Pathology Compliance Management
Working with over 140 Medical Pathology labs, Ideagen recognises the importance of delivering a holistic solution that meets the specific needs of sector.
We provide a unified platform for Medical Pathology Labs, that fosters a culture of shared learning and best practice.
"Q-Pulse is able to deliver an integrated QMS that crosses the boundaries between different pathology departments and the clinical arms of these departments...we now have proper control of documentation. During the most recent CPA assessment, there was no document control non-compliance raised at all, which is highly unusual for CPA assessments."
— Gary Cheung, Quality and Training Manager at King's College NHS Trust
Compliance, Efficiency, Safety and Productivity
The College of American Pathologists (CAP), Clinical Pathology Accreditation (CPA), Medicines and Healthcare Products Regulatory Agency (MHRA) and the Food and Drug Administration (FDA) are committed to ensuring quality and best practice is maintained to a high level. Compliance with ISO 15189 demands commitment to operational excellence and this places a burden of work on the laboratory.
The historic management approach of fragmented systems, paper and manual processes, electronic documents, spreadsheets and email is inadequate and creates a crippling bureaucratic burden.
- Audits must be carried out to ensure these procedures followed, staﬀ can easily report problems.
- Assets must calibrated and maintained with an audit trail.
- Suppliers must be audited to ensure their products and Services are of the necessary standard.
- Risks must be identiﬁed and treated.
- Staﬀ must be shown to be competent.
Q-Pulse, from Ideagen, is a fully integrated Electronic Quality Management Solution (eQMS) that helps laboratories transform their operational processes and substantially decrease the time spent on compliance activities.
ISO 15189 Compliance
Q-Pulse helps medical laboratories worldwide achieve and maintain ISO 15189 accreditation.
- Ensuring effective diagnosis through accurate analytical work
- Improving patient care with streamlined and robust quality processes
- Releasing resources to help improve service quality and reliability
"Q-Pulse, in our view, is the leading software solution for managing Pathology quality systems to meet the requirements of ISO 15189 and MHRA."
— Tony Harvey, National Quality Manager at Nuffield Health Diagnostics
Implementing Compliance Management Systems for Laboratory Accreditation
Government initiatives to modernise pathology services have required laboratories to adopt a compliance management approach:
- Patients obtain the services they need in the place that they need them.
- Laboratories must improve consistency in service delivery and seek opportunities for continual improvement.
Pathology-speciﬁc quality assurance standards such as ISO 15189 require laboratories to implement and maintain accreditation systems. Within the UK, Clinical Pathology Accreditation (UK) Ltd (CPA) is nationally recognised as providing a set of minimum quality standards for pathology laboratories.
This white paper examines both the regulatory environment and how Q-Pulse can help you achieve accreditation, remain compliant and at the same time improve operational efficiency.