CMS-10191 CPE Self-Assessment Questionnaire

ATTACHMENT I-A
MEDICARE ADVANTAGE AND PRESCRIPTION DRUG COMPLIANCE PROGRAM EFFECTIVENESS
SELF-ASSESSMENT QUESTIONNAIRE (SA-Q)
(Rev. 6, 10-2016)
Name of Sponsoring Organization:
MA-PD/PDP Contract Numbers:
Name/Title of Person(s) Completing Assessment:
Date of Assessment:
This version of the SA-Q tool is to be used with the Compliance Program Effectiveness Audit Protocol.
Sponsoring Organizations should not interpret every question as a mandatory CMS requirement, but rather as a guide to establish and
maintain the core requirements of a compliance program to prevent, detect and correct Medicare program non-compliance and fraud,
waste and abuse. This questionnaire is identical to the Medicare Part C and D Compliance Program Guidelines and can be used as a
monitoring tool to assist sponsors with evaluating their compliance program for CMS requirements. While Element V of the Medicare
Part C and D Compliance Program Guidelines – Well Publicized Disciplinary Standards –is a required and critical component of a
compliance program, it has been omitted from this version of the SA-Q. However, sponsoring organizations must ensure structures
and procedures are in place to successfully implement all required elements of a compliance program Please note the use of this tool
by itself does not constitute a formal audit of the compliance program. For example, the formal audit of the compliance program
effectiveness should be meet the definition of “audit” noted in the Compliance Program Guidelines and performed by staff not
affiliated in any way with the Compliance department.

Directions for completing the self-assessment questionnaire:
Please respond to each question according to the status of your compliance program during the audit review period.
If the answer is “YES” to any question below, check the “YES” box and provide a BRIEF description of what documents support
that response in the “Documentation” column. The documentation description should also provide a cross reference (when
applicable) to where this documentation can be located. For example, if your response is “YES” to the third question below (“Do
your written Ps & Ps and/or Standards of Conduct articulate the organization’s commitment to comply with all applicable Federal
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and State standards including but not limited to statutes, regulations and sub regulatory guidance”), please indicate the section/page
of the Standards of Conduct or policies and procedures where these compliance provisions are found.
If the answer is “NO” to a question, check the “NO” box and document the rationale for the response in the “Documentation”
column. For the limited situations when a question does not apply to your organization, enter “N/A” in the “YES/NO” box
and document the rationale for the response in the “Documentation” column. If multiple individuals are responsible for the
compliance program (e.g. Corporate Compliance Officer, Medicare Compliance Officer, SVP of Audit and Compliance) and
have different responses to the questions, please consolidate responses and incorporate into one document.
Please specifically note the following when completing the questionnaire:
• “You” refers to your organization, not necessarily a specific person.
•

“Employees” refer to employees, including senior management, who support your Medicare business.

•

“Compliance Officer” refers to the compliance officer who oversees the Medicare business.

•

“CEO” refers to the Chief Executive Officer of the organization or the most senior officer, usually the President or Senior Vice
President of the Medicare line of business.

•

“Compliance Program” refers to your Medicare compliance program.

•

If the Medicare contract holder is a wholly owned subsidiary of a parent company, references to the governing body,
CEO and highest level of the organization’s management are to the board, CEO and management of the company (parent or
subsidiary/contract holder) that the organization has chosen to oversee its Medicare compliance program.

•

Unless specific reference is made in the question to the term “governing body”, it means either the full board or a
committee of the board of directors delegated to conduct oversight of the day-to-day operation of the Medicare compliance

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program on behalf of the full governing body.
•

“FDRs” refer to the organization’s first-tier, downstream and related entities contracted to perform an administrative or
healthcare service to enrollees on behalf of the Sponsor.

Written Policies and
Procedures and Standards
of Conduct
42 CFR §422.503(b)(4)(vi)(A); 42 CFR
§423.504(b)(4)(vi)(A)
No.

