DRUG TESTING IN THE PHILIPPINES

The best practices for drug testing in the Philippines are based on the general
princi
principle
pless tha
thatt hav
have
e bee
beenn est
establ
ablishe
ished
d int
intern
ernati
ationa
onally.
lly. The
They
y are des
design
igned
ed to
ensure that the entire drug testing process is conducted to give accurate and
reliable information about client/donor/subject’s drug use.

Background

Republic Act 9165 otherwise known as the “Comprehensive Dangerous Drugs Act
of 20
2002”
02” mamandndat
ates
es the
the DeDepa
part
rtme
ment
nt of HeHeal
alth
th to over
overse
see e and mo moninito
torr th
the
e
integration
integ ration,, coord
coordinatio
inationn and superv
supervision
ision of all drug rehabilit
rehabilitation,
ation, intervent
intervention,
ion,
after
after-ca
-care
re anandd fofoll
llow
ow-up
-up prog
progra
rams,
ms, proj
projec
ects
ts and ac acti
tivi
viti
ties
es as we wellll as th the
e
establ
est ablishm
ishment
ent,, ope
operat
ration,
ion, main
mainten
tenanc
ancee and mana
managem
gement
ent of pri privat
vately
ely-ow
-owned
ned
drug treatment rehabilitation centers and drug testing networks and laboratories
throughout the country, in coordination with DSWD and other agencies. The
responsibility of the DOH, through the Bureau of Health Facilities and Services
(BHFS,
(BH FS, former
formerlyly the Burea
Bureauu of Lic
Licens
ensing
ing and Regul
Regulati
ation)
on),, is to license
license and
accredit drug-testing laboratories (DTL) to assure the quality, competence and
integrity in the conduct of drug testing.

The Ea
The East
st Av
Aven
enue
ue Me
Medi
dica
call Ce
Cent
nter
er is de
desig
signa
nate
ted
d as th
thee Na
Natition
onal
al Re
Refe
fere
renc
ncee
Laboratory (NRL) for Environmental and Occupational Health, Toxicology and
Micronutrient Assay by virtue of Department Order No. 393-E s. 2000. The NRL
in coordination with BHFS shall assure the competence, integrity and stability of 
drug testing centers nationwide.

Objectives
1. Sta
Standar
ndardize
dize the proc
procedu
edure
re of dru
drug
g tes
testin
ting
g ser
servic
vices
es in the Phil
Philipp
ippine
iness
among all stakeholders
2. Imp
Imple
leme
ment
nt qu
qual
alit
ity
y assur
assuranc
ance
e prog
progra
ram
m in drdrug
ug test
testin
ing
g lab
labor
orat
ator
orie
iess
nationwide.

Scope
This covers all accredited government and private drug testing laboratories in the
Philippines.

Functions

The BHFS is mandated to formulate and establish the standards for regulation of 
hospitals, clinics and other health facilities and to enforce standards that shall be
the basis of issuance of license/accreditation of a facility. In accordance with this
mandate, BHFS shall be tasked to:
 

a) De
Deve
velo
lop
p popoli
lici
cies
es and gu guid
idel
elin
ines
es on es esta
tablblish
ishme
mentnt,, op
oper
erat
atio
ion
n anand
d
monitoring of drug testing laboratories.
b) Co
Cond
nduc
uctt accr
accred
edit
itat
atio
ion
n of al
alll priv
privat
ate
e and go govevern
rnme
ment nt dr
drug
ug test
testin
ing
g
laboratories.
c) Cond
Conduct
uct tr
traini
aining
ng of DOH reg
regula
ulator
tory
y offic
officers
ers..
d) Cond
Conduct
uct rese
researc
arch
h and deve
develop
lopmen
mentt of drug testtesting
ing and other rela
related
ted
activities

The NR
The NRL
L fo forr EnEnvi
viro
ronm
nmen enta
tall an
and
d Oc Occu
cupa
pati
tion
onal
al HeHeal
alth
th,, To
Toxi
xico
colo
logy
gy an andd
Micronutrient Assay is mandated with the following functions:
a) De
Devevelo
lop
p comp
comprerehe
hensi
nsive
ve proc
proced
edur
ural
al and sc scie
ient
ntif
ific
ic st
stan
anda
dardrdss for
for all
all
aspects of drug testing program.
b) Promot
Promote e quality as
assurance
surance p progra
rogram m in all drug test
testing
ing labor
laboratorie
atories.s.
c) As
Assis
sistt DO
DOH H dedesi
sign
gnat
ated
ed agen
agencicies
es in th
the
e cond
conducuctt of acaccr
cred
edititat
atio
ionn of 
confirmatory laboratories for drug testing and in the evaluation of test
kits and reagents.
d) Resolv
Resolve e conflict
conflicting/c
ing/challeng
hallenge
e results among confconfirmator
irmatory y laborator
laboratories.ies.
e) Train ttechni
echnical
cal staf
stafff of dr
drug
ug te
testing
sting la
laborat
boratories.
ories.
f) Cond
Conductuct res
resear
earch
ch and deve
develop
lopmen
mentt of dru
drugg testi
testing
ng and otheotherr relat
related
ed
activities.

LABORATORY PERSONNEL

The laboratory must have suitable qualified personnel.

DTL Owner

Head of Laboratory

Technical Personnel Administrative Personnel

 Analyst Clerk 
 Authorized Specimen Collector Secretary 
Laboratory Aide 

Organizational Chart 

Qualifications of Personnel

Head of the Laboratory

1. In a S
Scre
creeni
ening
ng La
Labor
borato
atory
ry mu
must
st b
be
e
 

a) a li
lice
cense
nsed
d ph
physi
ysici
cian
an cert
certif
ifie
ied
d in Clini
Clinica
call Pa
Path
thol
olog
ogy
y by th
the
e
Philippine Board of Pathology; or
b) a lic
licens
ensed
ed physi
physicia
ciann tra
traine
inedd in labor
laborator
atory
y mana
managem
gement
ent and
drug testing operation.

2. In a Co
Confi
nfirma
rmator
tory
y Lab
Labora
orator
tory
y must b be
e
a) a li
lice
cense
nsedd ph
physi
ysici
cian
an cert
certif
ifie
ied
d in Clini
Clinica
call Pa
Path
thol
olog
ogy
y by ththe
e
Philippine Board of Pathology with at least two (2) years of 
active laboratory experience in analytical toxicology, or
b) a lilice
cens
nsed
ed chchem
emis
istt wi
with
th MaMast
ster
er’s
’s de
degr
gree
ee in Ch
Chem
emis
istr
try,
y,
Biochemistry or a branch of chemistry and at least two (2)
years active laboratory experience in analytical chemistry.

NOTE: In cases where a drug-testing laboratory is a division, section or 

unit
unit of a ClClin
inic
ical
al La
Labo
bora
rato
tory
ry,, it ma
mayy be he
head
aded
ed eith
either
er by a lice
license
nsed 
d 
phys
physic
icia
ian,
n, chem
chemisist,
t, me
medi
dica
call te
tech
chno
nolo
logi
gist
st,, ph
phar
armac
macist
ist or chem
chemicical 
al 
engineer.

The Head of the Laboratory must have the following training in:
a) The
Theory
ory and prac
practic
tice
e of the dru
drug
g testi
testing
ng proc
procedu
edures
res used in the
laboratory;
b) Chain o off custo
custody,
dy, re
report
porting,
ing, and recor
record d keep
keeping;
ing;
c) Revie
Revieww and inter
interpret
pretation
ation of test result
results;
s;
d) Qua
Qualit
lity
y assu
assuran
rance
ce pr
progr
ogram;
am; anand
d
e) Dange
Dangerous
rous drugs regul
regulations
ations and p policie
olicies.
s.

The Head of the Lab abooratory ha hass the following fun uncctions and
responsibilities:
1. Ad
Admi
mini
nist
stra
rati
tive
ve
a) Ha
Hass ge gene
nera
rall an
andd over
overal
alll su
supe
perv
rvis
isio
ionn of th the
e faci
facili
lity
ty anand
d all
all
aspects of laboratory work;
b) Has gene
general
ral superv
supervision
ision and co conduct
nduct of alalll laborat
laboratoryory perso
personnel;
nnel;
c) Form
Formul ulat
ates
es and im impl
plem
emen
entsts ststand
andarard
d op
oper erat
atio
ionn man
manualual th
that
at
gove
go vern
rn the
the opoper
erat
atio
ionn of th the
e DTDTL.
L. ThThis
is shshal
alll be pe peri
riod
odic
ical
ally
ly
reviewed and updated;
d) Prep
Prepares
ares fina
financial
ncial and a annual
nnual re report
portss of the lab
laborato
oratory;
ry;
e) Prorovi
vide
dess otothe
herr adadmi
mini
nist
stra
rati
tive
ve supp
supporortt serv
servicices
es such
such as
communications, security and maintenance services.

2. Technical
a) Supervisesess and directs all analy alytical procedures of the
laboratory;
b) Ass
Assure
uress qua
qualit
lity
y of all llabo
aborat
ratory
ory test
test rresu
esults
lts;;
c) Issu
Issues,
es, ssign
ignss out a
and
nd in
inter
terpre
prets
ts lab
labora
orator
tory
y res
result
ults;
s;
 

d) Evalua
Evaluates
tes and recom
recommends
mends reage
reagents,
nts, suppli
supplies
es anand
de equipme
quipment;nt;
e) Reviews the CCF and reports received from aut uthhorized
collector;
f) Int
Interv
erview
iewss the Client
Client/Do
/Donor/
nor/Sub
Subjec
ject,
t, if nec
necess
essary
ary;;
g) Rev
Review
iewss perti
pertinen
nentt med
medicaicall recor
records
ds of Cli Client
ent/Do
/Donor
nor/Sub
/Subjec
ject,
t, if 
necessary;
h) Can
Cancel
celss the res
result
ultss of all spe
specim
cimen
en whi
whichch are no nott col
collec
lected
ted or
tested not in accordance with the DTL manual;
i) Re
Revi
view
ews,s, rej
rejec
ects
ts,, an
andd re
refe
fers
rs for con
confifirm
rmat
atio
ion
n and re rete
test
stin
ing
g all
all
sp
spec
ecim
imen
en and te test
st reresul
sults
ts th
that
at araree poposi
siti
tive
ve,, adul
adulte
tera
rate
ted,
d,
substituted or invalid;
 j) Implements remedial actions necessary to maintain satisfactory
operation and performance in the laboratory;
k) Dir
Direct
ectss proto
protocol
col for pr
preve
eventintive
ve main
mainten
tenanc
ancee of equi
equipme
pment;
nt;
l) Prov
Provid
ides
es comp
comprerehehensi
nsive
ve,, cont
contin
inui
uing
ng trai
traini
ning
ng anand d ed
educ
ucat
atio
ionn of 
personnel related to conduct of DTL.

 Analyst
The personnel must be a registered
1. Chemist
2. Ch
Chem
emicical
al En
Engi
gine
neer
er
3. Me
Medi
dica
call Te
Techchno
nolo
logi
gist
st
4. Pha
harm
rmac
acis
istt

The analyst must have training in the following:

a) Ana
Analyt
lytica
icall metho
methods ds and pro
proced
cedureures;
s;
b) Mai
Mainte
ntenanc
nance e of cha
chain
in of cu
custo
stody;
dy;
c) Rev
Review
iewing
ing and rrepo
eporti
rting
ng tes
testt res
result
ults;
s;
d) Prope
Properr remed
remedial ial acti
action
on in resp
response
onse to p proble
roblems
ms that may a
arise;
rise;
e) Qualit
Quality
y con
control
trol proce
procedures
dures and p practi
ractices;
ces;
f) Dan
Danger
gerous
ous drdrugs
ugs rregu
egulati
lations
ons anandd pol
polici
icies.
es.

The functions and responsibilities of the analyst are as follows:

a) Verif
Verifies
ies the ccomplet
ompleteness
eness of C Custody
ustody anand
d Contr
Control
ol Form (C
(CCF);
CF);
b) Pre
Prepar
pares
es spe
specim
cimen
en for aanal
nalysis
ysis;;
c) Exami
Examines,
nes, pr
processe
ocessess and an
analyzes
alyzes sspecim
pecimenen for d
drug
rug te
testing;
sting;
d) Inter
Interpret
prets,
s, recor
records,
ds, rele
releases
ases and sigsigns
ns out labor
laboratory
atory re
results;
sults;
e) Assists iin
n the imp
implement
lementation
ation of q quality
uality as
assurance
surance progr
program;
am;
f) Assists in th
thee eva
evaluatio
luationn of rreagen
eagents,
ts, sup
supplies
plies and eq
equipme
uipment;
nt;
g) Refe
Refers
rs to the HHead
ead of th
the
e Labor
Laboratory
atory as tthe
he nee
needd arises.

 Authorized Specimen
Specimen Collector
There shall be a designated authorized personnel within the laboratory to
collect the specimen who must
 

1. Be at lea
least
st a h
high
igh sscho
chool
ol gr
gradu
aduate
ate
2. Have uunde
ndergo
rgone
ne app
approp
ropria
riate
te tr
traini
aining
ng

 An Authorized Specimen Collector must have undergone training in:

a) Colle
Collection
ction p
proced
rocedure
ure for each ttype
ype of speci
specimen;
men;
b) Cha
Chain
in of cust
custody
ody and rreco
ecord
rd kee
keepin
ping;
g;
c) Spe
Specim
cimen
en int
integr
egrity
ity an
and
d sec
securi
urity;
ty; an
andd
d) Dange
Dangerous
rous ddrugs
rugs regul
regulations
ations and p policie
olicies.
s.

Retraining of Authorized Specimen Collector shall be required under the

following conditions:
a) The col
collecti
lection
on proce
procedure
dure cha
changes
nges signi
significant
ficantly
ly (e.g
(e.g.,
., a new CCF
is used); or
b) The Aut
Authorize
horizedd Specim
Specimen
en Colle
Collector
ctor made a mimistake
stake ththat
at caused
a test to be cancelled.

The Authorized
Authorized Speci
Specimenmen Colle
Collector
ctor must observ
observee the following to ensurensuree
the security of a specimen at the collection site:
a) Re
Rest
stri
rict
ctss ununaut
autho
hori
rize
zedd pe
pers
rson
onne
nell to en
enteterr th
the
e coll
collec
ecti
tion
on site
site
during collection;
b) Verif
Verifies
ies ide
identity
ntity of the Client
Client/Donor
/Donor/Subj
/Subject;
ect;
c) Provi
Provides
des secsecurity
urity tto
o spec
specimen
imen sup
supplies,
plies, rrecor
ecordsds and doc
documents
uments
at collection site;
d) Inf
Inform
ormss the ClienClient/D
t/Donor
onor/Su
/Subje
bject
ct the proce
procedurdures
es of spe
specim
cimen
en
collection;
e) Perf
Performs
orms onl only
y one sp specime
ecimen n coll
collectio
ection
n at a titime;
me;
f) Acce
Accepts
pts and seals tthe he spe
specimen
cimen ccontaine
ontainerr in ththe
e pre
presence
sence of the
Client/Donor/Subject;
g) Ac
Acco
comp
mpli lishe
shess CC
CCF.
F.

The following are persons who are not authorized to collect specimen:
a) Emplo
Employer
yer of the Clien
Client/Don
t/Donor/Sub
or/Subject
ject
b) Inv
Invest
estiga
igator
tor at tthe
he cr
crime
ime sc
scene
ene
c) Co
Comp
mpla
lain
inan
antt
d) Owner
Owner/Admin
/Administrat
istrator
or of estab
establishmen
lishmentt

Other Laboratory Personnel

1. Each pe
personnel
rsonnel m
must
ust have tthe
he educ
educationa
ationall backgr
background
ound app
appropria
ropriate
te for
the tasks assigned.
2. Eac
Each
h per
personn
sonnel
el must have appro
appropri
priate
ate trai
trainin
ning
g and pref
prefera
erably
bly with
experience.
 

Evaluation and Personnel Development

1. The labo
laborator
ratory y must esta
establish
blish cr
criteri
iteria
a for evalu
evaluation
ation of pe
performa
rformance
nce of 
all personnel.
2. Tra
Traini
ining
ng reco
records
rds must be maint
maintaine
ained d for all pers
personn
onnel.
el. The
These
se shoul
shouldd
include all job related formal trainings taken by the personnel which
pertains to any aspect of their responsibilities, including but not limited
to anaanaly
lyti
tica
call me
meth
thod
odol
olog
ogy,
y, la
labo
bora
rato
tory
ry saf
safet
ety,
y, sam
samplplin
ing,
g, qu
qual
alit
ity
y
assurance and data analysis.
3. Th
The e HeHead
ad of the LaboLabora
rato
tory
ry mu
mustst evalu
evaluat
ate
e th
the
e pe
perf
rfor
orman
mancece of all
all
personnel as the need arises.

FACILITIES AND EQUIPMENT REQUIREMENTS

Floor Plan

 A Screening Laboratory shall have at least twenty (20) square meters in floor
area. The work area must be ten (10) square meters with an exhaust fan, sink 
and storage cabinet.

 A Confirmatory Laboratory shall have at least sixty (60) square meters in floor
area. The clinical work area must be thirty (30) square meters with exhaust fan,
sink, fume hood, stock room and instrumentation room.

 A laboratory of whatever category shall have within its premises an area, which
can rece
receive
ive or accomm
accommodate
odate at least five (5) prosp
prospecti
ective
ve Client
Client/Donor
/Donor/Subje
/Subjects
cts
at a time
time,, a ha
hand
nd-w
-wash
ashing
ing fa
faci
cili
lity
ty,, to
toil
ilet
et fac
facil
ilit
ity,
y, and ststal
alll for
for th
the
e or
orde
derl
rly
y
collection of specimen.

 A DOH-accredited hospital
h ospital or non-hospital bas
based
ed Secondary or Tertiary Category
Clinical Laboratory which intends to put up a Screening Laboratory for Drug
Testing need not provide an additional twenty (20) square meters to its existing
floor area. It shall only designate an area for drug testing within the clinical
laboratory.

Equipment/Maintenance/Supplies
Equipment/Maintenance/Supplies and Materials

Collection Device
The col
collec
lectio
tion
n dev
device
ice con
consid
sidere
ered
d for the fol
follow
lowing
ing typ
types
es of spe
specim
cimen
en
collected:
Chapter .3

FACILITIES
FACILITIES AND EQUIPMENT REQUIREMENTS
 

3.1 Floor plan

3.1.1 Screening Laboratory- shall have at least

least twenty (20) square meters in floor ar
area.
ea. The work area must
 be ten (10) square meters with an exhaust fat, sink, and storage cabinet.

3.1.2 Confirmatory Laboratory- shall have at least sixty (60)

(60) square meters in floor area.
area. The clinical work 
area must be thirty (30) square meters with exhaust fan, sink, fume hood, stock room and instrumental
room.

A laboratory of whatever category shall have within its premises an area, which can receive or 
accommodate at least five (5) prospective Client/Donnor/Subjects at a given time, a hand washing facility,
toilet facility, and stall for the orderly collection
coll ection of specimen.

A DOH-accredite
DOH-accreditedd hospital
hospital or non-hospita
non-hospitall based
based Secondary
Secondary or Tertiary
Tertiary Category
Category Clinical
Clinical
Laboratory which intends to put up a Screening Laboratory for Drug Testing need not provide an additional
twenty (20) square meters to its existing floor area.
area. It shall only designate an area for drug testing within
the clinical laboratory.
laboratory.

Refer to Figures 2 and 3 (Prototype of Floor Plan).

3.2 Equipment/Maintenance/Supplies and Materials

3.2.1 Refer to Table 2, page 166

(T
(Table
able to Technique/ Equipment/Glassware/Reagents/Supplies and Materials)

3.2.2 Collection Device

The collection device considered for the following types of specimen collected:
 
(a) For urine specimen:
specimen: Screw
Screw capped,
capped, wide mouth, 30 or 60mL capacity
capacity polyethylen
polyethylenee specimen
specimen
container.
(b) For scalp hair specimen: Self-sealing transparent
transparent plastic bag,
bag, 200 mg capacity.
capacity.
(c) For oral fluid
fluid (saliva
(saliva)) specime
specimen:n: Screw
Screw capped
capped wide mouth
mouth 30mL
30mL capac
capacity
ity polyeth
polyethyle
ylene
ne
specimen container.
container.
(d) For swea
sweatt specim
specimen:
en: patch
patch pla
placed
ced on the skin and transfe
transferre
rredd in a contain
container
er with suitable
suitable
transport medium.
(e) For blood:
blood: 10 ml capa
capacity
city plain
plain te
test
st tube.
tube.
(f) For tissue:
tissue: specimen immediatel
immediatelyy frozen and transpor
transported
ted placed in clean,
clean, dry,
dry, tightly capped
capped
 plastic container with no additives.
(g) For fingernails:
fingernails: Self-seal
Self-sealing
ing transparen
transparentt plastic
plastic bag, 200 mg capacity
capacity..

