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 Department of Health and Human Services
Substance Abuse and Mental Health Services Administration
Center for Substance Abuse Prevention

Urine Specimen Collection Handbook

for
Federal Agency Workplace Drug Testing Programs

EFFECTIVE OCTOBER 1, 2017

revised January 2022

Note: This manual applies to federal agency drug testing programs that come under
Executive Order 12564 dated September 15, 1986, section 503 of Public Law 100-71, 5
U.S.C. section 7301 note dated July 11, 1987, and the Department of Health and
Human Services Mandatory Guidelines for Federal Workplace Drug Testing Programs
(82 FR 7920) dated January 23, 2017 (effective October 1, 2017).

This manual does not apply to specimens submitted for testing under U.S.
Department of Transportation (DOT) Procedures for Transportation Workplace Drug
and Alcohol Testing Programs (49 CFR Part 40).

Previous Versions of this Handbook are Obsolete

 Table of Contents

Introduction ..................................................................................................................... i
Chapter 1. The Collector ............................................................................................ 1
Chapter 2. Collector/Collection Site Records ............................................................. 4
Chapter 3. The Collection Site ................................................................................... 4
Chapter 4. Federal Agency Blind Samples ................................................................. 6
Chapter 5. The Federal Drug Testing Custody and Control Form (Federal CCF) ....... 7
A. Acceptable Formats for a Federal CCF.......................................................... 7
B. Federal CCF Problems .................................................................................. 9
C. Federal CCF Content Requirements ............................................................ 11
D. Federal CCF Instructions for Use with Urine Collections .............................. 12
E. Federal CCF Distribution ............................................................................. 15
Chapter 6. Verification of Donor Identity................................................................... 16
Chapter 7. Urine Specimen Collection .................................................................... 17
A. Collection Site Security ................................................................................ 17
B. Collection Supplies ...................................................................................... 17
C. Collection Procedure ................................................................................... 19
Chapter 8. Miscellaneous Collection Issues ............................................................. 28
A. Direct Observed Collection .......................................................................... 28
B. Monitored Collection .................................................................................... 29
C. Inability to Provide a Sufficient Specimen .................................................... 30
D. Donor Conduct ............................................................................................ 32
E. Multiple Collectors for a Specimen Collection .............................................. 33
F. Refusal to Test ............................................................................................ 33
G. Problems with Specimen Bottle Labels/Seals .............................................. 34
Chapter 9. Collector Errors and Corrective Actions .................................................. 35

Appendices
Appendix A: Federal CCF Decision Trees for Collectors
Appendix B: Direct Observed Collection Procedure
Appendix C: Two Specimens from the Same Collection Event
Appendix D: Insufficient Specimen
Introduction
The Substance Abuse and Mental Health Services Administration (SAMHSA) within the U.S.
Department of Health and Human Services (HHS) establishes the scientific and technical
guidelines to be used by U.S. federal agencies and drug testing facilities for federally regulated
drug testing. Testing must be performed at facilities certified by SAMHSA under the National
Laboratory Certification Program (NLCP). HHS has maintained oversight of federally regulated
drug testing through this program since it began in 1988. SAMHSA certifies two types of test
facilities: laboratories and instrumented initial test facilities (IITFs). IITFs are allowed only for
urine testing, and perform only the initial tests for those specimens.

The HHS Urine Specimen Collection Handbook provides information and guidance for the
collection of urine specimens for federal agency workplace drug testing programs, based on the
HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine (UrMG). 1

The HHS Oral Fluid Specimen Collection Handbook provides information and guidance for
the collection of oral fluid specimens for federal agency workplace drug testing programs, based
on the HHS Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral
Fluid (OFMG). 2

All federally regulated oral fluid specimens must be sent to an HHS-certified laboratory for
testing. IITFs are not allowed to test oral fluid specimens.

This document and additional specimen collection resources are available on the SAMHSA
website: https://www.samhsa.gov/workplace/resources.

1
Mandatory Guidelines for Federal Workplace Drug Testing Programs using Urine, Substance Abuse and
Mental Health Services Administration, Department of Health and Human Services, 82 FR 7920, effective
10/01/2017.
2
Mandatory Guidelines for Federal Workplace Drug Testing Programs using Oral Fluid, Substance Abuse
and Mental Health Services Administration, Department of Health and Human Services, 84 FR 57554,
effective 01/01/2020.

i
Chapter 1. The Collector

A collector is the person trained to instruct and assist a donor in providing a specimen.

The following restrictions apply:

1. The immediate supervisor of an employee may only collect that donor’s specimen when no
other collector is available. A supervisor serving as a collector must be a trained collector.
The supervisor must maintain an explanatory memorandum to explain why they collected
their employee’s specimen.

2. The hiring official of a federal agency applicant may only collect that federal agency
applicant’s specimen when no other collector is available. A hiring official serving as a
collector must be a trained collector. The hiring official should maintain an explanatory
memorandum to explain why they collected the applicant’s specimen.

3. A coworker who is in the same testing pool or who works with an employee on a daily basis
must not serve as a collector when that employee is tested.

4. An applicant or employee must not serve as the collector by collecting their own specimen.

5. An individual working for an HHS-certified test facility may not serve as a collector if that
individual can link the donor with the specimen drug test result or the report from the test
facility.

6. An individual who has a personal relationship with the employee (e.g., spouse, ex-spouse,
relative, close personal friend) must not serve as the collector.

To qualify as a urine specimen collector for a federal agency program, an individual

must:

1. Be knowledgeable of the collection procedure described in the HHS Mandatory Guidelines

for Federal Workplace Drug Testing Programs using Urine (UrMG).

2. Be knowledgeable of any guidance provided by the federal agency’s Drug-Free Workplace

Program and additional information provided by HHS relating to the collection procedure
described in the UrMG.

3. Receive training from a qualified trainer for urine specimen collectors on the following topics:

a. All steps to correctly perform a urine specimen collection in accordance with this
Specimen Collection Handbook.

b. Completion and distribution of the Federal Custody and Control Form (CCF). (See Note
below.)

c. Problem collections.

d. Fatal and correctable flaws and how to correct problems during collections.

1
 e. Collector responsibilities to maintain the integrity of the collection process, ensuring the
privacy of the donor, ensuring the security of the specimen, and avoiding conduct or
statements that could be viewed as offensive or inappropriate.

4. Demonstrate proficiency in urine collections by successfully completing five consecutive

error-free mock collections that include: one uneventful scenario, one insufficient specimen
quantity scenario, one temperature out of range scenario, one scenario in which the donor
refuses to sign the Federal CCF and one scenario in which the donor refuses to initial the
specimen bottle tamper-evident bottle seal.

a. The qualified trainer for collectors must monitor and evaluate the individual being
trained, in person or by a means that provides real-time observation and interaction
between the trainer and the trainee, and the trainer must attest in writing that the mock
collections are error-free.

5. Document their completed training as a collector in accordance with the above requirements
before collecting any specimens for a federal agency.

6. Maintain training documentation and provide it to a federal agency upon request.

Note: The collector training outlined above must be conducted using a paper Federal CCF. To
use an electronic Federal CCF (ECCF) for oral fluid collections, a trained collector must
complete separate additional training from the ECCF system provider. That training should
address use of the ECCF system for uneventful collections as well as problems that may arise
during an ECCF collection including, but not limited to, a donor’s refusal to test, a printer
problem, insufficient specimen, and a donor’s refusal to sign the CCF. See also ECCF
definitions and requirements in Chapter 5, Section A.

A trained urine specimen collector must:

1. At least every five years from the date of initial training, complete refresher training that
includes all initial training items (items 1-5 above).

2. Document training in accordance with the above requirements before collecting any federal
agency specimens more than five years after initial training.

3. Maintain training documentation and provide it to a federal agency upon request.

To qualify as an observer for a direct observed urine specimen collection for a federal
agency program, an individual must:

1. Be knowledgeable about the direct observed collection procedure as described in the UrMG.

2. Be knowledgeable about any guidance provided by the federal agency or by HHS relating to
the direct observed collection procedure described in the UrMG.

3. Receive training on the following subjects:

a. All steps necessary to perform a direct observed collection.

b. The observer’s responsibility for maintaining the integrity of the collection process.

2
 c. Ensuring the security of the specimen throughout the collection process by maintaining
visual contact with the collection container until it is delivered to the collector.

d. Ensuring the privacy of the donor being tested.

e. Ensuring that the observation is done in a professional manner, to minimize the

discomfort to the donor.

f. Avoiding conduct or statements that can be viewed or interpreted as offensive or

inappropriate.

4. Be the same gender as the donor’s gender, as determined by the donor’s gender identity.
There are no exceptions to this requirement. Note: The donor’s gender identity may be the
same as or different from the donor’s sex assigned at birth.

5. An observer is not required to be a trained collector.

To qualify as a trainer for urine collectors for a federal agency program, an individual
must:

1. Be qualified as a trained collector and have regularly conducted urine drug test collections
for a period of at least one year OR have successfully completed a “train the trainer” course
given by an organization (e.g., manufacturer, private entity, contractor, or federal agency).

2. Complete refresher training in accordance with collector requirements (see above) at least
every five years from the date of the individual’s initial training.

3. Maintain records documenting trainer qualification (e.g., original records for initial and
refresher collector training, “train the trainer” course certificate, employment records) and
provide copies to a federal agency or to a federal agency’s Medical Review Officer (MRO)
upon request.

Before a collector is permitted to collect a urine specimen for a federal agency, the
agency must:

1. Ensure that the collector has satisfied the urine specimen collector requirements described
in the UrMG.

2. Ensure that the collector, who may be self-employed, or an organization (e.g., third party
administrator that provides a collection service, collector training organization, federal
agency that employs its own collectors) maintains a copy of the collector’s training
documentation.

3. Provide the collector with the name and telephone number of the federal agency’s
designated representative.

The collector should have identification with their name and their employer’s name, address,
and telephone number. The collector is required to provide their identification (employee badge

3
or employee list) if requested by the donor. There is no requirement for the collector to have
identification (ID) with their photo or to provide their driver's license with an address.

Chapter 2. Collector/Collection Site Records

The collector must maintain their original collector training records (i.e., for initial, additional, and
refresher training) and provide copies to their employer and, as requested, to the federal
agency.

Collection site records must be stored at a secure site designated by the collector or the
collector’s employer for a minimum of two years. Collection site records include the collector
copies of the Office of Management and Budget-approved Federal CCF for each specimen.
Both hardcopy and electronic collection records must be stored and disposed of in a manner
that ensures donor confidentiality is maintained. The collection site may convert hardcopy
records to electronic records for storage and discard the hardcopy records after 6 months.

Personally identifiable information (PII) is information that can be used to distinguish or trace an
individual’s identity alone or when combined with other personal identifying information which is
linked or linkable to a specific individual. PII that may be on the Federal CCF includes the
donor’s Social Security Number (SSN), name, date of birth, telephone numbers, and
employment status. All federally regulated employers and drug testing service providers
(including collectors) must implement procedures and administrative, technical, and physical
controls to ensure donor privacy by restricting access to PII on hardcopy and electronic
collection records (e.g., on Federal CCFs, in information entered into a computer system or
database). Access to donor PII must be limited to those individuals requiring access to fulfill job
duties. Such individuals must receive training to make them aware of their responsibilities for
protecting the information. The confidentiality must be maintained from the time the donor PII is
obtained through transmission/transport of the Federal CCF copies and record handling (i.e.,
storage, retrieval, and final destruction). Both hardcopy and electronic collection records must
be stored and disposed of in a manner that ensures donor confidentiality is maintained.

The collector must not solicit or record a donor’s medical information during the collection
process.

Chapter 3. The Collection Site

A collection site may be a permanent or temporary facility, located either at the work site or at a
remote site, where donors present themselves for the purpose of providing a specimen for a
drug test. When there is an immediate need to collect a specimen (e.g., a post-accident
investigation) and there is no agency-designated site available, a public restroom may be used
for the collection using the procedures for a monitored collection (see Chapter 8, Section B).
The site must have all necessary personnel, supplies, equipment, facilities, and supervision to
provide for specimen collection, security, and temporary storage until the specimen is
transferred to an HHS-certified IITF or laboratory, and must have arrangements for the transfer
of the specimens to a certified IITF or laboratory.

A facility used as a urine collection site must have:

1. Provisions to ensure donor privacy during the collection. Only authorized personnel and the
donor may be present in the restricted access area where the collection takes place. The

4
 collector must give the donor visual privacy while providing the specimen. The following
facilities provide adequate privacy for urine collections:

a. An enclosed stall in a multi-stall restroom

b. A single person restroom

c. A partitioned area that allows for individual privacy

d. A mobile restroom (e.g., a vehicle with an enclosed toilet stall).

2. A means for washing hands:

a. If practical, the water source should be external to the restroom where collection occurs.
If a water source is in the enclosure where the collection occurs, the collector must
secure it prior to the collection or conduct a monitored collection (see Chapter 8,
Section B).

b. If a water source is not available, another means (e.g., waterless cleanser, moist
towelettes) outside the restroom is an acceptable alternative.

3. A suitable clean surface inaccessible to the donor for the collector to handle the specimen
and complete the paperwork.

a. If practical, the collector work area should be external to the restroom where collection
occurs.

b. The collector work area may be inside the restroom only if the donor can have privacy
while providing the urine specimen.

4. A secure temporary storage area for maintaining specimens until they are transferred to an
HHS-certified IITF or laboratory. Specimens must be shipped within 24 hours or no later
than the next business day. Specimens that will not be shipped within 24 hours (e.g.,
collected on a Friday for shipment on Monday) should be kept in secure refrigerated
storage.

Note: Specimens should NOT be exposed to high temperatures for an extended time.
These conditions may affect the test results of a urine specimen.

5. A restricted access area where only authorized personnel may be present during the
collection.

6. Provisions for the collector to:

a. Restrict access to collection supplies before, during, and after collection,

b. Store collection site records securely, and

c. Restrict donor access to items that could be used to adulterate, substitute, or dilute the
specimen (e.g., soap, disinfectants, cleaning agents, water).

5
Chapter 4. Federal Agency Blind Samples
The UrMG require each federal agency to have blind samples (i.e., negative samples, positive
samples, adulterated samples, substituted samples) submitted to each HHS-certified laboratory
that tests donor specimens for its workplace drug testing program. The blind samples may be
purchased and supplied to the collector by the federal agency or the agency’s external service
provider, or purchased by the collector and submitted to an HHS-certified IITF or laboratory that
the collector sends the agency’s specimens. The UrMG specify the approximate percentage of
each type (i.e., 75 percent negative, 15 percent positive for one or more drugs, 10 percent either
adulterated or substituted). At a minimum, each federal agency must submit 3 percent blind
samples with its donor specimens based on the projected total number of donor specimens
collected per year (up to a maximum of 400 blind samples). Every effort should be made to
ensure that blind samples are submitted quarterly. The collector should distribute blind samples
randomly with donor specimens rather than submitting blind samples as one group.

