TB PATIENT MANAGEMENT PROJECT BUSINESS USE CASE SPECIFICATION 100: CONSENT
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1 TB PATIENT MANAGEMENT PROJECT BUSINESS USE CASE SPECIFICATION 100: CONSENT Version /23/2004 This document has been developed by Science Applications International Corporation (SAIC) under a contract with the U.S. Centers for Disease Control and Prevention Department of Health and Human Services.
2 VERSION HISTORY Date Version Description Author 08/07/ Initial Draft T. Oemig 09/02/ Revised R. Tracy 09/04/ Added Issues section R. Tracy 09/12/ Added include used case UC.311.Document Care R. Tracy Notes 11/14/ Revise template G. Casdorph 02/10/ Revise from reconciliation of Post-JAD session Use G. Casdorph Cases to Final Use Cases 02/23/ Document baselined per PM CCB. G. Casdorph Revision Date: 02/23/2004 Page 2 of 7
3 TABLE OF CONTENTS 1 BUSINESS USE CASE 100: CONSENT Brief Description Actors Activity diagram Flow of Events Pre-Conditions Triggering Event(s) Basic Flow Alternative Flows Post Conditions Relationships Requirements Functional Capabilities Business Rules Supplemental Requirements Sources Issues... 7 Revision Date: 02/23/2004 Page 3 of 7
4 1 BUSINESS USE CASE 100: CONSENT 1.1 BRIEF DESCRIPTION This business use case will allow a user to provide evidence that consents have been requested from the patient and that the patient has given or refused consent. A patient is asked to consent to protocols and procedures that may include permission to receive medical treatment, release medical information, release of information based on HIPAA regulations, comply with TB quarantine policies, submit to HIV testing, submit to other testing and fulfill other actions necessary for a treatment successful outcome. 1.2 ACTORS Health Care Worker (HCW) 1.3 ACTIVITY DIAGRAM 1.4 FLOW OF EVENTS Pre-Conditions User must have security rights in the system to record consent (or refusal) to care Patient must exist in the system User must be viewing the patient information in the system Consent forms must be available in a language suitable to be understood by the patient Consent forms must be legally appropriate Patient (or guardian) must be accessible to sign the printed consent forms User can communicate using a language clearly understood by the patient. (Translation services may be required) Triggering Event(s) Patient requests an appointment User orders a test User updates patient demographic information User determines that the patient has not provided consent User schedules an appointment / provides care to the patient / request additional information. Revision Date: 02/23/2004 Page 4 of 7
5 1.4.3 Basic Flow User retrieves the consent forms from the system The system inserts patient demographic information into the consent forms User prints consent forms. (The forms should be written in a language understandable to the patient) User explains the consent forms to the patient (or guardian) User requests that the patient (or guardian) signs the consent forms Patient (or guardian) signs the consent forms User selects the consent form status option System displays a list of the consent forms For each consent form, the user selects the signed status indicating that the form was signed by the patient (or guardian) User saves consent form status data in system Use case ends Alternative Flows Patient refuses to sign the consent form From Step , the patient (or guardian) refuses to sign the consent forms User documents the refusal to sign consent forms by capturing patient (or guardian) signature on a refusal form Patient is informed of the consequences of refusal to sign consent forms (treatment not provided, testing not provided, legal proceedings for court ordered compliance, etc.) User selects the consent form status option System displays a list of the consent forms For each consent form, the user selects the status indicating refused to sign User records a care note to be associated with the refusal to sign User saves consent form status data in system Use case ends User requires health department staff signatures on consent forms From step , for forms that require health department signatures, user provides forms to staff Health department staff sign consent forms Use case end The patient s signature on consent forms obtained elsewhere From step , User takes the consent forms to the Patient User gives an explanation of the consent forms User requests the patient (or guardian) to sign consent forms. Revision Date: 02/23/2004 Page 5 of 7
6 Patient (or guardian) signs the consent forms User returns the completed forms to the user Return to step Identification is required for execution of consent process From step , User requests government-issued identification of the person signing the consent form The type of identification provided is entered into the system Return to step Post Conditions Consent forms are signed by the patient (or guardian) Consent form status is recorded in the system Relationships UC.102.Demographics (to note the language(s) that are understood by the patient, need for an interpreter, etc) UC.104.Billing (to provide information for reimbursement of charges) UC.105.Schedule Appointment (to schedule appointments for testing, assessment, follow-up visits, therapy, chest x-ray, etc) UC.108.Legal Action (to initiate legal processes if the patient refuses to sign consent forms, etc) UC.250.Create Template (to create consent forms in languages appropriate for the patient) UC.311.Document Care Note (to record general consent issues to support legal action, to assist the HCW, etc) 1.5 REQUIREMENTS Functional Capabilities Business Rules Supplemental Requirements 1.6 SOURCES Revision Date: 02/23/2004 Page 6 of 7
7 1.7 ISSUES # Issue Opened Owner Status mm/dd/yy Revision Date: 02/23/2004 Page 7 of 7
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