MANUAL OF OPERATIONS FOR DRUG TESTING LABORATORIES

FUNCTIONS AND RESPONSIBILITIES

HEAD OF THE LABORATORY

ADMINISTRATIVE:

a. Has general and overall supervision of the facility and all aspects of
laboratory work.
b. Has general supervision an conduct of all laboratory personnel.
c. Formulates and implements standard operation manual that govern
the operation of the drug-testing laboratory. This shall be periodically
reviewed and updated.
d. Prepares financial and annual reports of the laboratory
e. Provides other administrative support services such as
communications, security and maintenance services

TECHNICAL

a. Supervises and directs all analytical procedures of the laboratory

b. Assures quality of all laboratory test results.
c. Issues, signs out and interprets laboratory results.
d. Evaluates and recommends reagents, supplies and equipment
e. Reviews the CCF and reports received from authorized collector.
f. Interviews the Client/Donor/Subject, if necessary.
g. Reviews pertinent medical records of Client/Donor/Subject, if
necessary.
h. Cancels the results of all specimen which are not collected or tested in
accordance with this manual.
i. Reviews, rejects and refers for confirmation and retesting specimen
and test results that are positive, adulterated, substituted or invalid.
j. Implements remedial actions necessary to maintain satisfactory
operation and performance in the laboratory.
k. Directs protocol for preventive maintenance of equipment.
l. Provides comprehensive, continuing training and education of
personnel related to conduct of drug testing laboratory.

ANALYST

a. Verifies the completeness of CCF.

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 MANUAL OF OPERATIONS FOR DRUG TESTING LABORATORIES

b. Prepares specimen for analysis.

c. Examines, processes and analyzes specimens for drug testing.
d. Interprets, records, releases, and signs out laboratory results.
e. Assists in the implementation of quality assurance programs.
f. Assist in the evaluation of reagents, supplies, and equipment.
g. Refers to the Head of Laboratory as the need arises.

AUTHORIZED SPECIMEN COLLECTOR

a. Restricts unauthorized personnel from entering the collection site

during collection.
b. Verifies identity of Client/Donor/Subject.
c. Provides security to the specimen supplies, records and documents at
the collection site.
d. Inform the Client/Donor/Subject the procedures of specimen
collection.
e. Performs only one specimen collection at a time.
f. Accepts and seals the specimen container in the presence of the
Client/Donor/Subject.
g. Accomplishes CCF.

THE FOLLOWING PERSONS ARE NOT AUTHORIZED TO COLLECT

SPECIMEN.

a. Employer of the Client/Donor/Subject.

b. Investigator at the crime scene.
c. Complainant.
d. Owner/Administrator of the establishment.

EVALUATION and PERSONNEL DEVELOPMENT

a. The laboratory must establish criteria for evaluation of performance of

all personnel.
b. Training records must be maintained for all personnel. These should
include all job related formal training taken by the personnel which
pertains to any aspect of their responsibilities, including but not
limited to analytical methodology, laboratory safety, sampling, quality
assurance and data analysis.
c. The Head of the Laboratory must evaluate the performance of all
personnel as the need arises.

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EQUIPMENT/ MAINTENANCE/ SUPPLIES AND

MATERIALS

COLLECTION DEVICE:

For urine specimen: screw sapped, wide mouth, 30 or 60mL capacity

polyethylene specimen container.

*** The collection device should not affect or alter the specimens collected.

CALIBRATION AND MAINTENANCE

a. All equipment must be calibrated and maintained according to the

procedures in the manufacturer manual.
b. There shall be a record indicating that the equipment has been
calibrated and/or checked on a regular schedule based on established
procedures.
c. Trained personnel should be assigned to calibrate equipment
regularly.

d. Corrective actions and recommendations must likewise be

documented when instruments fail to function as expected

e. Contents of calibration/maintenance record.

1. Name of instrument, model, serial number

2. Name of accessory parts
3. Name and address of local distributor
4. Date and amount of purchase
5. Date of calibration
6. Date of malfunction
7. Date of repair/corrective action(s) taken
8. Recommendations; and
9. Name of authorized person who performed the
calibration/maintenance of equipment.