Each urine blind sample must meet the following requirements:

1. Drug-positive and -negative blind samples must be validated by the supplier as to their
content using appropriate initial and confirmatory drug tests.

2. The supplier must provide the blind samples as matched A and B pairs, along with
information on their content, validation, expected results, and stability to the collection
site/collector that will send the blind samples to the laboratory or IITF. The supplier must
also provide the information upon request to the MRO, the federal agency for which the
blind sample was submitted, or the HHS Secretary. If the collector purchases the samples
for the federal agency’s blind program, the collector must send the supplier’s information
(e.g., the content and concentration of the blind samples) to the MRO to enable the MRO to
interpret the results and report them to the agency. The MRO will contact the supplier and/or
collector as needed when investigating discrepant results.

3. Drug-positive blind samples must be fortified with one or more of the drugs or metabolites
listed in the UrMG, and the concentration should be 1.5 to 2 times the initial drug test cutoff
concentration.

4. Drug-negative blind samples (i.e., certified to contain no drugs) must be validated by the
supplier as negative using the appropriate initial and confirmatory tests.

5. Substituted or adulterated blind samples must be validated by the supplier using appropriate
initial and confirmatory specimen validity tests, and must be shown to meet substitution or
adulteration criteria specified in the UrMG at the time of validation.

Each blind sample must be submitted as a split specimen (specimens A and B) with a current
Federal CCF (paper or electronic) that the HHS-certified laboratory or IITF uses for donor
specimens.

1. The collector provides the required information to ensure that the Federal CCF has been
properly completed, including fictitious donor identification in Step 1c of the Federal CCF
and fictitious donor initials on the A and B specimen bottle labels/seals.

6
2. The collector indicates that the sample is a ”blind sample” on the MRO copy where the
donor would normally provide a signature (Step 5 on Copy 2 of the Federal CCF).

3. The collector may either discard Copies 4 and 5 of a paper Federal CCF (the employer copy
and the donor copy) or maintain them with Copy 3 of the Federal CCF (the collector copy).

Chapter 5. The Federal Drug Testing Custody and Control Form

(Federal CCF)
Federal agencies are required to use the Office of Management and Budget (OMB)-approved
Federal CCF when collecting specimens for their workplace drug testing programs. Federal
CCFs are available from a number of different sources (e.g., laboratories, collectors, third party
administrators, MROs, ECCF providers). The same Federal CCF is used for urine and oral fluid
specimens. Note: References to instrumented initial test facilities (IITFs) in this chapter apply to
urine specimens only.

2020 Federal CCF: OMB approved the use of the 2020 Federal CCF as of September 1, 2020,
for urine and oral fluid specimens. The 2020 Federal CCF may be used as a paper or electronic
form. Acceptable formats are described in Section A below.

A proof of the current Federal CCF, guidance for its use, and Instructions for Completing the
Federal CCF (i.e., separate instructions for urine specimens and for oral fluid specimens) are on
the SAMHSA website: https://www.samhsa.gov/workplace.

2017 Federal CCF: OMB originally extended the use of the expired 2017 Federal CCF for
urine specimens until August 30, 2021 and subsequently extended its use until August 31,
2023. The 2017 Federal CCF is not authorized for use with oral fluid specimens; the 2020
Federal CCF should be used for oral fluid specimens. Beginning August 31, 2023, the 2020
Federal CCF must be used for federally regulated specimens, and the test facility (laboratory or
IITF) must treat the use of the 2017 Federal CCF for urine specimens as a correctable
discrepancy. See Section B.1 below regarding use of an incorrect CCF.

Employers are prohibited from using the Federal CCF for:

1. Private-sector employee drug testing, with the exception of transportation industry testing
conducted under the Department of Transportation (DOT) regulations.

2. State workplace drug testing programs

3. Department of Justice drug testing programs

A. Acceptable Formats for a Federal CCF

A federal agency may use the Federal CCF as:

1. A paper form: a five-part form that is either preprinted or printed at the collection site before
the collection, or

7
2. An electronic form (ECCF): either a digital (paperless) form or a combination electronic and
paper form. All ECCFs must be the functional equivalent of a paper Federal CCF with
respect to integrity, accuracy, and accessibility.

The two types of combination electronic and paper ECCF systems are:

a. Type 1: The collector uses an ECCF system to document the collection process, then
prints Copy 1 and Copies 2–5 (without signatures). The donor signs in Step 5 of Copies
2–5 using a wet-ink signature and the collector signs in Step 4 of Copies 1–5 using a
wet-ink signature. The electronic form is not signed.

b. Type 2: The collector uses an ECCF system to document the collection process, the
collector and donor sign using electronic signatures (the donor uses a digitized
signature), and the collector prints Copy 1 with his or her electronic signature. The
printout of ECCF Copy 1 must be designated as the single authoritative copy of the
ECCF.

HHS-certified test facilities must receive approval from HHS before accepting regulated
specimens collected using an ECCF system. SAMHSA maintains the list of HHS-certified
test facilities (laboratories and IITFs) approved to use an ECCF, with the ECCF system(s) that
each is authorized to use, on the SAMHSA website: https://www.samhsa.gov/workplace.

If a laboratory or IITF receives a specimen that was collected using an ECCF system whose use
has not been approved by SAMHSA for that test facility, they will reject the specimen.

All collection sites must maintain a supply of paper Federal CCFs. A paper Federal CCF must
be used in the event of a software/hardware problem preventing collections using an ECCF. In
addition, collection sites must have the ability to print the Federal ECCF on demand. This
capability allows the collector to print the Federal CCF in the event of a problem preventing
completion of a collection using an ECCF (e.g., allowing for handwritten collector and donor
signatures in the event of a problem with the electronic signature system or when a donor
refuses to sign electronically but agrees to sign using a wet-ink signature).

Federally regulated employers and drug testing service providers (e.g., collectors, test facilities,
MROs) who use an ECCF must implement procedures and administrative, technical, and
physical controls to ensure the authenticity, integrity, and confidentiality of electronic records,
and to ensure that electronic signatures are the legally binding equivalent of traditional
handwritten signatures. These procedures and controls include, but are not limited to:

1. System validation.

2. The ability to generate accurate and complete copies of records in both human-readable
and electronic form suitable for inspection, review, and copying upon request of authorized
parties (e.g., the MRO, federal agency, or SAMHSA).

3. Protection of records to enable accurate and ready retrieval throughout the records retention
period.

4. Limiting system access to authorized individuals (e.g., trained collectors). Procedures must
be in place for managing the user authentication system (e.g., assignment, review,
revocation).

8
5. Secure, computer-generated, time-stamped audit trails to independently record the date and
time of operator entries and actions that create, modify, or delete records from the time of
initiation of the Federal CCF (changes should be evident when reviewing the original record,
and any electronic or paper copy of the original record).

6. Use of authority checks to ensure that only authorized individuals can use the system,
electronically sign a record, access the operation or computer system input or output device,
alter a record, or perform the operation at hand.

B. Federal CCF Problems

See also Appendix A: Federal CCF Decision Trees for Collectors.

1. Use of an Incorrect CCF

a. As noted above, if a laboratory or IITF receives a specimen that was collected using an
ECCF system whose use has not been approved by SAMHSA for that test facility, they
must reject the specimen.

b. In rare cases, a collector may use a non-federal CCF or an expired Federal CCF for a
federal agency collection by mistake or as the only means to conduct a collection under
unusual circumstances (e.g., post-accident test with insufficient time to obtain an OMB-
approved Federal CCF).

• If the collector realizes an incorrect CCF was used, they must include remarks on the
CCF noting that it is a federal agency specimen or that an expired Federal CCF was
used, provide the reason that the incorrect form was used, and include all collection
information required on the current Federal CCF for that specimen type (urine or oral
fluid). (Instructions for using the current Federal CCF are in Section D below.)

 If the CCF used for the collection does not include space for all collection
information required on the current Federal CCF, the collector must include the
missing information in a signed memorandum for the record (MFR) sent to the
test facility with the specimen.

 If a laboratory or IITF discovers or is notified that a federal agency specimen was

collected using an incorrect CCF and the collector did not provide explanatory
collector remarks and required 2020 Federal CCF information on the CCF or on
a signed MFR sent with the specimen, the test facility will contact the collector for
an MFR to recover the missing information, with the following exception.

- For an oral fluid collection device with diluent, if a laboratory receives an

oral fluid specimen with an incorrect CCF and no collector documentation that
they observed the device volume indicator(s) during the collection (i.e., on the
CCF or a signed MFR sent with the specimen), the laboratory will reject the
specimen. An MFR cannot be used to recover this missing information
after the collection.

 If an MRO discovers the use of a non-federal or expired Federal CCF, the

collector is notified to provide an MFR to the MRO with the reason for using the

9
 incorrect form and with other information required on the 2020 Federal CCF, with
the following exception.
- For an oral fluid collection device with diluent, if a laboratory receives an
oral fluid specimen with an incorrect CCF and no collector documentation that
they observed the device volume indicator(s) during the collection (i.e., on the
CCF or a signed MFR sent with the specimen), the laboratory will reject the
specimen. An MFR cannot be used to recover this missing information
after the collection.

c. The collector must take immediate steps to provide an MFR when notified. A laboratory
or IITF holds specimens for a short time (i.e., a minimum of five business days) after
notifying the collector, before reporting a “rejected for testing” result to the MRO, who will
cancel the test.

• In the case of an expired (urine-only) CCF for a urine specimen, if the collector is not
available, the collection site supervisor may sign the MFR.

2. Incorrect CCF Copy

Section E below describes proper distribution of Federal CCF Copies 1–5. The collector
sends the Test Facility Copy (Copy 1) with the specimen to the laboratory or IITF.

a. If the collector sends an incorrect CCF copy (i.e., Copy 2–5) with the specimen, the
laboratory or IITF will not test the specimen until the collector provides documents to
recover the error. The collector must send a signed explanatory MFR and the original
Federal CCF Copy 1 signed by the collector using a wet-ink signature. The collector
must send the Federal CCF Copy 1 with their wet-ink signature by courier or mail to the
test facility (i.e., it is not acceptable to send a fax or pdf copy).

b. The collector must take immediate steps to provide an MFR when notified. In the case
of an ECCF reprint error, if the collector no longer works at the collection site, the
collection site supervisor may sign the MFR. A laboratory or IITF holds specimens for a
short time (i.e., a minimum of five business days) after notifying the collector, before
reporting a rejected for testing result to the MRO, who will cancel the test.

3. Reprint ECCF Copy 1

For a Combination Electronic and Paper Federal CCF that has been signed by the collector
and donor using electronic signatures, the collector must send the printout of Copy 1
designated as the single authoritative copy of the ECCF with the specimen.

a. The ECCF system will distinguish the authoritative copy from subsequent printed copies
of Copy 1 (e.g., identifying subsequent copies as “Reprint”). If there is a problem with
printing the authoritative copy (e.g., a printer error):

• The collector must sign the reprinted Copy 1 (in the presence of the donor) using a
wet-ink signature in Step 4 (near their printed name and electronic signature) to
designate this copy as the single authoritative copy.

10
 • The collector (or the ECCF system) must include a remark in Step 2 of the ECCF
reprint noting the reason for reprinting Copy 1. Alternatively, the collector must send
a signed MFR to the laboratory or IITF with the specimen, including the reason that a
reprinted Copy 1 was sent with the specimen.

• If the collector fails to sign the ECCF reprint using a wet-ink signature and/or fails to
provide an explanatory remark or an MFR, the laboratory or ITTF will not test the
specimen, but will hold the specimen pending receipt of collector documents to
recover the error(s). The collector must reprint the ECCF Copy 1 for the specimen,
sign using a wet-ink signature, and provide an explanatory MFR. The collector must
send the reprint ECCF with their wet-ink signature by courier or mail to the test
facility (i.e., it is not acceptable to send a fax or pdf copy).

b. The collector must take immediate steps to provide an MFR when notified. In the case
of an ECCF reprint error, if the collector no longer works at the collection site, the
collection site supervisor may sign the MFR. A laboratory or IITF holds specimens for a
short time (i.e., a minimum of five business days) after notifying the collector, before
reporting a rejected for testing result to the MRO, who will cancel the test.

C. Federal CCF Content Requirements

1. Test Facility Identification

At the top of the Federal CCF, the test facility (i.e., HHS-certified laboratory or IITF) must be
identified by one of the following:

a. The name and address of the specific test facility,

b. A list of addresses with checkboxes to allow the collector to check the box for the
specific laboratory or IITF to which the specimen will be shipped, or

c. A corporation name and telephone number. Note: Either the collector will annotate the
address of the specific test facility within the corporation to which the specimen will be
shipped, or the test facility that receives the specimen for testing will annotate its
address.

2. Labels/Seals

The tamper-evident labels/seals for the specimen bottles/tubes may be at the bottom of
Copy 1 or may be separate from the form:

a. There must be two labels/seals: one marked with the letter “A” to designate the primary
specimen and the other marked with the letter “B” to designate the split specimen.

b. Each label/seal must have:

• The same specimen ID number that is at the top of the Federal CCF,

• A place for the collector to annotate the date of the collection, and

11
 • A place for the donor to initial the label/seal after it is placed on the specimen
bottle/tube.

 For oral fluid specimens: The label/seal must not cover the expiration date on
the oral fluid specimen tube and must allow visual assessment of the contents of
the tube.

3. Required Statements and Instructions

Wording of required statements must be identical to that on the OMB-approved Federal

CCF. Instructions and statements must be provided as follows:

a. Instructions for Completing the Federal Drug Testing Custody and Control Form
for Urine and Oral Fluid Specimen Collections

• Separate Instructions for Completing the Federal CCF (for urine specimens and for
oral fluid specimens) are available for downloading on the SAMHSA website:
https://www.samhsa.gov/workplace/resources.

• The collector must provide the instructions to the donor (e.g., hardcopy, onscreen,
posted at the collection site).

b. Public Burden Statement

• Paper Federal CCF: The Public Burden Statement is printed on each Federal CCF
copy (i.e., on the back of Copies 1 through 5).

• Electronic CCF or Combination Electronic and Paper Federal CCF: The Public
Burden Statement is provided to employers and donors on the printed or
electronically transmitted ECCF (Copies 4 and 5) and to collectors on the ECCF
(Copy 3) maintained in collector/collection site records. The statement must be
provided to test facilities and MROs on a separate page (hardcopy or electronic).

c. Privacy Act Statement (For Federal Employees Only)

• Paper Federal CCF: The Privacy Act Statement is printed on the back of the donor
copy (Copy 5).

• Electronic CCF or Combination Electronic and Paper Federal CCF: The Privacy Act
Statement is provided to donors on the printed or electronically transmitted Federal
CCF (Copy 5).

D. Federal CCF Instructions for Use with Urine Collections

Note: Chapter 7, Section C includes step-by-step instructions for urine collections, including
instructions for collector and donor entries on the Federal CCF.

