&anuar' $ $%%$ Repea*in! RA 6+$5 other,ise no,n as the
0t is the po*i"' o# the tate to sa#e!uard the inte!rit' o# its territor' and the ,e**-2ein! o# its "iti3enr' parti"u*ar*' the 'outh #rom the harm#u* e##e"ts o# dan!erous dru!s on their ph'si"a* and menta* ,e**-2ein! and to de#end the same a!ainst a"ts or omissions detrimenta* to their deve*opment and preservation4
A"t o# introdu"in! introdu"in! an' dan!erous dru! into the 2od' o# an' person ,ith or ,ithout hisher hisher no,*ed!e 2' ine"tion inha*ation in!estion or other means or o# "ommittin! an' a"t o# indispensa2*e assistan"e to a person in administerin! a dan!erous dru! to himse*#herse*# un*ess administered 2' a du*' *i"ensed pra"titioner #or purposes o# medi"ation4
Re#ers to the pro#essiona* ,ho per#orm the dru! testin!4 Certi#ied ru! Ana*'st7 Ana*'st7 Medi"a* Te"hno*o!ist Chemist Chemi"a* En!ineer /harma"ist Authori3ed pe"imen Co**e"tor Co**e"tor A person person ,ho is authori3ed authori3ed to "o**e"t spe"imen spe"imen #rom the "*ient to se"ure and prevent a*teration a*teration o# 8rine spe"imen4 spe"imen4 14 Must Must 2e at *eas *eastt hi!h hi!h s"hoo s"hoo** !radu !raduate ate $4 Must Must have have unde under!o r!one ne appr appropr opriat iatee train trainin! in!
The pro"edure to a""ount #or ea"h spe"imen 2' tra"in! the hand*in! and stora!e #rom point o# "o**e"tion to #ina* disposa*4 0t pro"edure reuire that the app*i"ant:s identit' is "on#irmed and that a "hain o# "ustod' #orm that is used #rom the time o# "o**e"tion to re"eipt 2' the *a2orator'4 A #orm is used to do"ument the pro"edures #rom the time o# "o**e"tion unti* re"eipt 2' the *a2orator'4
There are hundreds o# an!erous dru!s 2ut the most important and the most "ommon tested in s"reenin! *a2orator' is7 a4 Meth Metham amph phet etam amin inee (ha (ha2u 2u)) 24 Tetrah'd trah'dro" ro"ana ana2in 2ino* o* (Mari (Mariuan uana) a) ;ther parameters that are tested in"*udes7 a4 E"sta"' 24 ;pium "4 Co"aine d4
14 East Ave4 Medi"a* Center The
en!ue in#*uen3a TB and other M'"o2ateria Ma*aria and other parasites Ba"teria* Enteri" diseases meas*es and other ?ira* e=anthems M'"o*o!' M'"o*o!' Enterovirus Antimi"ro2ia* Antimi"ro2ia* resistan"e and emer!in! diseases #or "on#irmator' testin! #or 2*ood donor units (H0?) 4 an La3aro Hospita* > H0? (ero*o!i"a* test) Hepatitis and other T +4 Hemato*o!' in"*udin! 0mmunohemato*o!'