LIGHTING AND VENTILATION

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

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COLLECTION SITE

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

a. It shall be a designated area within the laboratory or a

temporary facility located at a remote site.
b. The selection of an appropriate collection site will depend on the
type of specimen to be collected.
c. A collection site must have the following.
i. A suitable clean surface for handling the specimen and
completing the required paperwork.
ii. A secured temporary storage capability to maintain a
specimen until it is tested or shipped to the laboratory.

iii. An area to provide Client/Donor/Subject privacy

appropriate to the specimen being collected.
iv. A controlled and secured area for supplies and records.
v. A poster of information bulletin with detailed description
of the proper specimen collection process.
vi. A source of water for hand washing external to toilet
facility (for urine collection)
d. Collection of specimen at a temporary/remote facility can only
be conducted at the following locations/conditions.
i. Workplace/school/jail or prison/rehabilitation center for”
1. Random
2. Follow-up
3. Reasonable suspicion/cause
4. Crime scene and post accident.
ii. Person who are critically ill/disabled.
e. Collection of specimen for all mandatory drug testing (e.g.
driver’s license, R.A. 9165) shall be at a permanent facility
except for crime scene and post accident.
f. The DTL must secure a permit from BHFS/CHD ten (10)
working days prior to the scheduled activity except crime
scene/ post-
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accident. The secured permit must be kept confidential among

drug testing laboratories, requesting party and BHFS/CHD.
Failure to secure a permit will be dealt with accordingly.

g. No examinations must be conducted at temporary collection

facility.

SPECIMEN

The NRL shall evaluate the protocol for each type of specimen.

TYPES OF SPECIMEN

1. Blood
2. Fingernails
3. Saliva (Oral fluid)
4. Scalp hair
5. Sweat (patch)
6. Tissue urine

REASON FOR TEST

1. Blood Reasonable suspicion/cause

2. Fingernails Reasonable suspicion/cause
3. Scalp hair Pre-employment, random, return to duty,
follow-up
4. Saliva (Oral fluid) Pre-employment, random, reasonable
suspicion/cause
5. Sweat (patch) Return to duty, follow-up
6. Tissues Reasonable suspicion/cause
7. Urine Pre-employment, random, reasonable
suspicion/cause,

** More than one type of specimen may be collected at the same time from
the same Donor/Client/Subject

***A specimen may be tested for other purposes provided that the quality of
the specimen for which it will be tested is maintained and the chain of
custody is intact.

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MINIMUM OF QUANTITY OF SPECIMEN TO BE COLLECTED

TYPE OF SPECIMEN AMOUNT TO BE COLLECTED

Blood 5 ml

Fingernails To be determined

Scalp hair 100 mg of hair or its equivalent ion

number of strands, or 1 cm above the
scalp

Tissue To be determined

Saliva ( Oral Fluid) 2 ml collected as a “neat” specimen

divided as follows:

 At least 1.5ml the primary

specimen and at least 0.5ml

FOR THE CHALLENGE TEST.

1. Sweat 1 “patch” worn for 7 to 14 days.

2. Urine 60ml in a single container or 30ml each in
2 separate Containers for split specimen

**The type and quantity of specimen listed above may vary depending on the
existing technology.

***Specimen may be collected using single container, however split

specimen collection may be done upon request if situation permits.

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HANDLING AND STORAGE

Type of Specimen MODE OF STORAGE

Blood Separate serum then
immediately freeze specimen
Fingernails to be determined
Scalp Hair Stored at cool dry place
Tissue macerated and frozen
Saliva deep frozen at least -8 to -10
degrees Celsius
Sweat to be determined
prolonged storage at -20 degrees
Celsius
Urine
Urine may be stored initially in
the refrigerator between 2-6
degrees Celsius for not more
than 1 day.

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.

IMPORTANT POINTS

1. Minimize the number of personnel handling the specimen

2. Document that date and the purpose on the CCF each time a
specimen is handled and transferred. Identify each person who
handled he specimen. When courier services are utilized, the time of
receipt from the collection site and time of delivery to the laboratory
must be documented on the CCF.
3. Place specimen in sealed transparent plastic bag and an appropriate
transport container designed to minimized damage, and seal them
securely to eliminate the possibility of tampering.
4. Ensure that the CCF accompanies the appropriate specimen
transport container.
5. Mail or deliver the specimen to the testing laboratory. The transport of
samples shall be accomplished while maintaining adequate specimen
validity if a commercial courier or postal service is used. If a staff
member delivers the specimen, the laboratory must issue a receipt-of-
delivery slip. The receiving laboratory must record and report any
apparent tampering with the container or specimen, or any
discrepancy in the specimen and the CCF.

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LABORATORY PROCEDURE FOR SPECIMEN HANDLING

A DOH-accredited laboratory must have a standard operating procedure

(SOP)manual that describes, in detail, all laboratory operations about
specimen handling. When followed, it ensures that all specimen is tested
using the same procedure and in a consistent manner.

- OBSERVED SPECIMEN COLLECTION FOR URINE

Observed samples are to be collected in the presence of the Authorized

Specimen Collector.

The Authorized Specimen Collector shall:

a. Prepare and secure all collection supplies, materials and

record.
b. Verify the Client/Donor/Subject’s identification
c. Explain the basic collection procedure to the
Client/Donor/Subject.
d. Answer any reasonable and appropriate questions the
Client/Donor/Subject may ask regarding the collection
procedure.

