Private Medical Clinks (Ucell'dng) Rrgulatlons, 1995

t .N. 161 of 1995

MEDIC AL AND KINDRED PROFESS IONS ORDlNANCE

(CAP. 31)

Private Medical Clinks (Ucell'dng) Rrgulatlons, 1995

IN exercise of the powers conferred by section 98 (2) of lhe Medical

and Kindred Professions Ordinance, the Minister for Social

Developmen t has made the followinr. rer.ul ations:-

These regulations may be ti led as the Private Medical Clinics

(Licensing) Regulations. 1995,

In these regulations. unlcs.~ the co nt ext otherwise requires -

Regulation 9(9)

Optuting Tbearn racilltles

(I)

Facilities must include:.

(a )

two operating tables;

(b)

a separate anesthetic room for each theatre ;

(c)

a reeovery room orarea ;

(d)

a cleansing room ;

(c) a sterilising roo m, including racilities for ste ril ising equipment which

ca nnot be autoclaved ;

(t) a plant room or area which mayor may not be integrated with the

remainde r of the suite

(g) storage space;

(h)

a restlrefreshme nlS room ;

(i)

toilets, wash basins and showers;

U)

barrie r zone;

(k)

a theatre con trol office;

(I) faci lities fo r intra-operative radiography incl ud ing on the spot

development of X-Ray films .

(2) The floor area of the operating theatres shall be of an area nOl less than

37 square metres , and that of the anesthetic rooms of an area not less than \ 6.S squa re

(3) Th e ceilings. floors and applied wall finishes of the operating suite shall

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

similarly cove red with material and have appropriate ant ista tic propcnies. All finishes

shall be able 10 withstand daily clea nsi ng with water and disinfectants.

(4) (i) The operating suite shall be mecha nically ventilated by a

satisfactory system which shall be capable of providing and maintaining

te mperatures (use r adj ustable) within a range of lIT and 1S'C;

(a)

(b) relative hum idity of the atmosphere within the range 40% -60%. Only

steam injection type humidifi ers are permissible;

(e) sufficient fresh air for the requisite temperature and humidity control,

dilution of ai rborne bacterial con tamination and control of air movements

between clean and less clean areas - see 4{iiXb);

filtration of the incoming air as specified in the C04 specificationS of

(d)

4(ii)a;

(e) positive pressures in the opera ting the~tu rel a tin~ to other pans of the

operating suite, with different pressures as apphcable for dIfferent rooms - see

4{ii)(b).

(ii) For the purposes of tbe above provisions, ~satisfactory system"

means a system acceptable by the inte rnational standards recognised by the

Superintendent.

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

anesthetic gases in accordance with specifications " BS 6834: 1987 Active Anesthetic

Gas Scavenging Systems" or equivalent specifications.

(i) The opera ting theatre shall have clinical quality lighting ~pable of

(S)

rendering not less than 400 lux (excluding the illumination from operating lamp). The

preparation, scrubbin g and recovery arel)S shall have lighting of not less than 2SO lux

while the anesthetic areas should have an illumination of not less than 300 lux. The

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

(ii) E5scn tiallighling and power shall be provided in the theatre suite.

These shall be fed from an au tomaticstandby power source which shall assume the load

after a period of not more than 10 seconds.

(iii) Emergency ligh ting fed from a D .C. Source mall also be available

tor the esse ntial parts of the ope rating theatre suite. There shall be ensured a no brea k

supply to the operatin g theatre lamps.

(6) CliniC$ carrying out surgery or admining acutely ill medical pa ti ents shall

require a cardiac IOOnitor, a pulse oxime ter, a defibrillator, a fully equipped

resusci tation trolley and oxyge n and suction! in all areas where acu tely 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

c.mergency equipment, if 50 required, have to be on duty 24 hours a day.

Publi>brd by tbo ~ oflnformauOCl _ C4!~lle

KastilJ'

Ippubblibt mid-Dip"';""'" to' l-lnf<>rmaZZJ""'

Pra. 22c - Pricllllc

"authorised person" means a person authorised by the

Minister 10 exercise powers under regulation 13 of these

regulations;

"clinic" means a priVllte medical clinic;

" Department" means the Departmen t of Health;

;;Minisler" means the Ministe r responsible for health;

" Minislry" means the Ministry responsible for heal lh;

"the Ordinance" means lhe Medical and Kindred Professions

O rdinance;

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

care medical clinic. but does oot include a medical flraClitioncr's

consulting room;

"Superintendent" means the Superintendenl of Public Health.

A licence for the opening or carrying on of a clinie under Clinic 1<> .omply

section 98 of the Ordinance may only be granted or renewed provided with lhc pt .,...~

such clinic complies with the prOvisions of these regulations.

( I) An application for a lice nce for a clinic shall be made 10

the Ministe r in wriling and sent or delivered to the Ministry

Provided that where an application for a lice nce is al ready

pending before the coming into force of these regulat ions, such

appliell tio n shall be deemed to have been made underthese reguhuions.

