Quality healthcare service is not only the expectation but also the right of the patient. There are many different components that work together to provide accurate diagnosis and proper treatment for a patient. Laboratory results play a crucial role in this process and are often the defining factor in planning treatment. In the U.S., for example, 70% of medical decisions are made according to the laboratory results. Unfortunately, in countries like ours, patients and even medical professionals are often not confident about the accuracy of laboratory test results they receive. It is particularly alarming when doctors have to reconfirm test results with more than one facility when treating a critical patient. This process takes time and can pose dire risks to a patient’s condition. Patients mostly lack trust in local healthcare facilities and those who are affluent tend to travel abroad for healthcare.
Ensuring reliability, increasing efficiency, reducing risks, and providing cost effective services are the major challenges facing clinical laboratories. Only sound quality management will engender test results that are internationally accepted. This quality product is directly related to a company’s credibility and business promotion.
The best way to ensure that a laboratory is performing at its optimal level, with the highest possible accuracy, is by obtaining international accreditation. The first step to achieve this is to implement a quality management system.
What is Quality Management System?
A quality management system (QMS) is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives. It aids in coordinating and directing an organization’s activities to meet customer and regulatory requirements and improve its effectiveness and efficiency on a continuous basis.
The following are the goals of QMS:
• Meet regulatory requirements and operate efficiently and effectively through laboratory organization, staff training, quality assurance, sample collection, transportation, processing, analysis, reporting and customer satisfaction.
• Ensure all employees understand their responsibilities and the timeline required to complete their activities.
• Continuous improvement through systematic review, evaluation of effectiveness, implementation of quality indicators, training, and development.
• Accreditation of laboratories.
Laboratory accreditation is a means of determining the technical competence of laboratories to perform specific types of testing, measurement and calibration. It also formally recognizes competent laboratories and enables customers to identify and select reliable testing while measurement and calibration services are able to meet their needs. Accreditation is not just a one-time achievement; to maintain this recognition, laboratories are periodically re-evaluated by the accreditation body to ensure their continued compliance with requirements and to determine that their operational standards are being maintained. One set of specified requirements for medical laboratories is the ISO-15189 standards.
So, what does it take to get an accredited lab? The following are a list of the high-level steps required for acquiring accreditation:
- Situation analysis: baseline assessment
- Laboratory management committee
- Document preparation (quality manual, technical document and forms)
- Document review and approval
- Implementation and training
- Internal audit
- Pre-assessment audit
- Deficiency correction
- Final assessment
Benefits of Accreditation:
Accreditation brings about benefits to all stakeholders in healthcare, from patients to doctors and employees. Once a medical laboratory is internationally accredited, patients who come for laboratory investigations will trust that results will be accurate; consequently, they are assured that those test results guarantee medical treatment of the highest standards, reliability, and service.
Doctors can also be confident in using the results of an accredited laboratory to either confirm or rule out a diagnosis. Laboratory personnel and management can feel confident that the rigorous systems and processes are accountable and confirmed by the international assessment body. They are also assured of the quality of the investigations and accuracy of results.
An internationally accredited laboratory boosts a healthcare company’s reputation as well. The company is also more accountable and less dependent on external support, as competent personnel and mechanical integrity ensure capital effectiveness. By earning international recognition, the company also gains access to the global marketplace for business development purposes.
Let us look forward to a day when all medical laboratories achieve the highest possible standards and are maintaining them strictly. Praava Health is committed to facilitating that change.