 Note:
(i) The collection
collection device
device shall
shall not affect
affect or alter
alter the specimen
specimen collecte
collected.
d.
(ii) All specimen containers shall be properly labeled and sealed.
(iii) If the collection device is unique and integral part of the collection and analytical testing
 procedure, it must be registered by an appropriate agency designated by DOH as a medical device
(e.g., the sweat patch)
(iv) Single-use items are not unique collection devices and are not required to be cleared by the
DOH.

3.2.3 Calibration and Maintenance

Properly functioning equipment is essential

essential for accurate testing. The equipment maintenance and
calibration record shall document that all instruments are properly maintained, calibrated, cleaned and
monitored.
 

3.2.3.1 All equipment must be calibrated and maintained according to the procedures in the manufacturer’s
manual.

3.2.3.2 There shall be a record indicating that the equipment has been calibrated and/ or checked on a
regular schedule based on established procedures.

3.2.3.3 Trained personnel should be assigned to calibrate equipment regularly

regularly..

3.2.3.4 Corrective actions and recommendations must likewise be documented when instruments fail to
function as expected.

3.2.3.5 Contents of calibration/maintenance record:

(a) Name ofof instrumen

instruments, ts, model,
model, seria
seriall number;
number;
(b) Nam
Namee of acces
accessor
soryy parts;
parts;
(c) Name and
and address
address of local
local distribu
distributor;
tor;
(d) Dat
Datee and amount
amount of purcpurchas
hase;
e;
(e) Date
Date of
of ca
calibr
librati
ation;
on;
(f)
(f) Date
Date of
of malf
malfununct
ctio
ion;
n;
(g) Date of repair
repair/corre
/corrective
ctive action(
action(s)
s) taken;
taken;
(h) Rec
Recomm
ommendendatio
ations;
ns; and
(i) Name of authorize
authorizedd person who perforperformed
med the calibration/
calibration/ maintenan
maintenance
ce of equipment.
equipment.

3.3 Lighting and Ventilation

Ventilation

There shall be adequate lighting and ventilation in all work areas.

Chapter 4

COLLECTION SITE

There shall be a designated space or area for collection of specimen:

4.1 It shall be a designated area within the laboratory or a temporary facility located at a remote site.

4.2 The selection of an appropriate collection site will depend on the type of specimen being collected.

4.3 A collection site must have the following:

4.3
4.3.1
.1 A suita
suitable
ble clean
clean surfa
surface
ce for
for handlin
handlingg the speci
specimen
men and
and complet
completinging the
the requir
required
ed
 paperwork;
4.3.2 A secured
secured tempor
temporary
ary storag
storagee capabilit
capabilityy to maintai
maintainn a specime
specimenn until
until it is tested
tested or shipped
shipped
to the laboratory.
laboratory.
4.3.3 An area
area to provide
provide Client/Donor
Client/Donor/Subje
/Subjectct privac
privacyy aapprop
ppropriate
riate to the
the sspecime
pecimenn being
being
collected (e.g., toilet);
4.3
4.3.4
.4 A contr
controlle
olledd and
and secur
secured
ed area
area for supplie
suppliedd and
and recor
records;
ds;
4.3.5 A poster
poster or information
information bulletin
bulletin wit
withh a detailed
detailed descrip
description
tion of the
the proper
proper specimen
specimen
collection processes.
4.3.6 A source
source of water for hand washing
washing externa
externall to toilet
toilet facility
facility (for urine collection)
collection)

4.4 Collec
Collection
tion of
of specim
specimen
en at a tempo
temporar
rary/r
y/remo
emote
te facili
facility
ty can
can only be
be conduc
conducted
ted at
at the follow
following
ing
locations/conditions:
4.4
4.4.1
.1 Workpla
orkplace/
ce/sch
school/
ool/jail
jail or
or prison
prison// rehabi
rehabilita
litation
tion cent
center
er for:
for:
4.4.1.1 Random
4.4.1.2 Follow-up
 

4.4
.4..1.3 Rea
Reasonable suspic icio
ionn/c
/caause
4.4
.4..1.4 Crim
Crimee scene and post accident
4.4.
4.4.22 Pe
Pers
rson
on who
who aare
re cr
criti
itica
cally
lly ill/d
ill/dis
isab
able
ledd
4.5 Collec
Collection
tion of
of specim
specimen
en for
for all manda
mandatortoryy drug
drug tes
testin
tingg (e.g.,
(e.g., drive
driver’
r’ss license
license,, R.A. 9165)
9165) shal
shalll
 be done at a permanent facility except for crime scene and post accident.
4.6 The DTLDTL must
must secu
secure
re a perm
permitit from
from BHBHFS/
FS/CHD
CHD ten
ten (10)
(10) worki
workingng days
days prio
priorr to the
the schedu
scheduled
led
activity except crime scene/post accident.
accident. The secured permit must be kept confidential
among drug testing laboratories, requesting
requesting party and BHFS/CHD. Failure to secure a permit permit

4.7 will be mination

No exa dealttions
examina wi th
with accordingly.
accordingly
s must
mu con.ducted
st be conduc ted at a tempo
temporar
raryy ccolle
ollecti
ction
on faci
facility
lity..

 Note: Refer to Appendix J (BHFS Bureau Circular No. 09 s. 2003 re: Guidelines for Remote Collection for
Drug Testing Specimen)

Chapter 5
 

SPECIMEN

The NRL shall evaluate the protocol for each type

t ype of specimen.

5.1 Types of Specimen

A Drug Testing Laboratory may collect:

5.1.1 Blood
5.1.2 Fingernails
5.1.3 Saliva
iva ((ooral flu
fluiid)
5.1.4 Scalp Hair  
5.1.5 Sweat (Patch)
5.1.6 Tissue
5.1.7 Urine

5.2 Reason for Test

5.2.1 Blood : Reasonable suspicion/ cause
5.2.2 Fingernails : reasonable suspicion/ cause
5.2.3 Scalp Hair : Pre-employment, random, return to
duty, follow up
5.2.4 Saliva (Oral Fluid) : Pre-employment, random, reasonable
suspicion/cause
5.2.5 Sweat (patch) : Return to duty, follow up
5.2.6 Tissues : Reasonable suspicion/cause
5.2.7 Urine : Pre-employment, random, reasonable
suspicion/cause, mandatory
5.3 More
More than
than one typ
typee of spec
specimen
imen maybe
maybe colle
collecte
ctedd at same
same time
time from
from the same
same Client/
Client/ Donor
Donor//
Subject.

5.
5.44 A spec
specime
imenn may be teste
testedd for othe
otherr purpo
purpose
sess provide
providedd that
that the qualit
qualityy of the spec
specime
imenn for 
which it will be tested is maintained and the chain of custody is intact.

5.
5.55 The
The mini
minimu
mum
m qua
quant
ntity
ity of spec
specime
imenn ttoo bbee col
colle
lect
cted
ed::

5.5.1 Blood : Minimum of 5 mL

5.5.2 Fingernails : To be determined
5.5.3 Scalp Hair : 100 mg hair (or its equivalent in number  
 of strands or 1 cm. Abov the scalp)
5.5.4 Tissue : To be determined
5.5.5 Saliva (Oral Fluid) : 2 ml collected as a “neat” specimen
(divided as follows: at least 1.5 mL the
 primary specimen and at least 0.5 mL for the
challenge test)

5.5.6 Sweat : 1 “patch” worn for 7 to 14 days

5.5.7 Urine : 60mL in single container or 30 mL each
in two separate containers for split
specimen.

 Note:
(I)
(I) The
The ty
type
pe and
and qua
quant
ntit
ityy of sspe
peci
cime
menn list
listed
ed abo
above
ve may
may var
varyy depe
depend
ndin ingg on the
the
existing technology.
technology.
(II)
(II) Sp
Spec
ecim
imen
en may be colle
collect
cted
ed using
using singl
singlee co
cont
ntai
aine
nerr, ho
howe
weve
verr, sp
spli
litt sp
spec
ecim
imen
en
collection maybe done upon request if situation permits.
 

5.6 Handling and Storage

Proper handling and storage of specimen must be taken to ensure the integrity of the drug
and/or metabolite.

5.6.1 Blood : separate serum then immediately freeze

specimen
55..66..23 F
Sicnaglperhnaaiirls :: tsotobreeddaettecromoilnaendd dry place
5.6.4 Tissue : macerated and frozen.
5.6.5 Saliva : deep-frozen at least- 8 to 10OC
5.6.6 Sweat : to be determined
5.6.7 Urine ; prolonged storage at –20OC

 Note: Urine maybe stored initially in the refrigerator between 2-6OC, for not more than 1 day.

5.7 Transport

Specimen must be properly labeled, sealed and placed in a cooler with dry ice or a suitable
alternative. The following must be observed in its transport:

5.7
5.7.1
.1 Minimiz
Minimizee the
the nu
numbe
mberr of per
person
sonnel
nel han
handlin
dlingg the
the sspec
pecimen
imen..
5.7.
5.7.22 Docu
Documement
nt the date
date and the
the purpo
purposese on the CC CCF F each
each time a speci
specimemenn is handle
handledd or 
transferred. Identify each person who handled the specimen. When courier services are
utilized, the time of receipt from the collection site and the time of delivery to the
laboratory must be documented on the CCF. CCF.
5.7
5.7.3
.3 Place
Place specim
specimenen in sealed
sealed transpa
transparerent
nt plastic
plastic bag and and an appropri
appropriate
ate transp
transport
ort contai
container 
ner 
designed to minimized damage, and seal them securely to eliminate the possibilities of 
tampering.
5.7.4 Ensure
Ensure that
that the CCF accompanie
accompaniess the appropriat
appropriatee specime
specimenn transpo
transportrt container
container..
5.7
5.7.5
.5 Mail
Mail or delive
deliverr the speci
specimen
men to the
the testin
testingg labora
laborator
toryy. The trans
transpor
portt of sample
sampless shall
shall be
accomplishe
acco mplishedd while maintaining
maintaining adequate
adequate specimen validity if a commercial
commercial courier or 
 postal service is used. If a staff member delivers the specimen, the laboratory must
re
reco
cord
rd an
andd re
repo
port
rt an
anyy ap
appa
pare
rent
nt tatamp
mperering
ing with
with th thee co
conta
ntain
iner
er or sp spec
ecime
imen,
n, an
anyy
discrepancy in the specimen and the CCF.
 

Chapter 6

LABORATORY
LABORATORY PROCEDURE FOR SPECIMEN HANDLING

A DOH- accredited laboratory must have a standard operating procedure (SOP) manual that
describes, in detail, all laboratory operations
operations pertaining to specimen handling. When followed, it
ensures that all specimen are tested using the same procedure and in a consistent m
manner
anner..

6.1 Observed Specimen Collection for Urine

Observed samples are collected in the presence of the

t he Authorized Specimen Collector.
Collector.

6.1
6.1.1
.1 The Prelimi
Preliminar
naryy proce
procedur
dures
es ffor
or specim
specimen
en colle
collecti
ction.
on.

The Authorized Specimen Collector shall:

6.1
6.1.1
.1.1
.1 Pr
Prep
epar
aree and
and sec
secur
uree all
all col
colle
lect
ction
ion susupp
pplie
lies,
s, mat
matereria
ials
ls and
and re
reco
cord
rd
6.
6.1.
1.1.
1.22 Ver
erif
ifyy the Clie
Clientnt/D
/Don
onor
or/S
/Sub
ubje
ject
ct’’s ide
ident
ntif
ific
icat
atio
ionn
6.1
6.1.1
.1.3
.3 Expla
Explain in the
the bbas
asic
ic col
colle
lect
ctio
ionn proc
procededur
uree to the ClClieient
nt/Do
/Dono
nor/
r/Su
Subje
bject
ct;;
6.1
6.1.1
.1.4
.4 Answ
Answer er any
any rea
reaso
sona
nabl
blee and app
approropr
pria
iate
te ques
questio
tions
ns the
the Clien
Client/D
t/Don
onor
or/Su
/Subj
bjec
ectt may
ask regarding the collection procedure.
6.1
6.1.2
.2 Basic
Basic step
stepss in collec
collectin
tingg urine
urine spe
specim
cimen
en for
for drug
drug testi
testing:
ng:

6.1
6.1.2
.2.1
.1 The
The Clien
Client/D
t/Dononor
or/S
/Sub
ubje
ject
ct remo
removevess all unn
unnececes
essa
sary
ry oute
outerr garm
garmen ents
ts (suc
(suchh as coat
coat
or jacket), after which, he/she will be subjected to a bodily search.
6.1
6.1.2
.2.2
.2 The
The Aut
Autho
hori
rize
zedd Spec
Specime
imenn Colle
Collect
ctor
or ddir
irec
ects
ts the
the Clien
Client/D
t/Don
onoror/Su
/Subje
bject
ct to emp
emptyty
his/her pockets and checks items that may be used to adulterate tthe he specimen.
6.1
.1..2.3 The Auth
Authoorize
ized Specim imeen Coll
Colleecto
torr either giv ivees or allo llows the Clien ient/
Donor/Subject washes and dries hands prior to collection. After washing hands,
the Client
Client/Don
/Donor/
or/Sub
Subjec
jectt must
must remain
remain in the presenpresencece of the Authoriz
Authorized ed
Specimen Collector and must not have access to anything that could be used to
affect the specimen.
6.1.2.4 The Authorized Specimen Collector either gives or allows the
Client/Donor/Subject to select the collection container from available supplies.
The specimen container is opened in full view of the Client/Donor/ Subject.
6.1
6.1.2
.2.5
.5 The
The Auth
Authororiz
ized
ed S
Spe
peci
cime
menn Colle
Collect
ctor
or dir
direc
ects
ts the
the Clie
Client/
nt/Do
Dono
nor/r/Su
Subj
bjec
ectt to go in
in the
the
toilet facility for urination and to provide at least 60-mL either collected in singe
or split specimen.
6.1
6.1.2
.2.6
.6 The
The Autho
Authoririze
zedd Speci
Specimemenn Colle
Collect
ctor
or shal
shalll obser
observe
ve clos
closel
elyy the ent
entir
iree colle
collect
ctio
ionn
 procedure and take note of the t he conduct and demeanor of Client /Donor/Subject
for attempts of substitution, adulteration and dilution of specimen.
 

6.
6.1.
1.2.
2.77 A tampe
tamperred specpecim
imen
en is sentent to the
the lab
labor
oraato
tory
ry for
for valid
alidit
ityy test
testin
ingg and the
the
Authorized Specimen Collector shall document the tampering on the CCF with
appropriat
appro priatee remarks. The authorized
authorized Specimen
Specimen Collector
Collector shall instruct
instruct the
client/Donor
client/Donor/Subjec
/Subjectt to provide
provide another
another urine specimen immediately
immediately,, under 
dir
direct
ect observe
observedd collec
collection
tion.. Thi
Thiss second
second specime
specimenn shall
shall also be sent sent for 
examination.
6.
6.1.
1.2.
2.88 Afte
Afterr the
the clie
client
nt/D
/Don
onor
or/S
/Sub
ubje
ject
ct han
handsds the speci
specimemen,
n, th
thee au
auth
thor
oriz
ized
ed Spe
Speci
cime
menn
Collector must measure the temperature, check volume and inspect its physical

6.
6.1.
1.2.
2.99 characteristics.
The
The Autho
Authori
rize
zedd Sp
Spec
ecim
imen
en Colle
Collect
ctor
or and Clien
Client/t/Do
Dono
nor/
r/Su
Subj
bjecectt mu
must
st kee
keepp ththee
specimen in full view at all times prior to sealing of all specimen containers.
6.
6.1.
1.2.
2.10
10 A tampe
tamperr-e
-evi
vide
dent
nt label
label/s
/sea
eall mu
must
st be us used
ed to se secu
cure
re the entir
entiree sp
spec
ecim
imenen
container.
6.1.2.1
6.1.2.111 Both Authori
Authorize
zedd Specim
Specimen en Colle
Collecto
ctorr and
and Client/
Client/Don
Donor/
or/Sub
Subjec
jectt must
must affix
affix thei
their 
r 
signature on the seal together with the date and time of collection
6.1
6.1.2
.2.1
.122 The
The Auth
Author
oriz
ized
ed Spec
Specime
imenn Collec
Collecto
torr must
must comple
completete step
stepss 1 an
andd 2 an
andd initia
initiate
tess
step 4 of CCF.
6.1
6.1.2
.2.1
.133 The
The Client/
Client/Do
Dono
nor/r/Do
Dono
nor/
r/Su
Subje
bject
ct mus
mustt affix
affix his/he
his/herr signat
signatur
uree at Step 5 of the
CCF. The Authorized Specimen Collector may ask the Client/Donor/Subjec
Client/Donor/Subjectt to
list any prescription, medication he/she may have taken for the past two weeks
at the back of the CCF (Analyst
(Analyst copy). Authorized
Authorized Specimen
Specimen Collector
Collector shall
distribute each copy as required.
6.1.2.1
6.1.2.144 In case
case of spec
specime
imenn collec
collection
tion at a remo
remote
te site
site and
and trans
transpor
portt via a couri
courier/
er/mail
mail,,
the specimen container together with the CCF shall be placed in a sealed,
labeled and secured transparent plastic bag.

 Note: Protocol for collection for other types of specimen shall be determined in a later publication.

6.1
6.1.3
.3 Visu
isual
al priv
privacy
acy re
requir
quireme
ements
nts when
when colle
collectin
ctingg a spec
specime
imenn

6.1.3.1 For urine specimen:

A la
labo
bora
rator
toryy must
must have
have the
the re
requ
quir
ired
ed re
restr
stroo
oom/s
m/sta
tall
ll with
with a totoile
ilett fo
forr the
the
Client/Donor/ Subject to have privacy while collecting the urine specimen.

6.1.3.2 For scalp hair specimen:

The Authorized Specimen Collector shall collect available scalp hair 1 cm.
above the scalp from the Client/Donor/Subject at a designated area.

6.1.3.3 For sweat specimen:

The sweat patch is applied to the Client/Donor/Subject’s upper arm, chest, or 
 back and removed by the authorized Specimen Collector at a designated area.

6.1.3.4 For blood specimen:

At least 5mL whole blood is extracted from Client/Donor/Subject placed in a 10-

ml capacity test tube without anticoagulant at a designated area.

6.
6.1.
1.3.
3.55 Fo
Forr sali
saliva
va (or
(oral
al flu
fluid
id)) tiss
tissue
ue/f
/fin
inge
gern
rnai
ails
ls sspe
peci
cime
men:
n:

The “neat” saliva (oral fluid)/tissue/fingernails specimen is collected directly

into an app
approp
ropria
riate
te contain
container
er by the Client/D
Client/Done
oner/S
r/Subje
ubject
ct under
under the dir
direct
ect
observation of the Authorized Specimen Collector at a designated area.
 

6.
6.22 Unob
Unobse
serrved
ved Spe
Speccim
imen
en Coll
Collec
ecti
tion
on::

Unobserve
Unobse rvedd sample
sampless ar
aree collec
collected
ted in the absenc
absencee of Authori
Authorized
zed Specim
Specimen
en Collect
Collector
or or 
submitted
submitted samples that are not collected at the collection
collection site or laboratory
laboratory. Unobserve
Unobservedd
samples are subject to specimen validity test.

Conditions when unobserved

unobserved specimen collection is allowed. When Client/Donor/Subject is:

6.2
6.2.1
6. .12
6.2.
2.2 IPhysic
Phy
nv sicall
nvol
olveally
d yin
ved inunable
una
cr blee to
crim
ime tssc
ocene
goe to the
en the lab
labora
orator
toryy or desig
designat
nated
ed collec
collection
tion site
site
6.
6.2.
2.33 Invo
Involvlved
ed in post
post-a
-accccid iden
entt
6.2.4 Critically ill

6.3 Inte
teggrity of Ur
Urine Sp
Specimemenn
The
The Auth
Authororiz
ized
ed Sp
Spec
ecime
imenn Co
Colle
llect
ctor
or mu
must
st ad
adop
optt proc
proced
edur
ures
es to mi
minim
nimiz
izee th
thee risk
risk of 
adulteration
adulte ration,, substitution
substitution or dilution
dilution of the specimen
specimen during the collection procedure
procedure.. The
following precautions shall be taken to ensure the integrity of the specimen.

6.3.1 To deter
deter the
the dilution
dilution of specime
specimenn at the collec
collection
tion site,
site, toilet
toilet water
water coloring
coloring agents
agents should
 be placed in toilet tanks or in
i n the toilet bowl. Any other sources of water in the enclosure
where urination occurs (e.g., taps, shower) will be secured prior to collection.

