Meaningful Use Stage 2 Transport Option User Stories. Transitions of Care & View, Download, and Transmit. Version 2.2

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1 Meaningful Use Stage 2 Transport Option User Stories Transitions of Care & View, Download, and Transmit Version 2.2

2 Table of Contents 1. Transitions of Care (ToC)/Referral Introduction Beacon Context Actors Preconditions Story Narrative Post conditions s/data Elements Vocabularies/Coding Systems Diagrams/Supporting Material Triggers Transports Achieving ToC MU 2 Objective: Numerator/Denominator Calculations A. Update Clinical Data Repository and Disease Registry A.1 Beacon Context A.2 Actors A.3 Preconditions A.4 Story Narrative A.5 Post Conditions A.6 s/data Elements A.7 Vocabularies/Coding Systems A.8 Diagrams/Supporting Material A.9 Outbound Triggers (from EHR to HIE) A.10 Outbound Transports (from EHR to HIE) A.11 Achieving ToC MU 2 Objective: Numerator/Denominator Calculations B. Query Clinical Data Repository and Disease Registry (User story 2 cont.) B.1 Beacon Context B.2 Actors B.3 Preconditions B.4 Story Narrative B.5 Post Conditions B.6 s/data Elements B.7 Vocabularies/Coding Systems B.8 Diagrams/Supporting Material B.9 Outbound Triggers (from EHR to HIE) B.10 Outbound Transports (from EHR to HIE) B.11 Inbound Triggers (from HIE to EHR) B.12 Inbound Transports (from HIE to EHR) B.13 Patient Identity View, Download and Transmit to a Third Party Introduction Beacon Context Actors Pre Conditions Story Narrative Post Conditions Definition of Terms

3 3.7 s/data Elements Vocabularies/Coding Systems Diagrams/Supporting Material Triggers Transports Achieving the VDT MU 2 Objective: Numerator/Denominator Calculations

4 1. Transitions of Care (ToC)/Referral Introduction The Beacon Communities program represents ONC s innovation portfolio for demonstrating health IT s role in accelerating gains in health care quality, efficiency, and population health; the triple-aim. This $250 million program includes 17 diverse communities across the US where clinicians, hospitals, health plans and other partners are testing novel information technologies and clinical improvement strategies to measurably improve each component of the triple-aim in the delivery of care to patients. With a principle focus on primary care, each Beacon has chosen chronic disease conditions on which to target their efforts. These include diabetes, asthma, COPD, congestive heart failure, and cardio vascular disease. This second version of the user stories was prompted by the recent industry focus on Meaningful Use Stage 2 (MU2) exchange requirements. While these standards are primarily focused on Direct, we tie the existing Beacon work to the current regulatory requirements and provide guidance to integrate their different approaches. 1.1 Beacon Context Integral to all Beacon programs is the meaningful use of electronic health records (EHRs). The effective coordination of care of patients across care settings is of primary concern to most Beacon programs. Meaningful Use Stage 2 has recognized this and has outlined a set of required and optional standardized transports to facilitate this workflow. While our previous whitepaper outlined workflows that allowed for similar exchange of information the MU2 ToC/Referral workflow targets exchange with a specific provider (or setting) for the transition. This allows for workflows where the information would not be made available to the healthcare community at large. This User Story describes the use of EHR technology and clinical information exchange standards to improve care coordination through the electronic exchange of a standards-based clinical summary between two participating care givers and their EHR systems. The occasion for this exchange will most commonly be the referral of a patient from a primary care setting to a specialist and the return of the patient from specialist to primary care. It can also be the transitioning of a patient from one primary care to another, from an inpatient to outpatient setting or from a behavioral health provider to another (provided that consent management meets CFR title 42 requirements). 1.2 Actors Originating Provider In this case a Primary Care Provider (PCP) The PCP provides both the first contact for a person with an undiagnosed health concern as well as continuing care of varied medical conditions, not limited by cause, organ system, or diagnosis. The primary care provider delivers care to the patient and documents care in a certified Electronic Health Record (EHR) system. Upon a referral to a specialist the PCP will capture the appropriate health information during the encounter and then cause their EHR to create an electronic, standards-based, clinical summary document and Direct (electronically send) that document to the specialist. 3

