AUDIT PLAN AND REPORT

AUDIT NUMBER: AUD-YYYY-EXT-001

AUDI T T IT L E Transplant Essential Data Forms Data Accuracy Audit

DI V I S IO N

DI V I S IO N
CO NT ACT
AUDI T
DAT E ( S )

RE S P O NS E S 30 business days from the date submitted to Auditee 1

RE Q UI RE D 7 business days from the date submitted to Auditee (for Critical
BY Observations)

AUDI T O RS

SO P S
RE V I EW E D
AUDI T To review the accuracy of information submitted to the CIBMTR data
O BJE CT I V E registry via FormsNet”.
Selected clinical data points, both as mandated during FACT inspection and
randomly chosen by auditor, in the completed CIBMTR data collection forms
AUDI T
(from pre-transplant to 100 days) and related source documentation for 10
S CO P E
allogeneic and 5 autologous transplants identified for upcoming FACT
inspection.
FACT-JACIE International Standards for Cellular Therapy Product
Collection, Processing & Administration (current edition)
AUDI T
CRI T E RI A
CIBMTR Data Management Manual
http://www.cibmtr.org/datamanagement/datacollectionforms/pages/index.as
px
P E RS O NNE L
I NT E RV I E W E
D

This report contains information from a confidential compliance audit. It is the recipient’s
responsibility to ensure that it is not copied or distributed. Under no circumstances should this
document be stored or archived in files open to regulatory agency inspections. The original
report will be archived as part of Quality Management files.

1
Only acknowledgement of receipt is required when there are no citations or requirements resulting from the audit.

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 AUDIT PLAN AND REPORT

AUDIT NUMBER: AUD-YYYY-EXT-001

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 AUDIT PLAN AND REPORT

AUDIT NUMBER: AUD-YYYY-EXT-001

AUDIT RESULTS
Overall Audit Grade: The audit reflected <NNN> Observations that include <N>
nonconformity issues, classified as follows (see the Audit Observations section below for
details):

NUM BE R OF
RATING
O BS E RV AT I O NS

Critical <N>
Nonconformities Major <N>
Minor <N>
Process Improvement Opportunities <N>
Good and Best Practices <N>

Overall Comments:
1. Source documentation, when requested, was located by the auditee for <NNN> data elements
reviewed on the CIBMTR forms provided.

Overall Recommendations:
1.

Instructions for Audit Response:

Please provide a written response to each observation listed in the tables below. To fully address the
observations, it is necessary to investigate and determine the root cause of each nonconformity and
include a corrective and preventive action plan for each finding with proposed completion dates.
Note:
o Critical and Major audit observations require an investigation to include root cause analysis and
appropriate corrective actions and preventive actions (CAPA) to address the root causes.
o Minor audit observations only require appropriate corrective action (root cause analysis and
preventive action are optional).
Provide the proposed action plan to the lead auditor for preliminary review to ensure that appropriate
corrective and preventive actions will be taken.
As CAPA activities are completed, the auditee provides, to the lead auditor, objective evidence of
completion for each action implemented.
Corrective Actions – Action taken to correct the cause(s) of a detected nonconformity or other
undesirable situation.

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 AUDIT PLAN AND REPORT

AUDIT NUMBER: AUD-YYYY-EXT-001

Preventive Actions – Action taken to prevent recurrence or eliminate the cause of a potential
nonconformity or other undesirable situation.
If there are questions and/or concerns, please contact the lead auditor, <NAME> (name@email.com)

Report Distribution
N A M E OF R E C I P I E N T TI TL E / JO B F UNCT I O N

Auditor File (Original)

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 AUDIT PLAN AND REPORT

AUDIT NUMBER: AUD-YYYY-EXT-001

Documents Reviewed and Copied

AT T ACHM E NT DE S I G N A T I O N
D O C U M E N T T IT L E ( IF CO PI E D / ATT ACH E D T O
RE P O RT )

CIBMTR forms and associated source documentation from

the official patient health record:
 ALLO <CRID> Pre TED R1
 ALLO <CRID> Pre TED R2
 AUTO <CRID> Post TED R1
 AUTO <CRID> Pre TED R1
 UALLO ALLO <CRID> Pre TED R2
 UALLO ALLO <CRID> 100 Day R3…

List of Abbreviations and Acronyms

CIBMTR = Center for International Blood & Marrow Transplant Research
FACT = Foundation for the Accreditation of Cellular Therapy
SOP = Standard Operating Procedure

The signatures below indicate that the audit report has been reviewed and approved for
distribution to the Auditee.

