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rd-{nrrdr65,A ffi Ed?rR Tn fi+1 Ec q.fu:-
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(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
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operations)
(q) fuqr{ {tdd ffirgi {frtlT (Sterilization facility),
tmt qiAt q+(9fnf++1 Vf5m qt+m (Proper waste management facility),
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management)
tat qtmrra r qrdrfiur+i $eTr (safety of personnel and environment)
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separate activities)
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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.
qrr ilrrT (qr{{ qrRrg {qdft FTtf{rfir
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ri-+r rrnfu-flii q+m rrnfu-w rrqmr rr+ qr{i Aq r
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Ereq fr<qr 3nqrffd r4trrsTmr qis r
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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
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processing and reporting
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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?
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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
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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.
(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
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greq rrirrrqrrqr <qFrnT dfi {qrd{ q[qryg {q?ft FTtftTfir lv
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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
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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.
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39. vi-d rrft Bnftia rrR qri 6ni{r{ f{fdrt6d rr+d r rkil 6rf'qr {ETr{ sfrrrqrmrqrg
q-qttra +rtr efrkq +rrqrfi-+r qrq {rt {qrr{ 3ffi.Fft q|dt qi {i6.tg I
rir rd+ rqfnrrqri uqt rr< rt+J (].qrm 3rtrfr {liqTtR.r{ H rrtr
3nr,n 9-ftnrrdrqT nq rea r arqt vrw rti?lt smrrsTrqr+l qqa r rai (E-4fI ffirur
T*.nrmrn ffi gsmal r{rsi ff:+H qrlTd qr{rcr ctr ?fd Tt i-dq rFt
qd-a r
(i) 9-*{rqTmr6ffi crt{nrrqr sqnfi orri rqrc+ rrci {ffcr t 4a r<r al
renzrqfrrQrrqr (ftffi qrqr{ - private practice l]ifar m ryi+rdft 3{rird
"Ti 6Ri
{qrfi rd qrsi&{ |
€rg s-frrrprrqr emt=tT iIqT qqgl rlrr<o-6 {qftft h{flr+I t1
ilL"J
40. 3r{trftT
uffi r: qdmnfl a-dH ffi 3{rtfi mr1[+i i5{r
rdFrqrrqml irq:
qqd trrr;rr
lqar:
qlv i.
rflzr:
qqlla' d'
s-ftrwmr+l F6f{c
o Tfrrl,Ylfdl t-sr qri r{rd rti yftnllnTr (stand alone Laboratory)
o foreign emplo),ment
o polyclinic/clinicbased
o sfFklTiIHI efmlfad fftt{rrqr (Hospiral based Laboratory)
o ir{SCIFMfrq{IfqT (Rosearchlaboratory)
o isrr T+rr$rfir(ReferenceLaboratory)
o 3rq t+ W G-frd rrfie
qk +wrrrqr 3narft-d d qil, 3rwdrs+1 q:
TEriIEiEr iEFR: gl;T?;I /
te sqr
t{si's-tr
etH ffi 3na-<t f<c +H
q6 (Category of Laboratory)
qrirrrqTrqr qqr a rri grq:
ABCDE
€r€q Ffrftrrmr PITTI;II dql { -IT.FI
qFr(rg (q+ft FTtftffir yo
11",o
41. +cfr{nTrqr qH ?fu rqka e I d! *qtr
qft e lri thozqrwrkfizqrt(+ cftmur rT{r {wI (sampte loail) gdq rr;trtq r
ffinfu-t€flr
NTTI 6rrr
fiil*{t
Ilt[ trrfl 6rt d (6i
vrrq
+fu-q-(
rdI{rPrwr+i ord' *r( Prem ises);
qqr dlrqq(sq ft.):
vreeninr+ qtctnrt
o iffia
*ta ttqr:
qreq rdrrrqrrqr eIFHT dqT fl*n-fi qFmrg {q+fl FTtiqrfir yl
frP
42. O 5gFRI
o Edde
o kE.ftd q?6qq
o dkq q!-fl qrffi qrTft
o rr+rft qtul
o 3rq {fiur66 lrd-e rrt-frqr
EIINT4I ts!.E{|'TFF
NTTI 6qfl TEII ?TFT qqE]TITT
z} a-.H
+hnd
qrFI nq{ tr<i yqrorrr+] mffi gqra q{)
rri qfo C'5TC+1 lfu( t fqtd
ffilC-{R qslft4lt qr {dr{rqTrqT
€r€rr rfrrrqrrdr eIFt;tT (qT Fqffi{ qFIE!-g
(REKI:
lu,,o
f{ii}r6r y?