5 Receiving Provider In this case a Specialist A specialist practice is limited to a particular branch of medicine or surgery. The specialist provider receives referrals from the PCP. Care for the patient is transitioned upon referral from the PCP to a specialist and generally, back to the PCP. An electronic (EHR to EHR) clinical care document (CDA-based clinical summary) exchange is envisioned at both points in the referral cycle. 1.3 Preconditions Patient presents for care and is seen by PCP at primary care setting. Patient demographic and clinical information is documented in the practice s certified EHR. Data is structured and encoded where appropriate with codes drawn from standard medical terminologies. 1.4 Story Narrative Patient Jim Smith, 17 years of age, presented to his primary care rural office as a same-day appointment. Chief complaint was, fatigue and not feeling well. During the assessment with Dr. Able, Mr. Smith reported increased thirst, with an onset of 3 months, and an unexplained ten pound weight loss. Clinical findings showed an elevated body mass index of 38. Patient had an in-office urinalysis and a finger stick blood glucose was performed. His urinalysis showed 4+ glucose, and his finger stick glucose was 345. Stat labs were drawn, and tests performed at a local laboratory. His HgA1C was 12%, out-of-control level, cholesterol elevated at 292, with LDL reporting unable to calculate due to an extremely elevated triglyceride of Electrolytes were within normal range. Patient was otherwise asymptomatic. Because of a positive family history of Type I diabetes, and positive myocardial infarction in the patient s father at the age of 48, the patient was referred to an endocrinologist in an urban setting located thirty miles away. Patient was scheduled for the next day. Dr. Able requested an electronic clinical summary of her patient to be produced by her certified EHR. The summary contained portions of the patient s clinical record that Dr. Able considered important to the endocrinologist. These included the patient history and physical, his problem list, medications, allergies and his current laboratory findings. The document was prepared as a standards-based clinical summary document and pushed to the specialist through Direct secure, encrypted messaging. Alternatively the clinical summary is directed to the Health Information Exchange (HIE) Clinical Document Repository (CDR) where it will be stored and available via query and pulled by the specialist to his or her EHR. Patient presented to the endocrinologist, Dr. Bentley. Dr. Bentley s staff had imported the standards-based clinical summary to the practice s EHR where it was viewable as structured data. Upon review of Dr. Able s provided clinical summary document and an examination of Mr. Smith, Dr. Bentley ordered additional laboratory tests including c-peptide and insulin level. These labs confirmed Type II diabetes, as opposed to Type I diabetes. Patient was started on Metformin 500 mg twice a day. Care was returned to the primary care setting. A consultation summary including the endocrinology history & physical, medication, treatment recommendations, along with the additional labs were communicated back to the primary care physician through Direct secure, encrypted messaging. 4

6 Patient underwent a series of diabetes education classes, and began a weight management program. Because of the elevated risk of cardiovascular disease in diabetics, the patient was encouraged to and ultimately quit smoking. Care continued at the primary care office, with a resultant significant improvement in HgA1C of 7.8 in six months, and a weight loss of 32 pounds. 1.5 Post conditions The patient s primary care provider has electronically shared important clinical information of the patient with a specialist. This documentation was provided in a standardized, structured, and encoded form via a standards-based clinical summary, enabling the specialist s EHR to both render the document in an easily readable and organized form and to consume all or part of the document as structured data into the EHR database. This facilitated the specialist s assessment of the patient s conditions, reduced the need for duplicative testing, and expedited the patient s placement on appropriate therapy. The specialist has returned a consultation summary electronically to the PCP, also in a well-formed and fully structured CDA-based clinical summary. This has enabled the PCP to fully record the specialist s care in the PCP s EHR and improves the coordination of care for this patient. Due to better care coordination the patient s diabetic control is improved resulting in an improved health outcome for the patient and lower overall costs to the payer and patient. 1.6 s/data Elements The bar has been raised on data requirements from the HITSP C32 CCD required in Meaningful Use Stage 1 to those required in a Consolidated Clinical Document Architecture (CCDA) in Meaningful Use Stage 2 summaries. Meaningful Use Stage 2 requires the following core data elements be contained in clinical summaries. This core data is referred to as the Common Meaningful Use. It is required regardless of the CCDA document template requirements (Continuity of Care, Discharge, Consultation Note etc.) or the MU Requirements (Clinical, Transition of Care etc.) Common MU Patient Name Sex Date of Birth Race Ethnicity Preferred language Smoking Status Problems Medication List Medication Allergies Common Meaningful Use Consolidated CDA Template General Header General Header General Header General Header General Header General Header Social History Smoking Status Observation Entry Problem Medications (entries required) Hospital Discharge Medications Allergies (entries required) 5

7 Laboratory test(s) Plan of Care Plan of Care Activity Observation Entry Results (entries required) Vital Signs Laboratory value(s)/result(s) Vital signs height, weight, blood pressure, BMI Care plan field(s), including goals Plan of Care and instructions Procedures Care team member(s) Referenced from the S&I framework data requirements document: wiki.siframework.org/file/view/mu2+data+requirements.docx Procedures (entries required) General Header The Meaningful Use requirements outline additional requirements depending on the type of summary document created. Below is the additional required information for the Transitions of Care / Referral. Data Requirements Cognitive Status Discharge Instructions- Inpatient Only Encounter Diagnoses Transitions of Care/Referral and Export Consolidated CDA Template Functional Status Hospital Discharge Instructions Problems (entries required) Hospital Discharge Diagnosis Functional Status Immunizations (entries required) General Header Functional Status Immunizations Provider Name & Office Contact Information- Ambulatory Only Reason for Referral- Ambulatory Reason for Referral Only Referenced from the S&I framework data requirements document: wiki.siframework.org/file/view/mu2+data+requirements.docx 1.7 Vocabularies/Coding Systems Data is encoded with standard medical terms and codes using ICD-9-CM, ICD-10-CM, LOINC, SNOMED-CT, RxNorm, HCPCS, and CPT. 1.8 Diagrams/Supporting Material The User Story does not prescribe a particular means of exchange from one EHR to another. It does require however that the clinical summary document be a CDA-based document, fully encoded and structured and that this document must be consumable as structured data by the provider s EHR technology. 6

