PIA - Lab-based Enteric Disease Surveillance

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Privacy Impact Assessment Form
v 1.45
Status Draft

Form Number

F-20292

Form Date

Question

Answer

1

OPDIV:

CDC

2

PIA Unique Identifier:

P-3096596-687484

2a Name:

1/27/2015 7:25:07 AM

Laboratory Based Enteric Disease Surveillance (LEDS)
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.

Operations and Maintenance
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

Business Steward

POC Name

Patti Griffin

POC Organization CDC/OID/NCEZID
POC Email

[email protected]

POC Phone

404.639.3384
New
Existing
Yes
No
February 19, 2015
Not Applicable

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11 Describe the purpose of the system.

LEDS is a combination of CDC-developed message handlers
and SAS programs that capture, store and analyze laboratory
confirmed isolate information obtained through the
transmittal and receiving of isolate information from external
laboratories. Data from this system is used by CDC for disease
surveillance and analysis. There are four programs that
participate and receive some or all of their data via this system:
Foodborne, Influenza, Rabies and FoodNet.

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Four independent programs fall under the umbrella that is
called LEDS. Each program collects the same basic
demographic information and differentiates themselves by the
additional information each collects. The external sites are
provided detailed instructions on how to create the disease
specific ASCII delimited files from their Laboratory Information
Management System (LIMS). They send these files via CDC’s
Public Health Information Network Messaging System
(PHINMS).
The information collection and analysis requirements of the
LEDS programs are managed independently through their
corresponding CDC divisions as follows:
Division of Foodborne, Waterborne and Environmental
Diseases (NCEZID\DFWED)
• Foodborne
o Diseases: Campylobacteriosis, Escherichia coli,
Salmonellosis, Shigellosis
o Detailed isolate information is collected along with
minimal demographic information such as State, Zip
code, County, Sex, Ethnicity, Race and Age.
Describe the type of information the system will
• FoodNet
collect, maintain (store), or share. (Subsequent
o Diseases: Campylobacteriosis, Cholera, Cryptosporidiosis,
12
questions will identify if this information is PII and ask
Cyclosporiasis, Escherichia coli, HUS, Listeriosis,
about the specific data elements.)
Salmonellosis, Shigellosis, Yersiniosis
o Detailed isolate information is collected along with
minimal demographic information such as State, Zip
code, County, Sex, Ethnicity, Race and Age. Once or twice
a year, case studies are conducted and the interview
questions are transmitted and added to the database.
No PII data is collected for case studies.
Influenza Division (NCIRD/ID)
• Influenza
o Diseases: Influenza
o Detailed isolate information is collected along with
minimal demographic information such as State, Zip
code, County, Sex, Ethnicity, Race and Age.
Division of High-Consequence Pathogens and Pathology
(NCEZID\DHCPP)
• Rabies
o Diseases: Rabies
o Detailed isolate information is collected along with
minimal demographic information such as State, Zip
code, County, Sex, Ethnicity, Race and Age.

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

LEDS is a combination of CDC-developed message handlers
and SAS programs that capture, store and analyze laboratory
confirmed isolate information obtained through the
transmittal and receiving of isolate information from external
laboratories. Data from this system is used by CDC for disease
surveillance and analysis. There are four programs that
participate and receive some or all of their data via this system:
Foodborne, Influenza, Rabies and FoodNet.
Detailed isolate information is collected along with minimal
demographic information such as State, Zip code, County, Sex,
Ethnicity, Race and Age.
Yes

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

No

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

Ethnicity

Race

County

Gender

Zip code

Employees
Public Citizens
16

Business Partners/Contacts (Federal, state, local agencies)

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

Vendors/Suppliers/Contractors
Patients
Other

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)

20 Describe the function of the SSN.

1,000,000 or more
The PII is used by programs for disease surveillance and
statistical analysis.
n/a
n/a

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20a Cite the legal authority to use the SSN.

n/a

21

Identify legal authorities governing information use
Public Health Service Act, Section 306(b) (42 U.S.C. 242k)
and disclosure specific to the system and program.

22

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

Yes
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.

