LABORATORY ACCREDITATION JOURNEY

PREAMBLE

Laboratory accreditation is a formal recognition earned by organizations proving they are qualified, competent, and comply with international standards In the accreditation world, each of these organizations is referred to as a conformity assessment body, or a CAB.

Accreditation bodies work closely with CABs all over the world to assess their laboratory procedures to determine whether they meet the criteria of international standards. Most often, labs are assessed to one or more standards set forth by the International Organization for Standardization, also referred to as ISO.

The International Organization of Standardization is “an independent, non-governmental international organization with a membership of 167 national standards bodies. Through its members, it brings together experts to share knowledge and develop voluntary, consensus-based, market relevant International Standards that support innovation and provide solutions to global challenges.”

A number and a year identify each ISO standard for a period it is developed. For example, ISO/IEC 15189:2012 is a standard that details the requirements for quality and competence. Experts from around the world develop these standards for organizations to follow and become accredited to. Standards cover a wide range of laboratory activities, from the qualifications of personnel and the calibration of equipment to the documentation of procedures and test methods.

Accreditation bodies, assess laboratories to ensure all the requirements of the standard are met. If non-conformities are found, the lab has an opportunity to correct them. Once all non-conformities have been corrected, the CAB can finally attain laboratory accreditation status for a specific standard.

Why is Laboratory Accreditation Important?

First, it shows that an organization and its personnel are qualified and competent. It also inspires confidence in test results and assures customers of a service’s quality, strengthening an organization’s credibility.

Meeting International standards equate to international acceptance of test results. Health facilities globally will not spend time and resources on tests which have been done in accordance to international standards, regardless of laboratory or country of origin.

Stages of laboratory accreditation

 STAGE 1: INITIAL APPLICATION

A laboratory may submit an unsolicited application for accreditation or WHO may invite a laboratory to apply for accreditation. The laboratory must communicate which types of testing it wishes to be accredited on and whether it can demonstrate its competency by conforming to accepted standards and share the required Laboratory Quality Management Systems documents.

STAGE 2: DOCUMENT REVIEW

Following the initial application submission for accreditation the accreditation body will review the documents submitted and avail a document review report to the applicant. There after assessment dates are scheduled by the accreditation body and confirmed by the applicant.

STAGE 3: AUDIT

A laboratory will need to undergo a full audit prior to granting accreditation status also known as initial assessment. The audit should take two days and covers all aspects of the laboratory's operation, including quality, testing and personnel. The auditor(s) must also witness every relevant test.

In the audit process, the auditor will make comments on observations made and document noncomformances revealed which are signed off by the Laboratory nominated representative there and then.

Feedback on the total observations and conformances is given and depending on the performance, the Laboratory is recommended for accreditation and given a period to address the identified non-conformances.

STAGE 4: DECISION AND ACCREDITATION

The accreditation body takes the final decision to accredit a laboratory based on the information dossier evaluation and the audit report availed by its assessors.

ACCREDITATION JOURNEY IN BUTABIKA HOSPITAL

Butabika laboratory has been implementing Laboratory Quality Management Systems for 11years under the SLMTA programme (Strengthening Laboratory Management Lowards Accreditation)

The laboratory started pursuing accreditation in June 2022 after a SLMTA exit audit. An assessment was done in March 2023 and accreditation status was granted in January 2024. Then the hospital received a license from the South African National Accreditation System (SANAS) which is valid up to 2028 on condition that quality standards are maintained which is evidenced through surveillance audits done by the accreditation Body annually. The hospital, therefore, undertook all the necessary steps listed above.