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1q) fi9fu6 fuEff 3fi[ff ar.fell (Uninterrupted etectricity supply - back up if
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operations)
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(iF)spacei150 sqft or more
(tr[)Equipment/consumables/reagent/Kits: As required to perform desiSnated
tests. Modern/advanced technology should be adopted.
({)Human Resource: Minimum two
(E)Servlces (range oltests): Tobe provided bythese laboratories include:
. Hematology: TC, DC, hemoglobin, ESR, blood8rouping for non{ransfusaon
purpose, BT, CT
. Biochemistry: Sugar, Urea, BilirubinT& D, S. UricAcid,Total protein, serum
albu min
. Microbiology: sputum AFB stain (z-N stain)
. Tests by RDTS: With simple interpretation
. Miscellaneous: Routine urine analysis, routine stool analysis, urine
pregnanry test, Stoolfor reducinS substances.
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ri-+r rrnfu-flii q+m rrnfu-w rrqmr rr+ qr{i Aq r
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processing and reporting
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tests. Modern/advanced technology should be adopted.
(rI) Human Resource: Minimum four, one of whome should be Lab Techonologist
or above
(E)Services (range of tests): To be provided by these laboratories include all the
services/tests approved for "E" cate8ory (Basic) laboratories plus the following:
. Hematology: RBC count, PT, APTT,Platelet count, Hematocrit, Red cell
lndices
. Biochemistryr SGOT, SGPT, ALP, tipid profile,creatinine, sodium, potasssium
. Microbiology: Gram stain and KoH mount for fungi
. Serological tests: RPR, Widaltest, ASO Titre, RA Factor, CRP,
. Tests by RDTS: All
. Miscellaneousi Stool for occult blood, Urine ketone bodies, urobilinogen,
bile salt, bile pigment, Bence Jones protein.
11
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processing and reporting
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(r[) Human Resource: Minimum six with at least 50% technical manpower should
be having Bachelo/s Degree or above with at least one having Masters
Degree or above depending upon the nature oftests
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following:
Hematoloty: Absolute counts, Blood grouping for transfusion purpose,
Cross matching, and reticulocyte count, peripheral blood smear
examination
Biochemistry: Cardiac Enzymes, other enzymes, Thyroid Function Test ( T3,
T4, TSH )
Micrgbiologvi All Routine bacteriology culture, ELISA for infectious disease,
e.g.: HlV, HBSA& HCV, etc.
Hlstopatholoty/Cytopathology, Bone Marrow aspiration and biopsy
service
Miscellaneous: CSF and body fluid analysis, Semen analysis
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laboratory services (depending on type ofservices).
q{a{ ii-gfrt{qt qrflft( q-*rnTrqr 1Tg rqf{nTrdrdEr qw x hur (microbiotosy,
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hall and office of the laboratory heads.
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tests. Modern/advanced technology should be adopted.
(r[) Human Resource: Twelve or four per discipline with50% technical manpower
should be having Bachelor's Degree or above with at least three having Masters
Degree or above depending upon the nature oftests
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3, "C" Category laborrtory
All "D" category, PLUS
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3. "B" Crtegory laboratory
All "C" category, PLUS
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All "8" category, PLUS
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gq-fiilrFc*1 trffi rq flq siu r rd qrrcr a-ql sr6{"ra6+i
(q{r irur4nr6 r grrit vr-+-rurro rftr eq eG cfu sff+l
qfrrffiotqr (+d {cr+fl r{ q.ia r r*o sq-6{"r61 fia-S orr{r
M k{iq RqAsT rFt q-ie
(1) grs-{ur41 r+n, dfsq rqr r kftre rqt 3f|Iiq r{ drt4
q+ nrgr 3ilgfi !-{rff{drT {Tftrr+d qrftr d{cq {rd {ffi{,
(R) grEEtlr qftE fuft iTqr iJT6{sr rqi, Tfrrr t -*-fit ar r{-d qrrR
lrftq+J fi-d 6I fr dI Pfl{"T 3{Rr+q rt,
rir rsrr+2ffi rrqd rqdt qq-trrt,
txtqRAsF€, *q( cra{ r q{a irrrrd 6.fi qq q}Tr+],
tu 4lto-& {{rq Et fufr,
rsr sft{ 'ial E{ vi-d r&d En rrft Fr* aqr rrci, trd rqt
tqqls rrft rdtqrndrff{r Eq{tr (a) vflf,{sr+i qrftr Eri-nq{ t
oy-ool, oy-ooR, 3nk {sqr 3r{[ff+J oY l1qfi ffi looY I
q-ar$ aq< $liE{trr rER ri qrr$er 3r.nffi Sizr q6 st{"
qM qrd { qd-S6t q-q rEradt srf{or+i nq5qrg q{rdBi I
(rs.) rAfi grdE{orcr {* ffiqar r rr{ +na6r 3n?R qttrd t6r@r
frcrsq {trer ft-fisr cAq qq+1 qlr{6 @t q1 wia t
(r) Ti {il#dr+1 qrftr .rftt q{( {Tr.dr atk61 r h-qrrqrq-rt,
Hr€q rfrrmrdr errrir dql qElrdn qTs(Eg {qift FTtftr+r {o
,2 a__--
€re4 q*rraTnTr erFr4T dqT iTEIIiFI qrErg qqdft FT*ftI+r
(,R
{1
rt) irrfiGr qiq r €rftatsn (qdl 6nfd erft{+q,
(i) sdrrfiFnc d c,id rit rffqd rrq Mr+l Brfi{nq,
(y)gqiF{sr sqm{6r rrcr ifuC+I 1i trerrr, {Htrrr+1 mtT
rf@ F6qrs-dTc, firsr vcftrri+i ilrffT rrnr+l *6-3{q (qnft
{qrfl?T I
(q) srcE{uFfi Trr€n srKqr -6rtrdr fuq.€{ qflr+q .Ft si6 r
(i) {TsI 3ng+1 fuft < vqatorm rfrrrqr r${ B@r frtd,
t trgr 3nq+J 6Rsr,
(?) (Fsr {qr$r++1 qTFr q@ ace, aqff-cdicTz q+ t-ar
sc-far q'+i rrq fr vffiI fq-{<qr
(v)tn rfr{rqr a'+1 fufu, rffi rrqr vtfficT d ct 4iin
ffir+] lrqfi ffi k{iur Er (TTFIEFI arttr w+l +ni+i qtleTul r
irfirrqr r+1 {+d r.irR qr qftii{s srrq rdq qr+l n-{q atgr.+1 gt rte
rrc* t
rfr{rrnil (tcfl
rfuflrqr+I it+o S(E|T (Biosafety] r fi< grrr (Biosecurity):
(1) qrurflT dffi -{i ik+ {len r fi-a {rm sd ild err6 r { fI tE
ks[66 fd-drm Ftrf, cr{ | sraRq 3{?iqr "dfuq Vet qfr frqulqz
qtffi g(w d n qf - frq Vw qane qtffeEz @ gftir rl
al r'
1qy $fa+ qrur r trra gtrrot {q shq rfrqqnqroff, {T{rq, qttrw{ur
( rfrrmrTqEFr if++ qrqr,lM drq il | A Fl{ferdrqr +ryi <ar+r
r*{rlrrdrF€fr it{fi $elr { fi-q $eTr+1 (EreIqT qm{r .r=t qi qnrri"r
3nqirrdrr[+] hq{cl gdq rrt(r+td I
(i) 3{..Ilqt{6 tIfr{fYnTlTEt biosafety level laboratories (BSL -3, -4) cT qIURuf
sfrrrw{r+] Ectrrr it++ gur*r arerfi:n wr.rd€ qqdq+.r@ q-q r
rqtwnm iko {{{rr
rftmrqr it++ ({eIri unintentional exposure to pathogens and toxins, or
their accidental release n[r{ ffi i5rtinlrt *rqiqq-{ rFi6I qTftf containment +1
igar<, vt{Pd { 3{r{rfi+J qtcr qr+fift rrrg+d r
cfrlmrfl d-{ $fl[
(l ) ffrrfcfrdr *s $S{la valuable biological materials (vBM) within laboratories, in
order to prevent their unauthorized access, loss, theft, misuse, diversion or intentional
retease tnf rM ilftr grm, ta-u-aur t irffi iltH qri-firfl rRrs{d r
r rfrrnrrqr ik+ gten i df{ g{eTrn hftrq ilfUc-awtii ow rr;i rq< rrr4
il{ ff c;n 3r+i6r Ta6 6-{ r rfr{reTrqr ++ $eTrflii nql Tqtrnrmr +t{+
$Hr+1 qqr+l trqr fa-firt rri c-fu r
T^,P
r.1greq sfrrrqTrqt eIFr;II iTelr { *rriFl qTT{Erg {E-tft friftrET
Erezl q-frrmrrfl eIFriTI iT?tr (EITqiI ff.rt'g gq+ft trifqr+t
t
{t
rftryfl-dr$m
(1) e-&+ tr*rrerrqri raizrqmq q-{cffi fit { rt;i 5{ rftnrrur qturar
3rqRTd qer66ilri TiI rA+1 fi rcs r rfr.rsrrdr {telrfi 3{rcrRTT rle[rn t6rq
u-gn v*u rft.+J s I
CO Chemical safety* lBox{}: preventing chemical hazards by implementing chemical
hygiene (all aspects of safe chemical handling)
(l ) Proper labelinB, storage, utilization and disposal
(i) Provision ofchemical hood
(?) Use of gloves and other appropriate PPE
(Y) Reading bottle labels carefully and double-checking the name of the
chemlcal
(EI) Elological safetyi preventing biohazards with the appropriate means of
biosafety and biosecurlty
(lD Radiolotical safety: preventing potential radiolo8ical exposure and hazards by
implementing appropriate use, disposal of waste, preventive and corrective
actions
(q) Flre safety; preventing /minimi2in8 fire ha2ards with the use of fire alarm and
extinguishers as appropriate
Cir) Eledric safety: preventing,/minimizing electrical shock, by maintaining
appropriate wiring, power supply and back-ups.
CiD lnstrumentation safety: preventing hazards resultinS from inappropriate
instrument manaBement
(1) Breakage of glassware
(l) Handling of sha.ps
(l) Use of pressure equipment and tas cylinders
(Y) Leakage of radioactive elements
({) Extremes of heat and cold environment inside the lab
(q) Malfundioning equipment posing risk {e.9., potential electrical shock)
(1) rrtrrflr{rcr fld rri {-qJf 6.ffin iiq-6 $sn { fi-4 {{err (ld-d+i
3rRrRXi rfr{nTrqr $eTr (qnft ilkc w< qt+i EI rfu r
(i) g11<(6l (R) Edffiq offi arffrc crH rrizn fffi{q {qeft
(Rra-{6t qm qr+1 eqa iqr .r-i q-fr tft rfrrnrrqrqr g{ierfr q-{ qE-d r
(Y) sc+Fr (1) {frfuq-+1 3rftrroli drfu{cr krr.iFr frm-+ryr vaffir
flc-fu1
lio Handling, precautions, risks, exposures and safeguards for blood-borne
pathogens
({0 Proper use of PPEs (prior to employment and periodically thereafter) on
(l) when to use
(R) Which PPE to use
(i) How to use
(Y) Their limitations
({) Proper care, maintenance, useful life, and disposal ofthe PPES
fi) Use of cryo8enic chemicals: dry ice and liquid nitrogen (for shipping,
receiving and/or storage of specimens, supplies, and reagents), based on
need.
(II) Transportation of potentially infectious materials
F[req sdIrrqTr{r TqFFrr (qT {qpq4 qsqr-g (E-dI FTtfr6r {y
Box4.*Material safety data sheet (MSDS)
MSDS is the technical bulletin providing detail hazard and precautionary informafion.
Laboratories must maintain the MSDS for all chemicals they use. Laboratories need to
follow precautions listed in the MSDS in order to ensure the chemicals they use are
handled and stored safely. The MSDS provides-
. product information;
. fire and explosion precautions;
. toxicology;
. health effects;
. recommended PPEsj
. storagerecommendations;
. leaks and spills-recommended actiofs;
. waste disposal recommendations;
. first aid and health reactivity
The MSDS should be-
. available to all employees prior to use of hazardous materia s;
. keep close to where the hazardous material is used and located
Trt€
(O Wastemanagement/biohazardcontainment
(g) Generalsafety
(it) First aid (8ox-5 :II cdq fiq r{qT-+lt
CiiI) staff traininS should always include information on safe methods for
highly hazardous procedures that are commonly encountered by all
laboratory personnel and which involve:
(1) lnhalation risks (i.e. aerosol production) when using loops, streaking
agar plates, pipetting, making smears, opening cultures, taking
blood/serum samples, centrifuging, etc.
(l) lngestion risks when handling specimens, smears and cultures
(l) Risks of percutaneous exposures when using syringes, needl€s and
sharps
(Y) Bites and scratches when handling animals
({) Handling of blood and other potentially hazardous pathological
materials
(q) Decontamination and disposal of infectlous material.
ikogwrfrtu
iP++ $er { f,tzr {iur {-qRfr wpi lilslar{ (d?rt rrffi ffi {rkq
rrseq qd-.nrrd{E;T 9frrp6qr trqaft erfqts ga q{r 6ffi it+a $eTr
sAE6+1 nqqr rrfuq q+sreq rfrrnTrdrn f+qm rr{ rfu t
qqr{ dt6il:
€r€q q-dtrnrrdr erFnl dqT rr=rTiFr qF[ -g se-+ft h{ftr+r u
p€
8ox-5,First Aid Box
The first-aid box should contain:
1. Instruction sheet givinS general tuidance
2. lndividually-wrapped steriLe adhesive dressings in a variety of sizes
3.sterile eye-pads with attachment banda8es
4. Triangular bandages
5. Sterile wound aoverings
6. Safety pins
7. A selection of sterile but u11medicated wound dressings
8. An authoritative {lrst-aid manual,
Protective equipment forthe person rendering first aid includesl
1. Mouthpiece for mouth-to mouth resuscitation
2. Gloves and other barrler protections against blood exposures, and
3. Clean'up kit for blood spills
(1) qqr{ qtddr rr* qr{itdld-df{Fq cfrRr (cMTs) an *nmrp qT?FqiFalT
$r rFial {rtr 3{r{erEF Tfrrrcl|mT :riqrq r qffi {ff d r
(i) s-*fi rfrrRnfli ffi srs {a+1 ilftr {{Hr qr ffqrr{d 6qr(i ctFTq {i
(qrr{ qr{qrr6i 3rr+rsTrr fi+ sd M rers" a qm mr;tait erftr
ffifq 3nqr€ t teftF{ qqnrst dB r
(l) 3nzrr(T {kd-+T qF€T]i 3Fftrr{qlr r r+f,I+< rrt c+ hftr-df t6rq 3r{{R
sdq ftqds I
(4') ff{: g;.roortanisms of Risk Category 2 or higher risk catetories
handrenfti *t6rdil fr{rcr q<iTrlqq erfrffi (-+a ra-"r+l fue:
I {r ?sl{q qd) qtfiFi FrrII {rq wig r rd +i-drcT i{dr
F<*qr t6rq u-5rr< rlrffi r
(1) [frtnrrf,I +r{ sqrrq rr{ et{qr sTrftr+rtm qfusri qr{ c+sr
rc1 rfu,
(1) rfrrrsnfffir il6r6{ {i e-< nq wia,
(i) e-frrnnqr +r{etTqr {qr q+dT-{ qalr f<{ E+{,
(Y)Access to animal houses should be specially authorized,
({) No animals should be admitted other than those involved in the
work ofthe laboratory.
AOMITTAI{CE IO AUTHOBIZEO PERSONNEL ONLY
R!5ponslbl. lnv.stig.tor:
ln c.l! ot.m.r!.,rcy call:
Oryrlma Fhonr: _ Hom. phon6:
A!$orh.tlon lor.nlranc. must !. oDl.ln.d kom
ln. A'rpon bl. lnv.rugrto. n.h.d .bow.
greq q-zilrrqlqr (qFrifl (qI €qrd{ qFKEg tq+ft frtftr+r
Na_
{q
BIOHAZARD
€r€4 r{t{rqrt{r eIFHT dqT q*ffi{ qFrflrg frq4fr iitftEr
T'W
{e
Hr t crql M {Ad
1q1 qfu.lrf, S{erx rfr{Rrrer (q+ft 6Efcr tarq-a qfurn $en
r++qq qtt rfu r
(i) TfriT{trfi (qift 6r.t wql-{r rtEt Laboratory aprons, gowns itt
uniforms 3{tFIRiTqqT qrn-et rfa
(1) T*{t{rrdr {E-;tft 9-&fi ctfql-tr{ q€ direct or accidentat
contact with blood, body fluids and other potentially infectious
materials or infected animals v.f 4Ff {qt(i-+1 s-ffi gf{i6
Tdtq qrrr$t q-t6, Tm.I qrqrd, [fr{r ffq"i rfrtt-qr-i
frqqrryR f{flnin rrft qffrcrd FT{r rre q1 wia,
(t) l{firtriF {q6[ { s-{r{r6{ ini HandtinS rttgfu iTqI
Tmrm-qr+l 6r{vqrfi eh d{t 3{fu a'ffi 3rffir{
6rd TI c.ig,
tvt qiql t ffi splashes, impacting ob.iects and sources of
artificial ultraviolet radiation gfe e-qf${+1 qrftr safety glasses,
face shields (visors)!{T sfel $Hfa[6 gqiFfuf66 qfoapf ffiqf
a.rru-1 rfu,
(t ) q-*rr{nf,r+t gtur va-*ft 6c-gr6{-drt rqt nrrqr erP6{ r
gflflqr+l qrftr flrd-{, otn sc, :Frqi-{q 4t6r, qrgnft,
-48fu, 3nfu YAn rFi {+q qrrEr+td,
(E) g<r+f ei-{ tH Ef,t (open-toed footwear) T{iITqTTqrqT vdrrt
.r{ dn,
($) rfr.ryrTtnm] fr{cr qri, Frei, {scn rTt, *-df-s
ffqFfr g-fr{ ri, 6q{r€ ffi yfrq ri qrar +nffi +ie
(q) n*{Isrrd arrieirn qr;rq qlq T(Iffi rT!-gRsrmri {+{
ilrEq6t4
(R,) {frrtsTrdTrcl q-ftrT qq6r $eTr(rw Tfrrmrrdr {qdft 6qgrF{
3rq +TsI <rtcq+t <fiq qT fiFr+fl rrq &t r
(rT) F4ftr6a s-fr{Hnqr (qift zrrfqr t6rffi Hftrrt cm{r rr{ c{u.
(1) Mouth pipettinS qTt {"tdqr q-+q qTt{r6t6,
(i) E+ ci{ ffcFi-66 Tqcr rtq q+{, drd qrq1 &{,
(l) All technical procedures should be performed in a way that
minimizes the formation of aerosols and droplets,
(Y) The use of hypodermic needles and syringes shoutd be limited. They
must not be used as substitutes for pipetting devices or for any
purpose other than parenteral injection or aspiration of fluids from
laboratory animals,
({) All spills, accidents and overt or potential exposures to infectious
materials must be reported to the laboratory supervisor. A written
record of such accidents and incidents should be maintained,
(q) {q{ spilts 41 decontamination 1 1ls'ri+i ertr kkd t{ftr
a-qn lltt qr"rcr Trt q{g,
(3) Contaminated liquids must be decontaminated (chemically or
physically) before discharge to the sanitary sewer. An effluent
treatment system may be required, depending on the risk
assessment for the agent(s) being handled,
(cl Written documents that are expected to be removed from the
laborato.y need to be protected from contamination while in the
laboratory.
(q) s-fr{Rnqr or{ f* rftnrro 6r{i &-{ AErq rlvn-+1 6 vta
(1) The laboratory should be kept neat, clean and free of materials that
are not pertinent to the work.
(l) Work surfaces must be decontaminated after any spill of potentially
dangerous material and at the end of the working day.
