THE PRIVATE HEALTHCARE FACILITIES
& SERVICES ACT 1998 AND
REGULATIONS 2006
MEMORANDUM TO THE
MINISTER OF HEALTH MALAYSIA
SUBMITTED BY
MALAYSIAN MEDICAL ASSOCIATION
AND
MALAYSIAN DENTAL ASSOCIATION
JULY 13TH 2006
PREAMBLE
1. Introduction
The Malaysian Medical Association and the Malaysian Dental Association
welcome the implementation of the Private Healthcare Facilities and Services Act
(PHFSA) 1998 and its Regulations 2006.
In principle, the Associations agree that there is a need for legislation to regulate
healthcare facilities and services in the country, especially to prevent the setting
up of such facilities by untrained and unqualified persons, and the provision of
services which may be below the accepted standards of medical care.
In this respect, we agree that there is a need to set standards with regard to
facilities and services, and understand and support the spirit of the law, with its
primary objective of ensuring a good standard of medical care which is the
rightful expectation and entitlement of the public.
The Associations are also thankful that Part XV of the Act on Managed Care
Organisation, as well as Part XIV relating to the role of Medical Advisory
Committees on the Board of Management of Private Healthcare Facilities, will be
enforced by the Act and Regulations.
2. Feedback and concerns
The Associations, over the past few weeks, however, have carefully studied the
Act and the Regulations, with useful feedback from the wide cross-section of
registered medical and dental practitioners who are members of the
Associations. We have observed that there are certain stipulations and
requirements in both the Act and Regulations which are too exacting and often
ambiguous and which may adversely affect the provision of health care to the
people in Malaysia specifically and the practice of medicine generally.
We are concerned that these may in the end be counter-productive and negate
the primary objectives and spirit of the Act and Regulations.
One particularly serious implication in the Act and Regulations is the possibility
that practitioners, who in general strive to provide a genuine professional service
and care to their patients, may, on the slightest failure to comply with the
stringent requirements spelt out throughout the Act and Regulations, be fined
heavily, imprisoned or both.
This may lead to defensive medical practice in our country and reluctance and
fear on the part of practitioners to commence private general practice or
specialist practice.
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3. Existing Safeguards
The MMA is aware that there are many existing safeguards in place to ensure
the good and ethical practice of Medicine. These include the Medical Act 1971
which regulates the registration and practice of medical practitioners including
the requirement for all medical practitioners to have an Annual Practising
Certificate (APC), and the Code of Professional Conduct and various Guidelines
issued by the Malaysian Medical Council. In addition, the professional bodies in
the country have also come up with several Clinical Practice Guidelines and
Standards of Practice for various specialties to ensure that the practice of
medicine is up to date and evidence-based.
However, we do admit that there are certain shortcomings in the administration
and provision of private healthcare facilities and services which need to be
addressed and streamlined.
4. Major concerns
Some of the over-riding concerns regarding the Act and its Regulations include

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That the Act seems to bring about a “criminalization” of medical and dental
practice in the country. We hope that the Honourable Minister will
seriously review and revise the severe penalties for offences committed
under the Act.
That the processes and procedures for registration are cumbersome and
time consuming, which may result in delays and unnecessary
complications. We hope that the forms can be simplified, and facilitated by
making on-line registration and submission of statistical returns possible.
That there are many requirements for documentation and written policies,
which may not be applicable to all practices. We hope that exceptions will
be made for different types of practices, particularly dental and solo
medical practitioners.
That the numerous requirements for standards will add to the cost of
running a clinic and this may lead to increased cost for the patients. We
hope that the Honourable Minister will ensure that in the enforcement of
the Act, the functional and service aspects of the facility will be the main
consideration, rather than the nitty-gritty details.
5. Proposal for changes
Details of the Associations’ concerns and proposals for changes are listed
systematically, following the Act and Regulations, in the accompanying
document.
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6. Action taken by MMA/MDA to ensure compliance by members
The MMA and MDA would like to assure the Honourable Minister that we on our
part are doing everything possible to facilitate compliance to the Act and its
Regulations by our members. Some of our actions include
 Road-shows to explain to our members the implications and
implementation of the Act.
 Practical help for our members in fulfilling the requirements for
registration, for example assistance with filling the forms and their
submission, working with MOX and other agencies to ensure timely supply
of proper oxygen cylinders and other equipment for resuscitation to clinics,
etc.
 Making available refresher courses on Basic Life Support for our
members.
7. Appeal to the Honourable Minister
The MMA and MDA would like to implore the Honourable Minister of Health to
kindly consider the above broad principles and submissions and invoke his
powers, as provided for in the Act and Regulations, to amend, exempt or delete
various sections in the Act and Regulations, as provided for in Part XVII Section
103(1) and Part XIX section 121(1) of the Act.
The MMA and MDA submit this memorandum to the Honourable Minister of
Health with a request to make a short oral presentation to highlight some parts of
the memorandum to allow the Minister to seek any clarifications directly from the
MMA/MDA delegation at this time, and if possible to give us some responses to
our feedback at the same time.
We will be happy to work with Ministry of Health officers in the practical aspects
of making the requested changes a reality, to ensure the timely and appropriate
implementation of this important legislation.
We shall be grateful for a favourable response at your earliest convenience.
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THE PRIVATE HEALTHCARE FACILITIES & SERVICES
ACT 1998 AND REGULATIONS 2006
DISCUSSION AND PROPOSALS FOR CHANGES
A. REGISTRATION OF CLINICS
PHFSA 1998: PART II: CONTROL OF PRIVATE HELTHCARE FACILITIES
& SERVICES
3. No person shall establish or maintain any of the following private
healthcare facilities or services without approval being granted under
paragraph 12(a) or operate or provide any such facilities or services
without a license granted under paragraph 19(a)
4.(1) No person shall establish, maintain, operate or provide a private
medical clinic or private dental clinic unless it is registered under section
27.
(2) Notwithstanding subsection (1), a private medical clinic or …..
which forms part of the premises of a licensed private healthcare facility
and to which the clinic is organisationally, administratively and physically
linked shall not be required to be registered separately but shall comply
with such standards and requirements as shall be prescribed.
