Section 21 in West Bengal Clinical Establishment (Registration, Regulation and Transparency), Rules, 2017
21. Sanitation, Hygiene, Safety and Security.
(1)The clinical establishment shall exercise reasonable care and take all necessary measures including disinfection, sterilization, infection control measures as specified in schedule IV or any such measures as may be notified in order to ensure adequate sanitary and hygienic condition.(2)No new license or renewal shall be granted unless the applicant has obtained a valid certificate of enlistment issued by the local authority and submitted a copy of such along with the application.Explanation. "certificate of enlistment": means a certificate of enlistment by whatsoever name called issued by the authority of the local self government like Municipal Corporation, Municipality, Panchayat, Notified Area Authority, Industrial Township Authority, as the case may be.(3)In order to ensure the safety and security, the clinical establishment shall either obtain the authorization/license / No Objection Certificate under the West Bengal Fire and Emergency Service Act, 1950 and shall submit a copy of such authorization/license / No Objection Certificate along with the application for new clinical establishment license/renewal thereof or shall submit a self-declaration in the form of an affidavit as a part of statuary Clinical Establishment Form III along with the application that she shall abide by the provisions of such Act.(4)In order to ensure the sanitation and hygiene, the clinical establishment shall either obtain the authorization/license / No Objection Certificate from Pollution Control Board under the Bio-Medical Waste (Management and handling) Rules, 1998 and shall submit a copy of such along with the application for new clinical establishment license/renewal thereof or shall submit a copy of application already submitted to obtain such authorization/license / No Objection Certificate under such rules.(5)In order to ensure the safety and security, the clinical establishment shall obtain the authorization/license / No Objection Certificate (NOC) under the Atomic Energy Act, 1962 (33 of 1962) and the Atomic Energy (Radiation Protection) Rules, 2004, if applicable and shall submit a copy of such authorization/license / No Objection Certificate along with the application for new clinical establishment license/renewal thereof.(6)In order to ensure the sanitation, hygiene, safety and security, the clinical establishment shall either obtain the authorization/license / No Objection Certificate under any such other relevant Acts or rules as may be notified and shall submit a copy of such authorization/license / No Objection Certificate along with the application for new clinical establishment license/renewal thereof or shall submit a self-declaration in the form of an affidavit as a part of statuary Clinical Establishment Form III along with the application that she shall abide by the provisions of such Acts/Rules as the case may be.(7)The clinical establishment shall generate and maintain a register called 'bio-medical waste disposal register' in such a manner as may be notified.(8)In order to minimize the undue risk for the service provider, the clinical establishment shall exercise reasonable care and take all necessary measures which include but not limited to 'Universal work precautions', chemoprophylaxis, vaccination, post-exposure prophylaxis and adequate capacity building.Explanation. - 'Universal work precautions' means infection control measures that prevent occupational and nosocomial exposure to or reduce the risk of transmission of pathogenic agents including Hepatitis B, Hepatitis C and HIV and includes the provision for education, training, personal protective equipment such as gloves, gown and masks, hand washing, cough hygiene and employing safe work practices.(9)The clinical establishment, as soon as it comes to its notice that any person, who has been received or accommodated in that establishment, is suffering from or has been suffering with any infectious diseases, the clinical establishment shall take appropriate precautionary measures for the protection of other patients, service providers and public at large.Explanation 1. - 'appropriate precautionary measures' includes but not limited to (a) Universal work precautions;(b)Barrier Nursing; (c) Isolation; (d) disinfection; and (e) any such scientific measures as may be notifiedExplanation 2. - "Infectious disease" means a laboratory confirmed or clinically manifested disease of man or animal resulting from an infection. Infection means the entry and development or multiplication of an infectious agent in the body of a man or animal.(10)The clinical establishment shall take such necessary measure for handling and disposal of general waste as per the provision of relevant Acts and rules of the local self government and obtain permission as such.(11)In order to ensure the safety, security and physical comfort of the service-provider as well as service-recipient, the clinical establishment shall exercise reasonable care and take all necessary measures including installation of such safety measures and physical amenities as may be specified in schedule IV.(12)To ensure safety and utilization of space by disabled and elderly people, the clinical establishment shall provide Barrier free access environment for easy access to non-ambulant(wheel-chair, stretcher), semi-ambulant, visually disabled and elderly persons as per "Guidelines and Space Standards for barrier-free built environment for Disabled and Elderly Persons" of Central Public Works Department/ Ministry of Social Welfare, Government of India.(13)Notwithstanding anything contained in rule 15, the patient's personal belongings including corpse shall remain in the safe custody of the clinical establishment in an appropriate manner unless he/she is released or handed over to the patient party, and the clinical establishment shall take appropriate safety and security measures thereof:Provided that, no clinical establishment shall release or handover or dispose of the same or try to do so in any manner without the consent of the patient or patient party;Provided further, that, no clinical establishment shall detain or try to detain the patient or the corpse against the will of the patient or patient party due to any reason including the failure of the patient or patient party to fully settle her financial obligations.Explanation. - Personal belongings shall include her specimen, sample, body, anatomical body parts, organs, tissues, Xray film, USG film and such other images, photographs, etc.(14)In order to maintain a conducive atmosphere and a safe and secure environment in the premises for all persons present there particularly the patient in confinement, the clinical establishment shall exercise reasonable care and take all necessary measures including measures to prevent the occurrence of any events of patient abuse or misappropriation of patient property and any failure to take such measures shall be treated as major deficiency under section 29 of the Act.Explanation 1. "Patient abuse" means the willful infliction of physical or mental injury of a patient or unreasonable confinement, intimidation, or punishment that results in pain, physical or mental harm, or mental anguish of a patient.Explanation 2. "Misappropriation of patient property" means exploitation, deliberate misplacement, or wrongful use or taking of a patient's property, whether temporary or permanent, without authorization by the patient or the patient party.(15)In order to ensure such atmosphere and environment under sub-rule (11), the clinical establishment shall have the right to impose reasonable restriction regarding entry and movement of the patient, patient party, escorts of the patient and visitors in the premises of the clinical establishment and formulate regulation or SOP thereof:Provided that, the patient has the right to communicate with the patient party and to receive visitors subject to such reasonable restriction.
