Table of Contents 1. Introduction... 2 2. User Stories... 2 2.1 Update Clinical Data Repository and Disease Registry... 2 2.1.1 Beacon Context... 2 2.1.2 Actors... 2 2.1.3 Preconditions... 3 2.1.4 Story Narrative... 3 2.1.5 Postconditions... 5 2.1.6 Data Sets/Data Elements... 5 2.1.7 Vocabularies/Coding Systems... 5 2.1.8 Diagrams/Supporting Material... 5 2.2 Patient Referral... 6 2.2.1 Beacon Context... 6 2.2.2 Actors... 7 2.2.3 Preconditions... 7 2.2.4 Story Narrative... 7 2.2.5 Postconditions... 8 2.2.6 Data Sets/Data Elements... 8 2.2.7 Vocabularies/Coding Systems... 9 2.2.8 Diagrams/Supporting Material... 10 1
1. Introduction This section is intentionally left blank. For more background please see the Work Product Description Document that was published as part of this set of deliverables. 2. User Stories 2.1 Update Clinical Data Repository and Disease Registry 2.1.1 Beacon Context Beacon 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 one or two specific chronic disease conditions on which to target their efforts. These include diabetes, asthma, COPD, congestive heart failure, and cardio vascular disease. 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. Real-time, standards-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: 2.1.2 Actors 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 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 2
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 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. 2.1.3 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. 2.1.4 Story Narrative The story which follows, while specific to diabetes and primary care, is representative of many Beacon programs which are aiming 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 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 a quarterly 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 3
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 standard CCD/C83- based 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 < 8.0 2. LDL < 100 3. 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: 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 2.1.4-1 4
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). 2.1.5 Postconditions 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. 2.1.6 Data Sets/Data Elements Data Specification A Continuity of Care Document (CCD) is specified for this exchange. The CCD shall conform to the HITSP C83 specification for content, structure, and encoding. Content modules may include the following 18 items: 1. Demographics 2. Language 3. Support (patient contacts) 4. Healthcare Providers 5. Health Insurance Provider 6. Allergy and Drug Sensitivity 7. Medical Problems or Conditions 8. Medications 9. Pregnancy 10. Information Source 11. Advance Directives 12. Immunizations 13. Vital Signs 14. Results 15. Encounter 16. Procedures 17. Social History 18. Orders 2.1.7 Vocabularies/Coding Systems Data is encoded with standard medical terms and codes using ICD-9-CM, LOINC, SNOMED- CT, RxNorm, HCPCS, and CPT. 2.1.8 Diagrams/Supporting Material 5
Figure 2.1.8-1 2.2 Patient Referral 2.2.1 Beacon Context Beacon 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 one or two specific chronic disease conditions on which to target their efforts. These include diabetes, asthma, COPD, congestive heart failure, and cardio vascular disease. Integral to all Beacon programs is the spread and meaningful use of electronic health record systems (EHRs). The effective coordination of care of patients across care settings is of primary concern to most Beacon programs. 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 6
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. 2.2.2 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. Upon a referral to a specialist the PCP will cause their EHR to create an electronic, standards-based, clinical summary in the form of a clinical care document (CCD) and direct (electronically send) that document to the specialist. 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 (CCD) exchange is envisioned at both points in the referral cycle. 2.2.3 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. 2.2.4 Story Narrative Patient Jim Smith, 17 years of age, presented to his primary care rural office as a sameday 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 1154. 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, 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 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 well-formed CCD/C83-based and pushed to the specialist through DIRECT secure, encrypted email. Alternatively the CCD is directed to the HIE Clinical Document repository where it will stored and available via query and pulled by the specialist to his EHR. 7
Patient presented to the endocrinologist, Dr. Bentley. Dr. Bentley s staff had imported the CCD to the practice s EHR where it was viewable as structured data. Upon review of Dr. Able s care and an exam of Mr. Smith, Dr. Bentley ordered additional laboratory testing 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 email. 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 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. 2.2.5 Postconditions The patient s primary care provider has electronically shared important clinical information of a patient with a specialist. This documentation was provided in a standardized, structured, and encoded form via a CCD, 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 an appropriate therapy. The specialist has returned a consultation summary electronically to the PCP, also in a well-formed and fully encoded CCD. 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. 2.2.6 Data Sets/Data Elements Data Specification A Continuity of Care Document (CCD) is specified for this exchange. The CCD shall conform to the HITSP C83 specification for content, structure, and encoding. Content modules may include the following 18 items: 19. Demographics 20. Language 21. Support (patient contacts) 22. Healthcare Providers 23. Health Insurance Provider 24. Allergy and Drug Sensitivity 25. Medical Problems or Conditions 26. Medications 27. Pregnancy 28. Information Source 29. Advance Directives 8
30. Immunizations 31. Vital Signs 32. Results 33. Encounter 34. Procedures 35. Social History 36. Orders 2.2.7 Vocabularies/Coding Systems Data is encoded with standard medical terms and codes using ICD-9-CM, LOINC, SNOMED- CT, RxNorm, HCPCS, and CPT. 9
2.2.8 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 CCD document be a standards-based document, fully encoded and structured and that this document must be consumable as structured data by the provider s EHR technology. Figure 2.2.8-1 10