CLINICAL Lecturer: Ms.

Dianne Rose C Mendoza, RMT, MPH

Transcribed by: Lylle Lorenz R. Malibago

CHEMISTRY
UNIT XVI: DRUG TEST SPECIMEN COLLECTION o Cancels the results of all specimen which are
AND ACCESSIONING not collected or tested not in accordance with
the DTL manual;
Outline: o Reviews, rejects, and refers for confirmation
I. Functions and Responsibilities and retesting all specimen and test results that
II. Facilities and Equipment Requirements are positive, adulterated, substituted or invalid;
III. Collection Site Requirements o Implements remedial actions necessary to
IV. On Site Specimen Collection
V. Remote Collection
maintain satisfactory operation and
VI. Collection Supplies performance in the laboratory;
VII. Types of Specimens o Directs protocol for preventive maintenance of
VIII. Methods of Specimen Collection equipment;
IX. Types of Specimen Collection
X. Preliminary Procedures Prior to Collection
o Provides comprehensive, continuing training
XI. Steps in collection and education of personnel related to conduct
XII. Forms of Tampering Specimen of DTL.
XIII. Custody and Control Forms
XIV. Storage of Specimen Analyst
XV. Specimen Retention
XVI. Specimen Rejection at Collection Site • Verifies the completeness of Custody and Control
XVII. Memorandum for Record
Form (CCF);
• Prepares specimen for analysis;
• Examines, processes and analyzes specimen for
REVIEW ON FUNCTIONS AND RESPONSIBILITIES drug testing;
• Interprets, records, releases and signs out laboratory
Head of the Laboratory
results;
• Administrative • Assists in the implementation of quality assurance
o Has general and overall supervision of the program;
facility and all aspects of laboratory work; • Assists in the evaluation of reagents, supplies and
o Has general supervision and conduct of all equipment;
laboratory personnel; • Refers to the Head of the Laboratory as the need
o Formulates and implements standard arises.
operation manual that govern the operation of
Authorized Specimen Collector
the DTL. This shall be periodically reviewed
and updated; • Restricts unauthorized personnel to enter the
o Prepares financial and annual reports of the collection site during collection;
laboratory; • Verifies identity of the Client/Donor/Subject;
o Provides other administrative support services • Provides security to specimen supplies, records and
such as communications, security and documents at collection site;
maintenance services. • Informs the Client/Donor/Subject the procedures of
• Technical specimen collection;
o Supervises and directs all analytical • Performs only one specimen collection at a time;
procedures of the laboratory;
• Accepts and seals the specimen container in the
o Assures quality of all laboratory test results;
presence of the Client/Donor/Subject;
o Issues, signs out and interprets laboratory
• Accomplishes CCF.
results;
o Evaluates and recommends reagents, supplies FACILITIES AND EQUIPMENT REQUIREMENTS:
and equipment; FLOOR PLAN
o Reviews the CCF and reports received from
authorized collector; • Screening Laboratory - shall have at least twenty (20)
o Interviews the Client/Donor/Subject, if square meters in floor area.
necessary; o Work area must be ten (10) square
o Reviews pertinent medical records of meters with an exhaust fan, sink, and
Client/Donor/Subject, if necessary; storage cabinet.

