HEALTH FACILITIES (MEDICAL LABORATORIES) ACT

ARRANGEMENT OF SECTIONS

PART I
Preliminary

   1   Short title and commencement

   2   Interpretation

PART II
Medical Laboratories Council

   3   Establishment of Medical Laboratories Council

   4   Functions of the Council

   5   Appointment of Registrar and other officers, agents and employees

   6   Ministerial directions

PART III
Financial Provisions

   7   Funds of the Council

   8   Borrowing powers

   9   Power to invest moneys

   10   Minister of Finance may guarantee loans

   11   Accounts and audit

   12   Exemption from taxes and duties

   13   Annual Report

PART IV
Licences and Certificates

   14   Grant of licence to operate laboratory facility or collection centre

   15   Certification of laboratory practitioner

   16   Display of licence

   17   Suspension of licence or certificate

   18   Revocation of licence or certificate

   19   Register

PART V
Complaints and Appeals

   20   Establishment of Complaints Board

   21   Establishment of Medical Laboratories Appeal Tribunal

   22   Appeals

PART VI
Offences and Penalties

   23   Offences of operating laboratory facility, etc without licence

   24   Offence of passing off as certified laboratory practitioner

   25   Making false statement, etc

   26   Assault, obstruction, etc

   27   Failure of licence to keep or produce books, records, etc

   28   Offence of employing uncertified laboratory practitioner

   29   Offence against this Act

PART VII
General

   30   Assessors

   31   Records

   32   Confidentiality

   33   Duty of licensee to notify Council

   34   Minister may amend Fourth Schedule

   35   Regulations

   36   Act bind Crown

   37   Transitional

      SCHEDULES

 

THE HEALTH FACILITIES (MEDICAL LABORATORIES) ACT

[The date notified by the Minister bringing the Act into operation]

Act 32 of 2005.

AN ACT to Provide for the establishment of a Medical Laboratories Council to regulate and control the activities of medical laboratories, to establish standards in respect to medical laboratories and to provide for connected matters.

PART I
Preliminary (sections 1-2)

1   Short title and commencement

   This Act may be cited as the Health Facilities (Medical Laboratories) Act, 2005 and shall come into operation on a day to be appointed by the Minister by notice published in the Gazette.

2   Interpretation

   In this Act-

   "assessor" means a person designated as such pursuant to section 30;

   "authorised person" means an assessor and any person acting in aid of the assessor in the performance of his function under this Act;

   "collection centre" means a place where-

   (a)   samples which are obtained from patients by medical or paramedical personnel or otherwise are handled and prepared for transportation to a laboratory facility;

   (b)   tests are carried out, that is to say-

         (i)   phlebotomy, smear preparation, Gram stain, serological screening test for syphilis, sickle test (slide or tube) and urinalysis by dipstick method;

         (ii)   centrifugal of blood samples, erythrocyte sedimentation test (ESR) packed cell volume (PCV), pregnancy test, haemoglobin and glucose determination all using instruments which require minimal intervention by staff for calibration; and

         (iii)   except for simple test carried out in the office of a medical practitioner, a dentist or a veterinary surgeon, such other tests, as may be developed from time to time, which require minimal technical supervision and the use of equipment needing minimal calibration and maintenance;

   "Complaints Board" means the Medical Laboratories Complaints Board established under section 20;

   "Council" means the Medical Laboratories Council established under section 3;

   "functions" includes powers;

   "laboratory facility" means any premises in respect of which certification is granted to carry out the following activities-

   collecting, handling, preparing, testing and analyzing samples provided by clients to medical, para-medical or other personnel authorised in that behalf;

   tests in chemistry, cytology, haematology, histopathology, immunology, microbiology and other scientific and medical tests and research;

   "laboratory practitioner" means-

   (a)   Medical Laboratory Technologists, as specified in the First Schedule to the Professions Supplementary to Medicine Act;

   (b)   any person falling within the categories specified in the Fourth Schedule;

   (c)   any other person who is employed to and performs tasks of a technical nature in a laboratory facility or collection centre;

   "licensee" means a person to whom a licence is granted under section 14;

   "Registrar" means the Registrar appointed under section 5;

   "specified discipline", in relation to any person, means a discipline specified in the Fourth Schedule;

   "Tribunal" means the Medical Laboratories Appeal Tribunal established under section 21.

PART II
Medical Laboratories Council (sections 3-6)

3   Establishment of Medical Laboratories Council

   (1) There is hereby established a body to be called the Medical Laboratories Council which shall be a body corporate to which the provisions of section 28 of the Interpretation Act shall apply.

   (2) The provisions of the First Schedule shall have effect with respect to the constitution of the Council and otherwise in relation thereto.

4   Functions of the Council

   (1) The functions of the Council shall be to monitor, regulate and control the operation and activities of all laboratory facilities and collection centres.

   (2) The Council shall have the power to-

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