LICENSING OF PRIVATE MEDICAL CLINICS REGULATIONS

SUBSIDIARY LEGISLATION 458.23

LICENSING OF PRIVATE MEDICAL CLINICS

REGULATIONS

10th November, 1995

LEGAL NOTICE 161 of 1995, as amended by Legal Notices 200 of 1996,

183 of 2003 and 426 of 2012.

The title of these Regulations is the Licensing of Private

Medical Clinics Regulations.

[Regulation 4(2)]

Matters in respect of which a health authority may require information to be

furnished by an applicant for a licence

1. The full name and address, and professional or technical qualifications (if

any) of the applicant.

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

the address of its registered office or principal place of business and the full names

and addresses and technical qualifications (if any) 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.

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

5. The accommodation available, and the equipment and facilities provided or

to be provided in the clinic.

6. The date on which the clinic was established or is to be established.

7. Whether any other business is or will be carried on in the same premises as

the clinic.

8. The type of clinic services to be provided including list of operations

proposed to be carried out.

9. The number of patients (excluding staff) for whom it is proposed to be used

distinguishing between different categories of patients and indicating the age-range

of patients in each category.

10. The full names, ages, qualifications and experience of persons employed or

proposed to be employed in the management of the clinic.

11. The arrangements for the management and control of the clinic.

12. The full names and qualifications of any employed medical practitioners.

13. The full names and (where appropriate) qualifications and grades of the

nursing and other professional, technical, administrative and ancillary staff (other

than staff included under paragraph 12 above) employed or proposed to be employed

in the clinic.

14. The details of arrangements made or proposed to be made in respect of the

provision of facilities and services.

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

16. The arrangements made for the provision of pathology and radiology

services.

17. The arrangements made for the insurance of patients, staff and third parties

against accidents and other mishaps.

In

these

regulations,

unless

the

context

otherwise

requires -

"the Act" means the Health Care Professions Act;

"department" means the Department of Health;

"clinic" means a private medical clinic;

"private medical clinic" includes a private hospital and a day

care medical clinic, but does not include a medical practitioner’s

consulting room;

"Ministry" means the Ministry responsible for health;

"Minister" means the Minister responsible for health;

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

exercise powers under regulation 13;

"Superintendent" means the Superintendent of Public Health.

Amended by

L.N. 183 of 2003.

[Regulation 9(9)]

Part I

The following operations may be carried out in a clinic, as referred to in sub-

regulation (9) of regulation 9, provided that the facilities and resources, as well as

the condition or medical fitness of the patient are such as to enable such operations

to be carried out under good medical, surgical and anesthetic practice in line with

guidelines established by international academic colleges of surgeons and

anesthesiologists recognised by the Superintendent.

Where day surgery is carried out this generally demands a high standard of

e x p e r t i s e , a n d s h o u l d b e u n d e r t a k e n o n l y, o r s u p e r v i s e d , b y e x pe r i e n c e d

practitioners. Such operations should be clean and elective surgical procedures and

should normally require a relatively short general anesthesia and should not carry the

risk of postoperative complications that normally require overnight stay in a clinic

and the patient is expected to recover sufficiently to return home in the early

evening. In particular haemostasis must be strictly ensured and where an operation

requires drainage, it may not always be suitable to be performed on a day care basis.

It is understood that the facilities should be similar to those required for in-patient

surgery with ward area near the operating theatre suite (including anesthetic room

and recovery room of the high dependency type) and, without prejudice to the

generality of this requirement, must have adequate lighting, basic equipment, piped

gases and gas scavenging devices. Basic equipment includes anesthetic machine and

monitoring apparatus, operating table, diathermy machine, dressing trolleys, scrub

facilities as well as other equipment required in accordance with good surgical and

anesthetic practice for specific operations.

The elderly and infants are normally excluded and the arrangements for post-

operative care outside the clinic must be satisfactory. In particular the patient must

have adult attendance and it must be ensured that such patient is in close reach of the

telephone for emergencies. After discharge from the clinic, the patient must be given

appropriate instructions following discharge and be accompanied home.

If the patient is deemed to be unfit for discharge from the clinic on the same day

either on anesthetic or surgical grounds, it shall be the responsibility of the person in

charge of the clinic to make appropriate arrangements for in-patient admission to a

clinic where overnight stay is allowed.

In every case the prudent exercise of clinical judgement by the surgeon and the

anesthetist, faced with an individual problem and particularly when faced with non-

ideal facilities, is mandatory.

A.