Step 1. To be completed by the collector or federal agency representative prior to the donor
providing a specimen.

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1. The employer's name, address, telephone and fax numbers, and employer ID number (if
applicable).

2. The specific MRO name, address, telephone number, and fax number.

3. Donor identification (e.g., SSN, employee ID number, or commercial driver’s license number
and state). The collector enters the donor identification after verifying the donor’s identity. If
the donor refuses to provide their SSN or ID number, the collector enters a remark in Step 2
on Copy 1.

4. The testing authority box indicating under which federal agency the specimen is being
collected. The HHS box is checked for a federal agency employee or pre-employment
specimen.

5. The appropriate box indicating the reason for the drug test. If the test is to be performed for
a reason other than those listed on the Federal CCF, the “Other” box is checked and the
specific reason is recorded.

6. The appropriate box for the drug tests to be performed. If the test is to be performed for a
drug other than those listed on the Federal CCF, the “Other” box is checked and each
specific drug is recorded.

7. The collection site address.

8. Collector contact information including telephone number, fax number, and other (e.g., email
address).

Step 2. To be completed by the collector after receiving the specimen from the donor and
measuring the temperature of the specimen within 4 minutes. This step requires the
collector to mark the appropriate boxes to indicate:

1. Specimen type. Check the URINE checkbox at the top of Step 2.

2. Collection type: Check the appropriate box to indicate whether the collection was a split
specimen or single specimen collection. Note: Split specimens are required for all federal
agency collections. If no specimen was provided, check the None Provided box and enter a
remark and print your name in Step 2. You may, but are not required to, sign the Step 2
Remarks.

3. URINE entries:

a. Temperature. Check the appropriate box to indicate whether the temperature of the
specimen was or was not within the required temperature range. If temperature was
outside the acceptable range, the collector enters a remark in Step 2 and takes action as
required.

b. Observed. If a direct observed collection was performed, check the Observed box and
enter the following information on the Remarks line in Step 2.

• Ask the donor to write the donor’s gender and initial it.

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 • Write the name and gender of the observer and the reason for an observed collection.
Note: If there is insufficient room on the Remarks line, the collector may provide a
separate MFR explaining the use of an observed collection. The collector must send
the MFR to the test facility.

4. Remarks: Enter collector remarks and take action as needed (e.g., unusual behavior or
appearance of the donor; failed collection attempts; unusual color, presence of foreign
objects or material in the specimen).

Step 3. This section lists actions to be performed by the collector and donor at the end of the
collection, after the primary (A) and split (B) specimens have been collected. The collector
assists the donor with completing the donor section of the Federal CCF in Step 5 on Copy 2.

1. Record or instruct the donor to record the donor’s information:

a. Printed name

b. Date of collection

c. Email address, daytime, and evening telephone numbers

d. Date of birth

2. Instruct the donor to:

a. Review information transcribed by the collector on the CCF

b. Read the donor certification statement and information in Step 5 on possible MRO
requests for donor medication information (i.e., based on MRO review of test results)

c. Sign and date the certification statement

3. If the donor refuses to provide their information or to sign the certification statement, enter a
remark in Step 2 on Copy 1.

For ECCFs: if the donor refuses to sign electronically but is willing to sign a paper CCF with
a wet-ink signature, print the ECCF, Copies 1–5. The donor must sign in Step 5 of Copies
2–5 using a wet-ink signature and the collector must sign in Step 4 of Copies 1–5 using a
wet-ink signature.

Step 4. To be initiated by the collector and completed at the test facility.

1. Sign the collector certification statement in Step 4 on Copy 1 to certify that the specimen
was collected, labeled, sealed, and released for shipment to the HHS-certified IITF or
laboratory in accordance with federal requirements.

2. Include your printed name.

3. Record the following:

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 a. Date of collection

b. Time of collection

c. The specific name of the delivery service to which the specimen bottles are released for
shipment to the HHS-certified IITF or laboratory

Note: Copy 1 entries in Step 4 below the first bold line and in the subsequent steps are
made at the HHS-certified IITF or laboratory.

E. Federal CCF Distribution

Note: Employers, collectors, test facilities, and MROs who send or receive CCFs electronically
are responsible for ensuring the security of data transmissions and limiting access to any data
transmission, storage, and retrieval systems.

Paper CCFs and Combination Electronic and Paper CCFs

1. Copy 1 (Test Facility Copy)

The collector sends the signed Copy 1 with the specimen to the HHS-certified laboratory or
IITF. Copy 1 is placed in the package with the specimen (i.e., in a compartment separate
from the specimen bottles).

For Combination Electronic and Paper CCFs: Copy 1 sent with the specimen must be either
the single authoritative copy, or a reprint of Copy 1 that has been signed by the collector
using a wet-ink signature.

2. Copy 2 (MRO Copy)

The collector sends Copy 2 signed by the donor to the MRO via courier, mail, fax, or other
electronic transmission method.

For a Paper Federal CCF: If a copy of Copy 2 is sent to the MRO via fax or provided
electronically, the collector maintains the original Copy 2 in the collection site records.

3. Copy 3 (Collector Copy)

Copy 3 is maintained in the collection site records.

4. Copy 4 (Employer Copy)

The collector sends Copy 4 to the federal agency employer via courier, mail, fax, or other
electronic transmission method.

5. Copy 5 (Donor Copy)

The collector gives Copy 5 to the donor as a hardcopy after the collection is complete or
sends it electronically.

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Digital Federal CCFs

1. Copy 1 (Test Facility Copy)

a. Copy 1 signed by the collector is electronically provided to the HHS-certified laboratory.

b. In addition, the collector must either:

• Include a printed copy of the Test Facility Copy (Copy 1) in the package with the
specimen (i.e., in a compartment separate from the specimen bottles), or

• Apply a label to the outside of the specimen package, with the specimen ID number,
test facility name and contact information, and collection site name and contact
information.

2. Copies 2 through 5

a. Copy 2 signed by the donor is electronically provided to the MRO.

b. Copy 3 is maintained in the collection site records.

c. Copy 4 is provided electronically to the employer.

d. Copy 5 is provided to the donor as a hardcopy or electronically.

Chapter 6. Verification of Donor Identity

The donor must provide appropriate identification to the collector upon arrival at the collection
site.

Acceptable forms of identification are:

1. A photo ID (e.g., driver’s license, employee badge issued by the employer, or an alternative
photo ID issued by a federal, state, or local government agency), or

2. Positive identification by the supervisor of the donor or by a federal agency representative.

If the identity of the donor cannot be established, the collector must not proceed with the
collection.

Unacceptable forms of identification are:

1. Identification by a co-worker,

2. Identification by another donor,

3. Non-photo ID (e.g., social security card, credit card, union or other membership cards, pay
vouchers, voter registration card), or

4. A faxed copy or photocopy of an identification document.

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Chapter 7. Urine Specimen Collection
A. Collection Site Security

The collection site must have a restricted access area to prevent unauthorized access to
specimens, collection supplies, and collection site records. A permanent site that is used solely
for specimen collections must be secured at all times. At facilities that are not dedicated
specimen collection sites, the area of the site used for specimen collections must be secured as
a restricted access area during the time a specimen is collected.

A collector must:

1. Prohibit unauthorized personnel from entering the collection site during the collection.

2. Ensure the privacy of the donor.

3. Perform only one donor collection at a time.

4. Restrict access to collection supplies before, during, and after the collection.

5. Ensure that only the collector and the donor are allowed to handle the unsealed specimen.

6. Ensure that chain of custody is maintained and documented from the time of collection until
the labeled and sealed specimen bottles are sealed in the specimen package for transport
to the laboratory.

7. Ensure that the Federal CCF is completed and CCF Copies 1–5 are distributed as required.

8. Ensure that specimens are transported to the test facility in a sealed and secure transport
container to minimize the possibility of damage during shipment and to prevent undetected
tampering.

B. Collection Supplies

The following items must be available at the collection site to conduct proper urine collections:

1. Single-use plastic collection containers: Each collection container must not substantially
affect the composition of drugs and/or metabolites in the urine specimen collected and must
be:

a. Supplied as an individually sealed item using a tamper-evident system (e.g., in a sealed

plastic bag, shrink wrapped, with a peelable or sealed lid, or another easily visible
tamper-evident system),

b. Large enough to easily catch and hold at least 55 mL of urine, and

c. Graduated with volume markings clearly showing the volume (e.g., 45 mL).

17
2. Single-use plastic specimen bottles: Each specimen bottle with cap must not
substantially affect the composition of drugs and/or metabolites in the urine specimen
collected and must be:

a. Supplied as individually sealed bottles with a tamper-evident system (e.g., using plastic
bag, shrink wrap, with a peelable or sealed lid, or another easily visible tamper-evident
system),

b. Able to hold at least 35 mL,

• The split specimen bottle may be the same size as or smaller than the primary
specimen bottle, but must be able to hold at least 20 mL.

c. Leak-resistant (i.e., have a screw-on or snap-on cap that prevents leakage),

d. Marked clearly to indicate the minimum levels of urine to be poured into each bottle (30
mL for the primary specimen and 15 mL for the split specimen),

e. Designed so that the required tamper-evident bottle label/seal from the Federal CCF is
not damaged when the donor initials it and has no overlap that conceals printed
information, and

f. Sufficiently transparent to enable an objective assessment of the urine specimen

appearance and identification of abnormal physical characteristics without opening the
bottle.

3. Thermometer: The thermometer must be capable of temperature readings between

90°-100°F (32°-38°C). The thermometer must accurately measure the temperature of the
specimen and not contaminate the specimen. The thermometer may be affixed to or built
into the collection container as supplied or placed on the collection container after the donor
gives the collection container with the specimen to the collector. Alternately, the collector
may use another technology to measure the specimen temperature (e.g., thermal radiation
scanning), providing the thermometer does not come into contact with the specimen.

4. Federal CCFs: An OMB-approved Federal CCF as described in Chapter 5 must be used

for the collection. All collection sites, including those using ECCFs (digital and/or
combination electronic and paper Federal CCFs), should maintain a supply of paper Federal
CCFs.

5. Tamper-evident labels/seals: Tamper-evident labels/seals are used to identify and seal

the specimen bottles containing the primary (A) and split (B) specimens. Occasionally, a
tamper-evident label/seal will not properly adhere to the specimen bottle (e.g., due to
moisture, temperature, or specimen bottle material). If this occurs, follow instructions in
Chapter 8, Section G for using another tamper-evident seal.

6. Leak-resistant container: A container (e.g., plastic bag) that is leak-resistant and large
enough to hold two specimen bottles.

7. Specimen package: The sealed, tamper-resistant container (e.g., plastic bag, box) that
contains the specimen bottle(s) and Federal CCF from a urine drug test collection. Note:
When an electronic Federal CCF was used for the collection, the collector must either
18
 (1) include a printed copy of the Federal CCF (for informational purposes only) in the
specimen package or (2) apply a label to the outside of the specimen package with the
specimen identification number, test facility name and contact information, and collection
site name and contact information.

8. Absorbent material: The absorbent material is placed inside the leak-resistant container
with the specimen bottles in case a specimen bottle leaks during shipment. The U.S. Postal
Service and other express carriers require the use of absorbent material when shipping
biological materials.

9. Shipping container: The container (e.g., box, mailer, bag) in which the collector places one
or more specimen packages for transport to an IITF or laboratory. The shipping container
must be securely sealed to prevent loss of a specimen during transport. It is not necessary
to use a shipping container if a courier hand-delivers the specimen package directly from the
collection site to the IITF or laboratory.

10. Bluing agent: Bluing agent is added to the toilet bowl and water tank to prevent undetected
specimen dilution by the donor.

11. Disposable gloves: HHS recommends that collectors use single-use disposable gloves
while handling specimens. The Occupational Safety and Health Administration has specific
standards addressing protection of employees who are exposed to potentially infectious
body fluids (29 CFR Part 1910.1030).

C. Collection Procedure

1. Prepare the collection site to collect urine specimens.

2. Assemble supplies.

a. Ensure that there is bluing agent in the toilet. If no bluing agent is available or if there is
an automatic flushing system, turn off the water supply and flush the toilet to remove any
water in the toilet when possible.

b. Turn off the water supply or secure water sources inside the restroom.

3. Provide a means for the donor to wash their hands under your direct observation. If there is
not a restroom or a sink within the collection area, provide another means (e.g., waterless
cleanser, moist towelette).

a. If a water source inside the restroom cannot be turned off or secured, you must perform
a monitored collection as described in Chapter 8, Section B.

b. Remove any soap, cleanser, disinfectant, or other potential adulterants, and

c. Inspect and/or secure areas or items that could be used to conceal adulterants (e.g.,
false ceilings, ledges, trash cans, towel dispensers).

4. Begin the collection process without delay when the donor arrives at the collection site. For
example, the collection should not be delayed because an authorized employer or employer

19
 representative is late in arriving. If the donor states that they are unable to provide a
urine specimen, continue with the collection procedure through Step 13 below.

a. If a donor fails to arrive at the collection site at the assigned time for the drug test, follow
the federal agency policy or contact the federal agency representative to obtain
guidance on the appropriate action to be taken.

5. Verify the donor’s identity with a photo identification (see Chapter 6). If the donor requests,
you must provide identification (e.g., employee badge, employee list).

See Chapter 5, Section D for step-by-step instructions for completing the Federal CCF.

Instructions below apply to all Federal CCF formats (see ECCF definitions and requirements in
Chapter 5, Section A).

6. Obtain the paper Federal CCF or log onto the Federal ECCF system for the collection.

7. Ensure that the specimen identification number on the Federal CCF matches the
identification number printed on each specimen bottle label/seal and on the specimen
package label (if any).

Note: Some ECCF systems require the collector to scan the barcoded specimen ID number
on each bottle label/seal and add that specimen ID number to the ECCF. This step may be
later in the collection process (as directed by the ECCF system).

8. Verify the preprinted laboratory information (e.g., name and address) at the top of the
Federal CCF, including the laboratory account number (if applicable).

9. Record and verify the information in Step 1 of the Federal CCF. Edit entries as needed. For
a paper CCF, line through incorrect information, handwrite the correct information and initial
and date the change.

10. Describe the basic collection procedure to the donor and inform the donor that the
Instructions for Completing the Federal Custody and Control Form for a Urine Collection are
available upon request. Answer any reasonable and appropriate questions that the donor
has about the collection process.

11. To deter adulteration or substitution of the specimen:

a. Ask the donor to remove any unnecessary outer clothing (e.g., coat, jacket, hat) that
could be used to conceal items or substances that could be used to adulterate or
substitute the urine specimen.

• It is not necessary for the donor to remove a hat or head covering that the donor
refuses to remove based on religious practice.

• It is not necessary for the donor to remove their footwear, unless you suspect that
they are concealing something that may be used to adulterate or substitute the
specimen.