A rapid test per#ormed to esta2*ish potentia*presumptive positive resu*t4 ua*itative test4 Re#ers to the 2od' #*uid that is "o**e"ted #rom a person4
;,nership7 overnment /rivate 0nstitutiona* Chara"ter7 0nstitutiona* Based reestandin! ervi"e Capa2i*it'7 "reenin! La2orator' Con#irmator' La2orator'
App*ied to the #o**o,in! 14 App*i"ants #or river:s Li"ense $4 App*i"ants #or irearms Li"ense 4 ;##i"ers and mem2ers o# the mi*itar' po*i"e and other *a, en#or"ements +4 Candidates #or /u2*i" ;##i"e 54 /ersons "har!ed 2e#ore the prose"utor:s o##i"e ,ith "rimina* "har!e o##ense havin! am impossi2*e pena*t' o# imprisonment o# not *ess than 6'ears and 1da' 64 /ersons apprehended #or the vio*ations o# this a"t
App*ied to the #o**o,in! 14 tudents o# e"ondar' or Tertiar' s"hoo*s $4 ;##i"ers and emp*o'ee o# pu2*i" and private and private o##i"es ,hether domesti" or oversees4
The "erti#i"ate o# a""reditation sha** state the name o# o,ner and head o# the *a2orator' the "*assi#i"ation and va*idit' o# period4 The "erti#i"ate sha** 2e va*id #or a period o# 1 'ear #or "reenin! La2orator' and $ 'rs #or Con#irmator' La2orator' Certi#i"ates sha** 2e si!ned 2' the BH or CH dire"tor
/h'si"a* /*ant 14 "reenin! La2orator' At *east $% sm in #*oor area The ,or area must 2e at *east 1% sm ,ith e=haust #an sin and stora!e "a2inet and a re#4 $4 Con#irmator' La2orator' At *east 6%sm in #*oor area The "*ini"a* ,or area must have at *east %sm ,ith e=haust #an sin sto" room and instrumentation room
A La2orator' o# ,hatever "ate!or' sha** have ,ithin its premises an area ,hi"h "an re"eive or a""ommodate at *east 5 "*ient at a time4 Dith a hand ,ashin! #a"i*it' Toi*et #a"i*it' and a sta** #or the "o**e"tion o# the spe"imen
14 ha** 2e headed 2' a *i"ensed ph'si"ian ,ith "erti#i"ation in C*ini"a* /atho*o!' or "erti#i"ation in C*ini"a* La2orator' Mana!ement trainin! "ondu"ted 2' the ;H4 The ma=imum num2er o# s"reenin! *a2oratories a ph'si"ian trained in "*ini"a* *a2orator' mana!ement "an hand*e is 1% provided the' are ph'si"a**' #easi2*e (,ithin 5 m radius) to supervise4 $4 in "ases ,here the s"reenin! dru!-testin! *a2orator' is a division se"tion or unit o# a "*ini"a* *a2orator' it sha** 2e headed either
2' a *i"ensed ph'si"ian "hemist medi"a* te"hno*o!ist pharma"ist or "hemi"a* en!ineer4 14 ha** 2e headed 2' a *i"ensed ph'si"ian "erti#ied in C*ini"a* /atho*o!' ,ith at *east $ 'ears o# a"tive *a2orator' e=perien"e in ana*'ti"a* to=i"o*o!' or $4 *i"ensed "hemist ,ith at *east a MasterFs de!ree in Chemistr' Bio"hemistr' or a 2ran"h o# Chemistr' and at *east $ 'ears o# a"tive *a2orator' e=perien"e in ana*'ti"a* "hemistr'4
"reenin! La2orator' > sha** have a ne"essar' euipment or it4 Con#irmator' La2orator' > sha** have a ne"essar' euipment #or s"reenin! ua*itative and uantitative e=amination in addition to the 2asi" euipment4
The La2orator' sha** have a""ess to an App*i"ation ervi"e /rovider approved 2' the ;H #or the authenti"ation o# resu*ts4
The La2orator' sha** maintain a re"ord o# a** o# its personne*4 The re"ords must in"*ude the resume trainin! and e=perien"e "erti#i"ation /RC *i"ense in"ident report (i# an') and other in#ormation ,hi"h ,i** esta2*ished the "ompeten"e o# an emp*o'ee4
The *a2orator' sha** have se"urit' measures to "ontro* a""ess to the premises to ensure that on*' authori3ed personne* hand*e or have a""ess to spe"imens or !ain a""ess to the *a24
The minimum reuired in#ormation on the Chain o# Custod' are7 14 0n#ormation identi#'in! the spe"imen $4 ate and time o# the spe"imen 4
tora!e o# La2orator' Reports and pe"imens
T/E ; /EC0ME<
?;L8ME
14 B*ood
Minimum o# 5 m* (,o anti"oa!u*ant)
$4 in!ernai*s 4 Tissue +4 ,eat (pat"h) 54 a*iva (;ra* #*uid) 64 "a*p hair .4 8rine
