Medical Laboratories Bill, 2024

No. of 2024. Medical Laboratories Bill, 2024. Saint Christopher and Nevis.

ARRANGEMENT OF SECTIONS

PART I – PRELIMINARY

1. Short title and commencement.

2. Interpretation.

3. Act binds the Crown.

PART II – MEDICAL LABORATORIES COUNCIL

4. Establishment of Medical Laboratories Council.

5. Tenure of office.

6. Alternate members.

7. Appointment of members of the Council to be published in the Gazette.

8. Revocation of appointment.

9. Acting appointment.

10. Remuneration.

11 Procedure of the Council.

12. Functions of the Council.

13. Powers of the Council.

14. Policy directions of the Minister and report.

15. Employment of persons for specific tasks.

16. Secretary to the Council.

17. Appointment of committees.

18. Delegation.

19. Disclosure of interest.

20. Confidentiality.

21. Seal of the Council.

22. Address for service of notice on the Council.

PART III – FINANCIAL PROVISIONS

23. Funding of the Council.

24. Use of funds and resources of the Council.

25. Exemption from taxes.

26. Financial year.

27. Accounts of the Council.

28. Auditing of accounts.

29. Public accounts.

30. Annual report.

PART IV – LICENSING OF MEDICAL LABORATORIES

31. Operation of a medical laboratory.

32. Premises of a medical laboratory.

33. Application for licence.

34. Issuance of licence.

35. Provisional licence.

36. Conditions of licence.

37. Form of licence.

38. Validity of licence.

39. Display of licence.

40. Licence not transferable or assignable.

41. Renewal of licence.

42. Variation of terms and conditions of licence.

43. Suspension and revocation of licence.

44. Surrender of licence.

45. Procedure on destruction, defacement or loss of licence.

46. Register of Licensed Medical Laboratories.

47. Publication of notice of suspension, revocation, removal or restoration.

PART V – MONITORING AND INSPECTION OF A LICENSEE

48. Request for information.

49. Appointment of inspectors.

50. Conduct of inspection.

51. Warrant.

52. Copies of documents.

53. Notices to rectify unsatisfactory conditions.

54. Offences relating to inspections.

PART VI – GENERAL

55. Establishment of Medical Laboratories Appeal Tribunal.

56. Appeal to Tribunal.

57. Confidentiality of records.

58. Evidence.

59. Offences and penalties.

60. Liability of person exercising duty.

61. Regulations.

62. Standards and guidelines.

63. Amendment of Schedule.

64. Transitional.

SCHEDULE 1

SCHEDULE 2

SCHEDULE 3

SCHEDULE 4

SAINT CHRISTOPHER AND NEVIS

No. of 2024

A BILL to establish the Medical Laboratories Council and provide for the licensing, monitoring and inspection of the operations of a medical laboratory and for related matters.

BE IT ENACTED by the Queen’s Most Excellent Majesty, by and with the advice and consent of the National Assembly of Saint Christopher and Nevis and by the authority of the same as follows:

PART I – PRELIMINARY

1. Short title.

This Act may be cited as the Medical Laboratories Act, 2024.

2. Interpretation.

In this Act ⎯

“accreditation” means the procedure by which formal recognition is given to a medical laboratory that it is competent to carry out a laboratory service;

“applicant” means a person who applies under section 33(1) for a licence to operate a medical laboratory;

“committee” means a committee appointed under section 17;

“Council” means the Medical Laboratories Council established under section 4(1);

“health care facility” means a place that provides health care or medical care to a patient including a hospital, clinic, health centre, outpatient care centre, diagnostic facility and a specialized care centre, such as a birthing centre and psychiatric care centre;

“health practitioner” means a medical practitioner registered under the Medical Act Cap 9:15;

“inspector” means a medical technologist, laboratory practitioner or standards officer designated under section 49 to be an inspector;

“laboratory practitioner”⎯

(a) means a medical technologist registered under the Medical Act Chap 9.15; and

(b) includes another person falling within the prescribed categories or who is employed and performs tasks of a technical nature in a medical laboratory;

“licence” means a licence issued under section 34 and includes a provisional licence issued under section 35;

“licensee” means a person who has been issued a licence;

“medical laboratory”—

(a) means a clinical laboratory for the biological, microbiological, chemical, immuno-haematological, haematological, biophysical, cytological, pathological or other examination of materials derived from the human body for the purpose of providing information for the diagnosis, prevention and treatment of disease in, or assessment of the health of, human beings;

(b) includes a clinical laboratory referred to in paragraph (a) which may provide a consultant advisory service covering all aspects of laboratory investigation including the interpretation of results and advice of further appropriate investigation; and

(i) a part of a health care facility, where specimens are not examined or analysed,

(ii) a temporary or ad hoc health promotion or screening program conducted for the general public which offers mass screening procedures; if the health promotion or screening program is conducted in accordance with a permit issued under the Public Health Act,

(iii) a laboratory maintained by a food preparation or processing establishment performing analysis to determine the quality of its products,

(iv) a laboratory performing only —

(aa) electrocardiogram,

(bb) electroencephalogram,

(cc) in-vivo imaging,

(dd) scanning or body counting procedures,

(ee) in-vivo cardiopulmonary,

(ff) cardiovascular,

(gg) cardiac catheterization,

(hh) respiratory therapy, and

(ii) pulmonary function procedures; and

(v) another prescribed service, prescribed place or prescribed category of places;

“medical practitioner” means a medical practitioner registered under the Medical Act;

“medical waste” means a bio-hazardous, chemical, immuno-haematological, haematological, biophysical, cytological, pathological material, including

(a) a needle, syringe or another object used in the course of laboratory procedures, the investigation of human or animal diseases or in analysis or research that involves the use of tissue or fluid specimens;

(b) sanitary waste that originates from or has been in contact with a person who has a transmissible communicable disease within the meaning of the Public Health Act;

(d) waste consisting of a cytotoxic substance or waste that is, or is likely to be, contaminated by a cytotoxic substance;

(e) another object that is discarded from a laboratory procedure and poses a significant risk to the health of a person who comes into contact with it;

(f) waste consisting of anything that has been in contact with waste mentioned in paragraphs (a) to (e);

(g) waste prescribed to be medical waste;

“member” means a member of the Council appointed under section 4; “Minister” means the Minister responsible for health;

“Ministry” means the Ministry responsible for health;

“patient” means an individual who receives medical attention, care or treatment by or undergoes a test with a health practitioner, medical practitioner, or laboratory practitioner or is admitted in a health care facility;

“prescribed” means prescribed by Regulations;

“public medical laboratory” means a medical laboratory operated by the Government;

“Register” means the Register of Licensed Medical Laboratories maintained under section 46;

“Regulations” means Regulations made under section 61;

“responsible Minister” means the Minister responsible for the subject matter;

“Secretary” means the person for the time being performing the function of Secretary of the Council, as appointed under section 16;

“test” means the examination or analysis of a specimen taken or collected from a human body to obtain information for —

(a) screening;

(b) diagnosis;

(d) treatment; or

(e) another health-related purpose;

“testing site” means a place where a test is done for the purpose of diagnosing and treating a patient, including but not limited to —

(a) the office of a medical or health practitioner, dental practitioner or veterinary surgeon;

(b) a health facility; and

“Tribunal” means the Medical Laboratories Appeal Tribunal established under section 55.

