Michigan Cancer Surveillance Program

Transcription

1 Michigan Cancer Surveillance Program Supplemental Guidance for the Implementation Guide for Ambulatory Healthcare Provider Reporting to Central Cancer Registries, HL7 Clinical Document Architecture (CDA)

2 Version 1.5 G. Alverson, G. Copeland, R. Humphrys, R. Kommareddi, L. Rappleye, T. McTaggart Michigan Cancer Surveillance Program Supplemental Guidance for the Implementation Guide for Ambulatory Healthcare Provider Reporting to Central Cancer Registries, HL7 Clinical Document Architecture (CDA) August, 2015

3 Preface This supplement describes Michigan s testing and validation process, the transport mechanism to be used once the provider s CDAs have passed testing and validation, as well as, Michigan specific reportable condition data elements and the conformance optionalities to include in the cancer CDA in order to meet both the cancer reporting meaningful use objective and Michigan s mandated cancer reporting requirements.

4 Table of Contents 1.0 Introduction Testing and Validation Cancer CDA Submission and Transport Data Elements and Conformance Optionalities Required to Meet Michigan Cancer Reporting Requirements... 4 List of Acronyms... 1 Michigan Cancer Surveillance Program i

5 List of Tables Table 3-1: Cancer CDA Routing and Tracking Requirements... 3 Table 4-1: Cancer Data Elements Cross Reference... 5 Table 4-2: RX Date CHEMO Flag Value Set... 7 Table 4-3: RX Date Hormone Flag Value Set... 8 Table 4-4: RX Date BRM Flag Value Set... 8 Table 4-5: Tumor, Nodes, and Metastases (TNM) Logical Observation Identifiers Names and s (LOINC) s... 9 Table 4-6: TNM Pathologic Tumor Value Set... 9 Table 4-7: TNM Pathologic Node Value Set Table 4-8: TNM Pathologic Metastasis Value Set Table 4-9: TNM Stage Descriptor Value Set Table 4-10: NAACCR TNM Pathologic Staged By Value Set Table 4-11: TNM Pathologic Stage Group Value Set Table 4-12: SEER SUMMARY STAGE 2000 Value Set List of Figures Figure 3-1: Routing Example... 4 Figure 4-1: TNM Pathological Stage Entry Example Diagnosis Michigan Cancer Surveillance Program ii

6 1.0 Introduction The Michigan Cancer Surveillance Program (MCSP) is supporting eligible professionals (providers) meet the Stage 2 Meaningful Use cancer reporting objective: capability to identify and report cancer cases to a public health central registry. Michigan s cancer registry will be accepting cancer case information in accordance with the implementation guide referenced in the Office of the National Coordinator s for Health Information Technology (ONC) 2014 Standards and Certification Criteria final rule, Implementation Guide for Ambulatory Healthcare Provider Reporting to Central Cancer Registries, Release 1, August The implementation guide was jointly developed by the Centers for Disease Control and Prevention (CDC) and the North American Association of Central Cancer Registries (NAACCR). The Implementation Guide contains specifications for the transmission of cancer case information from ONC certified electronic health record technology (CEHRT) to a public health central cancer registry. The guide defines the trigger event and business rules for CEHRT to identify reportable cancer cases, defines cancer case data elements and specifications for creating a valid Health Level 7 Clinical Document Architecture, Release 2 (HL7 CDA R2) cancer event report. Users of the guide must be familiar with the details of HL7 CDA R2. The guide is intended for use in ambulatory care setting implementations. The guide is not intended for hospital or pathology laboratories implementations. The Implementation Guide for Ambulatory Healthcare Provider Reporting to Central Cancer Registries, Release 1, August 2012 does not include specific statutory reporting requirements for each state or the transport mechanism for submitting cancer case information to the public health authorities jurisdiction. The Centers for Medicare and Medicaid Services (CMS) Stage 2 Meaningful Use final rule permits public health authorities to dictate the transport mechanism in their jurisdictions. This supplemental guide describes Michigan s testing and validation process, the transport mechanism to be used once the provider s CDAs have passed testing and validation, as well as, Michigan specific reportable condition data elements and the conformance optionalities to include in the cancer CDA in order to meet both the cancer reporting meaningful use objective and Michigan s mandated cancer reporting requirements. Michigan Cancer Surveillance Program 1

