In order to standardise healthcare services, the Health ministry has proposed a set of "minimum standards of facilities and services" that has to be adhered to by clinical establishments offering allopathy and AYUSH mode of treatments for obtaining registration. According to the "minimum standards" proposed in the amendments for the Clinical Establishment (Central Government) Rules, 2019, health facilities not complying with prescribed norms in terms of infrastructure, manpower, equipment, drugs, support service and record registration will not be granted registration.
Clinical Establishment (Registration and Regulation) Act, 2010, makes registration a must for running a clinical establishment. "At present, minimum standards are available only for medical diagnostic labs which were notified in May 21, 2018. The proposed amendments are aimed at bringing an uniformity in standard of healthcare services provided by several establishments," an official source said.
The draft notification on Clinical Establishment (Central Government) Third Amendment Rules, 2019, have been put up on the website of the Health Ministry and comments have been sought from stakeholders within 43 days.
According to the proposed standards, the physical facility shall be developed and maintained to provide safe and secure environment for patients, their families, staff and visitors and should be situated in a place having clean surroundings and shall comply with local by-laws in force, if any, from time to time.
There has to be a minimum space requirement for carrying out basic functions of the facility as prescribed in the rules. "The clinic facility shall be well illuminated, ventilated and clean with adequate water supply. It shall have a prominent board or signage displaying the name of the clinic in local language at the gate or on the building of the clinic," the draft amendments stated.
Besides, the name of the doctor with registration number, fee structure of various doctors or specialists, timings of clinics and services provided within the facility should be well displayed in signages in language understood by the local public in the area. Under the category of Human Resource, the proposed standards state that the general practitioner or specialist doctor or super-specialist doctors as per the scope of the clinic or polyclinic shall be registered with State or Central Medical Council of India.
"The services provided by the medical professionals should be in consonance with their qualification, training and registration. In a clinic or polyclinic, minimum one support staff must be available to meet the care treatment and service needs of the patient.
"However number may depend upon the workload and scope of the service being provided by the clinical establishment," the draft notification read.
These set of common minimum standards framed are applicable to a single practitioner or more than one doctor clinic manned by a General physician or specialist doctor or super specialist or a group of doctors who are themselves providing patient care services like dispensing of medicines, Injection and dressing.
The Health ministry from time to time has been writing to States and UTs to implement the Act citing alleged malpractices including exorbitant charges, deficiency in services, not following standard treatment protocols, etc in health facilities, resulting not only in compromised patient safety but also concerns about transparency and accountability in healthcare costs.
The clinical establishments act was been enacted by the Centre to provide for registration and regulation of all clinical establishments in the country with a view to prescribe minimum standards of facilities and services provided by them.
The act is applicable to all types (both therapeutic and diagnostic types) of clinical establishments in the public and private sectors. Till now, eleven states including Arunachal Pradesh, Himachal Pradesh, Rajasthan, Jharkhand Mizoram, UP and Uttarakhand have adopted the act but many of them are yet to implement it.
Health being a state subject, the Centre cannot force the states to implement it. Under the act, standard treatment guidelines are specified for 227 diseases, including dengue, chikungunya and malaria.
A technical committee is to be set up to decide on charges for treatment of diseases and procedures at clinical establishments, including private hospitals. Health facilities are supposed to display the charges for each procedure and facility to keep the patient informed in advance.