3. Act binds the Crown.

This Act binds the Crown.

PART II – MEDICAL LABORATORIES COUNCIL

4. Establishment of Medical Laboratories Council.

(1) There is established a body corporate to be known as the Medical Laboratories Council to which section 31 of the Interpretation Act, Chap 1.02 applies.

(2) The Medical Laboratories Council comprises seven persons, appointed by instrument in writing by the Minister, as follows —

(a) the Chief Medical Officer or his or her nominee;

(b) a representative of the Medical Board;

(d) an attorney-at-law of at least five years’ experience nominated by the Saint Christopher and Nevis Bar Association;

(e) two laboratory technologists of at least five years’ experience in medical laboratory pathology nominated by the Medical Board one of whom shall be a member of the Caribbean Association of Medical Technologists; and

(f) a representative of the Chamber of Commerce.

(3) The Minister shall select the Chairperson and Deputy Chairperson from among the members of the Council.

5. Tenure of office.

(1) Subject to subsection (2), a member shall be appointed to hold office for a period not exceeding three years from the date of the appointment of the member by the Minister.

(2) A person may be appointed to serve as a member for a period of less than three years to assist in providing continuity of experience as a member.

(3) On the expiration of the period of appointment of a member, the member is eligible for reappointment.

6. Alternate members.

(1) The Minister may appoint a person to be an alternate member for a member, other than the Chairperson.

(2) The alternate member may act as a member if that member is temporarily absent or incapacitated or ineligible to perform the duties of a member.

7. Appointment of members of the Council to be published in the Gazette. The Minister shall cause to be published by Notice in the Gazette ─

(a) the names of the members of the Council as first appointed;

(b) the names of the Chairperson and Deputy Chairperson;

(d) the termination of the appointment of a member.

8. Revocation of appointment.

The Minister may revoke the appointment of a member of the Council ⎯

(a) if the member ⎯

(i) is adjudged bankrupt,

(ii) is certified by a Medical Board or other tribunal or authority Tribunal or declared by a court to be mentally incapable of performing the duties of a member,

(iii) is, for whatever reason, incapable of performing or unable to perform the duties of a member,

(iv) has neglected the duties of a member or has engaged in misconduct,

(v) has been absent, without leave of the Chairperson, or without reasonable excuse from three consecutive meetings of the Council, or

(vi) has been convicted of an indictable offence or an offence under this Act or another enactment for which a penalty of six months imprisonment has been imposed; or

(b) for sufficient cause.

9. Acting appointment.

(1) Subject to section 6, the Minister may appoint a person, under section 4(2), to act in the place of a member during the period of absence or incapacity of that member or until a vacancy is filled, if the Minister is satisfied that ⎯

(a) the member is absent or temporarily incapable of performing the duties of a member; or

(b) the office of the member is vacant.

(2) A person appointed to act in the place of a member under subsection (1) may hold office for the unexpired term of the predecessor.

10. Remuneration.

(1) The Council may, subject to the approval of the Minister pay to —

(a) a member, in respect of the office of the member, the remuneration and allowances, as the Council determines;

(b) the Chairperson and Deputy Chairperson, the remuneration and allowances in respect of their offices as Chairperson and Deputy Chairperson, in addition to the remuneration or allowances in respect of their offices as members, as the Council determines.

(2) The remuneration and allowances of a member is a charge on the Consolidated Fund.

11. Procedure of the Council.

Schedule 1 has effect in relation to the procedure of the Council and for related matters.

12. Functions of the Council.

(1) The Council has the following functions —

(a) to licence, inspect, or cause an inspection to be undertaken of, a medical laboratory;

(b) to ensure the observance of standards in the provision of laboratory services; (c) to advise the Minister on —

(i) the accreditation and recognition of a medical laboratory, and

(ii) other matters under this Act and the Regulations; and

(d) to make recommendations to the Minister —

(i) on matters relating to the making of Regulations; and

(ii) with a view to achieving compliance with the requirements of this Act and the Regulations.

(2) Without limiting its general functions under subsection (1), the Council shall (a) maintain and publish or cause to be published in the Gazette a list of (i) accredited medical laboratories operating in Saint Christopher and Nevis;

(ii) accredited programmes in laboratory services offered in Saint Christopher and Nevis; and

(iii) persons certified as laboratory practitioners;

(b) advise the Minister on the recognition of, and may recognise a medical laboratory accredited outside of Saint Christopher and Nevis and operating in Saint Christopher and Nevis;

(c) establish a relationship including a joint exercise with a regional and international accrediting or quality assurance body and keep under review the systems of accreditation, procedures and practices of that body;

(d) report on the licensing of a medical laboratory and related matters;

(e) promote the standards to be observed to enhance the quality of the services provided by a medical laboratory;

(f) disseminate information on good practices to be adopted by a medical laboratory;

(g) assess or cause an assessment to be undertaken of an applicant and/or inspect or cause an inspection to be undertaken of a medical laboratory;

(h) provide the public with information about the quality and recognition of programmes and institutions in order to protect public interest;

(i) ensure that the appropriate prescribed standards are maintained and improved in the operation of a medical laboratory;

(j) cause an audit, review and evaluation to be undertaken of a medical laboratory independently or in co-operation with another body, as the Council considers necessary;

(k) advise the Minister on the authorization granted to a medical laboratory to operate or to continue to operate in Saint Christopher and Nevis;

(l) establish the criteria for the licensing of a medical laboratory seeking to operate or to continue to operate in Saint Christopher and Nevis;

(m) charge and collect the prescribed fee, for the provision of its services;

(n) perform another function related to the functions in paragraphs (a) to (m) that the Minister may assign to the Council; and

(o) do or cause to be done another thing that the Council considers expedient or necessary for the purposes of this Act.

13. Powers of the Council.

The Council may in carrying out its functions

(a) enter or cause a medical laboratory to be entered to conduct an assessment in accordance with the Regulations;

(b) delegate any of its functions for the efficient operation or implementation of this Act;

(c) collaborate with and enter into or co-ordinate an appropriate arrangement with another country, body or person, public or private, for the promotion or dissemination of materials and information relating to the licensing, recognition and accreditation of a medical laboratory;

(d) enter into or co-ordinate an appropriate arrangement with another competent authority, public or private, responsible for the certification or accreditation of a medical laboratory;

(e) with the permission of the Minister, acquire, purchase, take, hold and enjoy real and personal property of every description;

(f) convey, lease, assign, surrender and yield up, mortgage, hypothecate demise, re assign, transfer or otherwise dispose of, or deal with real or personal property vested in the Council on the terms that the Council considers fit, but the Council shall not dispose of property representing a significant amount of its asset base, without the permission of the Minister;

(g) hold property that may be vested in the Council;

(h) accept, surrender, assign or reconvey and exchange a property and enter into a contract;

(i) open and maintain accounts with a licensed financial institution; and (j) exercise another power prescribed under any other enactment.

