PRIVATE HOSPITALS AND MEDICAL CLINICS (AMENDMENT) BILL

Order for Second Reading read.

The Senior Minister of State for Health (Dr Aline K. Wong): Mr Speaker, Sir, I beg to move, "That the Bill be now read a Second time".

The Private Hospitals and Medical Clinics Act (Chapter 248 of the 1985 Revised Edition) was passed in 1980 to provide for the control, licensing and inspection of private hospitals, medical clinics and clinical laboratories and to prohibit trading in human blood. The Act came into operation when its regulations were gazetted in 1991.

The Act was passed in 1980 when most hospitals were run by the Government and the Act did not apply to them. With the restructuring of Government hospitals, the conversion of homes for the aged into nursing homes and the increasing number of private hospitals, clinics and clinical laboratories being set up, it was necessary to implement the law to oversee the operation of these healthcare institutions and uphold the high standard of medical care in Singapore. Regulations to the Act were finalised and the Act came into operation in 1991. My Ministry then established the Medical Audit and Accreditation Unit (MAAU) to license all private healthcare institutions, including the restructured hospitals, to regulate their professional standards and to audit their clinical activities.

With recent changes in medical practice and rapid advance in medical technologies, there is need for some amendments to the legislative framework under which MAAU works. Before I brief the House on the amendments to the Bill in detail, let me present the three main objectives that my Ministry intends to achieve with these amendments. They are:

(i) to ensure a high level of professional standard practised at health care establishments;

(ii) to provide for greater flexibility in licensing the establishments; and

(iii) to enhance our capability for regulatory enforcement.

The Bill will help to ensure a high level of professional standard by providing, firstly, for :

(a) more effective quality assurance (QA) programmes at health care establishments; and,

(b) more effective medical audits carried out by my Ministry.

QA programmes comprise a range of activities directed at ensuring the quality of patient care through objective and systematic monitoring, evaluation, identification of problems and action to improve the level and appropriateness of care. The programmes are by and large institutional activities for self-monitoring purposes. These have been established in all hospitals as a requirement for licensing since the implementation of the Private Hospitals and Medical Clinics Act in 1991.

My Ministry monitors closely these activities by requiring hospitals to submit regular six monthly returns on clinical performance indicators such as unexpected deaths; perioperative deaths; unplanned re-admissions to hospitals; and unplanned returns to the operating theatres, and so on. We also require six monthly returns on any report of Committees of Inquiry into medical incidents as well as the results of tissue audit.

The results of these returns are then closely scrutinised by my Ministry and in-depth medical audits are conducted if necessary.

While it is important to retain the self-monitoring element in QA programmes, they are, however, based on a peer review process which requires doctors to evaluate and pass judgement on each other's professional performance. Understandably, many doctors have been reluctant to participate in QA committees because firstly, the findings of a QA committee under the current provision of the law are open to legal discovery and could provide the basis for legal action against the hospital. Secondly, QA committee members are exposed to personal liability for the opinions they have expressed and to legal suits for defamation by aggrieved doctors.

But QA programmes must have the active involvement of doctors to be effective. There is therefore a need to formally recognise the roles and functions of QA committees and to provide the necessary safeguards for the hospital and members of the QA committees that will facilitate the conduct of effective QA programmes. Countries like Australia and the United States have also recognised the importance of effective quality assurance programmes in health care and have enacted legislation to address these legal issues.

The Bill lays down more definitive requirements for hospital QA programmes. It will also enable the Minister to make regulations on the composition, procedures, duties and responsibilities of QA committees in hospitals and other health care establishments.

The Bill will, secondly, enable my Ministry to conduct more effective medical audit programmes. To ensure that high standards of professional practice are maintained, it is necessary for my Ministry to conduct medical audits to evaluate the medical treatment that has been given to patients. To do so effectively, my Ministry must have access to the patient's medical records so that the clinical data, investigations performed, treatment prescribed and the outcomes of clinical management can be objectively reviewed and assessed for their quality and appropriateness.