(2) In maki ng an appl ication for a licence for a clinic, an

applicant shall furnish such particulllftl as are speciftCd in the First

Schedule 10 these regulations and such other information as the Minisler

may require ,

.

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

licence, fOf a clink shall be accompanied by a fee payable to

Governmen t as the Min ister may from time to time by notice in the

Gaze tte prescribe.

s.

(I) The Ministef may refuse to issue or renew, Of may

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

(a) Ihat 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 ,

conslructlon, state of repair, accommodation, staffing or

equipment, Ihe clinic is not fit to be used as a clink:; or

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

therewith arc, used , or proposed to be used, for PuI'JlO$CS wtuch arc

nOI related 10 the clinic or which arc in any way improper, unethical

or not lawfu l; or

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

therewith consist of or include works ellecuted in contravention of

the Development Planning Act, 1992; 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 thiny days of receipl 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 woo has. (or at least seven

yean;, been in possession of a warrant to practise the legal profession in

Malta as Chairman, and twO other members, one from among Ihe

medical profession and the other who shall be a represe ntative of the

Dcpanment.

(I) The licence certificate !hall specify the number of

numbcrolpa."cnl> inpa tient beds which may be kepI al the clinic.

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

in a clinic shall be those listed in the Second Schedule to these

regulations and subject 10 any conditions specified therein ,

(3) The licence cenificate issued under the Ordinance 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 althe clinic. shall be

kept affu"ed in a conspicuous place in the clinic.

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

patients ask.ing for or receiving a service arc infonned of the fees

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

charged, which copy shall be given 10 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 infonn the Minisler in

wriling of any change in the name of the persons running the company

with seven days from such change.

(2) (a) No lice nce for the running of a clinic shall be

granted, transfened or renewed unless the clinic is in the charge of a

medical practitioner o r a registered nu~ . hereinafte r rdened to as

"the person in charge".

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

anangements, to the satisfaction of the Superintendent, for the

running of the clinic while he, or, ifhe is not the person in charge of

the clinic, the person in charge is absent from such clinic, and

moreover 10 ensure that the name of any person at any rime 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

infonnalion is to be communicated forthwith to the

Superinteodent.

(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 10 have been operated without a

licence.

(d) It shall be the duty of the licensee to infono

fonhwith 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.

(0:::) 1bc:re must be a clear distinction and definition of

the roles and responsibilities of the person in charge and the

licensee in al l those inslances where these functions are not carried

out by the same perwn.

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

in-pa tients are receiving treatment at the clinic. there is avai lable

resident medical coverage for such patients to the satisfaction of tile

Superintendent. laking into considera tion the number and oondi tion of

such patie nts and the service being provided at the clinic

Provided that where the surgical opera tions to becarried ou t at

the clin ic are limi ted to those listed in Pan I of the Second Sclledule to

these regu lations. the presence of a regis tered nur.;e shalt be suffICient .

( I) II shall be the duty of the licensee to ensure th at there are t>u ,i<> j"",,_n,

presen t at all times at the clinic a sufficie nt number of nurses to ensu re (1ft t"lI>« .

pro per ca re of tho! patie nts in the: clinic taking into consideration the

followin g

(a )

th e number and category of patients accommodated;

(b )

the number of floors and the: numbe r of patients on each

noor

(c)

the ove rall layout of the buildi ng

(d)

th e fa cilities provided ;

(c) the number of additional part time staff and of other sta ff'

capable of providing nuning suppon.

(2) (a) Without prejudice to the ge nerali ty of the above

and to the: provisions of paragraph (S) of this regulation. there shall

be at least one registered nurse on duty in each ward or special unit

at all times patients are receiving a $C rvice in such ward or special

unil.

For tile purposes of this paragraph. no ward or

special uni t shall be considered as onc sueh ward or uni t unless it is

wholly si tuated on one floor.

(b) If a chi ldre n's ward or special uni t is inco rporated

with in the clinic there shall be at all times children arc rece iving

trea tment. a registered sick children's nu rse or a regis tered nurse

wit h significant experience in the nursing of childre n.

(cl Wh ere. in an ~ clini c. surgery is carried out there

must additiona lly be prese nt at all times such surgery is carried out

:md. for a reasonable period before and after such evc n! . a

registered nurse with ope rat ing theatre e.~pericnce

Provided th at patients recovering from an aneSlhe li-

shall be attended 10 by a qualified aneSlhe tiSl or b~ a suitably

trained rl"gislcrcd or enrolled nUrK.

(3) (a) No pat ie nt may be left in the sole l"ha rge of a person

who is not authoris.:<i to pr&l"lisc: as a nUrK.

(b ) The number of temporary or casual nurses on du ty

shall not exceed the number of penna!lenlly employed nul"So!S o n

duty and no temporary or casual nU rK shall be in solc charge of a

patie nt unless a pennanentty employed registe red nurse is present

o n the premises and can be called upon immediately.