14. Policy directions of the Minister and report.

(1) The Council shall perform its functions and exercise its powers in accordance with a special or general policy directions given to it by the Minister.

(2) The Minister may request the Council to provide the Minister with information concerning a matter relating to the functions of the Council and the Council shall provide the information requested within fourteen days of the request or within another period specified by the Minister.

(3) The Council may furnish to the Minister, a report relating to a matter investigated which, in its opinion, requires the special attention of the Minister.

(4) The Council shall take policy directions from the Saint Christopher and Nevis Bureau of Standards to be observed by a medical laboratory as may be prescribed in Regulations.

15. Employment of persons for specific tasks.

The Council may designate a person to perform a specific task that the Council considers necessary for the performance of its functions and exercise of its powers under this Act, on terms and conditions agreed between the Council and the person.

16. Secretary to the Council.

(1) The Council shall appoint a person to serve as Secretary to the Council, on the terms and conditions that the Council determines.

(2) The Secretary to the Council shall ⎯

(a) make preparations for and attend the meetings of the Council;

(b) prepare and keep the minutes of a proceeding of the Council;

(3) The Secretary to the Council shall not be a member of the Council.

17. Appointment of committees.

(1) The Council may appoint standing or special committees as it considers fit to assist it in the performance of its functions under this Act and may refer or assign to a committee a matter for consideration, inquiry or management by the Council.

(2) A committee appointed under subsection (1) shall consist of at least one member and another person, whether the other person is a member of the Council or not, whose assistance or advice the Council desires.

(3) If the Council appoints a committee it shall appoint a member of the committee to be the Chairperson of the committee.

(4) A reference or assignment under subsection (1) does not prevent the exercise by the Council of its functions, and that reference or assignment and an appointment under subsections (2) and (3) may be withdrawn or revoked by the Council.

(5) A committee appointed under this section may, subject to a specific or general direction of the Council, regulate its own procedure and business.

(6) A meeting of a committee shall be held at a time and place as the Chairperson of that committee determines or as the Council directs.

(7) A committee shall keep minutes of its meetings and shall keep the Council informed of its activities.

(8) The members of a committee appointed under this section may be paid from the funds of the Council, remuneration, whether by way of honorarium, salary or fees, and allowances that the Minister determines.

(9) The Council may by resolution reject a report of a committee appointed under subsection (1) or adopt the report either wholly or with the modifications, additions or adaptations as the Council determines.

18. Delegation.

(1) The Council may delegate, in writing, to a committee or to a member, the exercise of a power or the performance of a function vested in the Council under this Act, except the power to delegate under this section.

(2) A delegation under subsection (1) may be revoked or varied.

19. Disclosure of interest.

(1) A member of the Council or of a standing or a special committee appointed under section 17 ⎯

(a) who is interested, whether directly or indirectly, in a ⎯

(i) transaction, contract or an arrangement with the Council or in which the Council is interested; or

(ii) matter which is being dealt with by the Council; or

(b) whose material, pecuniary or proprietary interest in a company, partnership, undertaking or another business is likely to be affected by a decision of the Council,

shall disclose the nature of the interest of that member at the first meeting of the Council or the committee at which the member is present after the relevant facts come to the knowledge of the member.

(2) A disclosure under subsection (1) shall be recorded in the minutes of the meeting and after the disclosure the member making it shall not⸺

(a) vote on the transaction, contract, arrangement or matter; and

(b) be present or take part in the proceedings of a meeting at which the transaction, contract, arrangement or matter is being discussed or decided by the Council or committee.

(3) A member shall be treated as having an indirect interest in a ⸺

(a) transaction, contract or an arrangement with the Council or in which the Council is interested; or

(b) matter which is being dealt with by the Council,

if the member is a director, shareholder, trustee, agent or employee of the company or undertaking that is a party to the transaction, contract or arrangement or proposed transaction, contract or arrangement or matter with the Council or if the immediate relative of the member holds an interest in that company or undertaking.

(4) For the purposes of this section, a general notice given to the Council or a committee by a member to the effect that the member ⎯

(a) is a member of or is associated with a company or undertaking and is to be regarded as interested in a transaction, contract or an arrangement which may after the date of the notice be made with that company or undertaking; or

(b) is interested in a matter which is being dealt with by the Council,

is deemed to be a sufficient disclosure of interest in relation to a transaction, contract or an arrangement or matter referred to under subsection (1).

(5) In this section “immediate relative” in relation to a Council or committee member, means the spouse, parent, child, stepchild, brother or sister of the Council or committee member.

20. Confidentiality.

(1) An officer and employee of the Council and a member of the Council and of a committee ⎯

(a) shall at all times preserve and aid in preserving confidentiality with regard to a matter coming to the knowledge of the member in the performance of the duties of the member; and

(b) except for the purpose of the performance of the duties of the member or under legal obligation, shall not communicate confidential matter to a person nor permit, unless under legal obligation, a person to have access to the record in the possession, custody or under the control of the Council.

(2) An officer and employee of the Council and a member of the Council and a committee shall take an oath of confidentiality in the form set out in Schedule 2.

21. Seal of the Council.

(1) The Council shall have a common seal which shall be kept in the custody of the Chairperson, the Deputy Chairperson or the Secretary to the Council.

(2) The common seal of the Council may be affixed to an instrument pursuant to a resolution of the Council in the presence of ⎯

(a) the Secretary; and

(b) the Chairperson or in the absence of the Chairperson, the Deputy Chairperson; or (c) any other member of the Council authorized to act in that behalf.

(3) A document other than that required by law to be made under seal and a decision of the Council may be signified under the hand of the Secretary or the Chairperson or in the absence of the Chairperson, shall be signified by the Deputy Chairperson, or another person authorized to act for that purpose.

22. Address for service of notice on the Council.

(1) The Council shall have a fixed address in Saint Christopher and Nevis for the service of a notice, order or other document on the Council.

(2) A notice, order or other document to be served on the Council may be served by electronic means or by delivering it by hand or by sending it by registered post to the Secretary at the fixed address of the Council.

(3) The fixed address for service of a notice, order or other document on the Council shall be published in the Gazette.

PART III – FINANCIAL PROVISIONS

23. Funding of the Council.

The funds and resources of the Council shall consist of ⎯

(a) the amounts that may be allocated annually or for a special purpose by Parliament for the use and operations of the Council;

(b) the amounts that the Council may collect as payment for services rendered, fees for a licence, registration, recognition of accreditation or an application under this Act or the Regulations;

(c) contributions or sums arising from a grant, covenant, donation and another receipt from a person including a national and international body;

(d) proceeds of a loan; and

(e) any other sum or amount to which the Council may make a lawful claim.

