Section 36 in West Bengal Clinical Establishment (Registration, Regulation and Transparency), Rules, 2017
36. Inspection and Inquiry.
(1)The Licensing Authority, as soon as possible after receiving an application, shall order a scheduled inspection and/ or inquiry in respect of any clinical establishment in order to satisfy himself before granting or rejecting an application for new license or renewal thereof as mentioned under rule 35.(2)The Licensing Authority, as often as may be necessary, shall order a scheduled inspection and/or inquiry in respect of any clinical establishment at periodic interval as often as may be necessary to satisfy himself that the clinical establishment is being kept or carried on in accordance with terms and conditions of the license.(3)The Licensing Authority, as soon as possible after reasonably being satisfied, shall order an unscheduled inspection and/or inquiry in respect of any clinical establishment to verify the material facts and statement made in the complaint upon receiving such a written specific complaint of serious nature from a patient or a representative body of patients/ citizens alleging non-compliance of the provision of the Act by that clinical establishment:Provided that, the reason(s) for such inspection shall be recorded in writing in such order(4)The Licensing Authority, as soon as possible, shall order an unscheduled inspection and/or inquiry in respect of any clinical establishment if she is reasonably satisfied that there is a possibility that-(a)such clinical establishment is being kept or carried on without a valid license; or(b)an imminent danger to the safety and security of service-user, service-provider or public at large is existing with respect to such clinical establishment; or(c)such clinical establishment is not complying with any provision of this Act:Provided that, the reason(s) for such inspection shall be recorded in writing in such order(5)For the purpose of inspection and inquiry as per sub-rule (1) to (4), the Licensing Authority, by issuing a general or specific Authorization Notice, shall constitute a Supervisory Authority consisting of one or more members of Govt. servant headed by a government medical officer.Provided that, government medical officer(s) of different specialties or systems of medicine shall be included as member(s) depending upon the circumstances.(6)The Adjudicating Authority, West Bengal Clinical Establishment Regulatory Commission or any such appropriate authority as may be notified under section 36 sub-section (1) of the Act, by issuing a general or specific Authorization Notice, may constitute such Supervisory Authority under sub-rule (5) consisting of such member(s) as it deems appropriate.(7)The Authorization Notice under sub-rule (5) and (6) may impose reasonable restrictions on the powers of the Supervisory Authority and shall remain in force -(a)until it is executed; or(b)until it is cancelled by the person who issued it or, if such person is not available, by any person with like authority;(c)until the expiry of three months from the day of its issue; or the purpose for the issuing of the Authorization Notice has lapsed, whichever occurs first.(8)The Supervisory Authority, at any reasonable time, with such assistance as he/she reasonably require, shall enter the premises of a clinical establishment as per rule 39 and may-(a)inspect the premises of the clinical establishment or any part of it; and(b)inspect any apparatus, appliance, equipment, instrument, product, goods or item used or found in the clinical establishment; and(c)observe and examine any activity, operation process or procedure being carried out at the clinical establishment; and(d)require the owner or any member of staff of the clinical establishment to take reasonable steps to produce documents;(e)inspect, make copies of or take extracts from any document, records, registers;(f)require the owner or any member of staff of the clinical establishment to authenticate such copies and make such copies available to the Supervisory Authority at free of cost.(9)While conducting such enquiry, the Supervisory Authority shall enter the premises of a clinical establishment as per rule 39 and may-(a)ask relevant questions and take on the spot or otherwise the statement of any person as she deems necessary; and(b)ask relevant questions of any patient for the purpose of ascertaining any material fact; and(c)require the owner or any member of staff of the clinical establishment to answer a question to the best of that person's knowledge, information and belief(10)While conducting such inspection or inquiry, a member of Supervisory Authority-(a)shall serve a notice as per proviso clause of sub-section (1) of section 24 of the Act; and(b)shall take utmost care not to disturb or interfere with the service(s) being provided to the patient(c)shall exercise power vested upon him by the Act and rules reasonably for carrying out the purposes of this Act; and(d)shall not behave in a way unbecoming of a government servant.(11)Any person who obstructs, hinders or impedes the Supervisory Authority in the performance of its function or execution of its duty shall be guilty of a contravention under sub-section (1) of section 28 of the Act(12)Any person who refuses or fails, without reasonable cause, to furnish any information to the Supervisory Authority or; to produce any of the records, registers, reports, or any such instruments, either medical, medico-legal, mandatory or of any kind including the confidential medical records without delay or; gives any false or misleading information to the Supervisory Authority shall be guilty of a contravention under sub-section (2) of section 28 of the Act.(13)Nothing in this rule shall be deemed to deter any member of Supervisory Authority to inspect any medical record relating to any patient in a clinical establishment maintaining confidentiality and taking care that it doesn't come into public domain.