(4) The pcrwn in l"harge of a clinic shall maintain a roster of

du ties of nurses and such roster shall be lwailable to nufS<,'S and on

rcquest IQ an au thorised perwn .

(S) [I shall be the du[)' of Ihe licensee. ha ving reprd to the

number. age. sex and cond ition of patien ts treated at the clinic. to -

(a) provide adequate profeS5ional. technical. anl"illary and

othe r supporting start .

(b) provide f(lr each patient in the cli nic adequa te

accommoda tion and space, including. where appropri ate. day

room facilities

(cl provide adequate furniture. bedding. cunains and wh ere

indiC:Hed , sui table bed screens an d noor "overings In rooms

occupied or uscd by patients

(d) provide adequate medical . surgical and nursing

equipment and adequate treatment fatilities. includi ng an efficient

nurse/patient call system;

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

and baths or. where aa.:eptabJc. showers. su pplying hOl and cold

water and a sui table number of waterelosets and sluicingfacilities;

co provide adequate lighting. heating and ventilation in all

parts of the clinic occupied or uso.:d by pa tienlS;

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

and reasonably decorated ;

(h) ensure that adequa te facitities e~ist. and lake adequate

precautions, against the ris k of fire including the provision of

adeq uate means of escape in the event of a rire. as well as ma ke

adeq uate arrangements for ddecting, con taining and e ~tinguish ing

a fi re, for notices rega rding proccdun: to be used in case of rire and

for the giving of warnings. for the evacuation of the patients and

staff, for the maintenance of rire righting equipment. and for such

other arrangements as may in any case be req uired by law. and in

th e absence of any such law. as may at any time. be rlirected by th e

COIJtmissioner of Police;

(i) provide adequate kitchen eq uipmen t, crockery and

cutlery and adequatc faciliti<"S for the prepara tion and storage of

food;

U) supply adequate food fore very patient in accordance with

such pa tient's dic tary require ments;

(k)

arrange appropriau: laundering facilities

(I) make adequate arrnngements for the disposal of swabs.

soiled dressings. instruments and similar substances and materials

as we ll as for any other hazardous wastes;

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

respect of tong stay patients;

(n ) make adequate arrangements for

the

r«(Irding.

safekeeping. handling and disposal of drugs;

(0 ) provide adequate arr.lIlgeme nts for the prevention of

infection. 1O.~ic cond ition. or the spread of infection in the clinic;

(p)

take adequate precautions agai nst th e risks of acci den ts

(q) provide for adeq uate insurance coverage of p31ienls

treated. and of em ployees wor ki ng. at the clinic and for insurance

of third parties in each case in respect of accident or othe r misha p.

(6) The numberol domes tic stllff shall be sufficient to ensun,

a high 5tandard of cleanliness in all parts of the premisc:sand the licens:.!e

shall ensure th at such staff is supervised by a pel1iOn with knowledge of

cleani ng methods and materials applicable to a clinic.

(7) The re shall be a supply of wholesome drinking wate r at

suitable points.

(8) E~'ery cli nic shall be provided "ith adequate telephone

faci li ties. Similar facilities shall also be available for private use by

patie nts.

(9) (a) In TCSpect of operations listed under Part I of the

Second Schedule, the facilities and resources as well as the

condition or medical fitnesli of the patien t shall be such as toenable

such operations 10 be carried out under conditions of good surgical

and medical 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

Part 11 of the Second Schedule may be camed OUt at a clinic unless

there are adequat e operating theatre faci lities. as are specified in

the Third Schedule to these regu lations. to the ~Iisfact ion of the

Superinte ndent .

(c) Where in any clinic. surgical operations are

undertaken or a life support system is used. there shall be avai lable

adequat e faci lilies for immediate electrical supply in case of

interruption of the public supply as is needed 10 ~fcguard the !i,-cs

of the patients.

(10)

In thb regulation.

(a ) " to providc" includes. where app licable. to maintain

,od

(b) wh ere an y question arises as to suitability. acceptabi lity

or adequacy. il shall be deemed !O be suitable. acceptable or

adequate . as the case may be. if so conside red in the opinion of the

Superintendent .

Where antenatal. intranatal or postnatal care is gi'-en al a

clinic. Ihe following provisions shall moreove r apply

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

sc rvices and may. in respect of midwifery services only. act as

person in chnr g~ for the purposes of regulation 5 of these

regulations. In any case a practising midwife shall be prescnt on

duty at all times maternity care is provided .

(2) (a) The person·in-charge sho ll ld make ce rtain tha t

adequate general and specialist medical con'r is provid~d as

needed.

(b) Adc<.juate arrangements Shall exist for obtaining

obstet ric. paediatri,. anesthet ic and any other necessary help

in an emergency si(u"'iol' .

