Making health care healthy
WE have a drug policy and a regulatory authority like Drug Administration to monitor manufacturing and sale of safe drugs. Even then some unscrupulous people have been manufacturing drugs with poisonous compounds. Poisonous paracetamol is thought to have recently caused the death of more than twenty children. Bypassing the surveillance system of the Drug Administration some pharmaceutical companies manufacture low quality drugs and market them in rural areas.
Let us look into the state of another important area of health care, the medical diagnostic testing services in our country. Diagnostic service is an essential component of the medical system, and high-quality clinical laboratory services are critical for effective patient management. A diagnostic test is one of the most important parameters on the basis of which a patient gets right and timely treatment from a doctor. The laboratory test results must be accurate because misdiagnosis can give rise to wrong treatment, which results in increased cost and sometimes in death.
Allow me to relate a personal experience. Recently, a friend's minor daughter was admitted into a city hospital with prolonged high fever. Her physician had done some diagnostic tests but the laboratory results did not match the clinical symptoms of the patient. The results of platelet count and dengue virus antibody test were in conflict, making it difficult for the doctor to prescribe the treatment. So, the doctor was compelled to send blood specimen to another diagnostic laboratory.
The test results from the second laboratory came out different, but closer to the clinical symptoms of the patient. The utterly frustrated father of the child took the blood specimen to another laboratory for a third opinion before the doctor started the treatment. This is not an isolated incident. Patients have regularly received faulty diagnostic results, causing wrong treatment and increased suffering.
Why does this happen? What can be done to get rid of this and ease the sufferings of patients?
The quality of test results from any laboratory is influenced by the technical expertise of the personnel, quality of diagnostic reagents/kits used for the test and regular calibration of the instruments used. Moreover, measures to control the quality of the test results in a diagnostic laboratory are extremely important, along with the administrative measures employed before, during and after each assay. In an ideal laboratory setting, a good quality assurance program is designed to monitor this.
Quality assurance ensures producing the right result at the right time on the right specimen from the right patient, with the right interpretation based on correct reference material and equipment. Quality assurance includes quality control and quality assessment, and must be supported with effective safety procedures, decontamination and sterilisation process and equipment maintenance.
In Bangladesh, diagnostic laboratories have grown very fast in the last two decades. There are some first-rate diagnostic laboratories, and some are even moving towards international recognition through maintaining high standards. But in absence of policy guidelines and strict regulatory measures, most of the diagnostic laboratories do not implement quality control programs.
Reagents and kits are crucial for assuring quality laboratory results, but there is no policy guideline or regulatory authority to ensure their quality. These reagents are imported and sold to diagnostic labs through local traders. Recent technological advancement in the field of biotechnology has made the diagnostic kit manufacturing process easier than before. This has created scope for local traders to import kits from different manufacturers but has raised serious concern about the quality of these imported materials. We do not have adequate infrastructure and mechanism to assure quality of diagnostic kits, which is why the laboratories are being offered sub-standard diagnostic kits.
For the sake of ensuring high-quality laboratory testing services it is necessary to have quality reagents. This can be achieved by adapting policy guidelines that can be implemented through a national regulatory authority in whom all the legal powers will be vested. It is also necessary to establish an independent National Reference Laboratory (NRL). More than one laboratory may be designated as NRL for a specific category of diagnostic kits. These laboratories must have quality management system and meet high standards to provide technical support to the National Regulatory Authority (NRA) in all matters pertaining to diagnostic kits.
The government should also constitute an advisory committee for the NRA and the NRL, which will undertake evaluation of diagnostic kits. NRA, on the advice of the committee, should develop guidelines based on international criteria for manufacturers/importers to get the quality of diagnostic kits assessed for certification, licensing and registration. Moreover National External Quality Assessment Schemes must be initiated and the results of these NEQAS should be made available to the NRLs to monitor their competence and also to indicate the performance of various kits that have been used.
Our country needs cost-effective and quality diagnostic services. Problems associated with diagnostic laboratories should be assessed and monitored for the sake of ensuring quality health care services. This can be done through establishing strong infrastructure and proper regulatory environment under appropriate policy guideline. Having a good quality assurance program and participating in the external quality assurance schemes will assist the diagnostic laboratories to improve their service and ease patients' sufferings.