PHFSA 1998: PART V: REGISTRATION OF A PRIVATE MEDICAL CLINIC
Separate Registration for Private Medical Clinics
30. Separate registration shall be required for --(a) a private medical clinic and a private dental clinic which are
physically, administratively or organizationally linked to each other;
(b) a private medical clinic which is not physically, administratively
and organisationally linked to another licensed or registered private
healthcare facility;
(d) a private medical clinic which is not physically linked but is
organisationally or administratively linked to a registered private
medical clinic, or to a licensed healthcare facility or service;
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(f) a private medical clinic or private dental clinic which is under an
individual medical practitioner or dental practitioner, as the case
may be, sharing manpower, facilities or services, in the same
premises but which are not administratively nor organisationally
linked to each other.
(g) any other forms of organisation or administration of private
medical clinic or private dental clinic as the Director General may
determine.
Discussion:
a. First Schedule: Application for Registration 6.1 Variant of Clinic in respect
of section 30 of the PHFSA 1998, requires indication of physical,
organisational and administrative linkage of private medical clinics.
b. Specialist clinics which are located within private hospitals are physically
linked to the private hospital as well as organisationally and
administratively, for reasons considered below:
(i) Clinic: rented on session basis, whole clinic on rental, or clinic
space owned by doctor (title held)
(ii) Physically linked: clinic within the hospital complex, same
entrance-exit, clinic linked to all service areas of hospital
(iii) Organisational: admitting rights, using lab and imaging
facilities, using hospital pharmacy, on hospital on-call roster. (Refer
Part III Section 11. (4) of the Regulations, cited below)
(iv) Administrative: subject to standards and practice rules laid
down by the hospital, contract signed, stipulated clinic operating
hours, security cover, member of hospital committees (OT,
Infection Control, etc.)
c. Part III Regulations 2006: Organisation and Management of Private
Healthcare Facilities and Services, under Plan of Organisation, states:
11. (4) All registered medical practitioners privileged to practise in the
private healthcare facilities or services shall be considered as part of the
organisation.
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MMA/MDA proposal:
a.
Any specialist clinic within a private hospital (healthcare facility or service)
should not be required to be separately registered. However, the option
for separate registration should be allowed for those who wish to do so.
b.
Clinics physically located in the premises of a healthcare facility are to be
considered organisationally and administratively linked to the healthcare
facility.
c.
Private medical clinics closed down and reopened within the same locality
should not be required to be registered again.
d.
We request that the enforcement of the Act should be deferred for one
year from Nov 2006 to allow time for the details of the Act and
Regulations and their implications to be fully complied to by medical
practitioners.
B. First Schedule: Application for Registration to establish Private
Medical Clinic
A. Information on Private Clinic
B. Information on Applicant:
8. (k) Reference from two referees as to the character and
fitness.
8. (l) Statutory Declaration that he has not been convicted of
any offence involving fraud or dishonesty and is not an
undischarged bankrupt.
C. Information on Partnership or Body Corporate or Society
D. Information on Person in Charge (if different from applicant)
E. Other Information
12.1 Details of staff employed, engaged or privileged to practice
in the private medical clinic or private dental clinic.
12.2 Present or proposed clinic layouts
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(a) to be drawn to scale (not smaller than 1:100, which
include plans, drawings and specifications and each
document to be titled and numbered for identification
(b) Specifications shall show but not limited to the
followings:
(i) Internal dimensions of each compartment;
(ii) The purpose or use of each compartment;
(iii)The position and width of doors, windows,
entrances and exits;
(iv)The location and types of benches, beds or couch,
fixtures and major equipment;
(v)Location and type of lighting, electrical points, airconditioning, if any, fire fighting equipment, if any,
and the like
12.3 Details of any Managed Care Organisation having
any contract or arrangement with the private medical clinic.
Discussion:
a. Reference from referees and statutory declaration are felt to be
excessive. Registered medical practitioners are subject to the Medical
Act 1971 and are fully registered and have been issued Annual
Practising Certificate.
b. Information (MCO, etc) may not be available to specialists in clinics
in private hospitals as the contracts by MCOs are made directly with
the healthcare facility management.
MMA/MDA proposal:
a.
Sections 8 (k), 8(l) should be reviewed.
b.
Section 12.2 Details of clinic’s layouts should be limited to
functionality rather than dimensions of doors, windows,
entrances, etc.
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C. PHFSA 1998: Part V of the REGISTRATION OF PRIVATE
MEDICAL CLINIC
27.
Upon receiving and having considered the application, the Director
General may register the private medical clinic or private dental clinic with
or without such terms or conditions as he may deem necessary and
issue a certificate of registration upon payment of the prescribed fee
Discussion:
1. It is not clear what is meant by “with or without such terms or
conditions as he may deem necessary”, since the application is
believed to have been scrutinized, processed and formally approved
before issuance of the certificate.
2. We envisage that the MOH may have difficulty in the timely processing
of the registration of clinics, given the large workload. Even without this
Act, the MOH already has difficulty in issuing APCs and Hospital
Licenses in time.
MMA/MDA proposal:
a. To review the above “terms and conditions” in the certificate.
b. In recognition of the fact that there may be considerable
administrative time lapse between application, inspection and issuance
of (final) certificate, a Letter of Acknowledgement should be issued
on acknowledged receipt of the application.
c. This Letter of Acknowledgement should be considered for all intents
and purposes as a temporary certificate until the final certificate is
issued.
This is to facilitate practitioners to rent space, commence internal
construction, purchase equipment, employ staff and generally be
prepared , according to specifications, before certificate of registration
is issued as in Form B.
d. On-line registration should be made more user-friendly and practical.
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D. PHFSA 1998: Part IV
LICENCE TO OPERATE OR PROVIDE
PRIVATE HEALTHCARE FACILITY OR SERVCE OTHER THAN A
PRIVATE MEDICAL CLINIC
19. Upon receiving and having considered the report under section 16
and after giving it due consideration the Director General shall have the
discretion --(b) to refuse the application for licence with or without assigning any
reason for such refusal”
Discussion
It does seem irregular that a license can be refused without any reason.
