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Submission to the Food and Health Bureau on Regulation of Private Healthcare Facilities
1. The Consumer Council (the Council) is pleased to submit its views concerning a consultation document issued by the Food and Health Bureau (FHB) on Regulation of Private Healthcare Facilities (PHFs).
2. Currently, regulation of PHFs in Hong Kong is limited to a narrow set of facilities drawn up decades ago mainly covered private hospitals and non-profit sharing medical clinics. As stated in the consultation document, the existing regulatory regime for PHFs in Hong Kong is outdated and has outlived its usefulness in protecting patients' safety and consumers' rights, as well as the sustainable development of Hong Kong's healthcare system. There have been urgent calls for a major revamp to substantially strengthen the regulation of private healthcare services amid the evolving landscape of healthcare services.
3. The urgency has been further intensified by the unfortunate happenings of various fatal medical incidents resulting from high-risk medical procedures performed in ambulatory setting in recent years.
4. The Council appreciates FHB's effort in putting forward a proposed regulatory regime of PHFs for public to comment. As a whole, the Council supports the proposals as set out in the consultation document in principle and provides views on some specific proposals for consideration of the FHB.
5. This submission comprises of: (I) the Council's responses to specific proposals; and (II) the concerns that consumers may have in relation to the proposed regulatory regime.
(I) RESPONSES TO SPECIFIC PROPOSALS
Classes of PHFs and their respective definitions
6. The Council has no objection to the proposed three classes of PHFs to be regulated. While understanding that a mechanism would be introduced to regularly review and update the list of high-risk procedures (paragraph 3.10 of the consultation document), the Council considers that there should also be mechanism in place to review on a regular basis (e.g. every 3 years or when new issues emerged) the definitions of PHFs and the scope of regulation so that the regulation could be appropriately adapted in light of the advancement of medical technology, rapid changes in medical practice and the mode of service provision of PHFs.
Regulatory aspects and their applicability
Appointment of person-in-charge (PIC)
7. The Council supports the proposal of the appointment of a PIC for each regulated PHF be required mandatorily. Besides, the Council considers it important that the qualification needed, capacity and the responsibilities of the PIC be specified in details.
8. According to the consultation document, the PIC will be held accountable (and liable to penalty if the offence is substantiated) for breaches or non-compliance of the PHF concerned as noted at paragraph 5.8 of the consultation document. However, the Council is concerned with the responsibility of the PIC in case of the occurrence of medical malpractices and sentinel events. In view of the fatal incidents resulting from procedures/treatments conducted in beauty centres in recent years, the Council considers it important that the PICs, especially for facilities providing high-risk medical procedures in ambulatory setting, should also be held accountable for medical malpractices and sentinel events as occurred in the PHF concerned, in particular the responsibility on the management of the operation of medical devices and employment of unprofessional medical practitioners, and that this requirement should be clearly specified in the new legislation.
Complaints management system
9. While agreeing that a two-tier complaints handling mechanism be introduced under the new legislation and an Independent Committee on Complaints against Private Hospitals be established to handle complaints at the second-tier as noted in paragraph 5.19 of the consultation document, the Council considers it important as to the composition of the Independent Committee. The Council opines that the Independent Committee, as its name called, should be chaired by an independent person, have the majority of its members be independent persons and include a balanced mix of representatives from medical and non-medical sector so as to avoid potential biased decisions that might be made in favour of the medical professionals and the private hospitals involved in the complaints.
10. The Council notes that in paragraph 5.20 of the consultation document, it is proposed that the two-tier complaints handling mechanism will not be adopted in non-hospital PHFs. In view of non-hospital PHFs will conduct high-risk procedures/ treatments or small-scale operations which could also pose fatal risk to consumers, the Council considers the requirement of safety and integrity of these procedures/treatments and operations should not be substandard to the hospitals. To enable proper consumer redress, the Council opines that the two-tier complaints handling mechanism should be extended to non-hospital PHFs. Besides, the Council recommends that a complaint digest be provided to the Department of Health by non-hospital PHFs regularly possibly every month as required in hospitals.
Sentinel events management
11. As regards the proposed sentinel events management, the Council has reservation that reporting of sentinel events is not required for non-hospital PHFs for reasons of compliance cost and resource implications to the PHF concerned. For improving disclosure of information in connection with a sentinel event and guarding against unsafe care, the Council is of the view that non-hospital PHFs, especially for ambulatory facilities providing high-risk medical procedures, should also be mandated to timely report to the regulatory authority upon the occurrence of a sentinel event.
