Quality Assurance in Medical Laboratories
In healthcare today, medical laboratories are key partners in ensuring and maintaining patient safety, and it is seen that laboratory results influence approx. 70% of medical diagnosis. Maintaining quality standards of the laboratory service plays a major role in ensuring the accuracy of these results, providing better patient care as a whole and promoting excellence. While the absence of the same may lead to unreliable results, causing a delay in treatment, misdiagnosis and an increase in cost due to a need for retesting.
Good quality is never brought about by accident; it is almost always the cumulative result of sincere intentions, dedicated effort, intelligent direction and skilful execution. As a choice, good quality may not necessarily be the easiest or the cheapest; however it is definitely the wisest for both patient health and welfare as well as laboratory credibility.
International standard ISO15189, based upon ISO17025 and ISO9001 standards, provides the basic requirements for establishing competence and serves as the bible for quality in medical laboratories. And while this serves as an excellent guiding principle, no matter how good the quality mechanisms are on paper, truly good quality cannot be achieved if theory is not translated into practice day-in and day-out.
The entire process of managing a sample must be considered including the beginning i.e sample collection to end i.e reporting and saving results.
Laboratory Tests are Influenced by :
1. Lab environment
2. Knowledgeable staff
3. Reagents and Equipment
4. Quality control
6. Process management
7. Occurrence management
8. Record keeping
Following are the Quality essentials which act as building blocks for quality management.
Personnel: Human resources, job qualifications ,job descriptions, orientation, training, Competency assessment, professional development, continuing education.
Equipment : Acquisition, installation, validation, maintenance, calibration , trouble shooting, service and repair, records.
Purchasing and inventory : Vendor qualification, supplies and reagents, critical services, contract review, inventory management.
Process control: Quality control, sample management, method validation, method verification.
Information Management: Confidentiality, Requisitions, logs and records, reports, computerised laboratory information system(LIS)
Documents : Creation, revision and review, control and distribution.
Records: Collection, review, storage , retention.
Occurrence Management: Complaints, mistakes and problems,documentation, root cause analysis, immediate actions, corrective actions and preventive actions.
Internal: Quality indicators, audit reports, audit reviews.
External: Proficiency testing ,inspections, accreditation.
Process improvement: Opportunities for improvement (OFI), stakeholders feedback, problem resolution, risk assessment, preventive actions, corrective actions.
Customer Service: Customer group identification, customer needs, customer feedback.
Facilities and Safety: safe working environment, transport management, Security, Containment, waste management, Laboratory safety, ergonomics.
Implementing an efficient Quality Management system does not guarantee a 100% error free laboratory, but it goes a long way in detecting errors that may occur commonly, and prevents them from recurring. It essentially puts us on the path to continuous improvement, and brings us closer to our vision of bettering healthcare facilities every day.
There is a cost associated with Quality, but are we cognizant of the fact that poor quality costs us even more? Quality costs can be offset by quality payoffs like enhanced reputation, loyal clientele, reduced system failures & machine downtime, less need for retesting for complaints etc. However there is no offset for medical implications that may be caused by poor quality, and its impact on not just the laboratories in question but on healthcare as a whole. Thus, implementing and maintaining good quality standards in laboratories is no more a choice, as it is not just the ethical and moral duty of all laboratories to provide accurate, reliable results, but it is essential to all aspects of healthcare and the medical profession