The Government of India has recently issued a Gazette notification for Medical Diagnostic Laboratories. Learn more about the notifications, who they cover and how they may affect you?
Clinical diagnosis and treatment protocols are now highly dependent on different types and kinds of test/Investigation reports. This style of practice is referred to by an umbrella term called “Evidence based Medicine”. The shift to Evidence based Medicine is driven by changes in patient’s disease profile and the environment.
While the merits of this dependence on “report-based treatment” continue to be debated, the fact remains that modern diagnosis and treatments are no longer empirical based. A clinician is dependent on these test reports in their practice and in the case where these reports are erroneous both the diagnosis and treatment can go horribly wrong.
Till date there were no clear-cut guidelines for Medical Diagnostic Laboratories to follow but now that has been rectified. The Government of India has issued a gazette notification on the “Minimum Standards for Medical Diagnostic Laboratories”
The Minimum Standards for Medical Diagnostic Laboratories (or Pathological Laboratories) cover every clinical establishment relating to diagnosis or treatment of diseases, where pathological, bacteriological, genetic, radiological, chemical, biological investigations or other diagnostic or investigative services, are usually carried on with the aid of laboratory or other medical equipment. These institutions must comply with the minimum standards of facilities and services as specified in the Schedule.
This notification has classified these establishments under the following three categories of entities
- Basic Composite
- Medium
- Advanced
The requirements for each category of establishment have been further divided into “desirable” and “essential.” The standards cover the following areas:
- Infrastructure
- Human resource
- Instruments and medical diagnostic equipment
- Processes and protocols
- Legal & statutory requirements
- Record maintenance
Any move taken towards standardization of quality of treatment is to be lauded. Creation of such standards is a step in the right direction taken by the government in the interest of protecting the patient and doctors.
For more details please download and read the complete gazette notification by clicking here.
