SPECIMEN COLLECTION

SEMINAR/WORKSHOP ON THE MANUAL OF OPERATIONS

FOR SCREENING DRUG TESTING LABORATORIES
 Proper specimen collection is essential for
legally and scientifically defensible drug test
result; failure to follow any of these steps
will invalidate the results and make them
indefensible in legal settings.
Topics

1. Review of Functions of Authorized

Specimen Collector (ASC)
2. Preparation of Collection Site
3. Specimen Collection
4. Specimen Integrity and Security
5. Specimen Handling, Storage & Transport
Review of Functions of ASC

 ASC – designated specimen collector

 At least high school graduate who
undergone training on the following:
Collection procedure
Chain of custody and record keeping
Specimen Integrity and security
Dangerous drugs regulation and
policies
Review of Functions of ASC

Re-training shall be required when:

 collection procedure changes
significantly
 mistake has been made that caused
cancellation of test
Review of Functions of ASC

to ensure security of specimen at

collection site
 Restricts unauthorized personnel to
enter collection site
 Verifies ID of Client/Donor/Subject
 Provide security to specimen supplies,
records and documents
 Informs donor of the collection procedure
Review of Functions of ASC

to ensure security of specimen at

collection site
 Performs one collection at a time
 Accepts and seals the specimen
container in the presence of donor
Review of Functions of ASC

to inspect integrity of urine

 Checks temperature, physical properties
and volume of specimen

to record specimen
 Accomplishes Custody and Control Form
(CCF) Steps 1 to 5
 (When necessary) Rejects specimen and
issues Memorandum for Record (MFR)
Who are not authorized to collect
specimen?

 Employer of client/patient
 Crime investigator
 Complainant
 Owner/Administrator of Requesting
Agency
Preparation of Collection Site

Collection Site – a designated area

within the laboratory or a temporary
facility located at a remote site
where a donor provides specimen
for drug test. Selection of collection
site depends on the type of
specimen collected.
Collection site must have’s

 A suitable clean surface for handling the

specimen and completing paperwork
 A secured temporary storage capability
to maintain a specimen until it is tested
 An area to provide donor privacy
appropriate to the specimen being
collected
Collection site must have’s

 A controlled and secured area for

supplies and records
 A poster or information bulletin with a
detailed description of the proper
specimen collection process
 A source of water for hand washing
external to toilet facility & coloring agent
(for urine collection)
Collection at permanent facility

Collection of specimen for all

mandatory drug testing (e.g. drivers
license, RA 9165) shall be done at a
permanent facility except for crime
scene and post accident.
Collection at remote facility

The DTL must secure a permit from

BHFS at least 7 working days prior
to remote collection except crime
scene or post accident. The secured
permit must be kept confidential.
Collection site at temporary/remote facility

Locations and conditions:

1. Workplace, School, Jail, Prison,
Rehabilitation Center for:
Random
Follow-up
Reasonable/Suspicious Cause
Crime scene and post accident
2. Person who are critically ill/disabled
Bureau Circular No. 9, S 2004

Guidelines for Remote Collection is

available in Appendix J and in the
lecture topic “IRR Governing
Accreditation of Drug Testing
Laboratories in the Philippines”
Collection supplies

 Specimen containers
 Tamper evident seals
 Labels, water proof pens
 Gloves
 Leak-resistant plastic bags
 Coloring agents
 Thermometer/temperature strips
 Documents – CCF, MFR, Logbooks
 Shipping containers (ice chest)
Collection Device

 shall not affect or alter the specimen

collected
 shall be properly labeled and sealed
 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. sweat patch)
Collection Device

Single-use items are not unique

collection devices and are not
required to be cleared by the DOH.
Collection Device and Type of Specimen

Polyethylene bottle, 30 or 60 ml,

Urine
wide mouth with screw cap
Saliva Polyethylene bottle, 30 ml
Blood Plain test tube, 10 ml
Tissue Screw capped plastic container
Hair Self sealed transparent plastic bag
Sweat FDA approved sweat patch
Type of Specimen and Reason for Test

Urine Pre-employment, random, reasonable

suspicion/cause, mandatory
Saliva Pre-employment, random, reasonable
suspicion/cause
Blood,
Tissue, Reasonable suspicion/cause
Nails
Hair Pre-employment, random, return to
duty, follow-up
Sweat Return to duty, follow-up
Type of Specimen and Reason for Test

