ONC HIT Certification Program

Transcription

1 ONC HIT Certification Program Test Results Summary for 2014 Edition EHR Certification Part 1: Product and Developer Information 1.1 Certified Product Information Product Name: Care Compass Product Version: Domain: Ambulatory Test Type: odular EHR 1.2 Developer/Vendor Information Developer/Vendor Name: Productive Programming, Inc. Address: 1131 ills St Black Earth, WI Website: Phone: (608) Developer/Vendor Contact: Scott Dilts Part 2: ONC Authorized Certification Body Information 2.1 ONC Authorized Certification Body Information ONC ACB Name: InfoGard Laboratories, Inc. Address: 709 Fiero Lane Suite 25 San Luis Obispo, CA Website: Phone: (805) ONC ACB Contact: Adam Hardcastle This test results summary is approved for public release by the following ONC Authorized Certification Body Representative: Adam Hardcastle ONC ACB Authorized Representative EHR Certification Body anager Function/Title Signature and Date 2/28/ InfoGard. ay be reproduced only in its original entirety, without revision 1

2 2.2 Gap Certification The following identifies criterion or criteria certified via gap certification (a)(1) (a)(17) (d)(5) (d)(9) (a)(6) (b)(5)* (d)(6) (f)(1) (a)(7) (d)(1) (d)(8) *Gap certification allowed for Inpatient setting only No gap certification 2.3 Inherited Certification The following identifies criterion or criteria certified via inherited certification (a)(1) (a)(14) (c)(3) (f)(1) (a)(2) (a)(15) (d)(1) (f)(2) (a)(3) (a)(16) Inpt. only (d)(2) (f)(3) (a)(4) (a)(17) Inpt. only (d)(3) (f)(4) Inpt. only (a)(5) (b)(1) (d)(4) (f)(5) Optional & (a)(6) (b)(2) (d)(5) Amb. only (a)(7) (b)(3) (d)(6) (f)(6) Optional & (a)(8) (b)(4) (d)(7) Amb. only (a)(9) (b)(5) (d)(8) (g)(1) (a)(10) (b)(6) Inpt. only (d)(9) Optional (g)(2) (a)(11) (b)(7) (e)(1) (g)(3) (a)(12) (c)(1) (e)(2) Amb. only (g)(4) (a)(13) (c)(2) (e)(3) Amb. only No inherited certification 2016 InfoGard. ay be reproduced only in its original entirety, without revision 2

3 Part 3: NVLAP Accredited Testing Laboratory Information Report Number: R 0076 V1.4 Test Date: October 7, 2014; November 6, 2014 Location of Testing: InfoGard and Vendor 3.1 NVLAP Accredited Testing Laboratory Information ATL Name: InfoGard Laboratories, Inc. Accreditation Number: NVLAP Lab Code Address: 709 Fiero Lane Suite 25 San Luis Obispo, CA Website: ehr@infogard.com Phone: (805) ATL Contact: ilton Padilla For more information on scope of accreditation, please reference Part 3 of this test results summary is approved for public release by the following Accredited Testing Laboratory Representative: ilton Padilla ONC ACB Authorized Representative EHR Test Body anager Function/Title Signature and Date 2/28/ Test Information Additional Software Relied Upon for Certification Additional Software Applicable Criteria Functionality provided by Additional Software No additional software required 2016 InfoGard. ay be reproduced only in its original entirety, without revision 3

4 3.2.2 Test Tools Test Tool Cypress eprescribing Validation Tool HL7 CDA Cancer Registry Reporting Validation Tool HL7 v2 Electronic Laboratory Reporting (ELR) Validation Tool HL7 v2 Immunization Information System (IIS) Reporting Valdiation Tool HL7 v2 Laboratory Restults Intervace (LRI) Validation Tool HL7 v2 Syndromic Surveillance Reporting Validation Tool Transport Testing Tool Direct Certificate Discovery Tool No test tools required Version Test Data Alteration (customization) to the test data was necessary and is described in Appendix [insert appendix letter ] No alteration (customization) to the test data was necessary Standards ultiple Standards Permitted The following identifies the standard(s) that has been successfully tested where more than one standard is permitted Criterion # (a)(8)(ii)(a)(2) (b)(1) HL7 Version 3 Implementation Guide: URL Based Implementations of the Context Aware Information Retrieval (Infobutton) Domain Standard Successfully Tested (b)(2) HL7 Version 3 Implementation Guide: Context Aware Knowledge Retrieval (Infobutton) Service Oriented Architecture Implementation Guide (a)(13) (a)(15)(i) (a)(3) IHTSDO SNOED CT International Release July 2012 and US Extension to SNOED CT arch 2012 Release (b)(1) HL7 Version 3 Implementation Guide: URL Based Implementations of the Context Aware Information Retrieval (Infobutton) Domain (j) HL7 Version 3 Standard: Clinical Genomics; Pedigree (b)(2) HL7 Version 3 Implementation Guide: Context Aware Knowledge Retrieval (Infobutton) Service Oriented Architecture Implementation Guide (a)(16)(ii) (g) Network Time Protocol Version 3 (RFC 1305) (g) Network Time Protocol Version 4 (RFC 5905) 2016 InfoGard. ay be reproduced only in its original entirety, without revision 4