(c) Where epidu ral anesthesia is to be offered to women

in labour, this should beearriedout by an anesthetist trained in

this procedure.

(3) (a) Where materni ty beds are provided in a clinic lhey

shall be 50 designated and , hall nol , unkss lhese are single

rooms, be used to aaommodate any other type of patien t.

Maternity patients shall not share rooms with patients who are

not in the clinic for obstetric care.

(b) No mentally disordered patien t, akoholic or drug

5«tm

abuse r may be accommodated in the

reserved for

maternity patients un less such patient requ ires maternity care

in such case she shall be given separate accommodation.

(c) Adequate sanitary and bathroom faci lities restl"'ed

for the 501e use of maternity patients shall be provided. Grab

rails and nurse call systems shall be included, and where

practicable showe~ and bidcu,

Nursery accommodation shall be made ~vailable as

(d)

well 11.5 adequate facililie! for the preparation 11.5 may be

ne0e5S8ry o f infan! fonnula or other breast milk sumtitute.

(e) Single rooms shall be present for maternity cases

which have special needs,

(t)

Delivery rooms shall be adequately sound-proofed.

C8) Emergency e\carical supplies shall extend to

delivery rooms, nurseries and to any operating theatre .

(4) (a) Resuscita tion equi pment fOf" new· born babies shall

be provided ,

(b) When deliveries are being conducted. anestnetK

and suction machinessball be available.

(c) Each infant shall have its own cradle of appro"ed

design. thennomeler and bath.

(d) Each patient shall be provided with a comfortable

nursing chai r.

(5) The liccnsee shall in addition 10 th e records referred to

under paragraph (I) of regulation 11 of these regulations. keep a case

record of each child born to a patient in the clinic. which record shall

include the fol\o-..·ing paniculanl'

(a)

delailsof the lII'eight and conditIOn of child at birth

(b)

a daily stateme nt of Ihe child's health;

(c) detail5 of each of any of the following paediatric

examinations. if carried 01.11

(i)

examination for congenital abnonnaJities

(H)

measure ment of cireumference of the head of the

child

(iii )

mcasuremCn! of the lenglh of th e child

(iv) screening for phenyl ketonuria or other K"l"eening

for ron gc nit3 1 disordcr.

(6) The following additional paniculars dial! be included on

th c rcgister of patie nt~ kcpt at thc clinic in respeCt of maternity patients

(a) the date and time of delivery of each patient. the number

of children born 10 the patient. their scx and whether born alive or

dead

the estimated period of gestation prior to delivery

(b)

(c) the name and qualifications of the person who delivered

the p;!tie nt

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

elin ic. including the period of ges tatio n prior to miscarriage

(c) the date on which an y child born to a patient in the clinic

left the clinic: and

(l) if any child born to a patient died in the clinic. the date.

lime and cause of death.

(7) The provisio ns of paragraphs (2). (3 ). (4) and (5) of

regulation 11 of these regulations shall mmQris m!4t1l11dis apply to thew

(8) The provisions of th is regulation and, as applicable , of

th e othe r regulat ions. shalt apply 10 any premises lke nscd as a maternity

11 , ( I)

Prope r records are to be kept of patients treated at the

(a)

in respect of each patient , in a register showing

the name, address. date ofbinh and identity card number

of the pa tient and where the patient has no identity card , the

passpon number wit be included together with lhecountry of

issue , if such patient has a passpon;

-

the name, address, identi ty card number and telephone

number of the patient's next of kin or of any person authorised

to act on the palient's behalf;

-

the name

and

address of (he

patien t's medical

practitione r ;

-

the date when a nd the time d uring which the pa tien t was

adm itted and the date of discharge o r transfer to a cli nic o r

othe r place as may be a pplicable

-

if the patient died in the clinic, the date, time a nd cause of

death;

-

in the case of 8 child, where appli cable, th e name and

address of the school he attends or has attended before being

admi tted to the clinic;

(b) a separate register of all surgical operations perfo nn ed in

the clinic: such registe r shall include in respect of ead! operation ,

the date and time of such operation, the patient's name, the

identity card o r passpon number as may be appl icable o r as

provided for unde r the preceding sub-paragraph, the clinic case

history number, the name of the medical o rdental practitione r who

perfonned the operation , and whe re applicable, the name of any

othe r practitioner assisti ng him, as well as the name of (he

anesthe tist in atte ndance;

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

contain an adequate updated state ment of the patient's health and

condi tion and a no te of any investiJl.at io n and detail s 01 surgica l

opera tions carried o ut a nd treatmen t give n, including the

anaesthe tic record s heet.

(d) a record of each mcmber of the staff e mployed, which

re<X)rd shall include the na me, date ofbinh , iden tity card numbe r,

grade and dales of emplo yment at the clinic, and in respect of

n~rsing staff, detai ls of thei r qual ifications. Such records shall as far

as reasonably practicable include the times when individual

me mbers of the nursing staff as well as the perso n or persons in

charge were o n duty;

(e)

a record of the fo llowin g

all fire practices;

all fire ala rm tests, resul ts an d action take n whe re

applicable;

-

the maint enance carried OUt On medical, surgical and

nursing equipment in the clinic;

(f) such other records as th e Minister may. from li me to

time , require to be kepI.

