WBCE Rules 23Chapter III · Responsibilities, Obligation and Rights

Section 23 · Mandatory Reporting

(1)

The clinical establishment shall exercise reasonable care and take all necessary measures including generation, maintenance and submission of such mandatory reports and returns as specified in schedule VI or mentioned under different provisions of the Act and rules or any such reports and returns as may be notified in order to ensure proper patient care, legal formalities including medico-legal formalities, and proper implementation of public health programmes:Provided that, the clinical establishment shall, as soon as possible, generate and submit to the Licensing Authority such other reports, as may be demanded by the Licensing Authority pertaining to the discharge of his/her duties.

(2)

As a part of mandatory reporting, the clinical establishment shall generate and submit such a report regarding occurrence of any such notifiable diseases /sentinel events in that establishment, in such a manner to the licensing Authority or any such appropriate authority as may be notified, immediately after the clinical establishment has reasonable cause to believe that such event occurred.Explanation. - A sentinel event is an unexpected, unforeseeable or unanticipated occurrence which result in or may result in death or serious physical or psychological injury, or any serious adverse outcome of heath including disruption of service or the risk thereof needing immediate intervention. A Notifiable disease is one that has been notified by the Government.

(3)

In order to generate such reports of notifiable disease / sentinel events as mentioned in sub-rule (2), the clinical establishment shall generate and maintain a notifiable disease / sentinel event register as a part of mandatory record keeping in such a manner containing such particulars as may be notified

(4)

Unless mentioned otherwise, the clinical establishment shall generate and maintain all the mandatory reports mentioned under this Act or rules in hard copy duly authenticated:Provided that, the Licensing Authority may consider generation and maintenance of such reports in electronic form in any technologically appropriate medium if she is satisfied with such manner at the time of inspection or enquiry.

(5)

Unless mentioned otherwise, Authentication of reports may be done by affixing a written signature, or a digital signature with identifiable initials or computer key along with date and time.Provided that, any laboratory report shall be authenticated only by using a signature along with date written by the concerned doctor.

(6)

Unless mentioned otherwise, the clinical establishment shall submit all the mandatory reports mentioned in the Act or rules made thereunder to the Licensing Authority or to any such Reporting Officer subordinate to him as may be nominated by the Licensing Authority in hard copy form personally, or by messenger, or by registered post or any such effective manners as may be permitted by the licensing authority:Provided that, the Licensing Authority may consider submission in soft copy form in any technologically appropriate medium personally, or by messenger or electronically if authority is satisfied with such manner.

(7)

The clinical establishment shall obtain a written or computer generated acknowledgement regarding submission of such report mentioned in sub-rule (6) and shall submit a copy of such acknowledgement along with the application for renewal of license under rule 34.

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