LICENSING OF PRIVATE MEDICAL DIAGNOSTIC LABORATORIES

LICENSING OF PRIVATE MEDICAL DIAGNOSTIC

LABORATORIES

SUBSIDIARY LEGISLATION 458.25

LICENSING OF PRIVATE MEDICAL DIAGNOSTIC

LABORATORIES

9th July, 1996

LEGAL NOTICE 133 of 1996, as amended by Legal Notice 426 of 2012.

The title of these Regulations is Licensing of Private

Medical Diagnostic Laboratories Regulations.

In these Regulations, unless the context otherwise

requires -

"the Act" means the Health Care Professions Act;

"authorised person" means a person authorised by the Minister to

act on his behalf;

"good laboratory practice" includes the compliance at all times

with the ethical standards and with laws and regulations governing

the professions related with laboratory practice, as well as

compliance with international standards for procedures, practices

and methods used in a laboratory;

"laboratory" means a private medical diagnostic laboratory, and

includes any facility, building or otherwise, used for the purpose of

biological, microbiological, serological, chemical,

immunohaematological, haematological, biophysical, cytological,

pathological, or other examination of material derived from the

human or animal body, or for the purpose of providing information

for the diagnosis, prevention or treatment of any disease, condition

or impairment of health, or for the assessment of the state of health

of a person or animal, but does not include a government

laboratory;

"Minister" means the Minister responsible for health.

(1) No licence for operating a laboratory under article 98

of the Medical and Kindred Professions Ordinance may be granted

or renewed unless such laboratory complies with the provisions of

these regulations.

(2) No licence under the said article 98 of the Medical and

Kindred Professions Ordinance may be issued for any laboratory

except in respect of a premises used for medical laboratory tests

and procedures.

(1) An application for the issue or renewal of a licence for

a laboratory shall be made to the Minister in writing

Provided that an application has been filed before the date

of these regulations, it shall be considered to have been filed

according to these regulations.

(2) On making an application under subregulation (1), the

applicant shall present together with the application the

information specified hereunder

LICENSING OF PRIVATE MEDICAL DIAGNOSTIC

LABORATORIES

(a) a comprehensive list of all the tests and other activities

carried out or intended to be carried out at such

laboratory;

(b) a list of all the staff that are employed or to be

employed at the laboratory, including their name and

surname, a legally valid identification document

number, permanent address, date of birth, date of

employment, academic qualifications and duties and

responsibilities each employee shall have;

(c) a list of equipment that is used, or intended to be used

on the premises;

(d) a list of animals that are kept or used, or intended to be

kept or used for such tests;

(e) the policy and procedures for quality control and

safety

Provided that the Minister or any authorised person may

request of the applicant any additional information and more

specific information that is deemed to be related with the granting

of the licence.

(1) The Minister may refuse to issue or renew a licence in

respect of a laboratory if -

(a) the applicant, or any person employed or proposed to

be employed by the applicant at the laboratory, is not

of good conduct or that the technical staff is not

suitably qualified; or

(b) for reasons connected with the situation, construction,

state of repair, safety, accommodation, staffing or

equipment, the premises are not fit to be used as a

laboratory; or

(c) the laboratory or any premises in connection therewith

are used or proposed to be used for purposes which are

not related to the laboratory, or are in any way

improper, unethical or not lawful; or

(d) the laboratory or any premises used in connection

therewith consist of or include works executed in

contravention of the provisions of the Development

Planning Act; or

(e) the practice at the laboratory is not, or will not be,

under the supervision of a person indicated in

regulation 6; or

(f)

the management and control of the laboratory is not

likely to be adequate.

(2) Where a licence has been refused or is not renewed or has

been withdrawn, the applicant or licensee, as the case may be, may

within thirty days of receipt of notice of refusal, non-renewal or

withdrawal of licence, appeal to the Tribunal appointed under

regulation 5(2) of the Licensing of Private Medical Clinics

Regulations.

LICENSING OF PRIVATE MEDICAL DIAGNOSTIC

LABORATORIES

Every licensee shall ensure that medical laboratory tests

are carried out by, or under the professional direction, supervision

and responsibility of, a biochemist, microbiologist or other

pathologist, or a toxicologist, as the case may be, or a medical

practitioner or scientist qualified to assume professional, scientific,

consultative, organisational and administrative responsibility for

the service.

(1) The licence certificate shall specify the category and

types of tests that may be carried out at the premises as may be

determined by the Minister to be reasonable in accordance with

good laboratory practice taking into account the size of the

laboratory and the facilities available.

(2) The licensee shall ensure that no tests other than those

referred to in subregulation (1) shall be carried out at the laboratory

unless and until such test has been approved by the Minister.

