Introduction

The Nepalese health sector has turned into one big continuum upgrading process since time unknown, as an effort toward mitigating growth in population together with advanced pathology of diseases. Any well-functioning health always depends upon the pillars of quality diagnosis forming the very basis of appropriate medical decisions. ISO 15189 is the international quality management system standard that medical laboratories pursue in the delivery of diagnostic services. It aims at raising health outcomes to higher levels with a view to making medical laboratories appropriate, precise, and timely in the country.

It covers discussions on how ISO 15189 contributes to the Nepalese health sector, the challenges derived, the advantages derived from the use of it, and what a laboratory does towards attainment.

What is ISO 15189 Certification?

ISO 15189 addresses the competence requirements on quality and Continuous Quality Management System requirements of medical laboratories. It in turn addresses the needs of medical laboratories about patient care, accuracy, and consistency. The main focus is here unlike other general certifications.

Certification will make sure that the laboratories observe the following:

  1. Correct Testing and Reporting: All the diagnostic processes ensure reliable results.
  1. Patient-Centered Services: Ensured patient confidentiality, satisfaction, and safety.
  1. CQI: The standard inspires continued monitoring of the processes by the laboratories for further improvements.
  1. International Alignment of Standards: It also aligns operations against international benchmarks, thus allowing for any kind of collaboration from other global healthcare organizations.

ISO 15189 is a critical tool meant for Nepal in efforts at improving diagnostic reliability towards effective treatment and care.

Importance of ISO 15189 to Medical Laboratories in Nepal

Although laboratory medicine remains key in diagnosis and management, it nonetheless continues to grapple with several problems related to inconsistent quality, obsolete infrastructure, lack of equipment and consumables, and gross shortage in personnel required for this specialty. It is at this point, therefore, that ISO 15189 certification tackles these problems by providing the necessary framework on which such services should be amended.

Reasons why ISO 15189 Certification is important to Nepal

It also means betterment in diagnostic accuracy since the treatment is totally based on authentic test results. ISO 15189 provides error-free, highest quality in processing from the very collection of samples up to final reporting.

  1. Building Confidence: The more confident the patients are, the faster it will be for any patient and a medical practitioner to responsibly take any results provided by any laboratory facility where credibility blossoms, and therefore one will eventually trust that health care system.
  1. International recognition: ISO 15189 recognition provides scope for recognition at the international frontier; hence, it opens the way for laboratories to collaborate with any institution of their interest in knowledge, health, or research with a part of the world.
  1. Operational Efficiency: ISO 15189 requires ironing out redundancies in workflow for resource management.
  1. Public Health Benefits: Accurate diagnosis is important in disease surveillance and management. This becomes very important in a country like Nepal, which has to battle many infectious diseases.

This economic growth is contributed by attracting more patients, private investments, and partnerships in healthcare, enhancing the economic growth of the health sector in Nepal.

Steps to Achieve ISO 15189 Certification in Nepal

ISO 15189 attainment of certification is, in fact, a very structured process. It requires commitment, investment, and planning. Steps involved are summarized below.

  1. Gap Analysis Initial analysis comparing existing laboratory practice with requirements according to ISO 15189 highlighting what it is necessary to change.
  2. QMS Development and Implementation Establishment of QMS according to ISO 15189 by spelling the policies concerning handling of samples, tests, reporting, and record keeping.
  3. Personnel Training: The personnel within the laboratory are to be implemented, both technically and managerially, through given standards set by ISO 15189.
  4. Infrastructure Improvement: Up-gradation through the use of modern equipment, the needs of the technical requirement are met by doing maintenance and calibration.
  5. Record Keeping and Documentation: The records provided have to be in detail, which would allow traceability, account for procedures and processes.
  6. Internal Audit: To review running the laboratory periodically regarding identification of deficiencies on resolution.
  7. External Evaluation: Partner your laboratory with a certification body, which is certified in order that it may undertake audits independently of verification of conformance by your laboratory against requirements by ISO 15189 standard. 
  8. Continuous Improvement: Accreditation is one continuous process and requires laboratories to monitor their process continuously and accept new challenges.

Challenges in Implementation of ISO 15189 Certification

ISO 15189 Though offering a host of advantages for Nepal in ISO 15189, following is perceived in implementing challenges

  1. Expensive:  Accreditation might include infrastructural upgrade and other such processes involving retraining the human resource within laboratory facilities.
  2. Lack of awareness: Inadequate knowledge among laboratory managers and health professionals relating to scope and benefits pertaining to ISO 15189 could be another likely cause for a lesser number of facilities under the same.
  3. Resource Constraint: Most the laboratories in the rural areas have the dearth of modern instruments and skilled workers.
  4. Resistance to change: The resistance from staff and management to changes from traditional ways of working into standardized processes is also one.
  5. Few Accreditation Bodies: There are a few numbers of accreditation bodies in Nepal which may delay the process of certification.

Overcoming the Challenges

Following are some ways through which the identified challenges may be overcome for Nepal:

  1. Government Incentives: Financial support, subsidies, or exemption of taxes by the government will act as an incentive for the laboratories to pursue ISO 15189 accreditation.
  2. Public Awareness Campaigns Educational programs and campaigns regarding the contribution of ISO 15189 for improvement in the quality of healthcare are sorely needed.
  3. Collaboration with NGOs and International Organizations: Equally importantly, such collaboration has translated into much-needed technical expertise besides the financial support.
  4. Pilot Projects: The benefits related to accreditation will be demonstrated with the setting up of pilot projects in selected laboratories. This, in turn, would establish better uptake rates.
  5. Local Training Facilities: Investment in local training will ease the shortage of competent personnel.

Conclusion: ISO 15189 and the Future of Healthcare in Nepal

Probably, the ISO 15189 certificate will make a sea change in the Nepalese health system. Of course, when the facility itself has increased a single bar by incorporating an accredited laboratory for the best diagnosis-exerted follow-through management, confidence and development in public sectors increase automatically to higher stages, covering more healthcare facilities.

ISO 15189 would bring in innovation and collaboration that finally helped the Laboratories of Nepal to stay in competition long-term. Besides, it would also mean assured quality diagnostic services for the citizens in every geography. Visit https://www.isocertificationinnepal.com/ to learn more about ISO.