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Mcdical Clinics (Liccnsing) Regulations, 1981

17 Articles / Provisions · Malta
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Malta Government Gazette — Legal Notice 1981 110 — Mcdical Clinics (Liccnsing) Regulations, 1981

L.N. 110 of 1981

MEDICAL AND KINDRED PROFESSIONS ORDINANCE

(CAP.51)

Mcdical Clinics (Liccnsing) Regulations, 1981

IN exercise of the powers conferred by section 84 (3) of the Medi�

cal and Kindred Professions Ordinance, the Minister of Health and

Environment has made the following regulations:-

l. These regulations may be cited as the Medical C1inics (Licens-

Citation.

ing) Regulations, 1981.

In these regulations, unless the context otherwise requires

Malta Government Gazette — Legal Notice 1981 110 — Mcdical Clinics (Liccnsing) Regulations, 1981

Regulation 4(2)

MATTERS IN RESPECT OF WHICH A HEALTH AUTHORITY MAY REQUIRE

INFORMATION TO BE FURNISHED BY AN APPLICANT FOR LICENCE

The full name and address, and professional or technical gualifications (if any) of

1. the applicant.

Where the application is made by a company, society, association or body, the

2. address of its registered office or principal place of business and the fuH names

and addresses and techn ic a l qualifications (if an y) of the directors or partners.

3. The address of any other clinic in which the applicant has or had a business

interest and the nature and extent of his interest.

The situation of the clinic and its form of construction (plan te be attached).

4. The accemrnodatien available, and the equipment and facilities provided or to be

5. provided in the clinic.

The da te on which the clinic vvas established 01' is to be established.

6. Whether any other business is 01' wiH be caITied on in the same premises as the

7. clinic.

The type of clinic services to be provided inc1uding Iist of operations proposed to

8. be carried out.

The number ef patients (excluding staff) for whomit is proposed to be used

9. distinguishing between different categories of patients and indicating the age­

range of patients in each category.

The fuH names, ages, qualificaticns and experience of persons

employed

or

10. proposed to be em pl o yed in the management of the clinic.

The arrangements for the management and control of the clinic.

Malta Government Gazette — Legal Notice 1981 110 — Mcdical Clinics (Liccnsing) Regulations, 1981

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"authorised person" means a person authorised by the

Minister to exercise powers under regulation 10 of these regulations;

"Minister" means the Minister responsible for Public Health;

"the Ordinance" means the Medical and Kindred Professions

Ordinance;

"clinic" means a medical clinic.

Malta Government Gazette — Legal Notice 1981 110 — Mcdical Clinics (Liccnsing) Regulations, 1981

(l ) No licence for the opening or carrying on of a clinic under

section 84 of the Ordinance may be granted 01' renewed unless such clinic

complies with the provisions of these regulations.

(2) No licence under the said section may be issued for any

clinic except in respect of any premises used as a day care clinic where

the services provided on the premises do not entai! the need of ovemight

stay of the patient.

Malta Government Gazette — Legal Notice 1981 110 — Mcdical Clinics (Liccnsing) Regulations, 1981

( l) An application for a licence for a clinic shaH be made to

the Minister in writing and sent or delivered to the Ministry of Health

and Environment

Provided that where an application for a licence is already

pending before the coming into force of these regulations, such applica�

tion sha11 be deemed to have been made under these regulations.

(2) In making an application, an applicant shaH fumish such

particulars as are specified in the First Schedule to these regulations

and such other information as the Minister may reasonably require.

Malta Government Gazette — Legal Notice 1981 110 — Mcdical Clinics (Liccnsing) Regulations, 1981

( 1 ) The Minister may refuse to issue a licence in respect of a

clinic if he is satisfied

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(a) that the applicant, or any person employed Of proposed

to be

employed by the applicant at the clinic is not a fit person

(whether by age or otherwise) to carry on or be employed at the

clinic; or

(b) that for reasons connected with the situation, construc­

tion, state of repair, accommodation, staffing or equipment, the

clinic is not fit to be used as a clinic; or

(c) that the clinic is, 01' any premises used in connection there­

with are, used, of proposed to be used, for purposes which are in

any way improper or undesirable in the case of such a clinic; or

(d) that the clinic or any premises to be used in connection

therewith consist of or include works executed in contravention of

laws and regulations controlbng the construction of houses and other

matters related thereto; or

(e) that the clinic is not, or will not be, in the charge of a

registered medical practitioner.

(2) It shall be a condition of every licence that a medical

practitioner or a registered nurse shall be present on the premises at all

times that patients are receiving a service or waiting for such a service

at the clinic.

Malta Government Gazette — Legal Notice 1981 110 — Mcdical Clinics (Liccnsing) Regulations, 1981

(1) The licence certificate shall specify the nurnber of patients

to be kept at any one time as in-patients at the clinic but in any case not

more than two beds may be licensed

Provided that in the same building block there shall not be

licensed more than one clinic irrespective of whether such clinic

Of

clinics is carried out by a person Of persons engaged in single or in

group practice. The age, sex or other category of patients who may b�

treated at the clinic may be specified in the said certificate. The type of

surgical operations which can be carried out in a clinic shall be limited

to operations listed in the Second Schedule to the se regulations and sub­

ject to any restriction or limitation specified therein.