6.3.
6.3.22 The
The Author
Authoriz
ized
ed Sp
Spec
ecim
imen
en Co
Colle
llect
ctor
or wi
will
ll as
askk Cl
Clie
ient
nt/Do
/Dono
nor/
r/Su
Subje
bject
ct to re
remo
move
ve an
anyy

unnecessarythat
substances outer garments
could be used such as a with
to tamper coat or adulterate
jackets that
themight conceal items or 
Client/Donor/Subject’s
urine specimen. He/she shall be subjected to bodily search. The Authorized Specimen
Specimen
Collector will ensure that all persona belongings such as purse of briefcase remain with
the outer garments.

6.3.
6.3.33 The
The Clien
Client/D
t/Don
onor
or/S
/Sub
ubje
ject
ctss will
will be instr
instruc
ucte
tedd to was and dry his/h
his/her
er hands
hands prior
prior to
urination. After washing hands, the Client/Donor/Subject will remain in the presence of 
an Authorized Specimen Collector and will not have access to any unregulated source of 
water, soap dispenser, cleaning agent, or any other materials that could be used to
adulterate the specimen.

6.3
6.3.4
.4 The Author
Authorize
izedd Specimen
Specimen Colle
Collecto
ctorr will give
give or the Client/D
Client/Dono
onor/S
r/Subj
ubject
ect will
will choose
choose a
clean specimen
specimen container
container from the available
available supplies.
supplies. The Client/Donor/Su
Client/Donor/Subject
bject may
 provide his/her specimen in the privacy of a toilet cubicle or otherwise partitioned area
that allows for individual
individual privacy
privacy. The Client/Donor/S
Client/Donor/Subjec
ubjectt will be instructed
instructed not to
flush the toilet until the specimen is handed to the
t he Authorized Specimen Collector.
Collector.

6.3
6.3.5
.5 Upon
Upon receivin
receivingg the specime
specimenn from the Client/D
Client/Dono
onor/S
r/Subj
ubject
ect,, the Author
Authorize
izedd Specimen
Specimen
Collector will:

6.
6.3.
3.5.
5.11 Ch
Chec
eckk the
the volu
volume
me of urin
urinee in
in the
the sp
spec
ecim
imen
en co
contntai
aine
ner 
r 
6.
6.3.
3.5.
5.22 Ch
Chec
eckk the
the temp
temper
erat
atur
uree of the
the urin
urinee sp
spec
ecim
imen
en..
6.
6.3.
3.5.
5.33 Insp
Inspec
ectt the
the speci
specime
menn to dete
determ
rmin
inee its colo
colorr and appe
appear
aran
ance
ce for
for any sig
signs
ns of 
contaminants. Any unusual findings will be noted on the Custody and Contro Controll
Form.

6.3.
6.3.66 Bo
Bothth the
the Clie
Client/
nt/Do
Dono
nor/
r/Su
Subj
bjec
ectt an
andd the
the Author
Authoriz
ized
ed Specime
Specimenn CoColle
llect
ctor
or will ke
keep
ep the
specimen container/specimen bottles in view at all times prior to the urine specimen
 being sealed and labeled.
6.
6.3.
3.6.
6.11 The
The spec
specim
imen
en bott
bottle
le will
will have
have an ident
identif
ific
icat
atio
ionn label
label that
that co
cont
ntai
ains
ns pert
pertin
inen
entt
information such as date and time of specimen collection, signatures of the
 

donor/cli
donor/client
ent/su
/subje
bject
ct and Authori
Authorized
zed Specim
Specimen en Collec
Collector
tor and specim
specimenen ID
number.
6.3
6.3.6
.6.2
.2 The
The Auth
Authororiz
ized
ed S
Spe
peci
cime
menn Colle
Collect
ctor
or will
will fill
fill-u
-upp steps
steps 1 and
and 2 initi
initiat
ates
es ste
stepp 4 of 
the Custody and Control Form and pack together with the urine specimen
immediately for dispatch to the analytical laboratory.

6.
6.44 Sp
Spec
ecim
imen
en rej
rejec
ecti
tion
on and
and can
cance
cell
llat
atio
ionn of tes
tests
ts

All rejected specimen should be reported to the Head of the Laboratory stating the reason(s) or 
rejection.

6.4
6.4.1
.1 Criter
Criteria
ia for
for spec
specime
imenn rejec
rejection
tion tha
thatt are
are no
non-c
n-corr
orrect
ectabl
ablee

6.
6.4.
4.1.
1.11 Inco
Incomp
mpat
atib
ibil
ilit
ityy of the ID nu numb
mberer on the
the speci
specime
menn recei
receive
vedd by the
the labor
laborat
ator
oryy
with the number on the CCF
6.
6.4.
4.1.
1.22 Abse
Absenc
ncee of ID nunumb
mberer on the
the spe
specime
cimenn
6.4
6.4.1
.1.3
.3 No pri
print
nted
ed Auth
Author oriz
ized
ed SSpe
peci
cime
menn Colle
Collect
ctor
or nam
namee aand
nd sig
signa
natur
turee on th
thee CCF
CCF
6.
6.4.
4.1.
1.44 Brok
Broken
en or tamp
tamper ered
ed se
seal
al on the
the spe
speci
cime
menn ccon
onta
tain
iner 
er 
6.
6.4.
4.1.
1.55 Ins
Insuff
ufficie
icient
nt qu
quananti
tity
ty of spe
specime
cimen.n.

6.4
6.4.2
.2 Criter
Criteria
ia of spe
specime
cimenn rreje
ejecti
ction
on tha
thatt is correc
correctab
table
le

6.4
6.4.2
.2.1
.1 Fa
Failu
ilure
re of the Autho
Authori
rize
zedd Spe
Speci
cime
menn Col
Colle
lect
ctor
or to si
sign
gn CCF
CCF.

6.4.2.2
6.4.2.2 Failure
Failure to check
check and rec
record
ord the spe
specime
cimenn temper
temperatuature
re with approp
appropria
riate
te remark
remarks.s.
6.4
6.4.3
.3 Approp
Appropria
riate
te rreme
emedia
diall measu
measures
res for correc
correctab
table
le erro
errors:rs:
6.4
6.4.3
.3.1
.1 All err
error
orss must
must bebe prop
proper
erly
ly docu
docume
ment
nted
ed,, reco
recordrded
ed in
in a memo
memorarand
ndum
um for
for Rec
Recor
ordd
(MFR) and duly signed by the Authorized Specimen Collector.
6.
6.4.
4.3.
3.22 If the
the Au
Auth thor
oriz
ized
ed Spec
Specim
imen
en Coll
Collec
ecto
tor’r’ss si
sign
gnat
atur
uree ca
cann
nnot
ot be corre
correct
cted
ed by a
Memorandum For Record (MFR), the laboratory must repost the specimen
rejected for testing and provide a reason on the report.
6.
6.4.
4.3.
3.33 If the
the Auth
Authororiz
ized
ed Spec
Specim
imen
en Coll
Collec
ecto
torr canno
cannott provi
providede an MFR
MFR to atte
attest
st to the
the
fact he or she did measure the specimen temperature, the laboratory may report
the test results for the specimen but indicate that the Authorized Specimen
Collector could not provide an MFR to recover the omission.

6.5.4 Conditions that will not cause specimen rejection or cancellation of test

6.5.4.1 At the receiving area:

(a) Discrepanc
Discrepancies
ies of the
the laboratory
laboratory name
name andand address;
address;
(b) Inco
Incomplete
mplete/incor
/incorrect/u
rect/unrea
nreadable
dable employer
employer name or address’
address’
(c) Name of the head
head of the laborat
laboratory
ory is not
not indicated
indicated
(d) Inco
Incomplete
mplete/incor
/incorrect
rect address
address of the Head
Head of the Laboratory
Laboratory;;
(e) Incorrec
Incorrectt entry of the Client/Donor
Client/Donor/Subje
/Subject’
ct’ss ID number 
(f) Unmark
Unmarked ed “rea
“reason
son for
for test”
test” box;
box;
(g) Unmar
Unmarked
ked “drug
“drug tests
tests to be perfo
performed”
rmed” box;
box;
(h) The co
collectio
llectionn site address
address is not indicate
indicated;
d;
(i) Unmark
Unmarked ed “spec
“specime
imenn collectio
collection”
n” box
box;;
(j) Unmarked
Unmarked “observed”
“observed” box (if applicable)
applicable);;
(k) The da
date
te and time
time of collectio
collectionn is not indicat
indicated
ed
(l) Incorrec
Incorrectt entry of na
name
me of delivery/co
delivery/courier
urier service;
service; or 
(m) The Client/Donor/Subject’s
Client/Donor/Subject’s name inadvertently appear appearss on the laboratory copy of the
CCF or on the tamper-evident labels used to seal the specimen bottles.

6.5.4.2 Within the laboratory:

 

(a) Failure
Failure to pprint
rint aand
nd ssign
ign th
thee access
accessioner’
ioner’ss nam
name;
e;
(b) Failure
Failure to pprint
rint aand
nd ssign
ign th
thee Analyst’
Analyst’ name;
(c) The Anal
Analyst
yst accide
accidenta
ntally
lly initials
initials the CCF rather
rather tha
thann provi
providin
dingg a signatur
signaturee for a non-
negative result (Analyt’s initials are acceptable for a negative result);
(d) The accessio
accessioner
ner fails to mark
mark one of thethe “prima
“primary
ry specimen
specimen bottle seal
seal intact”
intact” boxes,
boxes, but
the laboratory reported a “rejected for testing” result with an appropriate comments on
the “Remarks” line.

 Note: The
less than oneabove errors,
percent omissions,
of the time. Theand discrepancies
expectation areeach
is that considered insignificantSpecimen
trained Authorized only when they occur 
Collector and
accredited laboratory will make every effort to ensure that the CCF is properly completed and that all the
information is correct. When an error occurs
occurs more than one percent of the time, the HeaHeadd of the Laboratory
must direct the Authorizes
Authorizes Specimen
Specimen Collector
Collector or labor
laboratory
atory personnel
personnel (whichever is responsibl
responsiblee for the
error) to immediately take corrective actions to
t o prevent the recurrence of the error.

6.5
6.5.4
.4.3
.3 Situa
Situatio
tionn / erro
errorr that
that may
may req
requi
uire
re the
the H
Hea
eadd of the
the L
Lab
abor
orat
ator
oryy to can
cance
cell a test
test

(a) The client/

client/ Donor/Subje
Donor/Subject’ct’ss signature
signature is missing on
on the Laboratory
Laboratory copy
copy of the CCF and
the Authori
Authorizedzed Specim
Specimenen Collec
Collector
tor fai
failed
led to provide
provide a commen
commentt tha thatt the Client
Client /
Donor /Subject refused to sign the form;
(b)
(b) The
The ananal
alys
ystt fa
faile
iledd to si
sign
gn thethe CCF
CCF fo forr a sp
spec
ecime
imenn be
bein
ingg re
repo
port
rted
ed drdrug
ug po
posi
sitiv
tive,
e,
adulterated, substituted, rejected for testing, or invalid test result; or 
(c) The electronic
electronic report
report provided
provided by the la laborat
boratory
ory does not
not contain all
all the data elements
elements

required
drug for thesubstituted,
positive, DOH standard electronic
rejected laboratory
for testing, report
or invalid testfor a specimen being reported
result.

6.5
6.5.4
.4.4
.4 Corre
Correct
ctiv
ivee measu
measure
ress that
that the He
Head
ad of the
the Labo
Labora
rator
toryy must
must do prio
priorr to canc
cancel
ella
latio
tionn of the
the test
test
in the above situation

(a) The Head

Head of the labo
labora
rator
toryy must
must con
contac
tactt the Autho
Authoriz
rized
ed Specimen
Specimen Collec
Collector
tor to obtain
obtain a
statement to verify
verify that the Client/Donor/Subject refused to sign the Laboratory copy.copy. If the
Authorized Specimen Collector cannot provide such a statement, the Head of the Laboratory
must cancel the test.
(b)) The
(b The Head
Head of the
the Labo
Laborarator
toryy mu
must
st obta
obtain
in a sta
state
teme
mentnt fr
from
om th
thee Analys
Analystt tha
thatt he or sh
shee
inadvertently forgot to sign the CCF, but did, in fact, properly conduct the certification
review.
(c) The Head of the Laborat
Laboratory
ory must require
require the laborator
laboratoryy to modify and retrans
retransmit
mit a corrected
corrected
electronic report.

6.
6.5.
5.55 Co
Cond
ndit
itio
ionns for
for re
rete
tent
ntio
ionn of spe
specime
cimenn

6.5.
6.5.5.1
5.1 A lab
labor
orat
ator
oryy must
must reta
retain
in a spe
speci
cime
menn that
that was rep
repor
orte
tedd as neg
negat
ativ
ivee for
for a minim
minimum
um of 
of 
five days after receipt of result.
6.5
6.5.5.2
.5.2 A labora
laboratortoryy must
must ret
retain
ain a spec
specime
imenn that
that was re
repor
ported
ted either
either as positiv
positive,e, adulter
adulterate
ated,
d,
substituted, or invalid result for a minimum of 15 days upon receipt of the result. A
specimen may be retained for a maximum of 1-year upon request. If no such request
is received, a specimen may be discarded.
di scarded.
6.5.
6.5.5.3
5.3 A ret
retai
aine
nedd speci
specime
menn must
must be ke
kept
pt in a seco
second
nd loca
locatio
tionn appro
appropr
pria
iate
tely
ly,, to ensu
ensure
re its
its
availab
ava ilabilit
ilityy for any necess
necessary
ary ret
retest
esting
ing during
during an admini
administr
strativ
ativee or jud
judicia
iciall
 proceeding.

6.6 Te
Tests
sts for additional drugs

Specimen can be tested for additional drugs upon request, depending on the service capability of 
the drug-testing
drug-testing laboratory
laboratory.. However,
However, when a laboratory
laboratory performs
performs a procedure
procedure to test specimen
specimen for 
 

which it is not accreted,

accreted, it must inform the Client/Donor
Client/Donor/Subje
/Subject
ct that the specimen
specimen is not being tested
under the Guidelines and the procedures are not subject to review by the NRL.

Chapter 7

LABORATORY SECURITY AND CHAIN OF CUSTODY

The
Th e labo
labora
rato
tory
ry mumust
accessioning/receiving, st aliquoting,
prov
provid
idee initial
an outl
outlin
andine
e rerega
gard
rdin
ingg testing,
confirmatory ch
chai
ain-
n-of
of-c
-cus
and usto
tody
dy prproc
disposition oced
ofedur
ures
es du
duri
specimen ring
ng
and
aliquots consistent with
wit h the laboratory’s actual procedures.

7.1 Chain of Custody

7.1.
7.1.11 Drug
Drug Tes
estin
tingg Cus
Custo
tody
dy aand
nd Con
Contr
trol
ol FFor
orms
ms
7.1
7.1.1
.1.1
.1 Burea
Bureauu of Hea
Health
lth Fac
Facil
iliti
ities
es Ser
Servi
vice
cess (BHF
(BHFS)
S) app
appro
rove
vedd Drug
Drug Tes
Testin
tingg Custo
Custody dy
and Control Form (CCF) must be used to document the collection of a specimen
 by all drug-testing laboratories.
7.1.1.2 The form is used to document chain of custody from the time a
Client/Donor/Subject gives the specimen to the Authorized Specimen Collector 
until the specimen is received for testing.
7.
7.1.
1.1.
1.33 The
The CCF usedused for
for each
each type
type of
of speci
specime
menn colle
collect
cted
ed shou
should
ld be avai
availa
labl
blee at the
the
drug testing laboratories. A sample of the BHFS-CCF ffor or each type of specimen

is available at the following website: 

website:  www.doh.gov.ph
7.2 Accessioning

The laboratory must:

7.2
7.2.1
.1 Provide
Provide a uniqu
uniquee access
accession
ion numbe
numberr upon entr
entryy of the speci
specimen
men to the
the laborat
laboratory
ory;;
7.2.2 Inspect
Inspect the specimen
specimen submitted
submitted and
and th
thee CCF
CCF to verify
verify the integrity
integrity and
and identity
identity of the
specimen;
7.2
7.2.3
.3 Examine
Examine the pac
packagkaging
ing for
for evid
evidenc
encee of tam
tamper
pering
ing in
in trans
transit;
it;
7.2
7.2.4
.4 Compare
Compare the
the infor
informat
mation
ion on
on the sample
sample bbott
ottles
les withi
withinn the ppack
ackage
age
7.
7.2.
2.55 Docu
Docume
mentnt all
all ddis
iscr
crep
epan
anci
cies
es

7.3 Security Me
Measures
7.3.1 A laboratory
laboratory must control
control access
access of unautho
unauthorize
rizedd individual
individual and ensure
ensure that
that no
unauthorized individual can gain access to specimen, aliquots, or records.
7.3
7.3.2
.2 All author
authorize
izedd visit
visitors
ors mus
mustt bbee esco
escorte
rtedd at all times.
times.
7.3.3 A laboratory
laboratory must maintain
maintain a recor
recordd that documents
documents the dates,
dates, time of
of entry
entry and
and exit,
exit, and
and
 purpose of entry of authorized escorted visitors accessing
accessing secured areas.

Chapter 8

ANALYTICAL METHODS

8.1 Techniques
8.1.1 Screening
8.1.1.1 Immunoassay

These methods are used for preliminary screenilg (i.e., initial screening), based on an
antibodq-antigen reaction. Small amounts of the drug and/or metabolite (s) may be detected.
The following are examples of this
t his technique:

(a) Enzyme
Enzyme immu
immunoa
noassa
ssayy (EIA)
(EIA)
 

(b) Enzym
Enzyme-mudt
e-mudtiple
iple immunoas
immunoassay
say techniau
techniauee (EMIT)
(EMIT)
(c) Fluore
Fluoresce
scence
nce polari
polarizat
zation
ion
(d) Rad
Radioim
ioimmun
munoas
oassay
say ((RIA
RIA!!

8.1.1.2 Chromatography

Separation of a mixture is the main

main outcome of the ahromatographic method. In this process,
a mixture of substances is separated in a stationarx medium. The types of chromatographic
 processes are:
(a) Thin
Thin Layer
Layer Chromat
Chromatogr
ograph
aphyy (TLC)
(TLC)
(b) Gas CChro
hromat
matogr
ograph
aphyy (GC)
(GC)
(c) Liquid
Liquid Chroma
Chromatog
tograp
raphy
hy (e.g.,
(e.g., HPLC)
8.1.2 Confirmatory

8.1.2. Hyphenated
Hyphenated technique
technique – combination
combination of tw
twoo sop
sophistic
histicated
ated technologie
technologiess (e.g.,-
(e.g.,- GC-MS)
GC-MS)
or other such modern and acceptable technique (e.g., LC-MS,
LC -MS, GC)MS-MS or LC-MS-
MS).

8.2 Test
8.
8.2.
2.11 Scre
Screen
enif
ifgg La
Labo
borrator
atoryy
8.2.1.1
8.2. 1.1 A labora
laborator
toryy that
that perfo
performs
rms a va
valid
lidate
atedd test
test to
to diff
differe
erentia
ntiate
te nega
negative
tive specime
specimenn from
from a specime
specimenn

8.2.1.2 that
T he requires
method ufurther
sed matesting
y be; for drugs and/or metabolite.

(a) A register
registered
ed testing
testing kits approv
approved
ed by the DOH
(b) Instrumente
Instrumentedd screeni.g
screeni.g method

8.2.1.3.1 A screenilg
screenilg laboratory may conduct a repeat screening test on the same sample prior to the
confirmatory test.

8.2
8.2.1
.1.4
.4 The
The scre
screen
enin
ingg labor
laborat
ator
oryy mus
mustt subm
submit
it al
alll samp
samplds
lds with
with pos
posid
idive
ive res
resul
ults
ts to any
any DOH
DOH
accredited confirmatory drug testing
testing laborator9. Together
Together with the sample, thd following
documents shall be submitted.:

(a) Accomplished
Accomplished Custody
Custody an
andd Control
Control Form
(b) Initial
Initial La
Labor
borato
atory
ry Rep
Report
ort
(c) Letter Request
Request for
for Confirmato
Confirmatory
ry Test
Test

8.
8.2.
2.1.
1.55 The
The rel
relea
ease
se of the
the res
resul
ults
ts will
will be depe
depend
nden
entt oonn the
the::
(a) Avail
vailaabili
bility
ty of
of co
conf
nfir
irma
mato
tory
ry la
labo
borrator
atoryy
(b) Distance
Distance of cmnfirmatory
cmnfirmatory laboratory
laboratory from
from the Screening
Screening laboratory
laboratory

8.2.1.6
8.2.1.6 The screen
screening
ing habora
haborator
toryy must
must jeep
jeep specim
specimen
en wat
wathh a negati
negative
ve res
result
ult for a minim
minimum
um of 5 ddays
ays
upon receipt
receipt of result. In c`se the result is not retrieved
retrieved by the Client/Donor
Client/Donor/Subje
/Subject
ct the
laboratory has the option to discard the specimen after 5 days.