20
 b. Take steps to safeguard the donor’s outer clothing and other personal belongings (e.g.,
briefcase, purse). The donor may retain their wallet.

• The belongings may be left unsecured if they remain within the line of sight of the
collector and the donor, and out of the donor’s reach, until the end of the collection,
or

• The belongings may be secured (e.g., in a lockable cabinet with access controlled by
the donor, in a sealed bag with a tamper-evident seal).

c. Ask the donor to empty their pockets and display the items.

• If there are no items that can be used to adulterate a specimen, instruct the donor to
return the items to their pockets and continue the collection procedure (i.e., with Step
12).

• If an item is present whose purpose is to adulterate, substitute or dilute the specimen

(e.g., a commercial drug culture product or other substance for which the donor has
no reasonable explanation), this is considered a refusal to test. You must stop the
collection and report the refusal to test to the federal agency to ensure immediate
notification is received (see Chapter 8, Section F). Create an MFR to document the
item (e.g., written description, photograph), and sign and date the MFR.

• If an item that could be used to adulterate, substitute, or dilute a specimen (e.g.,

common personal care products such as eyedrops, mouthwash, or hand sanitizer)
appears to have been inadvertently brought to the collection site, document the item
in an MFR (e.g., written description, photograph), sign and date the MFR, safeguard
the item with the donor’s belongings, and continue the collection procedure (i.e., with
Step 12).

• If the donor refuses to display the items in their pockets, this is considered a refusal
to test. Stop the collection and report the refusal to test to the federal agency to
ensure immediate notification is received (see Chapter 8, Section F).

Note: The collector must work with only one donor at a time and must protect each donor’s
privacy. Only authorized personnel and the donor may be present in the restricted access area
where the collection takes place. In addition, the collector must maintain the security and
confidentiality of donor information on the Federal CCF for each donor.

12. Prepare for the collection:

a. Instruct the donor to wash and dry their hands under your observation.

• Liquid soap is preferred over bar soap because bar soap gives the donor the
opportunity to conceal soap shavings under their fingernails in an attempt to
adulterate the specimen.

b. After washing their hands, the donor must remain in your presence and not be allowed
access to any water fountain, faucet, soap dispenser, cleaning agent, or other materials

21
 which could be used to adulterate, substitute, or dilute a specimen. Instruct the donor to
keep their hands within view and avoid touching items or surfaces.

• If the donor refuses to wash their hands when instructed, this is considered a refusal
to test. You must stop the collection and report the refusal to test to the federal
agency.

c. Provide or allow the donor to select the collection kit or packaged collection container (if
it is separate from the kit) from the available supply.

d. Unwrap or break the seal of the kit or collection container in view of the donor. You may
allow the donor to perform this step.

• Both the collector and the donor must be present.

• Only the seal on the collection container is broken at this time (i.e., the specimen
bottles remain sealed/wrapped).

Note: If the donor has stated that they are unable to provide a specimen, at this point in the
collection, request that the donor enter the restroom and attempt to provide a specimen. If the
donor comes out of the stall with an empty collection container, they have demonstrated the
inability to provide a specimen. Follow the Insufficient Specimen procedure in Chapter 8,
Section C, and Appendix D.

13. Direct the donor to:

a. Provide the specimen in the privacy of the restroom/stall/partitioned area to be used for
the collection,

b. Provide a specimen of at least 45 mL,

c. Not flush the toilet, and

d. Return with the specimen as soon as they have finished completing the void.

• You may inform the donor that the temperature of the urine specimen must be read
within 4 minutes after the void to be valid. Longer wait periods may cause the
temperature to be out of range and necessitate an observed collection.

• A reasonable time limit may be set for completing the void.

Note: Neither the collector nor anyone else may go into the restroom with the donor, except in
the case of a direct observed collection (see Chapter 8, Section A) or a monitored collection
(see Chapter 8, Section B).

Note: You must note any unusual behavior or appearance of the donor on the Federal CCF. If
you detect any conduct that clearly indicates an attempt to tamper with a specimen, you must
report a refusal to test immediately to the federal agency.

22
Note: Both you and the donor must maintain visual contact with the specimen from the time the
specimen is transferred to you until specimen bottles have been sealed for shipment to the IITF
or laboratory.

Note: After receiving the specimen from the donor, whenever practical, you may allow the donor
to wash their hands and to flush the toilet. (The collector may inspect the toilet for any materials
indicative of specimen tampering prior to flushing.)

14. After you receive the specimen from the donor, read the temperature.

a. Do this within 4 minutes after the void.

b. Mark the appropriate box in Step 2 of the Federal CCF:

• If the temperature is within the acceptable range (32° - 38°C; 90º-100ºF), mark
“Yes” and proceed with the collection procedure. Go to Step 15.

• If the temperature is outside the acceptable range, mark “No.” You will perform a
second, direct observed collection, and send both specimens to an HHS-certified
laboratory (not an IITF) for testing. (See exception in first Note below.)

 Record an appropriate comment on the Remarks line in Step 2 of the Federal

CCF for the first specimen to identify this as the first of two specimens collected
and the reason why two specimens were collected.

 Complete the first collection before initiating the second collection, including Step
15 (examining the physical characteristics of the urine).

 Begin the collection of a second specimen using a direct observed collection

procedure (see Chapter 8, Section A) and a new collection kit (i.e., a new
collection container and a new Federal CCF).

 Record an appropriate comment on the Remarks line in Step 2 of the Federal

CCF for the second specimen to indicate why two specimens were collected,
including a cross reference to the specimen identification number of the first
specimen.

Note: The specimen with unacceptable temperature and its Federal CCF are sent to an HHS-
certified laboratory regardless of the specimen volume. Exception: If the unacceptable
temperature is due to a measurement problem (e.g., no reading due to extremely low volume,
temperature strip failure) discard the urine collected and immediately begin a second collection
using the same Federal CCF and the same procedures (not directly observed). Use a new
collection container for the second collection.

Note: If the donor provides less than 45 mL for the second specimen, follow the Insufficient
Specimen procedures in Chapter 8, Section C. Discard the second specimen. Do not send the
second specimen for testing if the volume is less than 45 mL.

Note: If the donor refuses to provide a second specimen or leaves the collection site before the
collection process is completed, this is considered a refusal to test (see Chapter 8, Section F).

23
Discard any urine, document the refusal to test on the Federal CCF and send all copies of the
Federal CCF to the federal agency’s designated representative.

15. Inspect the specimen for adulteration or substitution by examining the physical
characteristics of the urine.

a. Note any abnormal characteristics such as:

• Unusual color (e.g., specimen is blue),

• Presence of foreign objects or material,

• Unusual odor (e.g., bleach), or

• Signs of adulteration (e.g., excessive foaming when shaken).

b. If there are no abnormal characteristics indicative of adulteration or substitution by the

donor, proceed with the collection procedure. Go to Step 16.

c. If you observe any abnormal characteristic(s) that appears to be due to adulteration or

substitution by the donor, you will perform a second, direct observed collection and send
both specimens to an HHS-certified laboratory (not an IITF) for testing:

• Record an appropriate comment on the Remarks line in Step 2 of the Federal CCF
for the first specimen to identify this as the first of two specimens collected and the
reason why two specimens were collected.

• Complete the first collection before initiating the second collection by continuing with
the procedure in Step 17.

• Begin the second specimen collection using a direct observed collection procedure
(see Chapter 8, Section A) and a new collection kit (i.e., a new collection container
and a new Federal CCF).

• Record an appropriate comment on the Remarks line in Step 2 of the Federal CCF
for the second specimen to indicate why two specimens were collected, including a
cross reference to the specimen identification number of the first specimen.

d. Follow the additional instructions below (also see Appendix C, Two Specimens from
the Same Collection Event).

• The specimen with abnormal physical characteristics and its Federal CCF are sent to
an HHS-certified laboratory regardless of the specimen volume.

• If the donor provides less than 45 mL for the second specimen, follow the Insufficient
Specimen procedures in Chapter 8, Section C. Discard the second specimen. Do
not send the second specimen for testing if the volume is less than 45 mL.

• If the donor refuses to provide a second specimen or leaves the collection site before
the collection process is completed, this is considered a refusal to test (see

24
 Chapter 8, Section F). Discard any urine, document the refusal to test on the
Federal CCF and send all copies of the Federal CCF to the federal agency’s
designated representative.

16. Check the specimen volume to ensure that the specimen contains at least 45 mL of urine.

a. If the specimen volume is at least 45 mL, complete the specimen collection procedure
continuing with Step 17.

b. If the specimen volume is less than 45 mL, discard the specimen and immediately begin
a second collection using the same procedures and the same Federal CCF. Use a new
collection container for the second collection.

Note: If the donor refuses to attempt to provide a second specimen or leaves the collection site
before the collection process is completed, this is considered a refusal to test (see Chapter 8,
Section F).

c. When a second specimen must be collected, follow the Insufficient Specimen procedure
in Chapter 8, Section C.

• When the donor hands you the second specimen, continue with the collection
procedure, including Step 14 (checking specimen temperature) and Step 15
(examining physical characteristics of the urine).

• If the donor is unable to provide at least 45 mL for the second specimen after a
period of three hours, stop the collection procedure. Record the reason for not
collecting a urine specimen on the Federal CCF, and notify the federal agency’s
designated representative for authorization of an alternate specimen to be collected.
The federal agency may choose to provide the collection site with a standard
protocol to follow in lieu of requiring the collector to notify the agency’s designated
representative for authorization in each case. You must send the appropriate copies
of the Federal CCF to the MRO and to the federal agency’s designated
representative (see Chapter 8, Section C).

• If an alternate specimen is authorized, the collector may begin the collection

procedure for the alternate specimen in accordance with the UrMG. If the donor
refuses to provide an alternate specimen, the collector stops the collection and
reports the refusal to test (see Chapter 8, Section F).

17. Unwrap the sealed specimen bottles in the donor’s presence.

18. In the donor’s presence, pour the urine from the specimen collection container into the two
specimen bottles labeled “A” and “B”.

a. Pour at least 30 mL into the “A” Bottle and at least 15 mL into the “B” bottle.

b. Secure the lid/cap on each bottle.

25
19. Seal the A and B specimen bottles while the donor watches, positioning the appropriate
label/seal over the lid/cap of each bottle to ensure that the lid/cap cannot be removed
without breaking the label/seal.

20. Discard any excess urine remaining in the collection container after the bottles have been
filled with the appropriate volumes of urine.

a. The only exception is when the excess urine is being used to conduct clinical tests in
conjunction with a physical examination that is required by the federal agency. No further
tests may be conducted on the excess urine.
21. Write the date on the tamper-evident labels/seals.

22. Ask the donor to initial the label/seal on each bottle, using care to avoid damage.

• If the donor fails or refuses to initial the seals, note this on the Remarks line in Step 2 of
the Federal CCF and complete the collection process. This is not considered a refusal to
test.

23. Inform the donor that it is not necessary for them to continue observing the collection
procedure after the bottles have been sealed, and that they are allowed to wash their hands.

24. Complete the Federal CCF.

See Chapter 5, Section D for step-by-step instructions for completing the Federal CCF.

Instructions below apply to all Federal CCF formats (see ECCF definitions and
requirements in Chapter 5, Section A).

a. Assist the donor in completing the donor section of the Federal CCF (Copy 2, Step 5)

• Record (or instruct the donor to record) donor information indicated on the CCF. The
collector must not solicit any donor medical information, and medical information
must not be recorded on the Federal CCF or other record maintained or distributed
by the collector. See Step 26 regarding a donor-recorded list of medications.

• Instruct the donor to read the donor certification statement, and to sign and date the
certification statement.

 If the donor refuses to provide their information or to sign the form, make a
comment on the Remarks line in Step 2 of the Federal CCF to that effect. This is
not considered a refusal to test.

b. Complete the collector chain of custody portion in Step 4 on Copy 1 of the Federal CCF.

25. Prepare the specimen package for shipment.

a. Place the sealed specimen bottles in a leak-resistant container (e.g., plastic bag)
including the absorbent material.

b. Place the Test Facility Copy (Copy 1) and any collector MFRs in the container with the
specimen (i.e., in a compartment separate from the specimen bottles).

26
 Note: For a digital Federal CCF, the collector must either (1) include a printed copy of the
Federal CCF (for informational purposes only) in the specimen package or (2) apply a label
to the outside of the specimen package with the specimen identification number, test facility
name and contact information, and collection site name and contact information. Any
collector MFRs for the specimen must be included in the package (i.e., in a compartment
separate from the specimen tubes) or sent electronically to the laboratory using established
procedures (e.g., secure fax, email).

c. Seal the bag so both compartments are sealed.

26. Provide the Donor Copy of the Federal CCF to the donor.

a. Remind the donor that they may list any prescription and over-the-counter medications
on a separate sheet or on the back of the donor’s copy of the Federal CCF. This
information may help the donor to remember what medications they may have taken if
they are contacted by the MRO.

Note: This information must not be recorded on any other copy of the Federal CCF or other
record maintained or distributed by the collector.

27. Inform the donor that they may leave the collection site.
Send the specimen package to the IITF or to the HHS-certified laboratory within 24 hours
after the collection or during the next business day. Specimens that will not be shipped
within 24 hours (e.g., collected on a Friday for shipment on Monday) should be kept in secure
refrigerated storage. If the specimen package is not shipped immediately, the collector is
responsible for ensuring its security:

a. For specimens in a sealed specimen package that has not been placed in a shipping
container, take necessary steps to prevent tampering or access by unauthorized
personnel.

b. For specimen packages in a sealed shipping container, take necessary steps to protect
the container from damage or theft prior to pick-up by the designated delivery service.

c. If the tamper-evident label/seal is broken on a specimen bottle after the donor leaves the
collection site, the collection must be cancelled.

• Notify the agency’s designated representative that the label/seal was broken on the
specimen bottle, and send all copies of the Federal CCF to the federal agency’s
designated representative.

29. Distribute the MRO and employer copies of the Federal CCF. Chapter 5, Section E
describes proper distribution of Federal CCF Copies 1–5.

a. The collection site and the MRO must coordinate the Federal CCF distribution process
to ensure that procedures meet the MRO’s and federal agency’s requirements.

b. The collection site or the MRO must maintain the original Copy 2 with the donor’s
signature (i.e., paper Copy 2 with the donor’s wet-ink signature, if signed).

27
Chapter 8. Miscellaneous Collection Issues
A. Direct Observed Collection

See also Appendix B: Direct Observed Collection Procedure

A direct observed collection procedure may only be used when:

1. A federal agency has authorized a direct observed collection because a donor’s previous
drug test result was reported by an MRO as drug positive, adulterated, substituted, invalid
without a legitimate medical reason, or cancelled because the split specimen failed to
reconfirm the primary specimen results or could not be tested, or

2. At the collection site, an immediate collection of a second urine specimen is required in one
of the following situations:

a. The temperature of the specimen collected during a routine collection is outside the
acceptable temperature range.

b. There is an indication that the donor has tampered with the specimen (e.g., abnormal
physical characteristic such as unusual color, excessive foaming when shaken, unusual
odor).

