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New regulations to monitor medical establishments

Even after emerging as a healthcare hub and hundreds from across the country and abroad flock the State due to quality as well as affordability, the health sector in Tamil Nadu still has certain dark areas. The rules to regulate clinical establishments here, which are coming into force in May, could help change the situation.

New regulations to monitor medical establishments
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Illustration: Saai

Chennai

Experts have been warning that beyond the façade of being a medical tourism hub, there are serious flaws ranging from lack of regulation to absence of data or statistics. Much to their relief, this is bound to change after the amendment to the Tamil Nadu Clinical Establishments (Regulation) Act, 1997, introduced in June 2018, that now mandates all medical institutions to register themselves.

Pointing out that the lack of a regulatory body was one of the main reasons for the prevalence of corrupt practices in the sector, Dr K Senthil, president, Tamil Nadu Medical Council (TNMC), said the amended rules will help address the issue, starting with registration of all medical institutions, big and small. “From big corporate hospitals to tiny institutions with just a consultation room, no one has any data or statistics,” he said, a comment that reveals the challenges that the health sector faces.

According to a government official, the rules, which were gazetted last June, would bring in a set of regulations that all health sector establishments should follow, ranging from certificates to facilities and manpower. Displaying a copy of the Certificate of Registration in a prominent place within the premises that is open to the public; maintaining records in electronic form showing the names, addresses and the qualifications of employees; and the equipment maintained by it are some of the regulations they must follow once it comes into effect.

The rules stipulate that it is extremely important that each change is recorded and the authority is kept informed. All clinical records of its activities relating to a patient must be preserved, the official said. “Any paper, film, printout, slide, solution, medium, which can be deciphered or used to indicate and diagnose the condition of the human body or a part of it, or any material taken out of it, and the course of treatment administered to or undergone by the person must be preserved,” she added.

Besides getting registered, all consulting rooms, clinics, polyclinics, hospitals, maternity hospitals, dental clinics, dental hospitals, clinical laboratories and X-ray centres in the State must ensure that they have adequate staff, facilities and equipment. They must also follow other aspects such as floor space and other requirements of a proper medical space in hospital buildings, the official added.

The rules also provide for advisors at the district and state levels. Each body related to the sector, such as the TNMC, the Indian Medical Association and the like, would nominate one person to be a part of the advisory body.

“Under this, we are not only licensing allopathic hospitals and clinics, but also institutions under the Indian medicine system. In addition, laboratories will also be registered,” added Dr Senthil from the TNMC.

He said that the establishment of a regulatory system would help in many ways, also ensuring that all clinical establishments in the State met a fixed standard. “The process of registration will help the government to keep track of all establishments–the facilities they have, staff strength and specialities. Without proper registration methods, quackery was blooming in the state in both rural and even urban areas. All that can be eradicated now,” said Dr Senthil.

On the benefits of these regulations, Dr Mohan K, a government hospital doctor, said if followed scrupulously, these rules would help improve the standard of the health facilities in Tamil Nadu. “We have been striving to meet international standards, doing so step by step. 

However, the lack of regulations was always a barrier. Now that our institutions will be closely and strictly monitored by the regulatory body, we can be assured that there will be significant growth,” he said.  With only three months left for the rules to come into force, the State Health Department will organise a mega programme on February 6 and 7 during which Health Minister C Vijaya Baskar will distribute license certificates to one hospital from each district.

“The implementation of the rules will ensure that no clinical establishment that lacks the required facilities will be registered under the government. It will also mandate all hospitals, clinics and other institutions to maintain proper records and refrain from turning away patients coming in for emergency or trauma care,” said Health Secretary J Radhakrishnan.

Broad Guidelines

  • The Tamil Nadu Clinical Establishments (Regulations) Rules, 2018, gazetted last June, will list out a set of guidelines that all institutions–big to small, government or private–must adhere to and register by May
  • The floor space and other facilities, the minimum number of staff and their minimum qualification, the minimum equipment and other conditions required for a clinical establishment of different systems for providing different medical services shall be in accordance with the rules
  • Every establishment should maintain records with particulars relating to the clinical observation, test, investigation, diagnostic opinion advice and treatment given to the person who has visited the hospital either as an in-patient or out-patient
  • It applies to consulting rooms, clinics, polyclinics, hospitals, maternity hospitals, dental clinics, dental hospitals, clinical laboratories and X-ray or radiograph centres as well as institutions falling under the ambit of the Indian system of medicine in the State
  • The Health Department has begun facilitation of the Act and will be distributing a license certificate to one hospital from each district on February 7

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