MMA/MDA proposal:
a. Grounds for refusal should be revealed.
b. The Inspection Report ( Part IV, Section 16), particularly the
adverse comments, or shortcomings, should be revealed to
applicant.
c. An appeal mechanism should be instituted within this section
without having to appeal to the Minister as provided for in Part
XVII of the Act Power of Minister Section 101.
d. Re-submission of application for re-inspection after remedy of
shortcomings should be allowed.
E. PHFSA 1998: CONTROL OF PRIVATE HEALTHCARE FACILITIES
AND SERVICES
5. (1) A person who contravenes section 3 or section 4 commits an
offence and shall be liable, on conviction --(a) in the case of an individual person --(i) to a fine not exceeding three hundred thousand ringgit or
to imprisonment for a term not exceeding six years or to
both; and
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(ii) for a continuing offence, to a fine not exceeding one
thousand ringgit for every day or part of a day during
which the offence continues after conviction;
Discussion
The fine and imprisonment imposed are very stiff and obviously are so
prescribed to serve as a deterrent. However, they are considered too
severe and are probably not consistent with the seriousness of the crime.
MMA/MDA proposal:
The punishments should be reviewed and adjusted to be consistent
with the scale of punishments relative to seriousness of such crimes.
F. PHFSA 1998: Part XIX SAVINGS AND TRANSITIONAL
PROVISIONS
122. A person who immediately before the date of commencement of this
Act was maintaining or operating a private medical clinic or dental clinic
may continue to maintain, provide or operate the private medical clinic or
private dental clinic without registration under this Act if within the first six
months of the date of commencement of this Act an application for
registration is made under this Act.
Discussion
There are various issues pertaining to the Regulations 2006 which need to
be addressed as stated above.
MMA/MDA proposal:
a. The time limit should be extended for one (1) year after
November 2006 to allow the existing clinic to remedy
deficiencies, if any.
b. Existing clinics should not be subjected to the requirements of
new clinics as it may not be possible to accommodate all the
standards stipulated in the Regulations without actually
rendering massive renovations of existing clinics at the expense
of closing down the clinic during such renovation.
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G. REGULATIONS 2006: Part IX: GENERAL PROVISIONS FOR
STANDARDS OF PRIVATE MEDICAL CLINICS
Location of private medical clinic
34. (1) A private medical clinic or private dental clinic shall be located free
from undue noise or, if the private medical clinic or private dental clinic is
located in a noisy area, the holder of a certificate of registration or a
person in charge of a private medical clinic or private dental clinic shall
take adequate measures to ensure that the noise is minimized to the
extent that no disturbance is caused to its patients.
(2) The location of any private medical clinic or private dental clinic
shall not be exposed to excessive smoke, foul odours or dust.
Discussion
a. This is a difficult regulation to comply with as clinics have to be
located in areas of patient requirements and accessibility.
b. The regulation implies that if a workshop or factory is built after the
clinic is in operation, the onus is for the holder of the certificate to “take
adequate measures to ensure that the noise is minimized”.
MMA/MDA proposal:
Section 34 (1) and (2) should be reviewed.
H. REGULATIONS FOR PHFS 2006: PART III: ORGANISATION AND
MANAGEMENT OF PRIVATE HEALTHCARE FACILITIES OR SERVICES
Person in charge of Private healthcare facility or service
12. A person in charge of a licensed private healthcare facility or service shall
hold such qualification, have undergone such training and possess such
experience as stipulated in the Fourth Schedule.
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Fourth Schedule: Qualifications, Training and Experience of Person in
Charge:
Facility – Private Hospital
Person in charge – Registered medical practitioner
Qualification – (a) Degree in Medicine from local universities or from other
universities recognised by the Government of Malaysia, and
(b) registered with the Malaysian Medical Council
Training – At least two years’ training in any specialty provided by the
healthcare facility or service
Experience – (a) Has served in a post in public service or has been
granted reduction, exemption or postponement of service under section
42 of the Medical Act; and
(b) at least two years experience in hospital management.
REGULATIONS FOR PRIVATE MEDICAL CLINIC AND PRIVATE DENTAL
CLINIC: Part III
Person in charge of Private Medical clinic or private dental clinic
8. A person in charge of a registered private medical clinic or registered private
dental clinic shall hold such qualifications, have undergone such training and
possess such experience as stipulated in the Third Schedule.
Third Schedule: Qualifications, Training and Experience of Person in
Charge:
Facility – Private Medical Clinic
(a) General outpatient
Person in charge– Registered medical practitioner
Qualification – Degree in Medicine from local or recognised
university; registered with MMC
Experience - has served in public service or postponement
under section 42 of the Medical Act 1971
(b) Specialised Outpatient
Person in charge – Registered medical practitioner
Qualification – Degree in medicine from local or recognised
university; postgraduate qualification recognised by the
Government; registered with the MMC
Experience - has served in a post in public service or
postponement under section 42 of the Medical Act 1971
(c) Private Dental Clinic
Person in charge – Registered dental practitioner
Qualification – degree in dentistry from local or recognised
university
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Experience – has served in a post in public service or
postponement under section 49 of the Dental Act 1971.
Discussion
There are private hospitals where the person in charge is not a registered
medical practitioner. There are also private medical clinics which are run
by persons not qualified and therefore not registered with the MMC.
MMA/MDA proposal:
The regulations should be enforced forthwith for both private healthcare
facilities and private clinics.
I. REGULATIONS 2006: PART IV: POLICY
17 (1) A private medical clinic or a private dental clinic shall, upon
request prior to the initiation of care or treatment, inform the patient --(a) of the estimated charges for services based upon an
average patient with a diagnosis similar to the tentative or
preliminary diagnosis of the patient; and
(b) of the anticipated charges for services that is routine,
usual and customary.
17. (2) Billing procedure: Patient has right to be informed of the
billing procedure.
17. (3) Patient has right to obtain itemised billing for the whole
course of treatment.
