Obtaining accreditation is a long-awaited status for microbiology laboratories in the ministry of health.
Laboratory testing is a multistep process involving preanalytical and analytical stages which is susceptible to error during the process. Accreditation is a widely accepted status, which help to maintain quality system and continue improvement of a laboratory. Quality, performance, reliability and efficiency will be evaluated during the assessment.
Guidance use for laboratory accreditation is internationally accepted and harmonized. Most widely accepted and recognized standards are ISO IEC 17025; General Requirements for the Competence of Testing and Calibration Laboratories and ISO 15189 for medical laboratories.
Accreditation bodies are authorized organization for assessing laboratories against these ISO standards and in Sri Lanka it is the Sri Lanka Accreditation Board for conformity assessment (SLAB). ISO standard will dictate how management system and the test methods are established and errors are minimized.
Once accredited, ISO IEC 17025 compliant proves that the testing laboratory is competent and can produce valid results which are acceptable word wide.
Food laboratories play a major role in food safety infrastructure required to monitor and ensure food safety in a country and capacity in these laboratories is critical for a successful food control system.
Food microbiology laboratories under the ministry of health are regulatory laboratories under the food ACT 1980. Reports generated by these laboratories are used for regulatory purposes and assurance of quality and safety of a food by authorities.
Accreditation of food microbiology laboratory MRI was a result of a long process which began in 2012. Activities were planned to fulfil requirement as per the Clauses laid down in ISO 17025.
Initially, process began with an understanding of what is necessary to be accomplished, how should be the learning process as well as what need to be done to achieve it.
There were many requirements to be addressed while facing many hardships and challenges.
There were obvious changes necessary to be addressed before moving to fulfil ISO standard requirements.
Dedicated areas were identified and developed for food and water testing, decontamination, documentation and storage.
While issues related to accommodation were resolved by partitioning of the existing laboratory to get dedicated spaces, equipment maintenance including daily maintenance, annual service and calibration of equipment were carried out.
Implementation of ISO IEC 17025 include development of quality manual, relevant procedures, Standard Operating Procedures, forms and records for guiding, direction and capturing all the activities of the laboratories.
Poor understanding of staff on accreditation and relevant ISO standards was a major challenge. Selected staff members were given opportunity to attend training conducted by SLAB while staff of food lab also started going through the standards and discussed how to develop documents and address related issues. Each staff member was given responsibilities on different clauses of ISO 17025. I functioned as the quality and the technical manager while the deputy quality manager was selected from technical staff who was most capable of making documents. Senior MLT took the responsibility of technical procedures under the guidance of consultant microbiologist, Deputy quality manger looked after the over all quality system. Responsibility for Equipment maintenance, training and supervision of junior staff, sample receiving, to waste disposal and decontamination were assigned to individual technical staff member and made them accountable for relevant activities.
Development of Standard Operating Procedures was an essential component of any laboratory as it will provide necessary guidance for all staff members to carry out procedures, making more uniform and stable laboratory results. Though all staff members supported the development of SOP, deputy quality manager finalized the documents as per ISO 17025.
One of the biggest challenges was the changing test methods to internationally validated methods e.g. ISO, Bacteriological Analytical Method etc. This process involved SOP development, purchasing new reagents and consumables, training of staff for test methods, verification of test methods and competency evaluation of staff for the analysis and interpretation of test result before establishment of test method into routine practice. This was an exhausting procedure as it involved many aspects which needed to be addressed.
Participation of a proficiency testing (PT) programme by individual laboratories was an essential requirement to verify staff performance and laboratory technique. Finding a PT provider was most challenging as Sri Lanka did not have a PT provider in food microbiology.
Participation in an accredited Proficiency testing programme conducted by an international agency was very expensive. But it provided various types of tests and matrices necessary for Food Microbiology PT programme and distributed throughout the year. This was very helpful as there is a requirement for PT results evaluation of each test method. In addition report provided by PT provider assisted to understand the trend and compare our position among participating laboratories.
In parallel to these activities staff members were given opportunity to participate in training programmes on ISO 17025. However due to the current transfer system in the ministry of Health for medical laboratory technologist, I could not retain the staff who were trained making the task more difficult.
Establishment of Measurement of Uncertainty (MU) is another requirement of ISO 17025. Analytical staff was given training on MU calculation to improve result calculation and interpretation
After developing a comprehensive quality management system to govern over and provide support, development and implementation of all the technical requirements also finalized. Implementation of ISO TEC 17025 was accomplished.
During the process due to the frequent staff turnover it became difficult to continue activities related to accreditation and badly felt the need of external support and MRI requested the assistance of UNIDO. Generous support by UNIDO financially and assisting capacity building of staff by providing additional training on ISO 17025, calibration of equipments , calculation of Measurement of Uncertainty made the process easy. In addition, UNIDO lend the assistance to strengthen support services by providing necessary equipment and technical advices.
With the assistance of UNIDO, process of implementation of ISO IEC 17025 standard was fast tract and all the gaps were addressed. After fully implementation of ISO IEC 17025, application for accreditation was submitted to the SLAB. Initial review of document and, pre assessment was carried out. After addressing the non-conformities and corrective action surveillance assessment was held.
Finally in July 2019 Food Microbiology Reference Laboratory MRI became ISO/IEC17025 accredited and is the first microbiology laboratory in the ministry of health and the first laboratory in the MRI to get accredited under international standards.
Preparing for accreditation is extremely challenging and need hard work as well as dedication in order to prepare all necessary documents including manuals, procedures and guideline to achieve the required ISO standards.
Accreditation is a continuous process need to be maintained and updated. It requires maintenance and attention of everyone involved in the laboratory management and activities at all time.
Obtaining and maintenance of accreditation status is an extremely difficult task with the existing system. Frequent changeover of technical staff, absence of dedicated staff to implement and maintenance of quality management system and financial requirement as the accreditation need large financial commitment by the individual institute are some of them.
In addition to issues related to the laboratory, compliance to standards which were fulfilled at the time of accreditation would be difficult when supportive systems are not following ISO standards relevant to those components.
Accreditation of food microbiology reference laboratory wouldn’t have been a reality without the staff that are committed and dedicated.
I Acknowledge all the support given by Ministry of health, EU Sri Lanka Trade Related Assistance, UNIDO, untiring effort by dedicate staff of food microbiology laboratory, Medical Research Institute.