Manual of Operations For Drug Testing Laboratories

Functions and Responsibilities

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 operatnio of the drug-
testing laboratoty. 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 withthis
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.

b. Prepares specimen for analysis.
c. Examines,process and analyzes specimen for drug testing.
d. Interprets, records, releases, and signs out laboratory results.
e. Assists in the implementations of quality assurance program.
f. Assist in the evaluation of reagents, supplies and equipment.
g. Refers to the Head of Laboratory as the need rises.

AUTHORIZED SPECIMEN COLLECTOR

a. Restricts unauthorized personnel to enter the collection site during collection.

b. Verifies identity of Client/Donor/Subject.
c. Provides security to the specimen supplies, records and documents at collection site.
d. Informs 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 trainings taken by the personnel which pertains to any aspect of their responsibilities,
including but not limited to analytical methdology, 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.
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
maufacturers’ 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 eb 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 acton(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.

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 completnig the required
paperwork.
ii. A secured temporary storage capablity to maintain a specimen until it is tested
or shipped to the laboratory.
iii. An ara 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 witha detailed description of the proper
specimen collection process.
vi. A source of water for hand washing external to toilet facility (for urine
collection)
d. Colelction 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 dibe 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 accident. The secured permit must be kept
confidential among drug testing laboratories, requesting party and BHFS/CHD. Failure to
secure a pemit will be dealt with accordingly.
g. No examinations must be conducted ata temporary collecton 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,
Mandatory

** 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 ismaintained and the chain of custody is intact.

MINIMUM OF QUANTITY OF SPECIMEN TO BE COLLECTED

1. Blood 5ml
2. Fingernails To be determined
3. Scalp hair 100mg of hair (or its equivalent in number of strands
Or 1cm above the scalp.
4. Tissue to be determined
5. Saliva (oral fluid) 2ml collected as a “neat” specimen (divided as follows:
At least 1.5ml the primary specimen and at least 0.5ml
For the challenge test.
6. Sweat 1 “patch” worn for 7 to 14 days.
7. 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.
HANDLING AND STORAGE

1. Blood Separate serum then immediately freeze specimen

2. Fingernails to be determined
3. Scalp hair Stored at cool dry place
4. Tissue macerated and frozen
5. Saliva deep frozen at least -8 to -10 degrees Celsius
6. Sweat to be determined
7. Urine prolonged storage at -20 degress Celsius

*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.

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 containerd
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 memebr 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, any discrepancy in the specimen and the CCF.
LABORATORY PROCEDURE FOR SPECIMEN HANDLING

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

1. 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 collcetion procedure to the Client/Donor/Subject.
d. Answer any reasonable and appropriate questions the Client/Donor/Subject may
Ask regarding the collection procedure.

2. BASIC STEPS IN COLLECTING URINE SPECIMEN FOR DRUG TESTING

a. The Client/Donor/Subject removes all unnecessary outer garments (sush 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
Sppecimen 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 availble supplies. The specimen is opened in full
view of the Client/Donor/Subject.
e. Teh Authorized Specimen Collector directs the Client/Donor/Subject to go to the toilet
facilty 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 Atuhorized 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 chall be placed ina a sealed, labeled and
secured transparent plastic bag.

3. UNOBSERVED SPECIMEN COLLECTION

Unobserved samples are collected in the absence of Authorized Specimen Collector o

submitted samples that are not collected th tha collection site or laboratory. Unobserved
samples are subject to specimen validity test.

CONDIIONS 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

4. INTEGRITY OF URINE SPECIMEN

The Authorized Specimen Collector must adopt procedures to minimize the risk of
adulteration, substitution or diliution of the specimen during the collection procedure. The
following precautions shall be taken to ensure the intergity 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. Anyother 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 taht 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 availble 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 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 ofthe urine specimen
iii. Inspect the specimen to determine its color and appearance of any signs of
contaminants. Any unusal findings willbe 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.

5. 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 nunber 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 tempeature with appropriate
remarks.
 APPROPRIATE REMEDIAL MEASURES FOR CORRECTABLE ERRORS.

a. All errors must be properly documented, recorded in a MFR and duly

singned by the Authorized Specimen Collector.
b. If the Authorized Specimen Collector’s signatire 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 labortory 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. Incorect ebtry odthe Client/Donor/Subject’s ID number
f. Unmarked “reason for test”box
g. Unmakred “drug test to be performed” box
h. The colection 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 labelsuse to seal the specimen
bottles

Within the laboratory:

a. Failure to print and sign the accesioner’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 that 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 on 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 meassures 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 rtest
results.

