The Nigerian Medical Laboratory Science Council is stepping up enforcement to shut down unregistered laboratories whose activities are endangering the lives of many, Donald Ofili, director of the agency has said.
Ofili on the sidelines of the 6th edition of the ISN Quality Assurance Summit held on Friday, told journalists that everyone who sets up a laboratory must be licensed and hundreds have been shut down in Nigeria due to the many operators opening laboratories without seeking the required accreditation.
However, to set up an accredited laboratory, Celestine Okanya, director-general, Nigeria National Accreditation System (NiNAS) said about N2 million is needed to accredit a medical laboratory in Nigeria, which takes 90 days.
The operators after getting a national license are also required by state laws to procure a registration from the state government.
ISO 15189, an international standard for medical laboratories is seen globally as a mark of confidence awarded to medical laboratories and proof of their dedication to delivering quality service across all aspects of their operation, and operators are required to have it, said Okanya.
Okanya said that less than 1 percent of laboratories in Nigeria are ISO 15189 accredited as some operators set up offices in prohibited areas such as residential buildings and even in petrol stations.
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Ofili said that laboratories should not be sited in residential buildings as pathogens handled should not come in contact with people.
According to Okanya, accreditation of a medical laboratory costs between $3000 to $5000 in Nigeria.
Accreditation is the assessment of an organisation to ensure that it is performing in accordance with the requirement of a required standard or regulation. And few among the over 4,000 labs in Nigeria have accreditation.
Okanya stressed that there should be 100 percent compliance with the standard of medical laboratories before accreditation, adding that achieving 99 percent level of quality means accepting a 1 percent error rate.
He said, ” No medical laboratory should accommodate one percent error, that one percent error can be a life.
“Laboratory errors cost time, personal effort and patient outcomes.”
He further stated that NiNAS has accredited 38 Conformity assessment bodies (CABs) with 25 of them active at this moment and about 151 trained accessors.
In addition, 98 training on standards including ISO IEC 15189 conducted impacting up to 2,4852. He added that the 1SO 15189 requirements are split into two namely management and technical requirements which strengthen the standard of medical laboratories.