8.
8.2.
2.22 Co
Conf
nfir
irma
mato
tory
ry Labo
Labora
rato
tory
ry

8.2
8.2.2
.2.1
.1 A labo
labora
rato
tory
ry that
that perfo
perform
rmss a co
conf
nfir
irma
mator
toryy analy
analysis
sis usin
usingg valida
validate
tedd analy
analytic
tical
al proc
proced
edur
uree by
 NRL of an aliquot of specimen submitted from a screening laboratory in order to identify and
quantify the presence of a metabolite.
8.
8.2.
2.2.
2.22 The
The proc
proced
edur
uree used
used mu
must
st comb
combin
inee chro
chroma
mato
togr
grap
aphi
hicc se
sepa
para
rati
tion
on anandd ma
mass
ss sp
spec
ectr
trom
ometetri
ricc
identification in the same procedure (e.g., GC/MS, LC/MS/MS or LC/MS/MS)
 

8.
8.2.
2.2.
2.33 All
All conf
confirirma
mato
tory
ry labor
laboratator
orie
iess mu
mustst ac
acce
cept
pt spec
specim
imenen teste
testedd po
posi
siti
tive
ve from
from a scscre
reen
enin
ingg
labora
laborator
toryy with accaccomp
ompany
anying
ing reques
requestt for con
confir
firmat
matory
ory testin
testingg and previo
previous
us res
result
ult of 
analysis.
8.2
8.2.2
.2.4
.4 Confi
Confirmrmat
ator
oryy labor
laborat
ator
oryy must
must keep
keep the rem
remai
ainin
ningg spec
specime
imenn teste
testedd positi
positive
ve.. Only
Only the
the resu
results
lts
of the confirmatory test will be given to the screening laboratory.
8.2
8.2.2
.2.5
.5 The
The confi
confirmrmat
ator
oryy labor
laboratator
oryy mus
mustt relea
release
se with
within
in thre
threee (3) to
to five
five (5) wor
worki
king
ng days
days upon
upon
receipt
rece ipt of the specimen
specimen depending on workload
workload and availability
availability of equipment
equipment and supplies.
supplies.
For criminal case-related drug testing, the confirmatory result should be released 24 houró
after submission
refer to of specimen.laboratory.
another confirmqtory In case, the test cannot be done, notify the requesting party to

Chapter 9

URINE SPECIMEN VALIDITY

VALIDITY TEST

A validity test is a test to determine the integrity of the specimen.

9.1 Validity
Validity procedures for unobserved urine collection to determine the integrity ïf`the specimen.

9.
9.1.
1.11 Perf
Perfor
orm
m init
initia
iall vali
validi
dity
ty tes
tests
ts..

9.
9.1.
1.1.
1.11 Urin
Urine(
e(ph
phys
ysic
ical
al exam
examin
inat
atio
ionn in the
the fo
foll
llow
owyn
yngg cond
condit
itio
ions
ns::
(a
(a)) Tem
empe
pera
ratu
ture
re
(b) Abnormal
Abnormal physical
physical appearance
appearance (e.g., color,
color, odor, excessive
excessive foaming);
foaming);
(c) Reactions
Reactions or responses
responses characteris
characteristics
tics of an adulterant
adulterant obtained during
during initial or confirmatory
confirmatory
drug tests (e.g., non-recovery of standards, unusual response); or 
(d) Possible
Possible unidentified
unidentified interfe
interfering
ring substance
substance or adultera
adulterant.
nt. The choice
choice of additional
additional validity
validity
tests is dependent on the observed indicators or characteristics as described in a (a) (b).

9.
9.1.
1.1.
1.22 Urin
Urinee sspe
peccific
ific grav
gravit
ityy, pH and
and nit
nitrrite
ites;
9.1
.1..1.3 Urine cre
creatin
tinine
ine con
concentra tratio
tion;
9.1
9.1.1
.1.4
.4 Val
alid
idity
ity te
test
st(s
(s)) for
for pre
presesenc
ncee of oxid
oxidizizing
ing ad
adult
ulter
eran
ants
ts as
as need
needed
ed..

9.1.22
9.1. Perfor
Perform
m confir
confirmat
matory
ory validit
validityy tests usi
using
ng other
other procedu
procedures
res,, ins
instru
trumen
ments
ts and/or
and/or methods
methods on the
same sample.

 Notes:

i) All
All unobs
unobser
erve
vedd samp
sample
less for
for vali
validi
dity
ty test
testin
ingg shal
shalll be subm
submititte
tedd to an accr
accred
edit
ited
ed
drug testing facility with at least secondary clinical laboratory capability.
ii)
ii) Validi
lidity
ty test
testss for
for othe
otherr type
typess of sp
spec
ecim
imeen shshaall be in
inccor
orppor
oraated
ted for futu
futurre
reference.

9.
9.22 Cr
Crit
iter
eria
ia for
for det
deter
ermi
mini
ning
ng urin
urinee sspe
peci
cime
menn

9.2.1 Invalid:

A urine specimen is invalid when:

9.
9.2.
2.1.
1.11 Adul
Adulte
terrated,
ted, sub
ubst
stit
itut
uted
ed and dilu
diluteted;
d;
9.
9.2.
2.1.
1.22 Impr
Improp
oper erly
ly coll
collec
ecte
ted,
d, hand
handle
ledd aand
nd stor
stored
ed;; and
and
9.2.1.3 Improperly ddoocumented.
 

9.2.2 Adulterated:

9.2
9.2.2
.2.1
.1 The
The nitr
nitrite
ite ccon
oncecent
ntra
ratio
tionn is con
confifirm
rmed
ed ttoo be ggre
reat
ater
er tha
thann or equ
equal
al to
to 500
500 ug/d
ug/dL;
L;
9.
9.2.
2.2.
2.22 The
The pH
pH isis les
lesss tha
thann 3 or grea
greate
terr tha
thann or
or equ
equal
al to 11;
9.
9.2.
2.2.
2.33 The
The spec
specimimen
en cocont
ntai
ains
ns an exoge
exogeno nous
us subs
substatanc
ncee (i.e
(i.e.,
., a su
subs
bsta
tanc
ncee whic
whichh is not
not a no
norm
rmal
al
constituent of urine); or 
9.
9.2.
2.2.
2.44 The
The spec
specimimen
en cocont
ntai
ains
ns an endo
endoge geno
nous
us subsubst
stan
ance
ce at a coconc
ncen
entr
trat
atio
ionn gr
grea
eate
terr th
than
an what
what is
considered a normal physiological concentration

9.2.3 Substituted:

A urine specimen is reported substituted for non-human urine specimen when both the initial and
confirmatory specific gravity tests have the following results:

9.2
9.2.3
.3.1
.1 The
The cre
creat
atin
inine
ine co
conc
ncen
entr
trat
atio
ionn iiss les
lesss tha
thann 4442
42.0
.0 um
umolol/L
/L;; aand
nd
9.2
9.2.3
.3.2
.2 Sp
Spec
ecif
ific
ic gra
gravi
vity
ty is
is les
lesss than
than 1.00
1.0022 or or gre
great
ater
er than
than oorr eequ
qualal to 1.0
1.020
20..

9.2.4 Diluted:

A urine specimen is reported dilute when the initial or confirmatory test have creatinine and
specific gravity results of:

9.2
9.2.4
.4.1
.1 The
The cr
crea
eatin
tinine
ine co
conc
ncen
entr
trat
atio
ionn is le
less
ss than
than 1768
1768.0
.0umo
umol/L
l/L;;

9.2.4.
4.2
2
9.2.4.3
9.2.4.3 The spec
The sp
cr ecif
creatific
ic grav
eatiningr
e avit
inine anity
dyspeci
and spisecific
less
less
ficthan
thgravity
anvity
gra 1.00
1.003;
3; ults
res and
and do not
results not me
meet
et the
the crit
criteri
eriaa for
for a subs
substitu
tituted
ted or inva
invalid
lid
result.

9.3 Proced
Procedure
uress for
for con
conduc
ducting
ting eac
eachh vvalid
alidity
ity test
test oonn a urine
urine specime
specimenn

9.
9.3.
3.11 Fo
Forr crea
creati
tini
nine
ne con
conce
cent
ntra
rati
tion
on::

9.3
9.3.1
.1.1
.1 The
The creat
creatini
inine
ne conc
concenentr
trat
ation
ion sha
shall
ll be meas
measurured
ed to one one decima
decimall place
place on both
both the
the initi
initial
al test
test
and the confirmatory tests;
9.3.1.2
9.3.1.2 The ini
initia
tiall creat
creatinin
ininee test
test shal
shalll have
have a ca
calibr
librato
atorr aatt eithe
eitherr 442.0
442.0umo
umol/L
l/L or at
at 1768.
1768.0um
0umol/
ol/L;
L;
9.3
9.3.1
.1.3.3 The
The initia
initiall creat
creatini
inine
ne test
test shal
shalll have
have a contr
control
ol in the
the ran
range
ge of 176
176.8
.8 umol
umol/L
/L toto 353.6
353.6um
umolol/L,
/L, a
cont
contro
roll in the the ra rang
ngee of 442.
442.0u0umomol/L
l/L to 171786
86.0 .0umo
umol/Ll/L,, an
andd a co
cont
ntro
roll in the rarang
ngee of 
1856.4umol/L to 2210.0umol/L;
9.3.1.4
9.3. 1.4 The confir
confirmatmatory
ory cr creat
eatinin
ininee test
test ((per
perfor
formed
med oonn ththatat spec
specime
imenn with
with a cre
creati
atinin
ninee conce
concentr
ntratio
ationn
less than 442.0umol/L on the initial tests) shall have a calibrator at 442.0umol/L or at
1768.0umol/L,a control in the range of 176.8umol/L to 353.6umol/L, and a control in the
range of 530.4umol/L to 707.2 umol/L.
9.
9.3.
3.22 For
For speci
pecifi
ficc gr
gravity
vity::

9.3
9.3.2
.2.1
.1 The
The speci
specifificc shall
shall be measu
measure
redd using
using a re
refr
frac
actom
tometeter
er on both
both initia
initiall and conf
confir
irma
matotory
ry tests
tests..
The refractometer shall be capable of reading in increments of at least 0.001 or less.
9.3.2.2
9.3.2.2 The ini
initia
tiall and
and confir
confirmato
matory
ry specif
specific
ic gravity
gravity tests
tests shall
shall have
have a ccalib
alibra
rator
tor at 1.0
1.000
00
9.3.2.3
9.3.2.3 The ini
initia
tiall and
and confir
confirmato
matory
ry specif
specific
ic gravity
gravity tests
tests shall
shall have
have the followi
followingng contro
controls:
ls:

(a) For the cutoff

cutoff less
less than 1.002,
1.002, one control
control at 1.001
1.001 and one control
control in the range
range of 
1.002 to 1.010.
(b) For the cutof
cutofff of greater than
than or equal to 1.020, one control
control greater
greater than or equal to
1.020 but not greater than 1.025, and one control in the range of 1.015 to 1.020.

9.3.3 For pH:

9.3.3.1
9.3.3.1 Dipstic
Dipstick,
k, pH
pH ppape
aperr or spe
spectr
ctrome
ometric
tric/co
/color
lorime
imetric
tric tests
tests may be used
used ffor
or init
initial
ial val
validit
idityy test.
test.
 

9.3
9.3.3
.3.2
.2 A pH me
meteterr ssha
hall
ll be used
used to perf
perfor
orm
m con
confi
firm
rmat
ator
oryy vval
alidi
idity
ty te
test
st..
9.3
9.3.3
.3.3
.3 The
The initi
initial
al and
and con
confi
firm
rmat
ator
oryy pH met
meter
er tes
tests
ts sha
shall
ll hav
havee the
the follo
followin
wingg contr
control
ols:
s:

(a) For the cutoff

cutoff of less
less than 3, one control
control in the range
range of 2 to 2.9 and one control
control in the range
range
of 3.1 to 4.
(b) For the cutoff
cutoff of greater
greater than
than or equal to 11,
11, one control
control in the range
range of 10 to 10.9 and one
control in the range of 11.1 to 12.
(c) Spectrometr
Spectrometric/col
ic/colorimet
orimetric
ric initial pH tests
tests shall have the followin
followingg controls;
controls;

(i) For the cutoff

cutoff of less than 3, one control
control in the range of 2 to 2.9.
(ii) For the cutoff of greater than or equal to 11, one control
control in the range of 11.1 to 12.

9.
9.3.
3.44 Fo
Forr oxid
oxidiz
izin
ingg adul
adulte
tera
rant
nt tes
tests
ts::

9.
9.3.
3.4.
4.11 At a minim
minimum
um,, the init
initia
iall test(
test(s)
s) for
for oxid
oxidiz
izin
ingg adult
adulter
eran
ants
ts shal
shalll be capab
capable
le of dete
detect
ctin
ingg
nitrites,
nitrites, chromates,
chromates, and halogens (e.g., bleach,
bleach, iodine). The detection
detection of these adulterants
adulterants
may be achieved by using either a general oxidizing adulterant tests or by using specific tests
for
for eaeach
ch ca
cate
tego
gory
ry of thes
thesee adadult
ulter
eran
ants.
ts. If an in initi
itial
al tetest
st fo
forr ox
oxid
idiz
izing
ing ad
adul
ulte
tera
rant
ntss
simultaneously tests for all oxidizing adulterants, the assay shall be able to detect at least the
activity equivalent to 20mcg/mL of chromate (chromium VI) or 200 mg/dL of nitrites as an
LOD. Each analytical
analytical run of specimen
specimen shall include
include a control without the compound
compound of 
interest (ie. Accredited negative control) and at least one positive control with one of the
compounds of interest at a concentration, which exhibits an oxidizing activity above the

9.3.4.2
9.3.4.2 documented
A conf
confirma LOD
irmator
tory tesof
y test fothe
t forr aprocedure.
spec
specific
ific oxi
oxidiz
dizing
ing adult
adultera
erant
nt shall
shall use
use a dif
differ
ferent
ent anal
analytic
ytical
al prin
princip
ciple
le
or chemical reaction than that used for the initial test unless a recognized reference method is
used for both the initial and confirmatory tests. Each analytical run of specimen shall include
a control without the compound of interest (i.e., accredited negative control) and a positive
control with the compound of interest at a concentration above the documented LOD of the
 procedure.

9.
9.3.
3.55 Fo
Forr ni
nitr
trit
itee conc
concen
entr
trat
atio
ion:
n:

9.
9.3.
3.5.
5.11 Dips
Dipsti
tick
ckss ma
mayy only
only be used used to dete
determrmin
inee if init
initia
iall an
andd co
conf
nfir
irma
matotory
ry nitr
nitrit
itee te
test
stss sh
shal
alll be
 performed.
9.3
9.3.5
.5.2
.2 A nitr
nitrite
ite spe
speci
cifi
ficc initia
initiall test
test shall
shall have
have a ca
calib
libra
rator
tor atat the cutof
cutofff conce
concentr
ntrat
atio
ion,
n, a negat
negativ
ivee
control (ie., accredited negative urine), one control in the range of 200 mcg/ml. To 500
mcg/mL., and one control in the range of 500 mcg/ml/ to 625 mcg/ml.
9.3
9.3.5
.5.3
.3 The
The confi
confirmrmat
ator
oryy nitrite
nitrite test
test shal
shalll have
have a ca
calib
libra
rato
torr at the cuto
cutoff
ff conc
concen
entr
trat
atio
ion,
n, a negativ
negativee
control (i.e., accredited negative urine), one control in the range of 200 mcg/ml to 500
mcg/ml., and one control in the range of 500mcg/ml. to 625mcg/ml.

9.3.66
9.3. For othe
otherr validit
validityy tes
tests
ts (e.g.
(e.g.,, glu
glutar
tarald
aldehy
ehyde,
de, surf
surfact
actant
ants):
s):

9.3.6.1
9.3.6.1 Each
Each analy
analytictical
al run
run of
of spec
specime
imenn shall
shall inc
include
lude a ccont
ontrol
rol without
without the compou
compound nd of intere
interest
st (i.e.
(i.e.,,
a negative control) an a positive control with the compound of interest at a concentration
above the documented LOD of the t he procedure.
9.
9.3.
3.6.
6.22 A confi
confirm
rmatator
oryy test
test for a spec
specifific
ic adult
adulter
eran
antt sh
shal
alll us
usee a di
difffe
fere
rent
nt analy
analyti
tica
call pr
prin
inci
cipl
plee or 
chemical reaction than that used for the initial test unless a recognized reference method is
used for both the initial and confirmatory tests.
9.3
9.3.6
.6.3
.3 The
The initia
initiall and conf
confir
irma
mator
toryy tests
tests for
for anion
anionic
ic surf
surfac
acta
tant
ntss shall
shall be able
able to dete
detectct at leas
leastt the
activity equivalent to 100 mcg/ml of dodecylbenzene sulfonate.

 Note: Deviations on the above numerical values may vary depending on the prevailing technology,
technology,
 procedure and reference materials used by the laboratory.
laboratory.
 

Chapter 10

RECORDING

The laboratory
collection, shall develop
accessioning, andofmaintain
result analysis clear and well-documented
and remedial records
measures, which detailing
shall not be procedures for 
limited to the
following:

10.1 Chain of Custody

Chain of Custody (COC) records must reflect the actual chain of custody procedures 9e.g., the
movement between individuals or movement to /from temporary storage) that are used for handling
specimen.

10.2 Memorandum for Records (MFR)

It is a record to document
document specimen that had been rejected or cancelled.
cancelled. In includes reason and
corrective measures done.

10
10.3
.3 Re
Resu
sult
ltss of Ana
Analysi
lysiss
Records for all screening/confirmatory test result and /or of the documents contain the following:

10
10.3
.3.1
.1 Test re
resu
sult
ltss
10.3.2
10.3.2 Test resul
results
ts of control/c
control/cali
alibra
brator
tor/st
/stand
andar
ardd
10.3.3
10.3.3 Labora
Laborator
toryy identif
identifica
ication
tion of sspec
pecime
imenn tested
tested
10.3.4 Identifica
Identification
tion of individual
individual peperfor
rforming
ming an
andd reviewing
reviewing the test
test results.
results.
10.3.5 Evidence
Evidence of review
review by the certifying
certifying Analyst
Analyst in confirma
confirmatory
tory tests
tests
10.3.6 Evidence
Evidence of confirmato
confirmatoryry work sheets
sheets or other
other review
review documents
documents of comparis
comparison
on of the initial
initial and
confirmatory testing data to ensure consistent results.
10.3.7
10.3.7 Strike
Strikeout
out change
changess made on tests tests results
results and other recor
records
ds must be properly
properly annota
annotated
ted by the
responsible individual.

10.4 Invent
Inventory
ory of reag
reagent
ent,, supplie
suppliess and
and mater
material
ials.
s.

There must be a record of all reagents, supplies and materials used.

10.5 Equipme
Equipment,
nt, mainte
maintenan
nance
ce and repair
repair rec
record
ord

The equipment, maintenance and repair record should document that all instruments are properly
ma
maint
intai
aine
ned,
d, ca
calib
libra
rate
ted,
d, cl
clea
eane
nedd an
andd mo
moni
nitor
tored
ed in
incl
clud
uding
ing the cocorr
rrec
ectiv
tivee me
meas
asur
ures
es an
andd
recommendations done.

10.6
10.6 St
Stor
orag
agee of coll
collec
ectio
tionn site
site reco
record
rdss
Collection site records must be stored for a minimum of 2 years in the laboratory or as required by
law.

10.7
10.7 Qual
Quality
ity Assu
Assura
ranc
ncee Progr
Program
am Reco
Record
rd

10.7.1
10.7.1 Intern
Internal
al qua
qualit
lityy con
contr
trol
ol
10.7
10.7.2
.2 Exte
Extern
rnal
al qua
qualit
lityy con
contr
trol
ol
 

10.8
10.8 Stora
Storage
ge of
of lab
labor
orat
ator
oryy reco
record
rdss

10.8.1 A labora
laboratory
tory must retain
retain all
all records
records generated
generated to support
support test
test results
results for at least
least 2 years.
years.
10.8.2 However
However,, all other records
records associate
associatedd with positive
positive results
results or a particular
particular specimen
specimen under
under legal
legal
challenge shall be maintained for an indefinite period.

