source documents the key to quality research data · examples of source documents progress notes...

Source DocumentsSource DocumentsThe Key to Quality The Key to Quality

Research DataResearch Data

ObjectivesObjectives

Definition Importance Real Life Scenarios Reporting Results

DefinitionDefinition

Original records or certified copies of clinical findings and observations

What does this What does this definition mean?definition mean?

Source DocumentSource Document

Document in which data are first recorded Permanent record kept by physicians or institutionsUsed to complete Case Report Forms

Why are source Why are source documents documents important?important?

Importance of Source Importance of Source DocumentsDocuments

Continuum of Patient CareInsuranceCoding & BillingLitigationClinical TrialsResearch Outcomes Database

What is considered What is considered a source a source

document?document?

Examples of Source Examples of Source DocumentsDocuments

Progress Notes & ConsultationsFace SheetReferring Physician CorrespondenceLaboratory ReportsMedication Administration RecordsPathology & Radiology Reports

Examples of Source Examples of Source Documents Documents (continued)(continued)

Physician OrdersNursing I & O Flow SheetsProgram Specific FormsProcedure Reports Transfusion Summary/Blood BankStem Cell Processing RecordsRadiation Therapy Records

Acceptable Formats of Acceptable Formats of Source DocumentsSource Documents

Electronic RecordsPaper Records (Hard Copy)PhotocopiesFaxesEmailsTelephone Communication Logs

Real Life Scenarios:Real Life Scenarios:

Which Source Which Source Document is Best?Document is Best?

Hierarchy Hierarchy

DefinitiveSource document with most conclusive evidence

AccurateAuthored by highest member in chain of command

Timely Source document dated closest to event

Consistency Within reporting practices between patients

What if data is What if data is recorded on multiple recorded on multiple source documents? source documents?

Scenario # 1Scenario # 1

Reporting the Recipient's Reporting the Recipient's Infectious Disease Markers Infectious Disease Markers

The recipient’s IDMs/Serologies are available in multiple locations:

Handwritten on a BMT Flow Sheet or Roadmap Laboratory ReportAdmitting History & PhysicalReferring Physician’s Progress Note


Which source document is best?Which source document is best?

Handwritten on a BMT Flow Sheet or RoadmapLaboratory ReportAdmitting History & PhysicalReferring Physician’s Progress Note


Reporting the Recipient's Reporting the Recipient's Diagnosis DateDiagnosis Date

The recipient’s diagnosis date is available in multiple locations:

Referring Physician’s Progress NotePathology ReportAdmitting History & Physical Discharge Summary



Referring Physician’s Progress NotePathology ReportAdmitting History & PhysicalDischarge Summary

Scenario #3Scenario #3

Reporting the Recipient's Reporting the Recipient's Neutrophil Engraftment Neutrophil Engraftment

The date of the recipient’s first ANC recovery post transplant is available in multiple locations:

Laboratory Report Discharge Summary Progress NoteHandwritten on a BMT Flow Sheet or Roadmap



Laboratory ReportDischarge SummaryProgress NoteHandwritten on a BMT Flow Sheet

What if data within What if data within source documents are source documents are

inconsistent?inconsistent?


Reporting the RecipientReporting the Recipient’’s s Preparative (Conditioning) Regimen Preparative (Conditioning) Regimen

The total dose of Busulfan administered to the recipient is inconsistently documented:

Chemotherapy Orders Medication Administration RecordAdmitting History & PhysicalDischarge Summary



Chemotherapy OrdersMedication Administration RecordAdmitting History & PhysicalDischarge Summary


Reporting the Severity of Reporting the Severity of Acute GVHD Acute GVHD

Acute GVHD grading & staging is inconsistently documented:

Attending Physician’s Progress NoteBiopsy/ConsultGVHD Assessment Team’s Summary Sheet



Attending Physician’s Progress NoteBiopsy/ConsultGVHD Assessment Team’s Summary SheetAll of the Above


Reporting Lymphoma Treatments Reporting Lymphoma Treatments Prior to Conditioning Prior to Conditioning

Pre-conditioning Lymphoma treatments are inconsistently documented:

Referring Physician’s Progress NoteDischarge SummaryMedication Administration RecordAdmitting History & Physical



Referring Physician’s Progress NoteDischarge SummaryTreatment SummaryAdmitting History & Physical


What if the source What if the source documentation is not documentation is not

available?available?


Post TransplantPost Transplant

The patient is sent back to referring physician after transplant. Data sent to transplant center is limited or insufficient.


What should you do?What should you do?

Do Not Report Undocumented DataCall Referring Physician – Request Additional DocumentationCall the Liaison at your assigned CIBMTR CampusAll of the Above

Have data reporting Have data reporting practices improved practices improved

over the past 10 years?over the past 10 years?

Source Document AuditsSource Document Audits

NMDP Audit Program NMDP Audit Program Quick ReviewQuick Review

Source documentation based auditEach TC audited once every four yearsCritical FieldsRandom FieldsError Rates

Cycle 1 and Cycle 2 Error Rates per Error Type

0.00%1.00%2.00%3.00%4.00%5.00%6.00%7.00%

Overall Errors Critical FieldErrors

Random FieldErrors

Error Type

Err

or R

ate

%

Cycle 1Cycle 2

Cycle 1 and Cycle 2Total # of Errors per Error Type

28560

9221

1933918614

6263

12351

0

5000

10000

15000

20000

25000

30000

Overall Errors Critical FieldErrors

Random FieldErrors

Error Type

Tota

l # o

f Err

ors

Cycle 1Cycle 2

Cycle 1 and Cycle 2 Critical Field Error Rates

0.00%

0.50%

1.00%

1.50%

2.00%

2.50%

K/L

Agvhd

Cgvhd

ANCDiagn

osis

Date

Major Critical Field Group

Tota

l % o

f All

Criti

cal F

ield

s Au

ditie

d

Cycle 1Cycle 2

Source Document Source Document WrapWrap--Up Up

Utilizing Source Documents Utilizing Source Documents is the KEY to is the KEY to

Quality Research Data!Quality Research Data!

Questions?Questions?

Audit TeamAudit TeamDeb Christianson

Clinical Research Associate, Manager (612) 362-3426, [email protected]

Krista SullivanSenior Clinical Research Associate(612) 884-8514, [email protected]

Amy HaysClinical Research Associate(612) 884-8559, [email protected]

Jody ZarembinskiClinical Research Associate(612) 617-8332, [email protected]

Kristin LawmanClinical Research Associate