Not-Applicable
Yes

24 Is the PII shared with other organizations?

No
Within HHS

24a

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

Other Federal
Agency/Agencies
State or Local
Agency/Agencies
Private Sector

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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

Is the submission of PII by individuals voluntary or
mandatory?

No prior notice is given. All information is obtained at the State
Health Department level. CDC does not interact with any
individual and therefore all responsibility for patient
notification resides with the State.
Voluntary
Mandatory

No option exists. All information is obtained at the State
Describe the method for individuals to opt-out of the Health Department level. CDC does not interact with any
individual and therefore all responsibility for patient
collection or use of their PII. If there is no option to
27
notification resides with the State. The LEDS system receives
object to the information collection, provide a
data after patient has voluntarily shared Data with the state
reason.
Department of Health with the express knowledge that such
data may be shared with other relevant entities/organizations.
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
State health department has the notification responsibilities as
28 and/or data uses have changed since the notice at
they are the collectors and originators of the data. Changes are
the time of original collection). Alternatively, describe received into LEDS System secondarily.
why they cannot be notified or have their consent
obtained.
Describe the process in place to resolve an
individual's concerns when they believe their PII has
29 been inappropriately obtained, used, or disclosed, or
that the PII is inaccurate. If no process exists, explain
why not.

The Security Steward and Information System Security Officer
(ISSO) are notified and analyze the incident. If the incident
proves that PII was disclosed, CSIRT and the CPO are notified
within one hour. At CDC's direction, the corresponding State
health departments will be engaged to notify affected
individuals since they are the collectors/originators of the data.

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.

OCISO requires annual security control assessment of the
systems confidentiality, integrity, and availability. In addition,
data cleaning and error reporting routines run on every State
Health Laboratory record received to ensure the data's
accuracy and relevance. At the end of each calendar year, final
reviews and corrections (if necessary) are conducted before
the calendar year data file is finally “Closed Out” and made
available for analysis and publication by the program in papers
and journals.

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Users

31

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

Administrators

Full Access to properly manage data

Developers

Read/Write Access in order to help
maintain data and its accuracy

Contractors
Others

SME; Read Access Level to help
interpret meaning of data

Describe the procedures in place to determine which
32 system users (administrators, developers,
Role-based Access Control (RBAC)
contractors, etc.) may access PII.
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.
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.
Describe training system users receive (above and
35 beyond general security and privacy awareness
training).

The Least Privilege model is used

Annual CDC Security and Privacy Awareness Training (SAT)

Role-based Training to use the database is given to individuals
with access priviledges.

Do contracts include Federal Acquisition Regulation
36 and other appropriate clauses ensuring adherence to
privacy provisions and practices?

Yes
No

Describe the process and guidelines in place with
37 regard to the retention and destruction of PII. Cite
specific records retention schedules.

Final reports and substantive reporting materials are
maintained permanently (CDC RCS, B-321, 4). Other input/
output records and system data that may be required for
follow-up are disposed of after 10 years. Disposal methods
include erasing computer tapes, burning or shredding paper
materials or transferring records to the Federal Records Center
when no longer needed for evaluation and analysis. In
addition, electronic media is subject to ITSO zero-wipe pass
methodology.

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

Operational Controls include physical facilities management
policies, data center and media protection procedures, security
& privacy incident response procedures; and mandatory
annual security & privacy awareness training; and Technical
Controls include application level role based access controls;
servers audit and accountability requirements; encryption of
PII at rest and in transit; and adherence to organizationally
defined minimum security controls.

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

Answer

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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

Reviewer
Notes
10

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

Yes
No

Reviewer
Notes
11

Does the PIA demonstrate compliance with all Web privacy requirements?

Yes
No

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Reviewer Questions

Answer

Reviewer
Notes
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

Beverly E.
Walker -S

Digitally signed by Beverly E. Walker -S
DN: c=US, o=U.S. Government,
ou=HHS, ou=CDC, ou=People,
0.9.2342.19200300.100.1.1=100144034
3, cn=Beverly E. Walker -S
Date: 2015.02.20 13:17:52 -05'00'

HHS Senior
Agency Official
for Privacy

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