10.9
10.9 El
Elec
ectr
tron
onic
ic stor
storag
agee syst
system
em

10.9.1 application
A DOH-accr
DOH-accredited
editedprovider.
service laborat
laboratory
provider ory
. shall
shall store and archive
archive all
all record
record electronicall
electronicallyy to duly authorize
authorizedd
10.9.2
10.9.2 The labora
laborator
toryy must
must valida
validate
te that the method used used to cre
create
ate the electron
electronicic records
records provide
providess an
accurate representation of the original records.
10.9
10.9.3
.3 The
The memeththod
od used
used to cr crea
eate
te the
the elelec
ectr
tron
onic
ic re
reco
cord
rdss mu
mustst pr
prev
even
entt th
thee alte
altera
ratio
tionn of an
anyy st
stor
ored
ed
information and/or data.
10.9.4 The method
method used
used must allow
allow easy
easy retrieval
retrieval an reproducti
reproductionon of the original
original records.
records.
10.9.5
10.9.5 The laborat
laboratory
ory shall
shall assure
assure the integrit
integrityy of data electro
electronica
nically
lly stored
stored under
under its inf
inform
ormati
ation
on
techno
technolog
logyy fac
facilit
ilities
ies with
without
out preprejud
judice
ice to pertine
pertinent
nt sta
statute
tutess on privac
privacy/c
y/conf
onfide
identia
ntiality
lity and
transparency.
10.9.6 The laborator
laboratoryy shall assure
assure the integrity
integrity of data
data by transmitting
transmitting it electron
electronically
ically from
from their facility
facility
to DOH within the prescribed time and measures to counter disruption of transmitted are installed
10.9.7 The laboratory
laboratory shall
shall assure
assure that the data stored
stored electronic
electronically
ally have back-up
back-up copies
copies for
for the purpose
purpose
of audit by the DOH and as a measure to preclude inadvertent of records.
10.9.8 Electronic
Electronic transmitta
transmittall of drug testing
testing results
results shall
shall be coursed
coursed by the DOH authorizauthorized
ed application
application
service provider.

Chapter 11

REPORTING

The labora
laborator
toryy shall
shall mainta
maintain
in specime
specimenn test
test res
results
ults suppor
supported
ted by dat
dataa ad ar
aree report
reported
ed in
accordance with the following written guidelines.

Procedure must be in placed to ensure confidentiality of records.

11.1
11.1 Guidel
Guideline
iness for
for re
repor
porting
ting a la
labor
borato
atory
ry rresu
esult.
lt.

11.1.1
11.1.1 All specimen
specimen submitte
submittedd shall have
have a corres
correspondin
pondingg laboratory
laboratory result
result issued
issued within
within 15 days.
days.
11.1.2
11.1.2 A positive
positive scree
screening
ning result
result shall
shall be subjecte
subjectedd to confirmato
confirmatoryry analysis.
analysis. The final
final report
report shall
shall be
 based on the confirmatory results.
11.1.3 The screening
11.1.3 screening labora
laboratory
tory shall
shall be the only
only authorize
authorize labor
laboratory
atory to releas
releasee the final
final report.
report.
11.1.4
11.1.4 All laboratory
laboratory reports
reports of a screen
screening
ing laboratory
laboratory sha
shall
ll bear the signatur
signaturee of the Analys
Analystt and Head of 
the Laboratory.
Laboratory. For a confirmatory laboratory,
laboratory, the reports shall bear the signatures of the Analyst,
Chief Chemist and Head of the Laboratory.
Laboratory.
11.1.5
11.1.5 All confirm
confirmato
atory
ry drug tests
tests re
result
sultss should
should specify
specify the concent
concentrat
ration
ion of the limit of detection
detection
(LOD) of the method of the drug or metabolites. However, for clinical or therapeutic purposes,
the concentration shall be quantified.
 

11.1.6
11.1.6 A laborato
laboratoryry shall report
report all tests
tests results
results using the DOH
DOH standard
standard electronic
electronic laborato
laboratory
ry report
report form.
The electronic report must be transmitted in a manner that ensures the confidentiality and security
of the information.
11.1.7
11.1.7 Reports
Reports for an adulter
adulterated
ated or substitu
substituted
ted test result
result must be based
based on an an initial and
and confirmator
confirmatoryy
validity test.
11.1.8
11.1.8 The laborat
laboratmry
mry must report
report the specifi
specificc validi
validity
ty test resu
result(
lt(s)
s) for a specim
specimen
en that is re
repor
ported
ted
adulterated or substituted.
11.1.9
11.1.9 No resul
resultt can
can b% relay
relayed
ed dhrou
dhroughgh te
telep
lephkn
hkne.
e.

11.2
11.2 Statis
Statistic
tical
al summar
summaryy of the llabo
aborat
ratory
ory report
report..

11.2.1 A habora
11.2.1 haboratory
tory must
must submit annuall
annuallyy to the BHFS
BHFS a report
report containin
containingg the following
following::
11.2.1
11.2.1.1
.1 Tota
otall number
number of spec
specime
imenn recei
received
ved and
and exam
examine
inedd as classi
classifie
fiedd accor
accordin
dingg to:

(a)
(a) Mand
Mandatator
oryy
(b) Ran
Random
(c)) Other
(c Other re
reas
asononss

11.2
1.2.1.
.1.22 The
The num
numbe
berr of spec
specime
imenn that
that w
wer
eree rep
repor
orte
tedd aas:
s:

(a) Positive
Positive for each drug
drug (listed
(listed separ
separately
ately))
(b) Adult
(b) Adulter
erat
ated
ed
(c)
(c) Su
Subs
bsti
titu
tute
tedd
(d)
(e)) Reje
(e Rejecte
Inva
In cteddre
valid
lid for
resultTesting
sult esting

11.2.1.3
11.2.1 .3 The numb
numberer ooff specim
specimen
en sent
sent for
for confir
confirmat
matory
ory test
testing
ing (for
(for scree
screening
ning labo
laborat
ratory
ory).
).
11.2.2
11.2.2 The report
report must
must be submitted
submitted to the
the BHFS by mail,
mail, fax or email
email within
within 10 working
working days
days after
after the
end of the year.

11.3 Reviewing
Reviewing a positive,
positive, aadulter
dulterated,
ated, substituted,
substituted, or invalid test result
result

Prior to making a final decision on a specimen that was reported positive, adulterated, substituted,
or an invalid test result by the laboratory, the Head of the Laboratory shall:

11.3.1
11.3.1 Allow the Client/Donor
Client/Donor/Subje
/Subject
ct to explain
explain an
anyy circumstan
circumstances
ces leading
leading to the
the test result.
result.
11.3.2
11.3.2 Evaluate
Evaluate alternative
alternative medical
medical explana
explanations
tions for the
the positive,
positive, adulterated
adulterated,, substituted,
substituted, or invalid
invalid test
results.
11.3.3
11.3.3 Review
Review current
current medical
medical explan
explanatio
ations
ns for the positive
positive,, adulter
adulterate
ated,
d, substi
substitute
tuted,
d, or invalid
invalid test
test
result.

11.4 When
When th thee la
labo
bora
rato
tory
ry re
repo
port
rtss an inv
inval
alid
id re
resu
sult
lt due
due to the pos
possi
sibl
blee pr
pres
esen
ence
ce of an unid
uniden
entif
tifie
iedd
interfering substance/adulterant, the Head of the Laboratory shall;
11.4.1 Send
11.4.1 Send the specimen
specimen to anothe
anotherr DOH accredi
accredited
ted laborat
laboratory
ory capable
capable of ide
identif
ntifyin
yingg the interfe
interferin
ringg
substances/adulterant;
11.4.2
11.4.2 Report
Report the result
result as “Test
“Test Cancelled”
Cancelled” if the explanatio
explanationn provided
provided by the Client/Don
Client/Donor/Sub
or/Subject
ject is:

(a) Acceptable
Acceptable then an
an immediate
immediate direct
direct observed
observed collecti
collection
on is not
not require
requiredd
(b) Not acceptab
acceptable
le then
then an immediate
immediate direct
direct observed
observed collecti
collection
on is requir
required.
ed.

11.5 For verificatio

verification,
n, the Client/Donor
Client/Donor/Subje
/Subject
ct may
may obtain
obtain other documents.
documents.

The Client/Donor/Subject must submit a written request addressed to the head of the drug t%sding
laboratoby to obtain a cerpified true copy of COC and pertinent analytical data.
 

Chapter 12

QUALITY ASSURANCE PROGRAM

12.1 Internal Quality Assuranbe Program (IQAP)

12.1
12.1.1
.1 Sc
Scre
reen
enin
ingg Labo
Labora
rato
tory
ry
12.1.
12.1.22 Val
alida
idatio
tionn of a ccre
ccreen
eniningg drug
drug test
test

(a) The laborator

laboratoryy must demonstr
demonstrated
ated and
and document:
document:

(i) The ability to differentiate positive and negative samples;

(ii) The performance of the test around the cut-off concentration; and
(iii) The performance of the test results at several concentrations between 0 to 150 percent of the
t he
cutoff concentration

(b) Performance characteristics

characteristics of new lots of
of testing kits
kits must be evaluated prior to its use.

12.1.2.1
12.1.2.1 Batch
Batch quali
quality
ty cont
control
rol req
requir
uireme
ements
nts when
when conduc
conducting
ting a sscre
creeni
ening
ng drug
drug testing
testing..

(a)
(a) Fo
Forr kit
kitss onl
onlyy

Each batch for specimen must contain the

t he following types of QC samples:

(i) At least one control registered and validated by the DOH to contain no drug metabolite;
(ii) At least one control that has the concentration of the drug or metabolite at 25 percent above the
cutoff concentration; and
(iii) At least one control that has concentration of the drug or metabolite at 25 percent below the
cutoff concentration.

(a
(a)) In
Inst
stru
rume
mente
ntedd

(i) Each batch of specimen must contain the types of QC sample as in drug testing laboratory using
kits.
(ii) At least 10 batch must be calibrators and controls
(iii)
(iii) A labora
laborator
toryy must
must docume
document nt that
that any car
carryo
ryover
ver tha
thatt might
might occur
occur betw
between
een
aliquots during the initial testing is detectable and corrected.

12.1
12.1.3
.3 Co Conf
nfir
irma
mato
tory
ry Labo
Laborarato
tory
ry
12.1
12.1.3
.3.1
.1 Valid
alidat
atio
ionn of a ccon
onfi
firm
rmat
ator
oryy drug
drug test
test

The laboratory must demonstrate and document:

. (a) The linear range of the analysis;
(b) The limit of detection (LOD)
(c) The limit
limit of quan
quantita
titatio
tionn (LOQ)
(LOQ)
(d) The accuracy
accuracy and precisio
precisionn at the cutoff concetr
concetration;
ation;
(e) The accuracy
accuracy and precisio
precisionn at 40 percent
percent of the cutoff
cutoff concentratio
concentration;
n; and
(f) The potent
potential
ial for
for interf
interfering
ering substances
substances..

12.1.3.2
12.1.3.2 Intern
Internal
al quali
quality
ty contr
control
ol rrequ
equire
iremen
ments
ts when
when cond
conduct
ucting
ing a confi
confirma
rmator
toryy drug
drug test
test..

(a) Each batch

batch of specimen
specimen must
must contain,
contain, at a minimum,
minimum, the following
following types
types of QC
samples:

(i) A three-point calibrator at the cutoff;

(ii) At least one negative control;
 

(iii)
(iii) At le
least
ast one
one posi
positive
tive contro
controll wit
within
hin 25 perc
percent
ent abov
abovee the
the cutof
cutofff conce
concentr
ntrati
ation;
on;
and
(iv)
(iv) At leas
leastt oone
ne blin
blindd ccon
ontr
trol
ol in ever
everyy bbat
atch
ch..

(b) At least 10 percent of each batch must be calibrators and controls.

(C) On a re-test/re-confirmation challenge, the batch must

m ust have one control that has the
concentration of the drug or metabolite at or below 40 percent of the cutoff concentration
(d) The linearre-evaluated
 periodically range, limitfor
of each
detection, and limitdrug
confirmatory of quantitation
test. must be documented and
(e) A laboratory must document that any carryover that might occur between
aliquots/extracts in the confirmatory batch is detectable and corrected

12.1.4 Analytical
Analytical and
and quality
quality control
control require
requirements
ments for performing
performing urine specimen
specimen validity
validity tests

12.1.4.1
12.1.4.1 A vali
validity
dity test
test res
result
ult for
for a sspec
pecime
imenn shall
shall be bis
bised
ed on
on perfor
performing
ming an
an initial
initial (firs
(first)
t)
validity test on one aliquot and a confirmatory (second) validity test on a second
iliquot
iliquot.. In some case cases,
s, roth validity
validity tests may use the same proced procedure
ure,,
instruments, and/ or method.
12.1.4.2
12.1.4.2 The perfo
performa
rmance
nce char
charact
acteri
eristi
stics
cs (e.g.
(e.g.,, accura
accuracy
cy,, precisio
precision,
n, LOD,
LOD, LOQ,
LOQ, linear
linearity
ity,,
specificity) shall be documented for eaci"validity test as appropriate
12.1
12.1.4.
.4.33 The
The LOD
LOD of of sus
suspepect
cted
ed ad
adul
ultetera
rant
ntss shal
shalll be de
dete
term
rmin
ined
ed
12.1.4.4
12.1.4.4 Each
Each analy
analytica
ticall run of sspec
pecimen
imen"fo
"forr which
which anan initia
initiall or conf
confirma
irmator
toryy validi
validity
ty te
test
st
is being performed shall include the
t he appropriate calibrators and controls.
12.
12.1.5
1.5 Blind
Blind Sample
Sampless Submitt
Submitted
ed by a Drug
Drug Test
Testing
ing LLabo
aborat
ratory
ory

(a) A blind
blind sample mus mustt be validated
validated as to its content
content by the suppler using
using initial
initial and
confirmatory tests.
(b) The supp
supplier
lier must provide
provide information
information regarding
regarding the shelf life
life of the blind sample.
(c) If the blind sample
sample is pos
positiv
itive,
e, the conce
concentr
ntratio
ationn of the drug it contain
containss must
must be
 between 1.5 and 2 times the initial drug test cutoff concentration
(d) If the blind sample is adulte
adulterated
rated or substituted
substituted,, its characteristic
characteristicss must clearly show
that it is an adulterated or substituted sample when validated by the supplier.
 
12.1.5.2 Requirements to submit blind samples

(a) Each Drug Testing

Testing Laborato
Laboratory
ry is required
required to have both negative non-nega
non-negative
tive blind
samples submitted with its Client/Donor/Subject specimen.
(b) Durin
Duringg the initial 90-day period
period of any new Drug Testing
Testing Laborat
Laboratory
ory,, it must ensure
ensure
tha
thatt at least
least 3 percen
percentt of the total
total number
numberss of Client/D
Client/Dono
onor/s
r/subje
ubjectct specime
specimenn
submitted are blind samples.
(c) After
After the ini
initial
tial 90-day
90-day perio
period,
d, the Drug
Drug Testing
Testing Laborat
Laboratory
ory must ensure
ensure tha
thatt a
minimum of 1 percent of the total number of Client/Donot/Subject specimen are
 blind samples.
(d) Appro
Approximate
ximatelyly 80 percent
percent of the blind samples may
may be negative (i.e.,
(i.e., accredited
accredited to
contain no drug) and the remaining non negative
(e) Each drug
drug positive sample
sampless must be spiked only
only with those drugs
drugs for which
which the Drug
Testing
Testing Laboratory is testing its specimen.

12.1.5.3 Submission of blind sample to the laboratory

(a) A blind sample

sample is submitted to the laboratory
laboratory together
together with the Drug Testing
Testing Laboratory’
Laboratory’ss
Client/Donor/Subject specimen.
(b) A blind
blind sam
sample
ple is always
always submitt
submitted
ed using the same BHFS
BHFS-ap
-appro
proved
ved CCF as used
used for a
Client/Donor/Subject specimen. The Authorized Specimen Collector provides the required
 

information to ensure that the CCF has been properly completed as well as providing
fictitious
fictitious initials on the specimen
specimen label/seal.
label/seal. The Authoriz
Authorized
ed Specimen
Specimen Collector must
indicate that the sample is a “blind sample” on the Head of the Laboratory copy where the
Client/Donor/Subject would normally provide a signature.
(c) Each Drug Testing
Testing Laborato
Laboratory
ry must ensures that the required
required blind samples are distr
distributed
ibuted
throughout the total number of Client/Donor/Subject specimen rather than submitted as a
single group of samples.

12.1.5.4
12.1.5.4 Proced
Procedure
uress to follow
follow when
when an inc
incons
onsist
istent
ent re
resul
sultt is report
reported
ed on
on a blind
blind sample
sample
If a laboratory reports an inconsistent result on a blind sample (e.g., a negative result on a blind
sample that was supposed to be positive, a positive result on a blind sample that was supposed to
 be negative, the laboratory cannot obtain a valid drug test):

(a) The Head of the Laborat

Laboratoryory must contact
contact the blind
blind sample
sample supplie
supplierr and determi
determine
ne if the
supplier may have made a mistake
mi stake when preparing the blind sample;
(b) The Head of the Laboratory
Laboratory must contac
contactt the Authorized
Authorized Specimen
Specimen Collector and determine
determine if 
the Authorized Specimen Collector made an error when preparing the blind sample for the
laboratory;
(c) If there is no obvious
obvious reason
reason for the inco
inconsi
nsiste
stent
nt result,
result, the Head of the Laborat
Laboratory
ory must
notify both the Drug Testing Laboratory for which the blind sample was submitted and the
 NRL; and
(d
(d)) The
The NRL
NRL will inve
invest
stig
igat
atee the
the blind
blind sampl
samplee ererro
rorr an
andd se
send
nd a re
repo
portrt to the Head
Head of ththee
Laboratory and the Drug Testing Laboratory describing the investigation and corrective action
taken.

 Note: The above procedure are recommended as the ideal internal quality assurance program, the
laboratory may improve this protocol depending on the prevailing technology and procedure.

12.2 Exte
terrnal Q
Quuality
ity Assurance Pr
Program (EQAP)

The DOH National Reference Laboratory (NRL) is tasked to conduct a Proficiency Test (PT)
for screening and confirmatory drug testing laboratory.

12.2.1 Requirement For Accreditation

12.2.1.1 Screening Laboratory

A screening laboratory shall pas the proficiency test conducted by the NRL before the
renewal of their accreditation.

12
12.2
.2.1
.1.2
.2 Conf
Confir
irma
mato
torry La
Labo
bora
rato
torry

As part of the accreditation, a laboratory shall pass the initial Proficiency Test and maintenance
Proficiency Testing
Testing condubted by NRL.

12.2
12.2.2
.2 Appd
Appdic
icat
atio
ionn fo
forr Cert
Certif
ific
icat
atee of Pro
Profi
fici
cien
ency
cy (CO
(COP)
P)

12.2
12.2.2
.2.1
.1 An inter
interes
este
tedd labo
labora
rato
tory
ry sh
shal
alll su
subm
bmit
it to NRL
NRL a le lett
tter
er of ijten
ijtentt fo
forr PT
PT,,
 properly `ccomplished appdication form and protocol prior tg the scheduled
PT.
PT.
12
12.2
.2.2
.2.2
.2 The
The app
applic
licatio
tion for
orm
m incl
includ
udees dedeta
tail
ileed re
rela
late
tedd in
info
forrma
mati
tion
on on bo both
th
administrative and analyticad procedures.

12.2
12.2.3
.3 Qual
Qualita
itativ
tivee aand
nd quan
quantit
titat
ative
ive spec
specif
ific
icat
atio
ions
ns of
of a pr
prof
ofic
icie
ienc
ncyy test
test sa
sampl
mplee
12.2.3.1 A PT sa sample may ccoontain:
 

(a) The drugs

drugs and/or
and/or metabohites
metabohites in in the drug classes
classes that each
each laboratory
laboratory must
must have the
the
capability to test for; or 
(b) No more than two drug classeclassess to imitate
imitate real
real Client/Door/Su
Client/Door/Subjec
bjectt specimen.
specimen.

12
12.2
.2.3
.3.2
.2 For
For con
onffirma
irmatotory
ry labo
labora
rato
torry, th
thee co
connce
cent
ntrration
tion of th
thee dr
drug
ugss an
and/
d/or 
or 
metabolites in a PT samples are:

(a) At least 50 perce

confirmatory percent
test nt above
above theoncutof
(depending cutofff concen
which con tcentra
o betration
is to tion for either
either the initial
evaluated0; initial test
test or the
(b) As low as 40 percent of the cutoff concentration
concentration when the PT sample is designated
designated as
a retest sample; or 
(c) At another
another concent
concentration
ration for
for a special
special purpose
purpose..

