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Issues In Regulation Of Medical Laboratories In Nigeria by Nobody: 7:48am On Feb 01, 2015 |
PUBLIC NOTICE The attention of the Association of Pathologists of Nigeria (ASSOPON) has been drawn to a publication of the Medical Laboratory Science Council of Nigeria (MLSCN) on page 32 of the Guardian Newspaper of March 3, 2014. The publication was in response to an earlier one made by the Medical and Dental Council of Nigeria (MDCN) in the Guardian and Daily Trust newspapers of February 24, 2014, which in turn was in response to an earlier public notice published on page 79 of the Guardian Newspaper of January 30, 2014 by MLSCN. The subject matter of all the publications border on Regulation of Clinical Laboratory Practice and performance of associated regulatory activities. We deemed it expedient to break our silence at this point because we were mentioned in one of MLSCN’s publications, and also out of deep concern for the unsuspecting and poorly informed members who may be misled and consequently injured by the incorrect information that riddled the MLSCN’s publications. Since patient care is the object of doctors’ training and practice we need to come to the aid and defense of patients or potential patients whenever their safety is threatened. Without holding brief for anyone it suffices to state that the MLSCN has over the years exploited the gentleness and maturity of the leadership of the MDCN to attempt to cross professional and regulatory boundaries, visiting medical practitioners with what is best described as organised thuggery in the name of carrying out regulatory duties. It is pertinent to remind the MLSCN of certain facts it tends to overlook or often disregard: That there was no discipline or profession called Medical Laboratory Science (formerly Medical Laboratory Technology ) anywhere in the world until Pathologists (Laboratory Medical Physicians) conceptualized, established and developed the training curriculum and trained persons to become who they are, as assistants to them (Pathologists) in Clinical Laboratory Practice. That prior to the award of the first certificate to a trained Medical Laboratory Technologist, Paul H. Adams in 1922, in the state of Indiana USA, pathologists had operated alone in clinical laboratories for centuries. This they did to have room to explore and discover new frontiers of knowledge while leaving routine activities to their assistants. That clinical laboratory practice is at the soul of the practice of Pathology (a specialized branch of Medicine). This naturally places the responsibility and liability for quality testing on the professional with ultimate responsibility- the Laboratory Medicine physician (the Pathologist). Indeed prior to the enactment of the Medical Laboratory Science Council of Nigeria Act in 2003, Pathologists were statutorily members of the Governing Council of the regulatory body of medical laboratory science and technology. Beside the MDCN which regulates the professions of medicine, dentistry and alternative medicine practice, there are 13 other regulatory bodies that regulate other professions and occupations in the health sector. This is so because of the recognition of the fact that though persons registered as medical practitioners by the MDCN are trained to practice all aspects of medicine, there are other persons who though not registrable as medical practitioners, are trained to carry out some specific functions related to medicine. MLSCN is one such regulatory body. Its regulatory functions are restricted to persons registered under the MLSCN. This was exactly what the MDCN said in her publication of Monday February 24, 2014 on page 32 of the Guardian Newspaper when it emphatically stated that “For the avoidance of doubt, medical doctors and dentists who are fully registered with MDCN do not come under the purview of any section of the Medical Laboratory Science Council of Nigeria Act, cap M25 LFN2004. ASSOPON believes that this is clear enough for any well-meaning individual or group to understand. Therefore, the attempt by the MLSCN to regulate or exercise regulatory authority over Pathologists is provocative, mischievous, delusional and a veritable attempt to advance the frontiers of the crises in the health sector. The MLSCN will do well to cure itself of self-inflicted paranoia. We wish to remind the leadership of MLSCN of the ugly event of HIV-positive blood transfusion into an innocent baby in a Lagos hospital a few years ago. The quality system had broken down due to the intransigence of the bench staff. After a high-powered investigation by the Federal Ministry of Health, the Pathologists were sanctioned for not providing effective supervisory leadership of the laboratory. This was despite the fact that the bench staff performed the screening and prevented the Pathologist from reviewing the entire process. The reason given for the weighty sanctions was that the pathologist has ultimate responsibility and liability for the quality of results from his laboratory. This is well understood and held as a global best practice. The MLSCN in her later publication made reference to the clamour in the House of Representatives on the need to curb poor test results issued by medical laboratories. It however, failed as expected, to acknowledge the fact that the clamour was the fall out of an alarm raised by the ASSOPON in a press conference in Abuja on April 24, 2013 to the effect that over 50% of our medical laboratory test results are unreliable. This was carried by virtually all papers in Nigeria including the Daily Trust on the 25th of April, 2013. The Daily Trust Newspaper of 10th May, 2013, made it an editorial comment, and pleaded with the Pathologists to come to the rescue of the nation. That editorial was highly instructive. Unfortunately, the war in clinical laboratories orchestrated and sustained by MLSCN and allies have denied Nigerians of the benefits of having Pathologists in numbers in the health system. At the 1st international conference of the African Society For Laboratory Medicine(ASLM), in Cape town, South Africa in December 2012, the South African Health Minister, Dr Pakishe Aaron Motsoaledi, in his address to the conference explicitly said “… our laboratories in South Africa are working because we have many pathologists…”. The leadership of MLSCN as well as Nigeria’s Hon. Minister for Health Prof. Onyebuchi Chukwu were present at the conference. ASSOPON notes with disappointment the dubious impression being created in the minds of Clinical Laboratory Operators that Strengthening Laboratory Improvement Process Towards Accreditation (SLIPTA) and Strengthening Laboratory Management Towards Accreditation (SLMTA) represent accreditation rather than what they really areSLIPTASLMTA, as their names even suggest, are not accreditation but accreditation preparatory programmes put in place to help mentor laboratories to be able to measure up to a standard where they can voluntarily invite accreditation bodies of their choice to assess them for accreditation. Therefore, the award of ‘five star’ accreditation certificates to unsuspecting institutions is therefore a huge joke