24. Use of funds and resources of the Council.

(1) The funds and resources of the Council may be designated for a specific project or made subject to a specific condition, in that case the funds and resources shall be preserved and utilized solely for the designated purpose.

(2) For all other purposes other than those provided for in subsection (1), the Council may pay for the following matters out of the funds and resources of the Council ⎯

(a) operating expenses of the Council, including the remuneration, fees and allowances of a member of the Council and committee, and salaries, fees, allowances, gratuities, pensions and other payments to an officer, employee and any other staff of the Council;

(b) the capital expenses, including maintenance and insurance of property under the administration and control of the Council;

(d) the payment toward real or immoveable property by the Council to further the performance of its functions under this Act; and

(e) any other expense that is related to the functions of the Council.

(3) A sum of money awarded in an action against the Council for an act or omission of the Council, its personnel or an authorized officer acting in good faith in the course of the operations of the Council, shall be paid out of the funds and resources of the Council.

(4) The balance of the revenue or resources of the Council shall be applied in accordance with section 29(2) or as determined by the Council with the approval of the Minister.

25. Exemption from taxes.

(1) Notwithstanding a provision of any other law to the contrary, the responsible Minister may by Order exempt the Council, in whole or in part, from the payment of tax imposed by or under an enactment.

(2) In this section “tax” includes assessments, fees, charges, value added tax, imposition and other levies that form part or are intended to form part of the general revenue of Saint Christopher and Nevis.

26. Financial year.

The financial year of the Council is 1st January to 31st December in each year.

27. Accounts of the Council.

(1) The Council shall keep proper books of accounts and records of the sums received and expended by the Council and shall record the matters in respect of which the sums were received and expended.

(2) The Council shall, not later that the first day of June in each year, prepare and submit to the Minister the estimates of revenue, other financial resources and expenditures of the Council for the next financial year, in the form that the Minister directs.

28. Auditing of accounts.

(1) The Council shall keep an account of its financial transactions in accordance with General Accounting Principles and Practices and ensure that a payment out of the funds of the Council is authorized.

(2) The accounts of the Council shall be audited annually by the Director of Audit.

29. Public accounts.

(1) The accounts of the Council shall be public accounts within the meaning of section 76) of the Constitution, Cap 1.01.

(2) Subject to section 24(4), at the end of a financial year, or an earlier period determined by the Minister responsible for finance, the balance standing to the credit of the accounts of the Council after allowing for funding for the operations of the Council and for specific projects or another designated purpose, may be paid into the Consolidated Fund.

30. Annual report.

The Council shall, within three months of the end of a financial year, submit to the Minister in respect of the preceding financial year ⎯

(a) an annual report of its activities in the preceding financial year; and

(b) a copy of the audited statement of accounts and information relating to the operation of the Council as the Minister requires.

PART IV – LICENSING OF MEDICAL LABORATORIES

31. Operation of a medical laboratory.

(1) Subject to section 64, a person shall not carry on a business of or operate a medical laboratory without a medical laboratory licence issued under this Act.

(2) A person who contravenes subsection (1) commits an offence and is liable on summary conviction to a fine not exceeding fifty thousand dollars and to imprisonment for a term not exceeding six months.

(3) Subsection (2) does not apply to a public medical laboratory.

(4) A testing site shall not operate as a medical laboratory unless its service is monitored by or it is linked to a medical laboratory licensed under this Act and provides the information and satisfies the requirements under section 33(5) and (6) and the Regulations.

32. Premises of a medical laboratory.

A person in possession of premises shall not —

(a) permit the premises to be represented as a medical laboratory by any means, such as the use of emblems, signs or titles unless that person is the holder of a licence in respect of those premises; or

(b) permit the premises, or any part of it, to be used as a medical laboratory, unless the premises, or the part so used, is licensed as a medical laboratory.

33. Application for licence.

(1) A person wishing to operate a medical laboratory shall apply to the Council for a licence to so operate.

(2) A person in possession of premises who wishes to operate a medical laboratory on the premises shall apply to the Council for a licence to operate a medical laboratory on the premises.

(3) Subject to subsections (4) and (5), an application under subsection (1) or (2) for a licence shall be made in the prescribed form and on payment of the prescribed fee.

(4) A person shall apply for a licence and pay the prescribed fee whether or not that person holds an accreditation certificate from an accreditation body.

(5) An applicant shall provide the following information to the Council — (a) the name and address of the applicant or operator of the medical laboratory;

(b) evidence that the applicant or operator is a fit and proper person to manage a medical laboratory;

(d) evidence of a self-assessment or an assessment conducted by an external agency to ensure the quality of medical laboratory procedures;

(e) evidence that the personnel of the medical laboratory possess the relevant authority, training and resources to carry out their duties, including —

(i) evidence that the medical laboratory has the appropriate number of staff, with the required education and training to meet the requirements of the services provided under this Act,

(ii) evidence that a person with executive responsibility and competence shall be employed within the medical laboratory with general responsibility for the services provided and to provide directions to staff, or

(iii) the names, qualifications and relevant experience of the laboratory practitioners to be employed to carry out laboratory medical procedures;

(f) evidence that the necessary and appropriate equipment for the operation of a medical laboratory will be available, managed and maintained;

(g) evidence that the appropriate system and procedure will be implemented and maintained to ensure the confidentiality of a patient;

(h) the arrangement that will ensure that the quality of work will not be adversely affected by an improper internal or external commercial, financial or other pressure;

(i) the arrangement that will ensure the protection of the confidential information of a patient and proprietary rights;

(j) evidence of the adequacy of the procedure for the disposal of medical waste;

(k) the arrangement that will address an activity that may diminish confidence in the impartiality and integrity of the operations of the medical laboratory;

(l) evidence that the premises to be used as a medical laboratory is suitable for the purposes of a medical laboratory; and

(m) any other prescribed information.

(6) An application for a licence shall include, but is not limited to, one or more of the following services and specialties that a medical laboratory may be licensed to provide —

(a) microbiology, including bacteriology, virology, mycology and parasitology; (b) immuno-haematology, including blood group and Rh typing and crossmatching; (c) diagnostic immunology, including syphilis serology and general immunology; (d) pathology, including tissue, oral and cytology;

(e) haematology, including coagulation;

(f) clinical chemistry, including urinalysis, endocrinology and toxicology; (g) radio-bioassay techniques;

(h) molecular biology; and

(i) any other prescribed service, specialty and subspecialty.