12.2
12.2.3
.3.3
.3 A neg
negat
ativ
ivee PT samp
sample le does
does not
not conta
containin a meas
measur
urab
able
le amou
amount nt of a tartarge
gett
drug and/ or metabolite.
12.2
12.2.3
.3.4
.4 A PT sampl
samplee ma mayy cont
contai
ainn an in
inte
terf
rfer
erin
ingg su
subs
bsta
tanc
nces
es,, an ad
adul ulte
tera
rant
nt,, or a
specimen that meets the criteria for a substituted specimen.
12.2
12.2.3
.3.5
.5 Fo
Forr each
each PT cyccycle
le,, the set
set of PT samp
sampleless for
for each
each labor
laboratator
oryy will
will vary
vary but,
but,
within each calendar year, each laboratory will analyze the same total set of 
samples.
12.
12.2.3
2.3.6
.6 The labora
laborator
toryy must,
must, ttoo th
thee great
greatest
est ext
extent
ent possib
possible,
le, hand
handle,
le, test
test,, and
and repor
reportt
a PT sample in a manner identical to that used for a Client/Donor/Subject
specimen, unless otherwise specified.
12.2
12.2.4
.4 Initi
Initial
al prof
profic
icie
ienc
ncyy tes
testt req
requi
uire
reme
ment
ntss ffor
or co
conf
nfir
irma
mato
tory
ry la
labo
bora
rato
tory
ry

12.2
12.2.4
.4.1
.1 The
The lab
labor
orat
ator
oryy must
must satis
satisfy
fy th
thee follow
followin
ingg crite
criteri
riaa on 3 consec
consecuti
utive
ve sets
sets of 
initial PT samples within 3 months:

(a
(a)) No fal
false
se pos
positi
itive
ve rres
esul
ults
ts;;
(b) Cor
Correc
rectly
tly identif
identifyy and confirm
confirm at least 80 percent
percent of the total drug
drug challeng
challengeses on
each of the 3 sets of samples;
(c) The quanti
quantitati
tative
ve values
values for at least
least 80 perce
percent
nt of the total
total drug challen
challenges
ges must
must be
within +5 percent of the calculated reference group mean;
(d) No quan
quantitative
titative value
value on a drug concen
concentratio
trationn may differ
differ by more
more than 20 percent
percent
from the calculated reference group mean; and
(e) For n individua
individuall drug, correc
correctly
tly detect
detect and quantify
quantify at least
least 50 percen
percentt of the total
total
drug challenges.

12.2
12.2.5
.5 Main
Mainte
tena
nanc
ncee for
for prof
profic
icie
ienc
ncyy te
test
st req
requi
uire
reme
ment
ntss fo
forr an accr
accred
edit
ited
ed confi
confirm
rmat
ator
oryy
laboratory.

An accredited laboratory must satisfy the following criteria on the maintenance

PT samples to maintain its certification:

12.
12.2.5
2.5.1
.1 The labora
laborator
toryy is req
requir
uired
ed once
once a yyear
ear of mainte
maintenan
nance
ce PT
PT ssamp
amples
les;;
12.
12.2.5
2.5.2
.2 Cor
Correc
rectly
tly ide
identif
ntifyy and
and conf
confirm
irm 90 perc
percent
ent of the total
total drug
drug chal
challen
lenges
ges over 
over 
two consecutive PT cycles;
12.
12.2.5
2.5.3
.3 Cor
Correc
rectly
tly quan
quantif
tifyy 80 per
percen
centt of the total
total drug
drug chal
challen
lenges
ges within
within ++55 perc
percent
ent
of the appropriate reference or peer group mean as measured over two
consecutive PT cycles;
12.2
12.2.5
.5.4
.4 Have
Have no more
more twotwo quant
quantita
itati
tive
ve re
resu
sult
lt diffe
differr more
more than
than 20 perc
percen
entt from
from the
target value over two consecutive PT cycles; and
 

12.
12.2.5
2.5.5
.5 For any ind
individ
ividual
ual drug,
drug, ccorr
orrect
ectly
ly dete
detect
ct and
and quan
quantif
tifyy at least
least 80
80 perce
percent
nt of 
the total drug challenges.

Chapter 13

WASTE DISPOSAL

13
13.1
.1 Haz
Hazardo
ardouus Was
Waste
te

13.1
13.1.1
.1 Bi
Bioh
ohaz
azar
ardd Sampl
Samples
es

Biohazard wastes are liquid, solid or concentration of solid waste which, because or its
quantity, concentration, physical chemical or infectious characteristics may pose a substantial or 
 potential
transportedthreat to human health or to the environment when improperly treated, stored,
or disposed.

13.1
13.1.2
.2 Ch
Chem
emic
ical
al Was
aste
te

To
Toxic
xic waste must undergo pre-treatment prior to disposa
disposal.l. Non chemical hazardous waste can be
disposed directly into the sink or treated as ordinary domestic waste.

13.2
13.2 Non-
Non-ha
haza
zard
rdou
ouss W
Was
aste
te

Various methods of disposal are applicable:

13.2
13.2.1
.1 Biode
Biodegr
grad
adab
able
le Was
aste
te

Suggested procedures for disposal are:

13
13.2
.2.1
.1.1
.1 Use
Use of sa
sani
nita
tarry land
landffill.
ill.
13.2
13.2.1.
.1.22 Compo
Compost sting
ing of bio
biode
degr
grad
adab
ablele wast
wastee ma
mate
teri
rial
als.
s.
13.2.1.3
13.2.1.3 Recycl
Recycling
ing schem
schemee for facto
factory-
ry-ret
return
urnabl
able,
e, fee
feed,
d, fermen
fermentab
table,
le, fertil
fertilize
izerr, fine craft
craftss and filling
filling
materials
13.2
13.2.1
.1.4
.4 Wher
Wheree a mumuni nici
cipa
pall or cit
cityy coll
collec
ecti
tion
on syste
systemm is avail
availab
able
le,, no
nonn hahaza
zard
rdou
ouss wast
wastee ca
cann be
disposed of with domestic/municipal/city waste.

13.2.2
13.2.2 Non-Bi
Non-Biode
odegra
gradab
dable
le Wast
Waste:
e: Recycl
Recycling
ing of:
of:

13.2.2.2 Glass
13.2.2.3 Metals
13.2.2.4 Plastics
13.2.2.5 Computer  
13.2.2.6 Cartridges
13.2.2.7 Others
 

Chapter 14

GOOD LABORATORY PRACTICE

14. 1 General

14.1.1 Chemicals/re
Chemicals/reagent
agents:
s: Chemicals
Chemicals and reage
reagents
nts used
used must
must meet
meet the specificat
specifications
ions in
in the method.
method. If 
not specified, then “Analytical reagent grade “(AR) or American Chemical Society (ACS) grade
chemicals or better should be used for analyses.
14.1.2 Reagent
Reagent water: Reagent
Reagent water
water must
must be free from
from interfere
interferences
nces for the
the analytes
analytes being
being measured.
measured.
14.1.3 Glassware
Glassware Prepar
Preparation:
ation: Specific
Specific requir
requirements
ements in the
the methods
methods for cleanin
cleaningg of glassware
glassware must
must be
followed.
follow ed. If no specifications
specifications are listed, then glassware
glassware should
should be washed
washed in a warm detergent
detergent
solution and thoroughly rinsed with tap water and then with distilled/de-ionized water.

14.2
14.2 Sa
Safe
fety
ty an
andd Cle
Clean
anli
line
ness
ss

14.2
14.2.1
.1 Drink
Drinking
ing an
andd Smok
Smokin
ingg

Easting, drinking and smoking should not be permitted in any area where activities might
adversely influence product quality or where stag may be expose to potentially harmful agents.
There should be areas designated for eating, drinking and rest personnel.

14.2.2 Control

Where pest control is needed, as in the case of storage of papers and records, it should be carried
out in such a way as to ensure that the chemical used do not contaminate other materials.

14
14.3
.3 Qual
Qualit
ityy Ass
Assuura
ranc
ncee

Laboratories should maintain current

current Quality Assurance Pr
Program
ogram as described in Chapter 111.
1. All
laboratory activities including sampling, test methods, instrument operation, data generation and
corrective action should be described in the program.

 Note: Please refer to UNDCP (United Nations Drug C

Control
ontrol Program) publication on Good Practice (GLP)
or other reference materials.

Chapter 15

MONITORING

15.1 Monitor
Monitoring
ing requi
requirem
rement
entss for an accred
accredited
ited labor
laborato
atory:
ry:

15.1.1 An accredite
accreditedd laboratory
laboratory shall under
undergo
go on site
site monitorin
monitoringg visits
visits by DOH.
DOH.

15.1.2 A team
team of at least two
two Regulatory
Regulatory officer
officerss inspects
inspects an accredite
accreditedd laboratory
laboratory..

15.1.3 Each inspecto

inspectorr conducts
conducts an independe
independent
nt evaluation
evaluation and review
review of all aspects
aspects of the laborator
laboratory’
y’ss
 procedures and facilities using the guidelines provide by the DOH.

15.1.4
15.1.4 To remain
remain accred
accredited
ited,, a laborato
laboratory
ry must continue
continue to satisfy
satisfy the req5ire
req5iremdn
mdnts
ts as sta
stated
ted in this
Manual.
 

15.2 Procedure
Proceduress to follow if a laboratory
laboratory fails
fails to satisfy
satisfy t(e reqeir
reqeirements
ements for
for either
either the PT progra
program
m or the
monitoring program.

15.2.1 If an applicant
applicant laborato
laboratory
ry fails to satisfy
satisfy the require
requirements
ments establishe
establishedd for the initial
initial certification
certification
 process, the app,icant laboratory must start the initial certification process from the beginning.

15.2.2 Af an accredite
accreditedd daboratory
daboratory fails
fails to satisfy
satisfy the require
requirements,
ments, the labora
laboratory
tory is given
given a period
period of 10
working days to provide any explanation for its performance and evidence that any deficiency has
 been corrected.
15.2.3 A laborato
laboratory’
ry’ss accre
accreditation
ditation may be
be revoked,
revoked, suspended,
suspended, or no further
further action
action taken
taken depending
depending on
the seriousness of the errors and whether there is evidence that any deficiency has been corrected
and that current performance meets the requirements for accredited laboratory.
laboratory.

15.2.4
15.2.4 An accredi
accredited
ted laborat
laboratory
ory may require
requiredd to und
under
ergo
go a specia
speciall ins
inspec
pection
tion or to test additiona
additionall PT
samples, depending on the nature of the performance, to verify that any deficiency has been
corrected.

15.2.5
15.2.5 If laborato
laboratory’
ry’ss accre
accredita
ditation
tion is revoke
revokedd or suspend
suspended,
ed, the laborato
laboratory
ry is not permitte
permittedd to test
specimen
specim en until
until the suspen
suspensio
sionn is lifted
lifted or the labora
laborator
toryy has succe
successf
ssfully
ully comple
completed
ted the
certification requirements as a new applicant laboratory.

15.3 All negative

negative and positive
positive results
results together
together with the membrane/ch
membrane/chromato
romatogram
gram or instrum
instruments
ents print
print out

15.4 shallNRL
The be submitted
shall conto BHFS
shall conduct
duct proorgram
a programto befor
forwarded
random cto NRL
random confir for further
onfirmatory
matory tests ofevaluation.
tests specime
specimenn with negative
negative results.
results.

15.5 Spot inspec

inspection
tion of drug te
testing
sting laboradori
laboradories
es shall
shall be conduc
conducted
ted by bHFS and
and NRL

15.6 All laborato

laboratories
ries shall follow the presc
prescribed
ribed DOH schedule
schedule of fees.
fees.
 

Chapter 16

REVIEW OF MANEAL OF OPERATION

16.1 The DOH

DOH shall
shall head
head and
and initiate
initiate pebiod
pebiodic
ic review
review of
of the manual
manual of operation.
operation.

16.2 All revisio

revisions
ns of this m
manual
anual shall be approv
approved
ed by the Dangero
Dangerous
us Drugs
Drugs Board
Board

BIBLIOGRAPHY/REFERENCE MATERIALS
MATERIALS

1.  European Laboratory
Laboratory Guidelines for Legally Defe
Defensible
nsible W
Workplace
orkplace Drug Testing . European Workplace
Testing 
Drug Testing
Testing Society (EWDTS). Germany.2002.
Germany.2002.
 

2. Guidelines for Testing Drugs under International Control in Biochemical Samples . United Nations
Nations
International Drug Control Programme (UNDCP). Vienna. 2001.

3. Guidelines for Testing Drugs under International Control in Hair, Sweat and Saliva . United Nations
International Drug Control Prog`amme (UNDCP). Vienna. 2001.

4. Guidelines for Testing

Testing Drugs under International Control in Urine.   United Nations International Drue
Drue
Coltrol Programme (UNDCP). Vienna. 2001.
5. Guide
Guideline
liness Good Labo
Laborator
ratoryy Practice. Unit
Practice United
ed Nation
Nationss Intern
Internatio
ational
nal Drug
Drug Contro
Controll Progra
Programme
mme
(UNDCP). Vienna.2001.
Vienna.2001.

6.  Implementing Rules and Begulations Governing Accre

Accreditation
ditation of Drug Testing Laboratorie
Laboratoriess in the
(As Revised), Department of Health (DOH). Philippines, July 10, 2003
 Philippines (As

7.  Republic Act
Act 9165, “Comprehe
“Comprehensive
nsive Danger
Dangerous Actt of 2002”., Philippines. June 7, 2002
ous Drug Ac

8. Substance of Abuse, substance Abuse and Mental Health Services Administratiol (SAMHSA), U.S.A.
2001.

Definidion of Terms
Terms
Adulterated.
Adulterated. A specimen
specimen conta)n)nc
conta)n)nc either a substance
substancess that is not a normal constituent
constituent for that ty`e of 
specimen or containing an endogenous substances at a concentration that is not a normal physiological
concentration.

Aliqmut. A fractional
fractional part of a sspecimen
pecimen used for testing. It is taken as a sampla representang the whole
whole
specimen.

Analyst. The individual,

Analyst. individual, who is responsi
responsible
ble for verifying the bhain of custo
custody
dy,, perform axamination,
axamination,
certify results and implement quality assurance program.

Authorized Specimen Codlabted.

Authorized Codlabted. A person,
person, who instrubts,
instrubts, assists Client/D
Client/Donor/
onor/Subje
Subjects
cts at a collection
site, receivds and maies initial inspection of specimen fgr drug testing and initiates documentary entries in
CCF.

Batch A set of specimen baing tested as a group

 

Blind Sample A. A. Sample with a known drug concentration

concentration or an accredited
accredited drug free sample used to
evaluate the ability of a laboratory to test a specimen for drugs and/ or metabolites. The laboratory to test a
specimen for drugs and/ or metabolites. The laboratory does not know either the concentration of the drug
or that it is a blind sample.

Calibrator
Calibrator A. Solution
Solution of known concentration
concentration in the appropriate
appropriate matrix
matrix that is used to define expected
expected
outcomes of a measurement procedure or to compare the response obtained with the response of a test
specimen aliquot/sample.( The concentration of the analyte of interest in the calibrator is known.

Cancelled Test.
Test. The Head of the Laboratory determines that the res
result
ult reported by the laboratory cannot
supqort either a positive or a negative test.

Chain of Custody (COC).

(COC). The procedures
procedures to account
account for the integrity of each specimen
specimen or aliquot by
traãking its handling and`{torage from point of specimen collection to final disposition of the specimen and
its aliquots.

Chain of Custody Document. The form(s) used to document

document the security of the specimen and all aliquots
of the specimen during
during testing and stor
storage.
age. The form, which may account
account for an entire test batch, shall
include the names and signature of all individuals who handled the specimen or aliquots and the date and
 purpose of the access.

Collection Site. A place where Client/Donor/

Collection Client/Donor/Subjec
Subjectt present
present themselves
themselves for the purpose of providing
providing a
specimen.

Confirmatoryy Drug Test. Refers

Confirmator Refers to the analytical
analytical procedure
procedure to identify
identify and quantify
quantify the presence of a
specific drug or metabolite, which is independent of the initial test and which uses a different technique and
chemical pvinciple from that0of the screening test in order to ensure reliabilit
reliabilityy and accuracy.
accuracy.

Confirmatory Validity Test.

Test. A second test
test pernormed
pernormed  n a different aliquot of the original specimen to
further support a specimen validity test result.

Control A. Sample wsed to evaluate whether an analytical procedure or test is operating within predefined
tolerance limits.

Custody and Control Form. A BHFS aapproved

pproved form used to document
document the collection, transport, security
and test results of the specimen.

Dilute. Refers to a specimen with less than normal physiological constituents.

DOH. The Department of Health or official

official representative of the Secr
Secretary
etary of Health.

DOH-accredited Instrumented Screening Drug Testing Laboratory (ISDTL) A laboratory in a permanent

location that conducts instrumented screening and validity test.

DOH-accredited Laboratory.
Laboratory. A laboratory
laboratory where screening and confirmatory testing is performed under the
supervision of the Head of the Laboratory and where Analysts perform the final review and release of test
results.

Failed to Reconfirm. The result rreported

eported when a laboratory
laboratory is unable to corroborate the original result. (ie.,
 positive, adulterated, substituted) reported to the Head of the Laboratory.
Laboratory.

Follow-up Test.
Test. A specimen
specimen collected from a Client/Donor/Subject to ensure that the Client/Donor/Subject
remains drug-free after
after being reinstated to a testing designated position.

Head of the Laboratory. A person who is accredited to supervise a drug testing laboratory.
 

Initial Validity
Validity Test. The first test used to determine if a specimen is adulterated, diluted, or substituted.

Limit of Detection (LOD).

(LOD). The constituent
constituent concentrati
concentration
on that produces a signal 3 times the standard
standard
deviations above the mean of black analyses.

Limit of Quantitation (LOQ). The constituent’s concentration that produces a signal sufficiently greater 
than the blank that it can be detected within specified limits by good laboratories during routine operating
conditions.

 Negative Results. The results reported by the DOH-accredited laboratory Analyst to the Head of the
Laboratory when a specimen contains no drugs or the concentration of the drug is less than the cut-off 
concentration.

 Non-Negative Results. The result reported by a laboratory when a specimen contains a drug or drug
metabolites greater than or equal to the cutoff concentration.

Positive Result. The result reported by a laboratory when a specimen co

contains
ntains a drug or drug metabolites
greater than or equal to the
t he cutoff concentration.

Post Accident
Accident Test.
Test. A test performed
performed on a specimen collect
collected
ed from a Client/Donor
Client/Donor/Subjec
/Subjectt involve
involve in a
related accident if suspiciously drug-related and upon request.

Pre-employment Test.
Test. A test performed
performed a specimen collected from a Client/Donor/Subject who is applying
for employment.
Quality Control Sample. A calibrator,
calibrator, control or blind sample.
sample.

Random Test.
Test. A test performed
performed on a specimen collected from a Client/Donor/ Subject who is selected at
random from a group of individuals.

Reasonable Suspicion/Cause Test. A test performed on a specimen collected from a Client/Donor/Subject

whenn the
whe there
re is suff
suffici
icient
ent eviden
evidence
ce to ind
indica
icate
te tha
thatt the Client/D
Client/Dono
onor/S
r/Subje
ubject
ct may have
have used
used an illicit
illicit
substance.

Reconfirmed. The result reported

reported when a laboratory is able
able to corroborate
corroborate the original result.
result. (ie., positive,
adulterated, substituted) reported to the Head of the Laboratory.

Rejected fro Testing.

Testing. The report of a laboratory or test facility
facility is issued when no test is done on a specimen

 because of an uncorrectable major deficiency.

deficiency.
Remote Collection Site. A collection
collection site outside of the drug testing labora
laboratory
tory

Return to Duty Test.

Test. A drug test to which a person is subjected prior to reinstatement.

Sample. A representative portion of a specimen or quality control material used for testing.

Screening Drug Test.

Screening Test. The test used to dif
differen
ferentiate
tiate a negative
negative specimen
specimen from one that requires
requires further 
testing for drugs or drugs metabolites.

Secretary
Secretary.. The Secretary
Secretary of the Department
Department of Health or the Secretary’
Secretary’ss designee
designee (e.g., Administrato
Administrator,
r,
BHFS; Director) that acts on behalf of the Secretary in implementing this manual).

Single Specimen Collection. A specimen collected at a given time and placed in a single container
container..

Specimen. Fluid or material derived from the body subjected for testing.
 

Split Specimen Collection. A specimen collected at a given time and place in two separate containers.

Substituted. A specimen which has been derived

derived through switching or replacement of the original sample

Validity Test. The test to determine the integrity of the specimen.

IMPLEMENT
IMPLEM ENTING
ING RULES
RULES AND REGUA
REGUATIO
TIONS
NS GOVERN
GOVERNING
ING ACCRED
ACCREDIT
ITA
ATIO
TION
N OF DRUG
TESTING LABORATORIES
LABORATORIES IN THE PHILIPPINES (AS REVISED)

Section 1. Scope:

  These rules and regulation embodied herein shall apply to all government and private drug testing
in the Philippines.

