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:

0920-0600

2a Name:

CDC Model Performance Evaluation Program (MPEP) for Mycoba
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)?

No
Yes
No
Agency
Contractor
POC Title

Project Officer

POC Name

Cortney Stafford

POC Organization NCHHSTP/DTBE/LB
POC Email

[email protected]

POC Phone

(404) 639-3420
New
Existing
Yes
No

8b Planned Date of Security Authorization
Not Applicable

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8c

9

Briefly explain why security authorization is not
required

Indicate the following reason(s) for updating this PIA.
Choose from the following options.

N/A
PIA Validation (PIA
Refresh/Annual Review)
Anonymous to NonAnonymous
New Public Access
Internal Flow or Collection

Significant System
Management Change
Alteration in Character of
Data
New Interagency Uses
Conversion

Commercial Sources
Other...
10

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

11 Describe the purpose of the system.

Project will use an online instrument instead of the previous
website to collect the MPEP results.
The purpose of the Centers for Disease Control and Prevention
(CDC) Model Performance Evaluation Program (MPEP), a
voluntary educational self-assessment information collection,
is to collect and analyze the performance and practices of all
known clinical and public health laboratories in the United
States that perform drug susceptibility testing of isolates
belonging to the Mycobacterium tuberculosis complex (MTBC),
a genetically related group of Mycobacterium species that can
cause tuberculosis in humans.

Data will be collected from a purposive sample of staff from
public health laboratories performing drug susceptibility
testing of MTBC. The "Participant Biosafety Compliance Letter
of Agreement" collects the name, city and state of the facility,
the name and business title of the person completing form,
Describe the type of information the system will
and because the person completing the form Emails the letter
collect, maintain (store), or share. (Subsequent
back to CDC, the responding Email address will be captured.
12
questions will identify if this information is PII and ask Data collected from the online survey instrument will include
about the specific data elements.)
the conventional drug susceptibility results and the molecular
test results obtained from testing performed on the isolates
the facility received from CDC. The pre-shipment Email will
request contact and address information, which includes the
name, participant site, mailing address, city, state, zip code,
phone, fax number and Email address.

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MPEP is a voluntary educational self-assessment and nonstatistical data collection program. The subsequent report
reflects data received from participating laboratory personnel.
Under MPEP, five isolates of MTBC are sent from CDC to
participating laboratories bi-annually for staff to monitor their
ability to determine drug resistance among the isolates.
The report produced from testing information received from
the participating MPEP sites includes results for a subset of
laboratories performing drug susceptibility tests (DST) for
MTBC in the United States. The aggregate report is prepared in
a format that will allow laboratory personnel to compare their
DST results with those obtained by other participants using the
same methods and drugs, for each isolate.

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?

Contact and address information, which includes the name,
participant site, mailing address, city, state, zip code, phone,
fax number and Email address for the laboratory contact for
"Participant Biosafety Compliance Letter of Agreement" is used
by CDC to ship isolates to the participating laboratory. This
information is used temporarily to conduct shipping and
confirm receipt and is stored in CDC email records as part of
routine CDC email records retention policy. Although the
name of the individual who completes the form on behalf of
the respondent laboratory is collected, the individual is
responding in their role as an official contact for the laboratory,
rather than via personal email or address. Drug susceptibility
results submitted by the laboratory through the survey include
conventional drug susceptibility results and molecular test
results obtained from testing isolates the laboratory received
from CDC. Drug susceptibility information based on
tuberculosis isolates is retained for 10 years. The aggregate
reports of drug susceptibility results are published and used to
to monitor the quality and effectiveness of laboratory testing
systems which support public health objectives of tuberculosis
treatment programs. Aggregate information collected from
participants is compiled, analyzed, and reported in a form
laboratories can use as a self-assessment tool to maintain the
skills for drug susceptibility testing of MTBC.
Yes
No

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15

Indicate the type of PII that the system will collect or
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

Unique Identifier: Facility
MPEP Number

Business related contact
information

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 Employees of clinical and public health laboratories

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
The primary purpose of the PII is to document the contact
information of persons completing and submitting the
"Participant Biosafety Compliance Letter of Agreement," used
to prepare shipments of MTBC isolates to institutions
participating in MPEP.
The name and business email address will be used to send a
final MPEP report to each MPEP participating site where they
can compare their DST results to expected results.

