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Introduction
Medical laboratories form the backbone of every health care system, and their contributions are invariably important in the diagnosis, disease prevention, and treatment of a patient. Due to this crucial role of quality health care availed in the country, improvements in the country's laboratories assure reliability and accuracy. ISO 15189 describes the requirements of medical laboratories globally for excellence in quality and competent technical aspects. This ISO is considered an important stepping stone for modernizing laboratory practices toward internationally accepted levels in Nepal.
This article, therefore, throws light upon ISO 15189 accreditation, its implications for the medical laboratories of Nepal, and why such accreditation was regarded as important in the development of Nepal's healthcare facilities.
What is ISO 15189 Accreditation?
ISO 15189 represents the international standard applicable to medical laboratories. This includes QMS and technical requirements for modern laboratory tests to realize timely, accurate, and reliable test results. Thus, it orients the laboratory toward patient care, management issues of the laboratory, and efficiency in its operations.
The key points in ISO 15189 revolve around:
a. Technical Competence: Requirements on personnel qualification, calibration of equipment, and test methods.
b. Patient-centered approach: Emphasis on confidentiality, patients' satisfaction, and correct reporting.
c. Quality Management Systems: This is a systematic approach that assures homogeneity, traceability, and continuous improvement.
d. Global Standards: It is recognized as a laboratory that meets the international benchmark set for health care around the world.
ISO 15189 does more-it builds confidence among patients, care providers, and regulators alike, rather than just assuring quality.
Status of Medical Laboratories in Nepal
The health system of Nepal has developed considerably over the last couple of years, but the problems that the medical laboratories face are numerous:
Poor quality standards, as many laboratories do not have standardized operating procedures and hence variable results; restricted availability of modern technology because old equipment and limited resources characterize it, affecting diagnostics and its effectiveness; shortage of skilled professionals, which means the quality of the services will be compromised; and inequalities between rural laboratories due to lack of infrastructure, training, and resources.
No Widely Available Accreditation System: Lack of widely available accreditation systems has made patients doubt the credibility of the test results.
Along with these, the necessity of ISO 15189 certification now oversteps all other needs.
Why ISO 15189 Certification Matters to Nepal
ISO 15189 certification of medical laboratories will have some consequences for Nepal. Among them are:
1. Improved Diagnostic Accuracy:
Accurately identifying diseases would be facilitated because ISO 15189 ensures all laboratories show drastic procedural responses, with a minimum of errors in test results.
2. Building Patient Confidence:
Certification will instill confidence in diagnostic services and bring more satisfaction and loyalty among patients.
3. Operational Efficiency:
ISO 15189, through standardization of processes, minimizes redundancy, smooths workflow, and reduces overall costs in the long term.
4. Global Recognition:
ISO 15189 offers international recognition to laboratories, increasing their scope for collaboration and research projects with international involvement.
5. Better Disease Surveillance:
Accurate diagnosis ensures better public health, helping policymakers combat outbreaks and control diseases effectively.
6. Economic Growth in Health Care:
There will be more patients and partnerships, increasing revenues, therefore avenues for investment in the health sector.
Steps to Achieve ISO 15189 Certification
A medical laboratory operating in Nepal must go through the development process step by step for its accreditation to ISO 15189.
1. Results
The prevailing operation, the identification of the prevailing practices, and the technical and quality gaps identified through assessment are presented.
2. The quality management systems dealing with taking care of the patients, maintaining competence of personnel and operational flows must be produced based on ISO 15189 Documentation followed should also be prepared, identified and controlled.
3. Training of Laboratory Staff:
Provide training programs to the staff so that they can acquire sufficient technical skills and knowledge to meet international standards.
4. Infrastructure Development at Laboratories:
The equipment is modern, well-maintained, and frequently calibrated to give accurate results.
5. Internal and External Audits:
Self-assessment for identifying areas for improvement, in liaison with accredited bodies for external audits.
6. Documentation and Record-Keeping:
To institute a robust system of documentation that will allow traceability and accountability of all activities.
7. Continual Improvement:
ISO 15189 is not a destination; it's a journey. Updates and frequent assessments are necessary to keep pace with compliance and newer challenges.
Challenges of Implementation of ISO 15189 in Nepal
The journey to ISO 15189 is not without challenges:
1. Cost of Accreditation:
The cost of getting accreditation to ISO 15189 is huge in terms of infrastructure, equipment, and training.
2. Limited Awareness:
Most laboratories and health providers are unconversant with the accrued benefits accruable from the same and thus ISO 15189 is always resisted.
3. Resource Limitations at Rural Level:
Accreditation cost and logistic issues make the pursuit of certification challenging in distant stations where mostly the laboratories would have been situated.
4. Legal loopholes :
No supporting policy/incentive of government to accord much weight that may impinge upon priorities while deciding whether the laboratories ought or ought not engage themselves.
5. Expert shortfall
There is a lack of consultants and professionals who guide the laboratories in the process of accreditation.
How to Overcome These Challenges
Following are some recommendations that can help smoothen the journey towards ISO 15189 accreditation:
1. Government Support
Incentives which could include subsidy, tax exemptions, and other forms of financial benefits shall motivate and inspire the laboratories to embark on accreditation.
2. Public Awareness
Workshops and education programs shall make health stakeholders aware of ISO 15189 and its relevance to their professional lives.
3. Partnerships with NGOs and International Organizations
International partnership with these organizations opens up more avenues for funding, training, and technical assistance.
4. Pilot Programs:
Target selected laboratories initially for pilot projects so that others get motivated by looking at the benefits accruing from ISO 15189 accreditation.
5. Local Training Programs:
Establish appropriate training programs so as to equip the workforce for implementation and sustenance of ISO 15189 standards.
A Future of Quality Diagnostics in Nepal
ISO 15189 certification can make a sea change in the health care system of Nepal. The accredited laboratories will become the pillars of trust and dependability, ensuring better patient outcomes and building public confidence to contribute to the well-being of the nation.
ISO 15189 means much more than the Nepalese context of an international standard being met. As a matter of fact, it is one step toward assurance that each and every citizen is served with valid and reliable medical diagnostics. That's where ISO 15189 accreditation comes in for Nepal.
Conclusion
ISO 15189 certification represents an opportunity to upgrade the medical laboratories of Nepal to a level that will demonstrate globally recognized best practice in serving the country's needs. Certification may take long and require huge efforts, but it is really worth its weight in gold: improved diagnosis, patient satisfaction, and community health in the long run.
ISO 15189 will no doubt act as the driving force toward a brighter, healthier future for one and all as Nepal aims at modernizing the healthcare sector. Visit https://www.isocertificationinnepal.com/ to learn more about ISO.
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