This is an excellent development for all professionals of the Ghana Association of Medical Laboratory scientists as Ghana Standards Authority (GSA) moves to adopt the International Organization for Standardization (ISO)’ s document (ISO 15189) for the practice of Medical Laboratory science in Ghana. It is not only good news for the professionals but for the Ghanaian public as well. The diagnostic sector is the center of modern medical care hence lack of standardization in that sector only puts the public at risk of complications from traditional reactive medical care that the world is moving fast away from.


Every student of the history of medicine knows that it started as a science. It can be argued that the father of Medicine Hippocrates was in fact a medical scientist. However, this article is not about the history of medical practice. In modern history the practice Medical Laboratory Science evolved from the mainstream Medicine in 1896.

This means Medical Laboratory Science as a profession is here for just a little over a century. This brings to bear the exponential nature the profession is growing globally. The reason for this is the relevance the laboratory to medical care and the growing global requirement of evidence based medical practice.

I have made it clear in an earlier article –the hospital’s unseen hero on how the medical laboratory practice in Ghana is not being given the needed attention to meet the global healthcare standards.

The Ghana Association of Medical Laboratory Scientist (GAMLS) has fought endlessly towards standardization of the sector. The problem was initially with the regulation of the profession as people who studied in the stand-alone biological sciences all ended up trying to handle patient samples. In the document by GAMLS in 2016 clarifying its position on the practice of the profession post Act 857, it is stated that “The absence of regulation created a phenomenon where individuals who had completed qualifications in Oceanography, Chemical Engineering, Natural Resources, Chemistry, Physics, Botany, Science Laboratory and other Basic sciences and some without any qualifications were employed in both public and private facilities as Medical Laboratory Science (MLS) professionals sometimes with or without any form of professional orientation or training.”

But now it is about  standardization of the practice the Medical Laboratory Science profession.
The struggles intensified after a draft was put together by a committee supported by the Center for Disease Control and prevention (CDC) of the USA. The document was supposed to be implemented in a span of 5 years from 2013 which was signed by the then minister of health as explained in the the hospital’s unseen hero.

The Health Professions Regulatory Bodies Act, 2013 (ACT 857) is the law that spells out the procedures for registration and practice for all recognized health professions in Ghana.
The act makes clear who is qualified to practice Medicine as well as who is qualified to practice the Medical Laboratory Science profession.

Section 1 of the Act establishes the Allied Health Professions Council (AHPC) to regulate the profession of Medical Laboratory Science. The schedule of Allied Health Professions defines Medical Laboratory Science as the study and practice of laboratory investigations necessary for the diagnosis and treatment of diseases by health professionals including Medical Laboratory Scientists, Medical Laboratory Technologists, and Medical Laboratory Technicians.

In spite of the clarity of the law on this, some Physicians (Medical Officers) who are members of the Ghana College of Physicians and Surgeons (GCPS) and another group who call themselves the Medical Scientists Society of Ghana (MSSG) was able to stop the policy from a smooth implementation with claims that parts of the policy was against their ‘interest’.

They thought that the Medical Laboratory Scientists of Ghana were not qualified to manage their the Medical Laboratory. As explained earlier it is like lawyers making claims to be head of schools. This group of people still want to live in the era where the Scientist was trained on benches. Unfortunately for them, today not only do the profession include innumerable first degree holders, it has almost equal number of Masters and PhD holders and even professors. Now there is a professional Doctorate of Medical Laboratory science which equates the Doctor of Medicine, Optometrist etc. Just few weeks ago the first purely locally trained Medical Laboratory Scientists who is chemical pathology consultant and Dean of School of Allied Health Sciences, University for Development Studies, Tamale  –Dr. Nafiu Amidu was awarded a professor. What again do they need in order to manage themselves?

It is against this background that the adoption of the ISO15189 development comes as a big win to the Medical Laboratory Professionals but most importantly to the Ghanaian public.

