Regulating the Hospital

In one line

Most medicine happens inside an institution, and the patient's dealings are with the institution rather than with any one doctor.

In the wording a student can write in an exam: the Clinical Establishments (Registration and Regulation) Act 2010 regulates the institution rather than the practitioner, by prohibiting the running of a clinical establishment unless it is registered, by making registration conditional on prescribed minimum standards of facilities, personnel and records, and by imposing on every registered establishment an undertaking to provide, within the staff and facilities available, such medical examination and treatment as may be required to stabilise the emergency medical condition of any individual who comes or is brought to it.

Why the law has this at all

The regulation of practitioners, described in [Regulating the Profession], leaves a gap that grows every year: it addresses persons, and medicine is increasingly delivered by organisations.

Three failures belong to the institution and to nobody in particular.

The empty cylinder. The facts of Jacob Mathew are an institutional failure described as a personal one. Somebody should have checked; the system should have made checking unnecessary; and the criminal law reached neither, for the reasons in [Medical Negligence: the Criminal Standard].

The absent capacity. In Paschim Banga six State hospitals turned a man away for want of a bed or a department. No practitioner refused to treat him. The failure was of provision.

The unqualified operator. A nursing home with no registered practitioner, no sterile facility and no records injures patients without any identifiable professional to discipline.

A patient cannot regulate an institution by suing it, and a professional council cannot discipline a building. Hence a statute directed at the establishment itself.

The scheme

Section 11 is the operative prohibition: no person shall run a clinical establishment unless it has been duly registered in accordance with the Act.

Section 12(1) sets the conditions for registration and continuation, and every one of them is left to be prescribed:

• (i) the minimum standards of facilities and services;
• (ii) the minimum requirement of personnel;
• (iii) provisions for maintenance of records and reporting; and
• (iv) such other conditions as may be prescribed.

Note the phrase "for registration and continuation": the conditions are not a hurdle cleared once but a standing requirement, which is what makes inspection meaningful.

Section 13 provides for the classification of clinical establishments of different systems into categories, which is how a single Act accommodates a district hospital and a single-doctor clinic.

The institutions. Section 3 establishes the National Council, whose functions are in section 5; section 8 provides for the State Council of clinical establishments; section 10 designates the authority for registration.