LE AD AUDI T O R SI G N A T U R E DAT E

TI TL E

Q UALI T Y M A N A G E R R E V I E W A N D AP P RO V AL SI G NAT URE DAT E

TI TL E

P ROG RAM D I R E C T O R A P P R O V A L SI G NAT URE DAT E

TI TL E

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 AUDIT PLAN AND REPORT

AUDIT NUMBER: AUD-YYYY-EXT-001

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 AUDIT PLAN AND REPORT

AUDIT NUMBER: AUD-YYYY-EXT-001

Audit Observations
Clinical
O BS E RV AT I O N Documentation
1 C L A S S I F I C AT IO N RAT I NG Compliant
NUM BE R and Registry
Reporting

O BS E RV AT I O N
S E E A UDI T R E S U LT S A BO V E .

CI T AT IO NS / REQUIREMENTS
None
E X AM P L E S
Not applicable
RE CO M M E ND A T I O N S
Re-audit annually
RE S P O NS I BL E P A R T Y :

RE S P O NS E (TO B E C O M P L E T E D B Y AUDI T E E O R RE S P O NS I BL E P ART Y )

I NV E S T IG AT I O N R E S U L T S ( P R O VI D E RO O T CAUS E FO R CRI TI CAL AND M AJO R

NO NCO NF O R M I T I E S )
<No response required.>
CO R R E C T I V E A C T I O N S
( R E Q UI RE D
FO R CRI TI CAL , M AJO R , AND M I NO R
NO NCO NF O RM IT I E S )

DATE
TARGET
PERSON COMPLETED
NO. ACTION DELIVERABLE COMPLETION
RESPONSIBLE (DATE/
DATE
INITIALS)

P RE V E NT I V E A C T IO N S (REQUIRED F O R CRI T I CAL AND M AJO R NO NCO NF O RM IT I E S )

DATE
TARGET
PERSON COMPLETED
NO. ACTION DELIVERABLE COMPLETION
RESPONSIBLE (DATE/
DATE
INITIALS)

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 AUDIT PLAN AND REPORT

AUDIT NUMBER: AUD-YYYY-EXT-001

Clinical
O BS E RV AT I O N Documentation
1 C L A S S I F I C AT IO N RAT I NG Compliant
NUM BE R and Registry
Reporting
RE S P O NS E C O M P L E T E D B Y : DAT E

O BS E RV AT I O N
1 C L A S S I F I CAT IO N RAT I NG
NUM BE R

RE S P O NS E A C C E P T A N C E - T O B E CO M P L E T E D BY L E AD AUDI T O R

Does the investigation and response address the observation adequately?

Yes No (return form to the responsible party for additional investigation)

Will the corrective actions cause any negative effects to other processes?
Yes (return form to responsible party to address potential negative affects) No

Will the corrective actions cause any negative effects to other documents?
Yes (return form to responsible party to address potential negative affects) No

Will the corrective actions cause any negative effects to other groups?
Yes (return form to responsible party to address potential negative affects) No
RE S P O NS E A C C E P T A N C E C O M P L E T E D BY : DAT E

O BJE CT I V E E VI D E N C E V E R IF I C A T I O N ( DE S CRI BE ACT I O NS T AKE N TO E V AL UAT E

E F F E CTI V E N E S S )

F I NDI NG S T A T U S

Complete (actions completed and verified to be effective)

Ineffective (actions completed but subsequent issues noted) – return to responsible

party for additional investigation and actions (use another form if necessary).

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AUDIT NUMBER: AUD-YYYY-EXT-001

Clinical
O BS E RV AT I O N Documentation
1 C L A S S I F I C AT IO N RAT I NG Compliant
NUM BE R and Registry
Reporting
V E RI F I CAT IO N P E R F O R M E D B Y : DAT E

Process Improvement Opportunities (formal response not required)

IT E M
P R O C E S S IM P RO V E M E NT OP P O RT UNI T I E S
NUM BE R

1
2

Good and Best Practices (no response required)

ITEM
GO O D AND BE S T P RACT I CE S
NUM BE R

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 FORM 2100
DAY 100 CRID: HSCT Date: Data Coordinator:

Transplant Type: Product Type: Disease Category:*

 Auto  HPC-A  Plasma Cell Disorder  MDS/MPS
 Allo / MUD/MMUD  HPC-M  Acute Leukemia  CML/CLL
 Allo/MSD/MRD/ Syn/Haplo  HPC-C – Single  Other Leukemia  Anemia
 Allo / Cord  HPC-C– Multiple  Lymphoma  Other Malignancies
Specify:
_______________________
Source Documentation
In-house Outside Reviewed
Critical Fields- CIBMTR/FACT* Yes No N/A Records Records by