(2) All records referred to in paragraph ( I) of this

regulatio n, othe r tha n patie nt case records , shall be retained fo r a

period of no t less than two years after the last entry made the rein , a nd

shall be open for inspection by a n authorised officer or by such autho rity

as may have such power under a ny law.

(3) Patient case records shall be retained and ~hall nOl be

destroyed ex.cept with th e approyal of the Minister.

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

ens ure prope r kee ping and slOrage of rcwrds and , subject to the

provisions of these regulations and to any other law re lating to

confidentiality of records. to limit disclosure only to persons en titled to

access of such information.

(S) All rcwrds shall be legibly entered in full and in proper

order. Any alterations. corrections or delet ions shall be initi alled by the

person making such altera tion. correction or deletion.

(6) Notwithstanding the provisions of the preceding

paragrn phs, computer rcwrd$ may. under such conditions a!i the

Minister may impose in the licence certificate, be acceptable provided

always that a hard copy of the da y'sentries are made each day and filed

in chronological order

Provided that such ahemaliYe shall nOl, in the case wh ere th e

Minister di r~ that a copy of the entries be sent regularly to the

Ministry and/or the Department, be construed as an y acceptance of any

irregularity carried out at the clinic on the pretext that the Ministry and/

or the Department had been regularly informed.

( I) No medical practitioner. dental surgeon . nurse,

midwife. pharmacist , pharmacy technician or any other person to whom

Part IX of the Ordinance refers, and who is also in the employment of

GOyernmcnt, may. during those hours in wh ich he is contracted to

provide his se rvi ces to Goye rnment. work in any medical clinic unless he

is on approved le Hye of absence. Any breach of this provision by any

such medical practitioner, den Ial surgeon, nurse. midwife , pharmacist ,

pharmacy technician or othe r person sha ll be deemed to be an offence.

Tt shall be the du ty of the licensee of such clinic to take all rea!)Onable

steps to ens ure that Ihis provision is complied with.

(2) The lice nsee shall require all persons to whom Part IX of

the: Ordinance refers 10 regiSter their attend ance at the medical clinic.

indicating date and time and whe the r en tering or leayi ng the clinic,

immedia tely on entering and immediately before leaving the clinic, in a

register kept for the purpose. The licensee shall transmi t the contents of

such register 10 the Ministry or Department in such manner as ma y be

specified by the Ministe r. The provisions of paragraph (6) of regulation

I J of these regulations shall also apply 10 the register refe rred 10 in Ihis

provision.

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

of a clinic to pe rmil on the premises any person to whom paragrnph ( I)

of this regu lation refers unl~ the conditions of the la!il preceding

paragraph have Been complied with.

(4) Where, except in an emergency, any lice nsee or pero;on in

charge of a clinic is in wi lful breach of any preceding provision of this

regulation , such clinic shall be deemed to have been operating without a

licence.

Il. ( I) Subject to the fo llowing provisions of tha regulation. tnoptctioru..

any authorised person , on producing if asked to do so. a du ly

authentica ted <Ioeumen t Ulowina that he is so authorised, may en te r I nd

inspect Iny premises which are used. or which he reasonably believa 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

regu la tions.

(2) Any a uthorised person may require the lia:nsee (Or his

representat ive to furnish information in re la tion to the clinic in respect

of any matters men tioned in the First Schedulc to these regulatio ns and

such o th e r info rmation as may reasonably be required for th e pu rposes

of ill5pection

Provided tha t noth ing in this regul ation shall be deemed to

authorise any person who is no t a medical officer to inspect an y clinical

record relating to a patient in the clinic.

(3) The licensee shall permit an y authorised person 10

inlerview in private any person in Ihe clinic.

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

person wi th a view 10 e nsuring full compliance with the provisions of

these regu la tions.

(5) Every clinic licensed under these regulations shall be

inspected a t !elllil twke in e veryperiodoftwelvemonths. The inspecting

officer o r officers ihaJ I conduct I systematic review of facili ties and

services with a vie w to ensuring com pliance with these regula tions and

wil h the conditions of the lice nce, and shall s ubmit a repan 10 Ihe

Minisler on the results of his inspec;tion.

The Ministry is 10 be informed o f the names , addresses and

q uatirlca tions of each member of the staff e mployed o n dale of iss ue,

renewa l or transfer of the licence and of an y changes in slaff subseque nt

thereto.

If a patie nt , or a child born 10 a patient di es in the clinic, the

IKens« ihaJI give notice to the Superintendent fo nhwith and shall

repon 10 hi m in writing within 24 hours after such death. Such notice

shall include full paniculan; of the patient , the circumstances and cause

or suspected cause of death , and any o ther information which may be

relevant .