Paediatric Surgical Operations

(i)

General

Examination under anesthesia

Repair of inguinal/umbilical/femoral/epigastric hernia

Varicocele

Ligation of communicating hydrocele

Orchidopexy (unilateral or bilateral), excluding second stage operations

or cases of high non-palpable testis

Laparoscopy

Circumcision, meatotomy

Minor hypospadias

Cystoscopy

Division of tongue tie

Proctoscopy, sigmoidoscopy, anal stretch, examination under anesthesia

Excision of local skin lesions, including biopsy

Lymph node biopsy

Branchial sinus, thyroglossal cyst

Correction of prominent ears

Excision of accessory auricles and digits

Correction of syndactyly

Minor revision following cleft lip and palate surgery

Biopsy/excision/destruction of lesions, or removal of excess mucosa, of

mouth

Removal of calculi from salivary ducts

(ii) Orthopaedic

Arthroscopy

Manipulations, closed reductions of simple fractures/dislocations

Change of plaster

Release of trigger finger

Excision of ganglion

(iii) Dental

Extractions/conservation dentistry

Supernumerary or impacted teeth

Biopsy of oral lesions, including excision

Lingual or labial frenectomy

Removal of fixators

Enucleation of simple cysts

(iv) Ear, Nose and Throat

Examination under anesthesia and removal of foreign body from ear,

nose and throat

Myringotomy and insertion/removal of tympanostomy tube

Electro-cochleography

Reduction for fractured nose

Electro-cautery for bleeding of nose

Submucosal diathermy

Simple nasal polypectomy

Antral puncture and washout

(v) Ophthalmic

Correction of squint

LICENSING OF PRIVATE MEDICAL CLINICS

Electro-diagnostic tests

Examination under anesthesia for ophthalmic conditions

Adult Surgery

(i)

General

Excision of lesions of skin and subcutaneous tissue, including rodent

ulcer

Cautery/cryotherapy of skin

Removal of foreign body in deeper tissue

Dermabrasion

Skin suture

Insertion/removal of skin expander into tissue

Repair of simple inguinal, femoral, umbilical or epigastric hernia

Anal fissure, anal stretch, sphincterotomy

Excision of anal fistula

Removal of anal warts

Repair of anal trauma

Rectal polypectomy

Haemorrhoidectomy

Diagnostic Laparoscopy

Needle biopsy of liver

Oesophagoscopy and dilatation

Biopsy breast, lymph node, skin, lesions of mouth

Removal of salivary calculus

Ligation, stripping of/other operations for, varicose veins

Excision of thyroglossal cyst

Excision of bronchial sinus

Incision and drainage of abscess, drainage of haematoma

Microdochotomy

(ii) Orthopaedic

Note: Facilities for image intensification and application of plaster casts

where necessary should be available

Axthroscopic procedures, including biopsy and operation on articular

cartilage

Manipulation

of

joints,

closed

reduction

of

simple

fractures/

dislocations

Removal of pins, plates or screws, external fixator

Excision of ganglia, synovial cysts and benign synoviomata

Decompression of carpal tunnel

Decompression of peripheral nerve

De Quervain’s release

Removal of neuroma, e.g. on the hand

Correction of minor deformity of hand/foot

Minor amputation of the fingers and toes

Operation on ingrowing toe nails

Subcutaneous tenotomy

Tendon transposition

Primary repair of peripheral nerve

Ulnar styloidectomy

Excision of exostoses

Interphalangeal fusion of the toes

Hallus valgus and osteotomy of metatarsals

Release of trigger finger

Simple excision of palmar fascia in Dupuytren’s contracture

Removal of foreign bodies

Scar revision

Biopsy, excision of small lesion, limited repair, of muscle

(iii) Urinary System

Note: Uncatheterised patients should not be sent home before they have

passed urine.