Description

Yes/No

Documentation (include specific
page number, paragraph,
section, system, location and/or
brief explanation

Responsible Party or
Department

1. Do you have written policies and
procedures (Ps & Ps) and/or Standards of
Conduct that: (A through G)
A. Articulate the organization’s
commitment to comply with all applicable
Federal and State standards?
B. Describe compliance expectations as
embodied in the standards of conduct?
C. Implement the operation of the
compliance program?
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D. Provide guidance to employees and
others on dealing with potential compliance
issues?
E. Identify how to communicate
compliance issues to appropriate
compliance personnel?

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No.

Description

Yes/No

Documentation (include specific
page number, paragraph,
section, system, location and/or
brief explanation

Responsible Part or
Department

F. Describe how potential compliance
issues are investigated and resolved by the
organization?
G. Include a policy of non-intimidation and
no-retaliation for good faith
participation in the compliance program,
including but not limited to reporting
potential issues, investigating issues,
conducting self-evaluations, audits and
remedial actions, and reporting to
appropriate officials?
2. Are your Ps & Ps detailed and specific
in their description of the operation of the
compliance program?
3. Do you distribute your Standards of
Conduct and Ps & Ps to your employees
within 90 days of hire, when there are
updates and annually thereafter?
4. Do you update your Ps & Ps to
incorporate changes in applicable laws,
regulations and other program
requirements?

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Compliance Officer, Compliance
Committee, Governing Body
42 CFR §422.503(b)(4)(vi)(B) and 42 CFR
§423.504(b)(4)(vi)(B)
Description

No.

Yes/No

Documentation (include specific
page number, paragraph,
section, system, location and/or
brief explanation

Responsible Part or
Department

Does your CEO receive your
compliance officer’s reports on the status
and activities of the compliance program?
6. If your compliance officer does not
report directly, in-person to your CEO, are
his/her reports routed through the President
of the division that houses the Medicare
and/or through the President of the
organization rather than through operational
management?
7. Does your compliance officer have
express authority (oral or written, preferably
written) to make in-person reports to your
CEO and governing body in the compliance
officer’s sole discretion?
5.

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No.

Description

Yes/No

Documentation (include specific
page number, paragraph,
section, system, location and/or
brief explanation

Responsible Part or
Department

8. Is your compliance officer employed by
your organization, parent organization, or
corporate affiliate?
9. If employed by your parent or corporate
affiliate, does your compliance officer have
detailed involvement in and familiarity with
your Medicare operational and compliance
activities?
10. Does your governing body periodically
receive compliance reports on Medicare
program noncompliance and Medicare
fraud, waste and abuse (“FWA”) which
include issues identified, investigated, and
resolved?
11. If your compliance officer does not
report in-person to your governing body, are
his/her reports routed through the
compliance infrastructure?
12. Is your compliance officer a full-time
employee?
13. Does your compliance officer have both
compliance and operational responsibilities?

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No.

Description

Yes/No

Documentation (include specific
page number, paragraph,
section, system, location and/or
brief explanation

Responsible Part or
Department

Yes/No

Documentation (include specific
page number, paragraph,
section, system, location and/or
brief explanation

Responsible Part or
Department

14. Do you have a compliance committee
whose responsibilities include oversight of
the compliance program?
15. Does your compliance officer and
compliance committee provide the
governing body with regularly scheduled
updates on the status and activities of the
compliance program, including compliance
program outcomes, the results of internal
and external audits and about all
government compliance enforcement
activity?
Effective Training and Education

No.

42 CFR §422.503(b)(4)(vi)(C) and 42 CFR
§423.504(b)(4)(vi)(C)
Description

16. Do you establish, implement and
provide effective training and education,
addressing compliance and FWA for your
employees, including temporary employees,
volunteers and governing body?
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No.

Description

Yes/No

Documentation (include specific
page number, paragraph,
section, system, location and/or
brief explanation

Responsible Part or
Department

17. Is your training for employees and board
members provided within 90 days of
hire/appointment and annually thereafter?
18. Do you maintain attendance, topic,
certificates of completion and/or test scores
for 10 years?
19. Do you ensure that your employees are
aware of Medicare requirements related to
their job functions?
20. Does your general compliance training
include the reporting requirements and
available methods for reporting
noncompliance and potential FWA?
21. Do you provide training on FWA risks
based on the individual’s job function?