Section 2. Authority:

  The rules and regulations

regulations are issued
issued to implem
implement
ent the provisions
provisions of republic
republic act 9165:
“Comprehensive Dangerous Drugs act of 2002” consistent with Executive Order 102 s. 1999: “Redirecting
the Functions and Operations of the Department of Health”.
 
Section 3. Definitions of terms:
  Accreditation refers to the formal authorization issued by the DOH to an individual, partnership,
corporation or association which has complied with all licensing requirements (input/structural standards)
and accreditation requirements (process standards and outcome/output/impact standards) as prescribed in
the Manual of Operations for Drug Testing Laboratories issued by the DOH.

Act refers to Republic Act No. 9165, “The Comprehensive

Com prehensive Dangerous Drugs Ac
Actt of 2002”.

Applicant refers to the owner or head of a laboratory that is applying for the issuance of accreditation.

Applications Service Provider refers to third party entities that manage and distribute software-based
services and solutions to customer across a wide
wi de area network from a central data center.

Bureau refers to the Bureau

Bureau of Health Facilities and Services of the DOH. It shall exercise the regulator 
function.
Bureau Director refers to the director of the Bureau of Health Facilities and Services.

Chain of Custody refers to procedures to account for each specimen by tracking its handling and storage
fro
from
m point
point of collec
collection
tion to final
final dis
dispos
posal.
al. The
These
se proced
procedure
uress requir
requiree tha
thatt the applican
applicant’
t’ss ide
identi
ntity
ty is
confirmed and that a Custody and Control Form is used from time of collection to receipt by the laboratory.
Within the laboratory,
laboratory, appropriate chain of custody records must account for the samples until disposal.

Custody and Control Form refers to the form used to document the procedures from time of collection until
receipt by the laboratory.
laboratory.

CHD. Refers to the Center for Health

Health Development, which is the DOH Regional Field Office.

Client/Donor. Refer to the individual from whom a specimen is collected.

 

Confirmatory Test refer to the analytical procedure to identify and quantify the presence of a specific drug
of metabolite, which is independent of the initial and which uses a different technique and chemical
 principle from that of the screening test in order to ensure reliability and accuracy.
accuracy.

Cut off refers to the concentration level set to determine whether the sample is positive or negative for the
 presence of a drug.

Dangerous Drugs include those listed in the schedule annexed to the Act and its implementing rules and
regulations.
DOH refers to the Department of Health.

Laboratory refers to a private or government facility that is capable of testing a specimen to determine the
 presence of dangerous drugs therein.

 NRL refers to the National Reference Laboratory for Environmental and Occupational Health, Toxicology
Toxicology
and Micronutrien
Micronutrientt Assay designated
designated by the Secretary
Secretary of Health. It is a laboratory
laboratory capable
capable of doing
screening and confirmatory laboratory services, training, and surveillance and external quality assurance
 program for laboratory tests. Whenever the drug testing laboratory result is challenged, the NRL shall
make the final decision.

Procedure Manual refers to the written document giving detailed steps to be followed when undertaking a
 particular task.

Screening Test refers to a test to eliminate negative specimen from further consideration and to identify the
 presumptively positive specimen that requires confirmatory testing.

Secretary refers to the Secretary of Health.

Specimen refers to the body fluid that is collected from a person.

Section 4. Classification of Drug Testing

Testing Laboratories:

Drug testing laboratories shall be classified according to:

t o:

1. Ownership

1.1 Gover
Governme
nment
nt – operate
operatedd and maintain
maintained
ed partia
partially
lly or wholly
wholly by the
the national
national,, provinc
provincial,
ial, city
city
or municipal
agency government, or other political unit, or by any department, division, board or 
thereof.
1.2 Pri
Privat
vate-
e- private
privately
ly owned,
owned, establis
established
hed and
and operate
operatedd with funds
funds through
through donation
donation,, principa
principal,
l,
investment or other means, by any individual, corporation, association or organization.

2 Institutional Ch
Character  
2.1 Instit
Institution-
ution-based
based-- a laborat
laboratory
ory that
that is locat
located
ed within
within the premises
premises and
and operate
operatess as part
part of
of an
institution (e.g., hospital, medical facilities for overseas workers and seafarers).
2.2 FreeFreestand
standing-
ing- a laboratory
laboratory that is loca
located
ted outside
outside the premise
premisess of an institution
institution and opera
operates
tes
independently.

3 Service Capability
3.1 Screen
Screening
ing Labor
Laborato
atory-
ry- a la
labor
borato
atory
ry ca
capab
pable
le of perfor
performin
mingg screeni
screening
ng tests.
tests.
3.2 Confir
Confirmat
matory
ory Labora
Laborator
tory-
y- a labora
laborator
toryy capable
capable of perform
performing
ing qualita
qualitative
tive and
and quantita
quantitative
tive
examinations of dangerous drugs from the specimen.

Section 5. Client/ Donor of Drug Testing

Testing Laboratories
 

As enumerated and described in R.A. 9165 Article III Section 36 the following persons shall
undergo drug testing:

Mandatory Drug Testing Random Drug Testing

a. Ap
Applicants for driver ’s license a. Students of secondary
 b. Applicants for firearm’s
firearm’s license and tertiary schools.
c. Officers and members of the military, b. Officers and employees
 police and other law enforcer of public and private or 
d. Persons charged before the overseas.
Prosecutor’s office with criminal
Offense having an imposable penalty
Of imprisonment of not less than six
(6) years and one (1) day
e. Candidates for public office whether
appointee or elected both in the
national or local government.
f. Persons apprehended or arrested for
violating the provisions of this Act.

Section 6. Technical
Technical Requirements for Accreditation:

The laboratory to be able to secure a DOH certificate of accreditation must comply gith the
follouing technical requirements.
1. Physical Plant

1.1 Screening
Screening Laborato
Laboratory-
ry- shall
shall have at
at least twenty(20
twenty(20)) square
square meters
meters in floor area.
area. The work 
work 
area must be ten (10) square leters with
wit h exhaust fan, sink and storage.
1.2 Confir
Confirmat
matory
ory Labora
Laborator
tory-
y- shall havd
havd at least
least sixty (60)
(60) square
square meters
meters in floor area.
area. The
clinical work area must be thhrty (30) square meters with exhaust fan, sink, stock room and
instrumentation room.

A laboratory of whatever category shall have within its premises an area which can receive or 
accommodate at least five (5) prospective client/donors at a given time, hand uashing facility,
toilet facility, and stall for the orderly collection of specimen.

A DOH licens
licensed
ed hospit
hospital
al or nof
nof-ho
-hospi
spital
tal based
based Cecond
Cecondary
ary or Tert
ertiar
iaryy Catego
Category
ry Clinica
Clinicall
Laboratory,twenty
Laboratory
additional , which (20)
intelds
int elds
squto
arepud
square up a Screening
meters Laboratory
to its existing floor for Drug
floor area. Testing,
It shall need not
te provhde
only designate
designa fan
an area for 
or 
drug testing within the clinical laboratory.

2. Headship of the Laboratory

Laboratory

The screening laboratory shall be headed by a licensed physician with certification in Clinical
Pathology from the Philippine Board of Pathology or certification in Clinical Laboratory Management
Training conducted by the DOH.

The maximum
maximum number
number of screen
screening
ing labora
laborator
tories
ies a physic
physician
ian traine
trainedd in Clinica
Clinicall Labora
Laborator
toryy
Management can handle is ten (10), provided that they are physically feasible (within 5 kilometer radius) to
supervise.

In cases where the screening drug-testing laboratory is a division, section or unit of a Clinical
Laboratory, it shall be headed either by a licensed physician, chemist, medical technologist, pharmacist or 
chemical engineer.
 

The confir
confirmato
matory
ry labora
laborator
toryy shall
shall be headed
headed by a licens
licensed
ed physic
physician
ian cer
certifi
tified
ed in Clinic
Clinical
al
Pathology by the Philippines Board of Pathology with at least two (2) years of active laboratory experience
in analytical toxicology or a licensed chemist with at least a Master’s Degree in Chemistry, Biochemistry or 
a branch of Chemistry and at least (2) years of active laboratory experience in analytical chemistry.
chemistry.

The head of the laboratory shall have training and/or experience in the theory and practice of the
 procedures used in laboratories, resulting in his or her thorough understanding of quality control procedures
and practices the review
review interpreta
interpretation
tion and reporting
reporting of test results; the maintenance
maintenance of chain of custody
custody
and proper remedial actions to be taken in response to test systems being out of control limitc or quality
control results.

The laboratory head shall have the overall responsibility for the professional, organijational, educational
and administrative aativities of the drug testing facidity.

3. Personnel

A laboratory shall have the following technical staff:

3.1 Screening
Screening labora
laboratory
tory – shall
shall ha
have
ve either
either a full
full timd licens
licensed
ed chemist,
chemist, medical
medical technolo
technologist,
gist,
 pharmacist or c`emical engineer with
wi th appropriate training
t raining in scbeening test procedures for 
dangerous drugs. The DOH shall recognize the training pr program.
ogram.
3.2 Confir
Confirmat
matory
ory Labora
Laborator
toryy – sha
shall
ll have a full time lic
licens
ensed
ed chemist
chemist,, who has success
successful
fully
ly
completed extensive and appropriate training in chromatography, spectroscopy and either a
medical
eningtechnologist,
screening
scre pharmacist
test procedure
procedure dangor
for dangerou chemical
s drugs.engineer
erous The DOH withshall
appropriate training
recognize
recognize in the
the training
 program. The laboratory staff of Confirmatory Laboratory shall be required to pass a
 proficiency test, which is to be established and administered by the NRL.

A laboratory shall have administrative or non-teaching personnel who shall have the necessary
training and skills for the tasks assigned to them.

4. Laboratory Equipment

A Laboratory shall be required to have the following equipment:

4.1 Scre
Screening
ening Labor
Laboratory
atory-- shall
shall have the necess
necessary
ary equipme
equipmentnt or kit
kit for
for screenin
screeningg tests
in addition to the basic equipment (refer to Annex A) A)..
4.2
4.2 Co
Conf
nfir
irma
mato
tory
ry Labo
Labora
rato
tory
ry-- shal
shalll ha
have
ve the ne
nece
cess
ssar
aryy eq
equi
uipm
pmenentt fo
forr sc
scre
reen
ening
ing,,
qualitative
to Annex A).and quantitative examinations in addition to the basic equipment (refer 

5. Information Technology
Technology Requirements

5.
5.11 The
The labo
labora
rato
tory
ry sha
shall
ll ma
main
inta
tain
in a sesett of infor
informa
mati
tion
on techn
technol
olog
ogyy eqequi
uipm
pmenentt whos
whosee
specification shall conform to the minimum
minim um requirement set by the DOH (see Annex A).
5.22
5. The
The labora
laborato
tory
ry shall
shall have
have acces
accesss to one duly
duly autho
authori
rize
zedd Applic
Applicatatio
ionn Servic
Servicee Provid
Provider 
er 
(ASP)
(AS P) approv
approveded and mainta
maintaine
inedd by the DOH select
selected
ed thr
throug
oughh compet
competitiv
itivee bidding
bidding
following existing government rules and regulations. The DOH shall formulate the Terms Terms
of Reference/ Request for Proposal for the selection of the Application Service Provider 
subject to the approval of the Dangerous Drugs Board.

6. Records

The laboratory shall maintain a record of all

all its personnel. These records shall include the res
resume
ume
of training and experience, certification or license, incident reports (if any) and such other information,
which will establish the competence of the employee.
 

The required documentation must include:

1. Train
Training
ing reco
records
rds on
on all indi
individ
vidual
ualss author
authorize
izedd to have
have acce
access
ss to samp
samples
les
2. Cu
Custo
stody
dy an
andd Con
Contrtrol
ol Fo
Form
rmss
3. Qua
Quality
lity assu
assuran
rance/
ce/qua
quality
lity contr
control
ol recor
records
ds
4. All
All data
data incl
includ
udin
ingg ca
cali
libr
brat
atio
ionn cu
curv
rves
es an
andd an
anyy ca
calc
lcul
ulat
atio
ions
ns usused
ed in
determining test results
5. Reports
6. Recor
Records
ds of perf
performan
ormance
ce testing
testing and compute
computerr genera
generated
ted data
data

The laboratory will be required to maintain documents for any sample under legal
challenge for a further agreed period.

7. Security

A laboratory shall have security measures to control access to the premises and to ensure that only
authorized personnel handle or have access to specimen or can gain access to laboratory processes or to
areass where records are stored.
area stored. With the exception
exception of duly authorized
authorized represent
representative
ative of the Bureau,
Bureau, all
authorized visitors, maintenance and service personnel shall be escorted at all times while inside the
laboratory.. The laboratory shall maintain a record hat indicates the date, time of entry and exit and purpose
laboratory
of entry of non employees.

The minimum information required on the Custody and Control Forms are the following:
1. Inform
Informatio
ationn ident
identify
ifying
ing the specim
specimen
en
2. Date
Date an
andd time
time of co
colle
llect
ction
ion
3. Name
Name of tetesti
sting
ng la
labo
bora
rato
tory
ry
4. Nam
Namee and signat
signature
uress of all individ
individual
ualss who had
had custody
custody of the
the sample
sample
during the collection process.

9. Sto
torrage ooff La
Laboratory R
Reeports and Sp
Specim
imeen

Reports pertaining to specimen shall be kept by the testing laboratory for a minimum period to be
determined by the DOH. Specimen with confirmed positive test rresults,
esults, which are not challenge
challengedd
within fifteen (15) days after receipt, shall be discarded.
discarded. A specimen may be kept
kept for a maximum
of one (1) year upon request.

10. Test Levels

The Bureau, until such time that the NRL is established and operational shall require each
laboratory to submit its protocol indicating the initial cut-off levels in screening specimen to
determine whether they are negative or for
for confirmation of the presence of da
dangerous
ngerous drugs. The
acceptability of the cut off levels shall depends on the methods used by the laboratory, its
equipment and registered testing kits.

11. Procedure Manual

A laboratory shall have a procedure manual validated by the NRL which shall include the
 principles of each test, the preparation of reagent, standard and controls, calibration procedures,
derivation of results, linearity of methods, sensitivity of the methods, cut-off values, mechanisms
for reporting results, control criteria for unacceptable specimen and results, remedial actions to
taken when the test systems are outside of acceptable limits, reagent expiration dates, references
and quality control measures. Copies of all procedures and dates on which they are in effect
effect shall
 be maintained as part of the manual.
 

12. Equipment and Instruments

Volumetric pipettes and measuring devices shall be certified for accuracy or be checked by
gravimetric, colorimetric or other verification procedures by the Department of Science and
Technology-Industrial Technology
Technology Development Institute. Automatic pipettes and dilutors shall be
checked for accuracy and reproducibility before being placed in service and checked periodically.
Thereafte
Ther eafter,
r, there shall be written
written procedure
proceduress for instruments
instruments set-u and normal
normal operations
operations,, a
schedule
schedule for checking critical
critical operating
operating char
character
acteristics
istics,, tolerance
tolerance limits for troubleshooting
troubleshooting and
repair.. Preventive maintenance records
repair records shall be kept.
13. Calibrations and Controls

Laboratory calibrators and controls shall be prepared using pure drug reference materials, stock 
sta
standa
ndard
rd sol
solutio
utions
ns obtain
obtained
ed fro
fromm oth
other
er labora
laborator
tories
ies,, or sta
standa
ndard
rd sol
soluti
utions
ons obtain
obtained
ed fro
from
m
commercial manufacturers.
manufacturers. The calibrators and controls shall be pr properly
operly labeled as to content
and concentrati
concentration.
on. The standa
standards
rds (e.g., pure reference
reference standa
standards,
rds, stock standard
standard solutions,
solutions,
 purchased standards) shall be labeled with the following: date received (if applicable); date
 prepared or opened; date placed in service and expiration date.

14.
14. Urin
Urinee Spe
Speci
cime
menn Col
Colle
lect
ctio
ion,
n, Hand
Handli
ling
ng and
and Dis
Dispo
posa
sall

The laboratory shall follow the DOH prescribed guidelines in the collection, handling and disposal
of urine specimen. Universal precaution shall be obse
observed
rved at all times.

15. Laboratory Report

15.
15.11 Screen
Screening
ing test
test result
result form-
form- the test re resul
sultt of an accredit
accrediteded laborat
laboratory
ory shall
shall be in the form
 prescribed by the DOH.
15.
15.22 Signat
Signatory
ory of test
test result-
result- all
all test results
results shall
shall bear
bear the signat
signature
ure of the analy
analyst
st and head
head of 
laboratory.
15.
15.33 Report
Reporting
ing tes
testt results
results-- a screeni
screeningng test
test result
result shall
shall be report
reported
ed as negat
negative
ive or positi
positive.
ve. A
confirmatory test shall report the presence of absence and the identity of the drug/
metabolite tested as well as its concentration.
The original copy of the test result form shall be given to the client/donor immediately
upon its completion. All specimen with positive sc screening
reening test results shall be submitted
for confirmatio
confirmationn before a final report will be issued. Other copied copied of the said test result
from shall be furnished
furnished immediately
immediately to the DOH and the reque requesting
sting agency
agency.. The drug-
testing laboratory shall retain one copy.

The test results

results tha
thatt are forward
forwardeded to the DOH sh shall
all include
include the membrane
membrane of the
registered drug testing kit in the case of screening tests and a copy of the chromatogram in
the case of confirmatory tests.

15.4 Access
Access to laborator
laboratoryy test results-
results- the
the drug
drug test result
result and the
the records
records shall
shall be confid
confidential
ential
subject to the usual accepted practices to protect the confidentially of the results.

16. Proficiency Testing

16.1
16.1 The
The NRL shal
shalll co
cond
nduc
uctt as
asse
sess
ssme
ment
nt of the pr
prof
ofic
icie
ienc
ncyy of Scree
Screeni
ning
ng an
andd co
conf
nfir
irma
mator
toryy
laboratories. All procedures associated with the handling and testing of the
 proficiency- testing sample shall to the greatest extent possible be carried out in a
manner identical to that applied to routine specimen, unless otherwise specified.

16.
16.22 Results
Results of
of pro
profic
ficien
iency
cy tes
test.
t. The la
labor
borato
atory
ry sha
shallll submit
submit to the
the NRL the
the results
results of
of the test
test
 performed on the unknown sample within three (3) weeks after the receipt of the test
sample. Said results shall be kept
kept confidential.
 

16.3 Failure
Failure to pass proficienc
proficiencyy test. A laboratory
laboratory that fails
fails to pass proficienc
proficiencyy test conducted
conducted
 by the NRL shall be given another test
t est not earlier than one (1) month after the failed test.
However, failure to pass proficiency test shall result in the suspension of its accreditation.
Such suspension shall
shall be lifted only after passing the second proficiency test. Failure to
 pass the second proficiency test shall result in the revocation of its accreditation.

Section 7. Validity of the Test

Test Result:

The drug certificates on tests performed by accredited drug testing centers shall be valid for one
(1) year period from the date of issue, which may be used for other purposes.

Section 8. Allowable Service Fee:

The drug-testing laboratory may collect a reasonable service fee for the performed examination,
which shall not be greater than the maximum allowable service fee presc
prescribed
ribed by the DOH. The maximum
allowable service fees shall be adjusted from time to time.

Section 9. Procedural Guidelines for

for Accreditation:

The applicant shall follow these

t hese procedures for application of initial certificate of accreditation.

1. Applic
Applicant
ant accompli
accomplishe
shess the require
requiredd docume
documents
nts and submits
submits the
them
m to the Bureau
Bureau or CHD for 
endor
endorsemen
sement
Cashier t toDOH
of the the Bureau.
Bureau . Upon
i n person,
in filing postal
or through of application,
applicatio
money n, the applicant
order. applicant pays the correspon
corresponding
ding fees to the

Documentary Requirements:

1.1 BHFS Application

Application Form- filed either at the Burea Bureauu oorr CHD
CHD
1.2 Letter
Letter of Endors
Endorsement
ement ttoo the Burea
Bureauu Director
Director (if
(if filled
filled at the
the CHD)
1.3 DTI/SEC
DTI/SEC RegisRegistra
tration
tion (For
(For pri
privat
vatee laborato
laboratory)
ry)
Enabling Act (for national government laboratory)
Approved Board Resolution (for local government laboratory)
1.
1.44 Mayor
ayor’’s perm
permitit
1.5 One (1) set set of Floor Plan
Plan showing
showing specific
specific location
location of equipment
equipment and work
work areas
areas required,
required,
appropriately dimensioned, properly identified and completely labeled.
It shall be signed and sealed by an architect or engineer.
1.6 List of Personne
Personnel, l, notarized,
notarized, including
including photocopies
photocopies of ccurreurrent
nt PRC identificatio
identificationn cards and
and

1.7 certificates
Lis of training
Listt of Equipme
Equipments nts with
with spec
specifi
ificat
cation
ionss
1.8 Contra
Contractct of lleas
easee (if fac
facilit
ilityy is rent
rented)
ed)
1.99 Cu
1. Cust
stod
odyy and
and Contr
Control ol ffor
orm
m

The following requirements shall be submitted within the fist six (6) months of operation after issuance of 
initial certificate of accreditation.