(4) Any person who contravenes this regulation commits an offence
and shall be liable on conviction to a fine not exceeding ten thousand
ringgit or imprisonment for a term not exceeding three months or to
both.
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Discussion
a.
The manner in which this will need to be implemented poses
problems. The consultation will take longer at the expense of other waiting
patients.
b.
It can be easily denied by the patient as having been discussed or
that he did not understand the explanations. Patient may refuse if asked to
sign consent for the charges.
MMA/MDA proposal:
a. To review section 17(1)(a) and 17 (1)(b)
b. The penalty is too severe. The quantum of the fine should be
reduced and the imprisonment deleted.
c. A pamphlet with the fees to be charged may be made available for
perusal by the patient and should suffice. It can be in four
languages.
J. Patient’s rights
18 (1) The holder of a certificate of registration or a person in charge of a
private medical clinic or private dental clinic shall take reasonable steps to
ensure that a patient is --(a) provided with information about the nature of his medical condition
proposed treatment, investigation or procedure and the likely cost of the
treatment, investigation or procedure;
(b) treated with strict regard to decency; and
(c) provided with medical report within a reasonable time upon request by
the patient and upon payment of a reasonable fee.
(2) Any person who contravenes this regulation commits an offence and
shall be liable on conviction to a fine not exceeding ten thousand ringgit or
imprisonment for a term not exceeding three months or to both.
Discussion
a.
18 (1) (b) is vague and if the implication is ethical behaviour then
the contravention should be subjected to disciplinary procedures as per
the Medical Act and Code of Professional Conduct.
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b.
There is no provision in the Medical Act 1971 for fines or
imprisonment for ethical or disciplinary infringements.
c.
The punishment is too severe for any contravention in this Part.
MMA/MDA proposal:
Sections 18 (1) (b) and 18 (2) should be reviewed.
K. REGULATIONS 2006: PART V: REGISTERS, ROSTERS AND RETURNS
Statistical returns
25. (1) The holder of a certificate of registration or a person in
charge of a private medical clinic or private dental clinic shall forward to
the Director General the following details;
(a) statistical information of International Classification of Disease
Ten (ICD-10) at every three month intervals; and
(b) any other information deemed necessary at any time by the
Director General.
Patient’s Medical Record Register
21. (1) The holder of a certificate of registration or a person in charge of a
private medical clinic or private dental clinic shall keep and maintain a
Patient’s Medical Record Register to record the movement of patient’s
medical record.
Discussion
a.
b.
c.
d.
The need for obtaining statistics on diseases treated in private
medical clinics is accepted as important and timely.
“Any other information” is vague, and unless clarified it would be
difficult to be able to produce “any other information” at short notice.
Statistical returns are most conveniently conveyed on-line to the
Director General rather than through hard copies which can be very
cumbersome and occupying space when received by MOH.
The requirement for a Patient’s Medical Record Register is
cumbersome and does not apply to a solo medical practice.
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MMA/MDA proposal:
These statistical returns should be transmitted through on-line links
and should be imposed initially on medical clinics or dental clinics
which have such facilities.
L. REGULATIONS 2006: PART VI:
GRIEVANCE MECHANISM
Patient grievance mechanism plan
26.
The holder of a certificate of registration or a person in charge of a
private medical clinic or private dental clinic shall provide a patient
grievance mechanism plan which shall include a method by which each
patient will be made aware of his rights to air his grievances and the
grievances procedures.
Discussion
a) It is not practical to provide common grievance mechanism plan as the
grievance situation may not be always the same. However, the practitioner
is normally aware of steps to take should a patient be aggrieved.
b) This provision may lead to public becoming frivolously litigious.
MMA/MDA proposal
Section 26 needs to be reviewed and its necessity in Regulations to
be re-considered.
M. REGULATIONS 2006:
PART IX: GENERAL PROVISIONS FOR
STANDARDS OF PRIVAE MEDICAL CLINIC or PRIVATE DENTAL CLINIC
Emergency power supply
50.
Adequate emergency electrical generating equipment with
automatic transfer in case of interruption of normal power supply to
essential equipment, rooms and areas shall be provided in a private
medical clinic or private dental clinic.
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Discussion
Only clinics which have operating facilities/theatres/delivery suites should
be required to have electrical emergency generating systems.
Clinics would normally have simple contingency measures to handle
emergency power failure.
MMA/MDA proposal
The need for all medical clinics to be so equipped is considered too
stringent. Section 50 above should be reviewed.
N. REGULATIONS 2006 PART IX: GENERAL PROVISIONS FOR
STANDARDS OF PRIVATE MEDICAL CLINICS or PRIVATE DENTAL
CLINICS
Section 34 to Section 55
• Location (noise, excessive smoke, foul odours)
• Vector Control (rodents and insects)
• Stairways and ramps
• Doors
• Floor finishes
• Wall surfaces
• Ceilings
• Signage and Labelling system
• Waiting area
• Janitor’s closet
• Storage
• Plumbing
• Toilet
• Water supply
• Electrical sockets
• Lighting
• Emergency power supply
• Ventilation
• Sewage and Sewerage system
• Refuse
• Hazardous waste disposal
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Section 56 to Section 72
* Organisation of Housekeeping Services (cleaning methods, equipment and
supplies, germicides, storage, dry dusting and sweeping)
• Soiled linen handling
• Hand washing
• Linen storage room or area
• Laundry
• Communication system
• Transport arrangements (to other facilities for consultation)
• Maintenance, repair (safety of patients)
• Staffing
REGULATIONS 2006: PART XII STANDARDS FOR OUTPATIENT
FACILITIES AND SERVICES
Sections 89 to 91
•
•
•
•
•
•
Section 90 (3)
Waiting room or area
Reception area/admitting facilities
Administrative office or area
Public and staff toilet
Public telephone and drinking facilities
Utility Room
90. (4) Notwithstanding sub-regulation 90. (3), in case of small outpatient
department, general and administrative facilities may be combined with
inpatient or emergency department general administrative facilities within
a private healthcare facility or service.
Discussion
a.
