Charter Func. Charter Req.
The PCO solution SHOULD provide the ability to enter and store a
PCO Entry through the PCO User Interface 4 5
The PCO solution SHALL have the ability to capture and store a PCO
Entry from a Clinical Exchange Instance 5, ?
A PCO Entry SHALL include Patient information
A PCO Entry SHALL include one or more Providers
A PCO Entry SHALL include one or more Diagnosis(es)
A PCO Entry SHOULD include one on more Intervention(s)
A PCO Entry SHOULD include one on more Outcome(s)
The PCO Solution SHALL have the ability to extract and transmit a
Patient PCO Record using standards-based formats. 5
The PCO Solution SHALL have the ability to extract and transmit an
XML message based on the HL7 Implementable Technology
Specification that contains all available information for a patient's
continuum of care. 5, 6
The PCO Solution SHALL have the ability to extract and transmit an
XML based on the HL7 Continuity of Care Document (CCD) that
contains a summary of all available information for a patient's
continuum of care that can be supported in the CCD using industry-
accepted notation. 5
The PCO Solution SHOULD have a graphical user interface based on
the data needed for a PCO Entry. 4
The PCO Solution SHALL be implemented with a Tolven Persistence
Layer. 3
The PCO Semantic Adapter SHALL have the ability to extract all TRIMs
for a specific patient, determine the appropriate mappings, and
present the resulting information in the caCIS Canonical Format. 1a
The PCO Semantic Adapter SHALL have the ability to determine the
information present on an inbound caCIS Canonical Format instance
and render a PCO TRIM to allow storage of the data in the PCO
solution. 3
The PCO solution SHALL have the ability to receive a TRANSCEND
CDA and store it to the Tolven Persistence Layer. 3
The PCO solution SHALL have the ability to receive a TRANSCEND
CCD and store it to the Tolven Persistence Layer. 3
The PCO solution SHALL have the ability to receive a TRANSCEND
XML-ITS and store it to the Tolven Persistence Layer. 3
Level Type
CIM Functional
CIM Functional
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Functional
PIM Functional
PIM Functional
CIM Functional
PSM Functional
PIM Functional
PIM Functional
PSM Functional
PSM Functional
PSM Functional
Charter
TRANSCEND SHALL have the ability to extract and transmit information supporting
the continuum of care for a patient using standards-based formats. 1 1
TRANSCEND SHALL have the ability to extract and transmit an XML based on the
HL7 Implementable Technology Specification that contains all available information
for a patient's continuum of care. 2, 2c, 6
TRANSCEND SHALL have the ability to extract and transmit an XML based on the
HL7 Clinical Document Architecture Release 2 that contains all available
information for a patient's continuum of care that can be supported using industry-
accepted notation. 2, 2a
TRANSCEND SHALL have the ability to extract and transmit an XML based on the
HL7 Continuity of Care Document (CCD) that contains a summary of all available
information for a patient's continuum of care that can be supported in the CCD
using industry-accepted notation. 2, 2b
The TRANSCEND Semantic Adapter SHALL have the ability to extract all TRIMs for a
specific patient, determine the appropriate mappings, and present the resulting
information in the caCIS Canonical Format. 1a
The TRANSCEND Semantic Adapter SHALL extract each combination of Patient, AE
Symptom, AE Grade, and AE Date as a unique instance.
Level Type
CIM Functional
PIM Functional
PIM Functional
PIM Functional
PIM Functional
CIM Functional
Charter
The Integration Platform SHALL have the ability to determine the information from a
Canonical Instance and render an HL7 Clinical Document Architecture Release 2
Instance to a specified trading partner. 1, 2a
The Integration Platform SHALL have the ability to determine the information from a
caCIS Canonical Instance and render an HL7 Continuity of Care Document Instance to
a specified trading partner. 1, 2b, 5
The Integration Platform SHALL have the ability to determine the information from a
caCIS Canonical Instance and render an HL7 XML Implementable Technology
Specification Instance to a specified trading partner. 1, 2c, 5, 6
The Integration Platform MAY have the ability to determine the information from a
caCIS Canonical Instance and render an HL7 V2 Message Instance to a specified
trading partner.
The Integration Platform SHOULD have the ability to receive a CDA R2 Instance from
TRANSCEND and determine and render a caCIS Canonical Format instance for
internal use. 3
Level Type
PIM Functional
PIM Functional
PIM Functional
PIM Functional
PIM Functional
Requirement
The canonical format SHALL include the most recent Vital Signs (Temp, Height, Weight, Pulse,
BP, ECOG-PS) and the name of the person that collected the information.
The canonical format SHOULD include the most recent Prior BP and Weight, if available.
