College of Nigerian Pathologists rejoinder to MLSCN Press Briefing on COVID-19 Test Kits validation

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College of Nigerian Pathologists, MLSCN, COVID-19

RE: PRESS BRIEFING BY THE MEDICAL LABORATORY SCIENCE COUNCIL OF NIGERIA ON

Progress report on Pre-market validation of (COVID-19) Rapid Test Kits (RTKs) and Unveiling of Guideline, for Private Medical Laboratories seeking to provide COVID-19 testing through completely private arrangement by the Registrar/Chief Executive Officer, Medical laboratory Science Council of Nigeria. CLICK HERE TO READ THE TEXT OF THE PRESS BRIEFING.

Following enquirers and concerns from Pathologists and many colleagues in other specialties of medicine, it has become necessary to make the following clarifications:

1. The College of Nigerian Pathologists (CNP) is happy that the Medical Laboratory Science Council of Nigeria (MLSCN)  has finally realized and stated that its mandate is limited to regulation of Medical Laboratory Science Practice and not Clinical/Medical Laboratory Science/Practice, as previously being touted.

2. The CNP is however concerned that the MLSCN in the Public Notice overreached its boundaries and took up roles not meant for it, and in the process created confusion, since Nigerians are generally not well-informed about clinical laboratory practices and the various professions involved. The aim of this Public Notice is therefore, to provide information and guidance for the public as well as correct some misinformation arising from the MLSCN press briefing
3. Medical Laboratory Science Practice, as stated in Section 29 of the MLSCN Act:

( a) “Means the practice involving the analysis of human or animal tissues body fluids, excretions, production of biologicals, design and fabrication of equipment for the purpose of medical laboratory diagnosis, treatment and research; and 
(b) includes medical microbiology, clinical chemistry, chemical pathology, haematology, blood transfusion science, virology, histopathology, histochemistry, immunology, cytogenetic, exfoliative cytology parasitology, forensic science, molecular biology, laboratory management; or any other related subject as may be approved by the Council;” 
These same activities are under the regulatory functions of the Medical and Dental Council of Nigeria (MDCN) in Section 2 (e) of the Medical and Dental Practitioners’ Act, 1992 (as amended). The import of this is that the laboratory practice of medical laboratory scientists is under the regulation of MLSCN while the laboratory practice of Pathologist; is exclusively under the regulation of the MDCN.
 4. We are surprised that an agency set up as a regulator would go on to set up a laboratory for the execution of the function it is meant to regulate. Can the MLSCN set up training schools and regulate them at the same time? The ethics of this procedure is doubtful as a person cannot be the judge in its own matter. This is why we wonder that NCDC will choose to use this route for validation of kits. We wonder whether the MDCN can establish a hospital or the Pharmacy Council of Nigeria establish a pharmacy store. The activity under reference is a breach of ethics, good laboratory practice and a clear case of conflict of interest. 
5. The  CNP wishes to inform all pathologists and colleagues that the standard practice of carrying out internal validation and verification of reagents and equipment before being deployed for services in their laboratories or laboratories under their supervision remains sacrosanct, bearing in mind that they remain accountable and responsible for the outcome (positive or negative) of all tests in such laboratories. It is important to remind medical practitioners, especially our Consultants that they have the primary duty of ensuring that patients under their care receive safe and quality care within the limits of available resources. 
6. We advise pathologists and colleagues to disregard the threats issued by the MLSCN to “Prospective Private Medical Laboratories regarding COVID-19 testing” as such was certainly meant for those under its regulatory ambit. We reiterate the fact that the regulation of Medical/Clinical Laboratory Practice in Nigeria, is under the authorities of MDCN by law, and it covers all medical or dental practitioners, including Pathologists. In as much as we realize the importance or significance of COVID-19 testing at this time in our nation’s history, we make bold to state clearly that Pathologists do not require any permission from anybody to carry out any clinical laboratory test that is within their competence and necessary for the care of the patients, and this includes COVID-19 testing. Pathologists should therefore report any form of harassment by MLSCN to CNP, MDCN, and law enforcement agents. 
 7. We are unable to offer any advice to anyone on the results of the “validation” of covid-19 test kits released by the MLSCN at the Press Briefing. ‘this is because we are not privy to the scientific/technical details including the gold standard employed in the validation. We will comment further when such technical details are made public.
Finally, we wish to state that: Validation of kits can be carried out by laboratories that have proper structure, are licenced by government, and are accredited. Government, FIT, and NCDC should be properly guided.

Signed:

Prof. P.O. Olatunji,

CNP President

Dr. A. O. Lawal

CNP National Secretary

4th June, 2020

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