BASIC STEPS IN COLLECTING URINE SPECIMEN FOR DRUG TESTING

a. The Client/Donor/Subject removes all unnecessary outer

garments (such as coat or jacket, after which, he/she will be
subjected to a bodily search.
b. The Authorized Specimen collector directs the
Client/Donor/Subject to empty his/her pockets and check
items that may be used to adulterate the specimen.
c. The Client/Donor/Subject washes and dries hands prior to
collection. After washing hands, the Client/Donor/Subject

must remain in the presence of the Authorized Specimen

Collector and must not have access to anything that could be
used to affect the specimen.

d. The Authorized Specimen Collector either gives or allows the

Client/Donor/Subject to select the collection container from
available supplies. The specimen is opened in full view of the
Client/Donor/Subject.

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e. The Authorized Specimen Collector directs the

Client/Donor/Subject to go to the toilet facility for urination
and to provide at least 60-ml either collected in single or split
specimen.

f. The Authorized Specimen Collector shall observe closely the

entire collection procedure and take note of the conduct and
demeanor of the Client/Donor/Subject for attempts of
substitution, adulteration and dilution of specimen.

g. A tampered specimen is sent to the laboratory for validity

testing and the Authorized Specimen Collector shall document
the tampering on the CCF with appropriate remarks. The
Authorized Specimen Collector shall instruct the
Client/Donor/Subject to provide another urine sample
immediately under direct observed collection. The second
specimen shall also be sent for examination

h. After the Client/Donor/Subject hands the specimen, the

Authorized Specimen collector must measure the temperature,
check volume and inspect its characteristics.

i. The Authorized Specimen collector and Client/Donor/Subject

must keep the specimen in full view at all times prior to sealing
of all specimen containers.

j. A tamper-evident label must be used to secure the entire

specimen container.

k. Both Authorized Specimen Collector and Client/Donor/Subject

must affix their signature on the seal together with the date and
time of collection.

l. The Authorized Specimen Collector must complete steps 1 and

2 and initiates step 4 of CCF.

m. The Client/Donor/Subject must affix his/her signature at step

5 of the CCF. The Authorized Specimen Collector may ask the
Client/Donor/Subject to list any prescription, medication
he/she may have taken for the past two weeks at the back of
the CCF (Analyst copy). Authorized Specimen Collector shall
distribute each copy as required.

n. In case of specimen collection at a remote site and transport via

a courier/mail, the specimen container together with the CCF
shall be placed in a sealed, labeled and secured transparent
plastic bag.

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UNOBSERVED SPECIMEN COLLECTION

Unobserved samples are collected in the absence of Authorized Specimen

Collector or submitted samples that are not collected at the collection site or
laboratory. Unobserved samples are subject to specimen validity test.

CONDITIONS WHEN UNOBSERVED SPECIMEN COLLECTION IS

ALLOWED.

a. When the Client/Donor/Subject is physically unable to go to

the laboratory or designated collection site.
b. Involved in a crime scene
c. Involved in post-accident
d. Critically ill

INTEGRITY OF URINE SPECIMEN

The Authorized Specimen Collector must adopt procedures to minimize the

risk of adulteration, substitution or dilution of the specimen during the
collection procedure. The following precautions shall be taken to ensure the
integrity of the specimen:

a. To deter the solution of the specimen at the collection site,

toilet water coloring agents should be placed in toilet tanks
or in the toilet bowl. Any other sources of water in the
enclosure where urination occurs (e.g. taps, shower) will be
secured prior to collection.
b. The Authorized Specimen Collector will ask the
Client/Donor/Subject to remove any unnecessary outer
garments such as coat or jacket that might conceal items
that could be used to tamper with or adulterate the
Client/Donor/Subject urine specimen. He/She shall be
objected to bodily search. The Authorized Specimen Collector
will ensure that all personal belongings such as purse or
briefcase remain with the outer garments.
c. The Client/Donor/Subject will be instructed to wash hands
and dry it prior to urination. After washing hands, the
Client/Donor/Subject will remain in the presence of the
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.
d. The Authorized Specimen Collector will give the
Client/Donor/Subject a clean specimen container from the
available supplies. The Client/Donor/Subject may provide
his/her specimen in the privacy of a toilet cubicle or
otherwise partitioned area that allows for individual privacy.
The Client/Donor/Subject will be instructed not to flush the
toilet

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until the specimen is handed to the Authorized Specimen

Collector.

e. Upon receiving the specimen from the Client/Donor/Subject,

the Authorized Specimen Collector will
i. Check the volume of the urine in the specimen
container
ii. Check the temperature of the urine specimen
iii. Inspect the specimen to determine its color and
appearance of any signs of contaminants. Any
unusual findings will be noted on th CCF.
f. Both the Client/Donor/Subject and the Authorized
Specimen Collector will keep the specimen
container/specimen bottles in view at all times prior to the
urine specimen being sealed and labeled.
i. The specimen bottle have an identification label that
contains pertinent information such as date and time
of specimen collection, signatures of the
Client/Donor/Subject and Authorized Specimen
Collector and specimen ID number.
ii. The Authorized Specimen Collector will fill-up steps 1
and 2 and initiates step 4 of the CCF and pack
together with the urine specimen immediately for
dispatch to the analytical laboratory.