7 2.0 Testing and Validation To ensure the structure and content of the CDA meets the quality assurance requirements of the MCSP, all provider organizations must complete a testing and validation process before the cancer CDAs are approved for production into Michigan s cancer registry. CEHRT vendors may begin the testing validation process on behalf of providers. Vendors and provider organizations interested in beginning the testing and validation process should contact MCSP technical assistance: mcsp.help@altarum.org. Providers who have registered their intent to initiate ongoing submission within 60 days of their reporting period and who have demonstrated their organization s ability to begin testing and validation with MCSP, will meet the Stage 2 meaningful use measure as long as the provider responds to requests for action from MCSP. If the provider fails to respond to requests for action within 30 days on two separate occasions, the provider may not meet the meaningful use measure. Questions regarding registration of intent and the public health Stage 2 meaningful use measures can be directed to: DCHPublicHealthMU@michigan.gov. Michigan Cancer Surveillance Program 2

8 3.0 Cancer CDA Submission and Transport The Michigan Department of Health and Human Services (MDHHS), Michigan s public health authority, requires public health reporting for meaningful use to be transported through the Michigan Health Information Network Shared Services (MiHIN). MiHIN is the state s designated entity to coordinate health information exchange. Providers must select a MiHIN qualified organization or sub-state health information exchange (HIE) to handle the transmission of the cancer CDA through the MiHIN and to the state cancer registry. CEHRT vendors must coordinate the transmission of the cancer CDA with the MiHIN qualified organization. Further information on MiHIN qualified organizations can be found at Table 3-1: Cancer CDA Routing and Tracking Requirements For routing and meaningful use registration and tracking purposes, the cancer CDA must contain the following information. CDA Data Element Organizational ID* (Organization of the Facility where event took place) Facility OID (Location where event took place) Information Recipient Receiving Public Health System Cancer CDA IG Optionality MI Cancer Transport Requirement CDA xpath Not present SHALL ClinicalDocument/custodian/assignedCustodian/repres entedcustodianorganization/id/@root *Instructions for obtaining organizational and facility OIDs can be found at: n_msss_26sept13.docx should not be equal to (NPI OID). Not present SHALL ClinicalDocument/componentOf/encompassingEncoun ter/location/healthcarefacility/id/@root should not be equal to (NPI OID). Not present SHALL ClinicalDocument/custodian/assignedCustodian/repres entedcustodianorganization/id[@root= '] MDHHS Not present SHALL ClinicalDocument/custodian/assignedCustodian/repres entedcustodianorganization/id[@root= ' '] MCSR Michigan Cancer Surveillance Program 3

9 Figure 3-1: Routing Example <custodian> <assignedcustodian> <representedcustodianorganization> <id root=" " extension="321cx" /> <!-- Organization NPI --> <id root=" " /> <!-- Organization OID --> <id root=" " extension="mdhhs" /> <!-- Receiving Facility --> <id root=" " extension="mcsr" /> <!-- Receiving Application -->... </representedcustodianorganization> </assignedcustodian> </custodian> <componentof> <encompassingencounter> <id extension=" " root=" " /> <code codesystem="" codesystemname="" code="" displayname="" /> <effectivetime> <low value=" " /> <high value=" " /> </effectivetime> <location> <healthcarefacility> <id root=" " /> <!-- Facility OID --> <id root=" " extension="12345" /> <!-- Facility NPI --> </healthcarefacility> </location> </encompassingencounter> </componentof> 4.0 Data Elements and Conformance Optionalities Required to Meet Michigan Cancer Reporting Requirements In Michigan, Act 82 of 1984 requires the Michigan Department of Health and Human Services to operate a cancer registry. Under this law and the associated administrative rules, cancer cases are reportable to MDHHS by physicians, dentists, clinics, hospitals and laboratories that diagnose or treat patients with reportable conditions. The existing Michigan cancer registry receives these reports and incorporates the information into a statewide registry. All in situ and malignant conditions are reportable, with the exception of basal and squamous cell skin cancers in nongenital skin. Benign tumors of the brain and central nervous system are also reportable. The table below lists the conformance optionalities needed for the data elements to meet the Michigan Michigan Cancer Surveillance Program 4

