Regulations, 1996

L. N. 133 01 1996

MEDICAL AND KINDRED PROFESSIONS ORDINANCE

(CAP. 3 1)

Private Medical Diagnostic Labornlories (Licensing)

Regulations, 1996

iN exercise of the powers conferred by subsection (3) of section

98 of the Medical and Ki ndred Professions Ordinance, the Minister for

Social Development has made the following regulations: -

I. These regulations may be c ited as the Private Medical

Diagnostic Laboratories (Licensing) Regulations, 1996.

In these regulations, unless Ihe context otherwise requires -

"aulhorised person" means a person authorised by Ihe Minister

to act on his behalf;

"good laboratory practice" includes the compliance al all times

wilh the ethical standards and with laws and regulations governing

the professions related with laboratory practice. as well as

compliance with international standards for procedures. practices

and methods used in a laboratory

"laboratory" means a private medical diagnostic laboratory;

"Minister" means the Minister responsible for health;

·"the Ordinance" means the Medical and Kindred Professions

Ordinance;

"private medical diagnostic laboratory" includes any facility ,

building or otherwise, used for the purpose of biological.

microbiological. serological. chemical. imm unohaematological,

haematologieal, biophysical, cytOlogical. pathological. or other

examination of material derived from the human or animal body.

or for the purpose of providing infonnation for the diagnosis.

prevention or treatment of any disease. condition or impainnent

of health, or for the assessment of the slate of health of a person or

animal. but does not include a Government laboratory.

( I) No licence for operating a laboratory under section 98

of the Ordi nance may be granted or renewed unless such laboratory

complies with the provisions of these regulations.

(2) No licence under the said section 98 may be issued for

any laboratory except in respect of a premises used for medical

laboratory tests and procedures.

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

laboratory shall be made to the Minister in writi ng

lic:aoco.

Provided that where an application for a lirence has already been

submitted before the coming into force of these regulations. such

application shall bedeemed to have been made in accordance with these

reg ulations.

(2) On making an application under paragraph (I) of this

regulation. the applicant shall present together with the application the

information specified hereunder

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

carried out or intended to be carried out at such laboratory;

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

at the laboratory . including their name and surname. Identity Card

number, permanent address . date of birth, date of employment,

academic qualifications and duties and responsibilities each

employee shall have;

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

(c)

on the premises;

(d) a list of animals that an: kept or used. or intended to be

kept or used for such tests;

(e)

the policy and procedures for quality control and safety

Provided that the Minister or any authorised perso n may requesl

of the applicant any additional infonnation and more speci fic information

that is deemed 10 be related with the granting of the licence.

S. (I) The Minister may refuse to issue or renew a licence in Ref\IIIIIot~.

respect of a laboratory if:-

(a) the applicant. or any person employed o r proposed to

be e mployed by the applicant at the laboratory, is not of good

conduct or that the technical staff is not suitably qualified; or

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

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

premises are not lit to be used as a laboratory; or

(c) the laboratory or any prem.ises in connection ,therewith

are use or proposed to be used for purposes which are not related

to the laboralOry, or are in any way improper, unethical or not

lawful; or

(d) the laboratory or any premises used in connection

therewi th consist of or include works executed in contravention of

the proviSions of the Development Planning Act, 1992; or

(c) the practice at the laboratory is not, or wi ll not be, under

the supervision of a person indicated in regulation 6 of these

regulations; or

the management and control ofthe laboratory is not likely

(f)

to be adequate.

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

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

within th irty days of receipt of notice of refusal, non-renewal or

withdrawal of licence. appeal to the Tribunal appointed under paragraph

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

Regulations, 1995.

( 1) Il-Ministru jista' jichad li johrog Jew igedded licenza L~ .. ;i.illld: • .

ghar-rigward ta' laboratorju jekk:-

(a) I-applikant, jew xi persuna li hi impjegata Jew li tkun

qcghda ligi proposla li tigi impjegata mill.applikant fil-Iaboratorju,

majkunux ta' mgieba tajbajew jekk il-persunal tekniku majkollux

il-kwalifiki mehtiega; Jew

(b) minhabba f'ragunijiet Ii jkoll hom x'jaqsmu mlls-

sitwazzjon i, kostruzzjoni, slat la' lisw ija, inko lumittl,

akkommodazzjoni , persunal jew taghmir, il-fond ma jkunx taiieb

biex jinluia bhaJa laboralorju: jew

(c) il-laboratorju Jew xi fond li ghandu x'jaqsam mieghu

jkun u qeghdin jintuiaw Jew ikunu mahsubin li jinluzaw ghal

ghanijiet li ma jkollhomx x'jaqsmu mal-Iaboratorju, jew li b'xi

mod ikunu mhux xierqa, mhux eliCi Jew mhux legittimi: Jew

(d) il-Iaboratorju Jew xi fond li ghandu x'jaqsam mieghu

jkunu maghmulin minn xoghlijiel,jew jinkludu xoghlijiel,li jkunu

saru bi ksurtad-dispoZizzjonijiet la' '·Att la' 1-1992dwar 1. lppjanar AM NfU.'

ta'l-Izvilupp;jew

""-1992.