(7) In determining whether an applicant or operator is a fit and proper person to be issued a licence, the Council shall have regard to —

(a) the probity of the applicant or operator, competence and soundness of judgement for fulfilling the responsibilities of the applicant or operator;

(b) the academic or professional qualifications or effective experience in the provision of laboratory services or any other relevant discipline of the applicant or operator;

(c) the diligence with which the applicant or operator is fulfilling or likely to fulfil the responsibilities of the position;

(d) whether the interest of a patient or potential patient of the medical laboratory is, or is likely to be threatened by the applicant or operator holding the position; and

(e) whether the applicant, operator or owner of the premises ⎯

(i) is a significant shareholder, director or officer or holds a position of authority in a medical laboratory locally or elsewhere whose licence has been suspended, or revoked otherwise than as a result of an amalgamation or voluntary liquidation or which has been or is being wound up or compulsorily liquidated,

(ii) is an un-discharged bankrupt or has been declared a bankrupt locally or abroad, or

(iii) has been removed or suspended from serving as a director or officer in a medical laboratory or a body corporate locally or abroad.

(8) Without prejudice to the generality of subsection (7), regard may be had to the previous conduct and activities in the provision of medical or laboratory services or business matters of the applicant, operator or owner of the premises in question and, in particular, to evidence that the applicant, operator or owner of the premises has —

(a) committed an offence involving fraud or other dishonesty or violence;

(b) contravened a position made by or under an enactment designed for protecting members of the public against financial loss due to dishonesty, incompetence or malpractice by a person concerned in the provision of medical, laboratory or other health services or the management of companies or against financial loss due to the conduct of a discharge or undischarged bankrupt;

(c) engaged in a business practice appearing to the Council to be deceitful or oppressive or otherwise improper (whether unlawful or not) or which otherwise reflect discredit on the method of conducting business of the applicant, operator or owner of the premises;

(d) engaged in or been associated with another business practice or otherwise behaved in a manner as to cast doubt on the competence and soundness of judgement of the applicant, operator or owner of the premises.

(9) A person commits an offence if the person ⎯

(a) knowingly provides false information on the application of the person for the purpose of procuring the grant or renewal of a licence; or

(b) when required to furnish further information, furnishes or causes to be furnished information that the person knows to be false.

34. Issuance of licence.

The Council shall consider an application for a licence received under section 33(5) and (6), and shall, within ninety days after receipt of the application for the licence or approval of premises to be used as a medical laboratory, inform the applicant of its decision and/or issue a licence, if the Council is satisfied that —

(a) the information provided under section 33(5) and (6) is adequate; and (b) the applicant meets the requirements under this Act and the Regulations; or

(c) the premises complies with the prescribed standards for a medical laboratory and is suitable for the operation as a medical laboratory.

35. Provisional licence.

(1) Notwithstanding section 34, if the Council is not satisfied with all the information provided under section 33(5) and (6) and determines that an applicant for a licence does not meet every requirement of the Act and of the Regulations, the Council may approve the application for a licence and issue a provisional licence to the applicant if —

(a) the applicant has demonstrated to the satisfaction of the Council a good faith intention to correct deficiencies through development and submission of an improvement plan; and

(b) the Council is satisfied that the applicant provides reliable reports of examinations of specimens and presents satisfactory evidence that the requirements for a licence can and will be met within a six period.

(2) If the Council approves an application to licence a medical laboratory provisionally, it shall —

(a) enter the particulars relating to the medical laboratory in the Register; and (b) issue to the applicant a provisional licence in the prescribed form.

(3) A provisional licence shall be for a term that the Council considers appropriate, but the term shall not exceed six months.

(4) An applicant shall not be issued more than two consecutive provisional licence.

(5) The prescribed fee for a provisional licence shall be the same as the prescribed fee for a general licence.

36. Conditions of licence.

(1) A licence issued under section 34 or 35 —

(a) is subject to the terms, conditions, limitations or restrictions that the Council determines and that may be attached to the licence; and

(b) applies only to the medical laboratory named in the application.

(2) A licensee —

(a) shall comply with —

(i) the terms, conditions, limitations or restrictions of the licence and under this Act and the Regulations; and

(ii) the prescribed standards; and

(b) may be required to establish a developmental plan for accreditation, as approved by the Council or by a medical laboratory accreditation body recognized by the Council.

37. Form of licence.

A licence shall be in the prescribed form and shall contain ⎯

(a) the name of the licensee and, if appropriate, its principals;

(b) the name and address of the medical laboratory; and

38. Validity of licence.

Subject to section 35(3) and (4), a licence is valid for two years, unless suspended, revoked under section 43 or surrendered under section 44 and may be renewed under section 41.

39. Display of licence.

A valid licence shall be displayed in a conspicuous place in the medical laboratory at all times.

40. Licence not transferable or assignable.

(1) A licensee shall not transfer or assign the licence issued under this Act to any other person.

(2) A licensee who contravenes subsection (1) commits an offence and is liable on summary conviction to a fine not exceeding fifty thousand dollars and to imprisonment for a term not exceeding six months.

41. Renewal of licence.

(1) If a licensee wishes to renew the licence issued to the licensee, the licensee shall apply to the Council, ninety days prior to the expiration date of the licence, on the prescribed form and pay the prescribed fee.

(2) A licence may be renewed for a further period of two years if the medical laboratory has met the conditions of the licence, the prescribed standards and other requirements under this Act and the Regulations.

(3) A licence may not be renewed if the medical laboratory ⎯

(a) has not met the conditions of the licence including the targets in its developmental plan; or

(b) has not maintained the prescribed standards and other requirements under this Act and the Regulations.

42. Variation of terms and conditions of licence.

The Council may on application of a licensee vary the terms or conditions of the licence of the licensee.

43. Suspension and revocation of licence.

(1) The Council may suspend or revoke a licence of the licensee, if the licensee ⎯ (a) fails to comply with ⎯

(i) a provision of this Act or the Regulations; or

(ii) a term, condition, limitation or restriction in the licence;

(b) fails to adhere to the prescribed limitations or prescribed restrictions applicable to the licence;

(d) misuses the licence with respect to the specialities or services for which the licence has been granted;

(e) fails to seek accreditation if required under section 35(2);

(f) misuses or misrepresents the accreditation status, certification or accreditation symbols of the medical laboratory;

(g) has had the accreditation of the medical laboratory withdrawn;

(h) operates the medical laboratory in an unsanitary or unsafe condition so as to render it likely that the conditions imposed under this Act or the Regulations are not being complied with;

(i) obstructs or hinders a person carrying out a duty or responsibility under this Act or the Regulations; or

(j) has been convicted of an offence under this Act.

(2) If a medical laboratory is no longer operated on the premises, the holder of the licence to which the premises relate shall within seven days from the cessation of operations deliver the licence to the Council.

(3) The Council shall, before suspending or revoking a licence under subsection (l), cause a notice to be served on the licensee requiring the licensee to take action and within a period, not exceeding three months, as specified in the notice.

(4) If the action specified in a notice served under subsection (3) is not taken within the time stated or within an extended time as the Council may allow, the Council may, after a hearing in accordance with Schedule 4, suspend or revoke the licence.

(5) If a licence is revoked under this section —

(a) the revocation has effect from the date that the Council directs; and

(b) the licensee shall deliver the licence to the Council.