10 reporting requirements. Further information on the provider mandated reporting requirements can be found at: Table 4-1: Cancer Data Elements Cross Reference NAACR Data Item # Element 630 Primary Payer at DX 1220 RX Date-- Chemo (YYYYMM DD) 1221 RX Date-- Chemo Flag National Cancer CDA Optionality MI Mandated Reporting Optionality Template ID CDA xpath SHOULD SHALL [Coverage Entry] SHOULD SHALL [Medications] Not present SHALL [Medications] ']]/entry/a ct[templateid[@root=' ']]/entryRel ationship/act/code/@* ']]/entry/sub stanceadministration/effectiveti me[1]/low Depending on the values of the below xpaths for Chemo, the flag will have value as shown in the Table. CDA will not have a separate tag for this item RX Date-- Hormone (YYYYMM DD) SHOULD SHALL [Medications] ']]/entry/sub stanceadministration/code And ']]/entry/sub stanceadministration/effectiveti me[1]/low ']]/entry/sub stanceadministration/effectiveti me[1]/low Michigan Cancer Surveillance Program 5

11 NAACR Data Item # Element 1231 RX Date-- Hormone Flag National Cancer CDA Optionality MI Mandated Reporting Optionality Template ID CDA xpath Not present SHALL [Medications] Depending on the values of the below xpaths for Hormone, the flag will have value as shown in the Table. CDA will not have a separate tag for this item RX Date-- BRM (YYYYMM DD) 1241 RX Date-- BRM Flag SHOULD SHALL [Medications] Not present SHALL [Medications] ']]/entry/sub stanceadministration/code And ']]/entry/sub stanceadministration/effectiveti me[1]/low ']]/entry/sub stanceadministration/effectiveti me[1]/low Depending on the values of the below xpaths for BRM, the flag will have value as shown in the Table. CDA will not have a separate tag for this item. 108 Date of Death 880 TNM Path T ']]/entry/sub stanceadministration/code And ']]/entry/sub stanceadministration/effectiveti me[1]/low Not present SHALL ClinicalDocument/recordTarget/ patientrole/patient/sdtc:deceas edind and ClinicalDocument/recordTarget/ patientrole/patient/sdtc:deceas Not present SHALL [TNM Stage Observation] edtime ']]/entry/ac t/entryrelationship/observation/ entryrelationship/observation/e ntryrelationship/observation[co de[@code=' ']]/value/@* Michigan Cancer Surveillance Program 6

12 NAACR Data Item # Element 890 TNM Path N 900 TNM Path M 910 TNM Path Stage Group 920 TNM Path Descriptor 759 SEER Summary Stage 2000 National Cancer CDA Optionality MI Mandated Reporting Optionality Template ID CDA xpath Not present SHALL [TNM Stage Observation] Not present SHALL [TNM Stage Observation] Not present SHALL [TNM Stage Observation] Not present SHALL [TNM Stage Observation] ']]/entry/ac t/entryrelationship/observation/ entryrelationship/observation/e ntryrelationship/observation[co de[@code=' ']]/value/@* ']]/entry/ac t/entryrelationship/observation/ entryrelationship/observation/e ntryrelationship/observation[co de[@code=' ']]/value/@* ']]/entry/ac t/entryrelationship/observation[ templateid[@root=' ']]/entryRela tionship/observation/value/@* ']]/entry/ac t/entryrelationship/observation[ templateid[@root=' ']]/entryRela tionship/observation/value/quali fier[name[@code=" "]]/value/@* Not present SHALL Will be derived from Clinical Stage Group, Primary Site, and Histology at the registry. Table 4-2: RX Date CHEMO Flag Value Set Value Set NAACCR RX Date CHEMO Flag TBD OID DYNAMIC System NAACCR RX Date CHEMO Flag TBD OID LOINC Flag for Date 1st chemo Cancer Flag explains why no appropriate value is in the field, RX Date Chemo [1220] 10 No information whatsoever can be inferred from this exceptional value (e.g., unknown if chemotherapy administered) 11 No proper value is applicable in this context (e.g., no chemotherapy administered; autopsy only case) Michigan Cancer Surveillance Program 7

