See also Events for training courses and other events of interest.
With the publication of the 6th edition of the FACT-JACIE Standards on 1 March 2015, JACIE Inspectors are now asked to complete the Inspector Exam. As with previous editions, the exam is designed to test inspectors' knowledge of the new standards and to offer explanations for why certain answers are incorrect or correct. By these means, the exam is considered to be an educational tool that helps to maintain and develop inspectors' skills and knowledge.
Who has to complete this exam?
All inspectors have to complete the exam. Failure to do so could result in being removed from the JACIE register of inspectors.
For non-inspectors - there is an open exam available to everyone to test their knowledge. Go here for more details.
The exam is divided into 2 parts. Part 1 must be completed by all inspectors and is an exam based on the JACIE Inspection Process and Common Standards. There are30 multiple choice questions in Part 1.
Part 2 consists of up to three exam(s) depending on the experience of each inspector. There are 20 questions in each exam. Please complete the exam for the area in which you quality to inspect. For instance, if you qualify to inspect only in the clinical setting, you should only complete the clinical exam. If you qualify to inspect processing and collection, then you should complete these two exams.
All inspectors will complete at minimum 2 exams and a maximum of 4.
With the online exam, you will be able to save your answers and return to the exam later if you wish. You will be asked to enter your email address and to create a password so that you can exit the exam and start again at a later date.
The next step is to enter your name and email so that we can easily identify who has completed the exam and also to complete the certificate that will be generated on passing the tests.
You should keep your password simple and easy to remember for future use.
The exams are separate and for this reason you are asked for your details for each exam.
A pass mark of 75% is required for each exam you complete. Note that marks are deducted for incorrect answers.
We calculate that you will need between 40-90 minutes in total. You will need to have the relevant documents at hand as the exams are open book, that is, you are expected to use the Standards, Manual, Comparison table of editions and the Inspection Guide. These documents are available on the exam page.
The deadline is 30 May 2015.
In order to start, go to www.jacie.org/inspectors/exam1. After you complete Part 1, you will be brought to another web page where there are 3 links to the remaining exams.
The 6th edition of the FACT-JACIE International Standards for Cellular Therapy Product Collection, Processing, and Administration are now available effective. See here for more information.
The JACIE Inspector Training Course will take place on 2-3 July 2015 in Manchester, UK.
This course is designed to train JACIE inspectors. Anyone working in the transplant setting who is interested in JACIE but is not interested or is not qualified to become an inspector can also attend. Note that priority will be given to inspector candidates.
For more information, go to the event registration site at ebmt.stagehq.com/events/3198.
Advance online publication 10 November 2014
Discrepancies exist between the care of unrelated donors (UDs) and related donors (RDs), particularly regarding medical suitability criteria, consenting procedures and donor follow-up. Changes to the most recent JACIE standards have addressed these issues. We studied 208 RDs who underwent PBSC or BM donation in a single centre during 2004-2013 to determine the impact of regulatory changes on donor care, and assessed the safety and efficacy of stem cell donation in donors not meeting UD medical suitability criteria. We observed significant improvements in donor consenting procedures (P=0.003) and donor follow-up (P=0.007) after stipulations in these areas were introduced. We saw a higher incidence of serious adverse events (SAEs) in RDs not meeting UD suitability criteria (P=0.018), and a higher incidence of SAEs in donors ⩾60 years (P=0.020). Haematopoietic progenitor cell donation is less safe in RDs who do not meet UD criteria for medical suitability. Although changes to JACIE standards have improved practice, development of specific medical suitability for RDs and guidelines around 'grey areas' where risks to a donor are unclear or theoretical, will be important in improving RD safety and standardising practice.Bone Marrow Transplantation advance online publication, 10 November 2014; doi:10.1038/bmt.2014.260.
Go to: http://www.nature.com/bmt/journal/vaop/ncurrent/abs/bmt2014260a.html
FACT and JACIE are finalizing the sixth edition of the FACT-JACIE International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration. Based on public comments and strategic initiatives, an additional standard is proposed:
“The Clinical Program should achieve one-year survival outcome within or above the expected range when compared to national or international outcome data. If expected one-year survival outcome is not met, the Clinical Program shall submit a corrective action plan.”
The FACT-JACIE Standards already require internal outcome analyses. With the introduction of published comparative national and international data, Clinical Programs have additional resources to evaluate their one-year survival rates and improve upon them when they fall below expected ranges. Note that this standard is written with “should,” signifying that it is a recommendation. If a Clinical Program does not meet expected outcomes, accreditation will not be withheld but the program will be required to submit a corrective action plan for achieving expected one-year survival.
The proposed Standard, general principles and limitations, proposed implementation process, and instructions for submitting comments are described in the official Request for Public Review and Comment: One-Year Survival for Allogeneic Transplant Requirements. We strongly encourage review of this document to gain a full understanding.
Access the online comment form at www.surveymonkey.com/s/clinicaloutcomes.
14-11-2014 Summary of results now available here.
Survey closed 10-10-14
JACIE is evaluating a new role for Quality Managers as part of JACIE Inspection Teams. Currently, teams are typically made up of physicians and scientists drawn from the clinical, cell collection and cell processing areas. The proposal is to add an experienced Quality Manager to this team since a significant part of the Standards in each of these areas concentrate on quality management and are currently assessed by the respective inspectors alongside the other standards. This represents a significant workload for the inspector.
The hypothesis is that
This survey is now closed. The deadline for participating was 10 October 2014.