MLSA Submission on Quality Manager Grading in Acute Hospital

Medical Laboratory Scientists Association
Submission to HSE Corporate Employee
Relations on Quality Manager Grading in
Acute Hospital Laboratories
January 2015
A survey undertaken by the MLSA in 2012 of grading for Quality Managers has revealed
that currently there exists a large disparity in grades for scientists working as Quality
Managers. The MLSA therefore argues that this disparity needs to be addressed.
As part of the 2011 Laboratory Modernisation Agreement, which was concluded in
accordance with the terms of the Croke Park Agreement, the HSE committed to engage
in discussions on the Quality Manager role.
Role of the Quality Manager:
The Role of Quality Manager is a work stream that developed at a time of considerable
change in Medical Laboratories on foot of the EU Directives 2002/98/EC, 2004/33/EC,
2005/61/EC, Government Legislation SI 360 of 2005 and the AML- BB Document on
Minimum Requirements for Blood Bank Compliance with Article 14 (Traceability) &
Article 15 (Haemovigilance). The key to successful hospital laboratory accreditation is a
Quality Management System and key to Quality Management is having a designated
Quality Manager in place.
The critical role of the Quality Manager is to act as a hub, co-coordinating with the
Laboratory Services Manager for all departments the many and varied accreditation
work streams on the path to achieving ISO 15189 Accreditation in laboratory disciplines,
or as is the case in larger hospitals where each major discipline may have a Quality Lead,
coordinating the work of the sub-specialties within that discipline.
A large measure of responsibility goes with the role of Quality Manager which needs
particular recognition in the Medical Laboratory setting. Accreditation places a
mandatory governance requirement that places the Laboratory Quality Manager in a
unique position reporting directly to the Laboratory Manager/Chief Medical Scientist.
Recognizing the unique role of the Quality Manager can be achieved by promoting the
position to at least the grade of Specialist Medical Scientist Level within the promotional
grades for Medical Scientists. The MLSA recognises that there can possibly be an
argument that Quality Managers responsible for quality in larger hospitals have a
greater workload, however, the responsibility and tasks for ensuring that accreditation
for ISO: 15189 remains the same regardless of the size of the hospital. Given the higher
workload and therefore a more onerous responsibility (more departments or
specialties), consideration should be given to promoting these positions to Chief Medical
Scientist level.
Current Situation in the HSE and Public Voluntary Hospitals:
There are numerous examples of higher level appointments throughout the HSE and
public voluntary hospitals. There is currently a desire amongst members of the MLSA for
appropriate grading for all Quality Managers in order to reflect the importance of the
Quality Managers in the governance of modern pathology laboratories. Quality
Managers normally have all grades within the laboratory, including that of Laboratory
Manager, reporting to them on quality matters. Additionally, the Quality Manager often
has a direct reporting role to the Hospital CEO.
A number of large teaching hospitals in Ireland have already recognised the importance
of the Quality Manager position by grading the position, and making appointments, at
the grade of Chief Medical Scientist i.e. Mater Misericordiae Hospital and the Children’s
University Hospital.
There is too often little by way of promotional or financial incentive for Medical
Scientists to take up quality management roles, given the requisite responsibilities the
position entails in a modern medical laboratory.
The Infrastructural deficit (one-off spending from an accreditation perspective) has
generally been absorbed into day to day spending and accreditation is continuing to be
achieved. Indeed, there are many papers showing that an efficient Quality Management
System (QMS) will generate significant savings (e.g. less repeated testing due to better
control of pre-analytical, analytical and post-analytical factors). Additionally, if
laboratory accreditation were to be withdrawn from any laboratory due to a Major nonconformance then the cost to the relevant hospital service provision could be significant
until the major non-conformance is closed out.
There is a requirement for designated named deputies for all key positions in the
laboratory. The ISO and INAB accreditation standards both recognise the importance of
the deputy to the maintenance of the QMS. While there is great emphasis on deputies
for key roles in the whole accreditation process, in small to medium labs most deputies
to Quality Managers are already performing routine duties concerned with their primary
employment role as a Medical Scientist. Large laboratories would have at least one
Senior Medical Scientist full time in a deputy quality manager role.
Laboratories in Ireland, having been early adopters of accreditation, have led the way in
healthcare accreditation in the Irish health service. A Laboratory Accreditation
programme provides a template that has enabled Laboratory staff to do what they do
best, even better than before while facilitating documentation of issues and quality
improvements to the service along the way all of which benefits clients and patients.
Quality Indicators are analysed and document the contribution of staff to improved
quality, productivity and outputs in the context of our patient care, and their work is
accountable to the public through external audit by INAB / IMB.
There is better management of risk, safety and quality within the hospital through
adherence to quality management systems, care pathways, disease programmes,
protocols, audit, information management systems, etc. Such systems must be
developed under the authority of the Quality Manager and Clinical Care team and
relevant department heads and activated under the direction and oversight of the
relevant clinical leaders at local level e.g. medical, nursing or allied health professional
grades, consistent with the recommendations of the Commission on Patient Safety and
Quality Assurance; measurable against the Health Information and Quality Authority
(HIQA) standards. In relation to this, the Medical Laboratory Quality Manager is a key
This includes the use of evidence-based performance measurement, to drive continuous
improvements in efficiency/effectiveness, measurable by use of Internal Quality Audits,
Vertical Haemovigilance and Traceability Audits for Blood Transfusion and External
regulatory audits by INAB inspectors.
MLSA Proposal:
In a large teaching hospital the designated or appointed Quality Manager should be at
Chief Medical Scientist Grade. In medium and small hospital laboratories the
Laboratory Quality Manager pay scale should be revised to that of at least Specialist
Medical Scientist grade to reflect the skill sets required and commensurate with the
responsibilities that the holder of the position bears in providing a quality
management service in the modern medical laboratory in the Hospital care setting.
Appendix 1
Summary of Quality Management & the Role of the Quality Manager
in the Laboratory.
A Quality Management Programme in a Medical Laboratory has a Quality &
Safety Manual which outlines the Management & Technical responsibilities in
accordance with the Quality Standard ISO15189 and Irish Law together with
the associated AML-BB document "The Minimum Requirements for Blood Bank
compliance with Article 14 (Traceability) and Article 15 (Notification of Serious
Adverse Reactions and Events) of EU Directive 2002/98/EC".
The ISO 15189 Standard is the document that external assessors / auditors use
to test a Quality Manual in the first instance.
All statements in a Quality Manual must be given effect through a master list of
approved documents, standard operating procedure (SOP's) quality records &
The role of the Quality Manager is to co-ordinate the activities of the quality
management system in conjunction with the Laboratory Manager and Heads of
The quality management programme will:
 document and control all standard operating procedures, quality
records and forms;
 identify, control and analyse non-conformances, complaints and
ongoing quality improvements;
 evaluate suppliers;
 document and control critical equipment using an asset register;
 manage equipment maintenance, documenting validation, calibration,
service & preventive maintenance and cleaning;
 document corrective action, preventive action and quality checks based
on approved quality indicators;
 review of contracts;
 review (clinical) advisory services;
 monitor operational systems through a comprehensive auditing
 document and review through regular (monthly) quality & safety
meetings the various activities outlined above;
 document and review through regular hospital blood transfusion
committee meetings on-going Haemovigilance activities and the patient
consequence / severity of any Serious Adverse Events (SAE's) / Serious
Adverse Reactions (SAR's);
 hold an annual management review to assess overall management and
technical operations;