To 2e determined To 2e determined 1 ;H "*eared Ipat"hJ ,orn #or .-1+ da's $ m* 1%% m! hair (1 "m4 A2ove the s"a*p) 6% m* (in sin!*e "ontainer) % m* ea"h "ontainer
Report pertainin! to spe"imens #or *a2orator' report sha** 2e ept 2' the testin! *a2orator' #or a minimum period determined 2' ;H (1 'ear) A *a2orator' must retain a spe"imen that ,as reported as ne!ative (-) #or a minimum o# 5 da's a#ter re"eipt o# resu*t4 A *a2orator' must retain a spe"imen that ,as reported positive (G) adu*terated su2stituted or inva*id #or a minimum o# 15 da's a#ter re"eipt sha** 2e dis"arded4 A *a2orator' must retain a** re"ords !enerated to support test resu*ts #or at *east $ 'ears A** other re"ords asso"iated ,ith positive (G) resu*ts or a spe"imen under *e!a* "ha**en!e sha** 2e maintained #or an inde#inite period4
The La2orator' sha** #o**o, the ;H pres"ri2ed !uide*ines in the "o**e"tion hand*in! and disposa* o# spe"imens4
14 e**o, > 0n#e"tious ,aste su"h as !au3e pad "ontaminated ,ith urine spe"imen
$4 reen > Biode!rada2*e ,aster (#ood ,aste) 4 B*a" >
14
ru! Testin! @its Dei!htin! s"a*e *ass,areFs used in testin! (2eaer Er*enme'er #*as pipettes) Automati" pipettes Chromato!raphs pe"trometerMass pe"trometer Bio*o!i"a* a#et' Ca2inet
i!nator' must 2e the ana*'st ,ho per#ormed the test4 And a*so the head o# the La2orator'4 or s"reenin! the test resu*t must 2e reported as /;0T0?E ;R
8n*ie pre!nan"' test resu*t a ne!ative dru! test resu*t indi"ates a presen"e o# *ine and a positive resu*t is an a2sen"e o# *ine4
A dru! "erti#i"ate is va*id #or 1 'ear #rom the date o# issue4 Dhi"h ma' a*so 2e used #or other purpose4 / %% > /rivate Hospita*ree tandin! La2orator' / $5% > /u2*i" Hospita*
The #o**o,in! must 2e su2mitted to ;H via BH 2e#ore "erti#i"ate o# a""reditation and *i"ense to operate is !iven7 14 Li"ense to ;perate $4 BH app*i"ation #orm 4 Ma'or:s /ermit +4 1 set o# #*oor p*an 54 List o# personne* *ist o# "redentia*s hea*th "erti#i"ate 64 List o# Euipments .4 Contra"t o# Li"ense (i# #a"i*it' is rented) K4 Cop' o# ;H *i"ense to operate 94 o"umentation o# CC
Certi#i"ation #or ua*it' Contro* tandard 'stem 2' a ;H re"o!ni3ed "erti#'in! 2od' (Con#irmator' La2orator') /ro#i"ien"' Testin! Resu*t
/ro"edure Testin! Manua*
14 $4 4 +4 54
0t sha** 2e #i**ed 9% da's 2e#ore the e=piration o# *i"ense Li"ense to ;perate App*i"ation #or rene,a*
The 2ureau or the CH ma' "ondu"t a visit on the site (La2orator') unannoun"ed4 And the monitorin! sha** 2e do"umented the overa** ua*it' o# the *a2orator' settin!4
Li"ensea""reditation sha** 2e !ranted in a""ordan"e ,ith the pres"ri2ed reuirement o# the ;H A *i"ensea""reditation that is not rene,ed on the e=pir' date sha** 2e "onsidered *apsed and ,i** 2e "an"e**ed4 An' "han!e in mana!ement name or o,nership #*oor p*an re*iever euipment et" sha** 2e reported to the ;H via BH4 Li"enseA""reditation sha** 2e p*a"ed in an area ,here it is seen 2' the "*ient
14 0ssuan"e o# #raudu*ent resu*t pena*t' o# imprisonment #rom 6 'rs and 1 da' to 1$ 'ears #ine ran!in! #rom 1%%%%% - 5%%%%% $4 ai*ure to prote"t the "on#identia*it' o# a dru! test resu*t 4 ai*ure to parti"ipate in a pro#i"ien"' testin! +4 ai*ure to re#er a positive resu*t to a "on#irmator' *a2orator'4 54 Re#usa* to CH to inspe"t their *a2orator' 64 An' a"t ,hi"h is "ontrar' to the a""epted "*ini"a* *a2orator' pra"ti"e4
Based on its o,n inspe"tion o# an' "omp*aint it sha** 2e investi!ated and a#ter due hearin! and dependin! on the ud!ment4 Revo"ation or suspension o# the *i"ense ,i** 2e done4 0# an' vio*ation is done (under se"tion 1.) preventive suspension sha** 2e done4 And shou*d not 2e more than 6%da's
A La2orator' ,hose "erti#i"ate o# a""reditation has 2een revoed ma' 2e reapp*' #or the issuan"e o# a ne, one upon "omp*ian"e ,ith the reuirements esta2*ished hereunder andor the "orre"tion o# the de#i"ien"' or vio*ation4
