The Gujarat government has recently issued fresh directives under the Gujarat Clinical Establishments (Registration and Regulation) Act of 2021. The primary motivation behind the new guidelines is to enhance patient rights and guarantee patient safety in clinical settings across the state. These initiatives have been shaped by concern regarding informed consent, the maintenance of infection control, and accessibility to medical records for all patients.
The state government moves in response to some reported cases where patient consent had been obtained, but doubts remained whether this consent was truly ‘informed’ – whether patients fully understood potential side effects and complications associated with respective clinical operations or procedures. Recognising this, the new directives necessitate clinical establishments to thoroughly explain the diagnosis, operation, and alternative options, with potential side effects, to the patients or their relations, ensuring that consent acquired is well-informed.
Also, for procedures that are neither emergencies nor immediate, and which substantially impact a patients’ life, it now becomes mandatory to obtain audio-visual recordings of the patient’s consent. Such records are to be kept for six months following the operation or procedure. An exception to obtaining informed consent is in emergency situations where immediate patient stabilization is required. In such cases, a doctor’s decision will be deemed final.
With instances of hospital-acquired infections leading to organ loss or extended hospitalization reported, all clinical establishments need to follow infection prevention and control guidelines issued by the Ministry of Health and Family Welfare strictly. Furthermore, in response to instances of clinical establishments withholding laboratory reports or doctors’ diagnoses or prescriptions from patients after discharge, the new directives call for all such records to be provided to patients as a matter of right upon discharge, without imposing any additional charges.