Before conducting a direct observed collection under Item 2 above, the collector must contact a
collection site supervisor for concurrence with the collector’s decision for a direct observed
collection. The collector must explain to the donor why a direct observed collection is being
conducted. If the donor declines to allow a direct observed collection it is considered a refusal to
test (see Chapter 8, Section F).

The procedure for a direct observed collection is the same as that for a routine collection except
an observer watches the donor urinate into the collection container. The observer’s gender must
be the same as the donor’s gender, which is determined by the donor’s gender identity. There
are no exceptions to this requirement. The donor’s gender identity may be the same as or
different from the donor’s sex assigned at birth. At the point in a routine collection where the
donor enters the restroom with the collection container (see Chapter 7, Section C, Step 13), a
direct observed collection includes the following additional steps:

1. The collector informs the donor that the gender of the observer will match the donor’s
gender, which is determined by the donor’s gender identity.

a. The collector asks the donor to identify the donor’s gender on the Remarks line in
Step 2 of the Federal CCF and initial it.

b. The donor is provided an observer whose gender matches the donor’s gender.

c. The collector documents the observer’s name and gender on the Remarks line in
Step 2 of the Federal CCF.

d. If there is no collector of the same gender as the donor’s gender, the collector or
collection site supervisor must select another individual trained in direct observed

28
 specimen collections. The individual must meet the UrMG qualifications for an
observer (see Chapter 1).

Note: If there is insufficient room on the Remarks line, the collector may send a separate
explanatory MFR.

2. The observer enters the restroom with the donor.

3. The observer must directly watch the urine go from the donor’s body into the collection
container. The use of mirrors or video cameras is not permitted. If the donor fails to follow
the observer’s instructions related to the direct observed collection, this is considered a
refusal to test (see Chapter 8, Section F).

4. With regard to chain of custody, the observer must never touch or handle the collection
container unless the observer is also serving as the collector.

5. The observer must maintain visual contact with the collection container until the donor
hands the container to the collector

6. After the donor has completed urinating into the collection container:

a. The donor and observer leave the restroom.

• The observer must ensure that the employee hands the collection container directly
to the collector as soon as the employee has exited the enclosure, or

• If the same individual serves as both observer and collector, the collector may
receive the collection container from the donor while they are both in the restroom.

7. The collector checks the box for an observed collection in Step 2 of the Federal CCF.

8. The collector continues with the routine collection procedures (see Chapter 7, Section C,
Step 14).

B. Monitored Collection

A monitored collection procedure must be used when:

1. The collection is being conducted in a public restroom (e.g., when the federal agency’s
designated collection site is not available and there is an immediate need for a collection), or

2. The restroom used for the collection has a water source that cannot be disabled or secured.

If the donor declines to allow a monitored collection when one of the above circumstances has
occurred, it is considered a refusal to test (see Chapter 8, Section F).

The procedure for a monitored collection is the same as that for a routine collection except a
monitor accompanies the donor into the restroom to check for signs that the donor may be
tampering with the specimen. At the point in a routine collection where the donor enters the
restroom with the collection container (see Chapter 7, Section C, Step 13), a monitored
collection includes the following additional steps:

29
1. The monitor accompanies the donor into the restroom and secures the restroom to ensure
that no one else can enter during the collection process. The monitor remains in the
restroom, but outside the stall, while the donor is providing the specimen.

a. The monitor must be the same gender as the donor’s gender, unless the monitor is a
trained medical professional (e.g., nurse, doctor, physician’s assistant, technologist or
technician) who is licensed or certified to practice where the collection occurs.

b. The monitor may be an individual other than the collector and is not required to be a
trained collector.

2. The monitor listens for signs of tampering with the specimen. The monitor must not watch
the donor urinate into the specimen container.

3. If there is evidence of specimen tampering, the monitor notifies the collector to immediately
begin to collect a second specimen using a direct observed collection procedure (see
Chapter 8, Section A).

4. With regard to chain of custody, the monitor must never touch or handle the collection
container unless the monitor is also serving as the collector.

5. After the donor has completed urinating into the collection container:

a. The donor and monitor leave the restroom.

• The monitor must ensure that the employee hands the collection container directly to
the collector as soon as the employee has exited the enclosure, or

• If the same individual serves as both monitor and collector, the collector may receive
the collection container from the donor while they are both in the restroom.

6. The collector provides the name of the monitor (if applicable) on the Remarks line in Step 2
on Copy 1 of the Federal CCF.

7. The collector continues with the routine collection procedures (see Chapter 7, Section C,
Step 14).

C. Inability to Provide a Sufficient Specimen

If a donor states that they are unable to provide a urine specimen during the collection process,
the collector must begin the collection procedure regardless of the reason given. The donor
demonstrates their inability to provide a valid specimen when they come out of the restroom
with an empty collection container. Immediately begin a second collection using the same
procedures, the same collection container (i.e., if no specimen was provided upon the first
attempt), and the same Federal CCF. Appendix D provides flowcharts for collector actions.

1. If the donor states that they may be able to provide a specimen if given more time:

30
 a. You must provide a period of up to 3 hours for the donor to attempt to provide a
sufficient urine specimen.

b. Inform the donor that they must remain at the collection site (in the area that you
designate) during the wait period. The donor must be monitored to prevent the donor
from possibly compromising the collection process.

c. Offer the donor a reasonable amount of fluid to drink distributed reasonably through a
period of up to 3 hours (e.g., an 8 ounce glass of water every 30 minutes, not to exceed
40 ounces over a period of 3 hours) or until the donor has provided a sufficient amount
of urine, whichever occurs first. The donor is not required to drink fluids during the
waiting period.

d. Instruct the donor to let you know when they are able to provide a sufficient quantity of
specimen. It is recommended that you allow sufficient time to have only one additional
attempt rather than having to document several unsuccessful attempts. Be sensitive to
how frequently you ask a donor to attempt to provide a specimen.

e. Record the time of the attempt to provide a sufficient volume of specimen (e.g., on the
Remarks line in Step 2 of the Federal CCF).

Note: The collector must NOT under any circumstances combine urine collected from
separate voids to create one specimen of sufficient volume.

2. If the donor states that they are unable to provide a specimen, or if the donor has not
provided sufficient volume of specimen in three hours from the time of the donor’s first
attempt, discontinue the collection and:

a. Record the reason for not collecting the specimen on the Remarks line and mark the
“None Provided” box in Step 2 of the Federal CCF.

b. Notify the agency’s designated representative for authorization to collect an alternate

specimen. The federal agency may provide the collection site with a standard protocol to
follow instead of requiring the collector to notify the agency’s designated representative
for authorization in each case. If an alternate specimen is authorized by the federal
agency, begin the alternate specimen collection procedure.

c. Discard the urine collected (if any).

d. Provide a copy of the Federal CCF (as described in the Collection Procedure in Chapter
7, Section C, Step 26) to the donor. Request that the donor leave the collection site or,
if authorized, proceed with the alternate specimen collection.

e. Discard Copy 1 of the Federal CCF (no valid specimen was collected).

f. Provide a copy of the Federal CCF to the MRO and to the federal agency’s designated
representative within 24 hours or the next business day (as described in the Collection
Procedure in Chapter 7, Section C, Step 29).

3. If the donor refuses to attempt to provide a specimen, refuses to provide a second

specimen, leaves the collection site before the collection process is completed, refuses a
31
 direct observed collection, or refuses to provide an alternate specimen, these are
considered a refusal to test. The collector must follow the procedure in Chapter 8,
Section F.

D. Donor Conduct

The collector should pay close attention to the donor’s conduct during the entire collection
process and take the following actions as necessary:

1. Note any unusual behavior or appearance of the donor in the Remarks line in Step 2 of the
Federal CCF.

2. If donor conduct clearly indicates an attempt to tamper with the specimen (e.g., substitute
urine in plain view or an attempt to bring into the collection site an adulterant or urine
substitute), report a refusal to test immediately to the federal agency in accordance with
Section F below.

3. If there is reason to believe the donor may have adulterated or substituted a collected
specimen (based on donor actions or an abnormal specimen characteristic including
temperature outside of range), complete the collection procedure for the first specimen;
perform a second, direct observed collection; and send both specimens to an HHS-certified
laboratory (not to an IITF) for testing.

4. Record an appropriate comment on the Remarks line in Step 2 of the Federal CCF for the
first specimen to identify this as the first of two specimens collected and the reason why two
specimens were collected.

5. Complete the first collection using the procedures in Chapter 7, Section C, before initiating
the second collection.

6. Begin the second specimen collection using a direct observed collection procedure (see
Chapter 8, Section A) and a new collection kit (i.e., a new collection container and a new
Federal CCF).

7. Record an appropriate comment on the Remarks line in Step 2 of the Federal CCF for the
second specimen to indicate why two specimens were collected, including a cross reference
to the specimen identification number of the first specimen.

Note: The first specimen and its Federal CCF are sent to an HHS-certified laboratory
regardless of the specimen volume.

Note: If the donor refuses to provide a second specimen or leaves the collection site before
the collection process is completed, this is considered a refusal to test (see Section F
below). Discard any urine, document the refusal to test on the Federal CCF, and send
all copies of the Federal CCF to the federal agency’s designated representative.

8. If the donor fails to arrive at the assigned time within a reasonable time, as determined by
the federal agency:

a. Contact the federal agency’s designated representative to obtain guidance on the action
to be taken.

32
 b. This is considered a refusal to test except for:

• A donor who fails to appear for a pre-employment test; or

• A donor for a pre-employment test who leaves the collection site before the collection
begins (i.e., before the collector provides or the donor selects the collection kit or
packaged collection container as described in the Collection Procedure, Chapter 7,
Section C, Step 12). If the donor for a pre-employment test leaves after that step,
before the collection is complete, the collector reports a refusal to test.

E. Multiple Collectors for a Specimen Collection

The procedures for collecting a federal agency drug testing specimen, as required by the HHS
Mandatory Guidelines and detailed in this Specimen Collection Handbook, are designed to be
performed from start to finish by one trained collector. Collection sites and federal agencies are
expected to schedule collections accordingly.

In the rare event when the collector who began a collection cannot complete all steps (e.g.,
when a collection coincides with a shift change, shy bladder, insufficient specimen), a second
trained collector may assume responsibility for the collection.

Prior to changing collectors:

1. The first collector must document their name, the time, and the reason for the change in
Step 2 of the Federal CCF. The first collector may, but is not required to, sign in addition to
printing their name in Step 2.

2. Before assuming responsibility for the collection, the second collector must:

a. Verify the donor’s identity with a photo identification (see Chapter 6). If the donor
requests, you must provide identification (e.g., employee badge, employee list).

b. Verify the donor ID number recorded on the Federal CCF.

c. Ensure that Step 1 of the Federal CCF is complete.

d. Review and verify any information in Step 2 of the CCF recorded by the first collector.

F. Refusal to Test

A federal agency will take adverse action against an employee whose drug test specimen is
reported as a refusal to test. The collector reports a “refusal to test” when:

1. The donor fails to appear for a collection within a reasonable time as determined by the
federal agency, consistent with federal agency regulations (except for a donor who leaves
the collection site before the collection begins for a pre-employment test as noted in
Chapter 8, Section D, Step 8 above).

33
2. The donor fails to remain at the collection site until the collection is complete (except for a
donor who leaves the collection site before the collection begins for a pre-employment test
as noted in Chapter 8, Section D, Step 8 above).

3. The donor fails to cooperate with any part of the testing process (e.g., refuses to provide a
specimen, refuses to display the items in their pockets at the beginning of the collection,
disrupts the collection process, refuses to wash their hands at the beginning of the
collection, or exhibits conduct that clearly indicates an attempt to adulterate, substitute, or
dilute the specimen or otherwise prevent collection of a urine specimen),

4. The donor declines to allow a direct observed collection when required, or fails to follow the
observer’s instructions related to the direct observed collection,

5. The donor declines to allow a monitored collection when required,

6. The donor declines to continue the collection process when their first specimen has
insufficient volume,

7. The donor fails or declines to participate in an alternate specimen collection (e.g., oral fluid)
as directed by the federal agency or collector,

8. The donor admits to the collector that they have adulterated or substituted their specimen.

9. The donor brings materials to the collection site whose purpose is to adulterate, substitute or
dilute their specimen

When reporting a “refusal to test,” the collector must:

1. Notify the agency’s designated representative by a means (e.g., telephone, secure fax,
email) that ensures immediate receipt of the refusal notification,

2. Document the refusal to test on the Federal CCF with appropriate comments, signature, and
date in the Remarks line of Step 2 of the Federal CCF, discards any urine, and

3. Send all copies of the Federal CCF to the federal agency’s designated representative.

G. Problems with Specimen Bottle Labels/Seals

If the tamper-evident label/seal does not adhere properly to the specimen bottle (e.g., due to
moisture, temperature, specimen tube material) or is accidentally broken or damaged during the
collection process:

1. Apply the unacceptable label/seal (i.e., printed with the same identification number as the
Federal CCF) to the bottle, and

2. Apply a second, separate tamper-evident seal to seal the specimen bottle.

a. Place the additional seal perpendicular to the original label/seal. Position the seal so
it does not cover information on the original label/seal and will allow visual
assessment of the bottle contents.

34
 b. Initial and date the second seal.

c. Ask the donor to initial the second seal.

d. Provide a comment on the Remarks line in Step 2 of the Federal CCF explaining why
the second seal was used.

Note: If the donor refuses to initial the second seal, the collector should note this on the
Remarks line in Step 2 and continue with the collection process. This is not considered a
refusal to test.

Chapter 9. Collector Errors and Corrective Actions

The Federal CCF is a forensic, legal document and will be part of the litigation package if a
specimen comes under legal challenge. Federal agencies will investigate reported collection site
deficiencies (e.g., specimens rejected for testing due to collector/collection errors).

The collector should never use correction fluid on the Federal CCF and should never overwrite
or obscure information recorded or printed on the Federal CCF. Unclear or improper edits to
Federal CCF information (e.g., donor ID numbers, signatures) could compromise the legal
defensibility of the document.

If the collector makes an error on a Federal CCF, they should:

1. Make a line through the erroneous information, leaving the original information legible,

2. Write the correct information near (e.g., beside or above) the original annotation, and

3. Initial and date the change.

It is acceptable for the collector to line out preprinted information on the Federal CCF that is
incorrect or inapplicable (e.g., collection site, MRO, IITF, laboratory, or employer information).
The collector must use the procedures described above for changing the information on the
form. This may be necessary in the event of unexpected collections (e.g., accident investigation)
or when Federal CCFs at the collection site have outdated information.

There are three categories of collector errors:

1. Fatal flaws that result in an HHS-certified IITF or laboratory rejecting a specimen or an MRO
canceling a test,

2. Correctable flaws that result in an HHS-certified IITF or laboratory rejecting a specimen or

an MRO canceling a test unless the flaw is corrected by an MFR from the collector, and

3. Omissions and discrepancies on the Federal CCF that do not require rejection by the HHS-
certified IITF or laboratory or cancellation by the MRO.

