Query+Health+Use+Case+-+Functional+Requirements

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= The content within this page has been incorporated into the Query Health Use Case which has now been approved through consensus. =

= __Definition of Terms__ = toc **Functional Requirements** identify the capabilities a system playing a role must have in order to enable interoperable exchange of the healthcare data of interest. This includes Information Interchange Requirements, System Requirements and Dataset Requirements as indicated in sections 12.1-12.3 below.
 * **Information Interchange Requirements** define the systems’ name and role and specify the actions associated the actual transport of content from the sending system to the receiving system.
 * **System Requirements** lists the requirements internal to the system necessary for the system to participate successfully in the transaction. System requirements may also detail required workflow essential to the Use Case.
 * **Dataset Requirements**. This table lists the data elements and data element sets that will be available within the message or document. Historically, the optional/required nature of each data element is deferred to the discussions during the harmonization phase of the Initiative. Each data element listed below is necessary for some aspect of the Use Case; however, the table does not specify exactly how they may be used together. All data element sets may contain multiple data elements unless otherwise stated. For the purposes of this section, do not assume that any data elements are inferred and provide elements at their most granular level. For example, if it is necessary to specify a zip code do not use the less specific data element set ‘address’.
 * //NOTE: Data element sets are defined for reuse within the Use Case Simplification Work Group. The identification of data elements forms the foundation for harmonization activities. The data elements identified in the use case set constraints on the contents of documents and messages. Workgroup members should make every effort to ensure that the dataset requirements are complete, accurate, and precise.//

=12.0 Functional Requirements= Information systems participating in this Use Case must meet certain functional requirements based on their role. Functional requirements are of two types: information interchange requirements and internal system requirements.

12.1 Information Interchange Requirements

 * **Initiating System** ||  || **Information Interchange Requirement Name** ||   || **Receiving System** ||
 * Information Requestor Information System || Send || Query || Receive || Intermediary Information System ||
 * Intermediary Information System || Send || Query || Receive || EHR System/Clinical Data Source ||
 * EHR System/Clinical Data Source || Send || Aggregate Query Results || Receive || Intermediary Information System ||
 * Intermediary Information System || Send || Combined Query Results || Receive || Information Requestor Information System ||
 * Information Requestor Information System without Intermediary || Send || Query || Receive || EHR System/Clinical Data Source ||
 * EHR System/Clinical Data Source without Intermediary || Send || Query Response* || Receive || Information Requestor Information System ||
 * Query response will most likely be results but it can also include errors or rejections.
 * Query response will most likely be results but it can also include errors or rejections.

12.2 System Requirements

 * **System** || **System Requirement** ||
 * Information Requestor Information System || * Create well-formed query (which includes query metadata) based on CIM
 * Process query results
 * Audit query response
 * Combine query results across organizations ||
 * Intermediary Information System || * Subscribe to queries
 * Examine query
 * Combine query results across organizations ||
 * Query & Result Reviewer Work Flow Information System || * Edit/Blur query responses
 * Audit query responses
 * Approve query
 * Approve response ||
 * Electronic Health Record System/Health IT System || * Publish patient data to a CIM
 * Aggregate data as needed for query results
 * Analyze query result data
 * Examine query responses
 * Edit/Blur query responses
 * Audit query responses
 * De-identify when needed
 * Maintain file or audit log of patient level data used for each query result
 * Approve query
 * Approve response ||

12.3.1 Envelope Metadata - Query Request
NOTE: A "query" may consists of one or more result entries.
 * **Data Element** || **Definition** || **Notes** ||
 * Package ID || Global identifier for the entire query request package/set. ||  ||
 * Query ID || A unique ID for one query request (there can be multiple query IDs under one request ID) ||  ||
 * Query Requestor || Information Requestor (Author or Organization's Name) who is initiating the query. ||  ||
 * Query Purpose || To answer the question that the query was created / initiated for. Examples include - Public Health Reporting, Research Reporting, Contracts, Biosurveillance, Quality Measure Reporting ||  ||
 * Query Type || Aggregated, De-Identified, Limited Dataset, Protected Health Information || __Aggregated__: Numeric data (e.g. counts, averages, sums).