Page 1 of 8
CCHM312LAB Drug Test Specimen Collection and Accessioning
CLINICAL
CHEMISTRY
• Confirmatory Laboratory- shall have at least sixty (60)
square meters in floor area.
o Clinical work area must be thirty (30)
square meters with exhaust fan, sink,
fume hood, stock room and instrumental
room.
• Designated area which can receive or accommodate
at least five (5) prospective Client/Donor/Subjects at
a given time, a hand washing facility, toilet facility, and
stall for the orderly collection of specimens.
COLLECTION SITE REQUIREMENTS
• A suitable clean surface for handling the specimen
and completing the required paperwork;
• A secured temporary storage capability to maintain a
specimen until it is tested or shipped to the laboratory.
• An area to provide Client/Donor/Subject privacy
appropriate to the specimen being collected (e.g.,
toilet);
• A controlled and secured area for supplied and
records;
• A poster or information bulletin with a detailed
description of the proper specimen collection
processes.
• A source of water for hand washing external to toilet
facility (for urine collection)
• Toilet coloring agent
ON SITE SPECIMEN COLLECTION
• Specimen are collected at a designated area within
the drug testing facility
• For all mandatory tests except for crime scene and
post-accident
REMOTE COLLECTION
• Specimen are collected at a temporary facility located
at a remote site.
Remote Collection: Allowable Conditions
• Workplace, school, jail, prison or rehab centers
o Random
o Follow-up
o Reasonable suspicion
o Cause
• Critically ill or disabled
• Secure permit from BHFS or CHD for remote
collection 10 working days prior to scheduled
collection
• No testing/examination to be done at a remote
collection site
CCHM312LAB Drug Test Specimen Collection and Accessioning
Lecturer: Ms. Dianne Rose C Mendoza, RMT, MPH
Transcribed by: Lylle Lorenz R. Malibago
COLLECTION SUPPLIES: SPECIMEN CONTAINERS
• Urine: 30 or 60 ml, polyethylene bottle wide mouth
with screw cap
• Saliva: 30 ml polyethylene bottle
• Blood: 10 ml plain test tube
• Hair: self-sealed transparent plastic bag
• Sweat: BFAD approved sweat patch; transferred in a
container with suitable transport medium
• Tissues: specimen immediately frozen; screw-
capped plastic container (no additives)
• Fingernails: Self-sealing transparent bag; 200 mg
capacity
TYPES OF SPECIMENS
• Blood; Reasonable suspicion/ cause, can be used for
confirmatory
• Hair; Pre-employment, random, return to duty, follow
up
• Saliva; Pre-employment, random, reasonable
suspicion/cause
• Sweat; Return to duty, follow up
• Urine; Pre-employment, random, reasonable
suspicion/cause, mandatory
• Tissues; Reasonable suspicion/cause
• Fingernails; Reasonable suspicion/cause
MINIMUM QUANTITY OF SPECIMEN
• Scalp hair: 100mg or its equivalent; collected at least
1 cm above the scalp
• Saliva: 2ml (single) 1.5 and 0.5 (split)
• Sweat: DOH cleared patch worn for 7-14 days
• Urine: 60ml single; 30ml each for split sample
• Blood: 5ml (at least 5-10 ml)
HANDLING AND STORAGE OF SPECIMEN
• Blood - separate serum then immediately freeze
specimen
• Scalp hair – stored at a cool and dry place
• Tissue – macerated and frozen
• Saliva – frozen -8 to -10°C
• Urine – prolonged storage at -20°C
Urine Specimen
• Least expensive, most popular
• Easy to do
• Standardized procedures
• Detects use within the week
Page 2 of 8
CLINICAL Lecturer: Ms. Dianne Rose C Mendoza, RMT, MPH
Transcribed by: Lylle Lorenz R. Malibago

CHEMISTRY
o Not effective in detecting past use if the last removed by the Authorized Specimen Collector at a
drug use was a long time ago designated area.
• Abstaining can produce negative reaction
For blood specimen:
• Established specimen validity tests
• At least 5 ml whole blood is extracted from
Hair Specimen
Client/Donor/Subject placed in a 10 ml capacity test
• Expensive and tedious tube without anticoagulant at a designated area.
• 2x more sensitive than urine test
For saliva (oral fluid)/tissue/fingernails specimen:
• Do not detect recent use
• Detects chronic substance abuse • The “neat” saliva (oral fluid)/tissue/fingernails
• Requires 1.5 x 1.5 cm hair clump specimen is collected directly into an appropriate
• Not affected by drug abstinence container by the Client/Donor/Subject under the direct
• Can determine temporal pattern observation of the Authorized Specimen Collector at
a designated area.
Blood Specimen
REASONS FOR DRUG TESTING
• Most accurate method
• Least common method • Mandatory tests
• Short detection time • Random tests
o Applicable for confirmatory only if drug use is • Reasonable suspicion/cause
recent • Post accidents
• Follow up, return to duty
Saliva Specimen
• Pre-employment
• Uncommon method METHODS OF SPECIMEN COLLECTION
• Easy to administer
• Short detection time • Observed collection
• No reference standardized o In the presence of ASC
• Unobserved collection
Sweat (patch) Specimen o In the absence of ASC
• Requires wearing of patch 1-2 weeks o Acceptable if the client cannot physically go
to the collection site (e.g. terminally ill) or in
• Uncommon methods
crime scenes
• No reference standards develop
• Submitted samples
• Surface contaminations can cause false positive
• Subject to validity tests
• Can detect use for extended period of time
TYPES OF SPECIMEN COLLECTION
VISUAL PRIVACY REQUIREMENTS
A. Single specimen collection
For urine specimen:
• Specimen is entirely placed in a single 60ml bottle
• A laboratory must have the required restroom/stall B. Split specimen collection
with toilet for the Client/Donor/Subject to have privacy • Specimen is collected at same time but placed in
while collecting the urine specimen. 2 separate containers at least 30ml each

For scalp hair specimen: PRELIMINARY PROCEDURES PRIOR TO

COLLECTION
• The Authorized Specimen Collector shall collect
available scalp hair 1 cm. above the scalp from the 1. Verify identity of donor
Client/Donor/Subject at a designated area. 2. Explain basic collection procedure
3. Answer questions regarding the procedure
For sweat specimen:
Donor Identification
• The sweat patch is applied to the
Client/Donor/Subject’s upper arm, chest, or back and • Photo ID (driver’s license, employee ID, passport)
Page 3 of 8
CCHM312LAB Drug Test Specimen Collection and Accessioning
CLINICAL Lecturer: Ms. Dianne Rose C Mendoza, RMT, MPH
Transcribed by: Lylle Lorenz R. Malibago