1.10 Documentation of Quality Control Program (for

(for screening
screening laboratory)
laboratory)
1.1
1.111 Certif
Certifica
ication
tion for Qua
Quality
lity Standa
Standard
rd System
System fro
from
m a DOH-re
DOH-recog
cogniz
nized
ed ce
certif
rtifyin
yingg body
body (fo
(for 
r 
confirmatory laboratory)

2. The Bureau conducts survey on site to determine compliance with standards and technical requirements
of accreditation.

3. The Bureau approves or disapproves the issuance of certificate of accreditation.

 

3.1 If approved, the Bureau registers the laboratory and issues a n initial certificate of accreditation
to the applicant upon deposit of twenty thousand pesos (20,000) cash bond.

3.2 If disapproved, the Bureau sends the findings and recommendations to the applicant for 
compliance.
complia nce. Failure
Failure to comply within fifteen
fifteen (15) da
days
ys shall be a ground
ground for denial of the application.
application.
Hence, the applicant has to
t o re-file his application and pays the required accreditation fees.

Section 10. Accreditation Fees:

1. The following schedule of fees for initial

initial and renewal of accreditation shall be to the Cashier of 
the DOH.

Accreditation Fees

1.1 Confirmatory laboratory Php 10,000.00

1.2 Screening laboratory Php 5,000.00

The initial certificat

certificatee of accreditation
accreditation of private
private drug testing
testing laboratorie
laboratoriess shall be issued
issued upon deposit of 
twenty thousand pesos (P20,000.00) cash bond per laboratory.
laboratory.

2. The Bureau if authorized to adjust the

the accreditation fees from time to time.

Section 11. Content of Certificate of Accreditation:

The certificate of accreditation shall state on its face the name of the owner and head of the
laboratory, the classification and validity period. It shall be signed by the Bureau or CHD Director.
laboratory,

Section 12. Validity:

The certificate of accreditation shall be valid for a period of two (2) years for Confirmatory
Laboratory and one (1) for a Screening Laboratory.

Section 13. Renewal Certificate of Accreditation.

1. Application for renewal of accreditation

accreditation shall be filled ninety (90) days before the expiry date
to the Bureau or CHD under whose jurisdiction the laboratory is located.

2. The applicant shall follow the

t he following procedures for renewal of certificate of accreditation:

2.1 Applicant accomplishes the required

required documents and
and submits them to the Bureau or CHD. Upon filing
of application, the applicant pays the corresponding fees for renewal to the Cashier of the Bureau or CHD
in person, or through postal money
m oney order.
order.

Documentary requirements:

2.1.1 Notarized: Application for Renewal of Certificate of Accreditation

2.1.2 Notarized List of Personnel

2.1.3 List of Equipment/Instrument
2.1.4 Current Certificate of Accreditation
2.1.5 Current Mayor’s Permit
2.1.6 Documentation of Chain of Custody
2.1
2.1.7
.7 Curren
Currentt Certif
Certifica
icate
te for Qua
Quality
lity Standa
Standard
rd Sys
System
tem (re
(renew
newed
ed yearly
yearly)-
)- for Confir
Confirmato
matory
ry
Laboratory
2.1.8 Current Proficiency Test Result (renewed yearly)
 

2.2 The Burea

Bureauu or CHD conducconducts
ts sur
survey
vey to determ
determine
ine complia
compliance
nce with sta
standa
ndards
rds and technic
technical
al
requirements for accreditation

2.3 The BBurea

ureauu or CHD approv
approves
es or
or disappr
disapproves
oves rene
renewal
wal of certificatio
certificationn of accreditati
accreditation.
on.
2.3.1 If approved, the Bureau or CHD renews the certificate of accreditation

2.
2.3.
3.2.
2. If disa
disapp
ppro
rove
ved,
d, the Bure
Bureau
au or CHD
CHD sends
sends the
the findi
finding
ngss and reco
recomm
mmenenda
dati
tion
onss to th
thee
applicant for compliance. Failure to comply within fifteen (15) da
days
ys shall be a ground
for suspension/revocation of accreditation.
Section 14. Monitoring of Laboratories:

The Bureau
Bureau or CHD may coldect an on site monitoring visits of accr
accredited
edited laboratorie
laboratories.
s. The
monitoring
monitor ing visits shall be conducted
conducted unannounced.
unannounced. The monitoring
monitoring visits shall document
document the overall
qualidy of the laboratory setting.

Section 15. Terms

Terms and Con`itions of Accreditation:

1. An accreditation shall be granted in accordance

accordance with prescribed ac
accreditation
creditation reauirements and
on the basis of specific cojditions
cojditi ons and limitation3 established during survey.
survey.

2. An accredi
accreditati
tation
on that is not rene
renewed
wed on the expiry
expiry date shall be consider
considereded lapsed
lapsed and
registration shall be cancelled. A new application for the issuance of accreditation shall be required be
before
fore
a laboratory can be allowed to operate.
3. The accreditation
accreditation as herein
herein granted as well as any right under the accred
accreditation
itation cannot
cannot be
assigned or otherwise transferred directly or indirectly to any party.
party.

4. The Bureau shall be notified of any change in management name or ownership. In cases of 
transfer of location, a new application for accreditation shall be required.

5. Failure to report in writing within fifteen (15) days of any substantial change in the condition of 
the laboratory (e.g., changes in the physical plant, equipment or manpower0 may be a basis for the
suspension or revocation of the accreditation.

6. A separate
separate accreditation shall be required for all laboratories or branches maintained in separate
 premises but operated under the same management.

7. The
regulations shallaccreditation shall befor
be readily available placed in anofarea
guidance readily seen
all personnel of by
the the public. . A copy of the rules and
llaboratory
aboratory.

Section 16. Violations:

Violations of this Implementing Rules and Regulations shall include among others the commission
of the following acts:

1. Issuan
Issuancece of false
false or frau
fraudul
dulent
ent drug
drug test
test results.
results.
2. failur
failuree to protect
protect the
the confide
confidentiality
ntiality of drug
drug test results
results
3. fai
failur
luree to partici
participat
patee or pass
pass the profi
proficie
ciency
ncy testi
testing
ng
4. Convic
Conviction
tion of the owner
owner or manager
manager of a laboratory
laboratory for anyany criminal
criminal offens
offensee
cgmmitted as an incident to thd operation of the laboratory
l aboratory..
5. Fa
Fail
ilur
uree to re
refe
ferr the
the posi
positi
tive
ve sc
scre
reen
enin
ingg te
test
st re
resu
sult
ltss to a CoColf
lfir
irma
mato
tory
ry
Laboratory.
 

6. Anx oth
otherer c`use
c`use which
which materiall
materiallyy affects
affects the abidity
abidity of the laborat
laboratory
ory to
ensure
ens ure the fullfull rel
reliab
iabilit
ilityy and acc
accura
uracy
cy of drug
drug tests
tests and the accura
accurate
te
reporting of reqults.
7. Fa
Failu
ilure
re on thethe pa
part
rt of the medic
medical
al facili
facility
ty to su
subm
bmitit docume
document ntat
ation
ion of 
Quality Control Program (for scre screening
ening laboratory)
laboratory) and certification
certification of 
Quality Standard
Standard System
System from a DOH-recogni
DOH-recognized zed certifying body (for 
confirmatory laboratory) within six (6) months
m onths of operation `fter issuance of 
initial certificate of accreditation.
8. Ref
Refusa
usall to allow
allow sur
survey
vey,, monitorin
monitoringg of a labgra
labgrator
toryy by the Bureau
Bureau or CHD
at af appropriate t)me.
9. Any acactt which is contrar
contraryy to the accepted
accepted clinical
clinical laborat
laboratory
ory practice
practices.
s.

Commission or omission of any of the aforementioned acts shall be a ground for suspension' revocation of 
certificate of accreditation without prejudice to the filing of any appropriate criminal action under Section
32 of R.A. 9165.

Section 17. Suspension or revocation

revocation Certificate of Accreditation:

The Bureau on its own or based on complaint, shall investigate and after due hearings may
suspend or revoke the accreditation of a laboratory for such period and under such terms as may be
necessary to ensure the full reliability and accuracy of drug tests and the accurate reporting of test results.

If upon survey or monitoring visits, the drug testing laboratory is found yo be violating the rules
and regulations as well as other violations stipulated under Section 17, the Bureau may immediately
 preventively suspend the operation of the said laboratory.
laboratory. Preventive suspension shall not be more than
sixty (60) days.

Section 18. Reapplication for Certificate

Certificate of Accreditation:

A laboratory whose certificate of Accreditation has been revoked may reapply for the issuance
i ssuance of a
new one upon
upon complia
compliance
nce with the requir
requireme
ements
nts establ
establish
ished
ed hereun
hereunder
der and/or
and/or the correc
correction
tion of the
deficiency or violation, which resulted in the revocation.

Section 19. Appeal:

Any laboratory or any of its personnel aggrieved

aggrieved by the decision of the Bureau may
may,, which fifteen
(15) days after receipt of the notice of decision, file a notice of appeal with the Office of the Secretary, and
serve a copy of the notice of appeal to the Bureau. Thereupon, the Bureau shall promptly certify and file a
cop ofSecretary
of the the decision, including
for review andthe transcript of the hearings on which the decision is based with the Office
consideòations.

Section 20.
20. Penal Provisions:

Any person authorized or accredited under this Act and its implemeîting rules to conduct drug
examination
examin ation or test, who issues
issues false or fraudulent
fraudulent drug test result
result knowingly
knowingly,, willfully
willfully or through gross
negligg
neg liggnce
nce,, shall
shall suf
suffer
fer the pen
penalt
alty$o
y$off imp
impris
risonm
onment
ent ran
rangin
gingg fr
from
om one hundre
hundredd tho
thousa
usand
nd pesos
pesos
(100,000.00) to five hundred thousand pesos
pesos (P500,000.00). Further, revocation
revocation of license to practice shall
 be recommånded to the Professional Regulations Commission.

Section 21. Transitory Provisions:

Until such time that the NRL for toxicology of the DOH is established and operational, the DDB-
Laboratory shall act as the NRL.

In administrative region where there are no Gas Chromatography- Mass Spectrometer (GCMS)
nor High Performan
Performance
ce Liquid Chromatography
Chromatography Mass Spectrometer
Spectrometer (HPLC-MS)
(HPLC-MS) equipment
equipment currently
currently
 

available, all DDB licensed drug testing laboratories using High Performance Liquid Chromatography
(HPLC) may be allowed to operate as Confirmatory Laboratory using such the absence of GC-MS and
HPLC with photodiode array o not more than two years licensed drug-testing laboratories using Thin Layer 
Chromatography (TLC) may be allowed to perform confirmatory tests.

In the event that a confirmatory laboratory with HPLC with photo diode array of not more than
two years is accredited by the DOH in administrative regions where GC-MS or HPLC MS is not available,
use of TLC shall be allowed only for a maximum period of ninety (90) days from receipt of notice of such
accreditation from DOH, which notice must be sent within ten (10) days from approval.

When modern and accepted methods for confirmatory testing emerge, the DOH shal| immediauely
conduct technical studies and submit recommendations to the DDB for appropriate action.

The use of DDB validated drug testing kits shall be allowed until Deceíber 31, 2003. thereafter,
thereafter,
only Bureau of Food and Drugs registeòed kits
kit s shall be used.

Manual processing of necessary documents shall be done in facilities where an Application

Service Provider (ASP) is not available).

These rules and regulations shall be subject for review annually.

Section 23. Separability:

In the event that any section, paragrqph, sentence, clause or work of this order is declared invalid
for whatever, any reison, other provisions thereof shall be affected thereby.
thereby.

Segtion 24. Effectivity:

These rules and regulations shall take effect upon approval of the Dangerous Drugs Board and
 publication yn a newspaper of general circulations.
 

 Name of Labïratory
Address
Te
Telephone
lephone Number 

MEM_RANDUM FOR RECORD (MFR)

(Form DT-006)

Memo For :(Head of the laboratory)

�From :(Name and Signature of Person who(makes the report)

Date
Date Sub
Submi
mitt
tted
ed :

Subject : (What to report)

Date of Incidence : (When the incidence occurred)

Incidence : (Reðort on how it happened)

 

Cut Off Concentrations

Hair 
Initial Test Cutoff Ãoncentration (pg/mg)
Maré
Ma réju
juan
anaa me
metatabo
boli
lite
tess ----
------
----
----
----
----
----
----
----
----
----
----
----
-- 1
Co
Coccain
inee me
metatabo
boli
lite
tess ----
-------
----------
-------
------
----
----
--------
----- 50
5000
Opiate metabolites1-------------------------------- 200
Ph
Phen
ency
cycl
clid
idin
inee ----
------
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
-- 300
300
Amphetamine2 --- -------
----------
-------
------
----
----
--------
-------
----------
---- 50
5000
1
Labs are permitted to initial test all specimen for 6-AM using a 300 pg/mg cutoff 
2d-Methamphetamine is the target analyte and test kit must cross-react with MDMA, MDA and MDEA
(~50 to 150% cross-reactivity)

Confirmatory Test C Cuutoff Co

Concentration (pg/mg)
Marijuana metabolite1 --  ----------------------------- 0.05
.05
Cocaine
Cocaine metabolite2 ------------------------------- 100
Cocaine2 --
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
-- 1000
1000
Opiates
Morphi
Mor phine
ne --
-----
------
------
------
------
------
------
------
------
------
------
------
------
------
-----
-- 200
Codei
Codeine
ne --
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
---- 200
200
6-Acetylmorphin3 --------------
------
------
-------
----------
-------
----------
----- 20
2000
Phencyclidine3 ----
-------
-------
----------
------
------
-------
----------
-------
------- 30
3000
Amphetamines
Amphe
Amp heta
tamin
minee ----
------
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
-- 300
300
Methamphetamine4 ---  -------------------------------- 300
MDMA
MDM A ---
------
------
------
------
------
------
------
------
------
------
------
------
------
------
------
----- 300
MDA -------
----------
------
------
------
------
------
------
------
------
------
------
------
------
------
------
--- 300
MDEA
MDE A ------
---------
------
------
------
------
------
------
------
------
------
------
------
------
------
-----
-- 300
1
Delta-9- tetrahydrocannabinol-9-carboxylic acid
2
Benzoylecgonine and Cocaine above cutoffs and BE/Cocaine ratio >0.1
3
Specimen must also contain Morphine at a concentration >200 pg/mg
4
Specimen must also contain Amphetamine at a concentration > 50 pg/mg

Oral Fluid
Initial
THC Pa PTe
Test
arestnCutoff aConcentration
t ddrrug an nd me
metabolit
lite --
--------------- 4(ng/mg)
Co
Coca
cain
inee met
metab abololit
ites
es ----
------
----
----
----
----
----
----
----
----
----
----
----
----
---- 20
1
Opiate metabolites   ------------------------------- 40
Phenc
Phe ncycyclid
lidine
ine ----
------
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
-- 10
2
Amphetamines  --  ----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
-- 50

1Labs are permitted to initial test all specimen for 6-AM using a 4 ng/mg cutoff 
2d-Methamphetamine is the target analyte and test kit must cross-react with MDMA, MDA, and MDEA
(~50 to 150% cross-reactivity)

Confirmatory Test C Cuutoff Co

Concentration (ng/mL)
THC
TH C Par
Parent
ent drug
drug ---
-------
-------
----------
------
------
-------
----------
----- 4
Co
Coca
cain
ine1
e1 ----
------
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
---- 8
Opiates

Mo
Morp
Co rphi
Code
deinhine
ineene----
------
------
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
---
--- 40
6-Ac
6-Aceety
tylm
lmoorph
rphin
inee ---
------
-------
-----------
----------
-------
----------
----- 4
 

Phe
Phencyc
ncycli liddin
inee ----
------
--------
-----
-------
-------
----------
-------
-----------
------ 10
Amphetamines
Amph
Am pheetami
tamine ne ----
------
--------
------
------
-------
----------
-------
-----------
------ 50
MDMA
MD MA ----
----------
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
-- 50
MDA
MD A ----
----
--------
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
---- 50
MDEA
MD EA ----
----------
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
-- 50
1
Cocaine or Benzoylecgonine
2
Specimen must also contain Amphetamine at a concentration > Limit of Detection (LOD ng/mg)

Sweat (patch)
Initial Test Cutoff Concentration (ng/patch)
Mari
Ma riju
juaana memetatabo
boli
lite
tess ----
----------
-------
----------
-------
------
----
---- 4
Cocaine metabolites ----------------------------25
Opiate metabolites1 -------------------------
-----------------------------25
----25
Phe
Phencyc
ncycli liddin
inee ----
------
--------
-----
-------
-------
----------
-------
-----------
------ 20
Amph
Am pheetami
taminenes2
s2 -----
------
----
--------
-------
----------
------
------
-------
------ 25
1Labs are permitted to initial test all specimen for 6-AM at 25ng/patch
2d-Methamphetamine is the target analyte and test kit must cross-react with MDMA, MDA, and MDEA
(~50 to 150% cross-reactivity)

Confirmatory Test Cutoff Concentration (ng/patch)

THC
THC pare
parent
nt drug
drug -----
-------
----------
------
------
-------
----------
-------
---- 1
Cocaine21 -----------
------
------
-------
----------
-------
-----------
----------
-------
------ 25
Opiates  - ------
-------
----------
------
------
-------
----------
-------
----------
------
------
--- 25
Phe
Phencyc
ncycliliddin
inee ----
------
--------
-----
-------
-------
----------
-------
-----------
------ 20
Amphetamines
Amph
Am pheetami
tamine ness ----
--------------
-------
----------
------
------
-------
----------
--- 25
2
Methamphetamine  --------------------------------------
-------------------- 25
MDMA
MD MA ----------
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
---- 25
MDA
MD A ---
-----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
---- 25
MDEA
MD EA --
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
-- 25
1
Cocaine or Benzoylecgonine
2
Morphine, Codeine or 6-Acetylmorphine
2
Specimen must also contain Amphetamine at a concentration > Limit of Detection (LOD ng/mg)

Urine
Initial Test Cutoff Concentration (ng/mL)
Ma
Mari
Coccriju
Co ajua
inaena
ine me me
meta
meta tabo
tabo boli
boli lite
lite
tesstes
-s---
----
-------
---
-----
-- ------
-------
--
----
-- -------
------
-----
-- ---
------
-----
--
-------
------
-----
------ 500
15
150
Opia
Opiatete m
meetabo
tabolilite
tess ----
---------
-------
----------
-------
-----------
--------- 20
2000
00
Phe
Phencyc
ncycliliddin
inee ----
------
--------
------------
-------
----------
-------
-----------
------ 25
Amphetamines2 ----------------------------------- 500
1Labs are permitted to initial init ial test all specimen for 6-AM using a 10 ng/mL cutoff 
2d-methamphetamine is the target analyte and test kit must cross-react with MDMA, MDA and MDEA
(~50 to 150% cross-reactivity)

Confirmatory Test C Cuutoff Co

Concentration (ng/mL)
Marijuana metabolite1
metabolit e1 --------------------------15
--------------------------15
Cocaine metabolite2 ------------------------
----------------------------
---- 100
Opiates
Morp
Mo rphi
hine
ne ----
------
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
---- 2000
2000
Co
Code
dein
inee ----
------
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
-- 2000
2000

6-ac
6-acet
Phe
Ph etyl
ylmo
encyc
nc mor
ycli rph
phin
liddine ine3
ine e3-----
----
------------
--
-------
--- --
--------
-- --
--------
--- --
-----
----------
---- --
--------
--- --
-----
-----------
---- --
-----
-----
---- 10
25
Amphetamines
 

Amph
Am pheetami
tamine ne ----
------
--------
------
------
-------
----------
-------
-----------
------ 25
2500
Methamphetamine4 -------------------------------------
-----------------
----250
250
MDMA
MD MA ----
------
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
-- 250
250
MDA
MD A --
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
---- 250
250
MDEA
MD EA ------
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
----
---- 250
250
1
Delta-9-tetrahydrocannabinol-9-carboxylic
Delta-9-tetrahydrocannabinol-9-car boxylic acid
2
Benzoylecgonine
3
iF a laboratory uses both initial initi al test kits to screen a specimen concurrently,
concurrently, it may report 6AM alone
4
Specimen must also contain d-Amphetamine at a concentration > 100 ng/mL