(6) A person who refuses or neglects to deliver a licence under subsection (5) (b) commits an offence and is liable on summary conviction to a fine not exceeding fifty thousand dollars and to imprisonment for a term not exceeding six months.

(7) If a public medical laboratory does not meet the prescribed standards and other requirements under this Act and the Regulations, the Council shall inform the Minister and may direct the public medical laboratory to forward its work to another licensed public medical laboratory that meets the prescribed standards and the requirements.

(8) If there is no licensed public medical laboratory that meets the prescribed standards and other requirements under this Act and the Regulations, to which the work of the public medical laboratory that did not meet the prescribed standards and other requirements under this Act and the Regulations may be forwarded, the Council may, with the approval of the Minister, direct that the work of the public medical laboratory be forwarded to a licensed private medical laboratory that meets the prescribed standards and other requirements under this Act and the Regulations, at the expense of the State.

44. Surrender of licence.

A licensee may surrender the licence of the licensee to the Council.

45. Procedure on destruction, defacement or loss of licence.

(1) If a licence is destroyed, defaced or lost, the Minister may if the Minister is satisfied as to the destruction, defacement or loss of the licence, grant the licensee a certificate setting out the terms, conditions, limitations or restrictions of the licence and noting the destruction, defacement or loss.

(2) A certificate issued under subsection (1) has the same force and effect as an original licence issued under section 34 or 35.

46. Register of Licensed Medical Laboratories.

(1) The Council shall maintain or cause to be maintained a Register of Licensed Medical Laboratories, which shall contain —

(a) the name of the licensee or applicant, and if appropriate, its principals; (b) the name and address of the medical laboratory;

(d) the licensing status of the medical laboratory, including an amendment, a suspension or revocation.

(2) The Register shall be kept at the published address of the Council or at the Ministry of Health and may be opened for inspection by the public each working day during office hours.

(3) The Council, on receiving an application in writing for the making of an alteration to an entry in the Register, shall make the necessary correction on being satisfied that the entry —

(a) was incorrect at the time it was made; or

(b) has become incorrect by reason of a circumstance that has arisen subsequent to the making of the entry.

47. Publication of notice of suspension, revocation, removal or restoration.

The Council shall publish a notice of the suspension, revocation, removal or restoration of the licence of a licensee in the Gazette as soon as possible after the —

(a) suspension or revocation of the licence;

(b) removal of the name of the licensee from the Register; or

PART V – MONITORING AND INSPECTION OF THE LICENSEE

48. Request for information.

(1) The Council may ⎯

(a) request from a licensee information that the Council requires for the purposes of this Act and the Regulations; and

(b) specify the manner in which, and a reasonable time limit within which, the licensee shall provide the information requested under paragraph (a).

(2) A licensee shall provide the Council, in the manner and within a reasonable time limit specified by the Council, information that the Council has requested under subsection (1).

49. Appointment of inspectors.

(l) The Council may, on consultation with the responsible Minister, designate a medical technologist or other laboratory practitioner or standards officer as an inspector for the purpose of enforcing the provisions of this Act and the Regulations.

(2) The Council shall issue or cause to be issued to an inspector a certificate of identity in a form that the Minister approves, which shall be signed by the Chairperson of the Council, and an inspector shall produce the certificate of identification of the inspector before entering premises for the purposes of section 50 if requested to do so by the licensee, operator, owner or occupier of the premises.

50. Conduct of inspection.

(1) For the purposes of administering this Act and the Regulations, and monitoring the operations of a licensee, the Council may require an inspector to conduct an inspection, assessment, investigation or inquiry, that the Council considers necessary.

(2) An inspector may enter premises if —

(a) an application for licensing under this Act has been made in respect of the premises;

(b) a medical laboratory is being operated in the premises; or

(c) the inspector has cause to suspect that a provision of this Act is being contravened in the premises, and may make an examination and inquiry, including the taking of samples, as may be necessary for ascertaining whether this Act is being contravened.

(3) A licensee, owner, operator or occupier of premises shall give to an inspector entering the premises the assistance or information within the power of the licensee, owner, operator or occupier of the premises as may be requested by the inspector.

(4) This section does not prevent an inspector from entering and inspecting the premises of a medical practitioner, dentist or veterinary surgeon, or any other premises in which the inspector has reason to believe that a medical laboratory is being operated.

(5) A licensee, owner, operator or occupier of the premises shall ⎯

(a) cause the medical laboratory for which the licence is issued to be open for inspection, assessment, investigation or inquiry by the person designated under subsection (1) at a reasonable time during the hours of operation of the medical laboratory; and

(b) cause the books, documents, records, specimens and equipment pertaining to the operation of the medical laboratory to be available for inspection, assessment or investigation by the person designated under subsection (1) during the time described under paragraph (a).

(6) The person designated under subsection (1) shall not enter a private dwelling without a warrant issued under section 51 unless the licensee, owner, operator or occupier of the private dwelling consents to the entry.

51. Warrant.

(1) A magistrate may issue a warrant authorizing the person designated under section 50(1) to enter and search the place or premises named in the warrant, if the Council believes, on reasonable and probable grounds, that —

(a) an offence has or is being committed under this Act or the Regulations; and

(b) there is evidence of the offence referred to under paragraph (a) to be found at the place or premises to be searched.

(2) With a warrant issued under subsection (1), the Council or a person designated under section 50(1) may ⎯

(a) enter and search the place or premises named in the warrant;

(b) use a machinery, an equipment, appliance or another thing located at the place or premises for the purposes of the search;

(c) require the production of and examine the books, records, papers or documents that the designated person believes, on reasonable and probable grounds, may contain information related to an offence under this Act or the Regulations;

(d) remove a book, record, paper or document examined under this section for the purpose of making a copy, if a receipt is given; and

(e) seize and remove from the place or premises searched anything that may be evidence of an offence under this Act or the Regulations.

(3) A person who obstructs a person who is authorized to conduct a search under this section commits an offence and is liable on summary conviction to a fine not exceeding fifty thousand dollars and to imprisonment for a term not exceeding six months.

52. Copies of documents.

(1) If a book, record, paper or document is inspected under section 50(5) or seized, examined or produced under section 51, the person designated under section 50(1) may make a copy of the book, record, paper or document, whether in electronic form or not.

(2) A person authorized to make a copy of the book, record, paper or document under subsection (1) shall ⎯

(a) make the copy as soon as is reasonably possible; and

(b) promptly return the book, record, paper or document from which the copy was made to —

(i) the place from which it was removed; or

(ii) another place that may be agreed to by the person authorized to make the copy and the person who provided it or from whom it was seized.

(3) A document certified by a Justice of the Peace, Commissioner for Oaths Notary Public, an attorney at law or the Council to be a copy made under this section ⎯

(a) is admissible in evidence without proof of the office or signature of the person appearing to have certified the document; and

(b) has the same probative force as the original document.