(e) iI.prallika fil·!aboralorju ml! tkunx qeghda ssir ,Jew ma

tkunx ser issir, laht is·sorveljanza ta' persuna mscmmija fir·

regolamenl6 ta' dawn ir-regolamenti;jew

(f) it·tmexxija u I·kontrolltal-Iaboratorju x'aklarx Ii ma

jlrunux !ajba biz·i.ejjed.

(2) Meta licenz3 tkun giel michudajew ma tkunx giet imgedda

Jew tkun giel iniraUl, I·applikant Jew id·delentur tal.liccnza, skond il·

kai.jista· fi zmien tletin jum minn mela jirCievi awiz li 1·licen7,a giel

miChuda, Jew li ma gieu imgedda Jew li gie! inirata, jaghmel appeJl

quddiem it-Tribunal mahlur bis·saMa tal·paragrafu (2) tar·regolament

5 tar-Regolamenti la' 1- 1995 dwar Licenz.i ghal KliniCi Medici Privati . ... · 1-1991.

It shall be the duty of every licensee to ensure that medical

laboratory tests are carried out by, or under the professional direction,

supervision and responsibility of. a biochemist, microbiologist or other

pathologist, or a toxicologist, as thecase may be,or a medical practitioner

or scientist qualified to assume professional, scientific, consultative,

organisational and administrative responsibility for the service.

(1 ) The licence certificate shall specify the category and types

of tests that may be carried out at the premises as may be determined by

the Minister 10 be reasonable in accordance with good laboratory practice

taking into account the size of the laboratory and the faci lities available

thereat.

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

referred to in paragraph ( I) of this regulation shall be carried out at the

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

(I) The licensee shal l keep and maintain an updated registe r

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

shall , in respect of each patient. include the following information

(a) the name and s urname, (or initia ls), Identi ty Card

number, sex , address and date o f birth of the patient;

(b) the name, sumame, address and med ical reg istration

number of the referring medical practitioner

the date when the request was received at the laboratory

(c)

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

practitioner

(e)

the type oftest carried out at the laboratory and methods

used

(0 the name of the microbiologist, biochemist or othe r

pathologist, or tOllicologist responsible for the test, as well as the

technical person who carried out the test

where practicable, the resu lt of the tcst

(g)

Provided that the requirements in respect of the identi ty of

the patient shall not apply when the blood of a patient is taken fOf testing

fOf the Human ImmunodefICiency Virus, so that this test is carried out

in a Government laboratory.

(2) 1ne licensee shall also keep records of reports of all

resul ts of tests carried out at his laboratory .

(3) (a) The licensee shall requ ire all persons to whom

Part II and Pan IX of the Ordinance refers, to register the ir

attendance at the laboratory , indicating date and time and whether

entering o r leaving the laboratory, immediately on entering and

immediately before leaving the laboratory. in a register kepI 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.

(b) Where, except in an eme rgency, a licensee is in

wilful breach of the preceding provision of this regUlation, such

laboratory shall be deemed to have been operating without a licence.

(4) The Mi nister may from time to ti me prescribe that

addi tional registers be kept as may be deemed necessary to ensure good

laboratory practice.

All information entered in the registers referred to in regulation

8 of these regulations. as well as all records , shall be retained by the

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

entry in the register or record

Provided that in respect of histological tests or any forensic or

toxicological tests. the result shall be kepi for a period of twenty-fi ve

years

Provided further that resul ts of tests of Quality Assessment or

maintenanc:e shall be kep indefinitely.

ID. The licensee shall inform forthwith the Superintendent of

Public Health of any infectious disease notifiable under the Prevcntion

of Disease Ordinance. diagnosed at the laboratory. as wcll as of all

pathological samples confirmed for malignancy. with the details of name.

address Ilnd Identi ty Card number of the patient , as well as the name.

address and medical registration number of the referring medical

~titio~r.

