On 20/05/2013,
you requested for the version in force on 20/05/2013
incorporating all amendments published on or before 20/05/2013.
The closest version currently available is that of 15/04/2011.
PART IV
CLINICAL LABORATORIES
47. A licence for any premises to be used as a clinical laboratory may be issued to —
(a)
a medical practitioner who has the relevant higher qualification and training in any of the disciplines specified in regulation 56(a) to (j); or
(b)
a person who has a degree in medicine or any other higher qualification in any of the disciplines specified in regulation 56(a) to (j) that is acceptable to the Director, and who has at least 5 years’ relevant working experience in a clinical laboratory acceptable to the Director.
48. Every licensee of a clinical laboratory shall be responsible for —
(a)
the proper administration of the laboratory and the compliance with any written law;
(b)
the close supervision over technical staff in their performance of examinations; and
(c)
notifying the Director immediately of staff changes or any other change that may affect the conditions governing the issue of the licence.
49. No person shall be appointed to manage a clinical laboratory unless he has —
(a)
a degree in medicine or a basic degree in a relevant science subject that is acceptable to the Director; and
(b)
at least 5 years’ relevant working experience in a clinical laboratory acceptable to the Director.
50. Every clinical laboratory shall be staffed by at least one trained person in each of the disciplines in which it is licensed to practise.
51.
—(1) All facilities in a clinical laboratory shall be adequate for the proper and efficient performance of any category of examinations for which it is licensed to undertake, and for its functions to be performed with accuracy, timeliness and safety.
(2) The equipment in such laboratories shall be regularly checked for accuracy and calibration.
52.
—(1) The licensee of a clinical laboratory shall ensure that there is an effective and documented quality control programme for the clinical laboratory.
(2) The licensee of a clinical laboratory shall —
(a)
ensure that quality control measures (including external quality assessments) are taken for every type of test performed at the clinical laboratory;
(b)
keep proper records and details of the quality control measures taken at the clinical laboratory under sub- paragraph (a); and
(c)
submit to the Director as and when required by him any of the records kept under sub-paragraph (b).
(3) The Director may issue guidelines specifying the standards of test performance for procedures performed by clinical laboratories and institute evaluation programmes, including surprise checks, on the accuracy of examination results.
(4) Where the licensee of a clinical laboratory intends to use the clinical laboratory to perform any specialised test or service as specified in the Fifth Schedule, he shall, before the clinical laboratory commences performing any such specialised test or service, obtain the prior approval of the Director in writing.
(5) An application for the Director’s approval under paragraph (4) —
(a)
shall be made in such form or manner as the Director may require; and
(b)
shall be submitted to the Director not less than 90 days before the date on which the clinical laboratory is to commence performing the specialised test or service.
53. Every licensee of a clinical laboratory shall keep records of specimens which shall include —
(a)
the name of the person from whom the specimen was taken, his age, national registration identity card number and address;
(b)
the name of the person who referred the specimen; and
(c)
the date and type of examination performed, examination result of each specimen and the person who performed the examination.
54.
—(1) Every report of any test or examination performed by a clinical laboratory shall be retained by the clinical laboratory.
(2) The report shall state the name and address of the clinical laboratory and shall be signed by the licensee of the clinical laboratory or his authorised representative, who shall be a person suitably qualified in the relevant discipline.
(3) Where the test or examination to which the report relates has been outsourced to another clinical laboratory under regulation 55, the report shall —
(a)
state clearly the name and address of the clinical laboratory in which the test or examination was performed; and
(b)
be accompanied by the original copy of the report of the clinical laboratory which performed the test or examination.
55.
—(1) Subject to paragraph (2), all tests and examinations to be performed by a clinical laboratory shall be performed at the licensed premises of such clinical laboratory.
(2) The licensee of a clinical laboratory shall not outsource the conduct of any test or examination or any part thereof except to —
(a)
another licensed clinical laboratory; or
(b)
any foreign clinical laboratory which has been accredited by an accreditation body approved by the Director.
56. Every clinical laboratory shall, according to the tenor of the licence issued in respect thereof, be used only for one or more of the following disciplines:
(a)
anatomic pathology;
(b)
chemical pathology;
(c)
cytogenetics;
(d)
forensic pathology;
(e)
haematology;
(f)
histocompatibility;
(g)
immunology;
(h)
medical microbiology;
(i)
transfusion medicine;
(j)
any other discipline acceptable to the Director.