(l) All contaminated materials, specimens and cultures must be
decontaminated before disposal or cleaning for reuse.
(Y) PackinS and transportation must follow applicable national and/or
international regulations.
({) When windows can be opened, they should be fitted with
arthropod-proof screens.
(s) Tqtrnnmr+J tr-qrrr r (fuarro: rfrrrsrrqr+l ts-qrrc ll-d t 6Fi
ftqrs{ rr<f, g<err-r retaa miaacrg ks}s rrFr Sgrst {{a I
frqTr{ 6Fiqr A€rr6I fl{u.{qr ran gqqr${ q-f,d I
(1) Formation of aerosols
(lt work with large volumes and/or high concentrations of
RrezT rfrrrcrrdll eIFriT dsIT {qfffi qFr{!-g (qdft FT{1}r6r {c
[t
a----
microorganisms
(i) Overcrowding and too much equipment
(Y) lnfestation with rodents and arthropods
l{) Unauthorizedentrance
(q) Workflow: use of specific samples and reagents.
(q) It{ifrtq]rmtisl fe-qrfffr ks1q-f,r6{ (oesirn features}: s{irrIgrdr+]
fu-qrfiqr tarr+r t+lkarrt 61 wia r
(1) Ample space must be provided for the safe conduct of laboratory
work and for cleaning and maintenance.
(l) Walls, ceilings and floors should be smooth, easy to clean,
impermeable to liquids and resistant to the chemicals and
disinfeqtants normally used in the laboratory. Floors should be slip-
resistant.
(i) Bench tops should be impervious to water and resistant to
disinfectants, acids, alkalis, organic solvents and moderate heat.
(Y) lllumination should be adequate for all adivities. Undesirable
reflections and glare should be avoided.
({) Laboratory furniture should be sturdy, Open spaces between and
under benches, cabinets and equipment should be accessible for
cleaninE.
(!) Storage space must be adequate to hold supplies for immediate use
and thus prevent clutter on bench tops. Additional lonS-term storage
space, conveniently located outside the laboratory working areas,
should also be provided.
(e) Space and facilities should be provided for the safe handlinS and
storage of solvents, radioactive materials, and compressed and
liquifled gases.
(c) Facilities for storin8 outer tarments and personal items should be
provided outside the laboratory working areas.
(1) Facilities for eating and drinkin8 and for rest should be provided
outside the laboratory working areas.
(1o) Hand-washing basins, with running water if possible, should be
provided in each laboratory room, preferably near the etit door.
(11) Doors should have vision panels, approprlate fire ratings, and
preferably be self- closing.
qreq sfrrrqrl{r rqFF dqT { €rTnFI rlFrflg {q+fl FTtftrfir
jtrt
{1
(11) An autoclave or other means of decontamination should be available
in appropriate proximity to the laboratory.
(li) Safety systems should cover fire, electrical emergencies, emergency
shower and eyewash facilities.
(1Y) First-aid areas or rooms suitably equipped and readily accessible
should be available.
(1{) ln the planning of new facilities, consideration should be given to the
provision of mechanical ventilation systems that provide an inward
flow of air without recirculation. lf there is no mechanical ventilation,
windows should be able to be opened and should be fitted with
arthropod-proof screens.
(lq) A dependable supply of good quality water is essential. There should
be no cross-connections between sources of laboratory and drinking
water supplies.
n9) There should be a reliable and adequate electricity supply and
emergency lighting to permit safe exit. A stand-by generator is
desirable for the backup of essential equipments, such as incubators,
biolo8ical safety cabinets, freezers, etc., and for the ventilation of
animalcages.
l1q) There should be a reliable and adequate supply of Bas, if needed.
Good maintenance ofthe installation is mandatory.
(1c.) Other measures should be considered and applied, as appropriate, to
augment laboratory biosafety and security.
(6) it+a $frr gqinlrrc yfrrrqrwrr{qr taru r1trr+r
itc-fi $Hr sr6{ur6{ sq(er qI .rfg r
(1) Pipetting aids - to avoid mouth pipetting. Many different designs are
available.
(1) Biologicalsafety cabinets, to be used whenever:
- infectious materials are handled; such materials may be centrifuged
in the open laboratory if sealed centrifuge safety cups are used and
if they are loaded and unloaded in a biological safety cabinet
- there is an increased risk of air borne infection
- procedures with a high potential for producint aerosols are used;
these may include centrifu8ation, Brinding, blendinS, viSorous
shakinB or mixinS, sonic disruption, openin8 of containers of
infectious materials whose internal pressure may be different from
the ambient pressure, intranasal inoculation of animals, and
qfeq qri-rfqnqf Eqrqdr (qT E .*llqir
lo
sq+ft tttftr+r r,o
(i)
(Y)
({)
harvesting of infectious tissues from animals and eggs.
Plastic disposable transfer loops. Alternatively, electric transfer loop
incinerators may be u5ed inside the biological safety cabinet to reduce
aerosol production.
Screw-capped tubes and bottles.
Autoclaves or other appropriate means to decontaminate infectious
materials.
Plastic disposable Pasteur pipettes, whenever available, to avoid glass.
Equipment such as autoclaves and biolotical safety cabinets must be
validated with appropriate methods before being taken into use.
Recertification should take place at regular intervals, according to the
manufacturer's instructions.
1l)
(e)
strr
n) sM aFrerFFr { kslia 6Fi it+o $en htftr+r qfrtdq mi sia r
{l) mift aq I rhtt( (contaminated materials and wastes) +1 q+eirq-t t t+q.h
kfd ffi qo-sfi sdq ffi'+t-6 |
(6) The principal questions to be asked before discharge of any objects or
materials from laboratories that deal with potentially infectious
microorganisms or animal tissues are:
(1) Have the objects or materials been effectively decontaminated or
disinfected by an approved procedure?
(l) lf not, have they been packaged in an approved manner for immediate
on-site incineration or transfer to another facility with incineration
capacity?
(i) Does the disposal of the decontaminated objects or materials involve
any additional potential hazards, biological or otherwise, to those who
carry out the immediate disposal procedures or who might come into
contact with discarded items outside the facility?
(q)Steam autoclaving is the preferred method for all decontamination
processes. Materials for decontamination and disposal should be placed
in containers that are color-coded according to the nature of waste
products (red for infectious wastes - nonsharps; yellow for infectious
wastes - sharps; black for non-hazardous - general wastes).
(lT)An identification and separation system for infectious materials and their
containers should be adopted. Cate8ories should include:
(l) Non-contamlnated (non-infedlousl waste that can be reused or
Rrezl rtrrF{rrdTr SFFII dql <=tTnFI qrrflg
iu"R
Frtfsror il
recycled or disposed of as general, "household" waste
(l) Contamlnated (lnfectlous) "sharps" - hypodermic needles, scalpels,
knives and broken glass; these should always be collected in puncture-
proof containers fitted with covers and treated as infectious
(l) Contaminated material for decontamination by autoclaving and
thereafter washinB and reuse or recycling -
. Contaminated material for autoclaving and disposal
. Contaminated mat€rial for direct incineration.
(q) af{q} irt{ (sharps)+l rdrrr r i{fl.iT tam er-ffiR rFt c?i6 r
(1) After use, hypodermic needles should not be recapped, clipped or
removed from disposable syringes. The complete assembly should be
placed in a sharps disposal container, Disposable syringes, used alone or
with needles, should be placed in sharps disposal containers and
incinerated, with prior autoclaving if required.
(l) Sharps disposal containers must be puncture-proof/-resistant and must
not be filled to capacity. When they are three-quarters full they should
be placed in "infectious waste" containers and incinerated, with prior
autoclaving if laboratory practice requires it. Sharps disposal containers
must not be discarded in landfills.
(g) Contamlnated (potentially infectious) materials fo. autoclaving and
reuse:No pre-cleaning should be attempted of any contaminated
(potentially infectious) materials to be autoclaved and reused. Any
necessary cleaninS or repair must be done only after autoclaving or
disinfection.
(q) Contamlnated (potentlally inf€ctious) materlals for dlsposal: Apart from
sharps, which are dealt with above, all contaminated (potentiallv
infectious) materials should be autoclaved in leak-proof containers, e.g.
autoclavable, color-coded plastic bags, before disposal. After autoclaving,
the material may be placed in transfer containerc for transport to the
incinerator. lf an incinerator is available on the laboratory site,
autoclaving may be omitted: the contaminated waste should be placed in
designated containers (e.9. color-coded bags) and transported directly to
the incinerator. Reusable transfer containers should be leak-proof and
have tight-fitting covers. They should be disinfected and cleaned before
they are returned to the laboratory for further use.
Discard containers, pans o. jars, preferably unbreakable (e.9. plastic),
should be placed at every work station. when disinfectants are used,
waste materials should remain in intimate contact with the disinfectant
Hre{ Tqt{rsTrqr errril aqT qEltr.fi qtqrys se?ft Friiqr4r
i)r
(i.e. not protected by air bubbles) for the appropriate time, according to
the disinfectant used. The discard containers should be decontaminated
and washed before reuse.
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Llst of routine and specialtests
Cllnical Biochemistry
Routine lest3: Plasma/ Serum: glucose, urea, creatinine, total protein, albumin, bilirubin, AST,
ALT, LDH, alkaline phosphatase, acid phosphatase, CK & CK MB, electrolytes, calcium,
phosphorus, cholesterol, triglycerides, HDL cholesterol, uric acid, amylase, T3, T4, TSH, FSH
and LH (except by RIA). Urine: 24 hours for biochemical examination, CSF: glucose, protein,
chloride. Effusion fluid and Ascitic fluid: glucose, protein; Calculi analysis
Special tests The tests other than those mentioned above.
Haematology
Routine t68ts Complete Blood Count (CBC), Erythrocyte Sedimentation Rate (ESR),
lralariallFilarial Parasite, Blood grouping, Compatibility testing for transfusion, D-Dimer/FDP,
PT, APTT, Fibrinogen, Bleeding time, Anti gloubulin (Coombs) lest (direct and indirect), c6
PD screen, sickling test,
Special tosts The tests other than those mentioned above.
HlstopathologyAll tests are considered special.
Cytopathology All tests are considered special.
Gonetics / molecular: All tests are considered special
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Mlcrobiology and Serology Routine Tosts: Urine routine stool routine, Examination of direcl
smear and stain preparalion under microscope in bacteriology, mycology and parasitology.
Slide and agglutination reaclion, ELISA and automated serological reactions
Spscial t€sts The tests other than those mentioned above
lt-2
S. No Qualitications Oisciplines
M.D. (Pathology) Histopathology, Cytopathology, Clinical Pathology,
Haematology, Clinical Biochemistry, routine
l,Iicrobiology and Serology; Non microbial Flow
Cytometry, genetics and molecular biology
B lvl.D. (Microbiology) Microbiology and Serology, , Clinical Pathology, routine
Haematology(non microscopy) and routrne
Biochemistry i microbial Flow Cytometry, genetics and
Molecular Biology
C Ph.D. (Microbiology) with
M.Sc./MMLT (Medical
Microbioloqy)
Microbiology and Serology, Clinical Pathology;
'microbial Flow Cytometry, genetics and Molecular
Biology
D M.D. (Biochemistry) Clinical Biochemistry, Clinical Pathology, Routine
Haematology (non microscopy), Routine Microbiology
and Serology((non microscopy)); Flow Cytometry and
Molecular Bioloqy related to metabolic disorders
E Clinical Biochemistry, Clinical Pathology, routine
Microbiology and Serology,
*Flow Cytometry and
Molecular Biology related to metabolic diorders
F M. D. in Lab Medicine Clinical Pathology, Haematology, Clinical Biochemistry,
routine Microbiology and Serology
G DCP Histopathology, Cytopathology, Clinical Pathology,
Haematology, Clinical Biochemistry, routine
Microbiology and Serology
H Clinical Biochemistry, Clinical Pathology, routine
Haematology, routine l,4icrobiology and Serology
M.Sc. in Medical
Microbiology
Microbiology and Serology, Clinical Pathology, routine
Clinical Biochemistry, rouline Haematology.
J BScMLT Routine hematology, Routine biochemistry and Routine
microbiology
K CMLT Tests of D category lab
L Lab assistant Tests o, E category lab
3r-td q
Qualification norms for authorized signatories and technical supervisors
'PhD should be in the relevant subiect area frcm recognized medical institution / medical
universu, which has to be fu -time (not distance education) lollowing an M.Sc. from a
recognized medical institution /medical universly
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Ph.D. (Biochemistry) with
M.Sc. (Biochemistry)
M Sc in Medical
Biochemistry
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Guideline on-Health-Laboratory-Establishment-and-Operational by NPHL