 More than one type of specimen may be

collected at the same time from the
same donor.
 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.
Urine Specimen

 Least expensive, most popular

 Easy to do
 Standardized procedures
 Detects use within the week
 Abstaining can produce negative
reaction
 Established specimen validity tests
Saliva Specimen

 Uncommon method
 Easy to administer
 Short detection time
 No reference standards
Blood Specimen

 Most expensive method

 Most accurate method
 Least common method
 Short detection time
 Procedure not established and
standardized
Sweat (patch) Specimen

 Requires wearing of patch 1-2 weeks

 Uncommon method
 No reference standards developed yet
 Surface contamination can cause false
positive
 Can detect use for extended period of
time
Hair Specimen

 Expensive and tedious

 Twice more sensitive than urine test
 Do not detect recent use
 Detects chronic substance abuse
 Requires 1.5 x 1.5 cm hair clump
 Not affected by drug abstinence
 Can determine temporal pattern
Minimum Quantity of Specimen

60mL in single container or 30 mL

Urine each in two separate containers for
split specimen
Saliva 2 ml, divided into 1.5 ml the primary
and 0.5 ml for challenge
Blood minimum of 5mL

Hair 100 mg hair (or equivalent number of

strands or 1 cm above the scalp).
Sweat 1 "patch" worn for 7 to 14 days
Methods of Specimen Collection

Observed collection
 In the presence of ASC

Unobserved collection
 In the absence of ASC
 Submitted samples
 Subject to validity tests
Conditions when unobserved specimen
collection is allowed -

When donor is:

 Physically unable to go to the laboratory
or designated collection site
 Involve in crime scene
 Involve in post-accident
 Critically ill
Types of specimen collection

Single specimen collection

 Specimen is entirely placed in a single
60 ml bottle

Split specimen collection

 Specimen is collected at same time but
placed in 2 separate containers at least
30 ml each
Specimen Donor Identification

 Photo ID (drivers license, employee ID,

passport etc.)
 Identification by authorized agency
representative
 Any other ID allowed by agency’s
workplace drug testing plan
Unacceptable forms of identification

 Identification by a co-worker
 Identification by another donor
 Use of a single, non photo ID (credit
card, voter’s registration card, others)
Preliminary procedures and the
basic steps in specimen collection
can be found in Chapter 6
“Laboratory Procedure for
Specimen Handling” of the Manual
of Operations for Drug Testing
Laboratories
Observed Specimen Collection for Urine

Seal
Begin
Specimen

Verify Complete
Donor’s ID CCF

Fill-up of Ready for

DT Forms Analysis

Collect End
Urine
Steps in collection

 Prepare and secure collection site and

collection supplies
 Verify donor identification
 Explain the basic collection procedure
 Answer any reasonable and appropriate
questions re: procedure
 Fill up step 1 of CCF
Prepare and secure the collection site
Put coloring agent when applicable
Verify Donor’s ID, fill up step 1 of CCF
Steps in collection

 either give or allow the donor to select

the collection
 the specimen container is opened in full
view of the donor
 label container legibly
Either give or let donor select container
Label container legibly
Steps in collection

 instruct donor to remove all unnecessary

outer garments and to empty his/her
pockets
 check items that may be used to
adulterate the specimen
 Instruct donor to wash hands thoroughly
Bodily search
Wash hands thoroughly
Steps in collection

 Observed one collection at a time

 Pay close attention to collection
 When unusual behavior is seen, repeat
procedure under DIRECT OBSERVED
COLLECTION
Pay close attention to collection
Steps in collection

 measure the temperature

 check volume
 inspect physical characteristics
 fill Step 2 and initiates Step 3 of CCF
Measure temperature and volume
Inspect for adulteration and substitution
Steps in collection

 Close and apply seal over the lid bottle in

front of donor
 Sign over seal and indicate collection
date and time
 Ask donor to fill up and sign Step 5 of
CCF
Affix signature to seal
Apply seal over the lid bottle in front of donor
Affix signature overlapping the cap and seal
Complete Step 3 of CCF
Fill up and sign Step 5 of CCF
Specimen Integrity and Security