CORRECTIVE MEASURES THAT THE HEAD OF THE LABORATORY MUST DO PRIOR TO CANCELLATION

a. Th Head of the Laboratory must contact the Authorized Specimen Colelctor to

obtain a statement to verify that the Client/Donor/Subject refused to sign the
laoratory copy. If the Authorized Specimen Collector cannot provide such
statement, the Head of the Laboratory must cancel the test.
b. The Head of the Laboratory must obtain a statement from the Analyst that he/she
inadvertently forgot to sign the CCF, but did, infact, properly conduct the
certification review.
c. The Head of the Laboratory must require the laboratory to modify and retransmit 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 colletion 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 interity 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 labortory must document all discrepancies.

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 autorized visitors must be escorted at all times.
3. A labortory 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 intergity of the specimen

Validity procedures for unobserved urine collection to determine the intergity 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 adulterantobtained 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.

Urine specific gravity, pH and nitrites

Urine creatinine concentration
Validity test/s for presenceof oxidizing adulterants as needed.

PERFORM CONFIRMATORY VALIDITY TESTS USING ALL OTEHR PROCEDURES,

INSTRUMENTSAND/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.

*** 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 concentraiotn greather
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 orgreater 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 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 refractomteter shall be capable of reading in increments of at
least 0.001 or less.
b. The initial and confirmatory specific gravity test shal have the following controls:

For the cutoff ofless 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 greather 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 spetrometric/colorimetric tests may be used for initial validity test.
b. A pH meter shall be used to perform confirmatory validity test.
c. The initial and confirmatory pH meter test shall have the following controls:

For the cutoff ofless 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.

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 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 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 conpounds
of interest at a concentration, which exhibits an oxidizing activity above the
documented LOD of the procedure.
b. A confirmatory test for a specific oxidizing adulterant shall use a different analytical
principle oe chemical reaction than that used for the initial test unless a recognized
reference method is used for both initial and confirmatory test. Eaach 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 fofr anionic surfactants shall be ale to detect at least
the activity equivalent to 100mcg/l of dodecylbenzene sulfonate.
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
folowwing”

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:

a. Test results
b. Test results of control/calibrator/standard
c. Laboratory identification of specimen tested
d. Identification of individual performing and reviewing the test reults
e. Evidence of review by the certifying Analyst in confirmatory tests.
f. Evidence of confirmatory work sheets or other review documentss of
comparison ofthe initial and confifrmatory testing data to ensure consistent
results.
g. Strikeout changes made on test results and other records must be properly
annonated by the responsible individual.

4. Invebtory of reagent, supplies and materials

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

5. Equipment, maintenance and repair record.

The equpment, maintenance and repair record should document that all instruments
are properly maintained, calibrated, cleaned and monitored including
correctivemeasures 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

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 prejuduce 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 coresponding laboratoty result issued within 15 days.
b. A positive screening result shall be subjected to confirmatory analysis. The final report shall
be based on the confrimatory result.
c. The screening laboratory shall be the only authorize laboratory to releas 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 bea 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 threpeutic
purposes, the concentration shall be quantified.
f. A laboratory shall report all test results using DOH-accredited standard electrnic laboratory
report form. The electronice report must be transmitted in a manner that ensures the
confidentiality and security of the information.
g. Reports for an adulterated or subtituted test result must be based on an initial and
confirmatory validity test.
h. The labortory 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 recieved and examined as classified according to:

Mandatory
Ranadom
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.
3. Reviewing a positive, adulterated, substituted, or invalid test result

Prior to making a final decision ona 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, substitued,
or invalid test result.
c. Review current mdedical 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 accredieted laboratory capable of identifying

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

Acceptable, then an immediate direct observed collection is not

required.
Not acceptable, then an immediate direct observed 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.
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:

The ability to differentiate positive and negative samples

The performance of the test around the cutoff concentration
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 conductin a screening drug testing

a. For kits only

Each batch of speecimen 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.

3. CONFIRMATORY LABORATORY

a. Validation of confirmatory drug test

The laboratorymus 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 leats 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 leats 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 othe carryover that might occur between
aliquots/extracts in the confirmatory batch is detectable and corrected.
WASTE DISPOSAL

1. Hazardous waste

a. Biohazard samples

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
ot 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 dometic/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. Chemincal 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 gass wre should be
washed in a warm and then distilled/de-inonized water.

2. SAFETY AND CLEANLINESS

a. Drinking and Smoking

Eating, drinking and smoking should not be permitted in any area where
activities might adversely influenceproduct 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, tet
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 teh DOH
d. To remain accredited, a labortory must continue to satisfy the requirementsas stated in
this Manual.

2. Procedures to follow if a labortory 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.
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 applicantlaboratory.

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 programfor random confirmatory tests of specimen with negativ
results.
5. Spot inspection of dryg testing laboratories shall be conducted by BHFS and NRL.
6. All laboratories shall follow the prescribes DOH shchedule of fees.
7. ss