Medical and Clinical Laboratories across the globe play key role in the fight against COVID-19. Sample collection, testing, result generation and communication are part of the processes in a standard medical and clinical laboratory that ensure efficiency and effectiveness of the laboratories if they are well managed and risk on the processes are mitigated, and ownership are well defined with appropriate accountability.
Beneficiaries of quality services from a well-managed medical and clinical laboratory are the patients who need quality health care services and the physicians who need timely, reliable, reproducible, valid and accurate results to support decision making in diagnostic process.
Researches have shown that one or more forms of quality management system needs to be adopted and used over time by a medical and clinical laboratory management as laboratory strategic management tool to achieve this feat consistently. Efforts to standardise laboratories in this light commenced over a decade ago thus making some laboratories ready to contend with the challenges COVID -19 presents in terms of quality of sample collection, examination processes, reliability of results, efficiency of test kits, error rates among other issues.
Good Laboratory Practice, Good Clinical Practice, ISO 9001 standard, ISO 17025 standard, national and regional framework, ISO 15189 standard etc are in use to manage medical and clinical laboratories.
Of late, ISO 15189 standard has been widely adopted for the management of medical and clinical laboratories. Extent of use in the Nigeria’s medical and clinical laboratories especially the molecular laboratories and other public laboratories cannot be ascertained. However, for the laboratory management to produce efficient and effective outcomes, the initiative must hinge on strong leadership and commitment from the executives of the laboratory. No quality management system thrives in an organization without deep involvement and pace setting tendencies of its leaders. ISO 15189 standard compels Laboratory Director to perform some responsibilities in order to ensure that quality management system based on ISO 15189 requirements delivers its intents.
The responsibilities tied to the Laboratory Director are outlined below:
- ensure adequate number of competent staff are used to render and deliver laboratory services
- liaise effectively with appropriate regulatory, accreditation bodies, health care and patients’ community, and other users of its services
- ensure effective use of the quality management system elements including the quality policy. delivery of the quality objectives and promotion of functionality of the system
- implement a safe laboratory environment practices in compliance extant rules and guidelines
- set up an effective process for selection and monitoring of laboratory suppliers and to select and monitor them
- In addition, to select referral laboratories and monitor their performance periodically
- Provide professional, career enhancement and development programmes for the laboratory staff and opportunities for the staff to participate in scientific programmes
- Direct and coordinate the use of standards and ensure performance monitoring and evaluation of the laboratory services
- Define and implement standards
- Ensure relevant clinical information is generated by the laboratories by putting monitoring process for tracking all activities
- Ensure complaints, request and suggestion are addressed timely
- Plan and direct research and development
- Design and implement a contingency plan to ensure continuity of business during emergency situation or other conditions when laboratory services are limited
- Provide effective leadership, budget planning and financial management of the medical laboratory
The overall responsibility for the success, and of the efficient and effective management of the medical laboratory rest on the laboratory director. The occupier of this office is accountable for professional, scientific, consultative, administrative, advisory, organizational and educational functionality of the laboratory and in relevance to the services offered.
Nigeria’s medical and clinical laboratories will derive much benefits by adopting and using ISO 15189 standard to standardize and optimize their performances. The leadership connection and commitment to the quality management system is a critical success factor.
Analytical Chemist, Certified Quality Auditor, Senior Lead Assessor, Lead Implementer & Trainer. He is available for any implementation support, gap assessment and training on ISO 15189, ISO 17025, ISO 31000 and ISO 9001. Contact: firstname.lastname@example.org