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  • 2. 'Ir<IFFII 3{rr{mfrtnini g*qqE r ryrgftq €r€a *frrnrrqr t-qr r<n rri s-MI qrftr rqtfd F.6rft, ftfr, qrT<rkfi, itrrr+rft at rr+rft wrqr enwr Et qrcq fiermr 3flutad rqt{rqTrqt 6 defl TriIrnrmr i-qrqrr q-ff{ rri rrft eTrc-{r 6.i ;drnmrtr+i tEr rqrm rr<t qrm rrtf v{ mr<.s dqr Rrc2r r*.rqrmr tir rqr+q rtqft 9-<r4 rr{' qqqrfl{ +rd, rre, e-{furd aqr c}Trffi {rFi qq q+efta r rjqr<fu (a,s+ qqrn loi1 cr qrft q-dr rrEq qreq rdrrnrrqr ffi .a qrcq frfr iocR t r+rq< fi {friqq qreq rdt rqTmr i-+ s-qrmfir€ a-qkrd < qqftra r<rga qr€fd-q rdird tqre qr+n qreq rqrr+t zfr Ere{ rdfrrq[dr {rrFr{T iTqT e *rTnFr cTwg (qafl FT{fir6r, ioct" firi {r{ ldd I cffd( 1 qRh{+ l.d{K irq ( rrc*t: (1) {q htftrfirdl flq rqrcq cqi.rqrrqr errc{r r q*rd qrrfie (qRfI ft{ft1ar, 10u1" <l+1 e r 11; fr ft{ftrq1 gt< vrrs* qta t f. qftqn[ kqq * re-flt i{al 3{{ Tflirqr rq frtftrE;rrn,- rtr) 'rfaliFl' T;{t+ Aqrfr q-A;r.. EIfezI <r.q rci r (q) 'Ht{r€ qftfr' Tqrn EFr t rfifdq rTtsd {futdmtii qnfi sd I (r) '(Er ntqk6 (ar66R qftft' lrqrn <6I { s'ilt{q rrtsa qfqkfii {T161 q-d I (s) '{tsq lrrFnel rfrrnril'rqri sreq rdtrrsrrfrr n-{r+1 fi-4rq-fi f{firq I q;rFnezr Tfrrmrflr t-4r+1 frdrq r{6rq ve.rt qd r (c) '{tqfr II<r{ IIi fu6rq' rr<ri rq,-r 11 cI skkd q-qrd{ {tqfu Tfl{ qi ti-6r4 {st rd I 1qy ,fift+ q-{€rg TqTrmrf,r,lr;{rn dffi r+ereq rfr{rqrrqr I-rEI rdr (g) 'frIqq qqil{' lrqri fufrtrr ffi i+qq-qr 3{t4rr{ ,r{ s?sq ki rqkd oq{ {friqq {qrrtr ,ri qrs (q+fl i-<r vi-a sqr+ rt;ia;I qrftr rtqta s-ff{ rri t++rq-qra er{cid crq freTur 3rwf,r( qEEt rd I FD r sr+kfllrq[ qHR-d vfr{Erfl'qqri rrrdlirFrqr qnnft+ rri rqirrlTrqr tqr {qrd{fri erlwta rr< ,qlarsTmratilt €re{ rfr{rsrmr eIFHT (sT r{EII.r;I rIFrFg qq+ft htftr+r w A.--''
  • 3. (|r') "ell-gqfrn (Standalone) gqtq{Iffl'q-rrt srFk FrF6rrT 3flurftd nlli {fr{rnrfl i-qr qrt 9416 rri .rt en r'n r{ rqrq-n qTc-ff wq qt6r frff rftnrr"rm, tr;ft frqk+2.ffi ffiraqr 3nqrfrd rdrrrqrqrar r +eftrfi n-{rnacr qrffi q-q}Tsrrdr cfterur rr+ T*rnrr{mri {TsI rd I (q) 'gqIqt.F-{!I Ti fri5FlGccreditation body)" ll-drn Td-{nirrdr6f*1 +qr {tffr+1 ffierur .rft gc{ar n-{T qf4fi qrr{rg 3r{5c qq qqr+} qiq rft hka aq fu rt wtr+rfr+ H-+rq rcrt rd r (z) 'YIJIqt6OI (A.c,editation)" tlirn ti P;r+rq qr afu-qr{ Afuqqir 6Ei ryTmt'{t{ftTffir+T qnt ssri q.i qa qtq sfliirfirt-+ l{orrqrc rfi{ rrfti qtrsn ger1 vei r (5) 'iEf4 grrrdl (competencyl' lIflrn {qfrI( arf wqr++q;r qrftr qr+er6 f,ri, frc { errrrori <cr1 ra r rt rsrrqr cfte1gr+i sk qi qr erf,dra|4 F'itrrqrrdr+{tdg qrqqq+ qt{-qr g{r rrft ffiq+1 qttsqqr r< qi hq{fli ci-< rqrre r (g) {6rf rrtf qtq (competency arsessment)" Tqri +{qrfi-q;I errdrqr{ qiq .ri r 3rFr+6-fior.r+ cffi eam-1 wi t errtn qiq+J qw affi i-{grd-{qTi qffi r ffi sftfrurcr qaTr4 qFi E-<r wi t s<r i.cg-r6adri fflT4asr r5i {ffi m hqq +q qfu ffiriid (G) .Fffisl rftRn-dr' rrqfn fufuRr rd]-rrsrr{r, Frrn rdf{nTrdr, tts6q rfrq$rqr, qrqreq qfr.nrrdr Er trEFI k{l{, ei?, rt+qrq, iterq vrqra+] tfliq, irrr+1 FrrRrfi zn qire{req (q{ft qfterurqil 4I{ ri sArrsnilqni acrl mi r 1q1 q1ffift (|IFqI ct qffr lrffn srq qllfi ftrsq retr*ra MBBS qT €I trr+] sctft qrq rrft ariteft+] {+ ftttr r€ qrrirffi, qr{nffiI, Hr fittr{ Er frETr{a-. fudqr sclfr Ert{-q TtI iqm itg+.( +rst<-dcr rai qr+r trrrsr qffi-qrg xrt51 c-ig t n) MBBS Er S r.fdi gcEfr 6rtw rr? qrqra uirffiqr MD/Dcp/M.phir/phDs'clfu crq rft iqrq itg4-d Ersftdcr rat qqqi' qrrffitqg (R) MBBS/BD5 Er s s{Ffil gcrfir drtffd rrt csqrd qr{il+t$rlrMD 4r qrfirffitr yrq rrft icrq tkrq +rcd-ccr ffii iTr+] MD qrffifuq (l) MBBS/BD5 Er {I Rd-+] scrtr 6rtfq ri crqrd qFfri{rdliirfrqT MD qr qrfH sqt?ff crq rft iqrq tk6q arsdlffir eai rr-+l Mt srca qfrrrsrrdr efiqfl (qr gqrdt 111,4 qq4fl hiftror i
  • 4. tdr flF*tqrd-dfuq iF+-{ ?ffhfr (tr rrqrn fl-q sTq ftrerq q.ensra ffi ftErqr sdkd scrfu ilfuq rri csqrd tqrq srs q+srfi cf(q-fiI <ai r+1 tflT+r qffi t*rI wia t (1) BMLr/B.sc.scrPr 6rtff{ .ri csqrd ffi6{/ik6q qrAaikqT MSCMMLT Er cr{rdl sclfr sI< rrt iqre qleq qqa1ff qftq{qr ftt sg4l "q1ft$fuq1 siqqh grn;r11 (i) BMLVBSc. vcrftr EIff,q ri cl-Erfr tterq zffi+;r-e qrg-nffi 'ft ar ffc*-e rrc*ffiffi $ mumr M.sc./ MMLr? qrflrqit gqnft qr< rrft icrq qreq q+srff qftqgr q-di r+1 qIEftffiiqE (Microbiolosist) G) BMLr/BSC. gCIftr drltrd rt Ce-{l( tqr6r 14rea q{flff cft$qlT cdi qqfir itsFd qr{ffi ffitqE (vt cN,rLT scrft atre qi ceqrd tqlil €rs 4{flfi qfts{qr ed r+16r ikw qr+n-efr l+ffts+< (t) Technical slc in medical laboratory technologv Sclfu ErttrdI ql qqqra tqra sreq q-4-flff qftq-flr <at r+r itg6d ar+ffi qffia qreq rfrrrqTrqr eIrHT dqT (*IIiFI qFr{!-g {qfrft trtRrfr Y lke 0,--
  • 5. cfid( r qftft(qfrq{sr i. F{trr6 <fuffi rron (t) rruflimi qreq sfrrrqTrqr {qdft t-4rrtE;t qq;q4 drll ir{rrF{ rr{ 6d {ffi {rftr tdr4 qfrtrc FTtsr+ qfuffi 116{ rrfu 1 talgfuq, Hrs qanerq -3rLqel (q) {6rfit1lfi, sRra Q-a1 faffrr - 3rIIL]rer (rr) ctdhP"r, frqs spq iryer< vftq - ({Fr (q) cftftftr, icrm tkFd cfts-{ - T(Fr (s) sfrfrfu, tqr{ €req q-c-flff qft.s-( - ({€T (q) sfrfiftr, rftnrrqr ce-+ft qdt(,{-;Fr c*qrc Tard{n r-+ff{ rrt+1 d q-{r - T(Er (E) yftftftr, Frff arscre qentsffi{ - {{er (q) HttFF, flEq q{srs g-frrrqrrmr - ((er (fuq (R) sr+6r (1) ol qEc tqr qqJta-q r1frft16 66s55 x"d 1 qar qrffi s{6 ( 16 rrr ikre ilr{n-.ft }ffidirfi vgr+i 6vfu r (!) fttrr+ qfcR qrirq?IEdr n{fiR {fqk+1 +56qr 6+ qttr 4r q-fltr6rft 4r f{qsrrqri qrqkf, ffisfi} rsqr 3fiqiflr rrd r*g r Y. htrriF qhk+] iFrc,odq r qfrr+rrm i6rq Edridq E{s- (6) Fne{ q-frrlarrdr t-{raffir T<fcr irEq €reT r{irrrsrriTr ffi r qqq qrter qrs dqT ctqtr t{FrffdEr ffi Rrwr rdrtrq 6q1 nfqq qaq;pa Ffr.rsTrffflii Trq qaelrd rfi{ rri , (q) s{II qle{ cun{Ifir rurdlftrffcr sre{ vfrrTrTrdr t-4rdRr qtlril{ Tr{ Td fqBrq q-qr{ aqr *s{r /9-6f{f,{-d srqq rri , (!r) irr{r aqr fffh lrqiurqr 3rtrqe-qir?rT ift ?if.rffi qaqrgi, (q) itlr4 vrrrqr tqrqt+r {fiffi s[{r trrrr r rsi t{rFf,dr r{<f{qir {<iiqr Frqfod 4r tsnr ddltr{dr ffi qr+qqrar ar{qR T6r{ Ti' , (s) T4i rfr{{ffqr erFrin dqT qftetq chftrd[d 5er-'< .r* , (q) Rr€Er rfrrnrrqr i-qnit (qt{rd f4nrq ks}srdr EIfuq rrt-+r vTrqra qt{Rr6 *rrfi{ rri {q-qq rt , qrs wtrnrrqr sFrifi dslt q=ffi{ qTlrfl-g vq*ft Fr{ftr+t rttp {
  • 6. (d) Rrszr rdlIfqnqrqr rdf{rqr @r{i qr{Ift r affT{tfdl $ {r}E+i EIFT r&q Rrdt r{ ffi cks6 rr;, rsl qq164rt dfu.ffq+r 3{q 6rri66 rri I {. nE{ trrqEr rfrimT.Tr crftfu6 (frr6fiR qftfurt r FrfurdF dcfd-flil crfuSr{ ffid{r+1 qrftr tarr+r rcftrorfi-rc {Bdi rt&q spsa sfrrprqr qrf{P{+ rdrffiR (fqft rkq tcts16 sfuftr+i M{-{cr sreq rrarfiri t6rq qfitqq r56q rrfui 1 (E,) frfuiF, rqt ra-oreu v-ftnr{I - 3r4H rq) sfrftfu, g-fr{Rrrdl qqfrft geittr{{;ra{ qrtqre (1 q ) - ffiFr trrt ffiq 3rgkflqatrc qrsffi ({i6r g6 q{r - s(el (s) flTff,/(.firfr ftre{or 3rtrdrr+r qtdaitr qr*qtfr, crE*4rA-ftfi-rr 1r6-snfiq6 qr Hl{r[fi-ft q*Era (r&+ (T6-qre V.F qrll)c+ rrft fi-c qil - s{€r tsl ma ersTirToF{rd ardH ?ffi {T16r r+ q{r - ({sr (-r) 3r{rrfi nrqr sw lqq ql-grea cfr{rerrfrr - rrs qfTa (1) vtr{$r (1) +l q(rs (q) q$fqq rit+a s-rsm crt t snr qrffiI q6srer (r4 s{r tkffi srffi iffi (Ti Ere E$fu | (i) sc(Er (1) {frtqq rri6d nqu €req rtrrRfifl clEtrfi {-frr6-6R qfukdr dr4 f4-{"r tdrq 3r{frK qtg :- (a;) Tfr{rlTrdl ffi ilftr 3nqw6 ct q-{, fffi, {&q FrtftTTT <fu tqr+q Hfu (sop) dqT qFrErsrt ilqR rrft (Eftrd ti-+TrsTE ffi qrqra er{ rnrsi, (q) esr rrr rqfua q-riffi 3rrqaq6dr ir{frR t-4r 9-{16-+1 sfuen rr{, (rr) rfrrrqTrqrF€+l eai, rqrrq, argfr r fwr"ft-+r"r+i(Accreditation) qFrfl-gFr ffr$.Ift{.r+, (q) rtrrRrr{I t-4rcl 6r+.d s-{flffi 4rrrdT t{6l{ft1 mtr qr+qq+ aFi6r-m iqrrftq rr+, (s) 3rFlqa-6d[ :rgm a+ 6Ri6] qrftr tqT {Er+1 gq qfuk6{ rl6a .rft 6Fi .Rrsi, 1q) ffiqrr ffi{tf,{re dtrcdr qq fid-6€ rr{, (E) g-frrHTr(rr€d Tqrm{ q-ttrfr lT nt{4-{q r ryrtrt h{aq slqd-+1 rI-tr truirot .rt t EIFHT f,qT (qld{ IIFRUg qqftft TT*fT6TE.req rziTnrr.{r frLP
  • 7. qfiB( i yfrfln-drfil IFFR r tFr6 flfi-i5.tlr t. TfrrRrr{r6r lr+g |qp6q, Rr€q Fqtrrqrrqr ffi erfrr farq +ittsrq+r 9qlrl{llell6t tqrrq a6tdn :- GF)d{Rrs rftRn-fi f l(IEq q-{sr€a rdf{rqrIf,l ?) et+4 q{greq rfrrrsrrqr i) t{dr s{grg orqtcqqr iflErfad qqt{nTrc{r GD 3rgril{ql qrsrft-d rtrrflqr (1) 1r.+Tft qskrr(qT i{r.ntad rdtftTrmr (q)A+4 3rsf,r{ql ifltlrkd rfr{rsrrqr l3nt frftqzqrkq 3tgk {ct a arfu( tr*.rsrrqr (g) gc-+{Iq 3rqdm { q*rq ir+kllqqT 3fl?nLd rfrrrerrfrr (t)kdr {wfrrdqr qrtrrkr cd-{rsrmr 1glqrrTfrrfi grg d-<qr 3{r?nkd lrfrrrsrrqr istttrfrqqr slrflrfa( qqrrrsTrqr (l)rf$I irqfrrdcr 3fltlrft-{ g-dr{nTrqr {i{)qErRUr erg<rocr orurftd rdr{rsTrqr (3Ir) filis{ t-sr cH E{r{ rr* rqirr"mr ifltlrft-fr sdr(sTrdr (t) {a+rft dqT Frff ikdq s.i-ezfTeTur 3rskrTirrfl qrufta rdtrrsnmr (rr) T*rrcrrdr fra1 qg yESa .ri s-frqqTlill (standalone Laboratory) (S)3I{(rfrrH lffrttQlfqT (Research Laboratory) (g)iqur rfrrrqrrqr (Referral Laboratory) (q)ftstq trraril qfr{rqnfl qreq rd-{tlIrqr erFr<T dfi {=tTiFI qFr{rg (qdft fT?fqr6r ILR 9 (vl qs qfom *e+r 3rmqqrdr r{gn qra afrq u) qrfktrfi fl-<re-+n qfuffi i{r{qliF'dT {1.{R sfuMI A66qT t+ qfu sr rflftrfift sr ffiqF-fl{ 3rlqt{d {(s-+J rrqr i{rFaur iri rd-s r
  • 8. e. lrfrqwql tqt qrt l-<tq T+ Tfrqtrrcr (standalone t-aboratory) : rdFTqffdf +Ef qr{ yff{ rr{ ftdl TqfrnTrqr (€!-gq-air+ T{ir{rsrmr) or qrq mt Frff ftrfi-+2tftffi+rqr qtfltad sdrTstTdT r iiftr+ rfficr qrffi cfterq rri Td-{nrqrr{ ct( qfr r{rqr q+in r gtt.{rqr{ ffr{rm-qr : (i) 3qs+rr{ fiI{nTrdri q qt rqrrdrqr ?{rflt-f, qrt{ rrT{rrn s{€T€zffi{r (qt{rd Farrr+ r tt-rtrra iI{rrndi 3r{ffftrm +tq I ti rt.t I (1) ss+Fr nt qitlqq qrt{ Ttr{rqr erlram ani rqrrq rrd nfuq q4srcq rqi{qrrffErc fu$Tf.{ Eq+1 er gt @r @t elci-d (t) 3r{ll4rr{ rftnrro qrqid Et sqIral.;rqr nEq q+tqrcq kafi Frrrrff, rr+rd qr sq-q{firft qfu+r rrt* r (y) q( Eqrr +dlqc erSn-+rn +Fi.ri Tfr.nTrff+l ffi 3rr{qq6 frfu+ gfrar vql "s' r'a'+1 qreq e-dr{nrff,r+l rrcr+1 q1 rfu r f. isq cftrslrdr (Referrat Laboratory) : (i) iEsr q-fr{rqrFTr tslnl{ 4r hT Ert6{ ri-+r rftrqrmr d qri rt r+fffi cTt6[dr qfteTur {fur{ r tqTftfi t-6I q-fr.rsrmrft cr;r+Ere {6kd itT;It t supptementary rftrvr qt confirmatory cfteTgl ctfi-al qT sttIRvI s-{iFrsrRrfl vfteru qt+ur gqnr4r qlTq6r i5{Teatri cfte{ur+1 orftr ffi r{ctd tqi i'q"r rdrrrqrrqrcr qdrs{ flH6i I (1) srrflF'r 111 qfrfuq tqr flr* rT+ qftHur+J {fq""r|{.m sfr{rqTrmr grmer n!rr+i :r+erqr {rEq ++req q-d-{e1lqr+1 qqtd f{{ tstsft *sor T{m qftmur+1 ft1 q5asa qffid 1 (t) ktsft lqq rfrrrqrr{r {rEq q;rqreq qfrrrqrr{rqrqlE qrqfrr qrR EI qfur (y) {rEq qa-sreq rfrrrqrFri t{r Erfr( qtsrsrfi} qrftr c6TtsI ct qfteTur ffi q* ir"tl-+-rcaT rqr qrft {rEq qrhP;6 {drd-+'R sfqtf,qrd dgo rnrel cfu r qrsq qdFTqtrfl erFnr dfi {€tTnFI qFr{rg {EdI i{tftr+r q 5 W 0r---''
  • 9. ({) iqsr rfr.rurTqTcl TTir qtrervr+1 qrftr c6K Err< q* rdrnrrrri w Tfr k{ crsi *c r is"r g-d{Tflrdrcr o6a1q qH ntdqr isq szt{n[rqT+ Report Form qt grlttel ffrel Vfu r (q )R?eft iqq rfr.rsrrern Refer lri 3ilqdr aTdTel{ srq q+lrqrrfiqr cftsor .Rrs{ cr{i Aq il{ ti iv"r r,innn-cr+i elrcrrfl 3rrqi TTrrrcdrt d-{ snqrd ter nrr rffi Tq vfuflrqrfl q6rc{ d qnn q+&{ r (r) t+ g-frrsrrq]- {'A 3ns.lT qmiTqTrqrqr d cfte{"r Q-aHr ;FRsr{s 3rrgi 3rrfifsfi erqiu-qr{ gmEn rrt+t eft qffi Ffrrnrrfiqr r[qr cfttT'rr lTt rRrg{ F*Bt{ r q-cfr B116l€-6 Backup ffit qrftr rd-.r r@r rd"ffirqrqr-{ isur rmrnrrqr qrtri *< r tcr tsr B11 sqd+r rrg6r cft+r"r66 d e-drrrr€r+l E4ir lrqqr ?fl srffi rfrtrqrrdrqr q-6rs{ {t*i-d, r rgft qfte{qr q-dr.,isr t-qrqrfifi} srti-{Fi tqkfr irdqfr (written consent) k{qfu { t +1 qr;rfirft {rkq s{gre4 rr(rs-{cfu | (R,) r+6 s-{ir{ryndri 3rEt ilT qlk q-6T-+} cfterorEil i{{{qr qrtffi ficr nQa q{€rs rfr{Rrrdrqr raregie r (1o) tn Ert6( TT{r cfrmqr+i qrftr s6rsi rfr{rqrlqr 6kcr e qr+1 q1 rfut nl)d qt{ eqt{refiil 3nst Tfrrwtrf,I rTI iqT ftrt {H nrumr urat cftHor i-ar ssqla1 aqffi Tfterur+1 qrftr iqor rrtqflrql 6i {fufiI Frci'6 rFi qrst #{ r (11) ftsftfr s-d-rrfll{r qi-dc "o" n-qrd 51rfu t (1i) iqur r{iFrsrrdr dqT d q-.iffflr{rqr a-qn rsrvt rftnrmr (Referring Laboratorv) t tarq srct$rc-6r faqq qrdnr .rtcfu :- (+) Referral { Referring f{ifi$r6{r+1 ftqq seg qC+1 fl c-ig t 1q1 |qq rffi ctterulr{-*l {fr fi?rtR-ir qr+1 En q*6 1 (rr) t-{rra-{r{ sc+l ctrHur isq r@I vr++rft 61 q-*a r qrt ffi 3{G iqtr s-trnrrqrqr .r€ ctle{or rrrsfl fu* sI@ ( Referrlng rfrrrqrdr qrd-d qiET ftrfr l5i+-+1 ettw ffi qr+nrft fi Bi6 t 1q) TT{r Earff HRr aqr cfuqr qE-{r ezn6 .rt fuPa qe e-t q.ie t erFfiTr n {*rrrFr qrrfl-g gq+fl FTtftrfirsr+q q*rrprrst W 9
  • 10. (E) Critical/ Life Threatening rlfuEra,TReferrin8 rfrrnrdrdr* (F< {fir er{r6 qi fufu we 6 r{-e r (s) isvr rfr{rtl-{ri qkmr (q{ft a.t fq-rrqr i-4md*drt grd4r rnrs{ {d fi Tfu i +d;t hftr qfr se qr=tc{E r (E) isvr Frif{rerrdri Referring Ttrrnrrqrqre qrr+1 3rrqiq t qT[{!-g 3rgc r"dra aT{rEE4i qAqr 6.'qft q*l-{ rr+ lIA hq{qr fukd ftft r+ ri wiu r 10. ftstq ((<{) Tfr{ftnqr G) ftstn rrirrrq[qr orq rd-qsTrqrradl ryrwr ffa Tr Ffiaq ri, sr6-{"r6-6dl catibration T{, [ft!{"r68+1 F:qtq rqrq q iri s<T a;i55 qq6a lTt q-d,rsrrqmri gtra r Fmt< trfriryrrdn (cFra4rd fr +1 qrftT ff-q flq 6 ro r ivr* Tafir.dRr qrikfi sTkr k< rdFrsrrdr qrts+ rq 6.ffi' g-fr{errdrn qrqdr rrqr ftqi-;s {16<+1 rdrrr rrd qr5tdi( | tt.qfir {-s-dr{ +-q r tlrqr (q* q{sr: n) t+ cf{ q'qlqqrrqT sl-<rid dtfl-+T TT{r {6d{ A;ran qrac e qTr+i s-qt{rsrrdr+I crrfig TiI riH flqfu { m& 3r--i-fi.41 i-{r qfr r<n .r{ cfu r q) TrI{r rr+,-d{ ffi sryi e-+enqr r 3rq ffrC-{rt 1w rftmmr* qta r er+ nrc src Fsrffd rfr.nrrdrcr r{{r Fcr< a-f6€ (16 crEi An r (i) T{ir {-re-{ +-{ { sTrqr d rftrrrrqr qrrq g (Td-6} Etct6 r {6I r{{r r+rr *q r nrer6a+1 qt{ {rEq q+srea rqtrnrrcnqr caf rr<re (qrfi{ srrqfu crq rrH flqfu | (y) ti Tfr{rsrTrql+i snsr+1 Tii?rR { {-{r Eq s?fuIrdr+ vgrd flcfu r d T<r 6'q lrgcr T{{r d6-d{ A-< qk 3t-{qft k{sfu I lR. rftr{n-dl snfu'flrrl qFrq!-96ff4{ Frlf}rorqr rqrqsrl{rf,.+r qfriq,{"I rqtrrsrrqr i-Er, rr{4 qqEI{ t gttrrrw qrurlra ,ri .rMa {rt rtr rsrrdr{-flti ffi ks+r€ql tqn ki qfttr{ur rTfttd- (d) Tiii{rqtrqr qftsor .Fi qrqeqfi frr{ r frr{dr, tqr cftetol r;t 3rrarq+ atkq r qT'r, (T) ftgird { {rqFftFr+1 rqrftzcfteil-+1 qfr-rdr, (s) (*Trqc fhfu z chP"r,, sTfrur6[al kttsdr, greq rfrrrqrr.Tl eIFHT dql ITEITiFI qFr{rg fiL,a P{tftr-6r 10