__Limited Data Set__: Allows a certain amount of identifiable information, defined by regulation to be exchanged (e.g. age, DOB) and requires a data use agreement.

__De-Identified__: Detailed patient information without any individually identified information.

__Protected Health Information__: Includes individually identified information on a patient level. ||
 * Notes/Annotation || Section dedicated to any notes or explanations in reference to overall query or elements within the query. ||  ||
 * Contact Information || The appropriate contact information (E-mail and phone number) of the Query Requestor / other assigned point of contact to be contacted with questions regarding the query. ||  ||
 * Priority Score || The purpose of this score is to prioritize the urgency and timing of requests execution and return of results. ||  ||
 * Query Request Expiration || The expiration date and time of the query request that has already been initiated. || This can be done either via the Information Requestor or the Source System. ||
 * Query Send Date || The date and time the query was distributed. ||  ||
 * Query Start Date || The date and time the query is expected to begin execution and send final results. || This can be done either via the Information Requestor or the Source System. ||
 * Query End Date || The date and time the query is expected to end execution and send final results. || This can be done either via the Information Requestor or the Source System. ||
 * Frequency || Defines the total number of iterations (i.e. how often) the query should run within the set parameters of the query start and end date. A specified number of days, weeks, months, etc. || This can be done either via the Information Requestor or the Source System. ||
 * Active Flag || Determines whether the query request is Active or Inactive allowing for past requests to be preserved. ||  ||
 * Renewal || Defines if the query can be reused (Yes/No) and therefore eliminating the need to repeatedly resend the same query. ||  ||
 * Security Data ||  ||   ||
 * Sender Data ||  ||   ||
 * Receiver Data || T ||  ||

12.3.2 Envelope Metadata - Query Response
NOTE: A "query" may consists of one or more result entries.
 * **Data Element** || **Definition** || **Notes** ||
 * Package ID || Global identifier for the entire query request package/set. ||  ||
 * Query ID || A discrete unique identifier for on query instance ||  ||
 * Response ID || A discrete unique identifier for the for the response instance. ||  ||
 * Query Requestor || Information Requestor (Author or Organization's Name) that is initiating the query. ||  ||
 * Entity ID || A unique identifier of the health system or overarching provider organization. Examples include - hospital, hospital system, health system. ||  ||
 * Entity Name || Name of the overarching organization. || Example - XYZ Health System ||
 * Facility ID || A unique identifier of the provider's facility. ||  ||
 * Facility Name || Facility where patient care was delivered. || Example - Hospital A within the XYZ Health System. ||
 * Provider Name || Name of the individual provider. ||  ||
 * Provider ID || Provider NPI or some other Unique Identifier (if available in the system) ||  ||
 * Response Date and Time || The date and time that query response is sent. ||  ||
 * Security Data || Applicable security information. ||  ||
 * Status Identifier || The individual or organization in charge of determining the Status of the query. ||  ||
 * Status || The status of the query dictates whether or not the query is Approved, Not Approved, Rejected, Pending Approval, In Progress, Complete, or Deferred ||  ||
 * Status Date and Time || The date and time the Status is identified. ||  ||
 * Error Type / Messages || The error type or message. ||  ||
 * Sender Data ||  ||   ||
 * Receiver Data ||  ||   ||

12.3.3 Query Syntax & Response Metadata (this will be defined outside the scope of the Use Case)
__NOTE:__ //The Query Health Technical Working Group will develop the detailed technical requirements to fulfill Use Case Functional and Data Requirements as part of standards and data harmonization process.//

This is the aggregate result response that includes the answer to the question. For example, this section can include grouping aggregate results by geographical, gender and ethnicity.

12.4 Dataset Requirements
__NOTE:__ //This section will be the starting point to gather the required data elements which will then be elaborated through the harmonization and standards development support activities.// Vocabulary value sets supporting the prioritized Query Health user stories, will be defined by the community participants from patient data included in the CIM derived from patient care. These value set requirements and recommendations may be derived from required standards associated with problems, procedures, etc. al. used by Clinical Summaries and Quality Metrics – SNOMED-CT; Medications - RxNorm; Immunizations - CVX; Results- LOINC.