53. Notices to rectify unsatisfactory conditions.

(1) If on conducting an inspection of a licensed medical laboratory, the Council is of the opinion that the laboratory is in an unsatisfactory condition, it shall notify the licensee in writing, within thirty days following its inspection setting out its findings and giving the licensee thirty days to ninety days, depending on the extent of corrective action required, within which to remedy the condition.

(2) An approved corrective action plan should be issued by the licensee within thirty days following its receipt of a notification under subsection (1), to indicate when and how the unsatisfactory condition shall be remedied.

(3) If the licensee fails to comply with the notice under subsection (1) within the specified period, the Council shall make a report to the Minister and shall on giving the licensee the opportunity to appeal the findings of the inspector, either revoke the notice given under subsection (1) or suspend or revoke the licence of the licensee under section 43.

54. Offences relating to inspections.

(1) A person commits an offence, if, in the execution of the duties of an inspector, the person⎯

(a) assaults, resists, obstructs or intimidates the inspector;

(b) uses indecent, abusive or insulting language to the inspector;

(d) by gratuity, bribe, promise or other inducement prevents or attempts to prevent the inspector from carrying out the duties of the inspector.

(2) A person who commits an offence under subsection (1) is liable on summary conviction to a fine not exceeding fifty thousand dollars and to imprisonment for a term not exceeding six months.

PART VI – GENERAL

55. Establishment of Medical Laboratory Appeal Tribunal.

(1) There is established for the purpose of hearing appeals from decisions of the Council, a Medical Laboratory Appeal Tribunal.

(2) The provisions of Schedule 3 have effect as to the constitution of the Tribunal. (3) The provisions of Schedule 4 have effect as to the conduct of hearings by the Tribunal.

56. Appeal to Tribunal.

(1) A person who is aggrieved by ⎯

(a) the failure of the Council to inform the person of its decision within the time specified in section 34; or

(b) a decision of the Council to ⎯

(i) refuse to issue a licence,

(ii) place a term, condition, limitation or restriction in a licence,

(iii) amend, suspend or revoke a licence,

(iv) to cause the name of the person or a medical laboratory to be removed from the Register, or

(v) refuse to enter the particulars of the person in the Register,

may appeal to the Tribunal against that failure or decision within thirty days after the period stated in section 34 or after the decision is made.

(2) The Tribunal may —

(a) at the hearing of the appeal against the failure of the Council to provide an applicant with a decision within the time specified under section 34 make an order that it considers appropriate and the Council shall comply with the Order;

(b) at the hearing of an appeal against the refusal of licensing, dismiss or allow the appeal and direct the Council to cause the licensing to have effect;

(c) at the hearing of an appeal other than an appeal against the refusal of licensing — (i) dismiss the appeal and confirm the decision of the Council, or

(ii) allow the appeal and set aside the decision of the Council, or

(d) vary the decision of the Council; or

(e) substitute the decision of the Tribunal for that of the Council.

(3) The Council shall take the necessary steps to comply with the decision of the Tribunal.

(4) A person aggrieved by a decision of the Tribunal may appeal to the High Court against that decision.

(5) On an appeal under subsection (4), the High Court may make an order that it considers appropriate and the Tribunal shall comply with the order.

57. Confidentiality of records.

(1) Except for the purpose of disclosure to a medical practitioner or another person lawfully entitled to the information, the licensee, operator and a staff member of a medical laboratory shall maintain the confidentiality of —

(a) a report and record relating to a patient; and

(b) the results of a test.

(2) A licensee, operator or a staff member of a medical laboratory who contravenes subsection (1) commits an offence and is liable on summary conviction to a fine not exceeding twenty-five thousand dollars and to imprisonment for a term not exceeding six months.

58. Evidence.

A certificate signed by an inspector, acting in the performance of the functions of the inspector, stating that the inspector has inspected premises or a medical laboratory under section 50 and stating the result of the inspection, is prima facie evidence of the contents of the certificate, and of the signature and the authenticity of the qualifications of its author.

59. Offences and penalties.

(1) A person commits an offence if the person —

(a) falsely represents that the person is a licensee;

(b) forges or fraudulently alters or uses or permits to be fraudulently altered or used a licence or certificate issued under this Act; or

(2) A person who contravenes a provision of this Act or the Regulations where no penalty is provided under this Act or the Regulations commits an offence and is liable on summary conviction —

(a) in the case of an individual, to a fine not exceeding ten thousand dollars and, in the case of a continuing offence, to a further fine not exceeding two hundred and fifty dollars for each day during which the offence continues;

(b) in the case of a corporation, to a fine not exceeding twenty thousand dollars and, in the case of a continuing offence, to a further fine not exceeding five hundred dollars for each day during which the offence continues.

60. Liability of person exercising duty.

(1) A member shall not be held to be personally liable for anything done, permitted to be done or omitted to be done in good faith in the exercise of the duties of the member under this Act.

(2) The prosecution of an alleged offence under this Act or the Regulations shall not commence after two years from the day of the commission of the alleged offence

61. Regulations.

(1) The Minister may make Regulations to give effect to this Act.

(2) Notwithstanding the generality of subsection (1), the Minister may make Regulations ⎯

(a) prescribing ⎯

(i) the requirements for the issue of a licence under this Act,

(ii) the minimum standards for the management and operation of a medical laboratory,

(iii) the minimum standards for equipment used in a medical laboratory,

(iv) the maintenance of a Register under this Act; and

(v) fees required to be prescribed under this Act;

(b) defining, enlarging or restricting the meaning of a word or expression used under this Act but not defined under this Act;

(d) exempting a person or category of persons from one or more of the provisions of this Act;

(e) exempting a place or category of places from the definition of medical laboratory for the purposes of section 2;

(f) designating categories of persons as laboratory practitioners for the purposes of section 2;

(g) prescribing the amount of the application fee for the purposes of section 33; (h) governing an appeal under section 56;

(i) governing the operation of a medical laboratory;

(j) without limiting the generality of paragraph (i) ⎯

(i) concerning the performance of a test in a medical laboratory;

(ii) establishing the standards for a facility of premises in which a medical laboratory is located;

(iii) requiring and governing the making, maintaining and retaining of records by a licensee;

(k) governing the licensing programme with respect to the operation of a medical laboratory and authorizing the Minister to designate the person who or association that will establish and operate the licensing programme;

(l) concerning confidentiality and access to information with respect to — (i) the administration of this Act and the Regulations; or

(ii) the operations of a medical laboratory;

(m) prescribing a matter or thing required or authorized under this Act to be prescribed in the Regulations;

(n) concerning any other matter or thing that the Minister considers necessary.

62. Standards and guidelines.

The Bureau of Standards may issue standards and guidelines for the operation of a medical laboratory, that are consistent with approved regional and international standards.

63. Amendment of Schedule.

The Minister may amend a Schedule by Order made by Statutory Rules and Orders published in the Gazette.

64. Transitional.

(1) A certificate or licence granted under the Public Health Act that is valid and in force on the day on which this Act comes into force continues under this Act and may be dealt with as if it were granted under this Act until its expiration date.