Percutaneous nephrostomy fine needle biopsy of kidney

Nephroscopic operations on ureter

Ureteroscopic extraction of calculus of ureter

Endoscopic examination/insertion/removal of prosthesis, ureter

Endoscopic retrograde pyelography

Operations on ureteric orifice

Endoscopic destruction of lesion of bladder

Endoscopic hydrostatic distention of bladder

Endoscopic extraction of bladder calculus or foreign body

Endoscopic dilatation of, or operations on, outlet of female bladder

Repair of epispadias

Endoscopic operations on urethra

Endoscopic examination of urethra/removal of foreign body

Dilatation of urethra

Endoscopic biopsy of prostate

(iv) Genital System

External meatotomy of urethral orifice

Orchidectomy and excision of spermatic cord

Orchidopexy

Correction of hydrocele

Excision of epididymal cyst, scrotal lesion

Biopsy testis

LICENSING OF PRIVATE MEDICAL CLINICS

Operations on varicocoele

Division of preputial adhesions

Circumcision

Vasectomy

(v) Ophthalmic Operations

Cataract surgery

Corneal transplant surgery

Procedures on the eyelid or tarsal plate

Operations on the lachrymal apparatus

Correction of squint

Surgery for refraction

Laser surgery

Keratoplasty

Iridectomy

(vi) Ear, Nose and Throat

Endoscopy of nasal cavity, sinuses, pharynx, larynx, including biopsy

Removal of foreign body from the nose or ear canal

Removal of impacted wax

Excision of lesion of external ear

Myringotomy/insertion/removal of tympanostomy tube

Removal of simple nasal polyps

Reduction of fracture nasal or molar bone

Electro-cautery of the nasal septum

Submucosal diathermy of the inferior turbinates

Antral puncture and washout

Removal of vocal polyp

Diagnostic laryngoscopy, pharyngoscopy and oesophagoscopy

(vii) Endoscopic/Laparoscopic procedures of gastro intestinal tract

Oesophagoscopy/oesophagostro duodenoscopy,

including

biopsy/

removal/laser or diathermy destruction of lesion

Endoscopy and removal of foreign body/insertion of prosthesis/

dilatation/recanalisation of tumour mass

Sigmoidoscopy including biopsy/removal/destruction of lesion

Fibreoptic colonoscopy including excision/biopsy/destruction of lesion

Endoscopic retrograde cholangiopancreatography

(viii)Plastic Surgery

Excision of skin lesion: direct closure, split skin or full thickness graft,

local flaps (other than grafts to the lower limbs)

Scar revision and soft tissue contouring

Separation and inset of certain flaps

Debulking and revision of flaps

Insertion and distension of tissue expanders

Operations for axillary hyperhidrosis

Laser and cryosurgery

Excision of tattoos

Blepharoplasty

Rhinoplasty

Mastopexy

Limited Liposuction

(ix) Gynaecologyical Operations

Note: Uncatheterised patients should not be sent home before they have

passed urine

Examination under anesthesia and curettage

Colposcopy,

cystoscopy,

diagnostic

hysteroscopy/laparoscopy,

including biopsy and minor laparascopic surgery

Biopsy/cautery of cervix, removal of cervical polyp

Hormone implants

Excision of vulval warts and other minor procedures to the vulva and

vagina

Marsupialisation of Bartholin’s cyst

Endometrial ablation with laser or resectoscope

Hysteroscopic resection of uterine septum

Hysteroscopic myomectomy

Laser treatment of cervical and vulval lesions

Tubal ligation

Biopsy of ovary or peritoneum

Coagulation of mild endometriosis

Aspiration of small ovarian cysts

Lysis of mild to moderate adhesions

Coagulation of moderate endometriosis

Exploration of small ovarian cysts

Uterine ventrosuspension

Salpingectomy

Salpingectomy for ectopic pregnancy

(x) Oral and Maxillofacial Surgery

Excision of uncomplicated impacted teeth and buried roots

Exposure of unerupted teeth for orthodontic treatment

Biopsy of hard and soft tissues

Enucleation of small cysts of jaw

Division of pedicles

Removal of direct bone plates and wires

Minor soft-tissue surgery

LICENSING OF PRIVATE MEDICAL CLINICS

EUA for suspected malignancy

Cryoblockade of peripheral nerves

Laser and cryosurgery of small lesions

Reduction of nasal and molar fractures

Temporomandlibular arthroscopy

Salivary ductoplasty and removal of calculi

(xi) Other

Bronchoscopy, including biopsy and/or remwal of foreign body

Oesophagoscopy and dilatation

Removal of pectus bar

Mediastinoscopy

Chest drainage

(xii) Interventional Radiology

CT Scan using contrast

Isotope scanning

Arteriography using small arterial catheters

(xiii)Pain Relief

Epidural injections - cervical, lumbar or thoracic

Peripheral nerve lesion - using injection, radiofrequency, cryoprobe or

phenol.