The ASC must adopt procedures to

minimize the risk of tampering
specimen during the collection
procedure.
Ways of Tampering Specimen

Forms of Tampering Specimen

 Dilution
 Adulteration
 Substitution

Tampered specimen is discussed in the topic

“Validity Test for Urine Specimen”
Specimen Integrity and Security

The laboratory must provide an

outline regarding chain-of-custody
procedures during accessioning or
receiving, aliquoting, initial and
confirmatory testing, and disposition
of specimens.
Chain of custody

 The procedure to account for the

integrity of each specimen or aliquot by
tracking from point of specimen
collection to its final disposition.
CCF (Custody and Control Forms)

A form used to document

 the security of specimen
 all steps of collection
 persons who handled the specimen
 status and integrity of specimen
 other pertinent information
CCF

 A form to document chain of custody

from collection to transport, analysis and
releasing of reports
 Improper entries will invalidate testing
procedure
 With legal and forensic implications
 3 copies (donor/employer, ASC,
laboratory)
DOH Template available at BHFS and NRL website
CCF

 Steps 1, 2, 3 Collection Site (ASC)

 Step 4 Lab entry (ASC/Lab)
 Step 5 Donor’s signature (collection site)
 Step 6 Screening Laboratory report
 Step 7 Confirmatory Test report
 Step 8 Report at NRL level
Data entries in CCF

 Donor’s info: name, address, sex

 Names, signature of person handling
specimen
 Status of specimen: temperature,
physical appearance, other remarks
 Drug test requested
 Result of test (screening, confirmatory,
challenge)
CCF and specimen security

Code and signature in specimen

bottle must match with CCF.
Handling, Storage and Transport

Proper handling and storage of

specimen must be taken to ensure
the integrity of the drug and/or
metabolite. Specimen must be
properly labeled, sealed and placed
in a cooler with dry ice or a suitable
alternative during transport.
Handling and Storage

Blood separate serum then immediately

freeze specimen
Hair stored at cool and dry place

Tissue macerated and frozen

Saliva deep-frozen at least - 8 to -10oC.

prolonged storage at -20 oC;
Urine stored initially between 2 - 6oC for not
more than 1 day
Conditions for retention of specimens

Negative result 5 days

Positive Result,
Adulterated, Substituted, minimum of 15 days
Invalid result

Judicial proceedings or up to a year

upon request
Specimen Transport

 Minimize the number of personnel

handling the specimen
 Document the date and purpose on CCF
each time a specimen is handled or
transferred
Specimen Transport

 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.
Specimen Transport

 Place specimen in heat-sealed

transparent plastic bag and an
appropriate transport container designed
to minimize damage, and seal them
securely to eliminate the possibilities of
tampering.
Specimen Transport

 Ensure that the CCF accompanies the

appropriate specimen transport
container.
 Specimen may be mailed or delivered to
the testing laboratory; the transport of
samples shall be accomplished while
maintaining adequate specimen validity.
Specimen rejection and cancellation of
tests

 All rejected specimens should be

reported to the Head of the Laboratory
(HOL) stating the reason(s) of rejection.
Criteria for specimen rejection that are
non-correctable

 Incompatibility of the code on the

specimen with the code on the CCF
 Absence of code on the specimen
 No printed name and signature of ASC
on the CCF
 Broken or tampered seal on the
specimen container
 Insufficient quantity of specimen
Criteria for specimen rejection that are
correctable

 Administrative flaws
 Failure of the ASC to sign CCF
 Failure to record the specimen
temperature and appropriate remarks.
 Incomplete entries, discrepancies in CCF
 Technical flaws
 Incomplete entries in electronic report
 Entries in CCF that can be corrected by
MFR
Appropriate remedial measures

 Correctable conditions  no rejection or

cancellation
Administrative flaws
Remedial measures with MFR

 Non correctable conditions

 No remedial measures
 “Test rejected” by ASC, Analyst
 “Test cancelled” by HOL
Memorandum For Record (MFR)

 A record to document the recovery,

corrective and remedial measures to
administrative errors
 Accomplished by ASC and other lab
personnel
 Recovery of errors not documented by
an MFR shall be rejected or canceled
Specimen collection

… considered the “weakest link“ of

the drug testing program. All efforts
must be done to make the collection
legally, forensically and technically
defensible.