12.4.1 Structured Data Elements for Generic User Story
__Note:__ //The initial set of computable data elements are derived from the ASTM CCR and HL7 CCD (as constrained by HITSP C32) which are specified for clinical summary documents in Stage 1 of Meaningful Use. These are included in the table below. A Transitions of Care Clinical Information Model will be offered as the source of the data elements for Stage 2 summaries. These are not included in this table.//
 * **Ref.[[file:///C:/Users/merideth.c.vida/Documents/ONC/Query%20Health/UC%20Shared%20with%20External%20Teams/HHS_ONC_QueryHealth_Use%20Case_DRAFT_v0%2012.docx#_ftn1|**[1]**]]** || **Section** || **Data Elements** || **Notes** ||
 * T.CC.1 || Personal Information/Demographic Information || Name, DOB, Next of Kin, Address, Phone Number, Gender, Marital Status, Religion, Race, Ethnicity || Note only DOB, Gender, race/ethnicity and city, state and zip code may be included in limited data set (as long as the data set results in a small cell). ||
 * T.CC.2 || Contact Information || Contact Name, Contact Number ||  ||
 * T.CC.3 || Insurance Information || Insurance Name, Phone #, Group #, Type, Member #, Subscriber Name, Financial responsibility ||  ||
 * T.CC.4 || Healthcare Provider || Provider Name, Address, Phone Number, Type ||  ||
 * T.CC.5 || Allergies and Other Adverse Reactions || Allergy Type; and Date

Substance intolerance

Associated Adverse Events ||  ||
 * T.CC.6 || Problem List || Current Diseases &

Conditions monitored for the patient and status ||  ||
 * T.CC.7 || History of Past Illness || Diseases & Conditions Patient has suffered in the past ||  ||
 * T.CC.8 || Chief Complaint || Description of Patient's Complaint (narrative) ||  ||
 * T.CC.9 || Reason for Transfer || Reason Patient is being referred ||  ||
 * T.CC.10 || History of Present Illness || Sequence of events proceeding patient's disease/condition ||  ||
 * T.CC.11 || List of Surgeries || List of types of surgeries and dates ||  ||
 * T.CC.12 || Hospital Admission Diagnosis || List of Hospital Diagnosis and dates ||  ||
 * T.CC.13 || Discharge Diagnosis || Conditions/Diseases identified during hospital stay and dates ||  ||
 * T.CC.14 || Medications || List of Current Medication Names ; date, route, dose, frequency ||  ||
 * T.CC.15 || Admission Medications History || List of historical medication names, dose, route, frequency, date patient has taken prior ||  ||
 * T.CC.16 || Hospital Discharge Medications || Medications names, doses, frequency, route ordered for the patient for after discharge ||  ||
 * T.CC.17 || Medications Administered || Medications administered to patient during the course of an encounter; name, dose, route, frequency ||  ||
 * T.CC.18 || Advance Directives || A summary of patient's expectations for care ||  ||
 * T.CC.19 || Pregnancy || Pregnant, Yes/NO ||  ||
 * T.CC.20 || Immunizations || Immunizations name, dose, route, date administered to the patient ||  ||
 * T.CC.21 || Physical Examination || Physical Findings of the Patient; VS, Biometrics, Review of Systems ||  ||
 * T.CC.22 || Vital Signs || Patient's Vital Signs ; Heart rate, Resp Rate, Pulse Ox, Temp, B/P, Pain ||  ||
 * T.CC.23 || Review of Systems || Functions of various body systems; Neuro, Derm, GI, GU, Cardiac, Pulmonary, MS, Repro, Nervous, Endocrine ||  ||
 * T.CC.24 || Hospital Course || Sequence of (name, diagnosis associated with) events and dates from admission to discharge of hospital stay ||  ||
 * T.CC.25 || Diagnostic Results || Results and dates of Diagnostic Procedures ||  ||
 * T.CC.26 || Assessment and Plan || Assessment of patients conditions and expectations/goals of care ||  ||
 * T.CC.27 || Plan of Care || Proposed interventions and procedures for patient ||  ||
 * T.CC.28 || Family History || Dates with Disease Suffered, Age of Death, other genetic information ||  ||
 * T.CC.29 || Social History || Patient's beliefs, home life, social/risky habits, family life, work history ||  ||
 * T.CC.30 || Encounters || Current and historical encounters; dates ||  ||
 * T.CC.31 || Medical Equipment || Implanted and External Medical Devices; Dates ||  ||
 * T.CC.32 || Preoperative Diagnosis || Diagnosis ( Date) assigned to patient prior to surgery ||  ||
 * T.CC.33 || Postoperative Diagnosis || Diagnosis ( Date) assigned to patient after surgery ||  ||
 * T.CC.34 || Surgery Description || Particulars of Surgery (narrative) (images) ||  ||
 * T.CC.35 || Surgical Operation Note Findings || Clinically significant observations found during surgery ||  ||
 * T.CC.36 || Complications Section || Known risks or unidentified problems ||  ||
 * T.CC.37 || Operative Note Surgical Procedure || Date and Description of Procedure Performed ||  ||
 * TBD || Procedures ||  ||   ||
 * TBD || Diagnosis Code ||  ||   ||
 * TBD || Laboratory Results ||  ||   ||
 * TBD || Security Information || Requestor, Time to Return to Data Sources ||  ||
 * TBD || Care Setting || Hospital, Inpatient ||  ||