The collector should not access the Federal CCF or the specimen bottles after the package has
been sealed in the presence of the donor. If the collector realizes they have made a correctable

35
flaw or omission after the Federal CCF Copy 1 has been sealed in the specimen package, the
collector should proactively send an explanatory MFR to the HHS-certified IITF or laboratory.

Chapter 5 includes instructions for when an incorrect CCF is used for a federal agency
specimen or an incorrect CCF copy is sent with the specimen. See also Appendix A:
Federal CCF Decision Trees for Collectors.

The collector must take immediate steps to provide an MFR to the HHS-certified IITF,
laboratory, or the MRO when notified of an error. An IITF or laboratory holds specimens for a
short time (i.e., a minimum of five business days) after the collector has been notified, before
reporting the specimen as rejected for testing and discarding the specimen.

36
Appendix A: Federal CCF Decision Trees for Collectors
Appendix A: Federal CCF Decision Trees for Collectors
Appendix A: Federal CCF Decision Trees for Collectors
Appendix A: Federal CCF Decision Trees for Collectors
 Appendix B: Direct Observed Collection Procedure
General Note:
For observed collections decided at the collection site - collector contacts a collection site
supervisor for concurrence and explains to the donor why a direct observed collection
is being conducted. If the donor declines to allow a direct observed collection, it is
considered a refusal to test (see Chapter 8, Section B).

1
Collector informs the donor that the gender of the
observer will match the donor’s gender (determined by the
donor’s gender identity).
• Collector asks the donor to identify the donor’s gender on the Remarks
line in Step 2 of the Federal CCF and initial it.
• Donor is provided an observer (gender matches the donor’s gender).
• Collector documents the observer’s name and gender on the Remarks
line in Step 2 of the Federal CCF.
If there is no collector of the same gender as the donor to serve as the
observer, the collector or collection site supervisor selects another
individual trained in direct observed specimen collections.

2
Observer enters the restroom with the donor.
• Observer must directly watch the urine go from the donor’s body into
the collection container.
If the donor fails to follow the observer’s instructions related to the direct
observed collection, this is considered a refusal to test (see Chapter 8,
Section B).
• Observer must never touch or handle the collection container unless
the observer is also the collector.
• Observer must maintain visual contact with the collection container
until the donor hands the container to the collector

3
After the donor has completed urinating into the
collection container:
• Donor and observer leave the restroom and the donor hands the
collection container directly to the collector OR
• If the same individual serves as both observer and collector, the
collector may receive the collection container from the donor while
they are both in the restroom.

4
Collector checks the box for an observed collection in Step 2
of the Federal CCF.
• Collector provides the reason for an observed collection on the
Remarks line in Step 2 of the Federal CCF.
• Collector continues with the routine collection procedures (see
Chapter 7, Section C, Step 13).
Appendix C: Two Specimens from the Same Collection Event

1st Specimen Suspect =

2nd Specimen Direct Observed Recollection

1 2

1st and 2nd Specimens

Sent to Lab to be Tested
YES
2nd Specimen
> 45 mL? 1 2

1st Specimen
Sent to Lab to be Tested
NO*
1
2nd Specimen
Discarded
* Collector follows routine
procedures for specimens
2
with insufficient volume,
including a wait period if
donor states that they could
provide a specimen if given
Collector Rejects – more time and/or after
Insufficient Specimen drinking fluids.

MRO Directs Medical

Evaluation

Legitimate YES MRO Reports

Medical “Test Canceled”
Condition?

NO MRO Reports
“Refusal to Test”
Another random document with
no related content on Scribd:
Conjectores Ægypti, cunctósq; Sapientes. And these doubtless
Pharaoh would not have sent for, but that either upon his own
knowledge he knew that they professed the ability of the
interpretation of dreams, and (perhaps) as the sequel shewed,
greater matters; or else upon common repute, or relation of others,
and that must needs arise from their own profession of the
knowledge of such abstruse matters: and so of necessity must have
pretended greater matters, than when they came to tryal they were
able to perform, and so must needs be Impostors. And the Woman at
Endor (falsely called a Witch, or a Woman that had a familiar Spirit,
when in the Hebrew she is only called the Mistress of the Bottle, as
we shall manifest hereafter) must needs be a Deceiver and Impostor,
because she pretended to bring up whomsoever Saul desired, which
was a thing absolutely not in her power, as I shall undeniably prove
afterwards. And notwithstanding the stories of Eusebius, and the
strong endeavours of Doctor Hamond to make it good, that Simon
Magus was a person that had peculiar and corporeal converse with
the Devil, and by that league and converse could perform strange and
wonderful things; yet was he but a notorious Impostor, as appeareth
by two reasons. 1. The Text saith, that he gave out that himself was
some great one, that is, that he had great skill, and was able to
perform wonderful things. This sheweth his presumption and
pretence, the certain badge of a Deceiver and Cheater. 2. But could
do little, except some petty jugling Tricks of Leger-de-main,
confederacy, and the like; because he wondred, or was amazed,
beholding the Miracles and signs which were done, and those were,
that unclean Spirits, crying with loud voice, came out of many that
were possessed with them: And many taken with palsies, and that
were lame, were healed. Now if he had been any great Magician, or
could have performed any great things, he could not have so much
wondred at those things that Philip wrought: or if he could have
flown in the air, as Eusebius (or those that have foisted such
incredible lyes into his Writings) pretendeth, then he need not have
been so amazed at the miracles and signs that the Apostles wrought,
nor to have offered to have bought the gift of bestowing the Holy
Ghost, but only because he was a notorious Dissembler and
Impostor. And if he had been in league with the Devil, surely he
might have cast forth Devils by the power of Beelzebub the Prince of
Devils: all which do plainly conclude him to be an absolute Cheater
and Impostor. And the story of Bel and the Dragon (though but an
Apocryphal piece, yet very ancient, and of sufficient credit as to
matter of fact) doth evidently demonstrate, that these sort of people
were abominable Cheaters and Impostors, and were not endowed
with any supernatural power, nor had assistance of any visible
Demon, but only the Devil of deceit and cousenage in their own
breasts, and so were, as Cardan saith, Carnales Dæmones ipsis
Dæmonibus callidiores.
5. And though by the Laws of our own Instit. p. 3. p. 45.
Nation these kind of people were to be
severely punished, as appeareth by the Statute 1 Jac. cap. 12. yet had
they respect in that Act, not only to the punishment in respect of
what these persons could or did do, but also in regard of their being
Impostors and Deceivers of the people; for so the Lord Chief Justice
Sir Edward Cook, the best Expositor of Law that hath written in our
Language, doth expound it in these words. The mischiefs before this
part of this Act were: “That divers Impostors, men and women,
would take upon them to tell or do these fine things here specified,
in great deceit of the people, and cheating and cousening them of
their money or other goods: therefore was this part of the Act made,
wherein these words [take upon him or them] are very remarkable.
For if they take upon them, &c. though in truth they do it not, yet
are they in danger of this first branch.”
6. And whereas in the objection Mr. Glanvil mentioneth converse
with Devils, if he mean mental, internal, and spiritual converse, such
as Murtherers, Adulterers, Thieves, Robbers, and all wicked persons
have with Satan, we grant it; for so had the Jews and the High Priests
in conspiring and acting to put our blessed Saviour to death: it was
their hour, and the power of darkness. But if he mean a visible and
corporeal converse, then we plainly affirm that there is not, nor can
be any such, whereby any such strange things (as Witchmongers
fondly and falsely believe) can be performed or effected. Therefore by
way of conclusion in this particular, we grant that there are many
sorts of such kind of Witches, as for gain and vain-glory do take upon
them to declare hidden and occult things, to divine of things that are
to come, and to do many wonderful matters, but that they are but
Cheaters, Deceivers, and Couseners.
 2. And as there are a numerous crew of active Witches, whose
existence we freely acknowledge; so there are another sort, that are
under a passive delusion, and know not, or at least do not observe or
understand, that they are deluded or imposed upon. These are those
that confidently believe that they see, do, and suffer many strange,
odd, and wonderful things, which have indeed no existence at all in
them, but only in their depraved fancies, and are meerly
melancholiæ figmenta. And yet the confessions of these, though
absurd, idle, foolish, false, and impossible, are without all ground
and reason by the common Witchmongers taken to be truths, and
falsely ascribed unto Demons, and that they are sufficient grounds to
proceed upon to condemn the Confessors to death, when all is but
passive delusion, intrinsecally wrought in the depraved imaginative
faculty by these three ways or means.
1. One of the Causes that produceth this depraved and passive
delusion, is evil education; they being bred up in ignorance, either of
God, the Scriptures, or the true grounds of Christian Religion, nay
not being taught the common Rules of Morality, or of other humane
Literature; but only imbibing and sucking in, with their mothers and
nurses milk, the common gross and erroneous opinions that the
blockish vulgar people do hold, who are all generally inchanted and
bewitched with the belief of the strange things related of Devils,
Apparitions, Fayries, Hobgoblins, Ghosts, Spirits, and the like: so
that thereby a most deep impression of the verity of the most gross
and impossible things is instamped in their fancies, hardly ever after
in their whole life time to be obliterated or washt out: so prevalent a
thing is Custom and Institution from young years, though the things
thus received, and pertinaciously believed, and adhered unto, are
most abominable falsities and impossibilities, having no other
existence but in the brains and phantasies of old, ignorant, and
doting persons, and are meerly muliercularum & nutricum
terriculamenta & figmenta, and therefore did Seneca say:
Gravissimum est consuetudinis imperium. And that this is one main
cause of this delusion, is manifest from all the best Historians, that
where the light of the Gospel hath least appeared, and where there is
the greatest brutish ignorance and heathenish Barbarism, there the
greatest store of these deluded Witches or Melancholists are to be
found, as in the North of Scotland, Norway, Lapland, and the like,
as may be seen at large in Saxo Grammaticus, Olaus Magnus,
Hector Boetius, and the like.
2. But when an atrabilarious Schenck. observ.
Temperament, or a melancholick medic. lib. 1. pag.
Complexion and Constitution doth happen 129.
to those people bred in such ignorance, and that have suckt in all the
fond opinions that Custom and Tradition could teach them, then
what thing can be imagined that is strange, wonderful, or incredible,
but these people do pertinaciously believe it, and as confidently
relate it to others? nay even things that are absolutely impossible, as
that they are really changed into Wolves, Hares, Dogs, Cats,
Squirrels, and the like; and that they flye in the Air, are present at
great Feasts and Meetings, and do strange and incredible things,
when all these are but the meer effects of the imaginative function
depraved by the fumes of the melancholick humor, as we might shew
from the Writings of the most grave and learned Physicians; but we
shall content our selves with some few select ones. 1. That distemper
which Physicians call Lycanthropia, is according to the judgment of
Aetius and Paulus, but a certain species of Melancholy, and yet they
really think and believe themselves to be Wolves, and imitate their
actions: of which Johannes Fincelius in his second Book de Mirac.
giveth us a relation to this purpose. “That at Padua in the year 1541.
a certain Husband-man did seem to himself a Wolf, and did leap
upon many in the fields, and did kill them. And that at last he was
taken not without much difficulty, and did confidently affirm that he
was a true Wolf, only that the difference was in the skin turned in
with the hairs. And therefore that certain, having put off all
humanity, and being truly truculent and voracious, did smite and cut
off his legs and arms, thereby to try the truth of the matter; but the
innocency of the man being known, they commit him to the
Chirurgions to be cured, but that he dyed not many days after.”
Which instance is sufficient to overthrow the vain opinion of those
men that believe that a man or woman may be really transformed or
transubstantiated into a Wolf, Dog, Cat, Squirrel, or the like, without
the operation of an omnipotent power, as in Lots Wife becoming a
Pillar of Salt; though St. Augustine was so weak as to seem to believe
the reality of these transformations: of which we shall have occasion
to speak more largely hereafter.
 2. Another story we shall give from the Observat. medic.
Authority of that learned Physician lib. 1. cap. 18. pag.
Nicolaus Tulpius of Amsterdam to this 38.
effect. A certain famous Painter was for a long time infected with
black Choler, and did falsely imagine that all the bones of his body
were as soft and flexible, that they might be drawn and bended like
soft wax. Which opinion being deeply imprinted in his mind, he kept
himself in bed the whole Winter, fearing that if he should rise, they
would not bear his weight, but would shrink together by reason of
their softness. That Tulpius did not contradict him in that fancy, but
said that it was a distemper that Physicians were not ignorant of, but
had been long before noted by Fernelius, that the bones like wax
might be softned and indurated, and that it might be easily cured, if
he would be obedient: and that within three days he would make the
bones firm and stable, and that within six days he would restore him
to the power of walking. By which promises it was hard to declare,
how much hope of recovering health it had raised up in him, and
how obedient it made him. So that with Medicines proper to purge
the atrabilarious humour within the time appointed, he was at the
three days end suffered to stand upon his feet, and upon the sixth
day had leave given to walk abroad: and so found himself perfectly
sound afterwards; but did not perceive the deceit in his phantasie,
that had made him lye a whole Winter in bed, though he was no
stupid, but an ingenious person in his Art, and scarce second to any.
3. Thomas Vt supr. Histor. 85. Cent. 1. Hist. 79.
Bartholinus the pag. 125. pag. 117.
famous Anatomist, and Physician to Frederick the Third King of
Denmark, tells us these things: “That it is the property of melancholy
persons to fear things not to be feared, and to feign things quæ nec
picta usquam sunt, nec scripta. A Plebeian (he saith) with them
abounding with melancholy blood did imagine that his Nose was
grown to that greatness, that he durst not go abroad, for fear it
should be hurt or justled upon by those he met. And that a famous
Poet at Amsterdam did believe that his Buttocks were of glass, and
feared their breaking, if he should sit down. Another Old man of
prime Dignity did suspect that he had swallowed a nail, which being
lost, he could no where find, and thought himself much tortured by
its being fixed in him. But was restored to his health, by having a
Vomit given, and the Physician conveying a nail into the matter that
he cast up. And that a certain man in England would not make
water, for fear that all the blood in his body should have passed forth
by that passage, and therefore straitly tyed the yard with a thred for
some days, which swelling he was not far from death, but that his
Brother by force untyed it.” The Books of Physicians are very full
with such relations, and we in our Practice have met with divers as
strange as these, and cured them. Also he tells us this: “A certain
Student of a melancholick Constitution, distracted with grief for the
death of a Sister, and wearied with lucubrations, did complain to
(Bartholinus) of the Devil haunting of him: and did affirm that he
felt the evil Spirit enter by his fundament with wind, and so did creep
up his body until it possessed the head, lest he might attend his
Prayers and Meditations with his accustomed devotion, and that it
did descend and go forth the same way, when he bent himself to
Prayers, and reading of Sacred Books. Before these things he used to
be filled with unheard of joy from his assiduous Prayers and
watching, that also he had heard a celestial kind of Musick, and
therefore despising all mortal things, he had distributed all things to
the poor; but that now piety waxing cold by too much appetite after
meat, and his brain troubled with that wind, that he had heard a
voice of one in his brain upbraiding him with Blasphemy, and that he
felt hands beating, and a stink passing before his nose. By all which
Bartholinus guessed, that it was Hypochondriacal Melancholy, and
by good Counsel, proper Physick, merry Company, and rightly
ordering of him, he was perfectly cured.”
4. To these we will only add this that is Histor. medic.
related by Marcellus Donatus, Physician to mirab. l. 2. c. 1. p.
the Duke of Mantua and Montferrat, to this 33.
purpose. “That he knew a Noble Countess of their City, that did most
earnestly affirm, that she was made sick by the Witchery and
Incantation of a certain ill-minded Woman; which was apprehended
by a learned Physician to be, notwithstanding her fancy, nothing else
but Hypochondriacal Melancholy, which he cured by giving her
proper Medicaments to purge that humour, and ordering her
Waiting-maid to put into the matter she voided Nails, Feathers, and
Needles; which when with a glad countenance she had shewed to her
Mistress, she presently cryed out that she had not been deceived,
when she had referred the cause of her disease to Witchcraft, and
afterwards did daily recover more and more.”
 3. And as ignorance and irreligion Relat. of Lancash.
meeting with a melancholick Constitution, Witches.
doth frame many persons to strange fancies
both of fear and credulity: so when to these is added the teachings of
those that are themselves under a most strong passive delusion, then
of all others these become most strongly confident that they can
perform admirable things. As when a person hath by education suckt
in all the grossest fables and lyes of the power of Witches and
familiar Devils, and therein becometh extremely confident,
heightned with the fumes of black Choler, and so thinks, meditates,
and dreameth of Devils, Spirits, and all the strange stories that have
been related of them, and becometh maliciously stirred up against
some Neighbour or other: And so in that malicious and revengeful
mind seeketh unto, and inquireth for some famed and notorious
Witch, of whom they believe they may learn such craft and cunning,
that thereby they may be able to kill or destroy the persons or goods
of those that they suppose have done them injuries. Then meeting
with some that are strongly deluded, and confidently perswaded, that
they have the company and assistance of a familiar Spirit, by whose
help they believe they can do (almost) any thing, especially in
destroying men or cattel, they are presently instructed what vain and
abominable Ceremonies, Observances, Unguents, Charms, making of
Pictures, and a thousand such fond, odd fopperies they are to use, by
which they believe they can do strange Feats. And from this do
proceed their bold and confident confessions of lyes and
impossibilities, that notwithstanding have abused so many to take
them for certain truths: so that according to the Proverb, Popery and
Witchcraft go by Tradition: and we shall find none of these deluded
Witches (if they must be so called) but they have been taught by
others, that thought themselves to be such also. And this is a truth, if
we may trust the confession of Alizon Denice at the Bar at Lancaster,
who saith thus: “That about two years agone her Grandmother called
Elizabeth Sotheres, alias Dembdike, did (sundry times in going or
walking together, as they went begging) perswade and advise this
Examinate to let a Devil or a Familiar appear to her, and that she this
Examinate would let him suck at some part of her, and she might
have and do what she would.”
But besides these two sorts of Witches, whose Existence we deny
not, there is an acceptation of the word Witch in another sense, the
Existence of which I absolutely deny, and that is this according to
Mr. Perkins. “A Witch is a Magician, who either by open or secret
League wittingly and willingly consenteth to use the aid and
assistance of the Devil in the working of Wonders.”
But the full Description and Notion that the common
Witchmongers give a Witch is this. “That a Witch is such a person to
whom the Devil doth appear in some visible shape, with whom the
Witch maketh a League or Covenant, sometimes by Bond signed with
the Witches blood, and that thereby he doth after suck upon some
part of their bodies, and that they have carnal Copulation together,
and that by virtue of that League the Witch can be changed into an
Hare, Dog, Cat, Wolf, or such like Creatures; that they can flye in the
air, raise storms and tempests, kill men or cattel, and such like
wonders.” This notion of a Witch may be gathered from the Writings
of these persons, Delrio the Jesuit, Bodinus, Jacobus Springerus,
Johannes Niderus, Bartholomeus Spineus, Paulus Grillandus,
Lambertus Danæus, Hemmingius, Erastus, Sennertus, and many
others. As also from the Writings of our own Country-men, Mr.
Perkins, Mr. Bernard of Balcombe, the Author of the Book called
Demonology, Mr. Gaule, Mr. Giffard, and divers others, who have
from one to another lickt up the Vomit of the first Broacher of this
vain and false opinion, and without due consideration have laboured
to obtrude it upon others. Yet was it in a manner rejected by the most
of the Learned, who had duly weighed the matter, and read the
strong and convincing arguments of Wierus, Tandlerus, Nymannus,
Biermannus, Gutierrius, Mr. Scot, and the like, until of late years Dr.
Casaubon and Mr. Glanvil have taken up Weapons to defend these
false, absurd, impossible, impious, and bloody opinions withal,
against whose arguments we now principally direct our Pen, and
after the answering of their groundless and unjust scandals, we shall
labour to overthrow their chief Bulwarks and Fortifications.
 CHAP. III.