11 . ( I) It shall be the duty of the licensee toe nsure that there is

sufficient space. equipment and facilities for the proper performance

within the meditallnboratory of the required volume ofwoli;: to ensure

that a high standard of acc uracy. precision. efficiency and safety is

always maintained to the satisfaction of the Minister.

(2) Without prejudice to the ge~ral.ity of paragraph (I) of

this regUlation. the licensee. having regard to the category of tests

performed at the laboratory . shall -

(a) provide adequate professional. tec hnical. ancillary and

other supporting staff;

(b) provide and mainlain adequate laboratory facilities in

accordance with good laboratory practice

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

state of repair. and. in particular, provide adequate lighting and

ventilation. and all. necessary safety

(d) mainlain a high degree of eleanliness and hygiene in all

parts of the bui lding;

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

make established arrangements for detecting. containing and

extinguishing fires and for the evacuation o f staff in the event of

such fire. In particular the licensee shall comply with such

instructions as may be given by the Commissioner of Police in

this respect;

(f)

make appropriate arrangements to the satisfaction ofthe

authorised person for the disposa! and incineration of infected

swabs and sharps besides other infected material and provide

adequate containers for them;

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

both physical and biological ,of all staff on the premises. Moreover,

hc shall provide and maintain adequate means of prOlection against

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

protection provided.

(3) It shall be the duty of the licensee to make available,

when so required by the Minister or by any authorised officer. the

following written codes of practice and procedures:-

(a) the laboratory's policy for quality contro l on a daily

basis, including accreditation of its tests from an au th ority that is

recognised by the Minister to be appropriate and reliable, with

in te r- laboratory calibrat ion exercises fo rming pa rt of this

accreditation

(b) the laboratory's policy on instrument fu nction checks

and preventive maintenance of instruments;

(c) the laboratory's safety polic ies to the wo rkers, the

patients and the public in general

Provided that the Ministermay from time to time require these

codes to be amended and updated as he may deem appropriate.

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

codes referred to in paragraph (3) o f this regulation are strictly adhered

to by all persons working in the laboratory,

11, It shall be lawfu l for any authorised person, to enter at any _CIf

lime of day and night without prior notice, and inspect any premises inspeaiool.

which are used or suspected to be used with or without a licence as a

medical laboratory, and such person shall be given by the person in

c harge allhe lime, all assistance requested or implied. The said person

in charge shall produce all registers and records available at that time

when asked 10 do so

Provided that where the information requested entails medical

confirmation regarding the patients , such information may only be

requested by and made available to an authorised person who is a

medical practitioner.

Id-detentur tal-licenza ghandu minnufih jgharraf lis- Id-<le"",u,

Suprintendcnt tas-Sahha Pubblika dwar kull mard infettiv li ghandu ~=!.;"ndU

jigi avzat skond 1-0rdinanza dwar it-Tharis mill-Mard, Ji tieghu issir «T1umlrd.

dijanjosi fiI-1aboratorju. kif ukoll dwar kull kampjun patologiku li jigi Kap.36

konfennat bhala malinn, bid-dcttalji ta' I-isem, I-indirizz u n-numru

tal-kana ta' l-Identitll tal-pazjent. kif ukoll I-isem, I-indirizz u n-numru

tar-registrazzjoni medika tat-tabib lijkun lalab li ssir l-ana1izi.

11 . ( I) Ikun id-drnir lad-detentur tal-licenza Ji jizgura li jkun Gbo<i .. '

faCililajieo

hemm spazju. taghmir u faCi litajiet sufficjenti ghal-Iwettiq sew fiI- u~ .

laboratorju mediku taI-volum ta> }(ogho\ mehtieg biex jiigura 1i dejjem

jini.amm standard gholi la' ei;auezza, preeizjoni ,efficjenza u inkol umita

ghas-sodisfazzjon tal-Ministru .

(2) Minghajr prc:gudizzju ghall-generalita tal. paragrafu (I)

UI' daD ir-regolament, id-dctentur tal·licenza, meta jikkuns idra 1-

kalegorija ta' kull analizi li ssir fiI -laborotOfju, ghaDdu _

(a) jipprovdi persunal professjonali. tekniku. aneillari u ta'

kull xorta ohra ta' ghajnuDa li jkun xieraq;

(b) jipprovdi u jl.omm facilitajict tal-Iaboralorju xierqa

skond prallika tal·laboratorju tajba;