SPECIMEN REJECTION AND CANCELLATION OF TESTS

All rejected specimen should be reported to the Head of the Laboratory

stating the reason(s) of rejection.

CRITERIA FOR SPECIMEN REJECTION THAT ARE NON-CORRECTABLE

a. Incompatibility of the ID number on the specimen

received by the laboratory with the number on the
CCF
b. Absence of ID number on the specimen
c. No printed Authorized Specimen Collector’s name and
signature on the CCF.
d. Broken or tampered seal on the specimen container.
e. Insufficient quantity of specimen.

CRITERIA FOR SPECIMEN REJECTED THAT IS CORRECTABLE

a. Failure of the Authorized Specimen Collector to sign

the CCF.
b. Failure to check and record the specimen temperature
with appropriate remarks.

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APPROPRIATE REMEDIAL MEASURES FOR CORRECTABLE ERRORS.

a. All errors must be properly documented, recorded in a

MFR and duly signed by the Authorized Specimen
Collector.

b. If the Authorized Specimen Collector’s signature

cannot be corrected by a MFR, the laboratory must
report the specimen rejected for testing and provide a
reason on the report.

c. If the Authorized Specimen Collector cannot provide

and MFR to attest to the fact that he/she did measure
the specimen temperature, the laboratory my report
the test result for the specimen but indicate that the
Authorized Specimen Collector could not provide an
MFR to recover the omission.

CONDITIONS THAT WILL NOT CAUSE SPECIMEN REJECTION OR

CANCELLATION

At the receiving area:

a. Discrepancies of the laboratory name and address

b. Incomplete/incorrect/unreadable employer name or
address
c. Name of Head of the Laboratory is not indicated
d. Incomplete/incorrect address of the Head of the
Laboratory
e. Incorrect entry of the Client/Donor/Subject’s ID
number
f. Unmarked “reason for test”box
g. Unmarked “drug test to be performed” box
h. The collection site address is not indicated
i. Unmarked “specimen collection” box
j. The date and time of collection is not indicated
k. Unmarked “observed” box (if applicable)
l. Incorrect entry of name of delivery/courier service
m. The Client/Donor/Subject’s name inadvertently
appears on the laboratory copy of the CCF or on the
tamper-evident labels use to seal the specimen bottles

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Within the laboratory:

a. Failure to print and sign the accessioner's name

b. Failure to print and sign the Analyst’s name
c. The Analyst accidentally initials the CCF rather than
providing signature for a non-negative result (Analyst’s
initials are acceptable for a negative result.
d. The accesioner fails to mark one of the “primary
specimen bottle seal intact” boxes, but the laboratory
reported a “rejected for testing” result with an
appropriate comment on the “remark” line.

*** The above errors, omissions, and discrepancies are considered

insignificant only when they occur less than one percent of the time. The
expectation is that each trained Authorized Specimen 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 more than one percent of the time, the Head of the Laboratory must
direct the Authorized Specimen Collector of laboratory personnel (whoever is
responsible for the error) to immediately take corrective measures to prevent
the recurrence of the error.

SITUATIONS/ERRORS THAT MAY REQUIRE THE HEAD OF THE

LABORATORY TO CANCEL A TEST

a. The Client/Donor/Subject’s signature is missing on the

Laboratory copy of the CCF and the Authorized Specimen
Collector failed to provide a comment that the
Client/Donor/Subject refused to sign the form.
b. The Analyst failed to sign the CCF for a specimen being
reported drug positive, adulterated, substituted, rejected for
testing or invalid test result.
c. The electronic report provided by the laboratory does not
contain all the data elements required for the DOH standard
electronic laboratory report for a specimen being reported
drug positive, substituted, rejected for testing, or invalid test
results.

CORRECTIVE MEASURES THAT THE HEAD OF THE LABORATORY

MUST DO PRIOR TO CANCELLATION

a. The Head of the Laboratory must contact the Authorized

Specimen Collector to obtain a statement to verify that the
Client/Donor/Subject refused to sign the laboratory copy. If
the Authorized Specimen Collector cannot provide such
statement, the Head of the Laboratory must cancel the test.