(1) The licensee shall keep and maintain an updated

register in connection with all tests carried out at the laboratory,

which register shall, in respect of each patient, include the

following information

(a) the name and surname, (or initials), a legally valid

identification document number, sex, address and date

of birth of the patient;

(b) the name, surname, address and medical registration

number of the referring medical practitioner;

(c) the date when the request was received at the

laboratory;

(d) the type of test requested by the referring medical

practitioner;

(e) the type of test carried out at the laboratory and

methods used;

(f)

the name of the microbiologist, biochemist or other

pathologist, or toxicologist responsible for the test, as

well as the technical person who carried out the test;

(g) where practicable, the result of the test

Provided that the requirements in respect of the identity of

the patient shall not apply when the blood of a patient is taken for

testing for the human immunodeficiency virus, so that this test is

carried out in a government laboratory.

(2) The licensee shall also keep records of reports of all results

of tests carried out at his laboratory.

(3)

(a) The licensee shall require all persons to whom Part II

and Part V of the Act refers, to register their

attendance at the laboratory, indicating date and time

a n d w h e t h e r e n t e r i n g o r l e a v i n g t h e l a b o r a t o r y,

immediately on entering and immediately before

leaving the laboratory, in a register kept for the

purpose. The licensee shall transmit the contents of

such register to the Ministry or department in such

manner as specified by the Minister.

LICENSING OF PRIVATE MEDICAL DIAGNOSTIC

LABORATORIES

(b) Where, except in an emergency, a licensee is in wilful

breach of the preceding provision of this regulation,

such laboratory shall be deemed to be operating

without a licence.

(4) The Minister may from time to time prescribe that

additional registers be kept as may be deemed necessary to ensure

good laboratory practice.

All information entered in the registers referred to in

regulation 8, as well as all records, shall be retained by the licensee

for a period of not less than two years from the date of the last entry

in the register or record

Provided that in respect of histological tests or any forensic

or toxicological tests, the result shall be kept for a period of

twenty-five years

Provided further that results of tests of quality assessment

or maintenance shall be kept indefinitely.

The licensee shall inform forthwith the Superintendent of

Public Health of any infectious disease diagnosed at the laboratory,

notifiable under the Prevention of Disease Ordinance, as well as of

all pathological samples confirmed for malignancy, with the details

of name, address and a legally valid identification document

number of the patient, as well as the name, address and medical

registration number of the referring medical practitioner.

(1) The licensee shall ensure that there is sufficient space,

equipment and facilities for the proper performance, within the

medical laboratory, of the required volume of work to ensure that a

high standard of accuracy, precision, efficiency and safety is

always maintained to the satisfaction of the Minister.

(2) Without prejudice to the generality of subregulation (1), the

licensee, having regard to the category of tests performed at the

laboratory, shall -

(a) provide adequate professional, technical, ancillary and

other supporting staff;

(b) provide and maintain adequate laboratory facilities in

accordance with good laboratory practice;

(c) maintain all parts of the building in a good structural

state of repair, and, in particular, provide adequate

lighting and ventilation, and all necessary safety;

(d) maintain a high degree of cleanliness and hygiene in

all parts of the building;

(e) take established precautions against the risk of fire and

make established arrangements for detecting,

containing and extinguishing fires and for the

evacuation of staff in the event of such fire. In

particular the licensee shall comply with such

instructions as may be given by the Commissioner of

Police in this respect;

LICENSING OF PRIVATE MEDICAL DIAGNOSTIC

LABORATORIES

(f)

make appropriate arrangements to the satisfaction of

the authorised person for the disposal and incineration

of infected swabs and sharps besides other infected

material and provide adequate containers for them;

(g) take all the necessary precautions to ensure the safety,

both physical and biological, of all staff on the

premises. Moreover, he shall provide and maintain

adequate means of protection against occupational

hazards, and ensure that all staff is making use of the

protection provided.

(3) The licensee shall make available, when so required by the

Minister or by any authorised officer, the following written codes

of practice and procedures

(a) the laboratory’s policy for quality control on a daily

basis, including accreditation of its tests from an

authority that is recognised by the Minister to be

appropriate and reliable, with inter-laboratory

calibration exercises forming part of this accreditation;

(b) the laboratory’s policy on instrument function checks

and preventive maintenance of instruments;

(c) the laboratory’s safety policies to the workers, the

patients and the public in general

Provided that the Minister may from time to time require

these codes to be amended and updated as he may deem

appropriate.

(4) The licensee shall ensure that the codes referred to in

subregulation (3) are strictly adhered to by all persons working in

the laboratory.

It shall be lawful for any authorised person, to enter at any

time of day and night without prior notice, and inspect any

premises which are used or suspected to be used with or without a

licence as a medical laboratory, and such person shall be given by

the person in charge at the time, all assistance requested or implied.

The said person in charge shall produce all registers and records

available at that time when asked to do so

Provided that where the information requested entails

medical confirmation regarding the patients, such information may

only be requested by and made available to an authorised person

who is a medical practitioner.

The licensee shall ensure that all measures be taken to

protect the staff and the neighbourhood from any nuisance or

danger arising from the activities of the laboratory.

These regulations do not apply to the medical tests carried

out by the use of medical diagnostic kits intended for home use,

irrespective of where these tests are carried out, or in respect of

tests carried out by a medical practitioner in his consulting room or

at the patient’s home, or bedside, using doctor’s office equipment

in the exercise of his profession.