Fo r each service carried out o n payme nt al the clinic, an

official itcmised recc:ipt shall be issued fro m the clinic 10 the person in

respect of whom such service was provided. The lice nsee shall mo reove r

ensu re tha t a register of financial accou nts of the clinic is kept.

Se .... , •• .

Nothing in th ese regula tions shall be deemed to e"empt any

applica nt or licensee from any requi rement of the law re garding any

ot her liccnces which may be needed in respect o f any facility o r service

provided at the clinic.

The Medical ai ni ~ (U ee n!ing) Regul ations, 1981 are hereby

1I.01'<"!'

L.~ 1111

repealed . without prejudice to anything wh ich may have been done

of 1I'M1 .

under any of the provisions hereby repealed.

Fl RST SCHEDULE

Regulation 4(1)

Matters In r"~t of which a HtIIlth Authority may .-equine InlOf"mlltion to be furnished

by 8ft applicant 10f" a U«nte

I. The full name IInd address. and professional or techn ical qualiflCations (if any)

of the applicant.

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

address of its registered office or princi pal place of business and the full names and ad-

dresses and technical qual ifications (if any) of the director.> or partner.>.

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

terest and th e nature and e"tenl of his inte rest.

4. The situation of the clinic and its form of construction (plan 10 be attached).

S. The accommodation available, and the equ ipment and facilities provided or to

be provided in the clinic.

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

7. Whether any other business is orwill be carried on in the same pre mises as the

clinic.

8. The type of clinic services 10 be provided incl uding list of operatio ns proposed

to be calTied out.

9. The num be r of patients (excl ud ing Slaff) fOl" whom il is proposed to be used

distinguishing betwee n differe nt categories of patie nts and indicating the age-range of

patients in each category.

10. The full names. ages. qual ificat ions and ex perie nce of persons em ployed or

proposed to be em ployed in the manage ment of the clinic.

1. The alTangements for the manage ment and conlrol of the clinic .

12. The full names and qua lifica tions of any employed medical practi tioners.

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

ing and other professional, technical, admin istrative and ancillary staff (other tban staff

included under paragraph 12 above) employed or pr"JXISCd to be employed in the

clinic.

14 . Thc details of arran ge ments made or proposed to be made in respect of the

provision of facil ities and services.

The arra.'gements made for tbe supply of blood and blood products.

15.

16. The arrange ments made for the provision of pathology and radiology ser·

vices.

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

against accide nts and other mishaps.

18. Whet her the clinic is intended to operate as a day care clinic onl y (Le. with no

overnight stay) or as a clinic with overnight sta y of patients.

SECOND SCH EDULE

Regulation 9(9)

"""'

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

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

medical fit ness of the patient are such as to enable such operations to be carried out

under good medical, surgical and ancsthetic practice in line with guidelines established

by international acade mic colleges of surgeons and ancsthcsiologists recognised by the

Superintendent.

Where day su rgery is carried OUI this gt;: nerally demands a high standard of

expenise, and should be undenaken only, or supervised, by e1l.perienced practitioners.

Such operations should be clean and elective surgical procedures and should normally

require a relatively shoon general ancst hesia Ind should not carry the risk of post-

operative complications that normally req uire overnight stay in I clinic and the patient

is expected to recover su(ficiently 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 suitab le to be performcd on a day care basis. It is understood that the

faci lities should be similar to thOloC requireri for in· patient surgery with ward area near

the operating theatre suite (incl uding anesthetlc room Ind rcrovery room of the high

dependency type) and without prejudice to the ge nerality of this requirement must have

adequate ligh ting, basic equi pment, piped gases and gas scavengi ng devices. Basic

equipment includes anesthetic machine and monitoring apparatus, operatin g table.

diathermy machine. dressing trolleys. scrub facilities as well as other equipment

required in accorda nce with good surgical and ancslhetic practice for specific

operalions.

B

The elderly and infanlS are nonnally excluded and the arrangements for post-

operative care ouWde the clinic mU5t be satisfactory. In pa n icular the patie nt must

have adu lt an endance and it must be ensured that such patient is in close reach of the

telephone for emergencies. After discharge from the clinic. the patien t must be given

appropri ate instructions following discharge and be acco mpanied home .

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

eithe r on anesthetic or su rgical grounds it shall be the re sponsibility of the person in

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

.-linlc where overnight stay is allowed.

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

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

ideal facilities. is mandatory.

P . edlatrk: Surgiall Ope",Uons

A.

