Setting Up An Audit Program

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Setting Up An Audit Program

• What I do
• How I determined what I needed to do
• How I do it

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Its an unfortunate fact of life that there are
many things that can put subjects at risk and
literally dozens of items that can get you into
serious trouble with literally dozens of
organizations

• What to audit?

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A Few Ideas
FDA
NCQA
OHRP
oro
Device Risks
Dispensing Logs
Conflict of Interest
IRB Quorums
Consent Process Documentation
Exempt Review
Form 9012s
Regulatory Binders
Deviations
Inclusion Exclusion Criteria
Approval Expiration
Protocol Violations
Consent Forms
Expedited Notifications
Research Alerts
Adverse Event Reporting
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The Right Approachand things to consider
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What to Audit?(things to consider)

• Audit Motivation
• Your capabilities and competencies
• Organizational Vulnerabilities
• Regulatory Hot Spots
• What data is already out there and available
  for your use.
  

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What to Audit?(things to remember)

• QA audits should encompass as many components of
  the HRPP program as possible
  
• There is often more than one way to express an
  indicator. Choose the way that most accurately
  reflects what is happening

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What to Audit?(things to remember)

• If you plan wisely, you can often get more than
  one indicator from a single database/
  spreadsheet and a single data gathering
  expedition
• Variability is a Virtue
• (broadens the scope and lessens the boredom)

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Overall Consent Form Accuracy
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Error Analysis

• Missing Witness Signature
• Pt name missing (top of page)
• Date missing (top of page)
• Pt initials missing (bottom of page)
• Name of person explaining study missing (last
  page)
  
• Signature of person obtaining consent missing
• Printed name of person obtaining consent missing
• Signature of PI missing

• 9. Last page signed by someone other than PI
• 10. Incorrect consent form used
• 11. Printed name of witness missing
• 12. Consents never turned in
• 13. No subject signature
• 14. Consent had no approval stamp
• 15. Witness person obtaining consent same
  person
  
• 16. Subject signature date missing
• 17. Expired consent

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PI Specific Data
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Protocol Audits

• Types of Audits
• Choosing Protocols
• Preparation
• The Audit Process
• What I Review

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Protocol Audits(types of audits)

• For Cause Audits
• RCO
• ACOS/R
• Medical Center Director
• IRB Chair
• Random Audits
• RCO

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Protocol Audits(choosing protocols)

• High or Moderate Risk
• Vulnerable Subjects
• Enrollment Status
• Actively enrolling
• Currently enrolling
• PI Experience History

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Protocol Audits(preparation)
?Get access to and learn how to use CPRS
?Know your protocol history

• Decide in advance what protocol specific items
  you will be looking for
  

• Develop a protocol specific audit tool

• Do as much as possible in advance, i.e. from your
  desk using CPRS (leaves far more time for
  discussion and education)
  

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Protocol Audits(the process)

• Notification and Scheduling

? Preliminary Briefing

• Audit

?PI Notification Response expected
?Written Report -To Medical Center Director
cc IRB/RD

?Verbal Summary of Report at IRB Meeting
?Copy of Report to PI
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Protocol Audits(what I review)

• Consent Forms
• Research Alerts
• Adverse Events
• Deviations/Adherence to Protocol
• Inclusion/Exclusion Criteria

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Protocol Audits
? Consent Forms -Redundant, but useful when
auditing new investigators ? Research Alerts
-View in CPRS (cover sheet)
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Protocol Audits
? Adverse Events -Sponsor Case Report Forms -N
otes in Subjects Research Folder
-Electronic Notes in CPRS (both research and
non-research
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Protocol Audits
? Adverse Events
-Inpatient admissions
-Emergency Room Progress Notes
-Crisis Notes/Clinical Warnings
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detailed inpatient inquiry
Select PATIENT NAME
Doe,John
CHOOSE FROM 1 NOV 30,2004_at_154411 DIR
ECT TO 1-4EM 2 JUL 31,2002_at_
171627 OPT-NSC TO 1-4EM
3 MAY 12,1987_at_1031 OPT-NSC
TO 1-4E) 4 APR 28,1987
A/C TO
1-4E
1
CHOOSE 1-4
ADMISSION NOV 30,2004_at_154411 DIRECT
TO 1-4EM TRANSFERS TREATING SPECIALTY
CHANGES NOV 30,2004_at_154411 SPECIALTY GENE
RAL(ACUTE M PROVIDER BELL,TINKER ATTENDING
CLAUS,SANTA J DX anemia
DISCHARGE DEC 3,2004_at_1845 OPT-SC
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Protocol Audits
? Deviations/Adherence to Protocol
(Focus)

-Labs/procedures that are part of the screening
process

-Items identified in the protocols safety
section

-Timelines described in the protocol
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Protocol Audits
? Inclusion/Exclusion Criteria
(often linked to screening process and
confirmation that PI is adhering to protocol
regarding screening procedures, often provides
confirmation that PI is complying with inclusion
exclusion criteria)
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Protocol Audits
? Inclusion Criteria Examples -PTSD
CPRS Problems Tab (lists patient problems)
CPRS Notes Tab - Primary Care Progress Note
often lists patients main diagnoses

