Surveys



Survey following RPMI shortage and controversy of risks associated with HES
(17 December 2013)

The EBMT through JACIE and the Cell Processing Committee has received information from a number of sources about a shortage of and/or conditions of use for ancillary materials used for cell processing (see examples below).
 
The FACT-JACIE standards provide rules and guidance for the validation and use of ancillary material, and so we wish to know more about the experience of European cell processing facilities and academic Advanced Therapy Medicinal Product (ATMP) manufacturers.

We would appreciate if you could take a few minutes to report on your experience since January 1st, 2010. Answering the questionnaire should take no more than 15 minutes.

Note that if you experienced a shortage of more than one material since 2010, you should complete a survey for each one.

Closing date is Wednesday 21 January 2013.

Access the survey here.

Authors
This survey has been designed by Prof. Christian Chabannon (Marseille, France) as Chair of the EBMT Cell Processing Committee and Past-President of JACIE. Prof. Ineke Slaper (Utrecht, The Netherlands) provided additional input.
The JACIE Accreditation Office supported the preparation and distribution of the survey.
Any question can be directed to eoin.mcgrath@ebmt.org.

Examples of the materials that are the subject of this survey:

• Anticoagulants
• Buffered solutions & culture media
• Cryoprotectants
• Sterile process buffers
• Tissue culture media
• Density gradient media
• BSA, HSA 
• DMSO
• RPMI without phenol red
• Tissue culture medium -199 (TC-199)
• Human albumine
• Hydroxyethylstarch (HES)
• Saline
• Phosphate buffered saline (PBS)
• Autologous plasma

Disclaimer
JACIE promotes compliance with applicable national and international regulations and the FACT-JACIE standards require that any ancillary material be validated for clinical use. Through this survey, JACIE is not necesarily validating nor endorsing the use of research material for human application.

Access the survey here.

References:

5th edition of the FACT-JACIE standards
- D4.12  The  Quality  Management  Plan  shall  include,  or  summarize  and  reference, policies  and procedures for actions to take in the event the Processing  Facility’s
operations are interrupted.
- D4.13  The  Quality  Management  Plan  shall  include,  or  summarize  and  reference, policies  and procedures for qualification  of critical supplies, reagents, equipment, and facilities.
Access the survey at https://www.surveymonkey.com/s/CT_ancillary_products

AHCTA Survey - Developing recommendations for cell processing laboratory staff qualifications, training and competency


AHCTA
The Alliance for Harmonisation of Cellular Therapy Accreditation (AHCTA) requests processing facilities to complete a survey to assist with developing recommendations for cell processing laboratory staff qualifications, training and competency.
Please limit your responses to just those staff responsible for the processing of minimally manipulated products like hematopoietic progenitor cells (HPC) for stem cell transplantation and therapeutic cells (TC)- T cells.
Only a single response from each processing facility is required.

Access the survey here.


JACIE and patients:

Among the key findings in a recent report on patient involvement in healthcare was the following:
"There was little awareness of patient safety and quality standards and patients were generally uninterested. Patients tended to be more focused on their own treatment and were willing to presume standards were met" (p.43)

We are interested to know if centres make their patients and donors aware of their accreditation.
  • Access the survey here*
  • See summary of results here*





Practices for Testing Cord Blood Units and Preparing Units for Administration


Preliminary surveys suggest that there are no uniform criteria concerning the identification of shipped cord blood units, nor does there appear to be a consensus regarding preparation of units for administration.

All transplant centers worldwide are invited to participate in an inter-organizational survey of transplant center practices for testing cord blood units and preparing them for administration. The primary goals of the survey are to

1) inquire about laboratory testing practices for characterization and assessing identity after cord blood units are received by your transplant center’s laboratory, and

2) inquire about thawing, washing, and dilution methods used by your transplant center.
 
Your participation in this 34-question, 20-minute survey will provide insightful information into practices around the globe and may result in useful guidelines for improving the use of cord blood as a source of cells.
 
Transplant centers are asked to limit themselves to one response. You may submit your responses anonymously or provide your information for further follow up. We suggest you seek input from your processing laboratory and transplant coordinators prior to completion. You may download the survey questions in advance to compile your center's response. Please coordinate with your colleagues to submit your response by September 30, 2013.
This survey is being coordinated by the Foundation for Accreditation of Cellular Therapy (FACT), Omaha, Nebraska, USA.