CHEMISTRY
• Identification by authorized agency representative Additives/Adulterants
• Any other ID allowed by agency’s workplace drug
• Bleach
testing plan
• Ammonia
STEPS IN COLLECTION • Liquid soap
• Table salt
1. Check on supplies, security of collection area
• Vinegar
2. Check of ID of donor
• Visine eye drops
3. Explains/answers questions about collection
procedures CUSTODY AND CONTROL FORMS (CCF)
4. Fills up step 1 of CCF
5. Gives specimen bottle or asks donor to select • A form used to document the security of specimen
specimen bottle from available supplies. Labels o All steps of collection
legibly o Persons who handled the specimen
6. Observes collection one at a time o Status and integrity of specimen
• Close attention to collection o Pertinent info
• Observe unusual behavior, if present repeat • A form document chain of custody from collection to
under DIRECT OBSERVED COLLECTION transport, analysis and releasing of reports
7. Collector performs the ff: • Improper entries will invalidate testing procedure
• Asks donor to remove outer garments (coat) • With legal and forensic implications
• Examinees pockets etc. for presence of • 3 copies (px/employer, ASC, lab)
adulterants
Data Entries in CCF
• Asks donor to wash and dry hands
8. Measure temperature, volume, inspect for • Patient info: name, address, sex, etc.
adulteration and substitution. Fills up Step 2 and • Names, signature of handling specimen
initiates Step 3 of CCF • Status of specimen: temp, physical appearance, other
9. Closes, places and initials seal over the lid bottle in remarks
front of donor • Drug test requested
10. ASC would complete the CCF initiating the Step 4
• Result of test (screening/confirmatory/ NRL level)
11. Asks donor to fill up and sign Step 5
• Medications of the donor should be indicated as STORAGE OF SPECIMEN
well
• Urine: -20°C
If specimen came from remote collection: • Scalp hair: cool and dry place
• Saliva: deep frozen at least -8 to -10°C
• Specimen container with CCF should be placed on a
• Blood: separate serum and immediate freeze at -20°C
sealed, labeled, transparent plastic bag.
• Tissue: macerated and frozen
FORMS OF TAMPERING SPECIMEN
SPECIMEN RETENTION
• Dilution
• Negative result = 5 days
• Substitution
• Positive result = minimum of 15 days
• Adulteration
• Adulterated, substituted, invalid result = 15 days
Dilution Techniques • Judicial proceedings or upon request = up to a year
@ -20°C
1. Internal dilution:
• Drinking plenty of water SPECIMEN REJECTION AT COLLECTION SITE
• Diuretic like Lasix, Tea, Coffee, Beer
• All rejected specimen shall be documented and
2. External dilution:
reported to the Head of the Laboratory (HOL)
• Addition of water to specimen

Page 4 of 8
CCHM312LAB Drug Test Specimen Collection and Accessioning
CLINICAL Lecturer: Ms. Dianne Rose C Mendoza, RMT, MPH
Transcribed by: Lylle Lorenz R. Malibago

CHEMISTRY
Criteria for specimen rejection that are non-
correctable

• Incompatibility of the ID number on the specimen

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

Criteria of specimen rejection that is correctable

• Failure of the Authorized Specimen Collector to sign

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

Appropriate remedial measures for correctable

errors:

• All errors must be properly documented, recorded in

a Memorandum For Record (MFR) and duly signed
by the Authorized Specimen Collector.
• If the ASC signature cannot be corrected by the MFR,
the lab must report the specimen rejected for
specimen testing and provide reasons on the report
• If the specimen collector cannot provide an MFR to
address the fact that they failed to add the
temperature, the lab may report results for the
specimen but the lab should indicate that the ASC
could not provide a MFR to recover the omission.

MEMORANDUM FOR RECORD (MFR)

• A record to document that recovery, corrective and

remedial measures to administrative errors
• Accomplished by ASC and other lab personnel
• Errors are not corrected by a MFR shall be rejected
or cancelled

The specimen collection is considered the “weakest

link” of the drug testing program.

All efforts must be done to make the collection legally,

forensically and technically indefensible

Page 5 of 8
CCHM312LAB Drug Test Specimen Collection and Accessioning
CLINICAL Lecturer: Ms. Dianne Rose C Mendoza, RMT, MPH
Transcribed by: Lylle Lorenz R. Malibago

CHEMISTRY

Page 6 of 8
CCHM312LAB Drug Test Specimen Collection and Accessioning
CLINICAL Lecturer: Ms. Dianne Rose C Mendoza, RMT, MPH
Transcribed by: Lylle Lorenz R. Malibago

CHEMISTRY

Page 7 of 8
CCHM312LAB Drug Test Specimen Collection and Accessioning
CLINICAL Lecturer: Ms. Dianne Rose C Mendoza, RMT, MPH
Transcribed by: Lylle Lorenz R. Malibago

CHEMISTRY

Page 8 of 8
CCHM312LAB Drug Test Specimen Collection and Accessioning