The absolute compliance of all these “extra” fittings, rooms,
facilities and services should be viewed or evaluated from the functional
and service aspects and not on strict dimensions of space and
allocation. Many of them are also primarily construction infra-structure and
would have been approved by the respective city/town councils.
b.
Clinics are rarely ‘custom’ planned, designed and constructed and
are usually rented from shop-house lots or shopping mall lots.
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c.
Clinics are established with various space constraints and to fit in
all these requirements may need much larger space and larger premises,
beyond the financial capability of medical practitioners just starting private
medical practice.
d.
By the government laying down numerous restrictions and making
it difficult for doctors to establish clinics and adding to the cost of running a
clinic; it may in fact be indirectly denying provision of essential healthcare
for the public.
MMA/MDA proposal:
a.
Some of the requirements, like public telephone and drinking
facilities are superfluous in view of present day habits where
cellular phones and drinking water bottles are so commonly carried
by most members of the public.
b.
Many of the requirements in this Part on General Provisions
for clinics should be reviewed.
eg. Plumbing
45 (3 ) – Hands-free faucet shall be on all hand washing
facilities….
Toilet
46 ( 1 )The private medical clinic shall provide
(b) each hand washing facility shall include soap , hand washing
appliance and sanitary hand drying facility
(d) water-spray at each water closet
Water supply
47 ( 2 ) There shall be sufficient water supply at all times…..
House keeping
55 ( 2 ) Person in charge shall be appointed to
supervise…………….
56 . Written Procedures There shall be specific written
procedures for appropriate cleaning of all service areas
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59 . Germicides …………………….
the selection of germicides shall be under the supervision of a
person appointed under 55 ( 2 )
61. Dry dusting and sweeping
No dry dusting and sweeping in any room or area of any private
medical clinic or private dental clinic are allowed
Maintenance
Written policies and procedures
71 ( 1 ) There shall be written policies and procedures for an
organized maintenance programme to keep the entire private
medical clinic in good repair………
O. PHFS 1998 PART VI : RESPONSIBILITIES OF A LICENSEE, HOLDER
OF CERTIFICATE OF REGISTRATION AND PERSON IN CHARGE
Emergency treatment and services
38(1) Every licensed and registered private healthcare facility or service shall
at all times be capable of instituting and making available essential life saving
measures and implementing emergency procedures on any person requiring
such treatment or services.
38(2) The nature and scope of such emergency measures , procedures and
services shall be as prescribed. (This is in Eighth Schedule of the
Regulations)
REGULATIONS 2006: PRIVATE HEALTHCARE FACILITIES & SERVICES:
Eighth Schedule
Basic Emergency Services
Each private healthcare facility or service shall, unless otherwise specified
by standards set for that private healthcare facility or service, provide at a
minimum the following services and equipment, for both adult and paediatric,
as applicable to the type of healthcare facility or service, level of care of such
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facility or service and scope and capability of the healthcare facility or
services to provide emergency care.
•
•
•
•
•
•
•
•
•
•
Private healthcare facilities & services
An emergency call system
Oxygen
Ventilation assistance equipment – airways, manual breathing bag
ECG monitoring and cardiac defibrillator
IV Therapy supplies necessary for the level of service to stabilise the
patient as specified by the person in charge
Laryngoscope and endotracheal tubes
Suction equipment
Indwelling urinary catheters
Drugs and other emergency medical equipment and supplies to stabilise
the patient as specified by the person in charge
In the case of private hospitals, private ambulatory centres, and private
maternity homes, basic obstetric supplies necessary for the level of
service to stabilise the patient as specified by the person in charge.
REGULATIONS 2006 Part X Special requirements for Emergency Care
Services (private medical clinics)
Basic emergency care services
75 (1) All private medical clinics or private dental clinics shall have a welldefined care system for providing basic outpatient emergency care services
to any occasional emergency patient who comes or is brought to the private
medical clinics…
(2) The nature and scope of such emergency care services shall be in
accordance with a private medical clinic’s capabilities.
(8) Equipment and services shall be provided to render emergency
resuscitative and life-support procedures pending transfer of the critically ill or
injured to other healthcare facilities or services.
75 (9) For the purpose of sub-regulation (8), the minimum capability
provided, unless specified otherwise, shall include equipment, apparatus,
materials, pharmaceuticals, substances or any other things deemed
necessary to stabilise or resuscitate a patient as listed in the Fifth Schedule
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REGULATIONS 2006: FIFTH SCHEDULE : Basic Emergency Services,
Equipment, Apparatus, Materials and Pharmaceuticals
Private Medical Clinic
• An emergency call system (also dental clinic)
• Oxygen
• Ventilation assistance equipment, airways, etc (also dental clinic)
• IV therapy supplies for the level of service to stabilise the patient as
specified by the person in charge
• ECG
• Laryngoscope and endotracheal tubes
• Suction equipment (also dental clinic)
• Indwelling urinary catheters
• Drugs and other emergency medical equipment and supplies, necessary
for the level of services to stabilise the patient as specified by the person
in charge. (also dental clinic).
Discussion
a.
The use of some of these equipment and apparatus require special
training and skills. We agree that all doctors should have basic
resuscitation skills (BLS) but the requirement for laryngoscope and
endotracheal tubes is not reasonable as intubation is not a skill that is
taught to all medical practitioners, and in the hands of an unskilled
practitioner can be very dangerous.
b.
It is estimated that a very ill/dying patient comes to a clinic on the
average about 1-2 in 10 years. It is very rare for patients to have actually
died in the clinic over a period of time.
c.
It is felt that this requirement will give rise to possible frivolous
complaints by patients and/or legal suits based on these very stringent
requirements.
d.
This will lead to “defensive medical practice,” and to higher
indemnity subscriptions for medical practitioners.
MMA/MDA proposal:
a.
Only clinics run by practitioners who have declared
themselves trained, experienced and prepared to provide emergency
care should be equipped with these special resuscitation items.
b.
The requirement for general medical clinics/ or specialty
clinics should be only for basic emergency assistance and
immediate transfer to a hospital.
c.
The Fifth Schedule in the Regulations should be reviewed.
