Introduction

In spite of the various benefits of ISO 15189 certification to Nepali medical laboratories, it has challenges to obtain the level of certification. Ranging from a lack of resources to a lack of awareness, Nepali laboratories face various challenges in trying to get the certification. In this article, worldwide challenges and the best way to approach them are addressed practically.

What is ISO 15189 Certification?

ISO 15189 is an international standard that states the competence of medical laboratories requirements and the quality requirements that are to be adhered to for activities. It helps the laboratories to guarantee that they provide reliable and correct test reports which are of ultimate significance while treating and diagnosing the patients. A QMS, and technical competence must be demonstrated by the laboratories in order to get their certification.

Difficulties Faced by Nepali Labs

Following are the most common problems of Nepalese medical labs to acquire ISO 15189 accreditation:

  1. Financial Inability
  • The greatest problem with Nepali labs is the expense of ISO 15189 accreditation. It comprises:
  • Infrastructures and equipment upgradation.
  • Employee training and recruitment of consultants.
  • Accreditation fees payment.
  • All these are typically beyond the budget of most of the labs, especially the small ones.

Solution: Government program funds, international organizations, or public-private partnerships may be looked into by laboratories. Or cost-saving options like step-by-step implementation of ISO 15189 standards may be explored.

  1. Limited Awareness and Understanding

The majority of laboratory owners and employees in Nepal lack sufficient awareness of the benefits of ISO 15189 certification or have limited awareness regarding standards. This may lead to:

  • Resistance to certification.
  • Implementation errors.

Solution: Certification becomes simple if labs know the benefits and how to get certified. Certification agencies, certified labs, and field experts can conduct training.

  1. Inadequate Training and Competence

Special training and competence should be there to follow the standards of ISO 15189, and Nepali labs may lack the same. Issues are:

  • No training center.
  • No expert staff to manage the certification.

Solution: The labs can utilize employees' training programs and ISO 15189 consultant services to guide them through the process. Knowledge availability on the web is also a cheap method of establishing expertise.

  1. Ageing Infrastructure and Equipment

Aged times infrastructures and equipment are those that are most all Nepal labs possess with them, which would not meet the ISO 15189 standards' expectations. This would impact their ability to:

  • Conduct tests correctly and accurately.
  • Documentations and quality controls in place.

Solution: Laboratories can invest on priority equipment and facilities upgradation even in stages. They can even approach collaborations with equipment firms or donations from foreign agencies.

  1. Over-Procedural Documentation

ISO 15189 accreditation requires massive documentation, i.e., SOPs, quality manuals, and internal audit reports. This daunts most laboratories because of:

  • Limited documentation experience.
  • Lack of adequate resources for investing in the project.

Solution: Laboratories can refer to templates and guidelines from consultants or accreditation agencies to make documentation easier. They can also employ a core team responsible for documentation.

  1. Resistance to Change

Implementation of ISO 15189 standard involves basic changes in processes and workflow. Resistance to change by staff or management will delay or dilute the certification process.

Solution: Certification can be embraced by employees if they are hired as stakeholders in continuous improvement. Continuous training and transparent communication can avoid issues and enable buy-in.

  1. Lack of Government Support

The Nepalese government has made some efforts towards improvement of healthcare standards, but more support is needed to encourage laboratories towards ISO 15189 certification. The challenges are:

  • Lack of funding and incentives for certification.
  • Lack of sufficient policy initiatives to upgrade the state of quality standards.

Solution: There can be lobbying by stakeholders and associations, which can compel the government to give incentives such as grants or subsidies or tax concessions to accredited labs so that they become cost-effective.

  1. Geographical and Logistical Issues

The following are the other rural labs' challenges in Nepal:

  • Fewer resources and training.
  • Not being able to carry equipment and samples.

Solution: Online training modules, online resources, and coordination with city-based labs are means of bridging the gap for rural labs. Logistic support can also be ensured by the government and NGOs.

Success Stories: Overcoming Overcoming Challenges

Even in the face of these challenges, a few of the labs in Nepal have managed to obtain ISO 15189 accreditation. A few of them are:

  1. National Public Health Laboratory (NPHL): Overcame the lack of resources by strategizing and cooperating with the government and in sync with them.
  2. Nepal Cancer Hospital and Research Center: Invested in human resource development and infrastructure to enable ISO 15189 compliance.

These success stories show that everything can be overcome with correct determination and attitudes to become successful.

Conclusion

Although the ISO 15189 certification process is challenging, its pros outweigh its cons. With due efforts against conventional obstacles in the form of financial constraint, ignorance, and resistance, Nepali medical staff can get certified and bring quality to healthcare heights. 

Call-to-Action: Ready to cross the barriers and achieve ISO 15189 certification? Learn about ISO 15189 Certification in Nepal and start your excellence journey today!