Dr. Neeraj Jain,
President, MELAP, New Delhi
The significance of quality assurance mechanisms in a medical laboratory increases the sense of independence without endangering the level of medical care.
Medical laboratories in healthcare are key partners in ensuring and maintaining patient safety. It is said that 70 percent of all medical decisions are based on laboratory results. 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.
Significance of quality standards in a medical laboratory
Good quality is never brought about by accident; it is almost always the cumulative result of sincere intentions, dedicated effort, intelligent direction, and skillful execution. As a choice, good quality medical tests 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, absolute quality cannot be achieved if the theory is not translated into practice day in and day out.
The entire process of managing a sample must be considered right from sample collection to reporting and saving results
Laboratory tests are influenced by :
- Lab environment
- Knowledgeable staff
- Reagents and Equipment
- Quality control
- Communications
- Process management
- Occurrence management
- Record keeping
Following are the quality assurance essentials which act as building blocks for quality management.
QUALITY ASSURANCE ESSENTIALS
Personnel:
Human resources, job qualifications, job descriptions, orientation, training, Competency assessment, professional development, continuing education.
Equipment:
Acquisition, installation, validation, maintenance, calibration, troubleshooting, 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, computerized 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.
Laboratory Assessment:
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.