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b. The Head of the Laboratory must obtain a statement from

the Analyst that he/she inadvertently forgot to sign the CCF,
but did, in fact, properly conduct the certification review.
c. The Head of the Laboratory must require the laboratory to
modify and re transmit a corrected electronic report.

CONDITIONS FOR RETENTION OF SPECIMEN

a. A specimen reported negative for a minimum of 5 days after

the receipt of result.
b. A specimen reported either as positive, adulterated,
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.
c. A retained specimen must be kept in a secured location
appropriately to ensure its availability for any necessary
retesting during an administrative or judicial proceeding.

CHAIN OF CUSTODY
DRUG TESTING CUSTODY AND CONTROL FORMS

1. Bureau of Health Facilities Services (BHFS) approved Drug Testing

Custody and Control Form (CCF) must be used to document the
collection of a specimen by all drug testing laboratories.
2. The form is used to document chain of custody from the time a
Client/Donor/Subject gives specimen to the Authorized Specimen
Collector until the specimen is received for testing.
3. The CCF used for each type of specimen collected should be
available at the drug testing laboratories.

ACCESSIONING

1. The laboratory must provide a unique number upon entry of the

specimen to the laboratory.
2. They must also inspect the specimen submitted and the CCF to
verify the integrity and identity of the specimen.
3. The laboratory must examine the packaging for evidence of
tampering in transit.
4. They must compare the information on the sample bottles within
the package with the information on the accompanying CCF.
5. The laboratory must document all discrepancies.
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SECURITY MESURES

1. A laboratory must control access of unauthorized individual and

ensure that no unauthorized individual can gain access to
specimen, aliquots, or records.
2. All authorized visitors must be escorted at all times.
3. A laboratory must maintain a record that documents the dates,
time of entry and exit, and purpose of entry of authorized escorted
visitors accessing secured areas.

URINE SPECIMEN VALIDITY TEST

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

Validity procedures for unobserved urine collection to determine the

integrity of the specimen

PERFORM INITIAL VALIDITY TESTS

Urine physical conditions in the following conditions:

1. Temperature
2. Abnormal physical appearance (e.g. color, odor, excessive foaming).

3. Reactions or responses characteristic of an adulterant obtained

during initial or confirmatory drug tests. (e.g. non-recovery of
standards, unusual response)
4. Possible unidentified interfering substance or adulterant. The
choice of additional validity tests is dependent on the observed
indicators or characteristics.

i. Urine specific gravity, pH and nitrites

ii. Urine creatinine concentration
iii. Validity test/s for presence of oxidizing adulterants as
needed.

PERFORM CONFIRMATORY VALIDITY TESTS USING ALL OTHER

PROCEDURES, INSTRUMENTS AND/OR METHODS ON THE SAME
SAMPLE.

**All unobserved samples for validity testing shall be submitted to an

accredited drug testing facility with at least a secondary clinical laboratory
capability.

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*** Validity test for other types of specimen shall be incorporated for
future reference.

CRITERIA FOR DETERMINING URINE SPECIMEN

a. INVALID

1. Adulterated, substituted and diluted

2. Improperly collected, handled and stored
3. Improperly documented

b. ADULTERATED

1. The nitrite concentration is confirmed to be greater than

or equal to 500ug/L
2. The pH is less than 3 or greater than or equal to 11
3. The specimen contains an exogenous substance
4. The specimen contains an endogenous substance at a
concentration greater than what is considered a normal
physiological concentration.

c. SUBSTITUTED

1. The creatinine concentration is less than 442.0 umol/L

2. Specific gravity is less than 1.002 or greater than or equal
to 1.020

d. DILUTED

1. The creatinine concentration is less than 1768.0 umol/L

2. The specific gravity isless than 1.003
3. The creatinine and specific gravity results do not meet the
criteria for a substituted or invalid result.

PROCEDURES FOR CONDUCTING EACH VALIDITY TEST ON A URINE

SPECIMEN

1. FOR CREATININE CONCENTRATION

a. The creatinine concentration shall be measured to one

decimal place on both the initial test and confirmatory test.
b. The initial creatinine test shall have a calibrator at either
442umol/L or at 1768umol/L
c. The initial creatinine test shall have a ccontrol in the range
of 176.8umol/L to 353.6umol/L, a control in the range of
442 umol/L to 1768 umol/L, and a control range of
1856.4umol/L to 2210 umol/L
d. The confirmatory creatinine test ( performed on that
specimen with a creatinine concentration less than

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442umol/L on the initial test) shall have a calibrator at 442

umol/L or at

1768umol/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
707.2umol/L

2. FOR SPECIFIC GRAVITY

a. The specific gravity shall be measured using s refractometer

on both initial and confirmatory test. The refractometer shall
be capable of reading in increments of at least 0.001 or less.
b. The initial and confirmatory specific gravity test shall have
the following controls:

For the cutoff of less than 1.002, one control at 1.001 and
one control in the range of 1.015 to 1.020

For the cutoff of greater than or equal to 1.020, one control

greater than or equal to 1.02 but not greater than 1.025, and one
control in the range of 1.015 to 1.020.

