Post on 15-Sep-2019
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
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
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
Scenario # 2Scenario # 2
Which source document is best?Which source document is best?
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
Scenario # 3Scenario # 3
Which source document is best?Which source document is best?
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?
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
Scenario # 4Scenario # 4
Which source document is best?Which source document is best?
Chemotherapy OrdersMedication Administration RecordAdmitting History & PhysicalDischarge Summary
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
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
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
Scenario # 6Scenario # 6
Which source document is best?Which source document is best?
Referring Physician’s Progress NoteDischarge SummaryTreatment SummaryAdmitting History & Physical
Scenario # 7Scenario # 7
What if the source What if the source documentation is not documentation is not
available?available?
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.
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
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, dchristi@nmdp.org
Krista SullivanSenior Clinical Research Associate(612) 884-8514, ksulliva@nmdp.org
Amy HaysClinical Research Associate(612) 884-8559, ahays@nmdp.org
Jody ZarembinskiClinical Research Associate(612) 617-8332, jzarembi@nmdp.org
Kristin LawmanClinical Research Associate