CRPS Cover Sheet (Patient inquiry lists clinics
patient is enrolled in)

CPRS Cover Sheet (Appointments/Visits
/Admissions) - lists patients recent clinic
visits

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Protocol Audits
? Exclusion Criteria Examples -Individuals Using
Beta Blockers

? Drug Information http//medlineplus.gov
(click on Drug Information)

? VISN Formulary Provides information on what
Beta Blockers are likely to be prescribed in your
facility

? Meds Tab in CPRS Identifies medica -tions for
the selected patient
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Study
Date Consented
Vet Y N Male
Female Research Alert
Subj Name Inclusion
Exclusion
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Provider CLAUS, SANTA Specimen URINE.
CH 0509 508
05/09/2005 1209 Test name
Result units
Ref. range Site Code AMPHETAMINES SCREEN
NEGATIVE NEGATIVE
689 BARBITURATES SCREEN NEGATIVE
NEGATIVE 689
BENZODIAZEPI SCREEN NEGATIVE
NEGATIVE 689
CANNABINOIDS SCREEN NEGATIVE
NEGATIVE 689 COCAINE SCREEN
NEGATIVE NEGATIVE
689 OPIATES SCREEN
NEGATIVE NEGATIVE
689
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Provider CLAUS, SANTA Specimen SERUM.
CH 0728 594
07/28/2005 1636 Test name Result
units Ref. range Site Code
CREATININE 2.0 H mg/dL 0.5 - 1.5
689
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Assessment/Screening Date
Hx PE
ROI to contact
family members
EKG
Psych Evals SGOT, SGPT
Wisc Scale of Psychosis
Creatinine
Brief Psychotic Rating Scale Urine Tox
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Procedures 3 test days 7-14 days apart Test da
y 1 Test day 2
Test day 3
Date Date Date
Urine Tox Urine Tox Urine Tox
EKG EKG EKG Profile of Mood States
Profile of Mood States Profile of Mood
States POM POM POM
Follow-up Calls 3 months, 6 months, 12 months
Month 3
Month 6 Month 12
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Follow-up Reports

• 1. PI action item status reports
• 2. Omission Reports

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Examples

• Item
• Protocol pt will be ter-minated if they miss 3
  sessions consent form says 4 sessions
  
• Protocol calls for 2 EKGs (1 pre 1 post
  research procedure). 1 being performed

• Required Action
• Amend protocol or consent to make them
  consistent
  
• 2a. Report deviation to IRB
• 2b. Amend protocol to reflect what is actually
  occurring

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PI Action Items Status Report

• Item
• 3. Protocol inclusion criteria stable housing
  for 6 months. CPRS progress note left homeless
  shelter 4 months ago.

• Required Action by PI
• 3a. Report deviation to IRB
• 3b. Amend inclusion exclusion criteria

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Audit Plans
? Purpose - improve compliance - promote human
subjects protections - provide support and educ
ation
? Selection of Studies
? Notification Process - scheduling who pic
ks the date and time is rescheduling allowed
rescheduling timeframes
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Audit Plans
? Reporting Process - who gets them - where ar
e they reported/discussed - Input from and to PI
s - Emergent Patient Safety Issues - Research
Misconduct
? Description of Audit Activities
- what things youre going to audit
- how youre going to audit those things
thresholds data sources methodology
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UsefulTools/Ideas
1. Interim Reports
2. Progress Notes Searches across Patients
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TIU
1 Progress Notes User Menu ...
2 Discharge Summary User Menu ...
3 Integrated Document Management .
4 Personal Preferences ...
Select Progress Notes/Discharge Summary TIU Op
tion
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• 1 Entry of Progress Note
• 2 Review Progress Notes by Patient
• 2b Review Progress Notes
• 3 All MY UNSIGNED Progress Notes
• 4 Show Progress Notes Across Patients
• 5 Progress Notes Print Options ...
• 6 List Notes By Title
• 7 Search by Patient AND Title
• 8 Personal Preferences ...
• ALL Documents requiring my Additional Signature
• Select Progress Notes User Menu Option

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Please Select the PROGRESS NOTES TITLES to search
for
1)
RESEARCH PROTOCOL ALERT
Start Reference Date Time
8/1/05
Ending Reference Date Time
8/10/05
Searching for the documents....
Patient Document
Ref Date Status
1 SMITH,BILL (S2648) RSCH PROTOCOL ALERT
07/15/04 Compl 2 DOE,JOHN (D2388) RSCH P
ROTOCOL ALERT 07/22/04 Compl
3 HYT, JOE (W8363) RSCH PROTOCOL ALERT
07/27/04 Compl 4 COLE,ABE (D8173) RSCH
PROTOCOL ALERT 08/10/04 Compl
Add Document Sign/Cosign
Change View Edit
Detailed Display Copy
Make Addendum Browse
Interdiscipl'ry Note Link ...
Print Quit

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Gerald Beccia VA Connecticut Healthcare Tel (20
3) 932-5711 ext. 5772
Gerald.Beccia_at_med.va.gov
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