Part II

The following operations may be carried out in a clinic where patients are kept

overnight subject to the facilities referred to under regulation 9(9)(b) being available

at the clinic

1. All operations listed under Part I of this Schedule.

2. Any other surgical intervention other than -

Neonatal surgery

Intracranial operations

Major laryngeal surgery

Surgery for kyphosis and scoliosis

Cardiac surgery

Aortic surgery

Transthoracic oesophageal resection and other thoracic surgery excluding

lobectomy and simple chest drainage

Surgery for portal hypertension

Organ transplantation irrespective of whether the organ is obtained from a

cadaver or from a live donor

Any other operation or procedure, including any operation referred to in

Part I of this Schedule where there is a probability of the patient requiring

intensive care after surgery or where significant amounts of blood loss are

anticipated, if intensive care facilities, to the satisfaction of the

LICENSING OF PRIVATE MEDICAL CLINICS

Superintendent, are not available;

unless such operations are specifically approved by the Minister and a note to this

effect is entered in the licence.

A licence for the opening or carrying on of a clinic under

the Act may only be granted or renewed provided such clinic

complies with the provisions of these regulations.

Amended by

L.N. 200 of 1996.

[Regulation 9(9)]

Operating Theatre facilities

(1)

Facilities must include

(a) two operating tables;

(b) a separate anesthetic room for each theatre;

(c) a recovery room or area;

(d) a cleansing room;

(e) a sterilising room, including facilities for sterilising equipment which

cannot be autoclaved;

(f)

a plant room or area which may or may not be integrated with the

remainder of the suite;

(g) storage space;

(h) a rest/refreshments room;

(i)

toilets, wash basins and showers;

(j)

barrier zone;

(k) a theatre control office;

(l)

facilities for infra-operative radiography including on the spot

development of X-Ray films.

(2) The floor area of the operating theatres shall be of an area not less than 37

square metres, and that of the anesthetic rooms of an area not less than 16.5 square

metres.

(3) The ceilings, floors and applied wall finishes of the operating suite shall be

smooth, impervious and jointless. The floor of the operating theatre shall be

similarly covered with material and have appropriate antistatic properties. All

finishes shall be able to withstand daily cleansing with water and disinfectants.

(4)

(i) The operating suite shall be mechanically ventilated by a satisfactory

system which shall be capable of providing and maintaining

(a) temperatures (user adjustable) within a range of 15°C and 25°C;

(b) relative humidity of the atmosphere within the range 40%-60%.

Only steam injection type humidifiers are permissible;

(c) sufficient fresh air for the requisite temperature and humidity

control, dilution of airborne bacterial contamination and control

of air movements between clean and less clean areas.

(ii) For the purposes of the above provisions, "satisfactory system" means a

system acceptable by the international standards recognised by the

Superintendent.

LICENSING OF PRIVATE MEDICAL CLINICS

(iii) An approved system should be included for the removal of exhaust

anesthetic gases in accordance with specifications "BS 6834: 1987

Active Anesthetic Gas Scavenging Systems" or equivalent

specifications.

(5)

(i) The operating theatre shall have clinical quality lighting capable of

rendering not less than 400 lux (excluding the illumination from

operating lamp). The preparation, scrubbing and recovery areas shall

have lighting of not less than 250 lux while the anesthetic areas should

have an illumination of not less than 300 lux. The remaining parts of the

suite should have an illumination of not less than 200 lux.

(ii) Essential lighting and power shall be provided in the theatre suite. These

shall be fed from an automatic standby power source which shall assume

the load after a period of not more than 10 seconds.

(iii) Emergency lighting fed from a D.C. Source shall also be available for

the essential parts of the operating theatre suite. There shall be ensured a

no break supply to the operating theatre lamps.

(6) Clinics carrying out surgery or admitting acutely ill medical patients shall

require a cardiac monitor, a pulse oximeter, a defibrillator, a fully equipped

resuscitation trolley and oxygen and suctions in all areas where acutely ill patients

may be kept. More than one set of equipment may be required in hospitals handling

large numbers of patients.

(7) Qualified and fully trained staff able to react and operate the cardiac

emergency equipment, if so required, have to be on duty 24 hours a day.

(1) An application for a licence for a clinic shall be made

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

Provided that where an application for a licence is already

pending before the coming into force of these regulations, such

application shall be deemed to have been made under these

regulations.

(2) In making an application for a licence for a clinic, an

applicant shall furnish such particulars as are specified in the First

Schedule and such other information as the Minister may require.

(3) Any application for a licence, including the renewal of a

licence, for a clinic shall be accompanied by a fee payable to

Government as the Minister may from time to time by notice in the

Gazette prescribe.

