On 23/05/2013,
you requested for the version in force on 23/05/2013
incorporating all amendments published on or before 23/05/2013.
The closest version currently available is that of 06/09/2001.
No. S 424
Private Hospitals and Medical Clinics Act
Private Hospitals and Medical Clinics (Amendment No. 2) Regulations 2001
In exercise of the powers conferred by section 22 of the Private Hospitals and Medical Clinics Act, the Minister for Health hereby makes the following Regulations:
1. These Regulations may be cited as the Private Hospitals and Medical Clinics (Amendment No. 2) Regulations 2001 and shall come into operation on 10th September 2001.
2. The Private Hospitals and Medical Clinics Regulations (Rg 1) (referred to in these Regulations as the principal Regulations) are amended by renumbering regulation 2 as paragraph (1) of that regulation, and by inserting immediately thereafter the following paragraph:
“(2) For the purpose of these Regulations, the reference to the number of beds of a private hospital shall include beds which are located in the premises of another licensed private hospital but which, under an arrangement between the first and second mentioned private hospitals, are intended for the use of patients who are admitted to and who are under the management and care of the first mentioned private hospital.”.
3. The principal Regulations are amended by renumbering regulation 4 as paragraph (1) of that regulation, and by inserting immediately thereafter the following paragraph:
4. Regulation 9 of the principal Regulations is amended by deleting paragraph (3) and substituting the following paragraph:
“(3) Every licensee of a private hospital, medical clinic or healthcare establishment who intends to cease operating or to let, sell or in any way dispose of the private hospital, medical clinic or healthcare establishment shall —
(a)
take all measures as are reasonable and necessary to ensure that, until the cessation of operation, letting, sale or disposal of the private hospital, medical clinic or healthcare establishment is completed, every person who remains a patient thereof continues to be provided with adequate and proper accommodation and care;
(b)
take all measures as are reasonable and necessary to ensure that the medical records of every patient in the hospital, medical clinic or healthcare establishment are properly transferred to the hospital, medical clinic or healthcare establishment to which such patient is to be transferred; and
(c)
comply with such directions as the Director may give with regard to the accommodation, medical records and care of the patients in the hospital, medical clinic or healthcare establishment pending the completion of the cessation of operation, letting, sale or disposal of the private hospital, medical clinic or healthcare establishment, as the case may be.”.
5. Regulation 10 (1) of the principal Regulations is amended by deleting the words “44 or” in sub-paragraph (e).
6. Regulation 11 of the principal Regulations is amended by deleting the words “, other than a maternity home or a nursing home,” in the 1st and 2nd lines.
7. Regulation 15 of the principal Regulations is amended —
(a)
by inserting, immediately after the words “private hospital” in paragraph (1), the words “(not being a nursing home or maternity home)”; and
8. Regulation 19 of the principal Regulations is deleted and the following regulation substituted therefor:
19.
—(1) Every private hospital shall have, in addition to normal electrical supply, emergency power and lighting in all patient care areas.
(2) Life support equipment shall be connected to emergency power at all times.
(3) Every private hospital shall have emergency water supply in its operating theatres, birthrooms and intensive care units.”.
9. Regulation 23 of the principal Regulations is amended by deleting the word “procedures” in the regulation heading and substituting the word “services”.
12. Regulation 26 (1) of the principal Regulations is amended by deleting the word “comprising” in the 2nd line and substituting the words “which shall be under the supervision of a registered nurse and which shall comprise”.
13. Regulation 29 of the principal Regulations is amended by deleting paragraph (1) and substituting the following paragraph:
“(1) Every private hospital (other than a psychiatric hospital, convalescent hospital, maternity home or nursing home) shall have a radiology service which shall —
(a)
be under the supervision of a radiologist;
(b)
comply with regulations 47 to 51; and
(c)
have among its equipment a static x-ray machine and a mobile x-ray machine.”.
14. The principal Regulations are amended by inserting, immediately after regulation 29, the following regulation:
29A. Where a private hospital also provides within its premises —
(a)
services that are available for use by persons who are not inpatients of the hospital; or
(b)
services that are unrelated to the reception, lodging, treatment and care of persons who require medical treatment or suffer from any disease,
the licensee of the private hospital shall ensure that the privacy and safety of the inpatients of the private hospital are not compromised by its provision of such services.”.
15. Regulation 30 of the principal Regulations is deleted and the following regulation substituted therefor:
30.