The denying of such a Witch as is last described in the foregoing

Chapter, doth not infer the denying of Angels or Spirits.
Apparitions no warrantable ground for a Christian to believe
the Existence of Angels or Devils by, but the Word of God.

Having declared in Preface. Of Credulity and

what sense and Incredulity, pag. 7.
acceptation we allow of Witches, and in what notion we deny them,
lest we be misunderstood we shall add thus much: That we do not (as
the Schools speak) deny the existence of Witches absolutè &
simpliciter, sed secundùm quid, and that they do not exist tali modo,
that is, they do not make a visible Contract with the Devil, he doth
not suck upon their bodies, they have not carnal Copulation with
him, and the like recited before, and in these respects, and not
otherwise, did Wierus, Gutierrius and Mr. Scot deny Witches, that is,
that neither they nor their supposed Familiars could perform such
things as are ascribed unto them. And that Dr. Casaubon and Mr.
Glanvil should charge those that hold this opinion with Atheism or
Sadducism, is to me very strange, having no ground, connexion, or
rational consequence so to do: yet doth Dr. Casaubon affirm it in
these words: “Now one prime foundation (saith he) of Atheism, as by
many ancient and late is observed, being the not believing the
existence of spiritual Essences, whether good or bad, separate, or
united, subordinate to God, as to the supreme and original Cause of
all; and by consequent the denying of supernatural operations: I
have, I confess, applied my self, by my examples, which in this case
do more than any reasoning, and (the Authority of the holy
Scriptures laid aside) are almost the only convincing proof.” And Mr.
Glanvil is so confident (I might justly say impudent) that he styled
his Book, A Blow at modern Sadducism, which, I confess, is so weak
a blow, and so blindly levell’d, and so improperly directed, that I am
sure it will kill or hurt no body: and tells us this boldly and roundly.
“And those that dare not bluntly say, There is no God, content
themselves, (for a fair step and introduction) to deny there are
Spirits or Witches. Which sort of Infidels, though they are not
ordinary among the meer Vulgar, yet are they numerous in a little
higher rank of understandings. And those that know any thing of the
World, know that most of the looser Gentry, and the small
Pretenders to Philosophy and Wit, are generally deriders of the belief
of Witches and Apparitions.” And the whole design of his Book is to
prove those men to be guilty of Sadducism, that deny the existence of
Witches understood in his sense, and this we oppose, and the state of
the question we lye down thus.
That the denying the existence of Angels or Spirits; or the
Resurrection, doth not infer the denying of the Being of God; nor the
denying of the existence of Witches (in the sense before laid down)
infer the denying of Angels or Spirits; and that they do unjustly
charge the Authors of this opinion with Sadducism, we shall prove
with irrefragable Arguments.
1. There can be no right deduction made, Argum. 1.
nor no right consequence drawn, where
there is no dependency in causality, nor no connexion of
dependency. For as in the Relative and Correlative, the denying of
the one necessarily destroys the other, yet fundamentum Relationis
non destruitur; so a father without a child, as a father, doth neither
exist nor is known, and yet the foundation of those two terms, of
Paternity and Childship, which is Man, doth remain. So he that
denieth Creation, doth destroy the Relative, which is Creator; yet the
foundation, which is God, doth remain: and the denying of the
Creation, doth not infer the necessary conclusion of denying the
Being of a God, because there might be a God, though there were no
Creation, because God is supposed to be, both in respect of causality
and duration, before Creation. So what relation can Mr. Glanvil feign
betwixt the Being of God and the Being of Angels or Spirits? For they
both belong to the Predicament of Substance, and not that of
Relation; and there is less relation betwixt the Being of a Witch and
the Being of Spirits: so that the denying of the one doth not infer the
denying of the other. And though there were relation (which Mr.
Glanvil cannot shew) the foundation of that Relation (which is so
necessary, that Relatives cannot subsist without it) might remain,
though the Relatives were taken away: and therefore the denying of
the existence of Angels or Spirits, doth not infer the denying of the
Being of God; and therefore the Authors of this opinion are
wrongfully and falsely charged with Atheism: and the denying of the
existence of a Witch (in the sense specified) doth not infer the
denying of the Being of Spirits; and therefore Scot, Osburne, and the
like, are falsely and wrongfully charged with Sadducism.
2. Though it be a Mat. 22. 23. Act. 23. Argum. 2.
true Maxime, that 8.
de posse ad esse non valet argumentum; yet on the contrary, the
possibility of that can never be rationally denied, that hath once been
in esse. But it is apparent, that the Sadducees denied the
Resurrection, and that there were either Angels or Spirits, that is,
they denied that Angels or Spirits, whether good or bad, did
separately exist, and that they were nothing but the good or bad
motions in mens minds: yet these men were no Atheists; for though
they denied the Resurrection, and held that there were no Angels or
Spirits, yet they held and believed there was a God, and did allow of,
and believed the five Books of Moses, else would not our Saviour
have used an argument, whose only strength was drawn from a
sentence in the third Chapter of Exodus, the sixth verse. So that even
the denying of the Existence of Angels and Spirits, doth not infer the
denying of a God; much less doth the denying the Existence of a
Witch, infer the denial of the Being of Angels and Spirits; and
therefore the charge of Atheism and Sadducism is false, injurious,
and scandalous.
3. Those things that in their Beings have Argum. 3.
no dependence one upon another, the
denying of the one doth not takeaway or deny the being of the other;
but where the being doth meerly exist in dependency upon another
superior Cause, there take away or deny the being of the first Cause,
and thereby you take away and deny the being of all the rest that
depends upon it. So he that denies the Being of a God, doth
necessarily deny the Being of Angels or Spirits; but not on the
contrary. For he that denieth the Existence of Angels and Spirits,
doth not therefore necessarily take away or deny the Being of a God,
because the Being of a God is independent of either Angel or Spirit,
and doth exist solely by it self. And therefore if Wierus or Scot had
denied the Existence of Angels and Spirits (which they did not) yet it
would not have inferred that they were Atheists; and therefore are
falsely accused by Dr. Casaubon and Mr. Glanvil. And though they
should have denied the Existence of Witches (which they did not
simpliciter, sed tali modo) yet it would not have inferred, that they
were guilty of Sadducism, because Spirits or Demons have their
Existence without any dependence of the being of Witches; and
therefore it is but a poor fallacia consequentiæ to say, he that denies
a Witch, denies a Demon or Spirit.
4. The denying of the Existence of Spirits, Argum. 4.
doth not infer the denying of the Being of a
God, because in the priority of duration God was when Spirits were
not, for they are not immortal à parte anté. So likewise the denying
of the Existence of Witches, doth not infer the denial of the Being of
Spirits, for in the priority of duration Spirits were existent before
Witches; for Adam and Eve could not be ignorant that there were
Spirits, both good and bad, and yet then there were no Witches. So
that a Spirit having, in respect of duration, a Being before that a
Witch can have any; the denying the Existence of the latter, doth not
infer the denying of the Being of the former, but is meerly
inconsequent, agreeable to no Rules of Logick, except that of Logger-
head Colledge.
5. Many properties or proper adjuncts Argum. 5.
may be ascribed unto a substance, the
denying of which adjuncts, doth not infer the denying of the being of
the substance. So that to deny that a Horse hath fins like a fish, or
wings like a bird, doth not infer the denying of the being of a Horse.
Therefore it is injurious and scandalous in Dr. Casaubon and Mr.
Glanvil, to charge Dr. Wierus and Mr. Scot with Atheism and
Sadducism, when indeed (as we shall prove hereafter) their own
Tenents tend to blasphemy, impiety, vanity, and uncharitableness.
Another thing that we oppose is, that Apparitions are no
warrantable ground for a Christian to believe the Existence of Angels
and Spirits by, but the Word of God, which these cogent reasons do
sufficiently prove.
 1. For to say that the Apparitions of Argum. 1.
Spirits, good or bad, do prove their
Existence, is but petitio principii, a begging of the question, that first
is in doubt, and ought to be proved. For how come we to be assured,
that the Apparitions that are made, and really by unquestionable
Witnesses attested for truth (not to speak of melancholy Fancies, and
Fables, Knacks of Knavery and Imposture, and other ignorant and
gross mistakes, which are often believed to be Apparitions, when
they are no such matter) that they are made by good or bad Spirits?
for that is the thing in doubt, and so is but a circular way of arguing
by way of begging the question, or proving ignotum per ignotius; for
Apparitions do not prove the Being of Spirits, except it be first
proved, that those Apparitions be made or caused by Spirits.
2. There are many Apparitions that are Argum. 2.
produced by natural and artificial Causes,
and need not be referred to supernatural ones, as are all those Idola,
Images, or Species that we see in Glasses, which cannot be denied to
be Apparitions, and yet arise from natural Causes. So the Apparition
of Comets, new Stars, and many other sort of strange Meteors, as
sometimes three Suns, the Rain-bow, Halones, and the like, that
have natural Causes to produce them, and are no proof of the Being
of Spirits. Nay as the best and most credible Historians have left
upon Record, and hath been known to be a certain verity in divers
parts of these three Kingdoms, within the space of these forty years,
strange and various Sights have been seen in the Air, both of Men,
and Horses, and Armies fighting one with another; and yet were
these no proof of the Existence of Spirits, because they may (and
doubtlesly do) proceed from other causes, and not from the
operation or efficiency of Angels or Spirits, either good or bad.
3. It is not Jo. Drusii Præterit. Argum. 3.
certainly known l. 7. p. 289.
what diversity of De Nymph. lib. pag. De Subtil. l. 19. p.
Creatures there 389. 1202, 1203.
may be that are mediæ naturæ betwixt The invisible World,
Angels and Men, that may sometimes sect. 6. pag. 303.
appear, and then vanish: so that if it be granted, that there be
Apparitions really and truly, yet it will not necessarily follow, that
these are caused by good or bad Angels, because they may be effected
by Creatures of another and middle Nature; and so Apparitions no
certain ground for the believing of the Existence of Angels or Spirits.
For the most learned Drusius gives us this account from one of the
Commentators upon the Book Aboth. “Debet homo intelligere ac
scire à terra usq; ad firmamentum, quod Rakia, id est, Expansum
appellant, omnia plena esse turmis & præfectis, & infrà plurimas
esse creaturas lædentes & accusantes, omnésq; stare ac volare in
aëre, neq; à terra usq; ad firmamentum locum esse vacuum: sed
omnia plena esse præpositis, quorum alii ad pacem, alii ad bellum,
alii ad bonum, alii ad malum; ad vitam & ad mortem incitant. Ob id
compositum fuit canticum occursuum, quod incipit, Sedet in occulto
Supremus.” And if this be a truth, here are orders and numbers
enough of several sorts to make Apparitions, and yet be neither the
good or bad Angels. And if there may any credit be given to the
relation that Cardan gives of his Father Facius Cardanus, which he
had from his own mouth, and also had left it in writing; then “there
are mortal Demons, that are born and do die as men do, that can
appear and disappear, and are of such most tenuious bodies, that
they can afford us neither help nor, hurt, excepting terrors, and
spectres, and knowledge”. And if there may be credit given to
Plutarch (so highly magnified by Dr. Casaubon) the God Pan of the
Heathens must have been one of these mortal Demons, because he
tells us upon the credit of Epotherses (a Tale of hear-say) “That
Thamus was by a voice thrice calling upon him, commanded that
when he came to Palodes, he should tell them, that the great God
Pan was dead”. And that there are such mortal Demons, is strongly
asserted by Paracelsus, and by him called Nymphæ, Sylphi, Pygmæi,
and Salamandræ, and that they are not of Adams Generation, and
that they have wonderful power and skill. And to this opinion do the
Schools both of the ancient and later Academicks wholly incline, and
seems to be favoured both by Dr. Moor and Mr. Glanvil himself; and
if there be any such matters, doubtless from thence did arise all the
strange stories and gests that former Generations have told and
believed concerning the Apparition of these kind of Creatures, which
the common people call Fayries: of which the Reverend and Learned
person Bishop Hall giveth us this touch: “The times are not past the
ken of our memory, since the frequent (and in some part true)
reports of those familiar Devils, Fayries, and Goblins, wherewith
many places were commonly haunted; the rarity whereof in these
latter times, is sufficient to descry the difference betwixt the state of
ignorant Superstition, and the clear light of the Gospel.” And
whosoever shall seriously read and consider that little Piece that was
printed some few years since, though written long ago, and by some
(that pretend to no small share of Learning) cryed up exceedingly for
a most convincing Relation, to prove the Existence of Spirits, called,
The Devil of Mascon, may easily gather, that if the thing were truly
related, as to the matter of fact, that it must needs be some Creature
of a middle Nature, and no evil Spirit, both because it was such a
sportful and mannerly Creature, that it would leave them, and not
disturb them at their devotions; as also (as far as I remember, for I
have not the Book by me) because it denied that it was a Devil, and
professed that it hoped to be saved by Christ.
4. That the Joh. 15. 15. Argum. 4.
Scriptures contain 2 Tim. 3. 15, 16, 17. Act. 20. 27.
in them all things 2 Cor. 2. 11. Eph. 6. 11, 12, 13.
necessary to Luk. 16. 29, 30, 31. 2 Pet. 1. 19.
Salvation, is so Isa. 8. 19, 20. Sup. Gen. ad lit. l. 2.
clear a truth, that
none but those that are wilfully blind can deny it; for Christ taught
his Disciples all things that he had learned of the Father, and the
Father sending him to be the Saviour of the World, and to preach the
Gospel of eternal Salvation, was not defective in declaring all things
that were necessary to accomplish the work and end, for which he
was sent forth of the Father. And the glorious Apostle St. Paul tells
the Disciples and Brethren, That he had not shunned to declare unto
them all the counsel of God, which must of necessity be abundantly
sufficient for their Salvations. And he telleth Timothy, That he had
known the Scriptures from a child, which were able to make him
wise unto salvation. All Scripture is given by inspiration of God,
and is profitable for doctrine, for reproof, for correction, for
instruction in righteousness: That the man of God may be perfect,
throughly furnished unto all good works. Nay the Woman of
Samaria had so much knowledge and faith, that she believed that
when the Messias was come, he would tell them all things. Now to
the obtaining of Salvation, there is nothing more necessary than to
know what enemies men have to fight against in their Christian
Warfare, which the Apostle tells in these words: For we wrestle not
against flesh and blood, but against principalities, against powers,
against the rulers of the darkness of this world, against Spiritual
wickedness in high places: Wherefore they are to take unto them the
whole armor of God, πανοπλίαν τοῦ Θεοῦ, that they may be able to
stand against the wiles of the Devil, μεθοδείας τοῦ διαβόλου: and
that made the Apostle say in another place, We are not ignorant of
his devices or crafts, νοήματα. Now the Scriptures being able to
make us wise to Salvation, it hath sufficiently declared the natures,
powers, knowledge, and offices of both the good and bad Angels, and
is a sure word of Prophecy, unto which it is good to take heed, and
not unto old wives fables of Apparitions and Goblins, such as Mr.
Glanvil would perswade us that they are tydings of another World,
when we are taught by unerring testimony of Truth, That those that
have Moses and the Prophets, and do not hear them, neither will
they be perswaded, though one rose from the dead. And therefore
we must be bold to tell Mr. Glanvil, that the Sacred Scriptures do
with infallible certitude teach us, that both good and bad Spirits have
most certainly an Existence, and therefore we need none of his
feigned nor forged stories of Apparitions; which if they were certainly
known to be true and real, by undeceivable matters of fact, yet he
that doth not believe what is written of the Being of Spirits by Moses
and the Prophets, will not believe Apparitions, no not of a man, if he
came from the dead. And therefore I will conclude with that precious
and pithy Sentence of St. Austin, who saith: Major est hujus
Scripturæ authoritas, quàm omnis humani ingenii perspicacitas.
And believe not them that say, If you would know the power of Devils
and Witches, go to the Writings of Dr. Casaubon, Mr. Glanvil, and to
the rest of the Demonographers and Witchmongers, that amass and
heap together all the lying, vain improbable, and impossible stories
that can be scraped forth of any Author, ancient, middle, or modern,
when we are commanded to go to the Law and to the Testimony, if
they speak not according to this word, it is because there is no truth
in them. And so I shall shut up this Chapter, wherein (I suppose) I
have sufficiently proved, that the denying of such a Witch as I have
described, doth not infer the denial of the Being of Angels or Spirits,
and that Apparitions are no sufficient grounds for Christians to
believe the Existence of Angels and Spirits by, but the Word of God;
which was the thing undertaken to be proved.
 CHAP. IV.

