Eccf 12.13.2013

Save

Privacy Impact Assessment Form
v 1.43
Status Approve

Form Number

F-85326

Form Date

Question

Answer

1

OPDIV:

SAMHSA

2

PIA Unique Identifier:

P-3946423-404481

2a Name:

12/6/2013 4:58:33 PM

ECCF
General Support System (GSS)
Major Application

3

Minor Application (stand-alone)

The subject of this PIA is which of the following?

Minor Application (child)
Electronic Information Collection
Unknown

3a

Identify the Enterprise Performance Lifecycle Phase
of the system.

Initiation
Yes

3b Is this a FISMA-Reportable system?

4

Does the system include a Website or online
application available to and for the use of the general
public?

5

Identify the operator.

6

Point of Contact (POC):

7

Is this a new or existing system?

8

Does the system have Security Authorization (SA)?

8b Planned Date of Security Authorization

No
Yes
No
Agency
Contractor
POC Title

Director, Division of Workplace
Programs

POC Name

Ronald R. Flegel

POC Organization SAMHSA/CSAP
POC Email

[email protected]

POC Phone

240.276.2611
New
Existing
Yes
No
1/1/0001 12:00:00 AM
Not Applicable

The Federal Workplace Drug Testing Programs were
established by Executive Order 12564 on September 15, 1986
and legislatively mandated in Section 503 of Public Law 100-71
dated July 11, 1987 . As a result of the Executive Order and
Public Law, the Department of Health and Human Services
Page 1 of 8
(HHS) initially published the Mandatory Guidelines for Federal

Save
The paper Federal CCF is a five-copy, carbonless form used to
identify a specimen and to document its handling at the
collection site. The 5 copies are as follows:
Copy 1 Test Facility Copy
Copy 2 Medical Review Officer Copy
Copy 3 Collector Copy
Copy 4 Employer Copy
Copy 5 Donor Copy
The reverse side of Copy 5 gives instructions on completing
the Federal CCF. There is also a privacy act statement for
federal employees on the reverse side of Copy 5 that explains
the donor’s rights relative to the release of information found
on the form.
The electronic Federal CCF has the same format as the OMBDescribe the type of information the system will
approved form. Because Copies 2-5 are identical, the electronic
collect, maintain (store), or share. (Subsequent
12
questions will identify if this information is PII and ask CCF consists of Copy 1 (Test Facility Copy) and Copy 2 (which is
distributed to the MRO, collector, employer, and donor). The
about the specific data elements.)
electronic Federal CCF is the functional equivalent of a paper
Federal CCF with respect to integrity, accuracy, and
accessibility.
All of the information on the Federal CCF is necessary to ensure
that the specimen can be forensically proven to be collected
from a specific donor, yet the privacy of the donor’s identity is
maintained (i.e., the laboratory is not given the donor’s name).
The NLCP Urine Laboratory Application Form and NLCP
Laboratory Information Checklist Sections B and C are kept
secure and private at the NLCP contractor facility. All the
records maintained at the certified laboratories are kept secure
and private in accordance with the Mandatory Guidelines for
Federal Workplace Drug Testing Programs.

Provide an overview of the system and describe the
13 information it will collect, maintain (store), or share,
either permanently or temporarily.

14 Does the system collect, maintain, use or share PII?

A separate Federal CCF is used for each urine specimen that is
collected. A urine specimen may be collected for one of the
following reasons: pre-employment, random, reasonable
suspicion/cause, post-accident, return to duty, or follow-up.
Each federal agency and employer regulated by DOT
establishes the frequency at which employees are randomly
selected for drug testing, while the frequency for testing for
the other reasons depends on the circumstances. The
deterrence effect of a workplace drug testing program is
related to the frequency that employees are tested.
Yes
No

Page 2 of 8

Save

Indicate the type of PII that the system will collect or
15
maintain.