43. uffi r: e<rfi sr{Tffi qrFr Fnlerur #de-
qdrrrrT66l ;Irq .
tqr.n:... .
hrf*n q-<mr+rftzrqr;iar irrT:. .
Zf,qst{ r ........ lssrfi r
tri{........ .
relir+ ertqrc lllffrrq-+l
ifrf6{Laboratory Category) :
lTqd (d rrCcr saq irffr{l:
ABCDE
I
ffiq{,rr lrffi ( q, 6RT*R r t+fte{rr ffiq-di fqtd
q EKTER
HteTur+l st{q
qtdfr c-r (qrm{ q1ctd
r< +-.t onur r1C 1gds qrt+{)
ictd
cqr+q rtrtr<ft at*+rq
'mffiwr M tfri arw trfufua edrFqn vfuffi qr4p44dr qaft cffiv
qt rFt ql (id r
srea qfrrrqrrer RFr;rT iTqT y.+fl Tft*
yi
)lt.s V---'
44. 1. s-flrfu't€{ll
F+{rqrYrsrz 6Fi
Fiffi
lrell T( frrq-dr +kq(
1. lrfr{mrqrqT sqir4r qC6r hk( <ffi4v6{
. A S-&6 adqfffi CV, Trainingvcompetency, academic certificates flfi qfF dl
qkrrf, Frf{ grdel g ?
. *.it{fi {reTr { t*{ $+Tr vq*ff kka qm+rftrt srtrer st ?
. + {ryf { cterur { trqrf;drq-64+1 ft1 qrEqr+ wfu rqrr< kRrrt gcdar
6{? qk r{ !Ti, + s(-dlii qrfiI rrf{q+1 6 ?
. & s-fr.rsrrqr rjurffi f{a!T rqaft tt-qr+-qrr6{ NEeAS/ EeASqT Fdfiftr q'+1
E?
. d rfrrrqrrqr sr6?qzRsi!-ezfiqrtffi qrftr ta-Szd-<m qrdr s$der d ?
. i ssfiq frrtfirft{tq qrl gq{er B ?
s*rrsTrdr+I q1f'a+ er+sn z qhrrrc:
. i:Frzieti cqiq e t
. + 1@ apfirq qiqur sqnrel E ?
. t t6m6r 6rffi ilftr q{zT S€ +r{fr* q€rsq6} s :
o fttwi
gr*q rfrrnrrqr eIFFIT (qT ltEITIr+ qFrfl-g qq-{ft ffriftrar yy
N,Q
45. o ;r{nT {snrT
o csirr4 { cfteToT
o ftfrf h-drlr
o RgirEz *fu+-qz {rcrffd{r+i q!-eriuT
o ffirr f{suiT6l qrfu $iq-d et{ qryr*qd e r
o & tht6.qri ffin rrd q-fdqd cRaFErg ffid.ri r@ A t
o i tEr r'qr+r+1 eftr grcer gr6wr+i {qr r ra,R sr{m 6 ?
q1p4 gfrqsrrcr €rrq;rr dqT q=tffi{ gTqflr-g sq+fl fiTtftrfir
i]l,+
Y{
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-.-
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
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
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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.
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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
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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
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
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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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