Pia

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Privacy Impact Assessment Form
v 1.21
Status

Form Number

Form Date

Question

Answer

1

OPDIV:

CDC

2

PIA Unique Identifier:

TBD

2a Name:

06/28/21

NCEH DLS Laboratory Quality Assurance Programs
General Support System (GSS)
Major Application

3

The subject of this PIA is which of the following?

Minor Application (stand-alone)
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)?

No
Yes
No
Agency
Contractor
POC Title

Deputy ADS

POC Name

Yan (Shirley) Ding

POC Organization DLS, NCEH
POC Email

[email protected]

POC Phone

7704887934
New
Existing
Yes
No

8b Planned Date of Security Authorization
Not Applicable

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8c

Briefly explain why security authorization is not
required

The program uses multiple CDC authorized systems for
information collection, storage, and processing.

10

Describe in further detail any changes to the system
that have occurred since the last PIA.

None

11 Describe the purpose of the system.

The Division of Laboratory Sciences (DLS) provides samples
and technical assistance to laboratories to improve the quality
and accuracy of tests. Some DLS quality assurance (QA)
programs provide certification for proficiency of testing (PT).
Some DLS QA programs are intended to ensure accurate and
consistent test results across multiple laboratories (i.e.
Standardization/Harmonization).

The program will collect and maintain the following
information: laboratory (laboratory name, organization,
Describe the type of information the system will
program name, address, phone number, etc.), user (name, title,
collect, maintain (store), or share. (Subsequent
12
questions will identify if this information is PII and ask email), sample (sampleID, analyte, instrument, protocol,
analyte concentration, sequence, analysis date, reagent lot,
about the specific data elements.)
calibrator lot, etc.), and analysis (differential between expected
and reported values, suggested remediation, etc.).
Laboratories use DLS-developed samples to test the quality
and accuracy of their methods/assays. Participating
laboratories enroll in the DLS QA program that fits their needs
(proficiency testing, certification, general quality assurance or
accuracy-based monitoring, standardization, etc.). After the
laboratories receive DLS QA samples and perform their
methods, they return test results to DLS. DLS then evaluates
the data using statistical methods and reports back to the
laboratories on their performance.

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

Laboratory information is used to identify a specific laboratory,
reduce duplicates, and send correspondence. This information
is not shared. These data are collected from participating
laboratories.
User information is needed to distribute lab results and
certificates of the proficiency testing, and to contact the lab
when there are problems with samples or questions about
submitted data. These data are collected directly from users in
participating laboratories.
Sample information is needed to compare values obtained in
the participating national and international labs versus the
accepted values from the standards that were sent to the labs.
Only de-identified, aggregate information is shared with all
participating labs. These data are collected from participating
laboratories.
Analysis information is used to improve the accuracy of lab
results from the participating labs. This information is shared
only with the lab to which the analysis and data pertains.

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

Yes
No

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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

Other...

Other...

Other...

Other...

Other...

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)

100-499
To distribute lab results and certificates of the proficiency
testing.
To contact the laboratory about issues with a sample or
questions with submitted data.

20 Describe the function of the SSN.

N/A

20a Cite the legal authority to use the SSN.

N/A

21

Identify legal authorities governing information use
Section 301 of the Public Health Service Act (42 U.S.C.241)
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.

N/A

Published:
Published:
In Progress

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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 package is in preparation
Yes
No
Within HHS

Identify with whom the PII is shared or disclosed and
24a
for what purpose.

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

Describe any agreements in place that authorizes the
information sharing or disclosure (e.g. Computer
24b Matching Agreement, Memorandum of
Information will not be disclosed or shared.
Understanding (MOU), or Information Sharing
Agreement (ISA)).
Describe the procedures for accounting for
24c
disclosures

Disclosures are not planned. However, if a disclosure needs to
be made, they will be accounted for in a spreadsheet that is
maintained by the study data manager and principal
investigator.

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.

There is no process in place to notify individuals that their data
will be collected. Users of the system will provide their name
and email in order to gain access to the system.

26

Is the submission of PII by individuals voluntary or
mandatory?

Voluntary
Mandatory

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Describe the method for individuals to opt-out of the
collection or use of their PII. If there is no option to
Individuals may opt-out of providing their PII. However, they
27
object to the information collection, provide a
will not be able to use the system if they opt-out.
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
Individuals will be contacted by email if major changes occur
28 and/or data uses have changed since the notice at
the time of original collection). Alternatively, describe to the system.
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.

Individuals may contact the program using the email or phone
number on the website if they believe their PII has
been inappropriately obtained, used, or disclosed, or
that the PII is inaccurate. The program will respond to the
concerns and correct the issues.

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.

The program will check with the laboratories to ensure that
current users are authorized to access the system. Individuals
will be contacted annually to verify their PII in the system.

31

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

Users

Create, edit, delete, view records and
reports

Administrators

Create new users and assign user roles

Developers
Contractors
Others

Describe the procedures in place to determine which Role-based access is in place. Users are authenticated by
32 system users (administrators, developers,
multiple CDC authorized systems including active directory,
contractors, etc.) may access PII.
and only administrators will have access.
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.

The least privilege model is applied. Managers can only view PII
for CDC employees who report to them within each module.
Managers can only access PII after having the managerial
group permission associated to their account by the system
business steward.

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.

CDC security awareness training will be provided to all internal
users.

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

Role-based training is provided to internal and external users
of the system.

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

Yes
No

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

PII in the system will be retained according to the Scientific and
Research Project Records, Records Control Schedule, 3. Minor
Research Records. Records are maintained at least six years,
but no longer than ten years, after the retirement of the system
—depending upon program need for scientific, legal, or
business reference—then deleted/destroyed.
The administrative controls educate system users of their
responsibility to protect PII and legally bind them to do so.
These controls include signed rules of behavior , nondisclosure agreements, CDC privacy and security awareness
training, and records management training. Records are
maintained according to CDC record control policies and
procedures.

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

The technical controls, implemented by the system, act to
either allow access to system PII data only to approved users or
to make PII data unreadable outside of the system. These
controls include encryption, authentication, firewalls, intrusion
detection systems, and anti-malware systems.
The physical controls, implemented by the system, restrict
access to CDC buildings and areas housing computers used by
this system. These controls include guards, identification
badges, key cards, locked doors, cipher locks, fences, alarms
and closed circuit TV.

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

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Reviewer Questions

Answer

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

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

Jarell
Oshodi -S

Digitally signed by Jarell
HHS Senior
Oshodi -S
Agency Official
Date: 2022.02.28
for Privacy
06:58:36 -05'00'

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