  • 11. (g) flr{RhFI, rjutFil{ h{aur { proficiency .rftsIr {rcr,ffiI t+elqdr r gqir4ldT, (q) gr6{q-6[6l rri( <rTR 3ftnacr , (g) cftsTur-+i r<rtqf 3tIfrg{ qi tnterpretation ( Judgement(qftft i{fflaiFitT, (q) oFifrr+ | 1i. fckfl rfr{mrffrrd ilft qrs{{6 eqivr atia.a rd-{nrrdr65,A ffi Ed?rR Tn fi+1 Ec q.fu:- (+) 1ltra qqq(Easily accessible), (tI) TrlIkI EI4l sllitd qr+A rrt (r{r{ (we ventilated), (rt) gqlki qr{rIlr sqrfr Tg+J (sufficient tight), (q) tifqf+fr 4klTfiq (Controlled environment)- temperature, moisture, air, sterility, dust, radiation etc.) (g) TqtR crft"df qrfff 4ir€[ (Adequate water suppty), 1q) fi9fu6 fuEff 3fi[ff ar.fell (Uninterrupted etectricity supply - back up if needed), (E) TfrTRITiII fi{dl { {sr<R (Efficiency and quality of laboratory operations) (q) fuqr{ {tdd ffirgi {frtlT (Sterilization facility), tmt qiAt q+(9fnf++1 Vf5m qt+m (Proper waste management facility), (q) ;t{{r r 64rft?it .{rffT gtt{tr trtrgRqr {fh?T (proper storage for transportation of biological/clinical samples and reagents) (e) 4f4 r+rsT{q, 3Tftfifffi-{uf ( a?fetFr{ (Data storage, recording and data management) tat qtmrra r qrdrfiur+i $eTr (safety of personnel and environment) (g) rJUrRfu ftgire f Afuaq-d qfrrl (Quality of reagent/chemical used) (d) 5GF 5GF f{-qr+-fl!l-6{-+i qrftI iFFi Fflrqn (Logical flow of work for separate activities) (ur) kff{a r rerffi lnkc Tfr rri q+*qt (d) 3fq {frUffi (other facilities e.g.: Refreshment/rest room/etc.) lY. Hfuq nE!-6r rftEn-drdr+t qft @ qt{fi-f€r&fi ertricr sti{d rdrrrqrrqrfi'cr d@ qr+qqrtr { srdar qfufil er."r+rc+r wi< gr6{ur, ftgi'rd, t+qv r r< qm,fi-fi grdaT flwi6 t grgq q-*rrqTlnIr PIFFIT iTrn $qTiFI qrrfl-g iLN frtftr+r tl
  • 12. 1{. ftffi qrf+r Tfr{mt-drtr€d ffi arqrTf qrfi dfiEfr rij mrrrerlqr ie. "E"rrFa lrfriFflrqra€ll)zir (Erqr qi rfr{rcTrqrm (rafirtffiqT qEnkd g-frrnrlirr Eig r (1) T{ sTrqr c+ trdl TfrtTcrlqra.6i trfi-rtl {{ R{idl qrFT r.srft rritrrsrqr6{-dr{ dt6s s-.6+ tnq c*ffrr+] rrrrfl€Er gn qH q;tqfu :- (iF)spacei150 sqft or more (tr[)Equipment/consumables/reagent/Kits: As required to perform desiSnated tests. Modern/advanced technology should be adopted. ({)Human Resource: Minimum two (E)Servlces (range oltests): Tobe provided bythese laboratories include: . Hematology: TC, DC, hemoglobin, ESR, blood8rouping for non{ransfusaon purpose, BT, CT . Biochemistry: Sugar, Urea, BilirubinT& D, S. UricAcid,Total protein, serum albu min . Microbiology: sputum AFB stain (z-N stain) . Tests by RDTS: With simple interpretation . Miscellaneous: Routine urine analysis, routine stool analysis, urine pregnanry test, Stoolfor reducinS substances. qrr ilrrT (qr{{ qrRrg {qdft FTtf{rfir iLDP greq g-d-rRrrqr 11 cftHsr+1 qrftr tq q-{flfu sc-{+r (-t cfu r rrt rsrrdr cfteTur arfqr sdrn En mflrfo d@ orettrq ricrd tterrq afsttr{z iqrq sreq q+qrfi ci{r(r qr (dt qC+1 q1 sid r (i) s-clqlrrflfiI 3{Fnq+-f,r ffi A@r q{ { rr<r +& r{wr r {+ q-.+1 {rftr d@ ra {& mrq-dr rrgm q<qfu lr{i .Fi qi T{ FT{f{rfiri artrr T(qrsi Aa I (i) qr;r+ €ffir++1 rrunr mi rmwrrdr+l +rtrdwq;I 3rrar{qT Ful Timel/fl kqfud p34 1ims qinTfu' fl c{ E I 3{t{qtffi Part time qT oncall TII ri-+r rrnfu-flii q+m rrnfu-w rrqmr rr+ qr{i Aq r 11. sffi {{d qtt6'flt <Fr ls m 11 (q sdkfr qrr{rs4l 3rftn qr ciq qrqr (irq afu crf|il{ "E' ?fu 'A' nqr qfti*.{ur fft.+ier
  • 13. lq. "o,it{ii6t r.FRtFIrra(l)?il sTiqr ci 9'{l{l9TTqT { F{+rSwaqT qrqfud Ereq fr<qr 3nqrffd r4trrsTmr qis r (t) {{I rd{rglrFrFnc qrqrq eEtrfir qfttTqrro Etw r (i) tt q{6cr c+ ftrft ffi.rsrrf,rra+t 66+rr qq n{a+l qrfrr Fa6ft rdFnrrqrreqr* dt+C {.6+ tarq-+r r+rr{''sr€ T{r rrt4;I 6.tq{d- iF) Spacer25o sq ft or more with designated areas for sample collection, sample processing and reporting (tI) Equipment/consumables/reaSent/Klts: As required to perform designated tests. Modern/advanced technology should be adopted. (rI) Human Resource: Minimum four, one of whome should be Lab Techonologist or above (E)Services (range of tests): To be provided by these laboratories include all the services/tests approved for "E" cate8ory (Basic) laboratories plus the following: . Hematology: RBC count, PT, APTT,Platelet count, Hematocrit, Red cell lndices . Biochemistryr SGOT, SGPT, ALP, tipid profile,creatinine, sodium, potasssium . Microbiology: Gram stain and KoH mount for fungi . Serological tests: RPR, Widaltest, ASO Titre, RA Factor, CRP, . Tests by RDTS: All . Miscellaneousi Stool for occult blood, Urine ketone bodies, urobilinogen, bile salt, bile pigment, Bence Jones protein. 11 ncn mErFr TfriRIFIrfc(l) {o +ssq6r qifa{ 3rskrTqqT 3fltrrkf, Tdfrrqrrqrdn qq qT6qr c(s I (t) {( vErqr qt trft rqt{rsrrqrF[4f 6+rn im q{df qTnr {a+rft rftnrqrrrqni frf6c rc6+ ter++r qrq-q!-efi gn ft+it q{ rfu:-r (iF) space:4oosqftor more with designated areas for sample collection, sample processing and reporting (tI) Equipment/consumables/reatent/Kits: As required to perform desiSnated tests. Modern/advanced technology should be adopted. (r[) Human Resource: Minimum six with at least 50% technical manpower should be having Bachelo/s Degree or above with at least one having Masters Degree or above depending upon the nature oftests ereq rfr{rqTmr erFr dqT 1l*n*tiI rIFRrg {r{ftft f{iflrfr l? ,IiL€
  • 14. (g) Services (range of tegts): To be provided by these laboratories ihclude all the services/tests approved for "D" category (lntermediate) laboratories plus the following: Hematoloty: Absolute counts, Blood grouping for transfusion purpose, Cross matching, and reticulocyte count, peripheral blood smear examination Biochemistry: Cardiac Enzymes, other enzymes, Thyroid Function Test ( T3, T4, TSH ) Micrgbiologvi All Routine bacteriology culture, ELISA for infectious disease, e.g.: HlV, HBSA& HCV, etc. Hlstopatholoty/Cytopathology, Bone Marrow aspiration and biopsy service Miscellaneous: CSF and body fluid analysis, Semen analysis Ro. "B"(rtrEiEr Et{RII-dfdc (1) tl tfu loo is {q6r q;f{( 3rsk q, (i 3fqq {qdrq ( gqsffq 3fsk Fr6{I 3fl'qrfad Tqj-{rqrrqr 4{ sT6cr c(d I (i) {o +ssq+r t{s}sf, i-{r r{16 rrt ii-gdr(6{qr 3rFntt{ rdtrrarrqrf{ r iqftrq i-+ kt €.s -dF sdmqrmr {i-d q++c e vq+i 61 rfu r (l) TiI q{FFr g-frrnrr{r+ tdr{fir crc<sc q{r Triq+dl :- (6) Space: 1000 sq ft or more with adequate rooms required for all specialized laboratory services (depending on type ofservices). q{a{ ii-gfrt{qt qrflft( q-*rnTrqr 1Tg rqf{nTrdrdEr qw x hur (microbiotosy, Histo cytology, haematology and biochemistry) q"A 6I|A.FI{ i furr+f i-+f sqd*l 61 vfu r fuftre n-4r i{{ t s rdt{ r*rrsTrqr qrs-+ fulqre qit 3n'drrqr q+ dr "ra fEurdr fi4 .rE "fi61 r There should be adequate space for Sample collection, lnformation/reception/cash counter, reporting room, QC unit, library, meeting hall and office of the laboratory heads. (q) Equipment/consumables/reagent/Kits: As required to perform designated tests. Modern/advanced technology should be adopted. (r[) Human Resource: Twelve or four per discipline with50% technical manpower should be having Bachelor's Degree or above with at least three having Masters Degree or above depending upon the nature oftests (q) Services (range of tests): To be provided by these laboratories include all the services^ests approved for "C" category (Standard) laboratories. ln addition, these specialized laboratories can provide all services includinE special coagulation profile, hormone analysis, lmmuno-histo chemistry (lHC), Tumor greq rrirrrqrrqr <qFrnT dfi {qrd{ q[qryg {q?ft FTtftTfir lv ilLa
  • 15. markers, Advance C/S (anaerobic culture, fungus culture), hemolytic profile, tests performed by ELISA/CLIA technique as per requirement, 11. 'A'mfFFr rftmlrdwe (C)t {{6qr qt rfrqqrrqrrcd 3{fu-f{ftTq rfrrrsrRr t-aT rqn rrifi r (t) {{ €TiqI Roo r{<r 4ff +gfir V.4rft qr Frff 3rqfrr6rqr qftIlft-fi rfrrnrr.Tr, ikff 6i-mcr 3nenft-( yfrrrsrmr, iqur r{t{rqrrqr , frfuq 6qr *{Ia :rs<r+sr 3ftnffd yd-{rsrrqr6a I {o a-s r<r qrfirar P{sis-fl i-{r yqr{ Tfti 3rsk Er6T rdfinrrqtfi€ qa a{fu faf|Tg t{I ki standatone sqt{nTlelr qdd{ G) {q qr+r qrd-{reTmrff& ?rrq efrffit crr{rs T{r rdr flci,a;- (6) Spacer2000 sq ft or more (depending upon the number of specialized services). There should be adequate space for sample collection, lnformation/reception/cash counter, reporting room, QC unit, library, meeting hall and office. (g) Equipment/consumables/reagent/Kits: As required to perform designated tests and expected advanced technologies. ({) Human Resource:Minimum 24 or six per discipline (Haematology, Biochemistry, lMicrobiology, Histocytopathology) with50% technical manpower should be having Bachelor's Degree or above with at least one per department having lvlasters Degree or above depending upon the nature oftests (lI) Services (range of tests)! Laboratories will provide advance level/sophisticated technologies in all the services^ests approved for "B" cate8ory (Specialized) laboratories , molecular tests, superspecilaised tests like flow cytometry, genetic study. ln addition to this, some special tests services provided by "A" category lab include super-specialized services in different disciplines. q{aq 3fskllqqT sntlrfad g-frrlqTrdr qs cftTqniTtrr Tq Y hqrdr ( microbiology, Histo Cytology, haematology and biochemistry) i-fl 3c{+f q1 cfu r faftre t-{r let it s q.frr rftnrr.r ertq-n Hftrrordt 3fltrrrcr g+ 4r {A hrrfir +4r rcq e+s{ r RR. Tfr{Rncr6} IEFR aFFIR E-Eqi q.rec (*t r*+ rdrrrqrmri qrr-n 9r6R *yn trr+ qfrtqrqit qililq {Tr+1 stirrnrrqr nclvfu r mk ryn Ff""rR, srfi"r { qr;l-E (srTu-{+J qaeTr rFiqfut, d{ tt ,*rflrqTn 3n$ -rTr{ci qTffic qd r<r crfffi Trid rdt rsnmr EIFfiT TFT qT6qI qTAT qiEt{ I 1a) e-41 ftq : E category (Tfrrrl]rqt Q-{r !qd+r !qqr) Hreq trfrrrqrl{r eIFF dqT {qrd{ qrqrys qq+fi ktftr+r lt iLW
  • 16. (q-) qfqk6 FTrsq +-q : D category (TfrrrqTFfl *Er gsq+r rTgqrt (rr) to Ag qqal q.ffi7ffi s{a{ 3rgkrnT { frfr +e sqr qCfir kfrr sf$kflifft : C category (s) {1-loo tg {qfir rcorftzffi qir.{ 3rsktTil, kwr erqare r efqq 3lglitlaT, 3-q *frq 3f({dl!I : B category (e) Roo tg vql qfq-6,r rr+rftzFrff qiraq Brskrrq, q+ frfi-a irsdr{, +kq SIgkIIiI: A category (s) {o a-g lTqr {q6r ksiq-f +{r qr{ r(I{ rr+ 3rsTirllr : B category (S) {o +g qqr T<r crf}r6r f{sis-f, tqr qr{ rff{ .ri q-garq : A catesory (q) ttdtfft{+ zi?ftr+ t-wrnrql qrfoi qftsrur rrt r*.rqrrdr : c catesory ($5) q{rEg il*{ fulteft : E to A category 1q) Hff ftmF{+'qr 3fl:rft( g-fr{rsrrdr : D category (Irfrirqlrf,T t-ar g.T 4r qgqr) (d) 3f{qf+fF Yqt{PTl?lf : B category (6) fufr€ rdFrellqr, qta lai]Tq (specialize, super specialized) Q-Er r*r< rri rfr.rsffir : B category 1g1 iqsr r*{rqrlilr : B cate8ory tat t<ii *qt{rqrrqr : A category (q) Fi-fi (fl {{6rft ikrd afrszftreTur 3Rq .r-fl Tfr{qTrqrf,{-d qrrfis iqm ttsrd +rs$-dn *ffikq qtd r ll. sTIERsfd i-{r E:Iqi : (l)3rsdr6rcr 3{rilrt-{ {+ riifrrarrdrrta -qre+fi, qdfiiftE r ffi;r+ qrffifu n-{r 3rk+t"i {qqT rr<FT rr;tq{E I qft isdi' arscrq ,{"{tt rcu i-qr {qrrr+ a.+ re(tr*rcdt 66qr qrinffiirtq +{r qtrqT{ flcfu ( qrl*iErffifqqdir i-qr sc-der q1vfu t tlt qffi loo {eT !r<r Efu triz5fr riopsy q+ erw+rr*w Histocytopathotogy t"r 3It{4Ei 6ri-a r wvrdke aI t-<r gq-q-el .nrct qfur 14fq g-{irrrqrRr erFrnT dql (Endi rrFKEg {qftft tTif{I{r lq W iy. qftqq ffi qrEr{ql qti4{uli rfrrrsrrffqr crq Et qfteiur ffit qr.nrqr rm.rsTmrrrdri fura er{qn aftiF{ur rrM e r (6) {ri 3lr6.r.fii rqt{nTrfl (small sized Laboratory): ttr+ 100 qm rq qtffif,{qrc a-grr rrr+ .r+ cqFrsrlmr, A-/'
  • 17. (€') qqq 3rr4'l.+1 Edf.nTrmT (Medium sized Laboratory;: ttr+ lol ?fu ioo {q qltrr{qrz T{{r {fd{ rrt rqt rsrrqr, (iT) qfr wr+roif q{frplElr lLargeSized Laboratory): [fu5 1oq [fu voo qkr{sra nar r-+-o-r rrt g?ilrnrr{r , (q) 3{fd qil (Very Large Sized Laboratory) :tkfi Yoo rT<t Efr qtffitfEtc T{{r fiFfr{ rri *df.r9Tlnlr r R{. Lfiq q;rsrs qt mrilnl:*ftq qa€r€q Ffrrrqrqr q+srs+1 qrr{rt eiffi isur rd-{nTrdr+1 fiqr 6Ff rriEl r (l) q( r s{€rsq rdrrrsTl{rn rJuK{ fffaur r ir{rrf{ Tqrfi{+r 6rrt6t {i-d qqrrq rrtER r G) T{ cql 6r q-{€rcq 9fr{Iqrqra 'D' { "c" rrr*r qfr{rqrri{rFn ffit r renff rqrr+ ir1cft f<t ( nt{6rqr rri 6r{ {i-d rrfu( | (v) ff tqq srf t+qr+{ .rst &-{rq q+sreq rqtrnrr{rr€i nfuq q+qreq qrqq arm rrftr- t lq. h<t qqzsrg 6rqk{(1)fsdr q4/€re4 +T{TiETqr rfrrrq[i{r vTFol {:a.r g { liF qTlGtrfituberculosis (TB), malaria, kalazar, HIV qffu q.dr q{(4re{fr{f {q{ft d6qur6€+1 rql-qqrrqr cftHur rl(d t (R) ti-ar q{/qre4 orqtq+& "e" rrcer rdFnrrqrrcdt rai r er+qr{t r.qr,q-r 3l-{cfd H { rt{+{ur.ri +rd.rfu r (t) {kil +Fi+] qrftr rs6r qrrsrsr arrrinFti 3rl{qq6f,r ergn fi rt{r[[{ { $ra&rur+l 6r{qr fsar sreq rfrrnrrqr qdfrrr rrfdF I (Y) kdr 'r{/Rr€q arqiq++ rftrqrrqT rat, rqr+q er1rft r+r+ rri r<r ar,t qrqr<r {qi etfi-q s{€r€q r{irrrsrmR{rT qrqq ar+q rfuR r 1ra6ril a-f,df {IEq islr sdirqTrqr 1qe ffiiFr$I ffi nQa qq"r edirrsrmr) n nQq q-{€re4 r4FnrErrr+l sqqqT{rfiFiqr arjqqrr+ .tict r greq TqtrnTrqr (qr(Flr aqr (*trtFl cFr4rg il"LR trtftrrr lie 1e. vc+rt 1lEq iqq rfrq{Irfi (w{<rs {qfr)s{€rsq (q+ft 6Fid ffi