(2) The licence certificate issued under the Ordinance in

respect of any clinic shall be kept affixed in a conspicuous place in the

clinic.

(3). The tariff of fees chargeable at the clinic in respect of

services, other than professional services provided at the clinic shall bc

kept affixed in a conspicuous place in the clinic.

Malta Government Gazette — Legal Notice 1981 110 — Mcdical Clinics (Liccnsing) Regulations, 1981

( l) The licensee shall maintain a register of all patients treated

at the clinic which register shall in respect of each patient include the

following particulars

(a)

the name, address and date of birth of the patient;

(b) the name and address of the patient's next of kin or any

person authorised to act on the patient's behalf;

(c)

the name and address of the patient's medical practitioner;

the da te on which the patient entered and left the clinic;

(d)

(e)

if the patient is transferred to hospital, the date of and

reasons for the transfer and the name of the hospital to which

transferred;

(f)

if the patient died at the clinic, the date, time, and cause

of death.

(2) The licensee shall maintain a separate register of all sur­

gical operations performed at the clinic, which register shall include the

name of the medical practitioner or den tal practitioner who performcd

the operation, and the name of the anaesthetist in attendance.

(3) For each service carried out on payment at the clinic an

official receipt from the clinic shall be issued to the person in respect

of whom the service was provided. A register of the financial accounts

of the clinic is to be kept.

(4) Any register maintained in pursuance of paragraphs ( l),

(2) and (3) of this regulation shall be retained for a minimum period of

one year from th e date of the last entry in the register.

(5) The licensee shall maintain a case record in the clinic in

respect of each patient, which r e cord shall include the following parti­

culars

(a)

an actequate statement of the patient's h e al th and co n d i

­

tion; and

(b) a note of a ny investigations and d etai l s of s u r gi c a l opera­

tions carried out, and of a n y treatment given.

(6) The c a s e records maintained in pursuance of paragraph

(5) of this regu!ation shall be re t a i n e d for a minimum of one year from

lhe date of death or discharge of pati e nt

.

(7) The licensee shall keep a record of the n u r si ng staff

employed in the clinic which r eco r d shall include the full name, qualifi­

cations and det a i l s of position and date of employment in the clinic of

each such n u rs e

.

(8) The M i ni s t ry of Health and Environment is t o be

informed of the names,.addresses and quaJifications of each me m ber of

the staff employed on the d at e of issue or re n e w al of the licence and of

any changes in staff subsequent to that date.

Malta Government Gazette — Legal Notice 1981 110 — Mcdical Clinics (Liccnsing) Regulations, 1981

(l) The licensee shall in respect of any patient who dies in the

clinic, send notice in writing to the Minister not later than o n e normal

working day after the death occurs.

(2)

For the purpose o f paragraph (l) of this regulation, no

account shall

be taken of a n y part of a period of 24 hours which falIs

on a Saturday, Sunday or other public holiday.

Malta Government Gazette — Legal Notice 1981 110 — Mcdical Clinics (Liccnsing) Regulations, 1981

(l) The licensee shall. having

regard

to

the

category

of

patients treated at the clinic

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(a) provide a de quat e professional,

ancillary

technical,

and

other s uppor t i n g staff;

(b) p r ov i de for each pati e n t in the clinic a d eq u a t e accommo­

dation a n d space;

(c) provide adequate furniture, bedding, curtains and if neces­

sary suitab1e screens and floor covering in r oo m s occupied or used

by patients;

s u r g i ca l

provide and maintain adequate medical,

and

(d)

n urs i n g equipment and treatment facilities;

(e) provide for use of patients a d eq u a t e wash basins and if

so considered llecessary, baths supplying hot and cold water and

adequate water closets and sluicing facilities;

(f) provide adequate !ight and ventilation and when n e ces

­

sary heating, in all parts of the clinic o c cup i e d by the patients;

keep all par ts of the clinic occupied or used by patients in

(g)

good structural repair, clean and reasonably decorated;

(h) take adequate precautions against the risk of fire and

make adequate arrangements for detecting, containing and extin­

guishing fires and for the evacuation of patients and staff in the

event of fire. In particular the licencee shall comply with such

instructions as may bc given by the C o mm i s s i o ner of Police in this

respect;

(i) provide adequate kitchen equipment. crockery and cutlery

and facilities for the preparation and storage of food;

supply adequate food for every patient;

(j)

arrange appropriate laundering facilities;

(k)

(l) make adequate arrangements for the disposal of swabs,

soiled dressings, instruments and similar substances and materiaIs;

(m) make adequate arrangements for patients in the clinic

where necessary to receive medicaI and den tal services;

(n) make adequate arrangements for the recording, safe keep­

ing, handling and disposaI of drugs;

(0) provide adequate arrangements for the prevention

of

infection, toxic conditions, or spread of infection at the clinic;

(p)

take adequate precautions against the risk of accident.