However, section 12(3) of the existing Act prohibits access to a patient's medical records except with the patient's consent. This prohibition is unduly restrictive for the purposes of statutory medical audit. Medical audits are conducted mostly on common medical conditions, and this should be done before any conclusion is reached on the quality of care. Obtaining the patient's consent at this stage will potentially cause undue alarm to the patient, and may raise doubts that some error in medical management has occurred, where none may have been made at all. The need for the patient's consent is also not practical when a large number of a particular type of patients is studied. For example, when we audited the appropriateness and outcome of caesarean sections performed for pregnant women under different clinical situations, we took a random sample of 10%. In 1997, out of 46,000 deliveries, some 12,600 or 27% were by caesarian section. A 10% sample for 1997 therefore entailed a study of 1,200 cases of caesarian sections. It is obviously impractical to ask each and every patient chosen in the sample for her consent to have her medical record examined. It will be more practical to allow access to medical records specifically and only for the purpose of statutory medical audit, while at the same time safeguarding the principle of medical confidentiality. I want to emphasise that the objective of having access to the medical records is for the purpose of studying the pattern of management of a particular group of patients and not for identification of the individual patient. The identity of the individual is protected and safeguarded under new provisions of the Bill (clause 10, section 12), which I will elaborate on later.

My Ministry is selectively auditing areas of clinical practice where there is a large number of patients or high volume, where the cost is high, and where there may be a potential for `errant practice'. Examples of areas being audited are caesarean sections, hysterectomies, endoscopies, arthroscopies and balloon angioplasties.

Most of the audits done so far have shown that there is a very high degree of conformity with acceptable "best practice". This is to the great credit of our medical profession. Where `deviations' are found, for example, with indications for performing caesarean sections, the doctors or professional bodies are given feedback to enable corrective action and improvement of practices.

Sir, the manner in which healthcare is delivered is evolving rapidly. The second objective of the Bill is to provide for greater flexibility in licensing of healthcare establishments. The Act currently provides for only three types of licences:

(1) Hospital licences for hospitals, nursing homes and maternity homes;

(2) Medical clinic licences for medical and dental clinics; and

(3) Clinical laboratory licences.

Since the Act was passed, new types of health care establishments have emerged, for example, ambulatory surgical treatment centres, renal dialysis clinics and MRI centres. I have no doubt that this trend of new types of healthcare establishments being set up will continue. There is therefore a need to build greater flexibility into the Act for the licensing of new health care establishments which can then be better controlled through their own specific regulations.

The third objective of the Bill is to enhance my Ministry's power of enforcement. The existing Act only allows my Ministry to inspect health care establishments but does not allow for the seizure of evidence which is frequently necessary for prosecution. The revision of the Private Hospitals and Medical Clinics Act will facilitate the enforcement work of my Ministry by allowing the seizure of evidence during raids especially on unlicensed premises. Presently, we have to rely on the police to exercise such powers. This is an unnecessary burden on the police and can be removed by enhancing the investigative powers of the officers acting under the authority of the Act.

Currently, all offences under the Act require prosecution in court before any penalty can be imposed. For greater flexibility in enforcement, there is a need to provide for composition of offences especially for the more minor ones. The penalties for offences under the Act also need to be updated.

Sir, I will now brief the House on the main provisions of the Bill which will address the concerns I have listed earlier.

Under clause 10 of the Amendment Bill, a new section 10 is enacted to require the setting up of quality assurance committees in hospitals. To facilitate the conduct of effective quality assurance programmes in hospitals and health care establishments, the section provides that:

(a) Documents arising from the deliberations of quality assurance committees cannot be compelled to be divulged to any court, tribunal, board or person;

(b) Findings and recommendations made by quality assurance committees on changes to be made to practices, in particular healthcare establishments, shall not be used as evidence that the service or practice was inadequate or inappropriate; and

(c) Members of quality assurance committees are protected from personal liability when they exercise their duties in good faith.

