Chennai: After passing the Clinical Establishment Act a few months ago, the state government has come up notified the related Tamil Nadu Clinical Establishments (Regulations) Rules,2018. The rules came in being with its publication in the Tamil Nadu Extraordinary Gazette dated June 4 and define the minimum infrastructure and manpower requirements to be maintained by all clinical establishments in the state.
The said rules cover all clinical establishments across the state including public or private starting from consulting rooms, clinics or polyclinics to dispensaries, diagnostic centers, x-ray centers, dentist centers, maternity centres, nursing homes and hospitals. Besides, Allopathy system, the act also sets suitable guidelines for AYUSH establishments and practitioners, in which it states various infrastructural as well as documentation rules.
An important feature of the rules deals with the definition and requirements of a “Consulting Room” versus a “Clinic” . As per the rules, for setting up a “Consulting Room”, a doctor would have to have a space of not less than 100 square feet with sufficient light and ventilation. The rules also specify the minimum requirements of staff and equipment such as examination couch, BP apparatus, Stethoscope, Torchlight, Tongue depressor, Thermometer, etc (see attachment for full details).
To be classified as a clinic, in addition to the norms prescribed for a consulting room, centres would have to have Sufficient space for two cots shall be available for keeping the patient under observation in case of anaphylaxis or for giving intravenous drip or for observation etc. besides having more staff requirements as well as more equipment such as autoclave etc.
The new notification mandates various guidelines that must be followed by the existing as well as the upcoming medical facilities practicing either system of medicine.
Likewise, for other clinics, polyclinics, hospitals, maternity hospitals, dental clinics, dental hospitals, diagnostic centers, the act specifies various requirements to be followed.
Duties for Medical Practitioners
Besides requirement for infrastructure, staff, and equipment, the rules lay down that Every Clinical Establishment shall maintain a register having the details regarding the name, age, sex and address of the patient, date of examination, date of admission. The patient shall be given a slip containing name, age, sex and date of consultation, diagnosis (either provisional or fi nal) and treatment advice, the investigation result shall be entered, if it was undertaken.
The rules clearly state that The Doctor shall sign the prescription slip with date and seal.
Duties and Responsibilities for clinical establishment
The Health and Family Welfare has specified the following duties and responsibilities ought to be followed by every clinical establishment:
(a) Display a copy of the Certificate of Registration in a prominent place of the premises open to the public;
(b) Maintain records in electronic form showing the names, addresses and the qualifications of its employees and the equipments maintained by it;
(c) Record and preserve all changes in the employment of the staff and the equipments and intimate the same to the competent authority;
(d) Maintain clinical records (i.e. 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), of its activities relating to a patient.
(e) Keep every record open for inspection by the competent authority;
(f) Surrender the Certificate of Registration and apply for fresh registration on change of ownership of the clinical establishment, on change of system of medicine for treatment;
(g) Surrender the Certificate of Registration, on ceasing to function as a clinical establishment
General conditions specified by the department to be fulfilled by the hospitals under Allopathy and AYUSH:
- Communication- A telephone connection shall be available for use by patients (on payment)
- Security- Sufficient security shall be provided for the safety of inmates and to prevent theft.
- Fire Fighting- Firefighting equipment with I.S.I. mark shall be provided as per rules in the hospital.
- Kitchen- If food is provided to inmates, the kitchen shall be clean and the cook(s) shall be periodically, medically examined for any infection or contagious diseases.
- Clothing and Linen- It shall be clean and changed daily.
- Water Supply- The potable water shall be provided to the patient.
- Waste Disposal- It shall be as per the Government of India norms and shall follow the guidelines of Tamil Nadu Pollution Control Board.
- Record Maintenance.-
(a) Every Clinical Establishment shall maintain the permanent records pertaining to details of the employees as well as the clinical records pertaining to the patients. The records shall be kept open for inspection by the competent authority or any other officer authorized in this behalf.
(b) Every Private Clinical Establishment shall make available a copy of list of observation, treatment etc., pertaining to the patient on payment of necessary charges within the reasonable time. Every Clinical Establishment shall display at a prominent place the charges for obtaining such information.
(c) Every Clinical Establishment may refuse to furnish such information, if such information is likely to cause injury to the person or his family members or if the treatment has been conducted on the direction of a public authority.
In addition, the notification attached below contains an application form for registration/renewal of registration of clinical establishment.