How MLSCN New Plan will Check Sub-standard Diagnostic Products - MLSCN Registrar

On 21/Mar/2014 / In Medical Advertorials

Prof. Anthony Emeribe is the reistrar/ chif executive officer of the  Medical laboratory Science Council of Nigeria (MLCN), an agency with the mandate to regulate the paratice of Medical Laboratory Science in Nigeria. In this interview eith EMEKA ANUFORE in Abuja, he speaks on a new five year strategic plan for the council, effots to enforce regulation and a fresh clamp down to reduce sub standard products in the diagnostic market by at least 50 per cent Excerpts:
WHAT is the main thinkingbehind the five-year strategic pian? The strategic plan of medical lab council of Nigeria really 
was developed to help abridge the misconception about what council is all about the mandate of the Council, about the scope of services for which council has been established. And of course, very importantly; with this information now, it becomes easier to let the various stakeholders, from government to various stakeholders (practitioners, providers of medical lab services,· among others), to know the direction where we are going to in the area of effective regulation, because normally the thing is that regulation has to do with norms in the society. We are the Police as regards medial lab services: human resources, facilities, infrastructure diagnosis and so on. That is why we have done this, so that between 2014 and 2018, anybody who browses through it will see where we are coming from, and where we are going to, and what are the milestones. In this age of performance indicators, it becomes easier with the plan for somebody to know how we are progressing, the extent of implementation of our per- formance indicators, among others. 
Very crucially, the public owns the institution, the government. It enables government to know where we are heading to and what is required. This is in the hands of all the key stakeholders: National Assembly; the executive and so on. The idea is so that they will be able to know where we are going to, what Council has set-up to do for the general public, the expectations in terms of funding, and all that. All that was integrated into the plan. 
If you were to summarize it all, what would you say is the Cruz of the plan?
There are key goals of the strategic plan, ranging form quality medical laboratory services delivery in terms of ensuring that laboratories are well approved, in terms of capturing them into a data- base, in terms of ensuring they have keyed into continuous quality improvement, and they have gotten to a level of being certified and accredited. 
The other goal has to do with laboratory workforce. We have reasonable number, but it is not enough. What has happened in terms of laboratory service sin this country is that there are a lot of charlatans in the system, where as those who are qualified are not having the work Those who have no business are there. 
This also has declared zero tolerance to quacks in the set up. Zero tolerance to substandard products, zero tolerance to untrained and uncertified human resources. It is part of want to ensure that no laboratory in this country whether public, private, faith based, community based, should be carrying out testing of human or animal specimen without having the component of external assurance. You cannot stand on your own and think that what you generate is accurate and reliable. We have said in several fora that laboratory service result bring in empirical data, science into healthcare delivery; very important. But once the results are not accurate, it is better we don't have them at all. 
So, every body has a part to ensure that we have quality, accurate and reproducibfe result For you to get that, there are indices that you need to consider and ,take into place. There are 17 key objectives and five goals that have been covered in that strategic plan. 
What are the main plans in the area of human capadty? 
We have 19 universities accredited by Council. We also have over 40 colleges of health technology. The 19 universities train medical lab scientists. The over 40 colleges of health technology train medical lab technicians and medical lab assistants. 
Council oversees the quality of the training. Council also gives approval for their carrying capacity. Our plan is that over the next 10 years, we should have add 10, 000 added to the stock of what we have now, taking into cognizance the carrying capacity in every university and the various colleges of health technology. 
What about the lab the president commissioned recently in Lagos, how is it performing? 
The Public Health In-vitro Diagnosis Control Laboratory that the president commissioned last December in Lagos is essentially there to fulfill one of the mandates Council that has to do with regulation, production, importation, use of in-vitro diagnosis in terms of laboratory reagents, chemicals, test kits, associated technologies and equipment. With the commissioning of the laboratory we have now put the processes in place. We have gone far. We have gotten human resources, we have gotten the materials to work with in the laboratory, we have gotten the Central Bank of Nigeria to put in place use of Council's certification as a prerequisite for granting approval for importation in terms of payment (forex). 
We are now in the process of getting the other stakeholders' key in. That is where we are now. We are ready. We have commenced registering the importers and manufacturers and distributors of these products. We want to ensure that anybody who has to market these products will be captured in our database and not just from the site of importation, where the office is Iocated, who are the directors, outlets across the country, among others. We are on that right now. When we are 
through with that, concurrently, we are product registration. We are sure that by the time we put all these things in place, and running fast fairly, the issue of substandard and fake diagnostic kits and reagents in the market would have dropped by more than 50 per cent where it is downwards. 
The challenge we have in the laboratory sector, the challenges we have with medical diagnosis based on laboratory is contributing significantly to substandard products, where we are having over 50 per cent of the products in the market being substandard for these diagnostics. For food and drugs, which NAFDAC oversees, they are less that 20% because of the continuous work in that area. That is what we have now restructured to do for the diagnostic market Moving now to those at the receiving end, you started a campaign that if people don't see your logo, they shouldn't use certain facilities. Where are you with that? We have done a reminder across to all providers of lab services, that the law is explic- It on this. Council is structured to maintain good standard of medical labs and services including mandatory inspection, approval and monitoring of all medical laboratories in Nigeria. 
We have done a reminder to them all again that any laboratory; wherever it is located; that has not gotten the approval of Council whether registered with state ministry of health or not, you have to get mandatory Medical Lab Science Council of Nigeria approval. For those places that we have approved, you will see our logo or sign. 
We have over 10,000 labora- tories in this country; less than 3000 is in our database. That is not satisfactory. 
Are those the orily ones regis- tered? 
The ones we have approved, as required by law. If you say reg- istered, ok, Most of the others are not yet We are passing a message across so that every body begins to know about it before we get back to the field and start sealing them for non-compliance. That seems to be the only language some people understand. They wouldn't ordinarily want to comply with the law until you start using enforcement and coercion, which is not the best. But we have no choice than to go that way f they don't go into the system properly. 
What are the technical differences between accreditation and registration? 
For a lab to run, you need to have approval. If it is a public laboratory, there is a law establishing the institution, or an edict, depending whether it is state or private. If it is private institution, you need the Corporate Affairs Commission (CAC) and of course, you have to register with the state ministry of 
health. 
But more importantly; when you have gotten this, you have to apply to Council to tell Council that you are desirous of establishing a diagnostic laboratory; a medical laboratory for purposes of processing human specimens and issuing out results. Council then sends its inspectors to look at what you have, not just in terms of infrastructure, in terms of personnel and in terms of processes. Once these gets back to us, we look at the report, then approve or not to approve or ask you to do additional things. It is only when you have gotten that that you are now in database of council. In essence, you are now formally recognized as a medical 
laboratory. That is step one. Step two is that now laboratories are encouraged to improve their quality so we expect you to do two things. Get into the national database by which you have now being approved, and then you have to key into external quality assessment. Council has a national EQA laboratory in Zaria at the National TB and Laboratory centre. You key in there and we start sending periodic panels to you. Panels that mimic human specie with which you can carry out different tests and then we get your results periodically. We have a national EQA team (COf- rective action committee). As we send these panels to you, you process them the way you process routine specimen. 
It is critical that every lab be in the national database. It is critical that every lab enrolls into the national EQA program, and then also it is important that every lab now enrolls into the national continue quality improvement. 
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