These provisions are similar to legislation which has been enacted in the United States and in Australia to support QA programmes in health care. These two countries have also drawn up legislation to prevent forced legal disclosure of QA matters in hospitals and other healthcare establishments. They have also enacted legislation to protect members of QA committees from personal liability when they act in good faith.

Clause 14 of the Amendment Bill also amends section 17 of the Act to allow the Minister to make regulations on the composition, procedures, duties and responsibilities of QA committees of healthcare establishments.

Under clause 10 of the Amendment Bill, another new section 11 is enacted which provides for the access to medical records of patients notwithstanding that the prior consent of the patient has not been obtained in order to:

(a) investigate whether this Act or any regulations made thereunder has been or is being contravened; or

(b) to assess the quality and appropriateness of the services provided and the practices and procedures being carried out at the healthcare establishment.

Section 12 of the existing Act which requires the patient's consent for access to medical records is therefore repealed. The new section 11 stipulates that the access to medical records without consent is allowed only for medical audit purposes. Access to medical records is also strictly confined to officers authorised by the Director of Medical Services.

Under clause 10 of the Amendment Bill, a third new section, section 12, is enacted to prevent the disclosure of any information contained in a patient's medical record which has come to the knowledge of the Director of Medical Services or an authorised officer in the course of performing any duty under this Act. This provision safeguards the need for doctors to maintain confidentiality of medical information. It provides an essential balance to the provision which allows access to patients' medical records by authorised officers.

The new section 12 only allows for disclosure of medical information for specific statutory purposes such as for disciplinary proceedings under the Medical Registration Act or the Dentists Act. The maximum penalty for wrongful disclosure of information under the Act has been increased from a fine of $2,000 to $5,000.

Under clause 3 of the Amendment Bill, a new section 2A is enacted to allow the Director of Medical Services to authorise any person to assist in the administration of the Act. This section also provides for the Minister to establish one or more advisory committees to advise on matters pertaining to the administration of the Act.

Under clause 13 of the Amendment Bill, a new section 16B is enacted to protect all authorised officers and members of advisory committees from legal liability for anything which is done in good faith in the performance of their duties under the Act. These amendments ensure that the appointed medical experts are adequately protected from any personal or professional liability in the exercise of their responsibility and judgement.

Under clause 2 of the Amendment Bill, section 2 of the Act is amended to include the definition of a healthcare establishment as any premises or conveyance which is declared by the Minister to be an establishment that requires licensing under this Act. This will give my Ministry the flexibility to license new types of healthcare establishments as and when required.

Under clause 10 of the Amendment Bill, a new section 11 provides the Director of Medical Services and authorised officers with additional powers to seize evidence, make copies or take extracts from relevant records or require the persons in charge of licensed establishments to do so when enforcing the Act.

Under clause 13 of the Amendment Bill, a new section 16D is enacted to allow for the composition of offences up to a maximum of $2,000.

Finally, the Bill updates the penalties for various offences under the Act, and proposes a couple of new offences, such as the failure of an unlicensed healthcare establishment to comply with an order to close the establishment; and failure to comply with an order to stop using an equipment or to stop carrying out a practice deemed dangerous or unsuitable.

Sir, medical knowledge, medical technology and medical practice have changed and advanced tremendously in the last two decades and will continue to evolve into the new millennium. New diseases pose new challenges that will present new modalities of treatment and new approaches to patient care. In the midst of these changes, there will always be a need to ensure that a high level of professional standard is upheld in healthcare establishments.

The amendments proposed in this Bill will strengthen the regulatory framework so that we can meet these challenges with confidence and achieve our goal of providing good quality health care to Singaporeans that is appropriate to their needs.

Sir, I beg to move.

Question proposed.

Mr Speaker: Order. I suspend the Sitting and will take the Chair again at 3.15 pm.

Sitting accordingly suspended at 2.52 pm until 3.15 pm. Sitting resumed at 3.15 pm