(1) The Minister may refuse to issue or renew, or may

withdraw a licence in respect of a clinic if he is satisfied -

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

to be employed by the applicant to assume

responsibility for the clinic is not of good conduct; or

(b) that for reasons connected with the physical location,

construction, state of repair, accommodation, staffing

or equipment, the clinic is not fit to be used as a clinic;

or

(c) that the clinic is, or any premises used in connection

therewith are, used, or proposed to be used, for

purposes which are not related to the clinic or which

are in any way improper, unethical or not lawful; or

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

therewith consist of or include works executed in

contravention of the Development Planning Act; or

(e)

that the arrangements for the management and control

of the services provided at the clinic are not 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 a tribunal to be appointed by the

President of Malta and made up of a person who has, for at least

seven years, been in possession of a warrant to practise the legal

profession in Malta as chairman, and two other members, one from

among the medical profession and the other who shall be a

representative of the department.

(1) The licence certificate shall specify the number of

patients in beds which may be kept at the clinic.

(2) The type of surgical operations which can be carried out in

a clinic shall be those listed in the Second Schedule and subject to

any conditions specified therein.

(3) The licence certificate issued under the Act in respect of

any clinic shall be kept affixed in a conspicuous place in the clinic.

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

services, other than professional services provided at the clinic,

shall be kept affixed in a conspicuous place in the clinic.

(5) It shall be the duty of the licensee to ensure that all patients

asking for or receiving a service are informed of the fees

chargeable at the clinic and can receive a copy of the relative fees

charged, which copy shall be given to any person on request.

(1) Where the licence for a clinic is issued on behalf of a

company, it shall be the duty of the licensee to inform the Minister

in writing of any change in the name of the persons running the

company with seven days from such change.

(2)

(a) No licence for the running of a clinic shall be granted,

transferred or renewed unless the clinic is in the charge

of a medical practitioner or a registered nurse,

hereinafter referred to as "the person in charge".

(b) It shall be the duty of the licensee to make adequate

arrangements, to the satisfaction of the Superintendent,

for the running of the clinic while he, or, if he is not the

person in charge of the clinic, the person in charge, is

absent from such clinic, and moreover to ensure that

the name of any person at any time in charge of such

clinic is fixed at all times in a conspicuous place and

visible to the public when the clinic is providing a

service. This information is to be communicated

forthwith to the Superintendent.

(c) If at any time during the absence of the person in

charge there is no person designated as being in

charge, the clinic shall during such time be deemed to

have been operated without a licence.

(d) It shall be the duty of the licensee to inform forthwith

the Superintendent in writing, and where possible and

practicable in advance, of any change, other than

aforesaid, of the person in charge of the clinic.

(e) There must be a clear distinction and definition of the

roles and responsibilities of the person in charge and

the licensee in all those instances where these

functions are not carried out by the same person.

It shall be the duty of the licensee to ensure that at all times

in-patients are receiving treatment at the clinic, there is available

resident medical coverage for such patients to the satisfaction of

the Superintendent, taking into consideration the number and

condition of such patients and the service being provided at the

clinic

Provided that where the surgical operations to be carried

out at the clinic are limited to those listed in Part I of the Second

Schedule, the presence of a registered nurse shall be sufficient.

(1) It shall be the duty of the licensee to ensure that there

are present at all times at the clinic a sufficient number of nurses to

e n s ur e p r op e r c a r e o f t he p a t i e n ts i n t he c li n ic t a k i ng i n to

consideration the following

(a) the number and category of patients accommodated;

(b) the number of floors and the number of patients on

each foor;

(c) the overall layout of the building;

(d) the facilities provided;

(e) the number of additional part time staff and of other

staff capable of providing nursing support.

(2)

(a) Without prejudice to the generality of the above and to

the provisions of subregulation (5), there shall be at

least one registered nurse on duty in each ward or

special unit at all times patients are receiving a service

in such ward or special unit.

For the purposes of this paragraph, no ward or

special unit shall be considered as one such ward or

unit unless it is wholly situated on one floor.

(b) If a children’s ward or special unit is incorporated

within the clinic there shall be, at all times children are

LICENSING OF PRIVATE MEDICAL CLINICS

receiving treatment, a registered sick children’s nurse

or a registered nurse with significant experience in the

nursing of children.

(c) Where, in any clinic, surgery is carried out there must

additionally be present at all times such surgery is

carried out and for a reasonable period before and after

such event, a registered nurse with operating theatre

experience

Provided that patients recovering from an

anesthetic shall be attended to by a qualified

anesthetist or by a suitably trained registered or

enrolled nurse.