13 12 A proper value is applicable but not known. This event occurred, but the date is unknown (e.g., chemotherapy administered but date is unknown) 15 Information is not available at this time, but it is expected that it will be available later (e.g., chemotherapy is planned as part of the first course of therapy, but had not been started at the time of the most recent follow-up) Blank A valid date value is provided in item RX Date Chemo [1220], or the date was not expected to have been transmitted Table 4-3: RX Date Hormone Flag Value Set Value Set NAACCR RX Date Hormone Flag TBD OID DYNAMIC System NAACCR RX Date Hormone Flag TBD OID LOINC Flag for Date 1st hormone Cancer Flag explains why no appropriate value is in the field, RX Date Hormone [1230] 10 No information whatsoever can be inferred from this exceptional value (e.g., unknown if any hormone therapy administered) 11 No proper value is applicable in this context (e.g., no hormone therapy administered; autopsy only cases) 12 A proper value is applicable but not known. This event occurred, but the date is unknown (e.g., hormone therapy administered but date is unknown) 15 Information is not available at this time, but it is expected that it will be available later (e.g., hormone therapy is planned as part of the first course of therapy, but had not been started at the time of the most recent follow-up) Blank A valid date value is provided in item RX Date Hormone [1230], or the date was not expected to have been transmitted Table 4-4: RX Date BRM Flag Value Set Value Set NAACCR RX Date BRM Flag TBD OID DYNAMIC System NAACCR RX Date BRM Flag TBD OID LOINC Flag for Date 1st BRM Cancer Flag explains why no appropriate value is in the field, RX Date BRM [1240] 10 No information whatsoever can be inferred from this exceptional value (e.g, unknown if immunotherapy administered) 11 No proper value is applicable in this context (e.g., no immunotherapy administered; autopsy only case) 12 A proper value is applicable but not known. This event occurred, but the date is unknown (e.g., immunotherapy administered but date is unknown) Michigan Cancer Surveillance Program 8

14 15 Information is not available at this time, but it is expected that it will be available later (e.g., immune therapy is planned as part of the first course of therapy, but had not been started at the time of the most recent follow-up) Blank A valid date value is provided in item RX Date BRM [1240], or the date was not expected to have been transmitted Table 4-5: Tumor, Nodes, and Metastases (TNM) Logical Observation Identifiers Names and s (LOINC) s LOINC Display Name TNM Pathology T TNM Pathology N TNM Pathology M TNM Path Descriptor Value Set TNM Pathologic Tumor Value Set TNM Pathologic Node Value Set TNM Pathologic Metastasis Value Set TNM Pathologic Descriptor Value Set A detailed site-specific code for the Pathologic tumor (T) as defined by American Joint Committee on Cancer (AJCC) and recorded by the physician. A detailed site-specific code for the Pathologic nodes (N) as defined by AJCC and recorded by the physician. A detailed site-specific staging code for the Pathologic metastases (M) as defined by AJCC and recorded by the physician. Descriptor.pathology Cancer Narrative Table 4-6: TNM Pathologic Tumor Value Set The AJCC Staging Manual TNM system is propriety and its definitions cannot be included in documents or electronic vocabulary systems without permission. Value Set TNM Pathologic Tumor DYNAMIC AJCC Website Link System TNM Pathologic Tumor (TNM 7. Edition) LOINC Primary tumor.pathology Detailed site-specific codes for the pathologic tumor (T) as defined by AJCC and recorded by the physician X Site specific descriptions prevent listing of text equivalents Michigan Cancer Surveillance Program 9