Social Security Number

Date of Birth

Name

Photographic Identifiers

Driver's License Number

Biometric Identifiers

Mother's Maiden Name

Vehicle Identifiers

E-Mail Address

Mailing Address

Phone Numbers

Medical Records Number

Medical Notes

Financial Account Info

Certificates

Legal Documents

Education Records

Device Identifiers

Military Status

Employment Status

Foreign Activities

Passport Number

Taxpayer ID

Employees
Public Citizens
16

Indicate the categories of individuals about whom PII
is collected, maintained or shared.

Business Partners/Contacts (Federal, state, local agencies)
Vendors/Suppliers/Contractors
Patients
Other job applicants

17 How many individuals' PII is in the system?
18 For what primary purpose is the PII used?
19

Describe the secondary uses for which the PII will be
used (e.g. testing, training or research)

1,000,000 or more
to link the biological specimen and drug test results to the
donor
none

20 Describe the function of the SSN.

donor identifier to link the biological specimen and drug test
results to the donor

20a Cite the legal authority to use the SSN.

The information on the Federal CCF is collected under the
authority in Executive Order 12564, 5 U.S.C. 3301 (2), 5 U.S.C.
7301, and Section 503 of Public Law 100-71, 5 U.S.C. 7301 note.
Test results may only be disclosed to an MRO, the federal
agency administrator of the Employee Assistance Program,
and a supervisor with authority to take adverse personnel
action. The information on each copy of the Federal CCF was
developed to protect the identity of the individual being
tested. Other federal agencies (DOT, NRC) require use of the
Federal CCF in workplace programs under their regulations
(DOT 49 Part 40 under authority of the Omnibus
Transportation Act; NRC 10 CFR Part 26.31 under authority of
the Atomic Energy Act of 1954, as amended the Energy
Reorganization Act of 1974, as amended, and 5 U.S.C 553. )

Page 3 of 8

Save
The information on the Federal CCF is collected under the
authority in Executive Order 12564, 5 U.S.C. 3301 (2), 5 U.S.C.
7301, and Section 503 of Public Law 100-71, 5 U.S.C. 7301 note.
Test results may only be disclosed to an MRO, the federal
agency administrator of the Employee Assistance Program,
and a supervisor with authority to take adverse personnel
Identify legal authorities governing information use action. The information on each copy of the Federal CCF was
21
and disclosure specific to the system and program.
developed to protect the identity of the individual being
tested. Other federal agencies (DOT, NRC) require use of the
Federal CCF in workplace programs under their regulations
(DOT 49 Part 40 under authority of the Omnibus
Transportation Act; NRC 10 CFR Part 26.31 under authority of
the Atomic Energy Act of 1954, as amended the Energy
Reorganization Act of 1974, as amended, and 5 U.S.C 553. )
22

Yes

Are records on the system retrieved by one or more
PII data elements?

No
Published:

Identify the number and title of the Privacy Act
System of Records Notice (SORN) that is being used
22a
to cover the system or identify if a SORN is being
developed.

Published:
Published:
In Progress
Directly from an individual about whom the
information pertains
In-Person
Hard Copy: Mail/Fax
Email
Online
Other
Government Sources

23

Within the OPDIV
Other HHS OPDIV
State/Local/Tribal
Foreign
Other Federal Entities
Other

Identify the sources of PII in the system.

Non-Government Sources
Members of the Public
Commercial Data Broker
Public Media/Internet
Private Sector
Other
23a

Identify the OMB information collection approval
number and expiration date.

