Introduction to Medical Laboratory Accreditation

Definition of Accreditation and Certification.

Accreditation is the “ formal recognition that a laboratory is competent to carry out specific laboratory tests according to best practices specified by the accreditation body”. In simple terms, accreditation tells the outside world that laboratory tests are of the highest possible accuracy and can be trusted.

Certification, on the other hand, is the audit of organizational management practices and how well they conform to national or international standards e.g. ISO 9001 Quality Management Systems. In Kenya, laboratory business registration by the County government and licensing by Kenya Medical Laboratory Technician ad Technologists Board (KMLTTB) encompasses certification. 

The Kenya National Accreditation Service (KENAS) is the body mandated with the accreditation of all organizations in Kenya, including medical laboratories.

In other jurisdictions like the US, there are specific certification bodies like the (Clinical Laboratory Improvement ( CLIA) programme that are mandated with the certification of medical laboratories. 

In the quality management scheme of things, certification is the bare minimum and mandatory. 

When a lab wants to go higher and uphold industry best practices and communicate to the world on the same, they opt for accreditation. At the present time, accreditation is not mandatory in Kenya ( rumors are that may change in the near future) but highly desirable for a laboratory worth its salt.

Regulatory Framework

So, certification (or licensing/registration) is mandatory approval by the authorities that minimum standards have been met. Accreditation is the recognition the lab has the competence to carry out specified laboratory tests. It goes without saying that certification is a prerequisite for accreditation.

Importance of accreditation and certification

 Accreditation and certification hold immense importance for both patients and healthcare providers. Accreditation ensures that laboratories adhere to rigorous quality standards, maintain accuracy, and deliver reliable results. It instils confidence in patients, assuring them of the laboratory’s credibility and the accuracy of their test results. 

Additionally, accreditation facilitates seamless cooperation and information exchange among laboratories, healthcare professionals, and regulatory bodies, contributing to enhanced overall healthcare quality and patient safety. 

Certification, on the other hand, further demonstrates a laboratory’s commitment to continuous improvement and adherence to specific standards, fostering excellence in service delivery. Together, accreditation and certification serve as essential benchmarks for quality assurance, instilling trust and promoting excellence in clinical laboratory practices.

Role of Kenya Accreditation Service(KENAS) in Medical Laboratory Accreditation

KENAS plays a crucial role in the accreditation of clinical laboratories in Kenya. As the national accreditation body, KENAS is responsible for evaluating and recognizing the competence of clinical laboratories, based on specific standards and guidelines. Within KENAS, the Medical Laboratory Accreditation Service (MLAS) department is specifically tasked with overseeing laboratory accreditation.

KENAS ensures that the accreditation process is conducted in a fair, transparent, and consistent manner, following internationally recognized principles and practices. The role of KENAS includes establishing and maintaining accreditation criteria, conducting assessments and on-site inspections, and granting accreditation to laboratories that meet the required standards. 

By working closely with regulatory bodies and industry stakeholders, KENAS ensures that accredited clinical laboratories adhere to high-quality standards, providing reliable and accurate testing services to healthcare providers and patients. KENAS’s involvement in clinical laboratory accreditation fosters trust enhances the quality of healthcare services, and contributes to the overall improvement of the healthcare system in Kenya.

ISO 15189:  The Laboratory certification standard.

ISO 15189 serves as the primary certification standard for clinical laboratory accreditation in Kenya. This internationally recognized standard specifies the requirements for quality and competence in medical laboratories. It provides a comprehensive framework for laboratories to demonstrate their technical competence, management systems, and adherence to quality assurance practices. ISO 15189 covers various aspects, including personnel competency, laboratory facilities and equipment, pre-analytical, analytical, and post-analytical processes, and the overall management of the laboratory. 

By adopting ISO 15189, clinical laboratories in Kenya can ensure consistency, accuracy, and reliability in their testing processes, leading to improved patient care and safety. The standard also emphasizes continual improvement, encouraging laboratories to review and enhance their quality management systems. Compliance with ISO 15189 not only strengthens the credibility and reputation of laboratories but also facilitates international recognition and collaboration. As the primary certification standard in Kenya, ISO 15189 plays a crucial role in elevating the standards of clinical laboratory services and promoting excellence in healthcare delivery.

NB: The ISO 15189 is available for purchase from the Kenya Bureau of Standards Website(KEBS) 

Accreditation Process for Medical Laboratories in Kenya

The accreditation process involves several  is clearly laid out and available for download from the KENAS website. The following is an abbreviated step by step guide on the accreditation journey.

1. Application for KENAS Medical Laboratory Accreditation (MLA)

The laboratory seeking accreditation submits a formal application to KENAS. They should be thoroughly versed with ISO 15189 as its the basis for quality standards used in the assessment. KENAS has a handy accreditation checklist to help laboratory teams plan and prepare for the accreditation process. Many laboratories find it easier to bring onboard an experienced and impartial  external consultant to help the laboratory prepare adequately for the rigorous accreditation process 

2. Payment of Applicable fees. 

Accreditation comes with a hefty financial commitment, and KENAS has published the applicable fees and the schedule of payment. 

3. Application Documents Review. 

After receiving the accreditation application, the KENAS MLAS secretariat peruses all the documents to assess suitability to continue the accreditation process. This assessment is based on the ISO 15189 standard. Once the review is finished, a report is issued, with a decision on whether to proceed with the accreditation.

4.On-Site Assessment

Once a decision to proceed is made, the secretariat appoints the lead assessor to oversee the process. The applicant laboratory is also notified in case of any conflict of interest. HE or she draws up an on-site assessment plan. Sometimes a pre-assessment visit may be conducted if deemed necessary.

During the on-site assessment, the assessors observe and record all aspects of the testing protocol for which accreditation is applied.

The team then summarizes their findings and notes any anomalies (called non-conformities). These have to be addressed by taking the appropriate corrective action before the final report is tabled to the MLAS secretariat.

5. Final Accreditation  Decision

The MLAS secretariat then makes its recommendations and hands over the report to the accreditation committee. This is the final decision-making entity and here a decision to grant or deny accreditation is made. 

Once it’s given, the accredited lab is bound to adhere to terms of accreditation including the use of KENAS marks and logos in their communication materials.

Validity of  Accreditation

In Kenya, medical laboratory accreditation is valid for 3 years, in which yearly onsite inspections are conducted. After 3 years, a re-accreditation application is done if the laboratory wishes to retain the accreditation status

Accreditation confers many benefits to the laboratory, their clients and patients and contributes to the development of quality healthcare services. 

We would like to hear your views and experience in the accreditation process in Kenya. Please comment below or contact us.