(3)

(a) No patient may be left in the sole charge of a person

who is not authorised to practise as a nurse.

(b) The number of temporary or casual nurses on duty

shall not exceed the number of permanently employed

nurses on duty and no temporary or casual nurse shall

be in sole charge of a patient unless a permanently

employed registered nurse is present on the premises

and can be called upon immediately.

(4) The person in charge of a clinic shall maintain a roster of

duties of nurses and such roster shall be available to nurses and on

request to an authorised person.

(5) It shall be the duty of the licensee, having regard to the

number, age, sex and condition of patients treated at the clinic, to -

(a) provide adequate professional, technical, ancillary and

other supporting staff;

(b) provide for each patient in the clinic adequate

accommodation and space, including, where

appropriate, day room facilities;

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

where indicated, suitable bed screens and door

coverings in rooms occupied or used by patients;

(d) provide adequate medical, surgical and nursing

equipment and adequate treatment facilities, including

an efficient nurse/patient call system;

(e) provide for the use of patients adequate wash hand

basins and baths or, where acceptable, showers,

supplying hot and cold water and a suitable number of

water closets and sluicing facilities;

(f)

provide adequate lighting, heating and ventilation in

all parts of the clinic occupied or used by patients;

(g) keep all parts of the clinic in good structural repair,

clean and reasonably decorated;

(h) ensure that adequate facilities exist, and take adequate

precautions, against the risk of fire, including the

provision of adequate means of escape in the event of

a fire, as well as make adequate arrangements for

detecting, containing and extinguishing a fire, for

notices regarding procedure to be used in case of fire

and for the giving of warnings, for the evacuation of

the patients and staff, for the maintenance of fire

fighting equipment, and for such other arrangements

as may in any case be required by law, and, in the

absence of any such law, as may, at any time, be

directed by the Commissioner of Police;

(i)

provide adequate kitchen equipment, crockery and

cutlery and adequate facilities for the preparation and

storage of food;

(j)

supply adequate food for every patient in accordance

with such patient’s dietary requirements;

(k) arrange appropriate laundering facilities;

(l)

make adequate arrangements for the disposal of swabs,

soiled dressings, instruments and similar substances

and materials as well as for any other hazardous

wastes;

(m) make adequate arrangements, as may be indicated, in

respect of long stay patients;

(n) make adequate arrangements for the recording,

safekeeping, handling and disposal of drugs;

(o) provide adequate arrangements for the prevention of

infection, toxic condition, or the spread of infection in

the clinic;

(p) take adequate precautions against the risks of

accidents;

(q) provide for adequate insurance coverage of patients

treated, and of employees working, at the clinic and

for insurance of third parties in each case in respect of

accident or other mishap.

(6) The number at domestic staff shall be sufficient to ensure a

high standard of cleanliness in all parts of the premises and the

licensee shall ensure that such staff is supervised by a person with

knowledge of cleaning methods and materials applicable to a clinic.

(7) There shall be a supply of wholesome drinking water at

suitable points.

(8) Every clinic shall be provided with adequate telephone

facilities. Similar facilities shall also be available for private use by

patients.

(9)

(a) In respect of operations listed under Part I of the

Second Schedule, the facilities and resources as well as

the condition or medical fitness of the patient shall be

such as to enable such operations to be carried out

u n d e r c o n d i t i o n s o f g o o d s u rg i c a l a n d m e d i c a l

practice, as recommended by academic colleges of

anesthesiologists and of surgeons recognised by the

Superintendent.

(b) No surgical operations as are listed or referred to in

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Part II of the Second Schedule may be carried out at a

clinic unless there are adequate operating theatre

facilities, as are specified in the Third Schedule, to the

satisfaction of the Superintendent.

(c) Where in any clinic, surgical operations are undertaken

or a life support system is used, there shall be available

adequate facilities for immediate electrical supply in

case of interruption of the public supply as is needed to

safeguard the lives of the patients.

(10) In this regulation -

(a) "to provide" includes, where applicable, to maintain;

and

(b) where any question arises as to suitability,

acceptability or adequacy, it shall be deemed to be

suitable, acceptable or adequate, as the case may be, if

so considered in the opinion of the Superintendent.

Where antenatal, intranatal or postnatal care is given at a

clinic, the following provisions shall moreover apply

(1) A registered midwife shall be in charge of all midwifery

services and may, in respect of midwifery services only, act as

person in charge for the purposes of regulation 5. In any case a

practising midwife shall be present on duty at all times maternity

care is provided.

