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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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