(c) iiomm!rull parti tal· fond fi stat ta' tiswija strutturali

tajjeb u, b'mod partikolari , lijipprovdi daw l u venrilazzjoni xicrqa,

u kull inkolumitll mehliega;

iiomm livell gholi ta' ndafa u igjene rkull parti tal-

(d)

fond;

(e) ihaddem prc:kawzjonijiet stabbiliti konTIa r-riskj u ta' hruq

u jhaddem arrangamenti Slabbiliti biex ifittex, iiomm u jitfi kull

xorta ta' hruq u sabiex il·persunal ilrun jista' johrog mill·fond fkai

ta' hruq. B' mod partikolari d-detentur tal-lieenza ghandu jhares

dllWk l-istruzzjonijicl li jistghu jinghalaw mill-Kummissalju lal-

Pulizija fdlln ir-rigward;

jaghmeJ arrangamenti xierqa ghas-sodisfazzjon tal-

(f)

persuna awtorizzata ghllt-tnehhija u I-hruq ta' garii u xfafarinfettali

minbarra kull mate rjal infenat iehor u jipprovdi bil.zejjed

konlenilUri ghalihom;

(g) jiehu I-prekawzjonijiet kollha mehticga biex jiigura 1-

inkolumila. sew fiiika sew biologika, taI-persunal kollu li jkun

hc mm fi l-fond . BaITa minn dan, huwa ghandu jipprovdi u jiomm

fi stat tajjeb mezzi ta' proteujoni xierqa konTIa kull periklu fuq

i.l-xoghol, u jiigura li I-persunal kollu jkun qed jaghmel uzu mill-

protczzjoni provduta,

(3 ) Ikun id-dmiT lad-detentur tal · licenza li jllghmcl

disponibbli, metajkun hell mehtieg li jaghmel mill-Ministru jew minn

ufficjal awrorizzat,dawn il-kodicijiet ta' prauika u proCedura bil·miktub

Ii gejjin:-

(a) iJ-policy tal-laboTlllorju ghal dik Ji hi quality control fuq

baii la' kuljum, inklui I·ghoti ta' kreditu ghal kull analiii li ssir

fi h mi nn aWlorilll rikonoxxuta mill-Minislru bhala wat'lda .lierqa u

ta' fi dueja, b'ciereizzi ta' inttr./abormory calibratiOll Ii jkunu

jughmlu parti minn dan l-ghoti la' kred itu;

(b) iI-policy tal-Iaboralorju dwar verifiki fuq il-funzjoni la'

strumen ti u I-manutcnzjoni preventiva ta' I-istrumenli

(c) il -policies tal-Iaborato rj u d war I-inkolumitil. tal-

haddic ma , taI-pazjenti u ta l-pubbliku b'mod gcnerali

lida I- Ministru jista' minn zmien ghal zmien jehtieg li dawn

il-kodic ijiet jigu emendati u aggomati hekk kif hu wa j ista' jqis 1i jkun

X1Craq.

(4) Ik un id-dm ir tad-detentur lal- liCenza li jiigura li

I-kodicijiet imsemmija fil-parngrafu (3) ta' <fan ir-regolament ghandhom

jithmu bl-ikbar reqqa minn kull min ikun jahdem fil-Iaboratorju.

l2. Kull persuna awtorizzata tista' legittimarnen t tidh ol fkull

hin tal-gumata u tal-Jej l minghajr ma laghli ebda avvii bil-quddiem, u

tispezzjona kull fond li jintu:i:a jew li jigi suspettat li jkun Qed jinlu:i:a

sew b'!ieenza sew mingbajrha bhala laboratorju mediku, u dik il-persuna

ghandha tinghata rn in n min ilrun responsabbli ghall-fond fdak il-waql,

kull ghaj nuna I; {ista' hekk lintalab Jew tintwera li te nht ieg. Dik iI ·

persuna respon sabbli ghandh a tipproduci kull regist ru u

doku mentazzjoni Ii jkunu rdak il-waqt disponibbli meta hi tintalab li

taghmel dan

lida meta t-taghrif mitlu b iku n jirrigwarda konfenna medika

dwar il'pazjen{i,dak iHaghrif jista' bissjinlalab minn, ujlrun disponibbli

ghal. persuna awtorizzata li tkun tabib.

It shall be the duty of the licensee to ensure that all measures

be taken to protect the staff and the neighbourhood from any nuisance

or da nger arising from the activities of the laboratory.

These regulations do not apply to the medical tests carried

N"" .aprtlicabil ;'1 of

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

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

carried out by a medical practitioner in his consulting room or at the

patient's home, or bedsidc, using doctor's office equipment in the

exercise of his profession .

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