior Consultant, Sanquin Consulting Services
President World Apheresis Association
Sanquin Blood Supply / Sanquin Blood Bank
Amsterdam, The Netherlands
Introduce yourself and your role(s) and position(s) within EBMT and outside of EBMT
My work started in 1985 at Sanquin Blood Supply Foundation predecessors in donor medicine and research in the screening of blood donors for transfusion transmittable viruses. This was in the beginning of the HIV period and even before the detection of the hepatitis C virus. Besides my work at Sanquin Blood Supply, I did clinical work (mainly internal medicine and gynecology and obstetrics until 1993) when I started with my training as transfusion medicine specialist and PhD thesis.
Why did you decide to become a JACIE inspector?
I got involved with apheresis in the mid-nineties and with the development of new apheresis programs, disposables, improvement of existing procedures and being involved with the development of new apheresis machines apheresis became my hobby including training of apheresis operators/nurses and physicians. With the establishment of the Sanquin Blood Foundation (the national blood supply organization in the Netherlands) I became also involved in therapeutic apheresis and with the collection of human progenitor cells for transplant intention as what you name now apheresis collection facility director in three different hospitals. With the development of the quality systems in the collection of cells for cellular therapies nationally, I was involved in a working group implementing the 3rd edition of JACIE standards in our centers and with that I became also JACIE inspector, a logical step since I had been already a GMP inspector for blood bank and hospital blood transfusion centers for years. So around 20 years ago I started my career as JACIE inspector in the Netherlands, some years later followed by inspections outside of the Netherlands.
An interesting step was also being involved in the European and USA team “making” the apheresis collection standards of the 5th and the 6th edition of the JACIE/FACT standards. Together with that, I was requested by various institutions to help with making their center JACE/FACT inspection ready also in countries from the countries classified by the World Bank as low- or middle-income countries.
What has been the most memorable inspection that you have ever done?
In my career working with JACIE standards (25 years), I performed up to now around 20 inspections, all for the C-part of the standards. Very memorable are the inspections performed in the (lower) middle income countries. These hospitals helped me so much in showing that there is so much possible in working at high quality levels of the JACIE standards with rather limited resources. Together with the experiences in working as senior consultant for blood bank, apheresis and transfusion medicine in various LMICs, I was able to give better tailor-made solution for several issues.
What ‘keys to successful JACIE accreditation’ can you share with us?
Besides this work as JACIE/FACT inspector, the last 10 years, I functioned as apheresis collection facility director in 6 different institutions in the Netherlands at the same time (Sanquin provides apheresis services to these hospitals). We standardized our process nationally, of course with small adaptations because of differences in the hospitals. And, since in the Netherlands JACIE accreditation is by law mandatory for performing hematopoietic stem cell transplants, we had many JACIE inspections (>20) in our centers. With my experiences and knowledge of the JACIE standards, we were always able to become accredited in all centers without any major issues. Most important in this is go and find friends and visit these centers. Together with the accreditation manual in which the standards are explained, your knowledge of collection center work and what you see at the centers of your friends / neighbors you can make your center adapted to your own processes and ready for JACIE accreditation. Essential is also the GMP principle “write down what you do, and do what you wrote”. In others words, write down how you always work, and work according that. And when you do this, no worries (only a normal “tension”) when an inspection team is coming. You are the expert in how you work. But keep in mind to be polite for yourself. For instance, don’t write that the temperature in your collection area always must be between 22 and 23°C, but say that it will be always be between 18 and 26°C. It saves you from a “red field” in the inspection reports. Be open minded and don’t fool yourself. Have a good reflection on the situation in your center and you will see the weak points in your center. Try to solve them, but don’t be afraid for the inspector. When the inspector is reporting some negative points, you always have some months to come to a solution solving the issue. Don’t be afraid to ask the inspector whether he/she is having a suggestion for something. This will also take time for the inspector he/she can’t spend in checking other area 😊.
How has your career/work benefited from being a JACIE inspector?
Working with standards and looking at centers how the standards are implemented is giving you a great help in a more constant quality in your own work. I always remember that my aim is not to follow the standards to become JACIE accredited, but my aim is trying to reach the most optimal quality for our patients, donors and co-workers.
Do you have any tips or advice for anyone who aspires to become a JACIE Inspector?
By becoming inspector in this field, you will be able to improve the work which is done in your own center. Be open minded. Doing something in a different way as you are doing in your center isn’t per definition the wrong way doing it. Maybe it’s the wrong way you are working. So (aspirant) inspectors, have thorough knowledge of the standards and what is meant behind these words, and compare this with what you see in the institution. When you see differences in the process compared to your institution, this can be of potentially useful in improving the process in your institution.