24 Is the PII shared with other organizations?

OMB No. 0930-015, expires August 31, 2013
Yes
No

Page 4 of 8

Save
Within HHS
Other Federal
Agency/Agencies

24a

Identify with whom the PII is shared or disclosed and
for what purpose.

specimen collector, HHS-certified drug testing laboratory,
federal agency employer and Medical Rview Officer: to link
the biological specimen and drug test results to the donor
State or Local
Agency/Agencies
Private Sector
specimen collector, HHS-certified drug testing laboratory,
federally regulated employer and Medical Review Officer: to
link the biological specimen and drug test results to the
donor

Describe any agreements in place that authorizes the
information sharing or disclosure (e.g. Computer
24b Matching Agreement, Memorandum of
Understanding (MOU), or Information Sharing
Agreement (ISA)).
24c

Describe the procedures for accounting for
disclosures

Describe the process in place to notify individuals
25 that their personal information will be collected. If
no prior notice is given, explain the reason.
26

The PII on the Federal CCF is shared in accordance with the
HHS Mandatory Guidelines for Federal Workplace Drug
Testing Programs and other federal agency regulations (e.g.,
DOT 49 CFR Part 40, NRC 10 CFR Part 26)
Please see answer to question #12
Privacy Act Statement (For Federal Employees Only) is
provided at the time of specimen collection. Employers inform
their employees of drug testing requirements.
Voluntary

Is the submission of PII by individuals voluntary or
mandatory?

Mandatory

Describe the method for individuals to opt-out of the
collection or use of their PII. If there is no option to
27
Individuals may object
object to the information collection, provide a
reason.
Describe the process to notify and obtain consent
from the individuals whose PII is in the system when
major changes occur to the system (e.g., disclosure
28 and/or data uses have changed since the notice at
the time of original collection). Alternatively, describe
why they cannot be notified or have their consent
obtained.

Only the specimen collectors and/or employee representative
have access to this form for custody and control purposes.
Consent is obtained at the time of acceptance of federal
employment by the federal employee.

Please provide a description of the process (if one exists) for
notifying and obtaining consent from individuals whose PII is
Question 28 Comments in the system when a major change occurs. A Federal Register
Notice does not constitute a process for obtaining consent. If a
process does not exist, please describe why the individuals
cannot be notified or their consent obtained.
Describe the process in place to resolve an
individual's concerns when they believe their PII has the Medical Review Officer verifies the accuracy of PII during
29 been inappropriately obtained, used, or disclosed, or the review/verification process. Individuals may report other
that the PII is inaccurate. If no process exists, explain concerns to their employer .
why not.

Page 5 of 8

Save
Describe the process in place for periodic reviews of
PII contained in the system to ensure the data's
30
integrity, availability, accuracy and relevancy. If no
processes are in place, explain why not.

HHS conducts periodic audits of HHS-certified drug testing
laboratories to ensure data integrity, etc.

Users

Collectors, laboratory staff, MROs and
MRO staff, employers, third party
administrators to facilitate federal drug
testing custody and control.

Administrators
31

Identify who will have access to the PII in the system
and the reason why they require access.

Developers
Contractors
Others

Managers of computer systems utilized
by drug testing service providers for IT
administration.

Question 31 Comments Please provide the reason why the individuals above require
access to the system.
Describe the procedures in place to determine which Collection organizations, laboratories, MROs, and employers
32 system users (administrators, developers,
limit access to PII to staff requiring access based on job duties
contractors, etc.) may access PII.
with federally regulated drug testing programs.
Describe the methods in place to allow those with
33 access to PII to only access the minimum amount of
information necessary to perform their job.

Collection organizations, laboratories, MROs, and employers
use an appropriate user identification and authentication
system for network operating systems, LIMS, and/or database
systems with PII.

Identify training and awareness provided to
personnel (system owners, managers, operators,
contractors and/or program managers) using the
34
system to make them aware of their responsibilities
for protecting the information being collected and
maintained.

The HHS Mandatory Guidelines for Federal Workplace Drug
Testing Programs specifies training required for collectors,
laboratory personnel, and MROs. Collector training must be
documented and provided to federal agencies upon request,
laboratory personnel training records are reviewed during
onsite inspections, SAMHSA approves MRO training/
certification organizations.

Describe training system users receive (above and
35 beyond general security and privacy awareness
training).