Major highlights

In the Forward of the document, GSA stated that the Ghana standards for Medical Laboratory practice are identical to the International Organization for standardization ISO 15189: 2012 Medical Laboratories –Requirements for quality and competence.
The committee that was responsible for the development of the standard GS ISO15189: 2012 (2017) was the National Technical Committee for Quality Management Systems (GSA/TC 18)

The policy explains in clear terms who is a Medical Laboratory Scientist as well as who is qualified to manage the medical laboratory. This settles the major concern of both the Ghana College of Physicians and Surgeons (GCPS) and the Medical Scientists Society of Ghana (MSSG).

The document also requires the establishment of a directorate for the Medical Laboratory Profession and goes further to state who is qualified to be the director for this directorate.

In the standards document, Medical Laboratory is defined as laboratory for biological, microbiological, immunohaematological, haematological, biophysical, cytological, pathological, genetic or other examination of materials derived from the human body for the purposes of providing information for diagnoses, management, prevention and treatment disease in, or assessment of the health of, human beings, and which may provide consultant advisory service covering all aspects of laboratory investigation including interpretation of results and advice for further investigations.

What the adoption ISO 15189 stands for

Ghana Standards Authority as an affiliate of the International Organization for Standardization adopted this document as a requirement to improve medical care in the country. This is to be achieved by strengthening the diagnostic sector with the needed infrastructure and human resources.

On the legal bases this means that Ghana cannot enforce any policy that will go contrary to the standards enlisted in the document.

I think that as a matter of urgency, government ought to be ruthless in implementing the National Health Laboratory Policy. why so? The ISO 15189 already covers almost all the major aspects of the policy so why keep it on the shelves any longer?

GAMLS also need to continually push for the full implementation of the standards as we await on a decision from the ministry regarding the policy implementation. Also, adoption of the standards does not necessarily mean implementation and this should be seen only as the beginning and not the end.

The document calls for continual development as a profession which means even after the full implementation, the profession has to always make adjustments to follow global scientific advancements.

It is also important for the Ghanaian public to be aware of this development and what it means to their safety and well-being when visiting the hospital. The laboratory is responsible for 60 to 70% of all clinical decisions regarding patients’ care thus more attention should be accorded to this sector.

There is the need to know that all the strikes and hustles by GAMLS have always been about the policy and standardization and not necessarily their condition of service. They fight to get the necessary environment to practice in order to meet the standards of health needs. The fight should therefore not be left for them alone; it’s a fight for as all.

As the voice of the public I want to know;
  • What is next after the adoption of the standards?
  • What is GAMLS role in seeing to the full implementation of the standards?
  • What is the maximum period for the implementation of the requirements of the ISO 15189
  • What should the ordinary Ghanaian expect?
  • Is this a development for the ordinary patient or just another headline-making move?

The interesting fact is that there is no established group of people termed as patients. Today you may be a minister of state, lawyer, law maker or even a physician and a patient helpless on the hospital’s bed the next day. We therefore need to take health policies as serious as possible. Let’s not leave the fight for standardization of practice in the hands of only the professionals of interest.

The media is not helping at all in this regard. It is unfortunate to see that when Sarkodie coughs, it makes front pages; when a bicycle hits a goat on Tema motto way it makes headlines yet the policies that determines how we are treated in our most vulnerable condition is left behind the scenes.

In as much as it is an excellent move by GSA adopting the international standards, it is left on to us the public and to the professionals of interest –Ghana Association of Medical Laboratory Science to put the government to its toes. Efforts have to be made to push the policy makers to implement either the National Health Laboratory Policy or at least see to the full implementation of the ISO 15189.

The Medical Laboratory is the beginning of every lifesaving medical care. When the diagnoses is weak there cant be proper treatment. When the laboratory is left to rot, patients die from erroneous decisions.  

Ghana Medical Laboratory Quality Standards: a way forward
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Ghana Medical Laboratory Quality Standards: a way forward
The Ghana Standards Authority have adopted ISO 15189 as a standard for the practice of Medical Laboratory Science in Ghana. This comes as an excellent news for the Ghanaian healthcare system but I like to caution that The Ghana Association of Medical Laboratory Scientist (GAMLS) have to make efforts to push for the full implementation as fast as possible.
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Ehm Kannde Notes
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