3. FOR pH

a. Dipstick, pH. paper or spectrometric/colorimetric tests may be

used for the initial validity test.
b. A pH meter shall be used to perform a confirmatory validity
test.
c. The initial and confirmatory pH meter test shall have the
following controls:

For the cut-off of less than 3, one control in the range of 2 to 2.9 and one
control in the range of 3.1 to 4.

For the cutoff of greater than or equal to 11, one control in the range of 10
to 10.9 and one control in the range of 11.1 to 12.

The spectrometer/colorimetric initial pH test shall have the following:

- for the cutoff of less than 3, one control in the range of 2 to 2.9

- for the cutoff of greater than or equal to 11, one control in the range of
11.1 to 12.

4. FOR OXIDIZING ADULTERANT TESTS

a. At a minimum, the initial test(s) for oxidizing adulterants shall

be capable of detecting nitrites, chromates and halogens
(bleach, iodine etc.,). The detection of these adulterants may be
achieved by using either a general oxidizing adulterant test or
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by using specific test foro each category of these adulterants. If

an initial test for oxidizing adulterants simultaneously tests for
all oxidizing adulterants, the assay shall be able to detect at
least the activity equivalent to
b. 20mcg/ml of chromate (chromium VI) or 200mg/ml of nitrite as
an LOD. Each analytical run of specimen shall include a control
without the compound of interest and at least one positive
control with one compounds of interest at a concentration,
which exhibits an oxidizing activity above the documented LOD
of the procedure.
c. A confirmatory test for a specific oxidizing adulterant shall use
a different analytical principle of chemical reaction than that
used for the initial test unless a recognized reference method is
used for both initial and confirmatory test. Each analytical run
of specimen shall include a control without the compound of
interest and a positive control with the compound of interest at
a concentration above the documented LOD in the procedure.

5. FOR NITRITE CONCENTRATION

a. Dipsticks may only be used to determine if initial and

confirmatory nitrite test shall be performed.
b. A nitrite specific initial test shall have a calibrator at the cutoff
concentration, a negative control, one control in the range of
200mcg/l to 500mcg/ml and one conrol at the range of
500mcg/l to 625mcg/l.

6. FOR OTHER VALIDITY TEST

a. Each analytical run of specimen shall include a control without

the compound of interest and a positive control with the
interest wat a concentration above the documented LOD pf the
procedure.
b. A confirmatory test for a specific adulterant shall use a different
analytical principle or chemical reaction than that used for the
initial test unless a recognized reference method is used for
both the initial and confirmatory test.

c. The initial and confirmatory tests for anionic surfactants shall

be ale to detect at least the activity equivalent to 100mcg/l of
dodecyl benzene sulfonate.
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RECORDING

The laboratory shall develop and maintain clear and well-documented

records detailing procedures for collection, accessioning, result of analysis
and remedial measures, which shall not be limited to the following”

1. Chain of custody

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

2. Memorandum for Records

It is a record to document specimen that had been rejected or cancelled. It

includes reason and corrective measures done.

3. Result of Analysis

Records for all screening/confirmatory test results and/or of the documents

contain the following:

Evidence of review by the certifying Analyst in confirmatory tests.

a. Evidence of confirmatory work sheets or other review

documents of comparison of the initial and
confirmatory testing data to ensure consistent results.
b. Strikeout changes made on test results and other
records must be properly annotated by the responsible
individual.

4. Inventory of reagent, supplies and materials

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

5. Equipment, maintenance and repair record.

The equipment, maintenance and repair record should document that all
instruments are properly maintained, calibrated, cleaned and monitored
including corrective measures and recommendations done.

6. Storage of collection site records

Collection site records must be stored for a minimum of 2 years in the

laboratory or as required by law.

7. Quality Assistance Program Record

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a. Internal quality control

b. External quality control

8. Storage of laboratory results

A laboratory must retain all records generated to support test results for at
least 2 years.

However, all other records associated with positive results or a particular

specimen under legal challenge shall be maintained for an indefinite period.