8 Transition of Care (ToC) / Referral With Return to Primary Care Originating Provider CDA Exchange Service HIE/HISP CDA Receiving Provider EHR CDA CDA EHR Page-1 Figure Triggers Since referrals are typically directed to a known party, or organization, the need to perform a push of information lends itself to be performed by a manual trigger. The need to identify the recipient out of a list is also something that requires human intervention and a manual process. In the case that the recipient, or the HIE, doesn t support the ability to send or receive a push of information the alternative would be to implement an architecture and triggers for query and retrieve of the patient summary. Some notification outside of the push workflow may be necessary to alert the specialist to the availability of information. One possibility in an HIE that supports XDS is to use the Notification of Availability (NAV) transaction Transports The push of information lends itself to the use of Direct or a specific transaction of XDS.b, known as XDR. These support the ability to push data to a known recipient. These have been specified in the Meaningful Use Stage 2 regulation as the required and optional transports for the Transitions of Care and Referrals measure. 1. Direct (required) 2. Direct + XDR/XDM (optional) 3. SOAP + XDR/XDM (optional) Direct 7

9 The Direct specification, as outlined in the Applicability Statement for Secure Health Transport, designates SMTP as message transport. It can be used alone or with an optional XDR/XDM payload. The XDR/XDM payload provides information on the recipient and the patient. Providing this information in a separate attachment eliminates the need to parse a structured clinical summary for that information (along with the included PHI). It can also be used to provide that information for unstructured documents (like PDFs, JPGs etc.) 1. The base, Meaningful Use Stage 2 required, transport is Direct which uses SMTP, S/MIME and X.509 certificates to facilitate a secure exchange with another endpoint. 2. Direct + XDR/XDM the 2 nd Meaningful Use Stage 2 transport alternative uses the same SMTP transport but has an additional attachment that provides additional structured data in an XML form. SOAP + XDR/XDM The 3 rd Meaningful Use Stage 2 transport alternative is to use SOAP + XDR/XDM. The HIE/HISP that receives this can then get this to the referring provider in a few ways. 1. Translate that message to SMTP (Direct) and send it to the specified recipient 2. Transmit an XDR message to the specified recipient 3. Make the document available in a repository to be pulled via query/retrieve transactions. a. This can be paired with a Notice of Availability (NAV) transaction to prompt the recipient to pull the summary. The first two SOAP + XDR/XDM options enable the sender to be reasonably sure of a closed loop transaction. This would allow them to measure those transactions for the use of attesting to the Meaningful Use Stage 2 requirement of sending 10% of ToC/Referrals electronically. No means of determining whether a recipient has pulled the information from a repository has been designated. ONC has published a white paper which provides further clarity for numerator/denominator calculation under this scenario Achieving ToC MU 2 Objective: Numerator/Denominator Calculations As an outcome of Dr. Able transmitting an electronic clinical summary document using the MU2 specified transports, she was also able to count the event toward achieving the MU Stage 2 Transition of Care objective. Her CEHRT will automatically count the electronic transmission in the numerator and the denominator. The specification for the TOC objective and measure 2, is as follows: Objective: The EP who transitions their patient to another setting of care or provider of care or refers their patient to another provider of care should provide summary care record for each transition of care or referral. Measure 2: The EP who transitions or refers their patient to another setting of care or provider of care provides a summary of care record for more than 10 percent of such transitions and referrals either (a) electronically transmitted using CEHRT to a recipient or 8

10 (b) where the recipient receives the summary of care record via exchange facilitated by an organization that is an ehealth Exchange participant. Denominator: Number of transitions of care and referrals during the CEHRT reporting period for which the EP (eligible provider) or eligible hospital s or CAH s inpatient or emergency department (Place or Service 21 or 23) was the transferring or referring provider Numerator: Number of transitions of care and referrals in the denominator where a summary of care record was a) electronically transmitted using CEHRT to a recipient or b) where the recipient receives the summary of care record via exchange facilitated by an organization that is an ehealth Exchange participant. The organization can be a third-party or the senders own organization. 9