That the Scriptures and sound Reason are the true and proper
Mediums to prove the Actions attributed unto Witches by, and
not other improper ways that many Authors have used. And of
the Requisites necessary truly to prove a matter of Fact by.

As we have in the former Chapter proved, that Apparitions (though

true) are no sufficient warrant to ground our belief upon, for the
Existence of Angels or Spirits, but the Word of God: so here we shall
endeavour clearly to manifest, that the Sacred Scriptures are the only
Medium, joyned with sound Reason, of deciding this point of the
power and operation of Demons and Witches, and not other
improper Mediums brought in by divers Authors, and first we shall
answer the Objection of Mr. Glanvil, that runs thus.
“That though the Pag. 96, 97. Object. 1.
New Testament
had mentioned nothing of this matter, yet its silence in such cases is
not argumentative. He said nothing of those large unknown Tracts of
America, nor gave he any intimations of as much as the existence of
that numerous people; much less did he leave instructions about
their Conversion. He gives no account of the affairs and state of the
other World, but only that general one of the happiness of some, and
the misery of others. He made no discovery of the Magnalia of Art or
Nature, no not of those whereby the propagation of the Gospel might
have been much advanced, viz. the Mystery of Printing and the
Magnet, and yet no one useth his silence in these instances as an
argument against the being of things, which are evident objects of
sense.” To which we answer.
Respons.
 1. He falleth into a common mistake in making the Proposition
universal, and dolus versatur in universalibus, when it ought but to
be particular: so for him to say, that no silence of Scripture is
argumentative, is too universal; for its silence in point of Geography,
as in describing America, and the people thereof, nor in discovering
the Magnalia Naturæ & Artis is not argumentative; and we do not
say, that all silence of Scripture is argumentative, but yet we affirm
that some silence of Scripture is argumentative. So we cannot
universally say, that nothing hath a being but what is mentioned in
Scripture; but we may very well affirm, that some things have no
being, or truth of existence, because not declared in Scripture.
2. The Scriptures were not written to Lib. 1. c. 1.
teach Natural Philosophy, Arts or Sciences,
humane Policy, or the like; but were given, that the man of God
might be perfect, furnished for every good work: and it is by them
that we have the doctrine of eternal Salvation revealed unto us, and
we positively affirm the sufficiency of the Scriptures unto Salvation,
which thing no Orthodox Divine (we suppose) will deny, and
Bellarmine himself did confess in these words: Prophetici &
Apostolici libri sunt verum verbum Dei, ac stabilis regula fidei. And
if it be a certain Rule of Faith, and the true Word of God, then
whatsoever it is silent of, we ought not to believe, and so its silence is
argumentative in that point. The Scriptures are utterly silent
concerning Purgatory, and therefore it is a good argument to affirm
there is no such place as Purgatory, because the Word of God is silent
as concerning it; but if it had been necessary to have been believed,
then there would have been mention made of it.
3. And as the Scriptures are sufficient in matters of Faith, and
circa credenda, and what they are silent in, are not to be received as
Articles of our Faith, but to be rejected, as having no truth of
Existence: So likewise what Worship God requireth of his people, is
fully revealed in his Word, and therefore I am to reject the
worshipping of Mahomet with the Turks, or Images, and praying to
Saints with the Papists, because I have neither precept nor president
in the Word, but it is silent in such matters; nay tells us, That he is
the Lord our God, and him only we ought to serve.
4. Though Mr. Origin. Sacr. l. 3. c. Pag. 87, 88. 23.
Glanvil say, that 6. p. 608.
God hath given no Joh. 17. 24. Invisib. World, p.
account of the Serm. c. 7. 112.
state of the other Luk. 23. 43. Wisd. 3. 1.
World, but only Luk. 16. 22, 23. Concio secunda de
that general one of 2 Sam. 12. 23. Lazaro.
the happiness of
Idem. 10. 20, 21. Job 7. 9, 10.
some, and the
misery of others; Homil. sect. 16. Bellarm. Enervat.
pag. 484. tom. 2. l. 5. p. 204.
yet Am I to believe
as Mr. Glanvil somewhere in his Book affirmeth, that Samuels Soul
was raised up by the Woman at Endor, and that those that he
feigneth to make Leagues and Contracts with Witches, are the Souls
of such as had been Witches when they lived, and asketh, Who saith
that happy Souls were never imployed in any ministeries here below?
Or am I to believe that both the Souls of the godly and wicked, do
rove up and down here upon earth, and make Apparitions, because
the Popish Teachers do hold it to be so? I hope not, and therefore I
shall in part give an answer here to some of these, and handle that of
the Woman of Endor in another place. 1. The Word of God doth
particularly teach us the state and condition of the Souls after death,
that they shall be like the Angels in Heaven; and all other things
necessary to move and draw us to believe the immortal Existence of
Souls, as that most able and learned Divine Dr. Stillingfleet hath
asserted in these words: “The Scriptures give the most faithful
representation of the state and condition of the Soul of Man. The
World (he saith) was almost lost in Disputes concerning the Nature,
Condition, and Immortality of the Soul, before divine Revelation was
made known to Mankind by the Gospel of Christ; but life and
immortality was brought to light by the Gospel, and the future state
of the soul of man not discovered in an uncertain Platonical way, but
with the greatest light and evidence from that God who hath the
supreme disposal of souls, and therefore best knows and
understands them.” A Sentence truly pious and orthodoxal. 2. Hath
not God in the holy Scriptures amply and plainly taught us the state
of the other World, in describing unto us such a numerous company
of Seraphims and Cherubims, Angels and Archangels, with their
several Orders, Offices, Ministeries, and Imployments? and this is
more than a general account, as may be seen at full in that learned
and godly Piece of Bishop Halls, called The invisible World. And
hath he not given us a particular account of the very Kingdom of
Darkness, telling us of the Devil and his Angels, and precisely in this
enumeration? For we wrestle not with flesh and blood, but against
principalities, against powers, against the rulers of the darkness of
this world, against spiritual wickedness in high places. And this is
more than a general account, and we must needs say, that what he
holds is very derogatory to the wisdom and goodness of God, and the
sufficiency and truth of the Scriptures. 3. Must I believe him that the
souls of the Saints do rove and wander here below? when as Bishop
Hall saith, where he is speaking against the opinion of those that
hold, that Souls do sleep until the Day of Judgment: “Indeed who can
but wonder that any Christian can possibly give entertainment to so
absurd a thought, whilst he hears his Saviour say, Father I will that
they also whom thou hast given me, be with me where I am, and
that (not in a safe sleep) they may behold my glory, which thou hast
given me.” Sure if the Souls departed be with Christ where he is, and
do behold his glory, then it is a Popish Fable of Mr. Glanvil, to feign
their coming upon Messages hither. The saying of St. Bernard is
remarkable in this case: Advertistis tres esse sanctarum status
animarum, primum videlicet in corpore corruptibili, secundum sine
corpore, tertium in corpore jam glorificato. Primum in militia,
secundum in requie, tertium in beatitudine consummata. And if the
second state of holy Souls be without a body, and be at peace and
rest, then it must necessarily be a truth, that they do not wander
here, nor run upon Errands; For the souls of the righteous are in the
hands of the Lord, and there shall no torment touch them. And our
Saviour told the Thief upon the Cross, This day thou shalt be with
me in Paradise, that is, as Dr. Hammond giveth the Paraphrase:
“Immediately after thy death thou shalt go to a place of bliss, and
there abide with me, a Member of that my Kingdom which thou
askest for.” Now if the souls of the godly, after their death, be
immediately in a place of bliss, and abide with Christ as Members of
his Kingdom, then they do not wander up and down here, as Mr.
Glanvil and the Papists vainly fancy and believe; for as Chrysostome
saith upon that place of Lazarus his being carried by Angels into
Abrahams bosome. “What is it then that the Devils say, I am the Soul
of such a Monk? Truly I therefore believe it not, because the Devils
say it, for they deceive their Auditors.” 4. Or must I believe that the
souls of the wicked do wander, and make Apparitions here, because