15 Table 4-7: TNM Pathologic Node Value Set The AJCC Staging Manual TNM system is propriety and its definitions cannot be included in documents or electronic vocabulary systems without permission. Value Set AJCC Website Link System LOINC X TNM Pathologic Node DYNAMIC TNM Pathologic Node (TNM 7. Edition) Regional lymph nodes.pathology Detailed site-specific codes for the Pathologic Node (N) as defined by AJCC and recorded by the physician Site specific descriptions prevent listing of text equivalents Table 4-8: TNM Pathologic Metastasis Value Set The AJCC Staging Manual TNM system is propriety and its definitions cannot be included in documents or electronic vocabulary systems without permission. Value Set TNM Pathologic Metastasis DYNAMIC AJCC Website Link System TNM Pathologic Metastasis (TNM 7. Edition) LOINC Distant metastases.pathology Detailed site-specific codes for the Pathologic Metastasis (M) as defined by AJCC and recorded by the physician. X Site specific descriptions prevent listing of text equivalents Table 4-9: TNM Stage Descriptor Value Set Value Set TNM Stage Descriptor DYNAMIC PHIN VADS Link System E B39829B TNM Pathology Stage Descriptor (TNM 7. Edition) LOINC Descript.Pathology Cancer Identify special cases that need separate data analysis 0 None 1 E (Extranodal, lymphomas only) Michigan Cancer Surveillance Program 10

16 2 S (Spleen, lymphomas only) 3 M (Multiple primary tumors in a single site) 4 Y (Classification during or after initial multimodality therapy) pathologic staging only 5 E & S (Extranodal and spleen, lymphomas only) 6 M & Y (Multiple primary tumors and initial multimodality therapy) 9 Unknown; not stated in patient s record Table 4-10: NAACCR TNM Pathologic Staged By Value Set Value Set NAACCR TNM Pathologic Staged By PHIN VADS Link TBD System NAACCR TNM Pathologic Staged By LOINC Stager.pathology Cancer Identifies the person who recorded the pathologic AJCC staging elements and the stage group in the patient s medical record 0 Not Staged 1 Managing physician 2 Pathologist 3 Pathologist and managing physician 4 Cancer Committee chair, cancer liaison physician, or registry physician advisor 5 Cancer registrar 6 Cancer registrar and physician 7 Staging assigned at another facility 8 Case is not eligible for staging 9 Unknown; not stated in patient record Table 4-11: TNM Pathologic Stage Group Value Set The AJCC Staging Manual TNM system is propriety and its definitions cannot be included in documents or electronic vocabulary systems without permission. Value Set TNM Pathologic Stage Group AJCC Website Link System TNM Pathologic Stage Group (TNM 7. Edition) SNOMED CT Detailed site-specific code for the pathologic stage group as defined by AJCC and recorded by the ambulatory healthcare provider (physician). 0 Site specific descriptions prevent listing of text equivalents Michigan Cancer Surveillance Program 11

17 Table 4-12: SEER SUMMARY STAGE 2000 Value Set Value Set NAACCR SEER SUMMARY STAGE 2000 TBD OID DYNAMIC PHIN VADS Link TBD System NAACCR SEER SUMMARY STAGE 2000 TBD OID LOINC TBD SEER SS2000 Identify special cases that need separate data analysis 0 In situ 1 Localized 2 Regional, direct extension only 3 Regional, regional lymph nodes only 4 Regional, direct extension and regional lymph nodes 5 Regional, NOS 7 Distant 8 Not applicable 9 Unstaged Figure 4-1: TNM Pathological Stage Entry Example Diagnosis <entryrelationship type="subj" inversionind="true"> <observation class="obs" mood="evn"> <templateid root=" "/> <code code=" " displayname="tnm classification of malignant tumor before any treatment" codesystem=" " codesystemname="snomedct"/> <!-- Narrative TNM Pathology Stage --> <text> Stage 0 TisN0M0 </text> <status code="completed"/> <value xsi:type="cd" code=" " codesystem=" " displayname ="Pathologic TNM Stage Grouping"> <!--TNM Pathology Stage Descriptor Observation --> <qualifier> <name code=" " displayname="descript.pathology Cancer" codesystem=" " codesystemname="loinc"/> <value xsi:type="cd" code="0" codesystem=" " codesystemname="tnm Pathology Stage Descriptor" displayname="none"/> </qualifier> <!--AJCC TNM Edition Number--> <qualifier> <name code=" " displayname="tnm Edition Number" codesystem=" " codesystemname="loinc"/> <value xsi:type="cd" code="7" codesystem=" " codesystemname="naaccr TNM Edition Number" displayname="7th Edition"/> </qualifier> </value> <participant type="pprf"> Michigan Cancer Surveillance Program 12