General

(i)

ExaminatK>n under anes thesia

Repair of inguinaVumbilicaUfemoraVepigastric he rn ia

Varic:occ:le

Ugation of communicating hydroce le

Orchidopexy (unilateral or bilateral) , excl uding seco nd Stage operations

or cases of high non-palpable testis

Laparoscopy

Circumcision, meatotomy

Minor hypospadias

Cystoscopy

Division of tongue lie

PrOClosoopy. sigmoidoscopy, anal stretch. namination unde r

anesthesia

Excision of local skin lesions. including biopsy

Lymph node biopsy

Branchial sinus. thyroglossal cys t

Correction of prominent ears

Excision of accc:ssory auric1es and digits

Correction of syndactyly

~inor re~,:m followi ng cldt lip and palat e su rgery

BlOpSyfexClSlonldcslructi-on of lesions. o r removal of ucess mucosa of

•

~th

Removal of calculi from salivary ducts

Orthopaedic

(ii)

Anhroscopy

Manipulations. closed red uctions of simple fractures/dislocations

Change of plaster

Release of trigge r finger

Excision of ga nglion

DlntGl

(in)

Extracdonslconsc rvation den tistry

Supernumerary o r impacted teeth

Biopsy of onJ leaions, includin, uc:ision

linJUaI or labial freneClomy

Removal of fiutOB

E nucleation of simple cysts

Ear, Nos~ {l/Id Throat

(iy)

Exa mination unde r anestbesia and removal o f foreign body from e ar,

DOle and throat

Myrinaotomy and insertloniTemoval o f tympanostomy tu be

E lectr()-('OCh leography

Reduction for fraclured nose

E lectro-a.utery for bleeding of DOle

Submuoofll diathermy

Simple nasal polypectomy

A ntral puncture and washout

Ophdwlmic

Con'cction o f squint

E lectro-diagnostic tests

Examination under a nesthesia for ophthalmic conditions

Adult Su.'iUY

(i)

Generlll

Excision of lesions o f skin and s ubcutaneous ti.Mue. including rodent

ulcer

Cau tery/cryotherapy of skin

Removal of foreign body in deeper tissue

Dermabrasion

Skin su ture

Insertion/removal of skin expande r into tiMue

Repair o f simple inguina l, femoral, umbilical o r epi,lStric herni a

An al rwure, ana l Slretc h, sphincte rotomy

Excision o f anal fistula

Removal of anal warts

Repair of anal trauma

Rectal polypectomy

H aemorrhoidectomy

Dia~tic Laparoscopy

Needle btopsy of live r

Oesophagoscopy and dilatation

Biopsy breast , lymph node , skin, lesions o f mou th

Re moval o f salivary calculus

Ligation, strippin, oC/ot he r operations for , varicose veins

Excision o f thyroglosul cyst

Excision of branchial si nus

Incision a nd dra ina,e of abscess, drainage of hae matoma

Microdochotomy

OrthOfXltdic

(ii)

Note: Facilities for image inte nsification and applica tio n of plaster

casts whe re necessary should be available

AnhrQS(:()pic procedu res, including biopsy and operation on arti<:ular

canilage

Manipulat ion of joints, dosed reduction of simple fractures!

dislocations

Removal of pins, plates or screws, exte rnal fixator

Excision of ganglia. synovial cysts and beni gn synovio mata

Decompressio n of carpal tunnel

Decompression of peripheral nerve

D e Quervain's re lease

Re moval of ne uroma . e.g. on th e hand

Correction of minor deformity of hand/foot

Minor amputat ion of the fingers and toes

Ope ration on ingrowing toe nails

SubOllaneous te nOtomy

Tendon transposition

Primary repai r of periphe ral nerve

Ul nar styloidectomy

Excision of exostoses

Interphalangeal fusion of the toes

Hallus valgus and osteotomy of me tatarsals

Release of trigger finger

Simple excision of palmar fascia in Dupuyt ren's con tracture

Removal of foreien bodie ~

Scar revision

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

U,inory System

Note : Uncatheterised pa tients should no t be sen t home before they

have passed urine.