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P. BOARD OF VISITORS
PHFSA 1998 Part XVII Power of Minister Section 104 Board of Visitors
104 (1) The Minister may appoint a Board of Visitors for each private
hospital.
Discussion
It is agreed that a Board of Visitors to periodically visit a private hospital
will help to establish a line of communication between the public and the
hospital management.
MMA/MDA proposal:
The Board should be appointed primarily by the Hospital management
and the Minister kept informed of the composition. Alternatively, the
Minister may appoint not more than one-third of the members in the
Board of Visitors. The privileges and functions of the Board to be
determined by the Minister in Section 104(2) should ensure that
members of the Board do not abuse their privilege, and conditions to
this effect should be built into the terms.
Q. SOCIAL OR WELFARE CONTRIBUTION
PHFSA ACT 1998: PART XVII: POWER OF MINISTER
105. (1) The Minister may prescribe the type of social or welfare
contributions or the quantum of social or welfare contribution that shall be
provided, and the manner in which it shall be provided, by any private healthcare
facility or service.
REGULATIONS 2006: MISCELLANEOUS
105. (1) The holder of a certificate of registration or a person in charge of
a private medical clinic or private dental clinic shall ensure that each private
medical clinic or private dental clinic submit details of the type or nature and
manner of social or welfare contribution provided or to be provided.
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(2) The social and welfare contributions referred to in sub-regulation
(1) may be one or a combination of types of contribution as listed in the Sixth
Schedule.
The Sixth Schedule stipulates the type of social or welfare contribution and
manner of discharging obligations:
-
Discount or exemption for charge or fee;
Provision for emergency care for poor patients
Public education
Providing donations to associations and organisations
Providing assistance to non-governmental or charitable
organisations
Organising blood donation campaigns
The clinics are required to submit yearly returns on the type of
programmes or activities or donation provided, the cost to the facility or
service and where applicable, the beneficiaries.
Discussion
This section presupposes that private medical clinics and other private
healthcare facilities and services do not make social or welfare
contributions and that practitioners do not contribute to community
healthcare services. This is grossly inaccurate.
MMA/MDA proposal:
This whole section should be reviewed and made into a simple
reminder of the practitioners’ duty to the community rather than a
prescribed and mandated activity with possible punitive implications.
R. FEE SCHEDULE
PHFSA 1998: PART XVII: POWER OF MINISTER
106 (1) The Minister may make regulations prescribing a fee schedule
for any or all private healthcare facilities or services or health related
facilities or services.
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(2) The Minister may, from time to time, after consulting the DG,
amend the fee schedule by order published in the Gazette.
(3) A private healthcare facility or service for which a fee schedule
has been prescribed under this section shall comply with such fee
schedule.
(4) A private healthcare facility or service which fails to comply
with any fee schedule prescribed under this section commits an offence.
Discussion
a.
The Act specifies that the Minister may make regulations
prescribing a fee schedule for any or all private healthcare facilities or
services or health related facilities or services.
b.
Yet, the fee schedule is only for doctor’s professional fees. The
coverage of procedures/treatments is also not complete.
c.
Hospital charges (facilities) and nursing care, catering, etc
(services) are not included in the Fee Schedule.
REGULATIONS 2006: PRIVATE MEDICAL CLINICS: PART XIV
MISCELLANEOUS (Chapter 4)
Fee Schedule
108. (1) The fees to be charged for any facility or service provided by any
private medical clinic ….shall be as stipulated in the Seventh Schedule.
(2) Subject to sub-regulation (1), all private medical clinics … shall have
a written policy on the quantum of fees to be charged.
•
•
PART A - MEDICAL FEE
Note: 1.
All charges shown are the maximum chargeable charges unless specified
otherwise.
When two procedures are performed through the same incision, the fee
chargeable for the lesser procedure should not exceed 50% of the fee
charged for the lesser procedure.
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•
•
•
•
When a repeat procedure is required, consequent to the first procedure,
the fee chargeable for the second procedure should not exceed 50% of
the first and when a third repeat procedure is required, the fee chargeable
for the third procedure should not exceed 25% of the fee charged for the
first procedure.
For procedures under local anesthetic (LA), when administered by the
operating practitioner, a charge not exceeding 20% of the procedure
charge may be levied.
Fee for monitored anesthesia care make up 80% of the anesthetic fee for
such procedure.
Surgeon includes all categories of specialist except for anesthetist.
Discussion
a.
The term “unless specified otherwise” leaves a dubious opening.
Does this mean fees can be negotiated, as the “maximum” may be
exceeded if the patient agrees with the doctor justifying higher charge?
b.
Can discounts be allowed?
c.
Practitioners should be allowed to charge a mutually agreed
amount above the maximum in the Schedule based on the expected
complexity or difficulty of a procedure and with the consent of the patient.
MMA/MDA proposal:
a.
b.
c.
d.
Hospital charges should be included to make the Fee Schedule
complete.
Discounts on the fee schedule should not be permitted as this
will open to various “fee splitting” possibilities through
undisclosed private arrangements between third party payers,
private healthcare facilities executives and even with
practitioners.
Practitioners should be allowed to charge reasonable fees for
procedures not listed in the Fee Schedule.
Fees which are mutually agreed between doctor and patient,
should be allowed even if they do not comply with the fee
schedule.
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S. PHFSA 1998 PART XV MANAGED CARE ORGANISATION
83 (1) The licensee of a private healthcare facility or service or the holder
of a certificate of registration shall not enter into a contract or make any
arrangement with any managed care organisation that results in –
(c) the contravention of any provisions of this Act and the
regulations made under this Act;
(d) the contravention of the code of ethics of any professional
regulatory body of the medical, dental, nursing or midwifery
profession or any other healthcare professional regulatory body;
(e) the contravention of any other written law.
Discussion
a.
Currently, insurance firms which are called “third party payers” act
to provide managed care to corporate bodies. Many of them demand
private healthcare facilities and providers
to give discounts (10%,
20%) on the MMA fee schedule, and those facilities or providers not
agreeing to their proposals of discounted fees are ‘black listed’ and taken
off their list of preferred facilities and providers.
b.