Provision of fee schedule
12. The Council supports that under the module of price transparency, provision of fee schedule, provision of quotation, provision of recognized service packages and disclosure of historical bill sizes statistics be required. Though enhancing price transparency is important for consumer protection, the Council considers that there should be measures in place to review and oversee the increment of service fees of PHFs in order to prevent a predisposition towards drastic increase of service fees upon the implementation of Voluntary Health Insurance Scheme (VHIS) or any other new policies imposed that would have significant impact on price setting.
Provision of recognized service packages (RSPs)
13. The Council notes that as proposed in the consultation document, provision of RSPs is voluntarily required among all regulated PHFs. Paragraphs 8.29 and 8.30 of the consultation document state that service packages should be encouraged to promote transparency and safeguard rights of patients, and that all regulated PHFs should be encouraged to offer RSPs to patients. The Council is of the view that, in order to better protect the rights of consumers for budget certainty and facilitate consumers to make comparison of medical services, PHFs should be mandatorily required to provide RSPs for common operations/procedures (e.g. cataract surgery for cataract, appendectomy for appendicitis, laparoscopic cholecystectomy for gallstones, endoscopies and colonoscopies) if the common operations/procedures are provided in the PHFs concerned.
14. The Council suggests that a timetable should be set by the Government for rolling out a specific number of RSPs within a certain time period. In addition, the Council suggests PHFs be required to notify the regulatory authority and make the information available at the common electronic platform provided by the regulatory authority in a timely manner any updates on the provision of RSPs and their prices.
15. Since the medical services provided in healthcare facilities are in nature life-concerned, the Council opines that the proposed maximum penalties for hospitals and other regulated PHFs in relation to unlawful operation and non-compliance of other provisions of the legislation are too low to be commensurate with the risk involved. Therefore, the Council considers it necessary that the penalties of all regulated PHFs and all sanctions be increased.
16. Regarding the case of facilities providing high-risk medical procedures in ambulatory setting, in view of the fact that these facilities will perform high-risk procedures/treatments which may involve life-risk and that should not be compromised due to a different category in PHFs, the Council opines that the proposed maximum penalties for these facilities, which is lower than the proposed level for hospitals, is not well justified when taking into account the risk involved. For that reason, the Council suggests the maximum penalties be set with respect to the medical services provided and risk level involved.
Powers of the regulatory authority
17. The Council agrees with the powers to be conferred on the regulatory authority and considers that the regulatory authority should take proactive action in administer and supervising PHF's compliance with the provisions of the Ordinance. In addition to the proposed powers, the Council considers it important to specify that the regulatory authority should have the function of conducting public education and publicity programs on the regulation of PHFs, and the rights of consumers.
(II) OTHER ISSUES OF CONCERN TO CONSUMERS
High risk medical procedures
18. The Council is aware that the consultation document has provided a list of recommended scope of high-risk and hospital-only procedures in technical and medical terms and definitions. The Council opines that this list should be made available to the public and be provided in layman terms with examples in practice for easy understanding of consumers. Since some of the consumers who plan to purchase high-risk medical procedures may not be well aware and informed of the risks involved, the Council recommends that service providers of high-risk medical procedures (including cosmetic/beauty services that fall into the scope of high-risk medical procedures/practices) be required to explain details of the procedures and risks involved to consumers before they agree to purchase the procedures/treatments under the new legislation.
Qualification of practitioners and premises which practise and carry on the business of practising cosmetic/beauty services with risks involved
19. The Council is concerned with the professional qualification of practitioners practising cosmetic/beauty services with risks involved. The Council understands that the review conducted early by the Working Group on Differentiation between Medical Procedures and Beauty Services considered that certain cosmetic services should be performed by registered medical practitioners because of the risks involved, Department of Health has subsequently issued advisory notes to the beauty industry and medical profession to remind practitioners of this requirement when providing cosmetic services.
20. Moreover, the Council noted that under the proposed new regulatory regime, any medical procedure defined as high-risk should be performed only in regulated ambulatory facilities or hospitals by qualified healthcare professionals, and that facilities providing high-risk medical procedures in ambulatory setting should be regulated by a statutory registration system and subject to a set of core facility standards and requirements. It seems to the Council that there could be two situations, medical practitioners that perform cosmetic/beauty services that involve risks (but not high-risks) and medical practitioners that perform cosmetic/beauty services that involve high-risks.
21. However, the shortcoming is that in both cases, the proposed new regulatory regime, has not specified the professional qualification of the medical practitioners involved. In other words, currently there is no requirement on the professional qualification of medical practitioners who perform cosmetic/beauty services. For the sake of better protect the right and safety of consumers, the Council proposes that all medical practitioners who perform cosmetic/beauty services that involve risks or high-risks be required to acquire corresponding medical specialist training and qualification (e.g. on aesthetic medicine), and that the medical specialist training and qualification should be accredited by a professional body, for instance, the Hong Kong Academy of Medicine.