and deception. The fact is that at present there are only two bodies in sub-Saharan Africa that have the capacity and have been certified and authorised by the International Standards Organisation (ISO) to accredit clinical laboratories at international standards; they are the South African National Accreditation Service (SANAS) and the Kenyan Accreditation Service (KENAS). The only two clinical laboratories in Nigeria that have international accreditation are the Pathcare Laboratories at Lagos and Abuja respectively – which were accredited by SANAS. ASSOPON wants to state for the benefit of the public the following: Quality practice in the clinical laboratory can never be achieved by any one group of professionals and staff in the clinical laboratory. It is the product of the contributions of members of various laboratory professional groups, as well as others such as clerks and cleaners. There is no form of enactment that can outlaw or over-turn nature. Pathology remains the primary profession in the clinical laboratory practice all over the world. Being a medical specialty the Pathologist remains the top-most in the hierarchical order with ultimate responsibility for decision making. With regard to the registration of laboratories and other health facilities including hospitals and clinics in Nigeria, the State Governments through their relevant health agencies or departments, have the exclusive statutory responsibility to register such facilities. Only a State Government can authorize and license the establishment and operation of any of these facilities. No other body, including MLSCN has such powers. Accreditation of laboratories, and indeed, any facility is a voluntary exercise, and undertaken at the discretion and invitation of the operator of the facility. You cannot suddenly appear in a facility that has not prepared for a process or invited you for accreditation to accredit it; that will be ambition taken too far. Not even in the USA do we have up to 30% of the laboratories seeking accreditation. You cannot suddenly appear in a health facility caring for very ill patients which has not prepared for such a visit or invited you to accredit it. This Rambo-style of operation falls short of the ideals of global best practices in accreditation of health-care facilities. International best practice for operation of health facilities is that the registration authority sets a standard which any operator must meet before being issued with operating licence. It must maintain the minimum standard to remain in that business. The facilities are monitored and inspected at periodic intervals to ensure they maintain the minimum standards by the licencing authority. This explains the existence of an Inspectorate Division in every state Ministry of Health and the FCT. ASSOPON condemns in no uncertain terms the ‘divide and rule’ tactics being employed by the Centre for Disease Control (CDC) and its implementing partners in Nigeria. The CDC cannot, and is not in a position to dictate to Nigeria; and her activities tantamount to interfering with the internal affairs of a sovereign country. CDC would do well to advise its implementing partners as to what obtains in its parent country – the USA. The Centre has been operating her support services in Nigeria as if Pathologists do not exist, while in her parent home Pathologists do not only superintend over laboratory practice but largely constitute the governing board of the most prestigious Certification agency for laboratory professionals such as the American Society for Clinical Pathology (ASCP). The domiciling of SLIPTA/SLMTA activities directly in CDC Nigeria has been the bane of the programmes, and need to be quickly reviewed for progress. As it stands today, it is only the MDCN that has the regulatory standards for different levels of laboratory, and operates in collaboration with the State Governments in realisation of the fact that the ultimate power over facilities in the states (other than Federal Government facilities) resides with the State Governments. The Lagos State Government, for example, regulates all health facilities in its jurisdiction in accordance with the Health Facility Monitoring and Accreditation Agency (HEFAMAA) Act. THE WAY FORWARD Now that the MLSCN has finally accepted that there are issues with test results, when it said ‘… as fellow citizens deserve better than the status quo exemplified by inaccurate and unreliable test results, quackery, forgery of test results etc.’, it behoves it to seek collaboration and partnership with all bodies involved in laboratory operations such as MDCN , Scientific Officers, Research Scientists, Hospital Administrators, Clinicians, States and Federal Ministries of Health etc. so that jointly we can raise our standards of practice and pursue a common agenda for the good of our citizens. This is the approach being adopted elsewhere and MDCN has adopted it. Violence, aggression, thuggery and turf protection or frivolous claims will yield no positive result. Life is too sacrosanct to be made an object of political or professional intrigues and manipulations. Team work presupposes that there is a leader to which every member of the team subordinates him/herself for order and desirable objectives to be achieved. The MLSCN and allies must learn with utmost diligence the rudiments of team work in health care delivery and recognise that their expressed, as well concealed hunger for autonomy can be accommodated in a team where everyone knows his role and respects his boundaries. Autonomy should not equate to acrimony and attempts at undermining other members of the team. The spurious claims and campaign of hate which as cancer, has eaten deep into the rubrics of the once flourishing health sector and consequently destroyed it, is a lugubrious commentary on the dark pages of our history book as a people. The leadership of MLSCN must be called to order and made to understand that it is an agency of Government under authority, not a labour union or political party. While we concede that as a result of the level of our socio-economic development, a few things are peculiar to Nigeria, it must never be allowed to reach the ludicrous state whereby a ‘tail seeks to actively wag the dog’. Finally, we reiterate the statement of the MDCN that “it wishes to inform all registered Medical and Dental Practitioners that they are entitled to practice all aspects of medicine to the extent of their expertise and experience. Such duly registered Medical and Dental Practitioners owe no allegiance whatsoever to any other health regulatory agency other than the MDCN”. We whole-heartedly adopt this as our stand. Pathology practice and training, which involves all aspects of Medical Laboratory Science and much more, MUST be practiced and taught by all pathologists without let or hindrance. Anything short of this will not augur well for our system. We assure Nigerians of our commitment and determination to work assiduously towards offering them high quality Clinical Laboratory Services in collaboration with all relevant and willing stakeholders. Signed: National Secretariat For ASSOPON. |
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