It is also known that these insurance firms have private direct
contract with preferred providers. This arrangement may be construed as
‘fee splitting’. The definition of Fee splitting in the PHFSA 1998 is:
•
“Means any form of kickbacks or arrangements made between
practitioners, healthcare facilities, organisation or individuals as
an inducement to refer or to receive a patient to or from another
practitioner, healthcare facility, organisation or individual.”
c.
The term “maximum fees unless specified otherwise” needs to
be defined. Whether the “specified otherwise” is related to specifications
set out by the Ministry, the MCOs or the private healthcare facilities needs
to be explained.
MMA/MDA proposal
In view of the continued absence of registration and regulation of
insurance firms acting as MCOs and Third Party Payers, and until
the proposed MCO Bill is passed, Part XV of the PHFSA 1998 on
Managed Care Organisation should be enforced forthwith.
27
T. REGULATIONS 2006: PART VII: PATIENT’S MEDICAL RECORDS
Private Healthcare facility & services
44. (1) A patient’s medical record is the property of a private healthcare
facility or service.
Private Medical Clinic
30 (1) A patient’s medical record is the property of a private medical
clinic.
Retention of patient’s medical record
31 (1) for Private Medical Clinics
45 (1) for Private Healthcare Facilities & Services
…all original patients’ medical records or documents relating to such
records shall be preserved at least for the period specified under any
written law pertaining to limitation period.
32. (4) Nothing in this regulation shall be construed so as to limit the right
of a healthcare professional or counsel to inspect the patient’s medical
record.
Discussion
a.
The term “property”’ needs to be defined as property can be a right
through possession, location, intellectual, assignment or legal.
b.
Section 44(1), may be interpreted by private healthcare facilities’
administrators to mean that all private specialist clinic notes (even those
belonging to ‘private’ patients) be centrally stored and secured in the
Hospital Records Department. The private patient notes are confidential
between the private patient and the practitioner and this privacy and
confidentiality may be breached by this section.
c.
The “Good Medical Practice” of the Malaysian Medical Council
states:
“It is well to remember that while the clinical notes and records
physically reside with the doctor and the hospital, the information
therein contained belongs, morally and ethically to the patient and
to regulatory authorities. ..”
28
MMA/MDA proposal:
a.
b.
The position stated in the Good Medical Practice should be
adopted.
The limitation period for preservation of patients’ medical records
should be specified for children and adults (7 years for adults and
18+5 years for children).
U. PHFSA 1998 Part XVII POWER OF MINISTER: VALID CONSENT
107. (gg) to prescribe the requirements to be satisfied for obtaining a valid
consent for any anaesthetic procedure, surgical operation or procedure,
diagnostic procedure, diagnostic procedure or medical procedure or treatment,
the method of obtaining such consent, the conditions under which such consent
may be dispensed with and for specifying the age at which a valid consent for
any anaesthetic procedure, surgical operation or procedure, diagnostic
procedure or medical procedure or treatment to be performed on a patient.
Discussion
a. Separate anaesthetic consent is required
b. There is no mention of “implied consent” which is a traditionally practised
norm.
c. There is no mention of “informed consent”.
d. There is no mention if a witness needs to sign in the consent which is required
to be “in writing”.
REGULATIONS 2006: PART VIII: CONSENT
Valid consent
47 (1) A licensee or a person in charge of a private healthcare facility or service
shall obtain or cause to be obtained valid consent from a patient before any
procedure or surgery is carried out on the patient.
(2) The valid consent under sub-regulation (1) shall be obtained from --(a) the patient;
(b) if the patient is mentally or physically disabled, the spouse, parent or
next of kin; or
29
(c) if the patient is unmarried and below eighteen years of age, the parent
or guardian.
d. Consent obtained or caused to be obtained under this regulation shall be in
writing.
e. Any person who contravenes this regulation 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.
Discussion
a. The legal age of consent in Malaysia is 18 years, but the age for consent
for marriage is 16 years. In Islamic law, the age of consent for marriage is
lower.b. This would mean that if a patient below the legal age of consent, like age
16 or below, is married, then that person can give “legal consent”.
c. Further, no mention is made about implied consent as it is not possible to
take consent for any diagnostic procedure as stipulated in Section 107 (gg) of
the Act 1998 above. Diagnostic procedures where consent is implied would
be taking plain X-rays or drawing blood for tests. This is normal clinical
practice.
MMA/MDA proposal:
a.
The above points need to be taken into consideration and section 47(2)
should be reviewed.
b.
There is a place for implied consent and this should be built in into the
Act.
V. FEE FOR REGISTRATION
REGULATIONS 2006. FEES FOR REGISTRATION: SECOND SCHEDULE
Private Medical Clinics
• Registration (Processing Fees)
• Registration (Issuance of Certificate)
• Transfer, assignment, otherwise disposal
• Variations of terms or conditions
or amendments to certificate
• Duplicate Copy
• Search on or extracts from Clinics Register
30
RM 500
RM 1000
RM 300
RM 150
RM 200
RM 50
Maternity Homes (as an example)
• Licence to Operate (processing)
• Issuance Fees (certificate)
Less than 25 beds
More than 45 beds
•
Approval to Establish (processing)
Renewal Fees (beds)
RM 900 + RM 5 per bed
RM 2000
RM 4000
RM 1500
RM 2000-4000
Discussion/Proposal
The fee payable at every stage of intended registration and type of facility
is exorbitant and should be revised
W. PHFSA 1998: PART XIV
: BOARD OF MANAGEMENT AND ADVISORY
COMMITTEE
Board of Management
77.(1) The licensee of a private hospital, private maternity home, private
ambulatory care centre, private hospice, or any other private healthcare facility or
service as the Minister may specify, shall establish a Board of Management of
whom two members shall be from the Medical Advisory Committee
established under paragraph 78(b)
Medical Advisory Committee
78 (b) where the facility or service is a private hospital…., there is established a
Medical Advisory Committee whose members shall be registered medical
practitioners representing all medical practitioners practising in the facility or
service to advise the Board of Management…on all aspects relating to medical
practice.