  • 18. qtdq Y Tfr{Rn-dr q-qmr qtqft r q-ft6-(qr Rc rtqrn-dr rqldn r{qft kt : rti 6+fr cft sryft ift{6-{ €r€q 9-fr.HTrqrft-{r r<rr< rr;i &o , d qt{ ti-fiEqr -dt Trrfr q.-{rft nt{i trqr{rrrmr {-qrfi rrd cri'ccr sd srs qerrflii rqtfi ivm ara+ {mft-c +r1ff 6rcr& rrt{t6 | s<r s*mrrflfiI tdii {rd ilf4qqr r+fr (qrfi ir{[ft qqn rrfti #{ 1 (1) 3r{ftrr{ ar4qr qr;ra TT'IT (human samples)2619*q rrft rd-rrqrrqr cfte{or .rt d qf{ <ipn'n Rre2I Tfr{raTrqtqrT qqfhrr err<rsqr€ qmn .rt cfu r r(ft vqre-+ Et argran orffi flftr llEfira f{fi{{ra e-fiTtrrdT {*lTeFr ertqfr ftrq+} gt cfu r (t) ftrersr dsr q 6r iltr qr* srd-rr qi rqlrwqrn rqr.ra u-5ch ftr1v+&t r t1. {Iqftc{ cr< Ird fta-fi k{ ci +-16{: (1) t6E+i sTiqil ErFq rd-rrqrrdrq 3r{qtdq qr< mi M orqjqqqr dt+q eq]firfti fq-fiqr r qrr+re {kd dt+q q-dtrr+1 aiqTcr A@ t5a faft Frta iq rie (iF) "r tW-+l rfrrRnqln {Efrrd kdr qrsrg +rqiq+cr, qfrrrqrrmrqr (rr) "9" 1 "A" {*r+1 nfu+ u-+arer q-dFrqrmrqr t R) sc(w (1) EtrP{q (did qrftr 3nifi.rEf trr+or rqrsr qqrtqr rt qfur (4) (g) qg{q qreI 3rr+fi snrq aqff rffrerc+l +rqiqqu ui-S aqr qmr rs-diq +rqfqqz qar+qrqrk+rr rrnqrtr+r z aforq flqimqqr cdi rftqqit rcrur sx+1 sffi qlg7qn {f,t dlTr 6i Tmr+i qqrrr r{qit $ffiI affi rqqqrfml +1 {* l(copies or updated cv, educational/ training certificates, council registration certificate fortechnical personnel, citizenship certifi cate, etc.) Fdqrtrqrr rrt 16r qE+<tdr cirMl s-ar6 rrffi tar+l {dr !nfd+ fqtqr.dr iad{'I ({) (q) eIFFIt dtIT *{TqiI qT{flrg llq+ft Frfftr+r (g) {q) (d) qreq rqrrrqnqr ItA 1c
  • 19. (q) (lF) gqir4r Ffr{reTrqr gr4Tur6€d f4-{{ol qrqr/q,.erE/qr qrsr+] e-€fttdr (qk r erqr trcS+l d .Ttt, f< vrw-t rnrr rqrql lM dt xt orugqiai sffi io t1 vqrq-{ fiqft Ti T.qtEF.rI: nt EFr 11 Efrr{q qrql qgfl {q!t 3iTa-.{€a?G sfom 11t{i6 | 3{54eai5 qq{ ffirur st6( C1q trC6r 3r6fi6Eqri Frdrrd t+fte+r r qaira rFi6i qrftr ritq qrftid I (l) gTflE'I (1) {frkq frrq 1T161 3nffi Fpqrm qc4{{ irt Ff,drld t+ftqq ant r6i; qryr'e" r,'a', cr rdisl qrftr i{r+({+f r6qr nEq ql qreq dt+cfir kf,zcrfrftrr{rd, qW'D'{,'c" qr ettiel qrftr 3nffiI r+qr A-ftq q+sreq rqtrrqrFrqrd dt+.fir t{f,zqrfaRlfqra r"r,r{!rqr miqi' {rftr qt6r 3{r+fi+l 66rn fu<r qrsreq +rqirrqrc dtt+'dr flftfu-m Ere {qiF{ rRr{ie I G) $r+6r (1) {frfqT+1 ftrftelorcr qrt tcrzqrfrftr+Efd *r{dr {qr6{ rtf.i rfrrnffir+t s-flrffi rr<r qfhd R.+1 Etd { f{frrq sTTar cfrmrri{rardl R-{r, TiftrR, qrfi (fitn :rtftt eror.rr Frftsq .r<i .rtai {qr6q T{ dr{iT qrwq-qfl emrtfta qi-a r <-qmt r{qtc rlt errrrra hfterq r Tqrf{ cr-qr( F{tHor ffin aarc+ ykr< tsT.rfu rgt- ffi ffit urarrl ( *rlnFr *rq ?ftsgcr c,o,r vqr+1 r+m dt4qd'Frffi-sTe rore 3rsrfi {qdn 3r{qdt qrft rrft errff er1rfi-*r aTftr vqf arrqm dilr{ Tft 3r{cfd qrft rr{ er +T{' tqs{qr Froiq k{6r qrftr (kq silsre{ q-*rrqrwmr r6rqc{, E I (1) A { B d 66qr qir{kl F{fteru r qql5a qsqrd ffiHur idli {qrr+ qfrrnfi tqr rrfu r so ffi ffi 3nuRqr nEq s-{€req Jrdlrryrmrn 3r{cid qrft {t qr r{r+ kqqcr Frdq h6 t (i) $r+Fr (1) i (1) q*kr41 rqre-r q-fcid qrft .r<t {flT6r-df 3flqraqr {qt+rd Edrrnrrfitn snifi .rei qm qH s$ llqr ild q{r6t cqre-{ 3r{qfd ql-d qrft fii sf6td t (Y) {qrnr{ 3i-tcfd qTtr r<i cga e, D { c +1 qrtr qt+1 3{r+6cr 3ni({ qrq qr+1 fuftrn 10 k{ flri {erff ir{Tfi { qra A t B qr qH qrffi F6'{r io kr itrr (qrq-{ 3r1ltd qrft rr+ Trri' fruirT rrft {E-+fla st rqTrdrd( qr++rft .nrc{ qfu r txl renff ir{cid crq nffi6 d T*{nrrqrn rftnrrqr t-+ tlt q.i q*6{ r FqRr qaqrcq arqira 3TT{r frtfi sreq ffr{rnrr+qra ilerrff llw._ ++*ftffirrr_ L-." 11qrpq rdtqqrrrt eIFF (qI ( *tTqil qFrryg
  • 20. r{cfd f@i rftrqrrqrac+1 qlffl6 {+ nEq q-+qnqq Ffrrrsnmrcr crq q]ffi's ntrq q+sreq r*rrflrqrt qr<tc+ W-rm^dr qrurrqr 3r{rlr4l ar{cfd srq rH futd efut vr{ effi e{ff ergcfk y<rt rri' qr rrr+ Frutq .rfu r (!,) Hflra f.r+rrrGrc rqrqq qrft qrfr qr+1 rdrqsrrqrF€cr rTEq qrsrsq q-frrmgrA {n S+ +er rlrrr< rrd rd-g r rcft 3ryrfi rrci ilt6q qilt{r+i qlq<rg 3i-{6c rcrgqcr {rqq qrsreq rllM fr rdmrrqrar+t qd E{{r rnrsi r qlHI ri-a rrd (-d-a r tl. q-{qtdq{ k{ FFR rr{ qfui : +rqicri Frirmrq vrH fr-{flr qfrfuc Hftsq aqr {qir{ qffir 3rurfi rrEi grca gfrTqtrrn {Entr{ rrrr r1cidc-i ffi sct'6 +gi ?fuqcr at ffi{or E{T aqfql ar w t.rq rqtqr 3rytdr{ tfi rqn rt;i <-fra r sffii Pdfuf, qrrorft Frtroffi ftt cfu, tr+6{ ilff (d : orqiqrt 3r{ctdr{ Til{ rrd 3rr+rqfi sriift drff {*g r sd srffi qrc-qr rFi el{qfuT{ qTqr Rr€q e-qtrnrlqrfl odq Eia r iY q-{qtfird q-qft: Prffr q-{qfr'Ti-dr q-4ftr fi-{ ef qarq rrfu r i{. q-{qHqi rfr6{ll : ttr qqftr (qrq q1 r<r nr& lT{ 4.nA 3r1ctffi{ a-fr-si'rr6T ffi qrea strrruTrtrt rfls$ eriffi sifr+fi ( NEaAs qfta-fi e-dr{ .rft dt6s qfrfirq-+1 <qr v?ra firriffiqr Afuq Emftrrdr clqrqr F{tfi k1 qfu r (l) +rqiffiA vr+nr (t) {frt+{ {A-6{ur6r eftr Frir+qrq srq srftia yffieq lurol5 qfuffi iflrrr.fl €req Ffrrr{rrdr+i +ni vqr<q-+1 {qrfi .rfu r (t) glr+6T (1) {*ffrq {qraq mi €rea Irfrrlarrdr+] i-+ rcrd ffifrq-iffia rffi qrgqqr orqte-+n Frirt wR q(r+l rt k{frrr {4-6-tvr rrft s{-+l qn-+rfr Hreq s-frrnrrerfli ftqcfu r rfrtrsrrqr ntc-6lol E sI.f+i efiT fudr q-{sre4n { c l D q6m ilffT *+q ft*qrtrtrt rrird-a r d Ei qmFft rrqqir (Rra-q qtrd tEq s{€rs drsrrdrilli qrfu+ tccr sTmer rRrs-{cfu | greq s*rrqrrqr lqTq;n dql ( *Itq;I qFr{rg {q4ft t{tftrfir 1o 1lt { 0..-
  • 21. (Y) q( (Fr qTilfuq 3r1qtd'c{ i-A-i{ur nT{ er{ftr {qrq qqqr sd Rr€q r*rrqTl{rfil q-{qftE sd: rE 6i-g I grg rftnnqr+l 1I*I Tflffi : (1)t+ Hr€4 rqtrlqlrqrn anqi *-am< 3r1cfuc-{ cr< lH qql rr<r qrftr-ffi cF1-qrc (t{r, XrfaR, q6a {qrrq, 3nitt r{r rrfr cti}rfrI sEr+1 {-qrq-{ qrftr frftE.di ffi{ur iln <<r {kfl {qtar( 6r4iq{cr f{ilfi ffi Td-g I (l) gtr+Fr (1) qfrtrq hlaq qrq rrS qlh +rqiq{n $fi to {qJkq errre frfterq dqr tat4-{ rrt fr 41 3{rqraqr {*r mitiaffi rq+rqr 3fl-Eqq6 Frotq rrfu | (1) sr+h.r (i) d-frkc orqicrn Ra;t ffi qr{fift ftiE6-{r{ frI qfur rvt reft wffi F{nfi fff {{fft erq ri+1 r{rcr okcr r, qk{r q=qrf,i rrft-cfr-+} fi qfu r ie. Flr€ur Tfrq{rrfifiJ (Ird q4II qI tntd rr{ <t6t : t1) +rqffi e5r fl (i) qtttqq d spsq r+trrqnfl-dl trlterur aqT rlrm+ rrzt rr<'I ercq 9qi{nr6r+1 qTr+l ffi dtt+gdi qlq{re T{r Trrtdit qntw gn {Trdr r{frr ai@ qrrcre Tfi rrr+i e qr8l q*rqr E-{4r Tlii {* eT crc{,g g{r nTrdrcr sltfr Tlii (-d-e t (i) gszr q{-t;dr srfu 3r"{cfu qr srq rli.fltcfu {qrmffir 3r|fqrirn q{d E{+r Er qrtq rri 3Tftr6T{ n&q srqa€< rqirrqnqF{g qlr qis I ic. ctkc qr d-ftq ffi€rg cfr{RTrffd 6rc rr{ rfr qrF{a q-{srcq FlirqrFrT ?r xi d-{cr frfrq qrqreq rfrrrqrmr nlrg sq ss-+1 qffd< v et'tfirr+l arq, ociq {q+frd ffi ffi-a qpq ftfurtr++t rrfu r il. trqkt q-trrt { (qfttqq: ErerT Tqr"Fr+l gIEr{r{IT nEq r+qrea s"frrnrmrn kqfua r+rrqq { {cftiepr+i sondl qR rrfu 1 6arsa 1 grftnerur arti nfuq q+tEreq rfrrnrrqr, &ftq q+sreq rfrrnrrqr r trqr qrRrezr Erz{iirlrA rrfda I Td ergrw r qrftia.Tur+i rfqFFqrq fuftrf, fufu iq-qlrrqnqrffiqrs srrer srrqftr+ qtdil+r6{4il {flta{, fl&q srpr rJvrHr ffiaur- NEoqs, lnft-fi{ccT qfterq qrkr sra rrft -d r r+ft r{rrm { {cft+eTur ssqr{ t+ gm r"irt cer6€ qTEqrIr sqfrr+ rqhrsrFrflii qqqiqrr {6r{fu t qreq rflrreTrqr tqFHT dqT q-qrq-q qrT{rg {qftft fltt i1
  • 22. Yo. q-tqtt <q< tnrEt q+ (1) Er€q cfr{rsTrer i-sr q1q-{r 1 Kit-rift rFi rtqte crw Wqr dqr f{6{ur rd {qt+r-d {srn wgqft 1vy m vdu rrq {qttsr+] rlata <-q< rtqft r<n nt n-+rrqri {mrct vie r (1) gqEwr (1) qr sdq q erlmrdr ar1qfr 1v1 cT sdkd sEld Ei 3r.[fr odrttql qtgliin rni <rEq crfuftr+ q@rrfiR qfrfa-i rrfu | 1,"1. qk{m:qta4rir ani gr"rar 9-qfd-d 6ft{ qqltrq qi-d I qftds r qrf,{ (fiqT q{gFl-{ Yi. Hfuq rrrqr qFtE( rffi qrftr 6ffi qftq1q-{ s:ffi 51q vqrct t {cftaHol rFi lrd Tft wgm aftr { 3r{rE sr<, qqtq tqnrrd r s56X 6ffirr w-e-+r g1 r*a r Yi. qftRlrffol *-dqrt-6€-d] rrei t<+rq:hlrafir rfr{nTmrfr.dl arrf+rqarcr Frqfufr 1trR r Trwt {tqftT.rdrfir ffi qriqft-+ r Frff rfrrrqrmrqr 6Fi rri a{qrffit lrr+r t++rs rC qTi 6r{fl{ 3rdrm qf,cftfi {rq gqrc 5{Irs1 qia r yy. Tfrq{Irfl (q* *n{r{{ arftq yrq q-ffrffi (1) ter+l 3{FrqrF.dr g{r .r+ t-d r1ft gq 656 gdrrnrrdr+ftd€ tgq qllers zirr+m st6il6n {qi< sfir({ t grder (ffi *+en t<r qrq 3{re!-a{ira6r tffiql{{ drkq vrq rrt+rr qrsrffi ggrrq 6pffi q{q.1gnrrqr +<.tri vfu r (i) Erq Er{ir< r}+r arq 3rfr€rarfdrgqFrrqrr 3rftrRTd +i i qfffi rrri Bq rqT wffi.r{ q-ta r Y{ si rm.nrrqrd qlqqrs : il )TaT q*rd qd-rrqTrqri rqrd r wtafu+ {{<qrrq-adr q+er qrf Ffu | Tfl-+1 ut<tro vq6 A { I +1 sfr{rqTFffqr delr d cf{ qf+i Ed t qh $ rdmmrm rftnrrff 9-{q (laboratory Head):bl qaq q1 q{-6 I greq rritrrqrrqr eIFr;IT dsIT HETTIFI rlrrfl-g gqfrft fir{f}rfr i? fu^<-
  • 23. (t) rftlrrqr+i 6r{iA-rn { 6r.i4l r6td tft c+ 4r {& yrtqftm {q?ar6m{ r Eqr'i En q661 I fira61 TiTr C-e qffi {q<rr6-fl, aqFi I c{€-+i Tfu-6T kqi6 rFi {trdn r (i) s-qlrnTrfrr cfteTsEi nd-i fcr!ftd Ti (Authorized signatory) ,Technicat supervisor) qffi {fr{dr {fl{i " qr Afu< cSttqq CTe r 1v) q.it r.rs< qdl rqfrrsTrqrt r*fi t{ilrdr {rfrr q{dc q+ rr;n Wiislf ;I authorized signatory (ftfii rqr"ftd .r{ qfo) dfuC?il qt wig r sM qta-q qr+rr+i RIffic rfi ffir Tsi 6rk{ authorized signatory r Fdri Tcr!ft-d rrt qfur A@ q1 rfu rs€ {rdt 3rr6R41 F4r{rerrqrqr authorized signatory qi?rc i qrdr+1 ffi gr.fer fl tr{d r rqr q* s-firafir rztrnrrqra€{r q-dfrrflfl gqrii Tf 6rfd{ E1 [rd L vrhk+ gwvrrw i yfrrwrm r{s ydmrrrmr rare-r qt krqr qrdq tid-r i srcrdl eftr ec-mar (1 qrd dqn -ffs'i{ r gte qFr iqkqrqra fdFrqrrqr+r qrfu 3rrEqrfi ci {n {+ sqaql grtrar EI Tid r (i) lrfrfrsrrdr {qFi sftIlr{rqra rqrrq qt tt++ vqrrqft* aiTr crhihs q{eTrc{ 6Efd ilftr filC-qR qi-rt r nqi{rard{r r{€'dt iltcftqfiilT rdlqqnqr r dl-{qr (qS qffi €{r ti-d iffr+r t+sk Ti-d{ | (e) vrt4nr+ {q{qrfd{ wt{rqTrqHr rfti 3ttEaTt AM qr sr {& qtqlT {q+ft 9rt{ftr6 Efu gwxrre .rt, .rfteT'r {qaft <fu e=-qrd{ f{ftr firsi, frftFf+1 cftHur*1 .1"rw {iftv< Tt q<r srfuflu-{ 4r4+l i{rftr fril*4R qtfi r qrEri kqrT {ffi qrfttrfi qfte{ur+1 qrftr gqr;i r vdrrnrrqr c1eilT rw"FcT rB 6r{i rrfun r (c) g-{if.nlrfi F{q [dfrr{Irqlail (Irq rrhftrfi €niEi qrftr ff{*4r 6iB-{ r s-d-rrerrqr c{qn emcrrrqr dqT qflrffi, ffi r Ht+.s+.rt {rqqir qq-qrqil qrfu tilC-dR qi61 r wi[.nrrqt vSci wrEgr*.m erlwt ffi r cfteTur rorsi kt.rtrrrcqrii qncsi H, qfte{or fuirf+i nt{qrqrE {arr{ rrfr itq qm qrnsi r 3rq f?t6tr6qri im r1<r< rrir.rsrrqr cftepr 6-+d rrrt {dd.r rr+{{ | (1) 3rgIitTE[IIr 3{rurftd A ifu c eqior rqlqqrrqffl rdrqsrRr r[q rqT?ffiI (TidI q-{ cfu t{t ffiftr+ {rttrrrq-< { Authorized Signatory rfldt . .{r Afuq q-mfuq q1 rfu r frdt qsrrfiFrrlt 3Iriliad rdrrrsrmr+f qrftr df@ ffi qri+ @rAd r5e ar vrflaftr+ {Tia{rlfi qT Authorized greq rftrnrrqr eIFFIT dqT (ErTiFI rlFrryg ,fttftTsT ti fl{ {q{ft
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  • 25. Yl' rM( { k{aq: tl lsreq rqtqnrrrqit q{{r rJurR{ {ii'ftq-d-dr+} qrftr r*4 Tqtrnrwrn rJurffi t+{avr qqrrffi ir"rrRundri crq-{ rrt c+6 | (l) Tfr{nrdn i-{r{r sqwad rlurkR sIkI rrdr" ffi 'A" {q-6T tqflrq {Erqr stft( {ryt sfrrnnqrtl-t -dq-+T frqqT{(qr€ {,t wrar fiqfur (4) TA+ TfrftTrqrA 3ns-n r{ilrrqTnr+1 tarmr gdfua ffi <qr Hkrr frfE+occr r+ r! rfu r (1) rJqffl{ iftfu (Quality policy) ll) lufkl-t ql{q-ffi (Quality manuals) il) rIufer{ fr,;l-{I (quality plan) (Y) rlFfflg f fqfSi i5EiHfu (standard and corrective action procedures) te'r r&fi TdrrnTrffA rJurKr crr{rs a-+ rr{ vfu r (rr) Td+ ydr{renqri 3ns.t q'W stfi-qrqr tdrq-6r ryr<-cel d-q{ cfu r (9) IrET]t +{qTffi drf'fi t(i Frain allstaff) (R) fukf, <fu rfqm+ hfir grrer rT{rgi (provide written sops) 1i) $RfrI dqf 3{$IAq iFIR rrt(Design forms and records) rvl cqsi q${n{ffi {frhqil .T* tAssure comptete documentation -over time and persons) (q) r&6 {m{nTrqrfr lEa era ryr€r {t{ft-{ddT/i[R rjsrtr{ St{ft?-d-dT iFr{i5qqt( Participate in NEQAS/EQA programs) {Aqlfrt q1 vfur G) Tfr.Rrmrrfi 3nF-+ rft.nTwr+l gszr lircIr er hirFrdl{ {61 qfiqr/fr'qFEFr saq qfu mnk 1"rm cftmsr firs{ q]ie t +<iI ir"i {Itrq srFI rJqrRr tftftqtrmuerg rJurtr{ {i{ftq-ildr { rrif.nrr{I cfte{q6r nff,drrt qfteTr (Review results of NEQAS/EQAS and audit) lTi-d rFi qfu | qrea r*rnrrqr eIFr4T dqT (EIrd{ qFr(Eg [^-a FrtfEr+r ir, cka( s rlgrffi r Turw< qftqtrt qsnff
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  • 27. Y6. qra {ur<( (frftqilfl: (i) .n*r TsrR{ tftftq+ar r+iEi rm{nmrdl sffi qrg h6rq qrcid rteror rmst qqnfi d rryps. qi{ftq-d-dra;t qritr r{irrrsrmr+i qra t{firq qrda cftHq rRpgq qffirr I (i) {di r{qfir IrETi rmTcrrfrrr{ tllPr rJurK{ {fIftE-d .'Tt t+ftqr {61Tr,ft E1 rfu r rd {ftft-{f,dT rri 6r{qT gErFI rrg{rq rfrrryninfr TErr<rI iT+ (rof cfteTor ctfqrr€ {rrier T{ qr.tq r qrg ryrffi {t{ftTtrdrn yd-qqrrer+1 or{ sqrf,dr{ erq rdrrnrrqrffit (-qmrar+ {P{fl-q-d r+ ErA ili $6rss I 6) qrar rJsr6r {frftTd-dr+i *$ fufu i qf5-arft grdar 61 r ivra-wr {rqqflar vlrqftd irrer ryrw< qftftvtrar cunfi (NraAs) q=flfi (tg r rccr rr.pt rd-qsTrqr6[ i{ftfird ffi'{Fft g1 ria r srfl rJqK( gftfqao fuP;ror sop *-"G 3{tiqrfuqfl qrq-{r mf rfu r (Y) sra ryrwt gtrft+a-dr flt {qara1 wr ftrffi nEq qrsrs qd-{rlrr{r+1 6fu r r+ r*ftTrdrn aim-t ro Frffi vqt*ra etr+r "r, ?fu "c"qq+r T*rnrrqr6{i{i' srer {q<{ qftftqd-dr {E-rft 6Fi rqmc rri etflq q-{spq trffi ffirtur qfu r ({) iqr +1 rqrg rftnrrqF€+l erftr {rEq wrgrpq rfrrrqrrf,rd 3{rd-s{r rrt {rEq Ers r]qwr qf{Rrildr (NEqAs) EFi6q M tkPa r vtx-qrqre q--qre-< qtg - (6) nE{ rrsreq vq}rnrrmzetfiq qrsrs rd-ftTrdrn {qftrd e-frqflqrrr t.qdqr qfriqd wimqrrqrreoii nkq wrcrcq rdrqrrRri { "E' td ncn {Eq.;Er rarcl afflqd g-frrrflrqrrr{r€ &frq s-{qrcq s-frrnrr{rit il.i r*m Y qfaqIIIT r eEiqr i rafit tqq rsi 6{ r+ftq qrrqr€q Efrrrarrfrrfr Nraqs hqrcqrq-rt Fqrffi rrd' rd h,qr+-{c g anqqT tqrm rri ffidr ksr{ rr-<rqq nEq qrqreq rdf{Rn"{nffi trqrqr +r{ qqr(r rr+si r rut w@ 3fl'ilRrld Tfr{nTrqr sfteTuftl (tftr *ftFi-S qrf,{qr ffiff, srdrAik, qrgffi r rrs qqifr NEoAsqri {ifui E I zRf.5T 3liIIiIT NEQAS qT isolation and antimicrobial susceptibility testing of AMR pathogens, CD4 count f efq feftTE parameter 6t {td 3{rifiairin er1'{R {ifui E r (tr) F6lTr{ft rfulTrqrf,rn 3nEt Era War qt{ftTdr sqfrft tq{6r qr< rH C6 6<T Brt sample process al ar{ rlftT{ cfu t (s) {-flrFft Tmrrsrl(rf,€n cteTul rtd q6 6Rrt{+ qfd-qr 16rg {{ cfur qreq rdr{rqrrfrr elTqifi (fi {qrq{ qFr(Eg l').^.-F filftr+r 1e