11 2A. Update Clinical Data Repository and Disease Registry 2A.1 Beacon Context Many Beacon communities will collect patient identifiable, visit specific, clinical summaries from EHR systems of participating primary care practices. These will drive specific Beacon clinical interventions and supply the basic information needs of their Beacon programs. Realtime, CDA-based clinical summaries will be received and consumed by applications and systems within the Beacon or Health Information Exchange (HIE) infrastructure to support one or more functions, including: A community longitudinal clinical repository or document repository A community-based chronic disease registry or population health tool A community analytical data warehouse for quality measurement and other clinical and cost analyses 2A.2 Actors Primary Care Provider (PCP) The PCP provides both the first contact for a person with an undiagnosed health concern as well as continuing care of varied medical conditions, not limited by cause, organ system, or diagnosis. The primary care provider delivers care to the patient and documents care in a certified Electronic Health Record (EHR) system. In some communities the Primary Care Provider will have the ability to query the HIE or Beacon systems for clinical records from other care settings. Specialist A specialist practice is limited to a particular branch of medicine or surgery. The specialist provider receives referrals from the PCP. Care for the patient is transitioned upon referral from the PCP to a specialist and generally, back to the PCP. Patient Care Coordinator, Navigator, or Case Manager The patient care coordinator or navigator will be defined in different ways in different organizations and communities. In some cases the role is internal to a medical practice and is assigned responsibilities to ensure optimal care for patients with chronic conditions. In other cases the role is a community-based role, to possibly include public health, ensuring optimal coordination of care across clinical settings and care transitions. The clinical training of care coordinators, navigators or case managers will also vary widely based on specific requirements of the role. Often the coordinator or navigator will employ software applications for population health such as disease registries or longitudinal clinical repositories to aid in identification of patients requiring proactive intervention. Identification of gaps in care against optimal clinical guidelines, recalling and scheduling patients for screenings, preventive care, or follow-up, and directing patients to available community services and education are common activities of a patient coordinator or navigator. Quality Improvement Data Analyst The QI Data Analyst is a secondary user of data within disease registries and clinical data repositories and utilizes the data to produce a wide range of provider, practice and community-wide metrics to track the effect of quality improvement initiatives in the care process and patient outcomes. 10

12 2A.3 Preconditions Patient presents for care and is seen by PCP or Specialist in their office. Patient demographic and clinical information is documented in the practice s certified EHR. Data is structured and encoded where appropriate with codes drawn from standard medical terminologies. 2A.4 Story Narrative The story which follows, while specific to diabetes and primary care, is representative of many Beacon programs which aim to improve outcomes related to one or more chronic conditions. In each case the ability to capture clinical data on healthcare encounters in an ambulatory setting and to supply that data in near real-time to centralized Beacon or HIE systems is vital to supporting the participating medical practices in meeting Beacon s objectives. A primary care practice enrolls in a Beacon cohort with the intention of demonstrably improving diabetic outcomes in their practice. Among the several initiatives undertaken by the practice are: a) Adoption and meaningful use of a certified EHR system b) Transformation of the practice culture and processes through NCQA certification as a Patient Centered Medical Home c) Integration of the EHR with a community-based disease registry to better understand the needs and gaps in care of the practice s diabetic patient population d) Measurement of diabetic quality of care measures and public reporting of results on an as required basis. The physicians and staff work to establish best practices for documentation of diabetic care within their EHR. By ensuring care is well documented in structured fields and appropriately coded with standard terminology the practice is able to utilize the EHR to its full potential and to communicate clinical information reliably and unambiguously to the disease registry and a community-based clinical repository. The physicians develop standing lab orders, provide training to the staff on diabetes care, and have the staff undergo additional training to do the microfilament diabetic foot exams. Upon the completion of every diabetic patient visit, the EHR produces a CDA-based clinical summary document to be transmitted to the Beacon disease registry and a clinical repository for quality reporting. This minimizes or eliminates the need to directly enter data into both the EHR and the disease registry. Data collection and analysis for diabetes centers on the D5 measures which include: 1. HgA1c < LDL < blood pressure < 140/90 4. smoking status = non-smoker 5. daily aspirin/anti-thrombotic if cardiovascular disease (unless contraindicated) The practice Care Coordinator/Navigator uses the registry each day to: 11

13 Produce a care plan for scheduled diabetic patients Identify patients requiring recall for preventive care, screenings, or follow-up Send patient reminders to patients Send report cards to patients including trended key lab values The Quality Improvement Analyst will additionally employ the registry and repository to produce quality measures and flow charts that show the progress the practice and individual providers are making at improving care for diabetic patients. A sample flow chart is shown below. Figure 2 These capabilities directly support a number of Stage 1 Meaningful Use criteria and many additional requirements for achieving Patient Centered Medical Home recognition from the National Committee for Quality Assurance (NCQA). 2A.5 Post Conditions The diabetes registry and/or Beacon clinical repository is populated with structured and encoded data enabling clinical guidelines to operate against the data for identification of gaps in care, tracking of patient outcomes (e.g. HbA1C is under 8) and measurement of physician, practice, and community quality scores. Various triggers and transport mechanisms are used to automatically generate and transmit CDA-based clinical summaries from practice EHRs to update the Clinical Data Repository (CDR) and/or Disease Registry. These triggers and transport mechanisms are either performed in real-time or are rule-based depending on the technology being utilized and/or the visit type, and are built into the provider s workflow. 12