New Patient vs. Follow-up (Pick)
A Clinical Note SHALL include the Date of Exam
A Clinical Note SHALL include a Time Point based on the Clinical Note Type (Baseline, Staging,
Medical or Surgical)
The Canonical Data Format SHOULD include one or more Initial Symptom(s)
A Clinical Not MAY include an Index Imaging Type.
The Canonical Data Format SHOULD include one or more Medications.
Each Medication SHALL include a Start Date, Medication Description, Dose, Route, and
Frequency).
The canonical format SHALL include one or more Menopausal Status entries.
Menopausal Status SHOULD include Date of Last Assessment, Date of Last Menstrual Period,
Estrogen Replacement, Bilateral Oophorectomy, Hysterectomy, and Menopausal Status.
Patient Information SHALL include Demographics and Vital Signs.
Demographics SHALL include Patient Name, Gender, Race, and Ethnicity.
Demographics SHOULD include Country of Birth, last 4 digits of SSN, and Medical Record
Number, and ISPY-2 Subject ID Number.
The Canonical Data Format SHOULD include the Institution Location
The Baseline Time Point SHALL indicate "Pre-Study" or "On Study"
The Staging Time Point SHALL indicate "Initial Visit" "Follow-Up Visit" or "Final Staging"
The Surgical Time Point SHALL indicate "Pre-Surgical Visit" "Post-Surgical Visit" or "Follow-Up
Visit"
The Medical Time Point SHALL indicate "Pre-treatment Visit" "Treatment Visit [1-12]" "AC Visit
[1-4]" "Post-treatment Visit" or "Non-Treatment Visit"
Patient Age or DOB (Age in BaselineNote)
Each Initial Symptom SHALL indicate one of the following: None, Lump, Pain, Nipple Discharge,
Skin Changes, Breast Swelling or Other.
An Initial Symptom value of "Other" SHALL require an accompanying text description.
The Canonical Data Format SHALL include Risk Factor information
Each Canonical Data Format MAY include Family History information
Each Family History Record SHOULD include Side, Relative, Cancer Type, and Genetic Markers
The Canonical Data Format SHOULD include Past Breast History information
Past Breast History SHALL include one or more Breast Cancer Diagnoses
Past Breast History SHOULD include a Treatment History.
Each Treatment History SHOULD include one or more Treatment Types.
Each Treatment Type SHALL be one of the following: Surgery, Chemo/Biologic, XRT, Hormone
Therapy, or Bisphonate.
Each Treatment History SHOULD include one or more Treatments.
The Canonical Data Format SHOULD include one or more Breast Exams.
The Canonical Data Format SHOULD include a General Medical History.
The Canonical Data Format SHOULD include a Social History.
The Canonical Data Format SHOULD include Review of Systems (ROS) information.
The Canonical Data Format SHOULD include Physical Exam information.
The Canonical Data Format SHOULD include one or more (Clinical) Impressions.
The Canonical Data Format SHOULD include Plan Information.
The Canonical Data Format SHOULD include Billing information.
The Canonical Data Format SHOULD Include Staging Status information.
Breast Exam SHOULD include Findings, Breast Density, Nipple, and Skin information
The Canonical Data Format SHOULD Include Metastasis information.
The Canonical Data Format SHOULD Include Breast Studies information.
The Canonical Data Format SHOULD Include (Surgical) Procedures information.
The Canonical Data Format SHOULD Include Clinical Staging information.
The Canonical Data Format SHOULD include Toxicity information.
Toxicity SHOULD include an Patient Hospitalized Indicator.
Toxicity SHOULD include an AE Resolved Date.
The Canonical Data Format SHOULD include Response Status information.
The Canonical Data Format SHOULD include Surgical Complications information.
The Canonical Data Format MAY include Surgical Complications information.
The Canonical Data Format MAY include Pre-Eligibility Checklist information.
The Canonical Data Format SHOULD include Registration information.
Registration SHOULD include Provider information.
The Canonical Data Format SHOULD include Core Specimen information.
Core Specimen SHOULD include Core Biopsy information.
Core Biopsy SHOULD include Core Biopsy Specimen information.
Core Biopsy SHALL include Core Biopsy Time Point.
Core Biopsy Time Point SHALL indicate "Pre-Treatment" "Early Treatment" "Early Regimen" or
"Surgery"
The Canonical Data Format SHOULD include Blood Specimen information.
Blood Specimen SHALL include Blood Specimen Collection Time Point
Blood Specimen Collection Time Point SHALL indicate "Pre-Treatment" "Early Treatment"
"Inter-Regimen" or "Pre-Surgery"
The Canonical Data Format SHOULD include MammaPrint information.
The Canonical Data Format SHOULD include RPMA-HER2 information.
The Canonical Data Format SHOULD include MRI information.
The Canonical Data Format SHOULD include Lab and Test information.
