THE LAW AND CLINICAL GOVERNANCE

8/11/2019 THE LAW AND CLINICAL GOVERNANCE

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THE LAW AND CLINICALGOVERNANCE

KPJ Health Conference 2014

The Legal Duties (Burdens) of Being a

Person in Charge

Raja Eileen Soraya binti Raja Aman

www.rajadarrylloh.com.my


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Governing Legislation

Private Healthcare Facilities and

Services Act 2006

Private Healthcare Facilities and Services

(Private Hospitals and Other Private

Healthcare Facilities) Regulations 2006


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Purpose of Legislation

To provide for the regulation and control of private

healthcare facilities and services and other health-

related facilities and services

Came into force : 1stMay 2006


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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 shallensure that the licensed or registered private healthcare facility

is maintained or operated by aperson in charge.


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Who is a PIC?

Section 2

A person possessing qualification, training and

experience as may be prescribed and who shall beresponsible for the management and controlof the

private healthcare facility or service to which a license

or registration relates.


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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 anyspecialty 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)


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Examples of the

Duties of a PIC


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Healthcare Professionals

Regulation 13

The PIC shall ensure that all healthcare professionals

are registered under any law regulating their registration orhave 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 bythe Director General


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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


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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


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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 thepatients medical record against loss, tampering or use by

unauthorized persons.


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Medical RecordsRegulation 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


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ConsentRegulation 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.


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Enforcement of the

Duties of a PIC


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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


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Enforcement

In the course of an inspection, the inspector or Director Generalmay:

Inspect, test and examine any apparatus or equipment usedor found in the facility

Inspect, examine and take samples of blood, blood products,human tissue or fluid or any part of the human body, orchemicals found in the facility

Inspect any test or procedure or operation performed orcarried out to ensure compliance with the provisions of the

Act


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Enforcement

Section 93Whenever the inspector or Director General exercises his powersunder the Act, the licensee,person in charge or employee has the dutyto:

Provide all such facilities and assistance as may be reasonablyrequired

Give all reasonable information as may be required in respect ofthe private healthcare facility or service which relates to itsmanagement and any other connected matter

To produce any records or documents in his possession or custodyor under his control which relates to the affairs of the privatehealthcare facility or services


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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 threemonths or to both.


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Other Examples of

Dutiesof a PIC


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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 orservices in terms of patient, nursing and personal care needs.


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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.


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Liability of the PIC

Regulation 434

Any person who contravenes or fails to comply with

these provisions commits an offence and shall beliable on conviction to a fine not exceeding five

thousand ringgit or to imprisonment for a term not

exceeding one month or both.


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Application of

The Act


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Breach of Statutory Duty

Criminal Conviction

Disciplinary Action


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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 andshortcomings

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


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Case Study

The PIC was found guilty of infamous conduct in a

professional respect under section 29(2)(b) of theMedical Act 1971 on the grounds that as the PIC ofthe hospital, he is accountable for the managementand control of all professional matters in the facility.


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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/herobligations under the legislation, this person must be

empowered and authorised to effect any changes required

Otherwise, the individual is faced with the discomfort of thelegal burdens without being armed with the managerial

powers to do anything and will ask the question


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... is it worth it?


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THANK YOU

Raja Eileen Soraya

Messrs. Raja, Darryl & Loh

[email protected]

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