18 <participantrole> <code code=" " codesystem=" " codesystemname="loinc" displayname="stager.pathology Cancer"/> <playingentity nullflavor="na"> <code xsi:type="ce" code="1" codesystem="tbd OID" codesystemname="tnm Pathology Staged By" displayname="managing Physician"/> </playingentity> </participantrole> </participant> <entryrelationship type="comp"> <!-- TNM Pathological Tumor Observation--> <observation class="obs" mood="evn"> <templateid root=" "/> <code code=" " displayname="tnm Pathological T" codesystem=" " codesystemname="loinc"/> <status code="completed"/> <value code="t2" codesystem=" " displayname="tumor > 20 mm but <= to 50 mm in greatest dimension"/> </observation> </entryrelationship> <!--TNM Pathological Nodes Observation --> <entryrelationship type="comp"> <observation class="obs" mood="evn"> <templateid root=" "/> <code code=" " displayname="tnm Pathological N" codesystem=" " codesystemname="loinc"/> <status code="completed"/> <value code="n1" codesystem=" " displayname="micrometastases; or metastases in 1 to 3 axillary lymph nodes; and/or in internal mammary nodes with metastases detected by sentinel lymph node biopsy but not clinically detected."/> </observation> </entryrelationship> <!-- TNM Pathological Metastases Observation--> <entryrelationship type="comp"> <observation class="obs" mood="evn"> <templateid root=" "/> <code code=" " displayname="tnm Pathological M" codesystem=" " codesystemname="loinc"/> <status code="completed"/> <value nullflavor="na"/> </observation> </entryrelationship> </observation> </entryrelationship> For questions regarding the Michigan Cancer Surveillance Program and physician reporting requirements please contact: Jetty Alverson, CTR Quality Improvement Field Representative Ph: Michigan Cancer Surveillance Program 13

19 Document Revision History Date Version Initial version published Added xpath details to the Michigan data elements, value sets and CDA example Updated Cancer CDA Submission and Transport section Updated Cancer CDA Submission and Transport section. 2. Added T, N, M value sets and updated the example Updated Cancer CDA Submission and Transport Section Updated to replace MDHHS logo with MDHHS logo. for Receiving Facility and Receiving Application in Table 3-1. Added Routing example code in Figure 3-1. Updated xpath for Date of Death and SEER Summary 2000 in Table 4-1. Michigan Cancer Surveillance Program 14

20 List of Acronyms Acronym AJCC CEHRT CDC CDA CMS HL7 LOINC MCSP MDHHS MiHIN MSSS NAACCR PHIN OID ONC R2 TBD TNM VADS Acronym Definition American Joint Committee on Cancer Certified Electronic Health Record Technology Centers for Disease Control and Prevention Clinical Document Architecture Centers for Medicare and Medicaid Services Health Level Seven Logical Observation Identifiers Names and s Michigan Cancer Surveillance Program Michigan Department of Health and Human Services Michigan Health Information Network Shared Services Michigan Syndromic Surveillance Syndrome North American Association of Central Cancer Registries Public Health Information Network Object Identifier Office of the National Coordinator for Health Information Technology Release Two To Be Determined Tumor, Nodes, and Metastases Vocabulary Access and Distribution System Michigan Cancer Surveillance Program 1