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MEMORANDUM TO THE MINISTER OF HEALTH MALAYSIA SUBMITTED BY MALAYSIAN MEDICAL ASSOCIATION AND MALAYSIAN DENTAL ASSOCIATION JULY 13TH 2006 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. 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
Details of the Associations? concerns and proposals for changes are listed systematically, following the Act and Regulations, in the accompanying document. 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
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. 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; (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. 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 (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, air-conditioning, 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. 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. 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. 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. 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 (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 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. There are various issues pertaining to the Regulations 2006 which need to be addressed as stated above. 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. 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 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. 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. b. There is no provision in the Medical Act 1971 for fines or imprisonment for ethical or disciplinary infringements. MMA/MDA proposal: Sections 18 (1) (b) and 18 (2) should be reviewed. c. The punishment is too severe for any contravention in this Part. 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. The need for obtaining statistics on diseases treated in private medical clinics is accepted as important and timely. b. ?Any other information? is vague, and unless clarified it would be difficult to be able to produce ?any other information? at short notice. c. 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. d. The requirement for a Patient?s Medical Record Register is cumbersome and does not apply to a solo medical practice. 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. 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 |
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