14 2A.6 s/data Elements The Use Case supporting populating a clinical data repository or disease registry doesn t have any specific requirements per Meaningful Use Stage 2. However, there are data requirements for the different types of summaries that are required under Meaningful Use Stage 2. Any of those summaries can be made available in a clinical data repository or disease registry. Below is a list of all of the data requirements outlined in Meaningful Use Stage 2 and the MU2 that data supports. Complete List of MU2 Data Requirements MU Data Requirement Consolidated CDA Template MU2 Care plan field(s), including goals and instructions Plan of Care Common Care team member(s) General Header Common Clinical Instructions Instructions Clinical Cognitive Status Functional Status 13 ToC/Referral and Export Date and Location of Visit General Header Clinical Date of Birth General Header Common Dates and Location of Admission and Discharge- Inpatient Only Diagnostic Tests Pending Discharge Instructions- Inpatient Only Encounter Diagnoses General Header Plan of Care Plan of Care Activity Observation Entry Hospital Discharge Instructions Problems (entries required) Hospital Discharge Diagnosis Inpatient Clinical ToC/Referral and Export Ambulatory or Inpatient ToC/Referral and Export Ethnicity General Header Common Functional Status Functional Status ToC/Referral and Export

15 Future Appointments Plan of Care Clinical Future Scheduled Tests Plan of Care Clinical Immunizations Immunizations Administered during the Visit Laboratory test(s) Laboratory value(s)/result(s) Medication Allergies Medication List Medications Administered during the Visit Immunizations (entries required) Immunizations (entries required) Plan of Care Plan of Care Activity Observation Entry Results (entries required) Allergies (entries required) Medications (entries required) Hospital Discharge Medications Medications (entries required) Hospital Discharge Medications Medications Administered ToC/Referral and Export Clinical Common Common Common Common Clinical Patient Name General Header Common Preferred language General Header Common Problems Problem Common Procedures Procedures (entries required) Common Provider Name and Office Contact Information General Header All Summaries Race General Header Common 14

16 Reason for Hospitalization- Inpatient Only Reason for Referral- Ambulatory Only Reason for Visit Recommended Patient Decision Aids Reason for Visit and/or Chief Complaint (s) Reason for Referral Reason for Visit and/or Chief Complaint (s) Instructions Inpatient ToC/Referral and Export Clinical Clinical Referrals to other Providers Plan of Care Clinical Sex General Header Common Smoking Status Social History Smoking Status Observation Entry Common Vital signs height, weight, blood pressure, BMI Vital Signs Common Referenced and adapted from the S&I framework data requirements document: wiki.siframework.org/file/view/mu2+data+requirements.docx 2A.7 Vocabularies/Coding Systems Data is encoded with standard medical terms and codes using ICD-9-CM, ICD-10-CM, LOINC, SNOMED-CT, RxNorm, HCPCS, and CPT. 15

17 2A.8 Diagrams/Supporting Material Update HIE Clinical Repository or Registry With CDA Push to CDR or Registry CDA Exchange Service HIE/HISP CDA Primary Care Provider EHR Beacon Repository or Registry Interactive User Session With Beacon Repository or Registry Care Coordinator or QI Data Analyst Page-1 Figure 3 2A.9 Outbound Triggers (from EHR to HIE) There are a variety of trigger events to support the population of the Clinical Data Repository (CDR) and Disease Registry. These triggers can happen automatically or manually. It is generally desired that the triggers are automatic and built into the provider s workflow. They are not mutually exclusive and more than one may be enabled within an EHR. The following options are not required but are presented as options to consider. Automatic The automatic process can support both real-time transactions as well as batch transactions. Real-time transactions transmit the data upon the occurrence of the designated event (e.g. upon conclusion of a patients encounter or addition or update of information to an existing patient record), as soon after the transaction occurs as possible (e.g. when new or updated data is officially committed to the patient record). Batch transactions transmit the data on a periodic basis. The rule-based triggers that initiate those transactions occur on different 16

18 schedules. Periodically an EHR checks for data that has been changed since the last time the rule was run. It gathers the new data and transports that information to the CDR. This can be done either once a day or multiple times per day. Triggers include: a. Clinical Data based A trigger to send data can be when a patient s clinical record is created, updated or signed. For some systems this would account for data that doesn t fit into a strict patient encounter because the patient has not seen a provider. (e.g. lab test visit) Another example of a clinical based trigger is the transmission of select clinical data to support a Disease Registry. Disease registries report on certain conditions and therefore when diagnoses of those conditions are documented transmission of that data supports the goal of the disease registry. b. Encounter based Many systems manage a patient s data at the encounter level. Similar to Clinical Data based triggers, this trigger can be managed by sending data collected as part of new encounter or encounters that have been saved or saved and signed. Manual There are times when a manual process will be needed due to unique situations such as loading a CDR with patient historical data or when human decision making is necessary. The need for a manual process may be as simple as a provider recognizing a gap in a patient s information in the CDR and therefore the need to trigger a transaction to populate it. The manual process can trigger a transaction to update the CDR to support the following workflows. a. On-demand Trigger For a variety of reasons a provider may want to initiate a transaction to populate the CDR. One example might be an OB-GYN triggering a full Antepartum on the recognition of the woman s readiness to give birth. b. Repository Load (Backfill of historical clinical information) This is an example of a unique situation and is typically completed once during the initial stages of implementation or go-live. An agreed upon scope of historical clinical data will be transported to the repository. This will be likely be triggered manually by someone on the EHR vendor implementation team. However it may also be triggered by a provider 17