The Canonical Data Format SHOULD include Study Checklist information.
The Canonical Data Format SHOULD include Method of Detection information.
The Canonical Data Format SHOULD include Allergy information.
The Canonical Data Format SHOULD include Symptoms information.
The Canonical Data Format SHOULD include Disease Assessment information.
The Canonical Data Format SHOULD include Chemo Adminstration information.
The Canonical Data Format SHOULD include Growth Factor information.
The Canonical Data Format SHOULD include Chemo Summary information
Chemo Summary SHOULD include Treatment End Reason
The Canonical Data Format SHOULD include Post Surgery Summary information.
The Canonical Data Format SHOULD include Pathology information.
The Canonical Data Format SHOULD include Survival Status information.
The Canonical Data Format SHOULD include Notice of Progression.
The Canonical Data Format SHOULD include Radiation Therapy.
The Canonical Data Format SHOULD include Long Term Therapy.
The Canonical Data Format SHOULD include Lost to Follow Up information.
The Canonical Data Format SHOULD include No Longer Lost to Follow Up information.
The Canonical Data Format SHOULD include Protocol Violation information.
The Canonical Data Format SHOULD include Off Study information.
Topic Source
Vital Signs Baseline Functional Spec
Vital Signs Baseline Functional Spec
Patient Baseline Functional Spec
Clinical Note Baseline Functional Spec
Clinical Note Multiple Functional Specs
Clinical Note Baseline Functional Spec
Clinical Note Baseline Functional Spec
Medications Baseline Functional Spec
Medications Baseline Functional Spec
Clinical Note Baseline Functional Spec
Clinical Note Surgical Functional Spec
Patient Baseline Functional Spec
Patient Registration CRF Spec
Patient Registration CRF Spec
Organization
Clinical Note Baseline Functional Spec
Clinical Note Staging Functional Spec
Clinical Note Surgical Functional Spec
Clinical Note Medical Visit Functional Spec
Patient Baseline Functional Spec
Clinical Note Baseline Functional Spec
Clinical Note Baseline Functional Spec
Clinical Note Baseline TRIM
Family History Baseline Functional Spec
Family History Baseline Functional Spec
Clinical Note Baseline Functional Spec
Clinical History Baseline Functional Spec
Clinical History Baseline Functional Spec
Clinical History Baseline Functional Spec
Clinical History Baseline Functional Spec
Clinical History Baseline Functional Spec
Clinical Note Baseline Functional Spec
Clinical History Baseline Functional Spec
Social History Baseline Functional Spec
Clinical Note Baseline Functional Spec
Clinical Note Baseline Functional Spec
Clinical Note Baseline Functional Spec
Treatment Plan Baseline Functional Spec
Billing Baseline Functional Spec
Staging Staging Functional Spec
Clinical Note Baseline Functional Spec
Staging Staging Functional Spec
Staging Staging Functional Spec
Procedures Staging Functional Spec
Staging Staging Functional Spec
Adverse Events Surgical Functional Spec
Adverse Events CTC-AE CRF Spec
Adverse Events CTC-AE CRF Spec
Outcomes Surgical Functional Spec
Clinical Note Surgical Functional Spec
Procedures Surgical Functional Spec
Pre-Eligibility CRF Spec
Registration CRF Spec
Provider Registration CRF Spec
Procedures Core Specimen CRF Spec
Procedures Core Specimen CRF Spec
Specimens Core Specimen CRF Spec
Procedures Core Specimen CRF Spec
Procedures Core Specimen CRF Spec
Specimens Blood Specimen CRF Spec
Specimens Blood Specimen CRF Spec
Specimens Blood Specimen CRF Spec
Diagnostic MammaPrint CRF Spec
Diagnostic RPMA-HER2 CRF Spec
Diagnostic MRI Volume CRF Spec
Diagnostic Lab/Test CRF Spec
On-Study CRF Spec
On-Study CRF Spec
Patient Baseline (non-Note) CRF Spec
Problems Baseline (non-Note) CRF Spec
Outcomes Response Evaluation CRF Spec
Interventions Chemo Treatment CRF Spec
Interventions Chemo Treatment CRF Spec
Interventions Chemo Summary CRF Spec
Interventions Chemo Summary CRF Spec
Post Surgery Summary CRF Spec
Post Surgery Summary CRF Spec
Outcomes Follow Up Status CRF Spec
Outcomes Follow Up Status CRF Spec
Interventions Follow Up Status CRF Spec
Interventions Follow Up Status CRF Spec
Outcomes Lost to Follow Up CRF Spec
Outcomes No Longer Lost to Follow Up CRF Spec
Outcomes Protocol Violation CRF Spec
Outcomes Off Study CRF Spec
Level Type
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information
CIM Information