Percutaneous nephrostomy fine needle biopsy of kidney

Neph roscopic operations on ureter

Urete roscopic ext raction of calculus of ure te r

EndoscopiC examinationlinsenionlremoval of prosthC$is , ureter

Endoscopic retrograde pyelography

Operations o n ureleric orifi ce

Endoscopic destruction of lcsion of bladder

Endoscopic hydrostatic distention of bladde r

Endoscopic ex traction of bladder calculus o r foreign body

Endoscopic dilataliort of. or ope rations on, outlet offemale bladde r

Rcpai r of episp3d ia~

EndoscopiC operations o n ure thra

Endoscopic exa mination of urethral removal of fo reign body

Dila tation of urethl1l

Endoscopic biopsy of prostate

B

Genital SY$tem

External meatotomy of urethral orirloe

On::hidectomy and ellcision of spermatic oord

On:bidopelly

Collectio n of hydroce le

Excision of e pididyma l cyst, 5Crota ll~ion

Biopsy testis

OJ;erations on van. ocoele

Division of pre putial adhesiom

Circumcision

Vasectomy

Ophllullmic OptnUioru

Cataract wraery

Corneal transplant surgery

Procedures on the eyelid or tarnl plate

Operations on the lachrymal apparatus

Con ectM>o of squint

Surgery for refraction

I aser surgery

Keratoplasty

Iridecto my

E.ilr, NOH and Thr(Hlt

Eoooscopy of nasal cavity, sinuses , phlr)'nll, Iarym:, including biopsy

Remo val of fo reign body from the nose or ear canal

Remo val of impacted Will

Excision of lesion of uternal ear

Myrinpomyli nsenionlrcmoval of tympaDOSlomy tube

Removal of si mple nasal polyps

Reduction of fracture nasal or malar bone

E1ectJ"O-Qlu tery of the nasal sepc um

Submucosal diathermy of the inferio r turbinales

Antral punaure and washout

Removal of voc:aI polyp

Diagnostic laryngoscopy, pharyngoscopy and oesophaaoscopy

(vii)

EmJo$copicl L4paroscopic prouduu$ of gas/ro iIIttstUwl trDCt

Qaophagosc.opy/ocsophagostro duudenos.copy , includ ing biopsy!

removaJllaser o r diathe rmy destructio n of lesion

Ertdo5oopy aoo removal of foreign body/insenion of prosthesis!

dilatationlrecanalisarion of tumour mass

Sigmoidoscopy including biopsy/removal/destruction of lesion

Fibreoptic ooloOO5COpy including e,;cisio nlbiopsyldcstructio n of

lesio n

Endoscopie retrograde cholangiopancrealogra phy

Plas~ Surstry

(viii)

ElIcision of skin lesion: direct closu re, split skin orfullthicknessgraft,

local flaps (othe r than Srafu 10 the lower limbs)

Scar revision aoo soft tissue oonlouring

Separation and insel of oenain Oaps

Debulking and revWon of naps

Insertion and diste nsion of tissue expanders

Openuions for axillary hyperhidrosis

I aser and cryo:surgery

Excision of tattoos

Blepharoplasty

Rhinoplasty

Mastopexy

umited Uposuction

Gynnu%gyi(;Q/Otnrll(ioru

(ir)

Note: Uncatheterised patients should not be sent home before they

have passed urine

Eumination under anesthesia and curettage

Colposcopy, cystoscopy, diagnostic hysterosoopynaparoscopy,

including biopsy and minor laparascopic surgery

Biopsy/cautery of cervix , removal of cervical polyp

Hormone implants

ElIcision of vulval wans and other minor procedures to the vulva and

vagma

Marsupialisation of Bartholin's cyst

Endometrial ablation with lase r or resectoscope

Hysteroscopic resection of uterine septum

Hysteroscopic myomeaomy

Laser treatment of cervical and vulval lesion!

Tuballigation

Biopsy of ovary or peritoneum

Coagulat;oo of mild endometriosis

Aspiration of small uvaria n cystS

Lysis of mild to moderate adhesions

Coagulation of IT'oderale endometriosis

Exploration of small ovarian cysl.5

Uterine ventTO!iuspension

Salpingectomy

Salpingectomy for ectopic pregnancy

(x)

Oral and MaxillofaCial Surgery

Excision of uncomplicated impacted teeth and buried roolS

Exposure of unerupted teet h for orthodontic treatment

Biopsy of hard and soft tissues

Enucleation of small cysts of jaw

Division of pedicle!

Removal of direct. bone plates and wires

Minor soft-tissue surgery

EUA for suspected malignancy

Cryoblockade of pari ph era I nerves

Laser and f;ryosurgery of small lesions

Reduction of nasal and malar fractures

Temporomamlibular arthroscopy

Salivary ductoplasty and removal of calf;UIi

OIMr

(xi)

Bronchoscopy, induding biopsy andlor remt)Val of foreign body

Oesophagoscopy and di latation

Removal of pectus bar

Mediastinoscopy

Chest drainage

(xii)

Inltrvt nljorwl Radiology

er Scan using contrast

Isotope sCllnnin,

Arteriography using small arterial catheters

(xiii)

Pain Relit!

Epidural injections · cervical, lumbar or thoracic

Peripheral nerve lesion · using injection, radiofrequency, cryoprobe

orpheool.

Part 11

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

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

the clink

2. Aa} othu surglcallnlerveatioo other than-

Neonatal surgery

Intracranial operations

Major laryn,eal sul,ery

Surgery for lr.yph05is and scoliosis

Card iac surgery

Aortic surgery

Transthoracic oesophageal resection and other thoracic surgery excluding lobec·

tomy and simple chest drainage

Surgery for portal hypertension

Any other operation or p~""'_edure , indudinl any operation referred to in

PaTls I of this Schedule where there is a probability of the patienl requiring inten·

sive care after surgery or where significant amounts of blood loss are anticipated,

if intensive care facilities. to the satisfaction of the Superintendent, are not .vaila-

ble;

unless such operations are specifically approved by the Minister and a note 10 this effect

is entered in the licence.