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Effective Lines of Communication

No.

42 CFR §422.503(b)(4)(vi)(D) and 42 CFR
§423.504(b)(4)(vi)(D)
Description

Yes/No

Documentation (include specific
page number, paragraph,
section, system, location and/or
brief explanation

Responsible Part or
Department

22. Do you have an effective method(s) to
communicate information from your
compliance officer to others, within a
reasonable time frame, including changes in
laws, regulations and sub- regulatory
guidance, HPMS memos, as well as
changes to your Standards of Conduct and
Ps & Ps?
23. Do your Standards of Conduct and/or
Ps & Ps require your employees and
members of the governing body to report
compliance concerns and potential FWA?
24. Do you have a system to receive,
record, respond to and track compliance
questions or concerns and reports of
potential FWA from your employees,
members of your governing body, FDRs
and their employees and enrollees?
25. Does your system allow anonymous
reporting and maintain confidentiality to the
extent possible?

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No.

Description

Yes/No

Documentation (include specific
page number, paragraph,
section, system, location and/or
brief explanation

Responsible Part or
Department

26. Does your system emphasize your
policy of non-retaliation and that of your
FDRs’?
27. Is your system well-publicized
throughout your facilities and those of your
FDRs?
28. Are your reporting mechanisms userfriendly, easy to access and navigate and
available 24 hours a day for employees,
members of your governing body and
FDRs?
29. Have you adopted, widely publicized
and enforced a no-tolerance policy for
retaliation or retribution against any
employee, FDR, or FDR employee who
reports potential FWA?
30. Do you educate your enrollees about
the identification and reporting of
FWA?

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Effective System for Routine Monitoring,
Auditing and Identification of Compliance
Risks

No.

42 CFR §422.503(b)(4)(vi)(F) and 42 CFR
§423.504(b)(4)(vi)(F)
Description

Yes/No

Documentation (include specific
page number, paragraph,
section, system, location and/or
brief explanation

Responsible Part or
Department

31. Do you have a system of ongoing
monitoring and auditing to test and confirm
compliance with Medicare regulations, subregulatory guidance, contractual agreements
and all applicable federal and state laws?
32. Are adequate resources devoted to your
audit function considering the scope of your
Medicare Parts C and D programs,
compliance history, current compliance
risks and resources available?
33. Do you have a monitoring and auditing
work plan that addresses risks associated
with Medicare Parts C and D?
34. Does your compliance officer receive
regular reports from the individuals or
component conducting auditing monitoring
activities, including providing the status and
effectiveness of corrective actions taken?
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No.

Description

Yes/No

Documentation (include specific
page number, paragraph,
section, system, location and/or
brief explanation

Responsible Part or
Department

35. Does your compliance officer or his/her
designees provide updates on the results of
monitoring and auditing activities to your
compliance committee, CEO, senior
leadership and governing body?
36. Have you established and implemented
Ps & Ps to conduct a formal baseline
risk assessment of the major compliance
and risk areas in all Medicare
operational areas?
37. Does your monitoring and auditing
strategies prioritize (a) risks identified
through CMS audits and oversight and
through your own monitoring; and (b) those
risks that have the greatest impact?
38. Do you periodically re-evaluate the
accuracy of your baseline risk assessment?
39. Do you have an auditing and monitoring
work plan that includes: (A through C)
A. A process for responding to all
monitoring and auditing results?
B. A process for conducting follow-up
reviews of areas found to be noncompliant
to determine if corrective actions have fully
address the underlying problems?

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No.

