Section 86
Power to make regulations
of Pathology Laboratory Act 2007
The Minister may make such regulations as may be necessary or expedient for the purpose of carrying into effect the provisions of this Act.
(2)
Without prejudice to the generality of the powers conferred by subsection (1), such regulations may be made for all or any of the following purposes:
(a)
to prescribe the circumstances under which a duplicate approval or licence may be issued and the fee payable;
(b)
to prescribe the procedure of amendment of any particulars contained in any approval or licence or its replacement with a new approval or licence and the fee payable;
(c)
to prescribe the records of persons whose sample has been tested in the licensed pathology laboratory and the manner in which such records are to be kept and issued;
(d)
to prescribe the manner of accessing a person’s laboratory results and the manner of obtaining the laboratory results by the person, the person’s representative or a healthcare provider;
(e)
to prescribe the records to be kept of the healthcare professional, staff or any other person employed or engaged by a licensed pathology laboratory;
(f)
to prescribe the minimum number, qualification or experience required of healthcare professionals including pathologists, scientific officers, medical laboratory technologists or other technical staff or other categories of staff to be employed or engaged in a licensed pathology laboratory;
(g)
to prescribe the minimum standards of the equipment, materials and other things to be used, provided and maintained by a licensed pathology laboratory;
(h)
to prescribe the type of training, continuing technical or medical education or any other type of healthcare professional education to be provided by a licensee to the healthcare professional, staff or any other person employed or engaged by the licensed pathology laboratory;
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(i)
to prescribe the minimum standards and specifications in respect of design and construction of a licensed pathology laboratory;
(j)
to prescribe the minimum standards of sanitation or other amenities in a licensed pathology laboratory;
(k)
to prescribe the minimum standards of cleanliness and hygiene, including infection control in a licensed pathology laboratory;
(l)
to prescribe the minimum standards and conditions required of pathology services with respect to the collection, screening, analysis, processing, handling, transportation, distribution, storage, or disposal of samples;
(m)
to prescribe the management, control, and supervision of a licensed pathology laboratory;
(n)
to prescribe the acceptable quality assurance and quality control in respect of a licensed pathology laboratory;
(o)
to prescribe the programmes and activities of a licensed pathology laboratory to ensure the quality of services provided;
(p)
to prescribe the form and particulars to be contained in the records or register kept or maintained under this
Act;
(q)
to prescribe the statistical information to be furnished by the licensee to the Director General and the manner of furnishing such information;
(r)
to prescribe the procedure for notification of the closure of a licensed pathology laboratory;
(s)
to prescribe the manner and form of applying for the transfer or assignment of the approval or licence in respect of, and the extension or alteration to the licensed pathology laboratory;
(t)
to prescribe the procedure for reporting incidents, the report and statistical data to be submitted by a licensee;
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(u)
to prescribe the categorization of pathology laboratories into different classes and specialities which may or may not be performed in particular classes and specialities of licensed pathology laboratories;
(v)
to prescribe the membership, duties and responsibilities of a Pathology Laboratory Advisory Committee; or
(w)
to provide for any matter which under this Act is required or permitted to be prescribed or which are necessary or expedient to be prescribed to give effect to this Act.