THE LAW AND CLINICAL

GOVERNANCE
KPJ Health Conference 2014
The Legal Duties (Burdens) of Being a
Person in Charge
Raja Eileen Soraya binti Raja Aman
www.rajadarrylloh.com.my

Governing Legislation
Private Healthcare Facilities and
Services Act 2006
Private Healthcare Facilities and Services
(Private Hospitals and Other Private
Healthcare Facilities) Regulations 2006

Purpose of Legislation
To provide for the regulation and control of private
healthcare facilities and services and other healthrelated facilities and services
Came into force : 1st May 2006

Person in Charge (PIC)

Section 31
A licensee or a holder of a certificate of registration in respect of
a licensed or registered private healthcare facility or service shall
ensure that the licensed or registered private healthcare facility
is maintained or operated by a person in charge.

Who is a PIC?
Section 2
A person possessing qualification, training and
experience as may be prescribed and who shall be
responsible for the management and control of the
private healthcare facility or service to which a license
or registration relates.

Who is a PIC?
The PIC shall have the following qualification and experience:
A degree in medicine
Registered with the Malaysian Medical Council
At least 2 years training in any
specialty provided by the
healthcare facility or service
Has served in a post in public
service
At least 2 years experience in
hospital management
(Fourth Schedule of the Regulations)

Examples of the
Duties of a PIC

Healthcare Professionals
Regulation 13
The PIC shall ensure that all healthcare professionals
are registered under any law regulating their registration or
have such qualifications and experience as are recognized by the
Director General; and
have such qualification, training, experience and skill to practise
in his particular specialty or subspecialty as are recognized by
the Director General

Medication or Treatment
Regulation 15
The PIC of a private healthcare facility or service shall
Ensure that the generic or trade names of drugs be written in full
before the usage of any abbreviation in the patients medical records
Ensure that any medication errors and adverse drug reactions shall
be recorded in the patients medical records
Keep all medications in properly labelled
containers

Patients Rights
Regulation 27
The PIC shall take reasonable steps to ensure that a patient is

Provided with information about the nature of his medical

condition and any proposed treatment, investigation or
procedure and its likely costs
Treated with strict regard to decency; and
Provided with a medical report within a reasonable time upon
request by the patient and upon payment of a reasonable fee

Medical Records
Regulation 43
The PIC shall have an appropriate patients medical record system
comprising of facilities, procedures and organization for keeping
patients medical records.
The PIC shall ensure that a separate patients medical record is kept
for each patient where each patient is assigned with a registration
number.
The PIC shall be responsible to safeguard the information on the
patients medical record against loss, tampering or use by
unauthorized persons.

Medical Records
Regulation 44
The PIC shall ensure that for each admission, the patients medical
record shall have the information specified in the Sixth Schedule,
which include
Registration number
Patients name, address, date of birth and gender
Contact details of a relative or legal guardian
Relevant clinical details
Consent form (if necessary)
Name and signature of attending medical practitioner
Administered drugs and dosages

Consent
Regulation 47
The PIC shall obtain or cause to be obtained valid consent from a
patient before any procedure or surgery is carried out on the patient.
Valid consent shall be obtained from

The patient;
If the patient is mentally or physically disabled, the spouse, parent or
next of kin; or
If the patient is unmarried and below eighteen years of age, the
parent or guardian
Consent obtained or caused to obtained shall be in writing.

Enforcement of the
Duties of a PIC

Enforcement
The authorities have very extensive powers:Eg:-

Section 88
An inspector or Director General has the power to enter and
inspect at any time private healthcare facility or any premises
which he suspects or has reason to believe to be used as a
private healthcare facility

Enforcement
In the course of an inspection, the inspector or Director General
may:
Inspect, test and examine any apparatus or equipment used
or found in the facility
Inspect, examine and take samples of blood, blood products,
human tissue or fluid or any part of the human body, or
chemicals found in the facility
Inspect any test or procedure or operation performed or
carried out to ensure compliance with the provisions of the
Act

Enforcement
Section 93
Whenever the inspector or Director General exercises his powers
under the Act, the licensee, person in charge or employee has the duty
to:
Provide all such facilities and assistance as may be reasonably
required
Give all reasonable information as may be required in respect of
the private healthcare facility or service which relates to its
management and any other connected matter
To produce any records or documents in his possession or custody
or under his control which relates to the affairs of the private
healthcare facility or services

Liability of the PIC

Any person who contravenes the abovementioned
provisions commits an offence and shall be liable on
conviction to a fine not exceeding ten thousand ringgit
or to imprisonment for a term not exceeding three
months or to both.

Other Examples of
Duties
of a PIC

Plumbing
Regulation 81
The PIC shall provide
A suitable shelf or equivalent and mirror at each hand washing
facility in toilet rooms, patient rooms, dressing rooms and locker
rooms;
Adequate toilet paper on toilet paper holder properly located at
each water closet; and
Suitable provision for soap at each water closet, sink and
bathing facility

Nursing
Regulation 124

Where there are six or more registered nurses in any private

healthcare facility or service, the PIC shall establish a
Department of Nursing to provide complete and effective care
to each patient.
Regulation 127
The PIC shall periodically evaluate the adequacy of facilities or
services in terms of patient, nursing and personal care needs.

Intensive Care Unit

Regulation 226
The PIC shall ensure that a critical care unit or an intensive care
unit is adequately staffed at all times and the ratio of the nursing
staff shall be one registered nurse to one patient.

Liability of the PIC

Regulation 434
Any person who contravenes or fails to comply with
these provisions commits an offence and shall be
liable on conviction to a fine not exceeding five
thousand ringgit or to imprisonment for a term not
exceeding one month or both.

Application of
The Act

 Breach of Statutory Duty

Criminal Conviction
Disciplinary Action

Case Study
A medical officer accepted the position as the PIC at a private
hospital
He was a junior employee in a private hospital and had no
authority to address any outstanding oversights and
shortcomings
Unknown to him, one of the doctors who was practising
medicine and treating patients at the private hospital did not
have a valid Annual Practising Certificate

Case Study
The PIC was found guilty of infamous conduct in a
professional respect under section 29(2)(b) of the
Medical Act 1971 on the grounds that as the PIC of
the hospital, he is accountable for the management
and control of all professional matters in the facility.

Conclusion
An individual who accepts the appointment as a person in
charge carries extensive legal obligations that he/she may
not in reality, have full control or authority over.
For the person in charge to be effective and fulfil his/her
obligations under the legislation, this person must be
empowered and authorised to effect any changes required
Otherwise, the individual is faced with the discomfort of the
legal burdens without being armed with the managerial
powers to do anything and will ask the question

... is it worth it?

THANK YOU
Raja Eileen Soraya
Messrs. Raja, Darryl & Loh
eileensoraya@rdl.com.my