20 Describe the function of the SSN.

N/A

20a Cite the legal authority to use the SSN.

N/A

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Public Health Service Act, Section 301, "Research and
Investigation," (42 U.S.C. 241); and Sections 304, 306 and 308(d)
which discuss authority to maintain data and provide
assurances of confidentiality for health research and related
Identify legal authorities governing information use activities (42 U.S.C. 242 b, k, and m(d)).Information use and
21
and disclosure specific to the system and program.
disclosure is governed under Departmental regulations, 5 USC
301. OMB #0920-0136, Epidemiologic Studies and Surveillance
of Disease Problems includes authorities for the System of
Records Notice (SORN) that covers laboratory assessments for
tuberculosis.
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?

0920-0600
Yes
No

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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

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?

Participant Biosafety Compliance Letter of Agreement is
completed by the laboratory employee. The pre-shipment
Email is sent to the employee based on contact information
provided by the laboratory. Therefore, participating
laboratories are aware that the contact information is required
in order to participate in the MPEP program, to receive cultures
from CDC to test, and to return the results to CDC. If individuals
do not want to be the contact person, the facility or lab will
identify another individual.
Voluntary
Mandatory

Describe the method for individuals to opt-out of the
Individuals may omit their contact information from the forms.
collection or use of their PII. If there is no option to
27
If individuals do not want to be the contact person, the facility
object to the information collection, provide a
or lab will identify a replacement individual.
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
If there are any changes to the system, individuals will be
28 and/or data uses have changed since the notice at
the time of original collection). Alternatively, describe notified by Email, mailing address, or phone number.
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.

No process exists to resolve an individual's concern because
they provide the contact information as the laboratory
representative. Nonetheless, the Participant Biosafety
Compliance Letter of Agreement provides contact information
for the system.

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.

MPEP participants must submit a Participant Biosafety
Compliance Letter of Agreement annually containing PII
contact information, allowing CDC program staff to update it
as needed.

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Users
Administrators
31

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

Developers
Contractors
Others

Only CDC program staff

Describe the procedures in place to determine which Only CDC program staff with administrative privileges can
access the shared drive containing contact PII for MPEP.
32 system users (administrators, developers,
Supervisory staff submit names of staff members to IT
contractors, etc.) may access PII.
personnel to allow permission to access shared drive.
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.

Only PII needed to conduct MPEP is available to CDC program
staff with administrative privileges. Other CDC program staff
will be denied access.

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.

All CDC program staff are required to complete Annual
Security and Privacy Awareness Training.

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

Additional training includes Office of Safety, Security, and Asset
Management (OSSAM) Insider Threat and Counter Intelligence
and annual refreshers for Records Management.

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
CDC uses the CDC Records Control Schedule for determining
retention and destruction of PII, specifically, section 04-4-40
Surveillance Report of STD Activity, which prescribes that
records be retained and destroyed when no longer needed for
administrative or research purposes or when 30 years old,
whichever comes first.

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Administrative: The CDC study team have defined that roles
and responsibilities to access PII, which is limited to only study
investigators will have access to recruitment, retention, survey,
and interview data. CDC personnel are required to complete
the annual OCISO Security Awareness Training to make them
aware of their responsibilities for protecting the information
being collected and maintained.
Describe, briefly but with specificity, how the PII will
38 be secured in the system using administrative,
technical, and physical controls.

Technical: Access to the server is controlled using individual
access controls and only authorized users will have access to
the data.
Physical: PII for MPEP is kept in a secure drive accessible only to
CDC program staff. The CDC campus is protected by armed
guards. Building and room access requires a Personal
Identification Verification (PIV) access card. A PIV card and
password are required to access computer systems, and
computer systems log off automatically according to timed
schedules.

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

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Reviewer Questions
7

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

Answer
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: 2021.11.03
for Privacy
16:15:32 -04'00'

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