  • 28. (e) tqq wreneq trftrqn riT / etftq s{€rs rftrnrrqr+ nffrqrfrr* Eqqur rft 16 cffiT{ {q!t FflrTftr rfrrnTrqrrwr{ ysmsq .r$e r rdt{rrft rfrrrerrdl rn qTq ysfrqsrd;I *r'm orm.n orfrft r emar v{ten r{ vi-a r (q) dftq qrr€rs rfrrnrrqr rq {-a,{rfu s-fr{rsrrqr fir6 + nEq qrren€zr lrfrrmmr+1 r.rrqAs cr ffiqrftr qI q+Bi r rar &ftq q+qreq rqrqsTrmri qr1-d 3mi etrqr cqrrq rrtEir NEo s ;Er+rs+1 (ryi sffifi lfq+ crrerea rdfrrqTrqr+1 iTEa rdrrsrrdr 3{ftr+qcr rsrq rfu r (q) (Ift{q q;ffie4 qdf{rflrdTl 3r<i{rEq rfr{rqTrdr6an rqrrq rri srFI rjurRt qft&+a-m er frffFffi qme cfteTur +ni*,ccr FdqFfI 6rfur yq. {Eq q-{€rqq rfr{mFfiqr iIEc ila {frfrrsn-dr*1 ilfu {ur€{ f{q-aq ffiffitrEqqiereq@ i{r{saiF rIvIK( Hq-aq qrcrff TqR .rt cfu r &{rq q+qreq rqhnrrqr {id{ui q"f NEoAs 6r{i6[+1 ffi nEq qaffira fifr{rsrmri rqn rH q]qrifr-a{ nqq qrr€{rp4 TfrfiTfqri sqnrer rRrsfui I {o. {vr€( ctq{q (qt{O (q* aFrelt.l )FIr€4 rdrrre.rql6Eqr gm .l=i, rrfti qfterur+} r1ur6t 6;4{ Tt6 rlol€{ cfteror r11r3n qftFfu r ilfu.r fgdrfi l@ TrR{ TfteTur (3{ka) n Ei-rftu"r, cftHor r cftHor c{qrfr+] FrfrftmI i ffiigft-d I (1)gtrflFl (1) emfu-q rJUrRt qfterur t3rlgIt .rd t6lq-6r {firr6 (6mn .r=i cfu , (6) rrtfi?T i (qrd{ fafu, rqt 6'ffi errm r arkc, (rt) 3li6'{trr, (q) iTrdr<ut , 1g1 T{nr 1tqql ;qii-elFFl, (s) {sr<{ hcqq r qftunq rqroftfiq, ret qftrffiaq r qm({ 3{:ql{ t (l) 3nflfrf cftHor tFda{q qtcetoni {qr${ crrrfffir 3lr+":Eort Fffi Tir i{gsr fi. qfh qis rFisi, dftrr yfrrrsrrqrfi rJUrHt q{eTrc{ cqnffi 6niqr ver< qi 6dqrfl-6fn t r:qrm rr&e r grcq rfrrnrr"Tr RIFt'tI frfl q*rrd{ qTq(Eg {q{il frtfuoT 1c 'I"0
  • 29. (y) 3rr<ft6 qftelgr (E€r+{ 3rfsct +1 Frd tar+ arlvn ri+r rt. r (6) qrar cfteTur (q€{.{q qkat+l erftr ilqft rFi, (rr) zF{qrftffqT rjqrffi csnffi 3rr4rq6dr41 qttcr +a-fl Eft r.i, trf t 5f .f* Tfis-+i t{qq qtfqr{ (identify the gaps or non conformities) qT qFnue qrm{r+i qrftr gm r{ v+ Fq!-46€- $n-+1 qrftr 3FRR, (s) it{qrq <r gm .ri qi 6r{idt qr+rft, (c) Rrerr sr drkrr+1 3rFnq6dr fr+6 q=i, tqr qrq-il rfrrrsniln rIurwr qrqqus Tn rt+i e,, A{ .rin .{fisn I (t) srfi{urwr sqt*ra ryrwt t{q-aur Erd ryrRfu qrFrnTqr M qrftr rE€tlt ceT d r sq6ror qgFr si-rkr, r*rrcr RTst t{ -dr6T iffi "-5i111-{ rrri qie I r+r q{( {}TR { q*rrdi 6FiA ilft RilffI ffi, (q) gtFFTgFFI crt( r wcr,fi-rFdr sffi orfirtrrfi{q .rt v"nfr f{6rq Ti', (rf) gqiF{lffi calibration, performance verification/validation, and proper operation lls{ft tqf€( trqr aqr< rrt r 1q) Frqfud {trd {}Tr.*l ark*r rq rrt sffcr tt{+, {rqrtffi { qrts-6 qt'H +rrR (qaft *Id 6q1 qrN-6 {fd mrr ffi+dr (AMc)1rcaar rr{, (g) gqiE{sl (qrdr rr+ft ifu iltq'q cr<rt rri, vq?FTur !q-{fi' affi tqrrq rFi {d rrft arkq crq rH 6'ffiffi{ cIT lfgn qqril{qr drns{ , (q) 5{Fn sqiFtqEr ctfq[rr{dt drPd4r qt{ftq'( qt, (B) sA6 gc-6{vrfi} S<T gd sr{q lrt .rft ro qrrtcr gT6{sI-6I mfu rqrrq kRr, 6E{qIz grrer rRrEr+I {qrd{ qr{irq { 3rq qT?P?iF qq-a555 1$ 1 (1) r&6-gr6-{ur+1 ffffi r (inventory lo8) 3{tfiFinccr nq qrig r tffi r rrqr ffi tfit'rr qflrnq rM fl s{-6 r (6) gr6(ur+1 5r?FR, d-gd rqr r kftrq qqt qfiriq rri tert+ q+ rrnqr ifiqcT qrfffilitT qmum+l erftr cqq-e rFi sffiqt, GI) gciFrur qL( fut{ dsT gttir-{q Tql, Tfr-rr ffi qr q{( qqr rM 6<t d d +1 k+r"r 3{B{nq rr{, qreq rqtrrsTrqr eIFFT dqT {qlir{ qFrfl-g Pv' qqafl ffis6r ia,
  • 30. v,l (rT) s f{4 /F{i r+J ffiS {E-4ft {E-{rf€, (s) (Rr+c6[, &{{ cras { q{( {rTra+] 6{R r{g i'|Ir6r, (s) slitr-& ffirq qt futd, (s) si.{ qftrfiI qti r ia-ffi a-qt cft6( e Tfr{En-qt qrfff (trc, ftEirc ( sqirltD { {wr {1. rctqrrrfl ficrff+} qrIfr (l) qrcq sdrrrqrrqr W Rfu 4flT{+1 ffi ll"rwfu r*,.rqrTqr qrcrff rfu-a, Rgira, sq-+'<or, qftt etr< rri vra enrrr ,r{cfu r (l) rfrirqnlir sqfr crmftr{ qfrs sq*t oni rqp6a rrd {r{qfi-+ sft( En iIqT F;rqqr{ff aqtn i.ri c{u r .J'r6fu srqFft cffi erfrr qrffii-r qt( (< r trr<rfttr qq+i <"erqTi :r++qq rrt qfr htRir+r+i ,r{q* r cr iirr si-a tar;r Pct cfu r rftmrtTr ltrm rfrrnTrdr glen sq{ft kv.rdFi rdt rsrrqr t-{r rrl{ift g-{t qrrcrg firt fit rrftt e r qQ rrr<.s rqn rri er{ ftirsqdir qrftr r+ fdftl-+r+i ryE* t tt ntqqd rdrrsrrdr $sr se-+ft .rrcq<.r{ cfur qtd< c tr+m, rgrm ( q{ftamur {t. rfr{ItlrltlE{-tF} i;rqffirtr<tqq Rr€q rftrcrmr flfrftr+ qdrr+R {fuR P{qrrs fi-firq (re8utatory body) +1 ocqr zEI* rI+E r r{ifrrm-dr6{-41 (qrrt r1ctd wt .r{ 6Ei t{i-r€ra rlitsol t{freTur+l ffi :nrqr rrfti*i r qq Eri+ ftTira z l+-au erq qrcFfi-6{zgr6{qta{ F{ r flLallq(6n qrtrd Rrirezfu-ez rq mftatzs[r{urft eaial qrq r 3rqnftrfi {r+ tmEi-4rft {t-fr i{qrf,+ t++rr+] qts r (i) Ti-{rqrrqr6[+] <rcm{qr rrd sqt{r rrfti qrec6{qr "{&q" qrq rr+rft rfrrnrrqr Eri6fir ir;q rdrrnrgr6{n sfrrr r1;t qrst d6a I i{M ,k<" rr< si-{ fi{ sr+rft wirqnrqri qrr rqtq n+ rrfr iqkd lt(.r} a €rezM+qqrdr eIFFn dqT (IEITIFI r{rrfl-g hL- fritmr io
  • 31. | {t, {-qrd{ 3t-{c'ft qTtr .nt q-er qr<rt+1 s-+.r rft rrcrfi{"r {ft.rr 3ryft qrt rrfti da r {Y. mFrfi ( wtasm n )irEq q{€req rftnrqrn Frqfud BrT{rq-{ r 1l.ftieffi+1 kftr n-q rfu r (l)nEq q+sreq qd-.rtnqrfr 'B'{ 'A"qTTrTr qftiCi' rm,Trnqr-add Tqt{nrrqrd'€qri r lsar sreq rdmrvr qraflEqad;l n-rftrcr fq-dr qrsreq arqiq+{ 'E' {*Iqr Etiqd s-diTsnqr6[+1 3r{TF{ r qcfteT"r 6r.i sfl?ras?Eiir agen fig1-1 r G rffiq, etftq r har rrcr {{rrf{ ( gftierr vurrfi-eni rwr< rrtri-oi r zrra qrftr tflq wlrn 1ftfu :- (6) {d-{nnqr6[$t 3r{rrq-{ { {ct4erlrdr qrftr i{qrF+ i}rfir{i' TIEq tqtqr+ qfuffi qsqq 1(r6niqr ffiq ra rrfuq q+ereq ra-.nTrdrdrii ftIr$T) I eti-q a-a t*frq qrrF{req q-drrrrrrqrqr; {srs{) t{fl (qr+i qtfsTT { 4rfi-iF{lr rig r q<t c{rqr 3{r{rT6dr {{srr+1 {+ f4k{df sfrrnTrqr n-{rqri d-{t Tft t6rf tnr-+ fufurr+r k* qffi qi-<t q-fu r (rr) 3l-{Trri { tcftAeTur lF-qr6-qrqr[+1 qrftr Rfu qqrcq kiu r ffidg6t 6qR .Fj E{S r (rr) cfrrRllfirf,f+1 3r{rrF{ r gtae+ur ri qri qfuErd zirr{dr 3r{rf,{ (n qrm q-frrRrr{r{r anirt wrtffi qtr+er r<t qrftFil frr{frr 6rl{( qH qr {qr{ tr{ r 6 ,1 q6 seftro +rd dfficr qfu rtrE akq lffis 6+. E1-dr {t{ftTd ,r't q-fu r (s) {+ d6+T s-frrntrrerrc+} qTrrt;r irqT grftAem rct qrq-{ qqrtr{, piur< ord, qrr;r, qrqFftTRgira./stlirflt) aqT t-Etzd {qm< r rarenl ri-6 *ia r (Y) q-&6 Frqkd 3]-{rrtrr dsT {sftaHq .ni vqt+ra gdlinnqrqT{ ggal ermr, 6fdt ( qtrrc+1 rr.rrrtr+r iffi Etfl qrtr+riq rRrr+ft ffi Frftr<-a t.rqr ysfrqq.ri, q@r6 H, S,Frs rqr {rt +r4 .f.i v.ie r ({) s(rflEr (t) {*kc rdrrrqrRrr@l Frqka rt rrt { {stBelqr rrd trrq-+r Prqra-qrqzt+ftrrt :r*+q< q{ qfu r (6) gtiFTirflfi rrfti qtttf6 tstqur qreq Ffr.rsrrqrf{di 3mrr{{ { qcftteT"r .ri q} gsa {q< F6-dWi h'Rr al r tr,rrrftqqr Tl-drFr+ii (3r{rrlr{ { {ilr6{ ffi) ffin rri 3rr4ftE hfteTurn Ereq rfrrrqrrdr enrtT dqT {€rriFT qFI(!-s Ed.ts"* p,J
  • 32. qrg tuRil +rdqtli tErg rJurw{ {tiit=tqrdr6r 3rq hRr6-{ ql:r{a il+r+l ar qqrq-firfr ftTR;t :r++qrqrt (i-d TTETTE{d I em{rdFqqr rrftt TqrF{ t6l..6r 6Rorn c?ETf q@- (t) TfrrEIrdTr ftgfu6 6qp6q tt?+l r*encr Bin rfrrnrrcnqre Tr€( 3{r{aT+ilrf{ 5{r W ir+1 qiq rrt rdmqrm aqrs+] csTrcl k{ crq rd, (i) 3IT<ft-6 chqT Srr.+1 ilftr {{{r 9.{E rFt, tlr gt r aru}ft crr{ rrri - "6rfr 6df d" TA qri-6rtl Erffiq rr+ (y) sdrrsnqr6Tqrt drkc, 3r{rrc-{ r grn-+r +r{rc+i t'imrr d""icr t arqiqc++1 ffi q+a1 riarq rFi (qrs{ r (<I) TrEq qrrFlrezl TfrTHITiTTA 3rG Er &-ftq q;rqreq rrirrrflrqrqil rrftrcr s{trnrrqrr6+1 3flirqqs-dT 3rtw{ (g-trrrsrrqr cq+n *ni crr<!-e 3r(€q arrqqi ri6r, 3nq nrrft-iE+J ym, arlr r<vrcc+r 3nfu q.*1 qirs{rqr) 3 irkfi tltterq r;i cmS r (q) qFrfu;F cka-q-fir*1 Tqi6q: (qli edrrqnqrlt 3irs.n Ffr.rqrrmr+] {i4rq Ertr6 qftTilfi {rEq qrqreq rfrrnrrqrqr ttq} trfsq q+sreq vd-qqrrer sr *ftq q+qrq rd-{rsTrdr qrcid dfuc emfqci s6rs1 cfu r {RI {fgrR qtrifi Neaasqiaarfi r tffi ttrsr. l{q.+i dtd-fi FrfteTurdiI cffifi sTM gq? cffi?{ qte r r+hnrr<r+l {sq +r{iqqrfi+l I1a16{ ttq4 ffisr€q rrirrrqrrqrz frfrq qrsreq gqt{ffir{rFwr{ wlq !Rrsr{i qrf$6 i{feTq skfi ttTqfir qtr{rf,r+1 3lftnccr rrftts I (l)(E[rf{ .tftg+1 rdtqllrdTr cftHUr (-@r (i){cq {f,I 1i151 55ffi f{qail fc-fisr (Y )sqdar E{erk-+1 {wr ,qualification and time t{ tsro{qrzftrirczsrqFm rq-dT hflur (srNEQAS qT (r6-q[ftk (s)qftd Fr+rq-qre ffirq+i Frflersr (c)frfu-e-S qr{i{ 1q1q|61 qasm-a6l qqT Rrsr rfrrrPrrdr erFFT dqT {Elrdi qFrfl-g te-eft triflr+t lvo
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  • 34. (Y) 3T<tFr (i) cT gdkf, yrtsP{fi (Rriq6{si qrq qr+ r+6 rftnrrmrn ?rrr+r r<ra-rro si-a qEf*rffircr rrc1 wia I (6) Tq srw (Master File): qi qRra-q r srfd+l 3r+en qtfi rrt $r{q, ((I) 1frf6iI (Organization): Structure and plan of organization, organotram showing relationshlp to any other organization/unit, floor plan, laboratory plan (rT) E-rffiPersonal ,ile, CV, qualification/trainingr/experience/competency records, professional license, job description, staff delegation lo& authorized si8n form, Signatures and initial Keys (t) {{,i (Rraq6n-d uafttqd 9dfrr,,E$r{lrr En*{rd fr.ns{ dan ffit Efun 6?r Fr r grnrrdr dqr {rfr q'iTrsfi} qhftE-d rFi+i qrftr rmriq fu{atrr+l cffi qlt (-{.er <ffiq( Fm.rsrrdrrfn r++a-r.r-t q:ie r r*+ rfrrnrrdr {RC-{6-{cr irfu (€r+q firqur qf{qT t{ftqd rFia;r qrftr t6rq-+r r+ena'nqr rqr< i€{ qfu | (6) r&6 rl.€ra-drn tar++r Aqq rdu q1 vae, tt re<rffi fesq, (R)(6{q rqt, G )qr{ qt futru T.nrrfr.rt ark+r tqrqqqa qgqrr, tx li-q rq{, r{ tr<r*e twm t g+tra-fram rqrr a+iqrffi qrqrqfi, ,"1 qRffi 3nfrr+rftrdr l{c rm.rsrrqr qu*z dq( (Rsd { fuh, t{l q-qfard q* +ffi kfaul qi'$-mrr rr+ k<cr sc{.tr Toiumr sTTm'((iliq !!T4r qr+1 1frftwfi rrit, (q) t+ (Rrtsqri Tfffid-+q rrir+] q-{€nqr, g6 5flrrd-F{ rtf@ e<ra-rqr.i 5n: dqa rrft 51: k*tq rri, (e) t+ ch <-€ra-q Ti-rrfiI+'-{ cb 5{rm (-ffilrqrt fu.-dt ffi, ,r, 6srlrrc qqriirCd cftcFfildrii ffi qrftr F{{ftq @ r{{ qr* fud 6i?rqr cri ci-is fri I te. qirftrd qrgRlr ( (tfrx (i) rdr+nrrrrq rqt+ra qfHc-46 dfFq+1 e{r.rqr dtrq-rr qfft' il?-r6l r{s rq-{ Tfr grHI qIE r{t-sRsr lt;t crig I (R) t+q-ftq dqi+ rrrsrqrei ilqr+ cffi f{€rflii {f{ft-{d rt fttd mrr{rfur (i) 9-&6 Fd-rnTr{r66i t6r{+r rfr.RTl{r qFrie-ro qo-eRvl rFfFiE r qTg g-TiFTqTRT EIFFIT dqT 1I*ITNFT qFIETg l1,8 f{ftr+r ?y
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  • 46. wgqfi 1: fsfuf, q(6,r c'nffir{r6€di erFr swwrtmi (* trrq 3t{qrafiI <arfi aftiqd Tmrt1T|qr6{-+1 qtftI srr{qq6 grtiFlnl dqT qrcr{fi-fi d Edfu rrft-q :r+qr sqfar fl c-{d r l. "E" Category laboratory All "Basic Equipmetrts", consumables, reagentV kits Basic equipmenls include- . Cent fuge . Colorimeter o Water bath . VDRL shaker o Hot air oven . lncubator . Micropipettes . DC corulter . Refrigerator . Power backup Glasswares-- Khan Tubes, Test tubes, peuidishes, €tc. ColrsuEables- Disposable syringes, vacutainers,Gloves and masks 2, "D" Category laboratory All "8" cat€9ory, PLUS -Semi-automated: Biochemistry analyzer etc 3, "C" Category laborrtory All "D" category, PLUS -Automated hematology analyser, Electrol],te analyzer, Coagulomater, ELISA etc 3. "B" Crtegory laboratory All "C" category, PLUS -Fully automated Biochemistry analyzer, CLIA etc.; 3. "A" Category laboratory All "8" category, PLUS - Basic molecular facility (PCR- Conventional/ Real Time) etc. qreq q-fr{rqTrqt eflr;Il dql s5qrffi qiq{rs {qftft FTtftTfir y! flu^' a-.-
  • 47. Rtflq sdFTarrqr eltq flqT {qrffi ffT{rg {q+fl FTtiqrfrr ys t{. { rd-rrqTrmrd ffic <4nT{r+i ilftr (q{ ffi <qr i nEtr {ftr+r rftrrstrffa{ lO,Oool l,oo o1 I 'D'g*rot c*rnrrfrrd{ 11,oool l,Yool 'c" {T16r rdrqqrrqrF€ 1{,oool i,ooo1 Y '8" (T16r Eqm{rqr6t io,ooot Y,OOOI t trAn {Er4r rdFnrrqrrt io,oool q,oool I dpr eft( c6rst qM daqr t@q azanaq ralqwiln it0 qq* v sftRrmr wrtr q-{qft dqr r+fiur {q5t (BEI lvdlr (EF?rd)
  • 48. q<trfi { sdrmrmr 3nrfi tt+-c, kEiq-c { scfi-rq) rclwndt irqffi qZ# (i) qreq rfrqqrrqr iffi Rtl-q firsf,+] qrftr {orffitrq rfr{rerrqr wcFft rffi-a, Rgira, vrotor, ilt<l qta( rr{ e-{a errr{r rr{ T{d r (l) ttiqq qreq rftrqrrfl qrftftm rarr+n qfuffi h[-41 3Twqrfi-dr fit€R eft< crcsug ffirft, {dffi qr qqre rrfu r <ryf rfrrntrqrrrn f6-c, ftqnra, srspr/ 3i-qraf{ qtt< rrd ffiT lMt qrq-<rcer{ vrr+r rr;i q-rd r qtn qrEt{6 {dr66R {fuftrn t&q qrq-<ve, i{{q erea vrraa;il qrwr-s, {Qrrfta imem, { rqroft+lq ffi qnrrcqr ffffi qtrqriqr drrq rdf{rarrf,r utcrr+€,-{ g* a-qn Tfu t d qfimi trqq f{furs {frftffii ffi qfu qqd adi r{'6r,,(qrd{ q$td' cTq6i rdtmrqracqri ryi:r+1 qnnrqr gw-ar .nrgts r (i) wirqTrr-qr yqr.ftqr ftqira r qrcFff qrrerrri-+] qrtr t6rr6r kwrfirn Err{ T(qrct q-{e r (iF) iricr+r+1 6+a: serr.r+i a:{te errf,rq 3rgrrfi-fl+i ifit;rrqT qB r +s+r qrt sflrr{ 6+c rrEi tsr nffi+1 sfterur 3{r{${fi-fl+i tstc"f,drdni ct-a ?nra gqqrs{ q-ca r qft( rrd rdt q'+1 wi ar *qffircere €rqr {di qq6r F+-azt<tiuazgs6{urr€ crr qfrE ri q{a , 3r-{r<Rm {ff nQq lTrrElr€zr Ffr.Terrqra terff-6-{Tqrt r+nrq rr+ erti6 ykficr (caer rrfu r (q) qt€ frfu: Tfrqlrrmmr rd.r Et fua, N.a, sq-6-{'r, 3flffi qfi< qtrqr ff+qti-6 qttE Fr+qn-ff rlvrr+1 ftwairr-+ etfiT{ strqrqrd i 61 *ia r 3rFgqirirr er1.sn cfieTqr+l d-d.ra Pqflrdr{ ri-a erq-fia{ rrd qffia r 3ntffi6F A-fi{qr ffiiilftr (r+f eftr ?6rq 3r{{R qc41 fi c+a rf r qrTft+at sd (trq s{Rrs qfr{Iqlrflql ral "rC4i (-t c'iB r grea rfrrnrm eIFFrr (qI {EIT.FI qFrrrg Frtftrrr yq iul
