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 Sandra Loaiza, Member of the Inspector and Accreditation Committees.
Introduce yourself and your role(s) and position(s) within EBMT and outside of EBMT
My name is Sandra Loaiza. I studied Biomedical Sciences and then specialised in Haematology and Blood Transfusion, when I started working in a central London hospital. During my time there, I was sponsored to undertake an MSc part-time in Biomedical Sciences at the University of Westminster, London.
In 2001, I took a career pivot and moved into the Stem Cells and Immunotherapy field. I started as a junior Scientist in The John Goldman Centre for Cellular Therapy (JGCCT) at Imperial College Healthcare NHS Trust. In 2017, I was appointed Director and Head of Operations & Regulatory Affairs, post I still hold today.
In 2012, I undertook a PhD part-time at Imperial College in London. During my PhD, I lead an innovative collaborative study that established the first model to study protein homeostasis with direct applications in biological, bioengineering and drug research.
In 2019, I was awarded a Make a Difference Award by Imperial College in recognition of my work, dedication and achievements.
The talented JGCCT team, supports the adult and paediatric transplant programmes and more recently other cellular therapies. The laboratory is involved in a programme for treating multiple sclerosis patients with stem cells, is currently working on a number of projects including in-house point of care manufacturing of CAR-T cells, in addition to facilitating the treatment of our patients with commercially available CAR T-cells. The laboratory supports several clinical trials including the gene therapy clinical trials using CRISPR gene editing for the treatment of red cell disorders approved by the MHRA in the UK last week.
Why did you decide to become a JACIE inspector?
I decided to become a JACIE inspector back in 2012, after being involved in the JACIE inspection of my centre. The reason behind my decision was to deepen my regulatory knowledge for my own development but also for the benefit of my centre. Since then, I have continued to work with the JACIE team in several roles, as part of the JACIE Accreditation Committee (JAC), JACIE Inspector’s Committee (JIC), JACIE representative for the review of FACT-JACIE standards and more recently as a representative in the British Society of Blood and Marrow Transplantation & Cellular Therapy (BSBMTCT) JACIE subcommittee.
What has been the most memorable inspection that you have ever done?
I have done quite a few inspections now, including some virtual inspections during COVID. I have a couple of memorable inspections; the first inspection I did as a trainee in a UK centre where I shadowed a very experienced Processing Inspector from which I learnt a lot from. The second memorable inspection, was a more recent inspection of a centre in Argentina. This centre was undergoing inspection for accreditation for the first time and it was memorable for several reasons; I undertook the inspection in Spanish working together with FACT inspectors from the US for the first time. I was amazed by the drive and enthusiasm from the centre to become accredited by FACT-JACIE, trying to achieve very high standards despite having limited resources.
What ‘keys to successful JACIE accreditation’ can you share with us?
Preparation and planning in advance are key to a successful inspection.
A good starting point is to go through the previous inspection report if the centre has been inspected before. This will give you a good idea of the strengths and areas of improvement the centre had last time they were inspected.
Read through the documentation provided by the centre in advance including the Quality manual, going through the completed checklist provided by the centre. Make notes of specific areas and questions you want to go through when you are onsite. This will save you time when visiting the centre as will keep the inspection process focused.
Last but not least, good communication before, during and after with the inspector team is fundamental for a successful inspection. Meeting the inspection team virtually and then in person before the actual inspection to go through the inspection plan and shared responsibilities. I find useful to set up a WhatsApp group with the inspectors to be used as a means of communication during and after the inspection process. Continuous communication during the onsite visit is also important, touching base regularly during the day with a team de-brief by the end of day 1.
Good communication with the centre during the on-site inspection is also essential. Ask questions and listen to the answers making notes as you go.
One last tip. Do not underestimate the labels sections and standards. Some of the labelling standards are shared between Collection, Clinical and Processing so avoid duplication. Allocate enough time to this part of the inspection process as it is not straight forward, and in my experience, often takes longer than you think.
How has your career/work benefited from being a JACIE inspector?
My career has benefited from being an inspector. I have learned and continue to learn from other inspectors and centres I have inspected. I have adopted good practices in my own centre from other centres I have inspected.
Being an inspector is a pleasant experience. I like meeting colleagues that I probably wouldn’t meet if I wasn’t a JACIE inspector. Being a JACIE inspector can also open other opportunities and gives a chance to network and establish potential future collaborations.
Do you have any tips or advice for anyone who aspires to become a JACIE Inspector?
Use the resources provided by JACIE and EBMT. There is a lot of information, webinars and training material available for inspectors, make use of them. If you know another experienced inspector in your area, ask them for mentorship and advice. Don’t re-invent the wheel, listen and learn tips from experienced inspectors as they would have gone through the same process you are going through yourself.
And last but not least, enjoy the process but do not underestimate the commitment and meaning of being part of the JACIE community as an inspector.