Section 8 in West Bengal Clinical Establishment (Registration, Regulation and Transparency), Rules, 2017
8. Standard Operating Procedures and Practices.
(1)Under clause (c) of sub-section (2) of section 7 of the Act, in order to ensure the quality of service, the clinical establishment shall exercise reasonable care and take all necessary measures including measures to comply with the standard operating procedures and practices related to all health care operations as mentioned in schedule V.Explanation. - Health Care Operations' mean Institutional activities that is necessary to maintain and monitor the operations of the institution. Examples include but are not limited to: conducting quality assessment and improvement activities; developing clinical guidelines; case management; reviewing the competence or qualifications of health care professionals; education and training of students, trainees and practitioners; fraud and abuse programs; business planning and management; and customer service. Research is not considered part of health care operations.(2)The clinical establishment shall ensure that no service provider or any person associated with the clinical establishment shall -(a)directly or indirectly request, receive or participate in the division, transference, assignment, or splitting of a fee; or(b)directly or indirectly request, receive or profit by means of a credit or other valuable consideration as a commission, discount or gratuity,in connection with (i) the furnishing of healthcare or non-health care related service; or (ii) the sale, rental, supplying or furnishing of drug, equipment, medical supplies and medical devices.(3)The clinical establishment shall ensure that no service provider or person associated with the clinical establishment shall -(a)practice fee-splitting; or(b)carry out multiple consultation or encounter with the patient when it is not medically necessary; or(c)refer the patient to a Visiting Consultant of a different speciality when it is not medically necessary; or(d)keep a patient in the clinical establishment as an in-patient when it is not medically necessary or longer than is medically necessary; or(e)carry out or undertake to carry out any form of investigation and healthcare intervention which is not medically necessary; or(f)insist upon the patient or party to get admission in a particular clinical establishment due to any reasons other than scientific; or(g)insist upon the patient or party to get the investigation done from a particular clinical establishment due to any reasons other than scientific; or(h)insist upon procurement or purchase of particular brand of drug, medical device or medical supplies due to any reasons other than scientific; or(i)procurement or purchase of drug, medical device or medical supplies from a particular shop, establishment, manufactures or vendor due to any reason other than the scientific; or(j)engage in any such other unethical or unfair trade practice as may be notified.Explanation. - "fee-splitting" means any form of arrangements made between practitioners, healthcare facilities, organizations or individuals as an inducement to refer or to receive a patient to or from another practitioner, healthcare facility, organization or individual for the sole purpose of financial gain.(4)Any act of violation mentioned under sub-rule (2) and (3) by any service provider or any person associated with the clinical establishment shall be considered as unethical or unfair trade practice by the clinical establishment under section 7 of the Act and such clinical establishment shall be liable of contravention.(5)The clinical establishment shall have the right to make its own set of regulations or standard operating procedures concerning the organization and operation of that establishment subject to the following terms and conditions:-(a)those regulation or standard operating procedures are not contrary to the provision of any law of the land; and(b)those regulation or standard operating procedures are not violating the fundamental rights or human rights; and(c)any such other terms and conditions as may be notified.Provided that the clinical establishment shall have to submit a copy, if any, of those regulation, and standard operating procedure along with the application under rule 34.Explanation. - "Regulation or standard operating procedures (SOP)' contains set of instruction for patients and patient party as well as for the service providers.(6)In order to provide assured quality service, the clinical establishment shall formulate and implement its Internal Quality Assurance programme including Medical audit and other necessary measures and exercise reasonable care to prevent the occurrence of events of patient neglect. It should be made mandatory to provide Bed Head Ticket to the West Bengal Medical Council / Competent Authority in the event of a complaint concerning treatment lodged with the Council / Competent Authority.Explanation. - "Patient neglect" means a failure, through inattentiveness, carelessness, or other omission, to provide to a patient goods and services necessary to avoid physical harm, mental anguish, or mental illness when an omission is not caused by factors beyond the person's control or by good faith errors in judgment.(7)The Licensee of the clinical establishment shall read and understand and make all the staff to read and understand the West Bengal Clinical Establishment (Registration, Regulation and Transparency) Act, 2017 (West Bengal Act IV of 2017) and the rules made there under as amended from time to time.(8)It shall be the duty of the licensee of the clinical establishment to make all service recipients and service providers aware of the relevant section(s) of such regulation or standard operating procedures developed or adopted by them.(9)The clinical establishment conducting or intending to conduct any kind of training or biomedical research shall take reasonable care not to cause any deficiency of the assured service there.(10)The clinical establishment shall actively take part in such External Quality Programme as may be formulated and set-up by the Department, in which the performance of a clinical establishment is assessed concurrently and consecutively by an external Quality Assurance Committee for maintaining high standards of performance and of improving standards where necessary.(11)The clinical establishment shall organize mandatory capacity building programmes for the service providers of that clinical establishment regarding (a) first Aid & Cardio Pulmonary Resuscitation Technique; (b) Fire-fighting drills and mass evacuation techniques; (c) mass casualty management protocols (d) any other training programmes as may be notified.