22. Regarding the premises carrying on the business of practising cosmetic/beauty services which involve risks but not high-risks, the Council is of the view that since a certain level of risks though not high-risks is involved, it is important that the good operation and maintenance of the facilities be regulated in order to safeguard consumer interests. The Council considers that a licensing regime be introduced to regulate this kind of premises.
Review mechanism on the judicious use of medical services of PHFs
23. In order to avoid a predisposition towards mis-use and abuse of medical treatments/operations by PHFs due to the implementation of VHIS or any other major Government policies, the Council suggests the regulatory body to establish a mechanism, with the contribution of The Medical Council of Hong Kong, to review on a regular basis whether the medical treatments/operations as performed by each regulated PHF are necessary and judicious. Also, the regulatory body should take a proactive role in reporting and disseminating the above information to the public.
Regulation of medical laboratories
24. Medical diagnoses and treatments have close relationship with medical examinations, tests and analyses, in other words, medical diagnoses/treatments are usually based on the results of medical tests/examinations/analyses. Some medical tests/examinations, for instance, blood tests for various parameters and purposes, Pap test, biopsy, X-ray, CT Scan, MRI, ECG and ultrasound, etc., are provided by private medical laboratories nowadays and such services are becoming more common. On the other hand, the demand of private medical tests/examinations services may be further driven up by the implementation of VHIS. The Council, therefore, is concerned with the quality of services provided by medical laboratories, for instance, the professionalism, safety, accuracy of the tests/examinations, as well as the sales practices. As integrated services to consumers, the Council considers it important that regulatory regime with respect to the operation and quality management of medical laboratories or premises carrying on the business of performing medical tests/examinations be introduced.
Companies/Premises carrying on the business of practising the medical laboratory technologist profession
25. Current regulations on medical laboratories are solely person-oriented and there is no provision on the requirement of operation and quality management. According to Supplementary Medical Professions Ordinance (Cap 359), a company carry on the business of practising the medical laboratory technologist profession should have at least one director thereof is a person who is registered in respect of medical laboratory technologist. All persons practising the medical laboratory technologist profession who are employed by the company are required to be registered in respect of that profession. The premises carry on the medical laboratory technologist profession should be considered by the board as specified in Cap 359 be suitable for such practice. However, the operation and quality management of medical laboratories is not regulated under Cap 359 or any other specific regulations in local.
26. According to the List of Companies Carrying on the Business of Practising the Medical Laboratory Technologist (MLT) Profession of the medical laboratory technologists board, there are 65 companies on the list as of January 2015, however, there are only 11 of them are accredited by HOKLAS based on ISO 15189 according to HOKLAS' record.
27. In order to better protect the consumers, the Council recommends that new regulation be introduced to regulate the operation, maintenance and quality management of medical laboratories. While understanding that there may be different scales of operation of laboratories in Hong Kong, the Council urges that the Government should consider benchmarking the regulatory approaches in overseas to enhance the quality and effective provision of laboratory services for betterment of Hong Kong consumers.
Companies/Premises performing medical tests/examinations which involve the use of medical devices
28. The Council is aware that the regulatory framework for medical devices, for instance energy-emitting devices such as X-ray, is currently under review by the Department of Health. However, the Council is concerned that there may be possibility that some devices used for common medical examinations may not be classified as high risk and that may not be regulated under the regulatory framework under the above review exercise. In this case, the Council recommends that companies/premises performing medical test/examinations which involve the use of medical devices but not practising medical laboratory technologist profession (e.g. processing clinical and medical specimens for analysis or examination in vitro) should also be regulated for their good operation, maintenance and quality management, for instance, the presence of required accreditation to operate.
29. Overall, the Council considers it important that the existing regulatory regime for PHFs should be revamped by new legislation as soon as practically feasible, regardless of whether the VHIS is to be implemented.
1. The regulations on medical laboratories include: Supplementary Medical Professions Ordinance (Cap 359), stipulated the definition of medical laboratory technologist profession, which refers to the practice of processing clinical, medical, legal, public health or veterinary specimens for the sole purpose of making and reporting on analysis or examination in vitro and the processing of all matters for human and animal consumption for the sole purpose of making and reporting on analysis or examination in vitro. Medical Laboratory Technologists (Registration and Disciplinary Procedure) Regulation (Cap 359A) stipulates the qualifications for registration of medical laboratory technologists.