Saturday, 5 March 2016

Tough times await fake, substandard labs

Imagine a patient reporting to a hospital with lymphoma, a potentially curable disease. Unfortunately, given its clinical similarities to tuberculosis (TB), lymphoma was misdiagnosed and the patient treated unnecessarily with potentially harmful TB medication.

Research has shown that about 70 per cent of the indices required for effective disease management or surveillance emanating from the medical laboratory.

A patient who visits the hospital expects that the symptoms presented will prompt the proper diagnosis, leading to a successful treatment and recovery. But, negligence leads to misdiagnose of a condition, creating additional health concerns for the patient.

The Medical Laboratory Science Council of Nigeria (MLSCN) has therefore embarked fresh regulatory exercise towards achieving quality laboratory diagnosis across the country. MLSCN has also restated its vows to shut down any facility which are illegally operating without the council’s certification and below its standards.

Already, 28 laboratories have been sealed in Lagos, while four persons are now under the police net for failure to meet the council’s minimum operating standards, following the inspection of 116 facilities in one week.

Announcing this on Tuesday in Lagos to journalists, was the Chairman, MLSCN Task Force on Laboratory and IVDS Inspection, Dr. Lawrena Okoro, who confirmed that of 116 facilities inspected in one week, the council shut down 28 laboratories with four arrests due to non-compliance to the council’s guidelines.

Okoro who said it will no longer be business as usual as quality medical laboratory services is the benchmark for international best practices.

According to the Chairman of MLSCN, “It is important to reiterate here that the Medical Laboratory Science Council of Nigeria is the only agency empowered by law as enunciated in Cap M25, LFN, 2004 to:    Inspect, regulate and accredit medical laboratories, including those in hospitals and adjoining clinics.

‘’ It also determine from time to time the standard of knowledge and skill to be attained by persons seeking to become Medical Laboratory Scientists, Technicians and Assistants. It regulates the practice of Medical Laboratory Science in Nigeria as well as regulates the production, importation, sales and stocking of in-vitro diagnostics.’’

She said that the recent pronouncements of the National Industrial Court (NIC) have also reinforced the sanctity of this mandate, adding that, to achieve the foregoing mandate, the council has articulated and launched a set of various guidelines and standards for services and practice.

She stated that the National Guidelines for Setting up a Medical Laboratory in Nigeria includes the following; ‘’Regulations for Registration, Approval, Monitoring and Accreditation Guidelines to Medical Laboratory Continuous Quality Improvement and Accreditation and for Laboratory Design, its MLSCN Approved Guidelines.

‘’These tools have been deployed to guide stakeholders accordingly and also to ensure that there are no justifiable reasons for any practitioner, or any facility, to engage in unethical practices. It can no longer be business as usual in the medical laboratory services sector,’’ she added.

Dr.  Okoro said that the Task Force, which is poised to go round the country, is already in Lagos with the intension to lead from the front, and to actualize as soon as possible the goal of irreversible transformation of the medical laboratory services sector.

She however pointed out that quality service delivery is the hallmark of every strong, robust and prosperous healthcare sector, ‘’more than ever before, we must be resolute in our commitment and drive towards its achievement. This is at the heart of Council’s vision of becoming a world acclaimed regulatory agency. In this regard, we are already combing the nooks and crannies of this mega city, flushing out quacks that have no business being in any medical laboratory; we shall rid facilities and markets of fake or substandard reagents, kits, chemicals, equipment and consumables.

‘’In doing so, we have sometimes encountered encumbrances along the way, including the nefarious operators that bolt away on sighting members of the task force, and those who remove their signs and pretend they never really existed. Some of the facilities were also found to be operating without regard for the approved guidelines.”

Collaborating, Mr. Godwin Aikpitayi, Deputy Director and Team Leader for Lagos Task force on In-Vitro Diagnostic medical Devices (IVDs) Inspection, said that every single result or report originating from any medical lab facility in this country should be accurate, reliable and reproducible. It is also to ensure that the right policies, processes, personnel, environment, equipment and of course iÍn-vitro diagnostics are deployed towards accomplishing these standards so that patients can expect the best outcomes in the management of their ailments.

He also said that these efforts have become necessary considering that research suggested that about 70 per cent of the indices required for effective disease management or surveillance emanate from the medical laboratory.

He also confirmed a total of 116 facilities were visited out of which 28 were sealed for failing to meet minimum standards, or for operating without Council approval or both within the first week of the National Task Force working in Lagos. He added, four persons were arrested for quackery and impersonation.


This story was published in Newswatch Times on February 25, 2016.

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