(2) Subject to subsection (1), a medical laboratory which was in operation prior to the coming into force of this Act, without a certificate or licence granted under the Public Health Act, may continue to operate for a period of six months] from the coming into force of this Act and thereafter shall cease to so operate unless it holds a licence issued under this Act.

SCHEDULE 1

(Section 11)

PROCEDURE OF COUNCIL

Resignation

1. (1) The Chairperson and Deputy Chairperson may resign from office by notice in writing addressed to the Minister, and any other member may resign from office by notice in writing addressed to the Chairperson.

(2) A resignation made under paragraph (1) takes effect as from the date on which the Minister or the Chairperson receives the notice of resignation in writing.

Meetings of the Council

2. (1) The Council shall meet as often as is necessary for the efficient performance of its functions, but shall meet at least once in each quarter, and a meeting of the Council shall be held on a day, and at a time and place that the Chairperson may determine.

(2) Notice of a meeting of the Council shall be given to a member in a manner approved by the Council.

(3) The Chairperson may call a special meeting of the Council, to be held within seven working days of the receipt of a written request, for that purpose addressed to the Chairperson by not less than three members.

(4) The Chairperson may convene a meeting of the Council, by video, teleconference or other electronic means, with the concurrence of a majority of the members.

(5) A member is deemed to be present at a meeting of the Council if the member participates by video, teleconference or another electronic means and the members participating in the meeting are able to communicate with each other.

(6) At a meeting of the Council ⎯

(a) the Chairperson presides;

(b) if the Chairperson is not present, the Deputy Chairperson presides; or

(c) if neither the Chairperson nor the Deputy Chairperson is present, the members present may appoint a member to preside at that meeting.

(7) The quorum for a meeting of the Council is three members.

(8) A decision of the Council shall be adopted by the votes of at least a majority of the members present and voting and in a case in which the voting is equal, the member presiding at the meeting shall, in addition to the original vote of that member, have a casting vote.

(9) If, in the judgment of the Chairperson, a proposed action by the Council requiring the approval of the Council shall not be postponed until the next meeting of the Council and cannot await the convening of a special meeting of the Council under paragraph (3), the Chairperson shall request the members to vote without a meeting.

(10) The Chairperson shall present to each member by rapid means of communication a motion embodying the proposed action referred to under paragraph (9).

(11) In that case, a member shall as soon as possible, notify the Chairperson of the decision or recommendation of the member on the proposed action.

(12) At the expiration of the period prescribed for voting, the Chairperson shall cause the results to be recorded, and shall notify the members of the results and of the status of the decision or recommendation on the proposed action.

(13) A decision or recommendation on the proposed action in writing signed by the members entitled to receive notice of a meeting of the Council, is valid and effectual as if it had been passed in a meeting of the Council duly convened and held and may consist of several documents in the like form each signed by one or more members.

(14) A decision on the proposed action by the method under paragraphs (9) and (10) shall be ratified by, and recorded in the report of, the next or subsequent meeting of the Council.

(15) Notwithstanding paragraphs (13) and (14), if a member so requests, the matter on which a decision is required shall be referred for consideration by the Council at its next meeting.

(16) An act or a proceeding of the Council may not be invalidated by reason of the existence of a vacancy amongst its members or of a defect in the appointment of a member.

(17) The Council may co-opt one or more persons to attend a particular meeting of the Council for the purpose of assisting or advising the Council, but the co-opted person does not have a right to vote.

(18) The minutes of a meeting of the Council shall be kept by the Secretary and shall be confirmed by the Council as soon as practicable at a subsequent meeting.

(19) The Secretary shall provide the Minister with a copy of the minutes of a meeting of the Council.

Rules of procedure

3. Subject to this Schedule and the Act, the Council may by resolution make rules to govern its own proceedings and these rules are binding on the Council.

SCHEDULE 2

(Section 20(2))

OATH OF CONFIDENTIALITY

Form of oath to be taken by officers and members of the Council and Committee

I, …………………………………………………..….. (name) swear and affirm that I will well and faithfully carry out my duties and obligations under the Medical Laboratories Act, 20[ ], the Regulations, orders and directions thereunder and that I will not without due authority in that behalf disclose or make known a matter or thing that comes to my knowledge by reason of my office on, or exercise of my duties with the Council.

SWORN TO at , )

in the State of [ ] )

This day of , 20. )………………………………………….. BEFORE ME: )

)

……………………………………….)

Justice of the Peace/Notary Public/

Commissioner for Oaths

SCHEDULE 3

(Section 55(2))

MEDICAL LABORATORIES APPEAL TRIBUNAL

1. The Tribunal shall consist of a Chairperson and two other members, each having at least five years’ special qualifications and experience in law, laboratory services, medicine or business and appointed by the Minister.

2. (1) The Members of the Tribunal shall, subject to the provisions of this Schedule, hold office for a period not exceeding three years and may be eligible for re-appointment.

(2) The offices of Chairperson or members of the Tribunal may be filled by persons appointed from the public or private sectors.

3. The Minister may appoint any person to act in the place of the chairperson or any other member of the Tribunal in case of the absence or inability to act as the chairperson or other member.

4. (1) The Chairperson may resign from the office of the Chairperson by instrument in writing addressed to the Minister and the resignation shall take effect from the date of receipt by the Minister of the instrument.

(2) Any other member of the Tribunal may resign from the office of the member by instrument in writing addressed to the Minister and transmitted through the Chairperson and from the date of receipt by the Minister of the instrument the member shall cease to be a member of the Tribunal.

5. The Minister may revoke the appointment of the Chairperson or any other member of the Tribunal if the Minister thinks it expedient to do so.

6. If a vacancy occurs in the membership of the Tribunal, the vacancy shall be filled by the appointment of another member who shall, subject to the provisions of this Schedule, hold office for the remainder of the period for which the previous member was appointed.

7. The names of all members of the Tribunal as first constituted and every change in its membership shall be published in the Gazette.

SCHEDULE 4

(Section 55(3))

PRACTICE AND PROCEDURE GOVERNING HEARINGS

1. Notice of hearing

Written notice of any proceedings or appeal under this Act shall be served on an interested person at least ten days prior to the date set for the hearing detailing —

(a) the time, place and nature of the hearing;

(b) the legal authority under which the proceeding or appeal is to be held; and

2. Procedure at hearing

(1) The Tribunal may regulate its own procedure.

(2) An aggrieved person shall be given the opportunity to be heard.

3. Findings

(a) On the completion of a full hearing the Tribunal, shall reduce its findings to writing.

(b) The findings shall be signed by the Chairperson and a copy sent to all interested parties, including the Minister.

……………………………..

Lanein K. Blanchette

Speaker

Passed by the National Assembly this day of , 2024.

……..………………………………….

Trevlyn Stapleton

Clerk of the National Assembly

The post Medical Laboratories Bill, 2024 first appeared on SKNIS.

Medical Laboratories Bill, 2024

Medical Laboratories Bill, 2024

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