The HHS Mandatory Guidelines for Federal Workplace Drug
Testing Programs specifies training required for collectors,
laboratory personnel, and MROs. Collector training must be
documented and provided to federal agencies upon request,
laboratory personnel training records are reviewed during
onsite inspections, SAMHSA approves MRO training/
certification organizations.

Do contracts include Federal Acquisition Regulation
36 and other appropriate clauses ensuring adherence to
privacy provisions and practices?
Describe the process and guidelines in place with
37 regard to the retention and destruction of PII. Cite
specific records retention schedules.

Yes
No
The HHS Mandatory Guidelines require collectors, laboratories,
and MROs to maintain drug testing specimen records for two
years. Laboratories must retain records of a specimen
undergoing legal challenge for a longer period when specified
in a written request from a federal agency.

Page 6 of 8

Save
Describe, briefly but with specificity, how the PII will
38 be secured in the system using administrative,
technical, and physical controls.

Authority checks are used 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 operations.

REVIEWER QUESTIONS: The following section contains Reviewer Questions which are not to be filled out unless the user is an OPDIV
Senior Officer for Privacy.

Reviewer Questions
1

Are the questions on the PIA answered correctly, accurately, and completely?

Answer
Yes
No

Reviewer
Notes
2

Does the PIA appropriately communicate the purpose of PII in the system and is the purpose
justified by appropriate legal authorities?

Yes

Do system owners demonstrate appropriate understanding of the impact of the PII in the
system and provide sufficient oversight to employees and contractors?

Yes

No

Reviewer
Notes
3

No

Reviewer
Notes
4

Does the PIA appropriately describe the PII quality and integrity of the data?

Yes
No

Reviewer
Notes
5

Is this a candidate for PII minimization?

Yes
No

Reviewer
Notes
6

Does the PIA accurately identify data retention procedures and records retention schedules?

Yes
No

Reviewer
Notes
7

Are the individuals whose PII is in the system provided appropriate participation?

Yes
No

Reviewer
Notes
8

Does the PIA raise any concerns about the security of the PII?

Yes
No

Reviewer
Notes
9

Is applicability of the Privacy Act captured correctly and is a SORN published or does it need
to be?

Yes
No

Page 7 of 8

Save
Reviewer Questions

Answer

Reviewer
Notes No SORN necessary since there is no data retention. Form simply used as chain of custody.
10

Yes

Is the PII appropriately limited for use internally and with third parties?

No

Reviewer
Notes
11

Yes

Does the PIA demonstrate compliance with all Web privacy requirements?

No

Reviewer
Notes N/A
12

Were any changes made to the system because of the completion of this PIA?

Yes
No

Reviewer
Notes

General Comments

OPDIV Senior Official
for Privacy Signature

The purpose of this PIA is to cover automation of the Federal Drug Testing Custody and Control Form
(CCF) which is stored on the Department of Transportation's (DOT) system. SAMHSA is merely responsible
for automating and maintaining the to ensure proper chain of custody in accordance with federal
regulations. The form is being converted from paper to PDF and information will not be maintained in a
computer system, so there is no SA. This PIA is also required as SAMHSA completes the OMB form
approval process.

Carla S.
Burch

Digitally signed by Carla S. Burch
DN: c=US, o=U.S. Government, ou=HHS,
ou=SAMHSA, ou=People, cn=Carla S.
Burch,
0.9.2342.19200300.100.1.1=2000939133
Date: 2013.12.11 12:06:07 -05'00'

HHS Senior
Agency Official
for Privacy

Kristofor T.
O'neal -S

Digitally signed by Kristofor T. O'neal -S
DN: c=US, o=U.S. Government, ou=HHS,
ou=OS, ou=People,
0.9.2342.19200300.100.1.1=2000455610,
cn=Kristofor T. O'neal -S
Date: 2013.12.12 14:58:25 -05'00'

Page 8 of 8