9. Electronic storage system

a. A DOH-accredited laboratory shall store and archive all

records electronically to duly authorized application service
provider.
b. The laboratory must validate that the method used to create
the electronic records provides an accurate representation of
all original records
c. The method used to create the electronic records must
prevent the alteration of any stored information.
d. The method used must allow easy retrieval and reproduction
of the original records.
e. The laboratory shall ensure the integrity of data
electronically stored under its information technology
facilities without prejudice to pertinent statuses on
privacy/confidentiality and transparency.
f. The laboratory shall ensure the integrity of data by
transmitting it electronically from their facility to DOH within
the prescribed time and measures to counter disruption of
transmittal are installed.
g. The laboratory shall assure that the data stored
electronically have back-up copies for the purpose of audit
by the DOH and as a measure to preclude inadvertent loss of
records.
h. Electronic transmittal if drug testing results shall be coursed
by the DOH authorized application service provider.

REPORTING
The laboratory shall maintain specimen test results supported by data
and are reported in accordance with the following written guidelines

1. GUIDELINES FOR REPORTING LABORATORY RESULT.

a. All specimen submitted shall have a corresponding laboratory

result issued within 15 days.

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b. A positive screening result shall be subjected to confirmatory

analysis. The final report shall be based on the confirmatory result.
c. The screening laboratory shall be the only authorize laboratory to
release the final report.
d. All laboratory reports of a screening laboratory shall bear the
signature of the Analyst and head of the laboratory. For a
confirmatory laboratory, the report shall be the signature of the
Analyst, Chief Chemist and Head of the Laboratory.
e. All confirmatory drug test results should specify the concentration
of the limit of detection (LOD) of the method of the drug or
metabolites. However, for clinical or therapeutic purposes, the
concentration shall be quantified.
f. A laboratory shall report all test results using DOH-accredited
standard electronic laboratory report form. The electronic report
must be transmitted in a manner that ensures the confidentiality
and security of the information.
g. Reports for an adulterated or substituted test result must be based
on an initial and confirmatory validity test.
h. The laboratory must report the specific validity test result(s) for a
specimen that is reported adulterated or substituted.
i. No results can be relayed through telephone.

2. STATISTICAL SUMMARY OF THE LABORATORY REPORT

a. A laboratory must submit annually to the BHFS a report

containing the following:

Total number of specimen received and examined as classified according to:

 Mandatory
 Random
 Other reasons

Number of specimen that were reported as :

 Positive for each drug

 Adulterated
 Substituted
 Rejected for testing
 Invalid result

The number of specimen sent for confirmatory testing (for screening

laboratory)

b. The report must be submitted to the BHFS by mail, fax, or email

within 10 working days after the end of the year.

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3. REVIEWING A POSITIVE, ADULTERATED, SUBSTITUTED, OR

INVALID TEST 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:

a. Allow the Client/Donor/Subject to explain any circumstance

leading to the test result.
b. Evaluate alternative medical explanations for the positive,
adulterated, substituted, or invalid test result.
c. Review current medical record of the Client/Donor/Subject
that could have resulted from taking legally prescribed
medication.

4. When the laboratory reports an invalid result due to the possible

presence of an unidentified interfering substance/adulterant, the
Head of the Laboratory shall:

a. Send the specimen to another DOH accredited laboratory

capable of identifying the interfering substance/adulterant.
b. Report the result as “Test Cancelled” if the explanation
provided by the Client/Donor/Subject is:

Acceptable, then an immediate direct observed collection is

not required.
Not acceptable, then an immediate direct observe collection
is required.

5. FOR VERIFICATION, the Client/Donor/Subject may obtain other

documents.

The Client/Donor/Subjects must submit a written request addressed

to the head of the Drug Testing Laboratory to obtain a certified true copy of
COC and pertinent analytical data.

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QUALITY ASSURANCE PROGRAM

1. Internal Quality Assurance Program (IQAP)

a. Screening laboratory
b. Validation of a screening drug test

The laboratory must demonstrate and document:

a. The ability to differentiate positive and negative samples;

b. The performance of the test around the cutoff concentration;
c. The performance of the test results at several concentrations
between 0 to 150 percent of the cutoff concentration.

Perform characteristics of new lots of testing kits must be evaluated prior to

its use.

2. Batch quality control requirements when conducting a screening

drug testing

a. For kits only

Each batch of specimen must contain the following types of QC

samples:

At least one controlled registered and validated by the DOH to contain

no drug metabolite;

At least one control that has the concentration of the drug or

metabolite at 25 percent above the cutoff concentration;

At least one control that has the concentration of the drug or

metabolite at 25 percent below the cutoff concentrations.

b. Instrumented

Each batch of specimen must contain the types of QC samples as in

drug testing laboratory using kits.

At least 10percent of batch must be calibrators and controls.

A laboratory must document that any carryover that might occur

between aliquots during the initial testing is detectable and corrected.

