Quality Managers as part JACIE Inspection Teams: results of recent surveySince the early years of JACIE, the idea of creating a role for Quality Managers on JACIE Inspection Teams was being proposed. One of the main factors blocking progress at that time was the heterogeneous profile of quality managers in Europe. While in some countries quality managers were clearly identifiable, formal training existed and a standard job description was established, in other countries the role was not clear, was often not recognisable within organisations and there was little or no preparation available.
However, since those early days, the role of quality managers in healthcare in general has evolved and there is now a much clearer acceptance and recognition of the position. Given their responsibility within transplant programmes in terms of the quality management system and compliance with standards and regulations, in 2014 JACIE decided to evaluate the effects of including quality managers alongside scientists, physicians and apheresis nurses in the inspection teams.
The hypothesis is that (1) a Quality Manager is an expert in quality management in the same way as the other inspectors are experts in their respective fields and so will ensure a more thorough assessment of the QM system; and (2) that the other inspectors will have more time to assess their main areas of competence (clinical, collection and processing) which will raise the overall quality of the inspection and reduce the time required on-site and reporting.
As a first step, during September and October 2014, JACIE conducted a survey to find out what support if any existed for creating a role for Quality Managers on JACIE Inspection Teams.
Results340 response were received to the survey from participants in 34 countries. This makes it one of the best responses to any JACIE survey.
Participants were asked to identify their role from the options: Doctor, Nurse, Quality Manager, Scientist, Other.
In response to the main question “Should a Quality Manager (QM) be incorporated into the Inspection Team subject to meeting established criteria?” overall 87.35% said yes and 12.65% said no.
Excluding those respondents who identified themselves as quality managers the overall response still showed 85.11% in favour of the proposal and when the answers were filtered for participants who identified themselves as doctors, the group of respondents least supportive of the proposal, 76.43% still said yes. Among those respondents who identified themselves as JACIE Inspectors, 83.78% supported the proposal.
47% of respondents considered that candidates to be inspectors should have at least 5 years experience while 26% suggested 3 years.
80% agreed that the QM inspector should examine the functioning of the quality management system across all areas of the transplant programme and not just in a single area.
104 comments were made ranging from support for the proposal to arguments against it. The Quality Managers Committee and the JACIE Office staff are working through all of the remarks as many of them – including those against the proposal – include interesting feedback which we will incorporate into the detail of the project.
The expected next steps are to run a small number of pilot inspections (normal JACIE inspections with a Quality Manager inspector and with the consent of the inspected centres) in the first half of 2015. A needs assessment will also be performed to establish if sufficient quality managers are available and what training needs exist. More details will be made available as the project progresses.
JACIE thanks everyone who participated for their time and input.
JACIE Operations Manager