Pathology Compliance Management
Due to the nature of the Pathology sector, standards and regulators such as ISO 15189, 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.
However, regulatory requirements have increased in recent years to demand that procedures are not the only area that are managed through a quality management system. Now regulators are demanding that Audits are carried out to ensure these procedures are maintained, that staff can easily log non-conformances and issues, that assets are calibrated and maintained - with full documented history - and that suppliers are audited to ensure they deliver products and services to the required standard. Similarly, areas of risk need to be identified and acted upon before they take place and staff must be shown to be competent in carrying out their tasks through documented training schedules for each employee.
Traditionally, each of these areas would be managed through a variety of disconnected systems - such as paper and electronic documents, spreadsheets, and paper audits - with little integration between them. As the requirement of regulatory bodies have increased, quality systems have often been viewed as a bureaucratic burden with little positive impact on a Pathology department.
Gael have developed solutions to help relieve these areas, and to change quality and risk management from a bureaucratic burden into an efficient benefit to the organisation.
Q-Pulse, from Gael, is a fully integrated Electronic Quality Management Solution (eQMS) that will help laboratories significantly decrease the time spent on day-to-day compliance activities including document control, auditing, incidents and non-conformance, suppliers, corrective and preventive actions (CA/PA) and staff training, and increase the time spent providing more patient focused services.
Gael Risk allows organisations to fully identify potential areas of risk, hazards, threats, consequences and control and the ability to manage these on multiple risk registers. The fully customised dashboard allows you to have an overview of the total risk environment across the department. Plus, with full integration into Q-Pulse, your risk register can be automatically updated as incidents are logged in your Q-Pulse solution. Similarly, as incidents are closed, Gael Risk changes accordingly.
Many international commercial labs, and over 130 Pathology Departments across the NHS, such as Biomnis Ireland, Nuffield Health Diagnostics, East Lancashire Hospitals NHS Trust, Sonic Healthcare, King’s College Hospital NHS Trust and University of Utah, use Gael’s solutions to help them with their compliance and risk needs. Gary Cheung, Quality and Training Manager at King's College NHS Trust, said of Q-Pulse: "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."
Contact us now for more information on how Gael can help you efficiently and effectively manage your pathology regulatory compliance activities, and ensure quality is kept at the high standards required by regulators.