  • 49. (R) qqf gTfrur/ftqirai Ps-c {rEq s{srs q-fi.nrRrqr ftt q.+1 EI q-fu t (l) ilEq qi-€req Ffrrryrnrn {ilr6-{ qran< rat,Tc#r (wr+t, sq-+u, ttgil-a { fu.'a{it {fr Bq rr*r rmgtg I (rT) <klFrrc {qrrd e-rftr+i icqr yTq gi gc-fiqrrf ffi r+enqr crr *+R .r{ *iB r ttt rsft rrfrq snrr qTR gi vrarwr qt{ nEq s{sre{ TfrrIqrrqmrd eqn qrRq+J trq sffrffir{a;l q{mr (ts-6( :r(-+1 fi Tfu, (1) sq-dTsr+l Eiz (qfrrd rd-rnTErn rFi vfrd, (i) (6dtrr qer qTqr srrivr qft s.d-{IeTrqr+i srr{qrfdrmri T{r rFi 3r{TT6 B qi er*+n lrt q:ia r (y) qfueqiF-torr€ iiftr+ q-6fr.r rr6q lrTkT d cscr q*i rrErrFFFm tecfu sld te-{ c-fu r (q) qf(( rr{ $ AEr[+[ od-6{ {ftnq< q{ qdB' rf r qt< {i{+ 1.sar qr{r+l acff srr+tur urcn { T{irrnnqrrff-fit grriFflr rrcrTnFr vE-{ft aftq fci ani wSdfoaR ,rt q-is t q*d Er+cr Errt {qd q{ qr+qo r{qrrT qTirtnd q* {ffi ++er wrgffit fuarr{ rfur r (1) sqiF rerc dt+q amffrr+1 ord sqr({ qt Tqr!fl-ir rFiai qrftr stir&qr rftiror 3nftr vcran r{c+t (-t r€ r G) 61r.fi sflTdl-*aR rri {+d i{rrR wE-{ft tnffi q-crAsT rF+ flFdFq I qf( {st {ri-d fr}rR 6rd qt d:{i ftrqfird Et il El-fi Vffi rr{ qfu, ret q{( dqR {q4ft aFrcsll nr qrui frqfud iltdfir u-t{c rrsrr+zffiar.3 '.1+( ut6 n / 3{rTff-6-dit ffi qfrttrc) t++rr+ r qtn<nq-6 g+ orf+l efiT Filkd r+( lrrrT fit ciia r d qfi cftt€rfrtqr, Frqfu< qnrnq {+d srrr.n sr6{sr+1 B{r{ sdrgr(6 | t+sR6 r {?rRr.[fi q{d r{rTra{rt qE{r.cr r*e TFi rfu r greq q-qt{nTrqr (qFFI (qr (*lTnFI qFrd-oB Frtftrm ye, Iro-
  • 50. (q) l4Ld-+l cttr.ql {{|T<t -6r{6r fuq€€qr ?qr{ T{qrs { qiE (1) ?Ftr.I{I enf,fq Er rEq Fr+rr+r qi t+trr+rr <*Au rr;j vi qCxr, scftr fit c{9, (R) tsrw.qr t+ ve+tdr qrrft q.qcr d qE d 3r{en rrgqr a-qrq 1t+, (i) rfrr{ndr+1 qEfla;Fin gtT }rqdr {hfqTd rFiqi {rftr (a R-cftte.r6f 5arrs-++a lri, rvr :{mrf,t a.'ctt rri'{ Harz qrtffi rrq-<l gtrqerfrr aqr qrff,ft r ftcira6f+1 ft-+rq q<qr 6sft rrd{ rlq fuq{cr 3ner< qn atr+r htfrrr .rt q-<e r (B) fu* qfrE rrt rdrqcnqrrfd ffirrq;tz qrXff-rah;r / serfl{+i errdrdri rrfuq tst *ie r qt { rrfti qrcrtffii €fuflF+.srq r 6+rffi f4ftrdri rri< qr+ k1 q,.is r (q) rJurtr{ Frcasr+l rsar qrrr+1 fiql, 9q}mmT6rt r-qoi gq-fiilrFc*1 trffi rq flq siu r rd qrrcr a-ql sr6{"ra6+i (q{r irur4nr6 r grrit vr-+-rurro rftr eq eG cfu sff+l qfrrffiotqr (+d {cr+fl r{ q.ia r r*o sq-6{"r61 fia-S orr{r M k{iq RqAsT rFt q-ie (1) grs-{ur41 r+n, dfsq rqr r kftre rqt 3f|Iiq r{ drt4 q+ nrgr 3ilgfi !-{rff{drT {Tftrr+d qrftr d{cq {rd {ffi{, (R) grEEtlr qftE fuft iTqr iJT6{sr rqi, Tfrrr t -*-fit ar r{-d qrrR lrftq+J fi-d 6I fr dI Pfl{"T 3{Rr+q rt, rir rsrr+2ffi rrqd rqdt qq-trrt, txtqRAsF€, *q( cra{ r q{a irrrrd 6.fi qq q}Tr+], tu 4lto-& {{rq Et fufr, rsr sft{ 'ial E{ vi-d r&d En rrft Fr* aqr rrci, trd rqt tqqls rrft rdtqrndrff{r Eq{tr (a) vflf,{sr+i qrftr Eri-nq{ t oy-ool, oy-ooR, 3nk {sqr 3r{[ff+J oY l1qfi ffi looY I q-ar$ aq< $liE{trr rER ri qrr$er 3r.nffi Sizr q6 st{" qM qrd { qd-S6t q-q rEradt srf{or+i nq5qrg q{rdBi I (rs.) rAfi grdE{orcr {* ffiqar r rr{ +na6r 3n?R qttrd t6r@r frcrsq {trer ft-fisr cAq qq+1 qlr{6 @t q1 wia t (r) Ti {il#dr+1 qrftr .rftt q{( {Tr.dr atk61 r h-qrrqrq-rt, Hr€q rfrrmrdr errrir dql qElrdn qTs(Eg {qift FTtftr+r {o ,2 a__--
  • 51. €re4 q*rraTnTr erFr4T dqT iTEIIiFI qrErg qqdft FT*ftI+r (,R {1 rt) irrfiGr qiq r €rftatsn (qdl 6nfd erft{+q, (i) sdrrfiFnc d c,id rit rffqd rrq Mr+l Brfi{nq, (y)gqiF{sr sqm{6r rrcr ifuC+I 1i trerrr, {Htrrr+1 mtT rf@ F6qrs-dTc, firsr vcftrri+i ilrffT rrnr+l *6-3{q (qnft {qrfl?T I (q) srcE{uFfi Trr€n srKqr -6rtrdr fuq.€{ qflr+q .Ft si6 r (i) {TsI 3ng+1 fuft < vqatorm rfrrrqr r${ B@r frtd, t trgr 3nq+J 6Rsr, (?) (Fsr {qr$r++1 qTFr q@ ace, aqff-cdicTz q+ t-ar sc-far q'+i rrq fr vffiI fq-{<qr (v)tn rfr{rqr a'+1 fufu, rffi rrqr vtfficT d ct 4iin ffir+] lrqfi ffi k{iur Er (TTFIEFI arttr w+l +ni+i qtleTul r irfirrqr r+1 {+d r.irR qr qftii{s srrq rdq qr+l n-{q atgr.+1 gt rte
  • 52. rrc* t rfr{rrnil (tcfl rfuflrqr+I it+o S(E|T (Biosafety] r fi< grrr (Biosecurity): (1) qrurflT dffi -{i ik+ {len r fi-a {rm sd ild err6 r { fI tE ks[66 fd-drm Ftrf, cr{ | sraRq 3{?iqr "dfuq Vet qfr frqulqz qtffi g(w d n qf - frq Vw qane qtffeEz @ gftir rl al r' 1qy $fa+ qrur r trra gtrrot {q shq rfrqqnqroff, {T{rq, qttrw{ur ( rfrrmrTqEFr if++ qrqr,lM drq il | A Fl{ferdrqr +ryi <ar+r r*{rlrrdrF€fr it{fi $elr { fi-q $eTr+1 (EreIqT qm{r .r=t qi qnrri"r 3nqirrdrr[+] hq{cl gdq rrt(r+td I (i) 3{..Ilqt{6 tIfr{fYnTlTEt biosafety level laboratories (BSL -3, -4) cT qIURuf sfrrrw{r+] Ectrrr it++ gur*r arerfi:n wr.rd€ qqdq+.r@ q-q r rqtwnm iko {{{rr rftmrqr it++ ({eIri unintentional exposure to pathogens and toxins, or their accidental release n[r{ ffi i5rtinlrt *rqiqq-{ rFi6I qTftf containment +1 igar<, vt{Pd { 3{r{rfi+J qtcr qr+fift rrrg+d r cfrlmrfl d-{ $fl[ (l ) ffrrfcfrdr *s $S{la valuable biological materials (vBM) within laboratories, in order to prevent their unauthorized access, loss, theft, misuse, diversion or intentional retease tnf rM ilftr grm, ta-u-aur t irffi iltH qri-firfl rRrs{d r r rfrrnrrqr ik+ gten i df{ g{eTrn hftrq ilfUc-awtii ow rr;i rq< rrr4 il{ ff c;n 3r+i6r Ta6 6-{ r rfr{reTrqr ++ $eTrflii nql Tqtrnrmr +t{+ $Hr+1 qqr+l trqr fa-firt rri c-fu r T^,P r.1greq sfrrrqTrqt eIFr;II iTelr { *rriFl qTT{Erg {E-tft friftrET
  • 53. Erezl q-frrmrrfl eIFriTI iT?tr (EITqiI ff.rt'g gq+ft trifqr+t t {t rftryfl-dr$m (1) e-&+ tr*rrerrqri raizrqmq q-{cffi fit { rt;i 5{ rftnrrur qturar 3rqRTd qer66ilri TiI rA+1 fi rcs r rfr.rsrrdr {telrfi 3{rcrRTT rle[rn t6rq u-gn v*u rft.+J s I CO Chemical safety* lBox{}: preventing chemical hazards by implementing chemical hygiene (all aspects of safe chemical handling) (l ) Proper labelinB, storage, utilization and disposal (i) Provision ofchemical hood (?) Use of gloves and other appropriate PPE (Y) Reading bottle labels carefully and double-checking the name of the chemlcal (EI) Elological safetyi preventing biohazards with the appropriate means of biosafety and biosecurlty (lD Radiolotical safety: preventing potential radiolo8ical exposure and hazards by implementing appropriate use, disposal of waste, preventive and corrective actions (q) Flre safety; preventing /minimi2in8 fire ha2ards with the use of fire alarm and extinguishers as appropriate Cir) Eledric safety: preventing,/minimizing electrical shock, by maintaining appropriate wiring, power supply and back-ups. CiD lnstrumentation safety: preventing hazards resultinS from inappropriate instrument manaBement (1) Breakage of glassware (l) Handling of sha.ps (l) Use of pressure equipment and tas cylinders (Y) Leakage of radioactive elements ({) Extremes of heat and cold environment inside the lab (q) Malfundioning equipment posing risk {e.9., potential electrical shock)
  • 54. (1) rrtrrflr{rcr fld rri {-qJf 6.ffin iiq-6 $sn { fi-4 {{err (ld-d+i 3rRrRXi rfr{nTrqr $eTr (qnft ilkc w< qt+i EI rfu r (i) g11<(6l (R) Edffiq offi arffrc crH rrizn fffi{q {qeft (Rra-{6t qm qr+1 eqa iqr .r-i q-fr tft rfrrnrrqrqr g{ierfr q-{ qE-d r (Y) sc+Fr (1) {frfuq-+1 3rftrroli drfu{cr krr.iFr frm-+ryr vaffir flc-fu1 lio Handling, precautions, risks, exposures and safeguards for blood-borne pathogens ({0 Proper use of PPEs (prior to employment and periodically thereafter) on (l) when to use (R) Which PPE to use (i) How to use (Y) Their limitations ({) Proper care, maintenance, useful life, and disposal ofthe PPES fi) Use of cryo8enic chemicals: dry ice and liquid nitrogen (for shipping, receiving and/or storage of specimens, supplies, and reagents), based on need. (II) Transportation of potentially infectious materials F[req sdIrrqTr{r TqFFrr (qT {qpq4 qsqr-g (E-dI FTtfr6r {y Box4.*Material safety data sheet (MSDS) MSDS is the technical bulletin providing detail hazard and precautionary informafion. Laboratories must maintain the MSDS for all chemicals they use. Laboratories need to follow precautions listed in the MSDS in order to ensure the chemicals they use are handled and stored safely. The MSDS provides- . product information; . fire and explosion precautions; . toxicology; . health effects; . recommended PPEsj . storagerecommendations; . leaks and spills-recommended actiofs; . waste disposal recommendations; . first aid and health reactivity The MSDS should be- . available to all employees prior to use of hazardous materia s; . keep close to where the hazardous material is used and located Trt€
  • 55. (O Wastemanagement/biohazardcontainment (g) Generalsafety (it) First aid (8ox-5 :II cdq fiq r{qT-+lt CiiI) staff traininS should always include information on safe methods for highly hazardous procedures that are commonly encountered by all laboratory personnel and which involve: (1) lnhalation risks (i.e. aerosol production) when using loops, streaking agar plates, pipetting, making smears, opening cultures, taking blood/serum samples, centrifuging, etc. (l) lngestion risks when handling specimens, smears and cultures (l) Risks of percutaneous exposures when using syringes, needl€s and sharps (Y) Bites and scratches when handling animals ({) Handling of blood and other potentially hazardous pathological materials (q) Decontamination and disposal of infectlous material. ikogwrfrtu iP++ $er { f,tzr {iur {-qRfr wpi lilslar{ (d?rt rrffi ffi {rkq rrseq qd-.nrrd{E;T 9frrp6qr trqaft erfqts ga q{r 6ffi it+a $eTr sAE6+1 nqqr rrfuq q+sreq rfrrnTrdrn f+qm rr{ rfu t qqr{ dt6il: €r€q q-dtrnrrdr erFnl dqT rr=rTiFr qF[ -g se-+ft h{ftr+r u p€ 8ox-5,First Aid Box The first-aid box should contain: 1. Instruction sheet givinS general tuidance 2. lndividually-wrapped steriLe adhesive dressings in a variety of sizes 3.sterile eye-pads with attachment banda8es 4. Triangular bandages 5. Sterile wound aoverings 6. Safety pins 7. A selection of sterile but u11medicated wound dressings 8. An authoritative {lrst-aid manual, Protective equipment forthe person rendering first aid includesl 1. Mouthpiece for mouth-to mouth resuscitation 2. Gloves and other barrler protections against blood exposures, and 3. Clean'up kit for blood spills
  • 56. (1) qqr{ qtddr rr* qr{itdld-df{Fq cfrRr (cMTs) an *nmrp qT?FqiFalT $r rFial {rtr 3{r{erEF Tfrrrcl|mT :riqrq r qffi {ff d r (i) s-*fi rfrrRnfli ffi srs {a+1 ilftr {{Hr qr ffqrr{d 6qr(i ctFTq {i (qrr{ qr{qrr6i 3rr+rsTrr fi+ sd M rers" a qm mr;tait erftr ffifq 3nqr€ t teftF{ qqnrst dB r (l) 3nzrr(T {kd-+T qF€T]i 3Fftrr{qlr r r+f,I+< rrt c+ hftr-df t6rq 3r{{R sdq ftqds I (4') ff{: g;.roortanisms of Risk Category 2 or higher risk catetories handrenfti *t6rdil fr{rcr q<iTrlqq erfrffi (-+a ra-"r+l fue: I {r ?sl{q qd) qtfiFi FrrII {rq wig r rd +i-drcT i{dr F<*qr t6rq u-5rr< rlrffi r (1) [frtnrrf,I +r{ sqrrq rr{ et{qr sTrftr+rtm qfusri qr{ c+sr rc1 rfu, (1) rfrrrsnfffir il6r6{ {i e-< nq wia, (i) e-frrnnqr +r{etTqr {qr q+dT-{ qalr f<{ E+{, (Y)Access to animal houses should be specially authorized, ({) No animals should be admitted other than those involved in the work ofthe laboratory. AOMITTAI{CE IO AUTHOBIZEO PERSONNEL ONLY R!5ponslbl. lnv.stig.tor: ln c.l! ot.m.r!.,rcy call: Oryrlma Fhonr: _ Hom. phon6: A!$orh.tlon lor.nlranc. must !. oDl.ln.d kom ln. A'rpon bl. lnv.rugrto. n.h.d .bow. greq q-zilrrqlqr (qFrifl (qI €qrd{ qFKEg tq+ft frtftr+r Na_ {q BIOHAZARD
  • 57. €r€4 r{t{rqrt{r eIFHT dqT q*ffi{ qFrflrg frq4fr iitftEr T'W {e Hr t crql M {Ad 1q1 qfu.lrf, S{erx rfr{Rrrer (q+ft 6Efcr tarq-a qfurn $en r++qq qtt rfu r (i) TfriT{trfi (qift 6r.t wql-{r rtEt Laboratory aprons, gowns itt uniforms 3{tFIRiTqqT qrn-et rfa (1) T*{t{rrdr {E-;tft 9-&fi ctfql-tr{ q€ direct or accidentat contact with blood, body fluids and other potentially infectious materials or infected animals v.f 4Ff {qt(i-+1 s-ffi gf{i6 Tdtq qrrr$t q-t6, Tm.I qrqrd, [fr{r ffq"i rfrtt-qr-i frqqrryR f{flnin rrft qffrcrd FT{r rre q1 wia, (t) l{firtriF {q6[ { s-{r{r6{ ini HandtinS rttgfu iTqI Tmrm-qr+l 6r{vqrfi eh d{t 3{fu a'ffi 3rffir{ 6rd TI c.ig, tvt qiql t ffi splashes, impacting ob.iects and sources of artificial ultraviolet radiation gfe e-qf${+1 qrftr safety glasses, face shields (visors)!{T sfel $Hfa[6 gqiFfuf66 qfoapf ffiqf a.rru-1 rfu, (t ) q-*rr{nf,r+t gtur va-*ft 6c-gr6{-drt rqt nrrqr erP6{ r gflflqr+l qrftr flrd-{, otn sc, :Frqi-{q 4t6r, qrgnft, -48fu, 3nfu YAn rFi {+q qrrEr+td, (E) g<r+f ei-{ tH Ef,t (open-toed footwear) T{iITqTTqrqT vdrrt .r{ dn, ($) rfr.ryrTtnm] fr{cr qri, Frei, {scn rTt, *-df-s ffqFfr g-fr{ ri, 6q{r€ ffi yfrq ri qrar +nffi +ie (q) n*{Isrrd arrieirn qr;rq qlq T(Iffi rT!-gRsrmri {+{ ilrEq6t4 (R,) {frrtsTrdTrcl q-ftrT qq6r $eTr(rw Tfrrmrrdr {qdft 6qgrF{ 3rq +TsI <rtcq+t <fiq qT fiFr+fl rrq &t r (rT) F4ftr6a s-fr{Hnqr (qift zrrfqr t6rffi Hftrrt cm{r rr{ c{u. (1) Mouth pipettinS qTt {"tdqr q-+q qTt{r6t6, (i) E+ ci{ ffcFi-66 Tqcr rtq q+{, drd qrq1 &{,
  • 58. (l) All technical procedures should be performed in a way that minimizes the formation of aerosols and droplets, (Y) The use of hypodermic needles and syringes shoutd be limited. They must not be used as substitutes for pipetting devices or for any purpose other than parenteral injection or aspiration of fluids from laboratory animals, ({) All spills, accidents and overt or potential exposures to infectious materials must be reported to the laboratory supervisor. A written record of such accidents and incidents should be maintained, (q) {q{ spilts 41 decontamination 1 1ls'ri+i ertr kkd t{ftr a-qn lltt qr"rcr Trt q{g, (3) Contaminated liquids must be decontaminated (chemically or physically) before discharge to the sanitary sewer. An effluent treatment system may be required, depending on the risk assessment for the agent(s) being handled, (cl Written documents that are expected to be removed from the laborato.y need to be protected from contamination while in the laboratory. (q) s-fr{Rnqr or{ f* rftnrro 6r{i &-{ AErq rlvn-+1 6 vta (1) The laboratory should be kept neat, clean and free of materials that are not pertinent to the work. (l) Work surfaces must be decontaminated after any spill of potentially dangerous material and at the end of the working day. (l) All contaminated materials, specimens and cultures must be decontaminated before disposal or cleaning for reuse. (Y) PackinS and transportation must follow applicable national and/or international regulations. ({) When windows can be opened, they should be fitted with arthropod-proof screens. (s) Tqtrnnmr+J tr-qrrr r (fuarro: rfrrrsrrqr+l ts-qrrc ll-d t 6Fi ftqrs{ rr<f, g<err-r retaa miaacrg ks}s rrFr Sgrst {{a I frqTr{ 6Fiqr A€rr6I fl{u.{qr ran gqqr${ q-f,d I (1) Formation of aerosols (lt work with large volumes and/or high concentrations of RrezT rfrrrcrrdll eIFriT dsIT {qfffi qFr{!-g (qdft FT{1}r6r {c [t a----