Description

Yes/No

Documentation (include specific
page number, paragraph,
section, system, location and/or
brief explanation

Responsible Part or
Department

C. A schedule (with estimated target dates)that
lists all auditing and
monitoring activities for the calendar year?
40. Do you use appropriate methods to: (A
through F)
A. Select operational areas for audit?
B. Select first tier entities for audit?
C. Determine sample size?
D. Extrapolate audit findings to the full
universe, using statistically valid methods
that comply with generally accepted
auditing standards?
E. Apply specialized targeted techniques or
stratified sampling methods driven by data
mining, complaint monitoring and aberrant
behavior?
F. Assess compliance with internal
processes and procedures?
41. Do you have internal staff dedicated to the
audit function? Are procedures in place to
ensure auditors are independent of
Medicare operations under review to
prevent self-policing?

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No.

Description

Yes/No

Documentation (include specific
page number, paragraph,
section, system, location and/or
brief explanation

Responsible Part or
Department

42. Are your auditors knowledgeable about
CMS operational requirements for areas
under review?
43. Does your audit staff have access to
relevant personnel, information, records and
areas of operation under review, including
operational areas at plan and FDR level?
44. Do you conduct a formal audit to evaluate
the effectiveness of your
compliance program at least annually (once
a year)?
NOTE: The formal audit should produce an
audit report with results and identified root
cause(s) and a corrective action plan should
be a part of the evaluation. The CMS
program audit of a sponsor’s compliance
program effectiveness does NOT satisfy this
audit requirement. Sponsor must conduct its
own audit of the effectiveness of its
compliance program at least annually.
45. Is the annual compliance program
effectiveness audit conducted by persons
other than your compliance officer and /or
compliance department staff?

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No.

Description

Yes/No

Documentation (include specific
page number, paragraph,
section, system, location and/or
brief explanation

Responsible Part or
Department

46. Do you share the results of the audits of
the effectiveness of the compliance program
with your governing body?
47. Do you review the OIG and GSA
exclusion lists for your employees
(including temporary employees),
volunteers, consultants and the members of
your governing body prior to
hiring/contracting/appointment and monthly
thereafter?
48. Do you utilize systems and data analysis for
monitoring FWA?
49. Do you either have a Special
Investigations Unit (“SIU”) or ensure that
the responsibilities generally conducted by
an SIU are conducted by your compliance
department?
50. If you have an SIU, is it accessible
through multiple channels, e.g. phone, mail,
Internet message?
51. Do your SIU and compliance
departments communicate and coordinate
closely?

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Procedures and Systems for Promptly
Responding to Compliance Issues

No.

42 CFR §422.503(b)(4)(vi)(G) and 42 CFR
§423.504(b)(4)(vi)(G)
Description

Yes/No

Documentation (include specific
page number, paragraph,
section, system, location and/or
brief explanation

Responsible Part or
Department

52. Do you make a reasonable inquiry into
all compliance incidents/issues and potential
FWA?
53. Do you require and ensure that your
inquiries are well-documented?
54. Do you require and ensure that inquiries
are initiated as quickly as possible, and not
later than two weeks after the date the
potential noncompliance or FWA is
identified?
55. Do you undertake appropriate corrective
actions that: (A through C)
A. Are designed to correct and prevent future
noncompliance, including conducting a root
cause analysis?
B. Are tailored to address the particular
FWA, problem or deficiency identified?
C. Include time frames for specific
achievements?

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No.

Description

Yes/No

Documentation (include specific
page number, paragraph,
section, system, location and/or
brief explanation

Responsible Part or
Department

56. Do you continue to monitor corrective
actions after their implementation to ensure
that they are effective?
57. Do you ensure that noncompliance or
FWA committed by your employees is
documented and includes ramifications
should the employee fail to satisfactorily
implement the corrective action?
58. Do you maintain thorough
documentation of all compliance
deficiencies identified and the corrective
actions taken?
59. Do you have procedures to refer
potential FWA issues to the NBI MEDIC
and serious issues of program
noncompliance to CMS?
60. Do you conclude your investigations of
FWA within a reasonable time after the
activity is discovered?
61. Do you review past paid claims from
entities identified in fraud alerts and remove
them from their event data submissions e.g.
PDEs?

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FDR Oversight
Sponsor Accountability for and Oversight
of FDRs

No.

