The regulatory framework in pathology across developed countries is way ahead of that in developing nations. In the UK, the regulatory framework is led by The Royal College of Pathologists and CLIA (Clinical Laboratory Improvement Amendments) and in the US, by The College of American Pathologists. If one looks at the US, the entire healthcare industry is regulated by a host of bodies, including the Joint Commission and Food and Drug Administration.
The scenario in India is an absolute contrast. India today has over 1,00,000 laboratories and only about 20 per cent of these are part of the organised sector. The rest of the industry is highly fragmented, unregulated and unfortunately, do not adhere to minimum standard requirements. Incorrect sample collection procedures, inaccurate testing protocol and non-adherence to guidelines are rampant in the industry. Additionally, many citizens are ignorant about accreditation and do not take enough care in choosing the right laboratory.
For instance, there is no policy or guideline for setting up and operating clinical laboratories. The Clinical Establishment Act is not implemented in most states.
Only recently, the Supreme Court has ruled that all laboratory reports should be signed by a registered medical practitioner, as per the Medical Council of India guidelines, but adherence is to be seen.
The National Accreditation Board for Testing and Calibration Laboratories (NABL) is the nodal agency for accreditation of laboratories, but it is not mandatory. According to details on the NABL website, 783 medical laboratories have been accredited as of January 31, 2018. It means less than 1 per cent of the total laboratories in the country got accreditation.
Time and again, various reports have emerged on unethical practices followed by laboratories. In an extreme case, reports were given out even without testing. In the most recent case that came to light, about 23,000 reports were handed out of a small dungeon 'lab' at Adarsh Nagar in Delhi. In other instances, reports were given without a pathologist reviewing and signing it.
The basic principles that drive the development of regulations, standard guidelines and benchmarks are based on the impact on patients' lives, effectiveness, affordability and adaptability to different settings. Also, any regulatory framework should be amenable to frequent updates and modifications, and also take into account the ease of implementation.
While achieving accreditation is the best available solution for the industry, it is not easy and may not be feasible for smaller laboratories. Lack of resources, training and readily available reference materials pose serious impediments to the accreditation process.
The road to accreditation is a long process and begins with the ability to achieve analytical quality. None of the other qualities will matter unless analytical quality is achieved. Internal quality control and external quality assessment schemes (also called proficiency testing) are used to evaluate and continuously improve analytical quality. Using a defined, standardised approach simplifies the accreditation process and also facilitates its wider introduction and use throughout the nation.