The licensee shalI -

(2)

(a)

provide for the clinic to be connected to a telephone

service;

(b)

where surgicaI operations are undeliaken at the clinic, or

when otherwise indicated, provide such electrical supply as during

interruption of public supply, is needed to safeguard the life of a

patient;

(c) make adequate arrangements for the care of patients in

medical emergencies.

Malta Government Gazette — Legal Notice 1981 110 — Mcdical Clinics (Liccnsing) Regulations, 1981

( l ) Subject to the following provlslOns of this regulation,

any authorised person, on producing if asked to do so, a duly authenti­

cated document showing that he is so authorised, may enter and inspect

any premises which are used, or which he reasonably believes to be

used as a clinic and may require the production of and may inspect any

register or records maintained or retained in pursuance of these regula­

tions.

(2) Any authorised person may require the Iicensee or his

representative to furnish information in relation to the clinic in respect

of any matters mentioned in the First Schedule to these regulations and

such other information as may reasonabJy be required for the purposes

of inspection

Provided that nothing in this regulation shall be deemed to

authorise any person who is not a medical officer to im;pe-::t any c1inical

record relating to a patient in the clinic.

(3) The licensee shall permit any authorised person to inter·

view in private any person in the clinic.

(4) The clinic shalI be open for inspection by any authorised

person with a view to ensuring full compliance with the provisions of

these regulations.

B

Malta Government Gazette — Legal Notice 1981 110 — Mcdical Clinics (Liccnsing) Regulations, 1981

The full names and qualifications of any employed medical practitioners.

Malta Government Gazette — Legal Notice 1981 110 — Mcdical Clinics (Liccnsing) Regulations, 1981

The fuH names and (where a�propriate) qualificat ions and grades of the nursing and

other professional, tec1mical, adrninist;'atlve and anciUary staff (other than staff

included under paragraph 12 above) employed Of proposed to be employed in

the clinic.

The details of ar r ang e m ents made Of proposed to be ma d e in respect of provision

Gazzetta tal-Gvern ta' Malta — Avviż Legali 1981 110 — Regolamenti ta' 1-1981 dwar Liċenzi għal Kliniċi Mediċi

ta' per sun al ieħor, professjonali, tekniku, a mm in is tr a t t iv u a n ċ illa r i (barra mill­

persunal inkluż fil p a r ag r a f u 12 t a hawn fuq) imp je gat i jew li jkunu se j iġu

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'

mpjegati f il k li nika .

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Malta Government Gazette — Legal Notice 1981 110 — Mcdical Clinics (Liccnsing) Regulations, 1981

of facilities and services.

The arrangements made for the supply of bIood and blood products.

Malta Government Gazette — Legal Notice 1981 110 — Mcdical Clinics (Liccnsing) Regulations, 1981

The arrangements made for the provisions of pathology and radiology services.

Malta Government Gazette — Legal Notice 1981 110 — Mcdical Clinics (Liccnsing) Regulations, 1981

SECOND SCHEDULE

Regulation 6(1)

The following operations may be carried out in a clinic provided that the condition

of the patient before Qperation is such as to preclude any increased danger of complica­

tions. Patients should not be too young Of too oId and should not have cardiopulmonary

disease or bleeding defects.

l.

General surgical operations

Simple hemiorraphy in otherwise fit patients

Circumcision

Simple biopsy

Cystoscopy (except when cutting and/or diathe1'my of la1'ge 01' deep

bladde1' lesions is involved)

Varicose veins (injection, ligation, stripping)

Minor ano1'ectal pr o c ed u r es (provided that no extensive exploration

is involved)

Skin lesions (excision)

Dennabrasion

C1'yosurge1'Y of minor surgical conditions

2. Orthopaedic Operations

Reduction of simple fractures and dislocations

Carpal tunnel release

Ingrowing toe nail (excision)

3. Ear, Nose and Throat Operations

Adenoidectomy

Anthral washout

Myringotomy

Inferior turbinates (cautery)

Laryngoscopy (except in patients with stridor)

4. Ophthalmic Operations

Meibomian cysts (incision and cu r et t age)

Lachrymal duct (probing and sy ringin g )

Cataract extraction

Glaucoma (drainage)

Squint (correction of)

5. Gynaecological Operations

Curettage (Diagnostic and therapeutic)

Simple biopsy

Perineal tears (repair of first and secondary degree

tea1's following

delivery)

Removal of cysts and polyps

Cervical smear and biopsy

6. Dental 0 perations (In respect of regulation 9 ( l ) (m) )

Dental extractions

Removal of impacted teeth

Removal of cysts from jaw

Repair of soft tissue lesions of the aral mucosa

7. Investigatory Procedures

Stemal!marrow puncture

Lumbar puncture

mit-Taqsima

Kastilja

Published by the Information Di.'ision

Kastilja

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tal-Gvern

Printed at

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