42 CFR §422.503(b)(4)(vi) and 42 CFR
§423.504(b)(4)(vi)
Description

Yes/No

Documentation (include specific
page number, paragraph,
section, system, location and/or
brief explanation

Responsible Part or
Department

62. Do you have a process or criteria for
determining which delegated entities (and
their employees) are properly identified as
FDRs subject to Medicare compliance
requirements?
63. Do you identify and communicate to your
FDRs which FDR employees are subject to
Medicare compliance requirements?

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No.

FDR Oversight
Written Policies and Procedures and
Standards of Conduct
42 CFR §422.503(b)(4)(vi)(A) and 42 CFR
§423.504(b)(4)(vi)(A)
Description

Yes/No

Documentation (include specific
page number, paragraph,
section, system, location and/or
brief explanation

Responsible Part or
Department

Yes/No

Documentation (include specific
page number, paragraph,
section, system, location and/or
brief explanation

Responsible Part or
Department

64. Do you ensure that either your Standards of
Conduct and Ps & Ps or comparable
Standards of Conduct and Ps & Ps are
distributed to FDR’s employees within 90
days of hire / contracting and annually
thereafter?

No.

FDR Oversight
Effective Training and Education
42 CFR §422.503(b)(4)(vi)(C) and 42 CFR
§423.504(b)(4)(vi)(C)
Description

65. Do you ensure that general compliance and
FWA training is completed by your
FDRs?
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No.

Description

Yes/No

Documentation (include specific
page number, paragraph,
section, system, location and/or
brief explanation

Responsible Part or
Department

Yes/No

Documentation (include specific
page number, paragraph,
section, system, location and/or
brief explanation

Responsible Part or
Department

66. Do you ensure that your non-deemed
FDRs’ employees receive FWA training
within 90 days of hiring/contracting and
annually thereafter?
67. Do you require your FDRs to maintain
records of their compliance and FWA
training activities for their employees for
ten years, as required?

No.

FDR Oversight
Monitoring and Auditing FDRs
42 CFR §422.503(b)(4)(vi)(F) and 42 CFR
§423.504(b)(4)(vi)(F)
Description

68. Do you have a strategy to monitor and
audit your first-tier entities?
69. Does your strategy for monitoring and
auditing first-tier entities include: (A & B)
A. Ensuring that they are in compliance
with Medicare Parts C and D program
requirements?

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No.

Description

Yes/No

Documentation (include specific
page number, paragraph,
section, system, location and/or
brief explanation

Responsible Part or
Department

B. Ensuring that they are monitoring their
downstream entities?
70. Do you monitor and audit your related
entities?
71. Does your monitoring and auditing
work plan include the number of first-tier
entities that will be audited and how the
entities will be identified for auditing?
72. If you do not monitor and audit all of
your first tier entities, do you perform a risk
assessment to identify the high risk first-tier
entities and then select a reasonable number
to audit from the highest risk groups?
73. Do you have procedures to ensure that
your FDRs are not excluded from
participation in Federal health care
programs? (42 CFR § 1001.1901)
74. Does your system include review of
the OIG and GSA exclusion lists prior to
hiring or contracting and monthly thereafter
for FDRs and their employees either by
you, your first entities, or the downstream
entities themselves?

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No.

FDR Oversight
FDRs: Procedures and System for Prompt
Response to Compliance Issues
42 CFR §422.503(b)(4)(vi)(G) and 42 CFR
§423.504(b)(4)(vi)(G)
Description

Yes/No

Documentation (include specific
page number, paragraph,
section, system, location and/or
brief explanation

Responsible Part or
Department

75. Do you ensure that corrective
actions are taken by first tier entities?
76. Do you continue to monitor FDR
corrective actions after their implementation
to ensure that they are effective?
77. Do you ensure that noncompliance or
FWA committed by FDRs is welldocumented and includes ramifications
should the FDR fail to satisfactorily
implement the corrective action?
78. Do you maintain thorough
documentation of all deficiencies identified
and the corrective actions taken?

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