  • 59. microorganisms (i) Overcrowding and too much equipment (Y) lnfestation with rodents and arthropods l{) Unauthorizedentrance (q) Workflow: use of specific samples and reagents. (q) It{ifrtq]rmtisl fe-qrfffr ks1q-f,r6{ (oesirn features}: s{irrIgrdr+] fu-qrfiqr tarr+r t+lkarrt 61 wia r (1) Ample space must be provided for the safe conduct of laboratory work and for cleaning and maintenance. (l) Walls, ceilings and floors should be smooth, easy to clean, impermeable to liquids and resistant to the chemicals and disinfeqtants normally used in the laboratory. Floors should be slip- resistant. (i) Bench tops should be impervious to water and resistant to disinfectants, acids, alkalis, organic solvents and moderate heat. (Y) lllumination should be adequate for all adivities. Undesirable reflections and glare should be avoided. ({) Laboratory furniture should be sturdy, Open spaces between and under benches, cabinets and equipment should be accessible for cleaninE. (!) Storage space must be adequate to hold supplies for immediate use and thus prevent clutter on bench tops. Additional lonS-term storage space, conveniently located outside the laboratory working areas, should also be provided. (e) Space and facilities should be provided for the safe handlinS and storage of solvents, radioactive materials, and compressed and liquifled gases. (c) Facilities for storin8 outer tarments and personal items should be provided outside the laboratory working areas. (1) Facilities for eating and drinkin8 and for rest should be provided outside the laboratory working areas. (1o) Hand-washing basins, with running water if possible, should be provided in each laboratory room, preferably near the etit door. (11) Doors should have vision panels, approprlate fire ratings, and preferably be self- closing. qreq sfrrrqrl{r rqFF dqT { €rTnFI rlFrflg {q+fl FTtftrfir jtrt {1
  • 60. (11) An autoclave or other means of decontamination should be available in appropriate proximity to the laboratory. (li) Safety systems should cover fire, electrical emergencies, emergency shower and eyewash facilities. (1Y) First-aid areas or rooms suitably equipped and readily accessible should be available. (1{) ln the planning of new facilities, consideration should be given to the provision of mechanical ventilation systems that provide an inward flow of air without recirculation. lf there is no mechanical ventilation, windows should be able to be opened and should be fitted with arthropod-proof screens. (lq) A dependable supply of good quality water is essential. There should be no cross-connections between sources of laboratory and drinking water supplies. n9) There should be a reliable and adequate electricity supply and emergency lighting to permit safe exit. A stand-by generator is desirable for the backup of essential equipments, such as incubators, biolo8ical safety cabinets, freezers, etc., and for the ventilation of animalcages. l1q) There should be a reliable and adequate supply of Bas, if needed. Good maintenance ofthe installation is mandatory. (1c.) Other measures should be considered and applied, as appropriate, to augment laboratory biosafety and security. (6) it+a $frr gqinlrrc yfrrrqrwrr{qr taru r1trr+r itc-fi $Hr sr6{ur6{ sq(er qI .rfg r (1) Pipetting aids - to avoid mouth pipetting. Many different designs are available. (1) Biologicalsafety cabinets, to be used whenever: - infectious materials are handled; such materials may be centrifuged in the open laboratory if sealed centrifuge safety cups are used and if they are loaded and unloaded in a biological safety cabinet - there is an increased risk of air borne infection - procedures with a high potential for producint aerosols are used; these may include centrifu8ation, Brinding, blendinS, viSorous shakinB or mixinS, sonic disruption, openin8 of containers of infectious materials whose internal pressure may be different from the ambient pressure, intranasal inoculation of animals, and qfeq qri-rfqnqf Eqrqdr (qT E .*llqir lo sq+ft tttftr+r r,o
  • 61. (i) (Y) ({) harvesting of infectious tissues from animals and eggs. Plastic disposable transfer loops. Alternatively, electric transfer loop incinerators may be u5ed inside the biological safety cabinet to reduce aerosol production. Screw-capped tubes and bottles. Autoclaves or other appropriate means to decontaminate infectious materials. Plastic disposable Pasteur pipettes, whenever available, to avoid glass. Equipment such as autoclaves and biolotical safety cabinets must be validated with appropriate methods before being taken into use. Recertification should take place at regular intervals, according to the manufacturer's instructions. 1l) (e) strr n) sM aFrerFFr { kslia 6Fi it+o $en htftr+r qfrtdq mi sia r {l) mift aq I rhtt( (contaminated materials and wastes) +1 q+eirq-t t t+q.h kfd ffi qo-sfi sdq ffi'+t-6 | (6) The principal questions to be asked before discharge of any objects or materials from laboratories that deal with potentially infectious microorganisms or animal tissues are: (1) Have the objects or materials been effectively decontaminated or disinfected by an approved procedure? (l) lf not, have they been packaged in an approved manner for immediate on-site incineration or transfer to another facility with incineration capacity? (i) Does the disposal of the decontaminated objects or materials involve any additional potential hazards, biological or otherwise, to those who carry out the immediate disposal procedures or who might come into contact with discarded items outside the facility? (q)Steam autoclaving is the preferred method for all decontamination processes. Materials for decontamination and disposal should be placed in containers that are color-coded according to the nature of waste products (red for infectious wastes - nonsharps; yellow for infectious wastes - sharps; black for non-hazardous - general wastes). (lT)An identification and separation system for infectious materials and their containers should be adopted. Cate8ories should include: (l) Non-contamlnated (non-infedlousl waste that can be reused or Rrezl rtrrF{rrdTr SFFII dql <=tTnFI qrrflg iu"R Frtfsror il
  • 62. recycled or disposed of as general, "household" waste (l) Contamlnated (lnfectlous) "sharps" - hypodermic needles, scalpels, knives and broken glass; these should always be collected in puncture- proof containers fitted with covers and treated as infectious (l) Contaminated material for decontamination by autoclaving and thereafter washinB and reuse or recycling - . Contaminated material for autoclaving and disposal . Contaminated mat€rial for direct incineration. (q) af{q} irt{ (sharps)+l rdrrr r i{fl.iT tam er-ffiR rFt c?i6 r (1) After use, hypodermic needles should not be recapped, clipped or removed from disposable syringes. The complete assembly should be placed in a sharps disposal container, Disposable syringes, used alone or with needles, should be placed in sharps disposal containers and incinerated, with prior autoclaving if required. (l) Sharps disposal containers must be puncture-proof/-resistant and must not be filled to capacity. When they are three-quarters full they should be placed in "infectious waste" containers and incinerated, with prior autoclaving if laboratory practice requires it. Sharps disposal containers must not be discarded in landfills. (g) Contamlnated (potentially infectious) materials fo. autoclaving and reuse:No pre-cleaning should be attempted of any contaminated (potentially infectious) materials to be autoclaved and reused. Any necessary cleaninS or repair must be done only after autoclaving or disinfection. (q) Contamlnated (potentlally inf€ctious) materlals for dlsposal: Apart from sharps, which are dealt with above, all contaminated (potentiallv infectious) materials should be autoclaved in leak-proof containers, e.g. autoclavable, color-coded plastic bags, before disposal. After autoclaving, the material may be placed in transfer containerc for transport to the incinerator. lf an incinerator is available on the laboratory site, autoclaving may be omitted: the contaminated waste should be placed in designated containers (e.9. color-coded bags) and transported directly to the incinerator. Reusable transfer containers should be leak-proof and have tight-fitting covers. They should be disinfected and cleaned before they are returned to the laboratory for further use. Discard containers, pans o. jars, preferably unbreakable (e.9. plastic), should be placed at every work station. when disinfectants are used, waste materials should remain in intimate contact with the disinfectant Hre{ Tqt{rsTrqr errril aqT qEltr.fi qtqrys se?ft Friiqr4r i)r
  • 63. (i.e. not protected by air bubbles) for the appropriate time, according to the disinfectant used. The discard containers should be decontaminated and washed before reuse. qr€q sdrrraTld[ iqrq;rT (qr q€Itfi ql.r{Irg {q+ft FTiler4T ita
  • 64. qq* s Llst of routine and specialtests Cllnical Biochemistry Routine lest3: Plasma/ Serum: glucose, urea, creatinine, total protein, albumin, bilirubin, AST, ALT, LDH, alkaline phosphatase, acid phosphatase, CK & CK MB, electrolytes, calcium, phosphorus, cholesterol, triglycerides, HDL cholesterol, uric acid, amylase, T3, T4, TSH, FSH and LH (except by RIA). Urine: 24 hours for biochemical examination, CSF: glucose, protein, chloride. Effusion fluid and Ascitic fluid: glucose, protein; Calculi analysis Special tests The tests other than those mentioned above. Haematology Routine t68ts Complete Blood Count (CBC), Erythrocyte Sedimentation Rate (ESR), lralariallFilarial Parasite, Blood grouping, Compatibility testing for transfusion, D-Dimer/FDP, PT, APTT, Fibrinogen, Bleeding time, Anti gloubulin (Coombs) lest (direct and indirect), c6 PD screen, sickling test, Special tosts The tests other than those mentioned above. HlstopathologyAll tests are considered special. Cytopathology All tests are considered special. Gonetics / molecular: All tests are considered special qreq Tfrrffirqr (qFF iTqT q *rrd{ qFr{!-g gE-dft f{ftr+r qy Mlcrobiology and Serology Routine Tosts: Urine routine stool routine, Examination of direcl smear and stain preparalion under microscope in bacteriology, mycology and parasitology. Slide and agglutination reaclion, ELISA and automated serological reactions Spscial t€sts The tests other than those mentioned above lt-2
  • 65. S. No Qualitications Oisciplines M.D. (Pathology) Histopathology, Cytopathology, Clinical Pathology, Haematology, Clinical Biochemistry, routine l,Iicrobiology and Serology; Non microbial Flow Cytometry, genetics and molecular biology B lvl.D. (Microbiology) Microbiology and Serology, , Clinical Pathology, routine Haematology(non microscopy) and routrne Biochemistry i microbial Flow Cytometry, genetics and Molecular Biology C Ph.D. (Microbiology) with M.Sc./MMLT (Medical Microbioloqy) Microbiology and Serology, Clinical Pathology; 'microbial Flow Cytometry, genetics and Molecular Biology D M.D. (Biochemistry) Clinical Biochemistry, Clinical Pathology, Routine Haematology (non microscopy), Routine Microbiology and Serology((non microscopy)); Flow Cytometry and Molecular Bioloqy related to metabolic disorders E Clinical Biochemistry, Clinical Pathology, routine Microbiology and Serology, *Flow Cytometry and Molecular Biology related to metabolic diorders F M. D. in Lab Medicine Clinical Pathology, Haematology, Clinical Biochemistry, routine Microbiology and Serology G DCP Histopathology, Cytopathology, Clinical Pathology, Haematology, Clinical Biochemistry, routine Microbiology and Serology H Clinical Biochemistry, Clinical Pathology, routine Haematology, routine l,4icrobiology and Serology M.Sc. in Medical Microbiology Microbiology and Serology, Clinical Pathology, routine Clinical Biochemistry, rouline Haematology. J BScMLT Routine hematology, Routine biochemistry and Routine microbiology K CMLT Tests of D category lab L Lab assistant Tests o, E category lab 3r-td q Qualification norms for authorized signatories and technical supervisors 'PhD should be in the relevant subiect area frcm recognized medical institution / medical universu, which has to be fu -time (not distance education) lollowing an M.Sc. from a recognized medical institution /medical universly €rsr FfrrHlrdr erFrnT (qT qqt-iH qFrfl,g llqnft iTffq[sr t Ph.D. (Biochemistry) with M.Sc. (Biochemistry) M Sc in Medical Biochemistry I"o