Malaysia legislation
Section 107
Section 107
(2)
Without prejudice to the generality of the powers conferred by subsection (1) regulations may be made for all or any of the following purposes:
(a)
to prescribe the manner of applying for an approval to establish or maintain, a licence to provide or operate, or a certificate of registration or a certificate to import and export natural human blood and blood product under this
Act, the forms to be used, the fees or charges payable and the form of the approval, licence, certificate of registration and certificate to import and export natural human blood and blood product;
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(b)
to prescribe the manner such national registry or registries as may be deemed necessary under this Act are to be kept and maintained;
(c)
to prescribe the terms, conditions and restrictions to be imposed on any approval, licence, certificate of registration or certificate and restrictions to be imposed on the applicant, licensee, holder of the certificate of registration, holder of the certificate or a person in charge;
(d)
to prescribe the circumstances under which a duplicate approval, licence or certificate may be issued and the fee payable;
(e)
to provide for the procedure of amendment of any particulars contained in any approval, licence, certificate of registration or certificate or its revocation and the issuance of a new licence, certificate of registration or certificate;
(f)
to prescribe the records to be kept of patients and persons treated in the private healthcare facilities or services including records of births and deaths of children, any miscarriages or stillbirths and of children so born who are removed from the private healthcare facilities or services otherwise than to the custody or care of any parent or person authorized by the parent;
(g)
to prescribe the manner of accessing a patient’s medical records and the manner of obtaining a patient’s medical report by the patient, the patient’s representative or a healthcare provider;
(h)
to prescribe the records to be kept of the staff or any other person employed or engaged by a private healthcare facility or service;
(i)
to prescribe the minimum number of medical staff, dental staff, nursing staff, technical staff and other categories of staff to be employed or engaged in a private healthcare
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facility or service and the minimum qualifications and experience required of such staff;
(j)
to prescribe the minimum standards of the apparatus, appliance, equipment, instruments, substance and other things to be provided and maintained by private healthcare facilities or services;
(k)
to prescribe the manner or type of training or continuing technical, medical, dental or nursing education or any other type of healthcare professional education to be provided by private healthcare facilities or services to their staff or any other person employed or engaged by the private healthcare facilities or services;
(l)
to prescribe the minimum standards and specifications in respect of siting, design and construction of private healthcare facilities or services;
(m)
to prescribe the minimum standards of accommodation, sanitation or other amenities in private healthcare facilities or services;
(n)
to prescribe the maximum bed or couch capacity or its equivalent in private healthcare facilities or services;
(o)
to prescribe the minimum standards of cleanliness and hygiene, including infection control, in private healthcare facilities and services;
(p)
to prescribe the minimum standards of safety, quality of care and welfare of patients in private healthcare facilities and services;
(q)
to prescribe the minimum standards and conditions required of services with respect to the collection, screening, processing, distribution, storage, dispensing, disposal and transfusion of human blood and blood products, and dialysate, chemical and pharmaceutical for
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haemodialysis treatment and other forms of treatment or service;
(r)
to prescribe the management, control, and superintendence and care of private healthcare facilities and services;
(s)
to provide for acceptable quality assurance and quality control in respect of a private healthcare facilities and services;
(t)
to require the licensee, the holder of a certificate of registration or person in charge of a private healthcare facility or service to maintain such books, records or registers necessary for the proper enforcement and administration of this Act;
(u)
to require the furnishing of specified statistical information to the Director General and the manner of furnishing such information;
(v)
to require notification be given of any births or deaths occurring in a private healthcare facility or service;
(w)
to provide for the notification of the closure of a private healthcare facility or service and the directions to be given prior to closure;
(x)
to prescribe the duties and responsibilities of the healthcare professionals and personnel,
Board of
Management, Medical Advisory Committee, Medical and
Dental
Advisory
Committee,
Nursing
Advisory
Committee, Midwifery Advisory Committee, and visiting registered medical practitioner;
(y)
to prescribe the manner and form of applying for the transfer of approval, licence or certificate of registration in respect of, and the extension or alteration to, any private healthcare facility;
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(z)
to prescribe the requirements and role of volunteers in private healthcare facilities and services, their training and supervision and to prescribe restrictions on their activities;
(aa) to prescribe all matters relating to policy statements and all matters relating to grievance mechanism;
(bb) to prescribe the organization of the private healthcare facility or services and the staff thereof;
(cc)
to prescribe the composition and duties and responsibilities of the committees which may be required to be set up by the private healthcare facilities or services;
(dd)
to prescribe the duties and functions of locum tenens and honorary consultants, their qualification, training and experience and supervision and to prescribe restrictions on their activities;
(ee) to prescribe the types of unforeseeable or unanticipated incidents to be reported, the procedure for reporting, the manner of investigation to be conducted, the report and statistical data to be submitted;
(ff) to prescribe matters relating to inspection and control;
(gg) to prescribe the requirements to be satisfied for obtaining a valid consent for any anesthetic procedure, surgical operation or 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 and under what conditions a patient may give a valid consent for any anesthetic procedure, surgical operation or procedure, diagnostic procedure or medical procedure or treatment to be performed on a patient;
(hh) to prescribe the fees that may be charged by private healthcare facilities and services or health-related services;
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(ii)
to prescribe matters relating to patients’ rights in relation to healthcare services provided by any healthcare facility or service, including patients’ privacy, confidentiality of information and access to patients’ medical reports and records;
(jj) to prescribe the minimum standards and requirements for all healthcare facilities, healthcare services and health-related services in relation to any healthcare services provided by any healthcare professional including medical care services, nursing services, allied health services, technical services, services relating to all disciplines of medicine and surgery including obstetrics and gynaecology, anesthesia, surgery, psychiatric, paediatrics, pharmaceutical services, critical care or intensive care services, services relating to medical supply, dietary services, linen and laundry, surgical supply, blood transfusion services, blood bank services, haemodialysis treatment services, rehabilitation services, outpatient and inpatient services, ambulatory care services, radiological or diagnostic imaging services, radiotherapy and radioisotope services, telemedicine services, nursing home services, hospice and palliative care services, services relating to autopsies and mortuaries, ambulance services, other support and ancillary services and all other policies and programmes relating to healthcare services provided and maintained by a private healthcare facility or service;
(kk) to prescribe any other matter relating to any healthcare or health-related facility or service or any matters which the
Minister deems expedient or necessary for the purpose of this Act.
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