(2)

(a) The person in charge should make certain that

adequate general and specialist medical cover is

provided as needed.

(b) Adequate arrangements shall exist for obtaining

obstetric, paediatric, anesthetic and any other

necessary help in an emergency situation.

(c) Where epidural anesthesia is to be offered to women in

labour, this should be carried out by an anesthetist

trained in this procedure.

(3)

(a) Where maternity beds are provided in a clinic they

shall be so designated and shall not, unless these are

single rooms, be used to accommodate any other type

of patient. Maternity patients shall not share rooms

with patients who are not in the clinic for obstetric

care.

(b) No mentally disordered patient, alcoholic or drug

abuser may be accommodated in the section reserved

for maternity patients unless such patient requires

maternity care; in such case she shall be given separate

accommodation.

(c) Adequate sanitary and bathroom facilities reserved for

the sole use of maternity patients shall be provided.

Grab rails and nurse call systems shall be included, and

where practicable showers and bidets.

(d) Nursery accommodation shall be made available as

well as adequate facilities for the preparation as may

be necessary of infant formula or other breast milk

substitute.

(e) Single rooms shall be present for maternity cases

which have special needs.

(f) Delivery rooms shall be adequately sound-proofed.

(g) Emergency electrical supplies shall extend to delivery

rooms, nurseries and to any operating theatre.

(4)

(a) Resuscitation equipment for new-born babies shall be

provided.

(b) When deliveries are being conducted, anesthetic and

suction machines shall be available.

(c) Each infant shall have its own cradle of approved

design, thermometer and bath.

(d) Each patient shall be provided with a comfortable

nursing chair.

(5) The licensee shall in addition to the records referred to

under regulation 11(1), keep a case record of each child born to a

patient in the clinic, which record shall include the following

particulars

(a) details of the weight and condition of child at birth;

(b) a daily statement of the child’s health;

(c) details of each of any of the following paediatric

examinations, if carried out

(i) examination for congenital abnormalities;

(ii) measurement of circumference of the head of the

child;

(iii) measurement of the length of the child;

(iv) screening for phenylketonuria or other screening

for congenital disorder.

(6) T'he following additional particulars shall be included on

the register of patients kept at the clinic in respect of maternity

patients

(a) the date and time of delivery of each patient, the

number of children born to the patient, their sex and

whether born alive or dead;

(b) the estimated period of gestation prior to delivery;

(c) the name and qualifications of the person who

delivered the patient;

(d) the date and the time of any miscarriage occurring in

the clinic, including the period of gestation prior to

miscarriage;

(e) the date on which any child born to a patient in the

clinic left the clinic; and

(f)

if any child born to a patient died in the clinic, the

date, time and cause of death.

(7) The provisions of regulation 11(2), (3), (4) and (5) shall

mutatis mutandis apply to these records.

(8) The provisions of this regulation and, as applicable, of the

other regulations, shall apply to any premises licensed as a

maternity home.

(1) Proper records are to be kept of patients treated at the

clinic -

(a) in respect of each patient, in a register showing

-

the name, address, date of birth and a legally

valid identification document of the patient and,

where the patient has no legally valid

identification document, the passport number

shall be included together with the country of

issue, if such patient has a passport;

-

the name, address, a legally valid identification

document number and telephone number of the

patient’s next of kin or of any person authorised

to act on the patient’s behalf;

-

the name and address of the patient’s medical

practitioner;

-

the date when and the time during which the

patient was admitted and the date of discharge or

transfer to a clinic or other place as may be

applicable;

-

if the patient died in the clinic, the date, time and

cause of death;

-

in the case of a child, where applicable, the

name and address of the school he attends or has

attended before being admitted to the clinic;

(b) a separate register of all surgical operations performed

in the clinic: such register shall include in respect of

each operation, the date and time of such operation,

the patient’s name, a legally valid identification

document or passport number as may be applicable or

as provided for under the preceding paragraph, the

clinic case history number, the name of the medical or

dental practitioner who performed the operation, and,

where applicable, the name of any other practitioner

assisting him, as well as the name of the anesthetist in

attendance;

(c) a separate case record of every patient which shall

contain an adequate updated statement of the patient’s

health and condition and a note of any investigation

and details of surgical operations carried out and

treatment given, including the anaesthetic record

sheet.