12.4.2 Structured Data Elements for Expanded Analysis (these data elements will be incorporated into the CIM)
NOTE: The technical framework must support the query details listed out in the "notes" column.


 * **Data Element** || **Definition** || **Notes** ||
 * Provider ||  || Obtain total counts for patients that were seen by an individual provider ||
 * Age ||  || Obtain total counts for patients that fall into identified age ranges ||
 * Zip Code ||  || Obtain total counts for patients that fall into regions identified by zip code ||
 * Gender ||  || Obtain total counts for patients that are male or female ||
 * Ethnicity || Ethnicity is a term that extends the concept of race. The coding of ethnicity is aligned with public health and other federal reporting standards of the CDC and the Census Bureau. || Obtain total counts for patients that fall into identified Ethnicity categories ||
 * Race || Race is usually a single valued term that may be constant over that patient's lifetime. The coding of race is aligned with public health and other federal reporting standards of the CDC and the Census Bureau. Typically the patient is the source of the content of this element. However, the individual may opt to omit race. || Obtain total counts for patients that fall into identified Race categories ||
 * Last Seen || Date of last outpatient or inpatient encounter. ||  ||
 * Alive || Y/N || Was the patient alive during the time of the query? ||
 * Diagnosis Code (Diabetes) || Diabetes diagnosis codes that indicate either Type I or Type II || Obtain total counts for patients that have identified Diabetes diagnosis codes ||
 * Insurance Coverage (Y/N) || Does patient have some type of insurance coverage? Yes or No. || Obtain total counts of patients that have insurance as well as counts of patients that do not have insurance ||
 * Insurance Type || The category that the patients' insurance coverage falls into - Commercial, Federal, or State || Obtain total counts of patients based on identified insurance types ||
 * Time Period || The data range that query should return results for. ||  ||
 * Practice || The location name of where patient care was provided ||  ||
 * HbA1c ||  || Total counts for the following categories

Count of patients with HbA1c > 9.0 %

Count of patients with HbA1c< 8.0 %

Count of patients with HbA1c< 7.0 % ||
 * Systolic and Diastolic Blood Pressure ||  || Total count of patients with BP ≥140/90 mm Hg* ||
 * Eye Examination || Y/N || Total count of patients who have had an eye examination ||
 * Smoking Status || Y/N || Total count of patients who have had smoking status of a Yes or No ||
 * LDL ||  || Total counts for the following categories

Count of patients with LDL ≥130 mg/dl

Count of patients with LDL <100 mg/dl ||
 * Microalbumin level ||  || Has it been completed? (Y/N) ||
 * Microalbumin result ||  || Count of patients with Microalbumin > 30 micrograms/mg Creatinine

Count of patients with Microalbumin < 30 micrograms/mg Creatinine ||
 * Foot Examination ||  || Has it been completed? (Y/N) ||
 * BMI ||  || Count of patients with BMI ≥ 25 ||
 * Medication by Class || Statin, Aspirin, Ace Inhibitor/ARB || Results should pull how many patients are taking medications in the identified categories. ||

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