—(1) The licensee of every private hospital shall, in accordance with such guidelines as may be issued by the Director, establish —
(a)
one or more quality assurance committees to implement, monitor, evaluate and review the hospital’s quality assurance programmes and all other quality-related activities undertaken at the hospital; and
(b)
a quality assurance committee to review any adverse event that occurs in the private hospital, and identify and resolve any problem relating to the quality and appropriateness of the patient care that is provided, or the practices and procedures that are carried out, by the private hospital as may have given rise to such adverse event.
(2) Each quality assurance committee shall consist of such members of the medical and nursing staff and any other administrative and ancillary staff as the licensee of the private hospital, having regard to the guidelines issued by the Director, thinks fit to appoint to the committee.
(3) Each quality assurance committee shall, in accordance with the guidelines issued by the Director —
(a)
maintain an on-going quality assurance programme for the purpose of —
(i)
monitoring and evaluating the overall quality and appropriateness of the patient care that is provided, and the practices and procedures that are carried out, by the private hospital;
(ii)
identifying and solving problems which may from time to time arise in connection with the functions of the private hospital; and
(iii)
pursuing opportunities for the improvement of the patient care and other services provided by the private hospital;
(b)
conduct such quality assurance activity or programme as may be required from time to time by the Director; and
(c)
furnish the Director, as and when required by him, with such records relating to any quality assurance activity undertaken by the private hospital.”.
16. Regulation 35 of the principal Regulations is amended by deleting paragraph (1) and substituting the following paragraph:
17. Regulation 41 of the principal Regulations is amended by inserting, immediately after paragraph (2), the following paragraph:
“(3) Where a medical clinic provides a laboratory service or a radiology service, the licensee of the medical clinic shall ensure that —
(a)
the medical clinic is provided with adequate and appropriate equipment for the service to be carried out accurately and safely, and that the service is carried out by a suitably trained person; and
(b)
the laboratory service or radiology service so provided complies with regulations 47 to 51.”.
18. The principal Regulations are amended by inserting, immediately after regulation 42, the following regulations:
42A. Where any sample of any matter derived from a human body is taken at a medical clinic for test or examination for the purpose of providing information for the diagnosis, prevention or treatment of any disease or for the assessment of the health of any person, the licensee of the medical clinic shall ensure that such sample is tested or examined —
(a)
by a licensed clinical laboratory;
(b)
where the medical clinic provides a laboratory service which is capable of performing the requisite test or examination, by a suitably qualified person employed to carry out the laboratory service at the medical clinic; or
(c)
where the sample is intended to be sent for testing or examination abroad, by a foreign clinical laboratory which has been accredited by an accreditation body approved by the Director.
42B. Any premises that are being used as a medical clinic shall be physically separated from premises that are being used for the provision of other services, and the premises being used as a medical clinic shall have a separate entrance from those premises being used for the provision of those other services.
42C. The licensee of a medical clinic shall, whenever required by the Director —
(a)
participate in such quality assurance activities as may be specified by the Director; and
(b)
furnish to the Director such information as the Director may require in relation to the quality assurance activities of the medical clinic.”.
19. Regulations 43, 44 and 45 of the principal Regulations are deleted and the following regulations substituted therefor:
43. 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 microbology;
(i)
transfusion medicine;
(j)
any other discipline acceptable to the Director.
44. 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 43(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 43(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.
45. 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.”.
20. Regulation 47 (1) of the principal Regulations is amended by inserting, immediately after the word “undertake”, the words “, and for its functions to be performed with accuracy, timeliness and safety”.
21. Regulation 48 of the principal Regulations is amended —
(a)
by deleting paragraph (2) and substituting the following paragraph:
“(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).”; and
(b)
by inserting, immediately after paragraph (3), the following paragraphs:
“(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.”.
22. The principal Regulations are amended by inserting, immediately after regulation 50, the following regulation:
50A.
—(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.”.
23. Regulation 51 of the principal Regulations is deleted and the following regulation substituted therefor:
51.
—(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 licensee 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 50A, 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.”.
24. The principal Regulations are amended by inserting, immediately after the Fourth Schedule, the following Schedule:
“FIFTH SCHEDULE
Regulation 48(4)
Specialised Tests and Services
1. Blood Group ABO and Rhesus (D) Type tests. |
2. Acid-Fast Bacilli (Smear) test. |
3. Human Immunodeficiency Virus test. |
4. Malaria Parasite test. |
5. Legionella test.”. |
[G.N. Nos. S 8/2000; S145/2000; S 256/2000; S 90/2001]
[MH(Cf)78:04/4-2; AG/LEG/SL/248/1997/1 Vol. 2]