(d) a record of each member of the staff employed, which

record shall include the name, date of birth, a legally

valid identification document number, grade and dates

of employment at the clinic, and, in respect of nursing

staff, details of their qualifications. Such records shall,

as far as reasonably practicable, include the times

when individual members of the nursing staff as well

as the person or persons in charge were on duty;

(e) a record of the following

-

all fire practices;

-

all fire alarm tests, results and action taken

where applicable;

-

the maintenance carried out on medical, surgical

and nursing equipment in the clinic;

(f)

such other records as the Minister may, from time to

time, require to be kept.

(2) All records referred to in subregulation (1), other than

patient case records, shall be retained for a period of not less than

two years after the last entry made therein, and shall be open for

inspection by an authorised officer or by such authority as may

have such power under any law.

(3) Patient case records shall be retained and shall not be

destroyed except with the approval of the Minister.

(4) It shall be the duty of the person in charge of the clinic to

ensure proper keeping and storage of records and, subject to the

provisions of these regulations and to any other law relating to

confidentiality of records, to limit disclosure only to persons

entitled to access to such information.

(5) All records shall be legibly entered in full and in proper

order. Any alterations, corrections or deletions shall be initialled by

the person making such alteration, correction or deletion.

(6) Notwithstanding the provisions of the preceding sub-

regulations, computer records may, under such conditions as the

Minister may impose in the licence certificate, be acceptable,

provided always that a hard copy of the day’s entries are made each

day and filed in chronological order

Provided that such alternative shall not, in the case where

the Minister directs that a copy of the entries be sent regularly to

the Ministry and/or the department, be construed as any acceptance

of any irregularity carried out at the clinic on the pretext that the

Ministry and/or the department had been regularly informed.

(1) No medical practitioner, dental surgeon, nurse,

midwife, pharmacist, pharmacy technician or any other person to

whom Part V of the Act refers, and who is also in the employment

of Government, may, during those hours in which he is contracted

to provide his services to Government, work in any medical clinic

unless he is on approved leave of absence. Any breach of this

provision by any such medical practitioner, dental surgeon, nurse,

midwife, pharmacist, pharmacy technician or other person shall be

deemed to be an offence. It shall be the duty of the licensee of such

clinic to take all reasonable steps to ensure that this provision is

complied with.

(2)

The licensee shall require all persons to whom Part V of the

Act refers to register their attendance at the medical clinic,

indicating date and time and whether entering or leaving the clinic,

immediately on entering and immediately before leaving the clinic,

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 may be specified by the Minister. The provisions of

regulation 11(6) shall also apply to the register referred to in this

provision.

(3) It shall be an offence for any licensee or person in charge of

a clinic to permit on the premises any person to whom

subregulation (1) refers unless the conditions of subregulation (2)

have been complied with.

(4) Where, except in an emergency, any licensee or person in

charge of a clinic is in wilful breach of any preceding provision of

this regulation, such clinic shall be deemed to have been operating

without a licence.

(1) Subject to the following provisions of this regulation,

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

authenticated 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 regulations.

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

representative to furnish information in relation to the clinic in

respect of any matters mentioned in the First Schedule and such

other information as may reasonably 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 inspect any

clinical record relating to a patient in the clinic.

(3) The licensee shall permit any authorised person to

interview in private any person in the clinic.

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

person with a view to ensuring full compliance with the provisions

of these regulations.

(5) Every clinic licensed under these regulations shall be

inspected at least twice in every period of twelve months. The

inspecting officer or officers shall conduct a systematic review of

facilities and services with a view to ensuring compliance with

these regulations and with the conditions of the licence, and shall

submit a report to the Minister on the results of his inspection.

The Ministry is to be informed of the names, addresses and

qualifications of each member of the staff employed on date of

issue, renewal or transfer of the licence and of any changes in staff

subsequent thereto.

If a patient, or a child born to a patient dies in the clinic,

the licensee shall give notice to the Superintendent forthwith and

shall report to him in writing within twenty-four hours after such

death. Such notice shall include full particulars of the patient, the

circumstances and cause or suspected cause of death, and any other

information which may be relevant.

For each service carried out on payment at the clinic, an

official itemised receipt shall be issued from the clinic to the

person in respect of whom such service was provided. The licensee

shall moreover ensure that a register of financial accounts of the

clinic is kept.

Nothing in these regulations shall be deemed to exempt

any applic ant or lice nse e from any re quirement of t he l aw

regarding any other licences which may be needed in respect of any

facility or service provided at the clinic.

Whether the clinic is intended to operate as a day care clinic only (i.e. with

no overnight stay) or as a clinic with overnight stay of patients.

LICENSING OF PRIVATE MEDICAL CLINICS