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3. CONFIRMATORY LABORATORY

a. Validation of confirmatory drug test:

The laboratory must demonstrate and document:

1. The linear range of the analysis.

2. The limit detection (LOD)
3. The limit of quantitation (LOQ)
4. The accuracy and precision at the cutoff
concentration
5. The accuracy and precision at 40 percent of the
cutoff concentration
6. The potential for interfering substances

b. Internal quality control requirements when conducting a

confirmatory drug test:

Each batch of specimen must contain, at a minimum, the

following types of QC samples

1. A three-point calibrator at the cutoff

2. At least one negative control
3. At least one positive control within 25 percent above
the cutoff concentration
4. At least one blind control in every batch

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

On a re-test/re-confirmatory challenge, the batch must have one control

that has the concentration of the drug or metabolite below 40 percent of the
cutoff concentration.

The linear range, limit of detection, and limit of quantification must be

documented and periodically re-evaluated for each confirmatory drug test.

A laboratory must document that any other carry-over that might occur
between aliquots/extracts in the confirmatory batch is detectable and
corrected.

WASTE DISPOSAL
1. HAZARDOUS WASTE

a. Biohazard samples

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Biohazard wastes are liquid, solid or concentration of solid waste which,

because of its quantity, concentration, physical, chemical or infectious
characteristics may pose a substantial or potential threat to any human
health or to the environment when improperly treated, stored, transported
or disposed.

b. Chemical waste

Toxic waste must undergo pre-treatment prior to disposal. Non-chemical

hazardous waste can be disposed directly into the sink or treated as
ordinary domestic waste.

2. NON-HAZARDOUS WASTE

Various methods of disposal are applicable.

a. Biodegradable waste
1. Use of sanitary landfill
2. Composting
3. Recycling scheme
4. As domestic/municipal waste
b. Non-biodegradable waste: recycling of:
1. Glass
2. Metals
3. Plastics
4. Computer
5. Cartridges
6. Others

GOOD LABORATORY PRACTICE

1. GENERAL

a. Chemical reagents: chemicals and reagents used must meet

the specifications in the method. If not specified, then
“Analytical reagent grade “AR or American Chemical Society
(ACS) grade for chemicals or better should be used for
analysis.
b. Reagent water must be free from interferences for the
analytes being measured.
c. Glassware preparation: specific requirements in the methods
for cleaning of glassware must be followed. If no
specifications re listed, then glassware should be washed in
a warm and then distilled/de-ionized water.

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2. SAFETY AND CLEANLINESS

a. Drinking and Smoking

Eating, drinking and smoking should not be permitted in any

area where activities might adversely influence product quality or
where staff may be exposed to potentially harmful agents. There
should be areas designated for eating, drinking and rest personnel.

b. 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.

3. QUALITY ASSURANCE

Laboratories must maintain current QAP. All laboratory

activities including sampling, test methods, instrument operation,
data generation and corrective action should be described in that
program.

MONITORING
1. Monitoring requirements for an accredited laboratory

a. An accredited laboratory shall undergo on site monitoring visits

by DOH
b. A team of at least 2 Regulatory Officers inspects an accredited
laboratory.
c. Each inspector conducts an independent evaluation and review
of all aspects of the laboratory’s procedures and facilities using
the guidelines provided by the DOH
d. To remain accredited, a laboratory must continue to satisfy the
requirements as stated in this Manual.

2. Procedures to follow if a laboratory fails to satisfy the requirements

for either the PT program or the monitoring program:

a. The applicant must start the initial certification from the

beginning.
b. The laboratory is given a period of 10 working days to
provide any explanation for its performance and evidence
that any deficiency has been corrected.

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c. An accredited laboratory may be required to undergo a

special inspection or to test additional PT samples,
depending on the nature of the performance, to verify that
any deficiency has been corrected.
d. If a laboratory’s accreditation is revoked or suspended, the
laboratory is not permitted to test any specimen until the
suspension is lifted or the laboratory has successfully
completed the certification requirements as a new applicant
laboratory.

3. All negative and positive results together with the

membrane/chromatogram for instrument printout shall be
submitted to BHFS or to be forwarded to NRL for further
evaluation
4. The NRL shall conduct a program for random confirmatory tests of
specimen with negative results.
5. Spot inspection of drug testing laboratories shall be conducted by
BHFS and NRL.
6. All laboratories shall follow the prescribes DOH schedule of fees.

END
Prepared by
OF Reviewed by: Approved by:

MAN
UAL
JOSEPH JOJO D. DAJAY, RMT
Laboratory Manager / Analyst
DR. PERLA E. PALAO, MD, DPSP
Head of Laboratory
JOHN CHRISTOPHER B. OSIA
Proprietor

Date: Date: Date:

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