1. Contact Date / Date of Follow-Up

2. Engraftment Indicator / Date
3. ANC Subsequent Decline
4. Second Infusion Indicator/Date
Acute GVHD Indicator/Date of
5. Onset/Skin/Gut/Liver/Other/Maximum Grade
Chronic GVHD Indicator/Date of Onset/Onset
Code/Maximum Grade/Organ
6. Involvement/Present on Date of Contact
7. Immunosuppressant Therapy Indicator
New Malignancy, Lymphoproliferative or
8. Myeloproliferative Disorder
9. Karnofsky/Lansky Performance Score
10. Death Indicator
11. *Remission Assessment Post-BMT
12. *Assessment Date Post- BMT
13. *Relapse/Disease Progression Post-BMT
14. *Method of Latest Disease Assessment
15. *Cause of Death
Notes:

Corrective Action Required: # of Critical Fields :

 Audited <NN>
 Correctly Reported <NN>
 Correction Required: <NN>
 Error Rate: <NN>%

Auditor Signature: ________________________________ Date : _________________

Acceptable forms of Documentation:
Recipient Identification
Unique ID
Date of HCST
Transplant Type
Product Type
Contact Date/Date of Follow-up
Engraftment Indicator
ANC Subsequent Decline
Second Infusion Indicator/Date
Acute GVHD Indicator/Date of
Onset/Skin/Gut/Liver/Other/Maximum
Grade
Chronic GVHD Indicator/Date of
Onset/Onset Code/Maximum
Grade/Organ Involvement/Present on
Date of Contact
Immunosuppressant Therapy
New Malignancy, Lymphoproliferative or
Myeloablative Disorder
Karnofsky/Lansky Performance Score
Death Indicator
Acceptable Source
Assigned by the CIBMTR
Stem Cell Transplant Infusion Record
Stem Cell Transplant Infusion Record
Stem Cell Transplant Infusion Record
Lab Report and Progress Note
Lab Report Calculations
Lab Reports
Lack of second infusion record
Physician Progress Note
Physician Progress Note
Physician Progress Note
Physician Progress Note
Physician Progress Note
Physician Progress Note
 FORM 2400 Pre-TED
Pre- TED CRID: HSCT Date: Data Coordinator:

Transplant Type: Product Type: Disease Category:*

 Auto  HPC-A  Plasma Cell Disorder  MDS/MPS
 Allo / MUD/MMUD  HPC-M  Acute Leukemia  CML/CLL
 Allo/MSD/MRD/Syn/Haplo  HPC-C– single  Other Leukemia  Anemia
 Allo / Cord  HPC-C – multiple  Lymphoma  Other Malignancies
Specify:_______________________
Source Documentation
In-house Outside Reviewed
Critical Fields-CIBMTR Yes No N/A Records Records by

16. Disease Stage

17. Patient Date of Birth
18. Patient CMV Status
19. Patient Race
20. Karnofsky/Lansky Performance Score
Prep. Regimen Drugs Indicator *reported as prescribed
21. doses
Radiation Indicator/TBI/TBI Dose/Unit of
22. Measure
23. Non-Myeloablative/Reduced Intensity (allo only)
24. Ex-Vivo Graft Manipulation
25. Disease Status Pre-HSCT
26. Cytogenetic Remission Pre-HSCT
27. Molecular Remission Pre-HSCT
Database Consent  Repository Consent 
28. *all checkboxes and required signatures must be complete
Notes:

Corrective Action Required: # of Critical Fields :

 Audited <NN>
 Correctly Reported <NN>
 Correction Required: <NN>
 Error Rate: <NN>%

Auditor Signature: _______________________________ Date :_______________________

Acceptable forms of Documentation:
Recipient Identification Acceptable Source
Unique ID Assigned by the CIBMTR
Date of HCST
Transplant Type
Product Type
Disease Category
Disease Stage
Patient Date of Birth
Patient CMV Status
Patient Race
Karnofsky/Lansky Performance Score
Prep. Regimen Drugs Indicator
Radiation Indicator/TBI/TBI Dose/Unit of
Measure
Non-Myeloablative/Reduced Intensity(allo
only)
Ex-Vivo Graft Manipulation
Disease Status Pre-HSCT
Cytogenetic Remission Pre-HSCT
Molecular Remission Pre-HSCT
Database Consent /Repository Consent