Discussion
The specialists in private healthcare facilities and service sometimes face
employment and service problems with the Board of Management and these
are often not discussed. The specialists’ representation though the Medical
Advisory Committee in the Board is considered an important avenue for them
to voice their opinions at the higher level.
31
MMA/MDA proposal:
a.
Sections 77 and 78 of the Act should be implemented forthwith,
although these are not addressed in the Regulations.
b.
Further, section 78 (b) should be expanded to cover the requirement
that the MAC should be elected from amongst all medical practitioners
in that facility or service.
X. PHFSA 1998: PART XVI:
ENFORCEMENT
Appointment of inspectors
87. (1) The Director General may appoint such number of persons to be
Inspectors as he deems necessary for the purposes of this Act.
(2) An Inspector may exercise all or any of the powers vested in him
under this Part.
Power of Inspector to enter and inspect
88. (1) An inspector shall have the power to enter and inspect at any time
any licensed or registered private healthcare facility or service which he
suspects or has reason to believe to be used as a private healthcare facility
or any other premises in or from which private healthcare services are
provided without a license or a certificate of registration.….without a license
or a certificate of registration.
Discussion
The powers vested on the Inspectors are vast and voracious
MMA/MDA proposal:
It is hoped that the powers of enforcement and inspection are not
executed without respect or dignity and the Inspector is a medical
practitioner from the Ministry of Health rather than a non-doctor.
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FURTHER GENERAL DISCUSSIONS
Y. CONVICTIONS AND PUNISHMENTS
•
•
•
The fines and imprisonment, or both, for many of the infringements or noncompliance appear to be on a “free-scale” and draconian.
If indeed these are based on established scales according to seriousness
of guilt, then majority of the infringements appear extremely serious.
When a registered medical practitioner is found guilty and fined,
imprisoned, or both, he will face further disciplinary procedures under
PART IV Disciplinary Proceedings of the Medical Act 1971 in Section 29
(2) of the Act, which states:
“The Council may exercise disciplinary jurisdiction over any registered
person who –
(a)has been convicted in Malaysia or elsewhere of any offence
punishable with imprisonment (whether in itself only or in addition to or
in lieu of a fine)”
•
Such practitioner, if found guilty as charged under the Medical Act section
29 (2) (a) may have his name struck off or suspended from the Register
on conviction to a fine, imprisonment, or both.
For example:
Part IV Regulations: For failure to discuss charges with patient:
“Any person who contravenes this regulation commits an offence and
shall be liable on conviction to a fine not exceeding ten thousand
ringgit or imprisonment for a term not exceeding three months or to
both.”
Part VIII Regulations 2006: For failure to control infection:
“Any person who contravenes this regulation 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 both.”
Part X Regulations 2006: For failure to have emergency car services or
equipment, apparatus, materials, pharmaceuticals …listed in Fifth
Schedule:
“Any person who contravenes sub-regulation (1), (4) (8) or (9) 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.”
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“Where no penalty is expressly provided for an offence under these
Regulations, a person who commits such offence shall be liable on conviction to
fine not exceeding five thousand ringgit or to an imprisonment for a term not
exceeding one month or to both.”
MMA/MDA proposal:
a.
The entire lot of convictions and punishments meted out for
contraventions in the Regulations should be reviewed.
b.
The part on imprisonment in all these punishments should be removed
so that a practitioner found liable on conviction under the Private
Healthcare Facilities and Services Act 1998 is not further charged under
Section 29 (2)(a) of the Medical Act 1971.
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SUPPLEMENTARY SUBMISSION BY THE
MALAYSIAN DENTAL ASSOCIATION
The Malaysian Dental Association supports the points raised in the
Memorandum submitted by the Malaysian Medical Association with whom
we have worked together.
In addition we would like to submit the following supplementary items
which affects mainly Dental Clinics.
1 Part V Regulation 25: Statistical Returns
Patients attending dental clinic are generally healthy individuals. Also dental
practitioners are not familiar with the International Classification of Disease
Ten (ICD-10).
WE WOULD LIKE TO APPEAL TO BE EXEMPTED FROM THIS
REGULATION.
2. Part VI Regulation 26: Greivance Mechanism
The vast majority of dental clinics are solo practitioners where compliance
with the procedures set out are going to be difficult.
WE SUGGEST THAT THE GRIEVANCE OF THE PATIENTS BE
DIRECTED TO THE MALAYSIAN DENTAL ASSOCIATION FOR
INVESTIGATION AND MEDIATION BEFORE BEING DIRECTED TO
THE DIRECTOR GENERAL.
3.Part VIII Regulation 33: Infection Control
Again the vast majority of Dental Clinics are solo practitioners dealing with
healthy individuals. The number of staff employed is small in number. It
will be very difficult for these dental clinics to comply with the provisions of
Regulation 33.
We, however, support the use of autoclaves or equivalent equipment for
infection control of equipments and materials in dental clinic.
35
WE SUGGEST THAT DENTAL CLINICS BE EXEMPTED FROM THE
PROVISIONS OF REGULATION 33 AND THAT ALL DENTAL
CLINICS BE EQUIPPED WITH AUTOCLAVES OR EQUIVALENT
EQUIPMENTS.
4. Part X Regulation 75
Most dental clinics and practitioners are not equipped and prepared to deal
with emergencies. Such events are not common in dental clinics of general
practitioners.
WE APPEAL TO THE MINISTER TO EXEMPT DENTAL CLINICS
FROM THIS REGULATION.
5. Part XI Regulation 81 and 82
The range of drugs stored and prescribed in a dental clinic is very small and
there is no need for the facilities provided for in regulations 81 and 82.
WE WOULD LIKE TO APPEAL FOR THE DENTAL CLINICS TO BE
EXEMPTED FROM PROVISIONS OF REGULATIONS 81 AND 82
Part XIII:Special requirements for radiological services.
Currently many dental clinics are performing endodontic and minor surgery
to remove buried and impacted teeth without the assistance of Xrays. This is
not satisfactory.
WE RECOMMEND THAT PROVISION FOR ALL DENTAL CLINICS
TO HAVE XRAY EQUIPMENT BE INCLUDED.
End of Submission
36