Source Documents The Key to Quality Research Data · Examples of Source Documents Progress Notes &...
Transcript of Source Documents The Key to Quality Research Data · Examples of Source Documents Progress Notes &...
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Source DocumentsSource DocumentsThe Key to Quality The Key to Quality
Research DataResearch Data
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ObjectivesObjectives
Definition Importance Real Life Scenarios Reporting Results
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DefinitionDefinition
Original records or certified copies of clinical findings and observations
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What does this What does this definition mean?definition mean?
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Source DocumentSource Document
Document in which data are first recorded Permanent record kept by physicians or institutionsUsed to complete Case Report Forms
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Why are source Why are source documents documents important?important?
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Importance of Source Importance of Source DocumentsDocuments
Continuum of Patient CareInsuranceCoding & BillingLitigationClinical TrialsResearch Outcomes Database
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What is considered What is considered a source a source
document?document?
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Examples of Source Examples of Source DocumentsDocuments
Progress Notes & ConsultationsFace SheetReferring Physician CorrespondenceLaboratory ReportsMedication Administration RecordsPathology & Radiology Reports
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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
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Acceptable Formats of Acceptable Formats of Source DocumentsSource Documents
Electronic RecordsPaper Records (Hard Copy)PhotocopiesFaxesEmailsTelephone Communication Logs
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Real Life Scenarios:Real Life Scenarios:
Which Source Which Source Document is Best?Document is Best?
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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
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What if data is What if data is recorded on multiple recorded on multiple source documents? source documents?
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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
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Scenario # 1Scenario # 1
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
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Scenario # 2Scenario # 2
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
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Scenario # 2Scenario # 2
Which source document is best?Which source document is best?
Referring Physician’s Progress NotePathology ReportAdmitting History & PhysicalDischarge Summary
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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
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Scenario # 3Scenario # 3
Which source document is best?Which source document is best?
Laboratory ReportDischarge SummaryProgress NoteHandwritten on a BMT Flow Sheet
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What if data within What if data within source documents are source documents are
inconsistent?inconsistent?
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Scenario # 4Scenario # 4
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
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Scenario # 4Scenario # 4
Which source document is best?Which source document is best?
Chemotherapy OrdersMedication Administration RecordAdmitting History & PhysicalDischarge Summary
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Scenario # 5Scenario # 5
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
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Scenario # 5Scenario # 5
Which source document is best?Which source document is best?
Attending Physician’s Progress NoteBiopsy/ConsultGVHD Assessment Team’s Summary SheetAll of the Above
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Scenario # 6Scenario # 6
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
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Scenario # 6Scenario # 6
Which source document is best?Which source document is best?
Referring Physician’s Progress NoteDischarge SummaryTreatment SummaryAdmitting History & Physical
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Scenario # 7Scenario # 7
What if the source What if the source documentation is not documentation is not
available?available?
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Scenario # 7Scenario # 7
Post TransplantPost Transplant
The patient is sent back to referring physician after transplant. Data sent to transplant center is limited or insufficient.
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Scenario # 7Scenario # 7
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
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Have data reporting Have data reporting practices improved practices improved
over the past 10 years?over the past 10 years?
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Source Document AuditsSource Document Audits
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NMDP Audit Program NMDP Audit Program Quick ReviewQuick Review
Source documentation based auditEach TC audited once every four yearsCritical FieldsRandom FieldsError Rates
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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
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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
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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
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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!
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Questions?Questions?
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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