Participating Organizations





Survey of guidelines and practices used for prevention of central venous catheter associated infection (CLABSI) in hematopoietic stem cell transplantation recipients.

​In 2009, the Infectious Diseases Working Party of EBMT with other international bodies introduced updated guidelines for infection prevention in hematopoietic stem cell transplantation setting. The prevention of Central Line-Associated Bloodstream Infection (CLABSI) is one of the key components of these guidelines. The central venous catheter infection prevention bundle consists of hand hygiene, full barrier precautions, cleaning the insertion site with chlorhexidine, avoiding femoral sites for insertion, and removing unnecessary catheters. So far the implementation of those measures has not been studied in EBMT centres.
 
There is need to assess how the guidelines for CLABSI prevention are implemented in European HSCT centres and if the implementation of those guidelines has influence on survival after hematopoietic stem cell transplantation.



ATG administration in European JACIE-accredited centres: a descriptive EBMT Nurses Group Survey


Anti-Thymocyte Globuline (ATG) is an important part of therapy within certain conditioning regimens for both adult and paediatric patients prior to undergoing allogeneic SCT. There is a little data on how ATGs are administered in different stem cell transplant
centres. For this reason the Research Sub Committee of the EBMT Nurses Group would like to invite you to fill in this questionnaire.

More information on the survey is available below:

Deadline: extended to 31 December 2012

Contact:
Simona Calza (RN, MSN, Phd Student University of Genoa)
Stem Cell Transplant Unit
Gaslini Children’s Hospital
Genoa (IT)
e-mail: calzasimona@fastwebmail.it

Note that this is not a JACIE survey. JACIE is facilitating the distribution of the survey via our website but all enquiries should be sent to Simona Calza.



EBMT/ IDWP survey: Protective Environment for SCT recipients

The Centre for International Blood and Marrow Transplant Research (CIBMTR) coordinated the Guidelines for Preventing Infectious Complications among HCT Recipients: A Global Perspective, in which EBMT was involved. In these guidelines there were clear recommendations with respect to hospital room design and ventilation.
The IDWP would like to gain an idea of what is done in Europe to attain the norms proposed and has for this purpose created a short survey, which can be accessed and completed by clicking on the following link:
 
http://www.surveymonkey.com/s/ProtectiveEnvironment

The IDWP would like to ask the representative physicians, nurses and data managers of EBMT centres to complete the survey, which will take approximately 20 minutes of your time.
Please be reassured that the information obtained will be handled to guarantee the anonymity of your centre. We only want to gain an impression of what is done on average, to see to what extent the recommendations made are feasible and to try to establish a norm for the EBMT.
 
Should you have any questions or concerns, please do not hesitate to contact idwp.ebmt@lumc.nl.
We would like to thank you in advance for your cooperation in this important study and are looking forward to your participation.
 
Sincerely,
Jennifer Hoek                  Peter Donnelly                                  Simone Cesaro
Study Coordinator           Investigator                                        IDWP Chair

Contact details:
European Group for Blood and Marrow Transplantation
EBMT Data Office Leiden
Department of Medical Statistics & BioInformatics
Postzone S-05-P
LUMC
PO Box 9600
2300 RC Leiden
The Netherlands
Tel: +31 71 526 5668
Fax: +49 711 4900 8723 (fax to e-mail system)
Fax: +49 180 500 290 623 (fax to e-mail system)
Email: idwpebmt@lumc.nl

[Note: This text was prepared by the authors of the survey. All questions should be directed to idwp.ebmt@lumc.nl and not to JACIE. See invitation letter at the end of this announcement.]



EDQM Survey: Quality of raw materials for cell based and gene therapy products

The purpose of this survey is to gather information from all stakeholders about their respective needs regarding the use and production of raw materials intended for the manufacture of cell based and gene therapy products which includes ATMPs either manufactured on a routine or non routine basis. The information we receive will be treated confidentially and be used in preparation of a meeting on 3 April 2013 in Strasbourg and during the drafting of a text of the European Pharmacopoeia (Ph. Eur.).

The scope of this Ph. Eur. text is to harmonise the quality requirements for the raw materials used for cell based and gene therapy product manufacture. Please note that Good Manufacturing Practice (GMP) is out of the scope of the proposed text.

The deadline for responses was 21 December 2012.

More information at www.edqm.eu




2011


Inspectors survey:
  • Survey closed.
  • See summary of results here*

* Links take you to the SurveyMonkey website