19 should the EHR system have the capability to send the agreed upon scope of historical data without involvement from the EHR implementation team. Whatever the means used to trigger the population of data in an HIE, the automatic method is the most consistent and inclusive, while having little to no impact on the providers workflow. For these reasons an automatic trigger is highly preferred to a manual trigger for this use case. 2A.10 Outbound Transports (from EHR to HIE) There are a number of ways of transporting CDA-based clinical summaries to populate a CDR. a. IHE XDS.b i. The Provide And Register Document Setb (ITI-41) transaction within IHE XDS.b profile is a mature and increasingly more common method of achieving transmission of a clinical summary. The ability to register document metadata that is part of this transaction offers consumers of such documents many more options in specifying parameters to filter out documents not needed or desired. ii. Transport infrastructure based on web-services following ehealth Exchange standards iii. Uses certificate exchange as the means of securing the transport iv. Can be tied into consent models by leveraging the document metadata to prevent the need to open a document to understand the level of consent allowed per document. v. Can be paired with other IHE profiles such as PIX and PDQ to establish and manage identity vi. Can be paired with ehealth exchange/ihe XCA profile to achieve cross community exchange b. Direct i. Can be achieved in 2 ways a) SMTP (Based on the Direct applicability statement) b) IHE XDR/XDM - Transport infrastructure based on web-services following ehealth Exchange standards ii. Uses certificate exchange as the means of securing the transport c. Minimal Lower Level Protocol (MLLP) i. Pipe delimited messages based on HL7 v2 standards, including MDM and ORU messages ii. Connectivity achieved by allowing access to an IP Address and Port on the receiving system iii. Uses VPN (virtual private network) as the means of securing the transport d. Secure FTP 18

20 This can be a good option for a bulk load of historical data into a CDR (i.e. to backfill). It is less time consuming when having to transport many files at once without concerns on the time and logistics to transport those files via messaging or other transport options. i. Uses VPN as means of securing the transport ii. Not transaction based so no feedback is available to notify of error Of the transports above, XDS.b Provide And Register is more suited to support automatic outbound triggers Direct would be more suited to the manual outbound trigger, but would support automatic outbound triggers if there was a single and static destination (e.g. via SOAP+XDR or a CDR with a dedicated Direct mailbox). 2A.11 Achieving ToC MU 2 Objective: Numerator/Denominator Calculations A provider sending or contributing a summary of care document to a registry, may also count that event toward satisfying measure 2 of the MU2 transitions of care objective. The specification for the TOC measure 2, is as follows: Denominator: Number of transitions of care and referrals during the CEHRT reporting period for which the EP (eligible provider) or eligible hospital s or CAH s inpatient or emergency department (Place or Service 21 or 23) was the transferring or referring provider Numerator: Number of transitions of care and referrals in the denominator where a summary of care record was a) electronically transmitted using CEHRT to a recipient or b) where the recipient receives the summary of care record via exchange facilitated by an organization that is an ehealth Exchange participant. The organization can be a thrid-party or the senders own organization. In a Query model, there are certain provisions for the sending provider to be able to count the transition of care in the numerator. One of the following must be true. 1. The receiving registry is a certified ehealth Exchange particpant (HealtheWay.org) 2. The sending provider s CEHRT must use one of the three certified transports outlined in the 2014 Edition Standards and Certification Critera (also see section 1.10) to transmit the summary of care document to the receiving registry If either of those statements is true, then the following condition must also be satisfied to meet the measure. Per the Meaningful Use rule, an EP or EH may only count transmissions in the measure s numerator if they are accessed by the provider to whom the sending provider is referring or transferring the patient. Further, an EP or EH may only count in the numerator transitions of care that first count in the denominator. Receipt by the provider occurs when either the clinician receives/queries or the 19

