Section 13 in West Bengal Clinical Establishment (Registration, Regulation and Transparency), Rules, 2017
13. Procedure, Medication and Critical care.
(1)Under clause (c) of sub-section (2) of section 7 of the Act, the clinical establishment shall ensure that the diagnostic procedure, medication, diet or treatment is being provided only on presentation of duly authenticated written requisition order of a registered medical practitioner and the requisition forms for all pathology laboratory or diagnostic imaging laboratory tests is containing all relevant particulars including such particulars as may be notified.(2)As the tests are not being performed there but only samples or specimens are collected, every collection centre' shall have such arrangement or affiliation with any reference laboratory to perform those tests and shall display the certificate of such arrangement or affiliation as a part of mandatory display under rule 22 and shall submit a copy of such certificate along with the application mentioned in rule 34.Explanation. - "Reference laboratory" means a pathology laboratory, other than a collection centre, registered under the Act or similar Act of other state, Union territory, Government of India or accredited by 'National Accreditation Board for Testing and Calibration Laboratories or NABL' or organization of similar repute, which accepts sample or specimens from other clinical establishments for testing and examination.(3)The clinical establishment shall ensure that all the pathology or diagnostic imaging lab reports are prepared without any errors and containing relevant particulars like measurement procedure, normal values etc. and any such particulars as may be notified.(4)The clinical establishment shall ensure that relevant particulars of all cases of surgical procedure along with classification of such cases into major or minor surgery are recorded in the standard OT register (Logbook) as a part of mandatory record keeping.Explanation 1. - 'major surgery' means all surgical cases done under general anaesthesia or spinal anaesthesia.Explanation 2. - 'minor surgery' means such surgical cases other than major surgery.(5)Before performing any specific procedure which requires permission in the form of No Objection Certificate (NOC)/License/Approval/Permission under different Acts like 'The Medical Termination of Pregnancy Act', 'The Transplantation of Human Organs Act', 'The PC-PNDT Act' or any such Act as may be notified, the clinical establishment shall obtain such prior permission and submit a copy of such No Objection Certificate (NOC)/License/Approval to the licensing Authority for entering relevant particulars into the register.(6)The clinical establishment shall display copy of such No Objection Certificate (NOC /License/Approval/Permission as a part of mandatory display under rule 22 and also generate and maintain registers, records related to such performance of such procedure as a part of mandatory record keeping under rule 18.(7)The clinical establishment shall ensure that-(a)the non-proprietary names of drugs shall be written in full before the usage of any abbreviation in the patient's medical record; and(b)all medication administered to the patient shall be recorded with date and time and signed by the concerned nursing staff; and(c)self administration of medications by patient shall be permitted only when specifically ordered in writing by a registered medical practitioner; and(d)any medication errors and adverse drug reactions shall be informed immediately to the prescribing Primary Consultant or RMO; and(e)any medication errors and adverse drug reactions shall be recorded in the patient's medical record; and(f)all medications shall be kept in properly labeled containers maintaining such appropriate storage conditions as recommended by the manufacturer.(8)No clinical establishment other than a maternity home or nursing home shall offer different special care/therapy/ treatment services in tune with the advance of modern medicine provided that the State Government shall have the power to relax this condition.(9)Such special care/therapy units as mentioned in sub-rule (8) shall be classified into following mutually exclusive categories: (i) Critical Care/Therapy unit; (ii) Intensive Coronary Care Unit; (iii) Intensive Neonatal Care Unit; (iv) High Dependency Unit; (v) Nuclear Medicine Therapy Unit; (vi) Radiotherapy Unit or (vii) any other care/therapy unit as may be notified. The consent of the patient party will mandatorily have to be obtained before transferring a patient to such a unit and the patient party should be explained in writing regarding the condition of the patient and the financial implications.Explanation 1. - The special care/therapy units are mainly in-patient department of a clinical establishment which is specifically designed, staffed by specialized personnel, located, furnished and equipped with sophisticated equipment and medical supplies to offer more specified and sophisticated service for the patient in need of those which cannot be provided in general department.Explanation 2. - The High Dependency Unit (HDU), also called step-down, progressive or intermediate care unit, is a special care unit of in-patient department to offer more specified and sophisticated service for critically ill patients in the form of more intensive observation, monitoring, treatment, nursing care and management than that is possible in a general ward but slightly less than that given in intensive care.Explanation 3. - The Critical Care Units (CCU) is a special care unit of in-patient department to offer more specified and sophisticated service for critically ill patients than that is possible in a general ward or High Dependency Unit.Explanation 4. - Dialysis centre shall not be considered as a special care/therapy unit for the purpose of this rule.
