THE LAW AND CLINICAL GOVERNANCE
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Transcript of 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