21 practice/facility at which the clinician works receives/queries the summary of care. In practice this means that either the HIO (exchange organization) or the sending EHR vendor will need to reconcile data on sent documents and those that are accessed within the reporting time window. More information on this can be found at: 2B. Query Clinical Data Repository and Disease Registry (User story 2 cont.) 2B.1 Beacon Context Many Beacon communities will collect patient identifiable, visit specific, clinical summaries from EHR systems of participating primary care practices. These will drive specific Beacon clinical interventions and supply the basic information needs of their Beacon programs. Realtime, CDA-based clinical summaries will be received and consumed by applications and systems within the Beacon or HIE infrastructure to support one or more functions, including: A community longitudinal clinical repository or document repository with ability for applications and systems to query and retrieve community patient records A community-based chronic disease registry or population health tool A community portal with single sign-on capabilities to view or print a longitudinal community patient record A community-level care gap (needs foot exam) and alert functionality (HbA1c>9) A community analytical data warehouse for quality measurement and other clinical and cost analyses 2B.2 Actors Emergency Department(ED) Provider An ED provider may be required to treat patients in the emergency room for non-emergent visits and in some cases is the first contact for a person with an undiagnosed health concern. The ED provider delivers care to the patient and documents care in a certified Electronic Health Record (EHR) system. The ED provider will have the ability to query the HIE or Beacon systems for a patients clinical records that have been provided from other care settings (e.g. Ambulatory Care). Primary Care Provider (PCP) The PCP provides both the first contact for a person with an undiagnosed health concern as well as continuing care of varied medical conditions, not limited by cause, organ system, or diagnosis. The primary care provider delivers care to the patient and documents care in a certified Electronic Health Record (EHR) system. The Primary Care Provider will have the ability to query the HIE or Beacon systems for clinical records from other care settings (e.g. Acute Care). Specialist when applicable) A specialist practice is limited to a particular branch of medicine or surgery. The specialist provider receives referrals from the PCP. Care for 20

22 the patient is transitioned upon referral from the PCP to a specialist and generally, back to the PCP. Patient Care Coordinator, Navigator, or Case Manager The patient care coordinator or navigator will be defined in different ways in different organizations and communities. In some cases the role is internal to a medical practice and is assigned responsibilities to ensure optimal care for patients with chronic conditions. In other cases the role is a community-based role, including possibly public health, ensuring optimal coordination of care across clinical settings and care transitions. The clinical training of care coordinators, navigators or case managers will also vary widely based on specific requirements of the role. Often the coordinator or navigator will employ software applications for population health such as disease registries or longitudinal clinical repositories to aid in identification of patients requiring proactive intervention. Identification of gaps in care against optimal clinical guidelines, recalling and scheduling patients for screenings, preventive care, or follow-up, and directing patients to available community services and education are common activities of a patient coordinator or navigator. Quality Improvement (QI) Data Analyst The QI Data Analyst is a secondary user of data within disease registries and clinical data repositories and uses these data to produce a wide range of provider, practice and community-wide metrics to track the effect of quality improvement initiatives in the care process and patient outcomes. 2B.3 Preconditions Diabetic patient is referred to her primary care physician office by the ED Provider who treated the patient in the ED. The ED provider was able to query the clinical data repository from within their own EHR product to retrieve a longitudinal view of the patients record, retrieve outstanding care gaps (requires HbA1c test) and alerts (HbA1c >9), identify the patients primary care provider and assist to schedule an appointment for the patient. 2B.4 Story Narrative Charlotte Jones is a 67-year-old woman going to her doctor because she is not feeling well. She is a diabetic and on daily insulin. When Charlotte visits the nurse, Tom, he is able to view the community patient health record in the EHR and saw that Charlotte was recently in the emergency department (ED). He is also able to view a visit planner in his EHR that identifies any care considerations that she requires for her diabetic condition. He notes that the BP and HbA1c from the ED visit are higher than it has been on previous visits to the office. He notes that Charlotte has not kept several doctor appointments and that she has not been to see the doctor for over a year, and that she is due for a foot exam. He also learns that her insulin prescription has not been refilled. Tom asks Charlotte why she has not come in for her appointments. She tells him that her car quit running and that she does not have the money to get it fixed. When he asks her how she got to the ED without a car she tells him that she called 911 and an ambulance brought her. She took a taxi home. Paying for the ride home meant that she did not have the money to buy more medication until she received her next check. Taking the bus is not really an option for 21

23 her. This has also affected her ability to get to the grocery store and buy the right kinds of foods. Tom then checks Charlotte s vital signs and asks her to remove her shoes and socks so the doctor can take a look at her feet. He records Charlotte s vitals in the EHR as well. When Dr. Ima Goodwon comes in she discusses Charlotte s ED visit and asks some questions relating to that visit and how she is feeling now. She informs her that she had some chest pain and that they said it wasn t a heart attack. Charlotte was not sure what the ED Provider said it was, but they sent her home with a bottle of tiny white pills and told her to put one under her tongue whenever the pain comes back. Dr. Goodwon views Charlotte s ED discharge notes via the community patient record document and sees that she was diagnosed with angina, prescribed nitroglycerine sub-lingual PRN for chest pain, and was told to see her primary care doctor. She accesses the results of the EKG from the ED visit and sees that her BP was 160/96, and her HbA1c result was 9.7. Dr. Goodwon performs a physical examination including examining Charlotte s feet. Charlotte tells her that they sometimes tingle and that she is more tired than she used to be. Before Charlotte leaves the office, they take a blood test and schedule an appointment for Charlotte to come back in two weeks. The office is a participant in the Beacon program and because Charlotte s diabetes seems to be less in control than previously, and she has some difficulty managing it, Dr. Goodwon asks Charlotte if she would like to have assistance from a patient health navigator. After answering her questions about how this person could help her and how the system protects her information from people who don t need to see it, Charlotte gives her consent for the referral. The patient navigator assigned to work with Charlotte s doctor calls her the next day. Her name is Brenda, and she informs Charlotte that Dr. Goodwon referred her and tells Charlotte about the program. She informs Charlotte that her e-referral notes that she has had some problems with her car and that transportation is an issue. She asks Charlotte what kind of support system she has and Charlotte tells her that her sister used to be able to drive her around, but that she is having trouble seeing now so she can no longer help her. Charlotte s children all live out of town. Brenda explains that there are many community resources that can assist Charlotte for little or no money. After more conversation, they agree that Brenda can begin to put together a plan for Charlotte to review to help her with getting to her doctors appointments (Brenda notes that Charlotte has another appointment in two weeks) as well as other needs she has. Since it s been a long time since Charlotte had education about her disease she suggests that they look into assistance in helping her better manage her diet and medication and even provide transportation to the grocery store. When they end the call, she says she will call her in two days to discuss the plan with her and talk about the specific people that might be able to help her out. The patient navigator s tracking notes are reported back to the referring physician. 22

24 2B.5 Post Conditions From the doctor s certified EHR, the office manager extracts trending information for each physician to see how well the PCPs diabetic patients are doing according to quality measures. The report highlights patients for whom additional intervention may be necessary. Dr. Goodwon uses this information to both improve her care and to use as documentation for the pay for performance incentive programs in which she participates. Back at the doctor s office Ms. Jones information, along with that of other diabetic patients, is made available via the community clinical data repository where it is compared with that of a baseline population for key measurements such as A1C, BP, etc. which are aggregated, analyzed, and reported on. Brenda enrolls Ms. Jones in a 90 day patient health navigator program, and performs a preassessment survey. She begins to monitor and track Ms. Jones appointment schedule, compliance, potential issues, and resolution and follow up including, date, time, provider, etc., and potential transportation or other issues. She searches for and retrieves appropriate community resources for addressing Ms. Jones issues. Brenda sends the patient navigator reporting notes/tracking back to Dr. Goodwon. She assesses the level of Ms. Jones knowledge about the diabetes disease process, and level of patient s self-management skills including: Frequency of glucose monitoring Frequency of foot self-exam Knowledge of current HbA1c level Brenda monitors Ms. Jones level of compliance with prescribed medication regimen including the full range of medications that the patient may be on. After Ms. Jones completes her 90 day assessment process, Brenda performs a post-assessment survey to learn of Ms. Jones level of satisfaction with the patient navigator process. Since Dr. Goodwon transmits her clinical summaries electronically to the clinical data repository and disease registry using CEHRT (Certified EHR Technology), she also is satisfying her MU2 Transitions of Care objective and measures. 2B.6 s/data Elements The Use Case supporting populating a clinical data repository or disease registry doesn t have any specific requirements per Meaningful Use Stage 2. However, there are data requirements for the different types of summaries that are required under Meaningful Use Stage 2. Any of those summaries can be made available in a clinical data repository or disease registry and therefore queried and retrieved for the purposes of this use case. Below is a list of all of the data requirements outlined in Meaningful Use Stage 2 and the MU2 that data supports. Complete List of MU2 Data Requirements 23

25 MU Data Requirement Consolidated CDA Template MU2 Care plan field(s), including goals and instructions Plan of Care Common Care team member(s) General Header Common Clinical Instructions Instructions Clinical Cognitive Status Functional Status ToC/Referral and Export Date and Location of Visit General Header Clinical Date of Birth General Header Common Dates and Location of Admission and Discharge- Inpatient Only Diagnostic Tests Pending Discharge Instructions- Inpatient Only Encounter Diagnoses General Header Plan of Care Plan of Care Activity Observation Entry Hospital Discharge Instructions Problems (entries required) Hospital Discharge Diagnosis Inpatient Clinical ToC/Referral and Export Ambulatory or Inpatient ToC/Referral and Export Ethnicity General Header Common Functional Status Functional Status ToC/Referral and Export Future Appointments Plan of Care Clinical Future Scheduled Tests Plan of Care Clinical Immunizations Immunizations Administered during the Visit Immunizations (entries required) Immunizations (entries required) ToC/Referral and Export Clinical 24

26 Laboratory test(s) Laboratory value(s)/result(s) Medication Allergies Medication List Medications Administered during the Visit 25 Plan of Care Plan of Care Activity Observation Entry Results (entries required) Allergies (entries required) Medications (entries required) Hospital Discharge Medications Medications (entries required) Hospital Discharge Medications Medications Administered Common Common Common Common Clinical Patient Name General Header Common Preferred language General Header Common Problems Problem Common Procedures Procedures (entries required) Common Provider Name and Office Contact Information General Header All Summaries Race General Header Common Reason for Hospitalization- Inpatient Only Reason for Referral- Ambulatory Only Reason for Visit Reason for Visit and/or Chief Complaint (s) Reason for Referral Reason for Visit and/or Chief Complaint (s) Inpatient ToC/Referral and Export Clinical Recommended Patient Decision Aids Instructions Clinical

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