5 (b)(2)(i)(a) (b)(7)(i) (i) The code set specified at 45 CFR (c)(2) (ICD 10 C) for the indicated conditions (i) The code set specified at 45 CFR (c)(2) (ICD 10 C) for the indicated conditions (a)(3) IHTSDO SNOED CT International Release July 2012 and US Extension to SNOED CT arch 2012 Release (a)(3) IHTSDO SNOED CT International Release July 2012 and US Extension to SNOED CT arch 2012 Release (e)(1)(i) Annex A of the FIPS Publication List encryption and hashing algorithms (g) (g) (e)(1)(ii)(a)(2) Network Time Protocol Version 3 (RFC Network Time Protocol Version 4 (RFC 5905) 1305) (e)(3)(ii) Annex A of the FIPS Publication List encryption and hashing algorithms Common U Data Set (15) (a)(3) IHTSDO SNOED CT International Release July 2012 and US Extension to SNOED CT arch 2012 Release None of the criteria and corresponding standards listed above are applicable (b)(2) The code set specified at 45 CFR (a)(5) (HCPCS and CPT 4) Newer Versions of Standards The following identifies the newer version of a minimum standard(s) that has been successfully tested Newer Version Applicable Criteria No newer version of a minimum standard was tested Optional Functionality Criterion # Optional Functionality Successfully Tested (a)(4)(iii) Plot and display growth charts (b)(1)(i)(b) Receive summary care record using the standards specified at (a) and (b) (Direct and XD Validation) Receive summary care record using the standards specified at (b)(1)(i)(c) (b) and (c) (SOAP Protocols) (b)(2)(ii)(b) Transmit health information to a Third Party using the standards specified at (a) and (b) (Direct and XD Validation) (b)(2)(ii)(c) (f)(3) Common U Data Set (15) Transmit health information to a Third Party using the standards specified at (b) and (c) (SOAP Protocols) Ambulatory setting only Create syndrome based public health surveillance information for transmission using the standard specified at (d)(3) (urgent care visit scenario) Express Procedures according to the standard specified at (b)(3) (45 CFR (a)(4): Code on Dental Procedures and Nomenclature) 2016 InfoGard. ay be reproduced only in its original entirety, without revision 5

6 Common U Data Express Procedures according to the standard specified at Set (15) (b)(4) (45 CFR (c)(3): ICD 10 PCS) No optional functionality tested Edition Certification Criteria* Successfully Tested Criteria # Version Version Criteria # TP** TD*** TP** TD*** (a)(1) (c)(3) (a)(2) (a)(3) (a)(4) (d)(1) (d)(2) (d)(3) (a)(5) (d)(4) (a)(6) (a)(7) (d)(5) (d)(6) 1.2 (a)(8) (d)(7) 1.2 (a)(9) (d)(8) (a)(10) (d)(9) Optional (a)(11) (e)(1) (a)(12) (e)(2) Amb. only (a)(13) (e)(3) Amb. only (a)(14) (f)(1) (a)(15) (f)(2) (a)(16) Inpt. only (f)(3) (a)(17) Inpt. only (f)(4) Inpt. only (b)(1) (f)(5) Optional & (b)(2) Amb. only (b)(3) (f)(6) Optional & (b)(4) Amb. only (b)(5) (g)(1) (b)(6) Inpt. only (g)(2) (b)(7) (g)(3) (c)(1) (g)(4) (c)(2) 1.8a *For a list of the 2014 Edition Certification Criteria, please reference (navigation: 2014 Edition Test ethod) **Indicates the version number for the Test Procedure (TP) ***Indicates the version number for the Test Data (TD) 2016 InfoGard. ay be reproduced only in its original entirety, without revision 6

7 Clinical Quality easures* Type of Clinical Quality easures Successfully Tested: Ambulatory Inpatient No CQs tested *For a list of the 2014 Clinical Quality easures, please reference (navigation: 2014 Clinical Quality easures) Ambulatory CQs CS ID Version CS ID Version CS ID Version CS ID Version Inpatient CQs CS ID Version CS ID Version CS ID Version CS ID Version InfoGard. ay be reproduced only in its original entirety, without revision 7

8 3.2.8 Automated Numerator Recording and easure Calculation Automated Numerator Recording Automated Numerator Recording Successfully Tested (a)(1) (a)(9) (a)(16) (b)(6) (a)(3) (a)(11) (a)(17) (e)(1) (a)(4) (a)(12) (b)(2) (e)(2) (a)(5) (a)(13) (b)(3) (e)(3) (a)(6) (a)(14) (b)(4) (a)(7) (a)(15) (b)(5) Automated Numerator Recording was not tested Automated easure Calculation Automated Numerator Recording Successfully Tested (a)(1) (a)(9) (a)(16) (b)(6) (a)(3) (a)(11) (a)(17) (e)(1) (a)(4) (a)(12) (b)(2) (e)(2) (a)(5) (a)(13) (b)(3) (e)(3) (a)(6) (a)(14) (b)(4) (a)(7) (a)(15) (b)(5) Automated easure Calculation was not tested Attestation Attestation Forms (as applicable) Safety Enhanced Design* Quality anagement System** Privacy and Security Appendix A B C *Required if any of the following were tested: (a)(1), (a)(2), (a)(6), (a)(7), (a)(8), (a)(16), (b)(3), (b)(4) **Required for every EHR product 2016 InfoGard. ay be reproduced only in its original entirety, without revision 8

9 Appendix A: Safety Enhanced Design The following required data was missing: Recruitment Information Name of recruiter/recruiting firm Compensation amount/incentive Total number of participants recruited Number of participants who failed to show Participant debrief session and time Number of system(s) interaction during usability test Set up of environment completed by (vendor or test laboratory) System platform Description of the display including screen size, resolution and color settings Type of system (training/test database) Connection (LAN/WAN) Test Forms and Tools ethod for recording session (Video/web camera) Participant Instructions Session testing time System exploration time and time for comments prior to test Total tasks to complete Usability etrics Types of measuring to assess: Effectiveness Task Success and Task Failures Efficiency Task Deviations and Task Time Satisfaction Task Rating Data Scoring Details of how observed data were scored Data scoring should show how tasks were scored, errors evaluated and the time data analyzed. Results Data Analysis and Reporting Provide details if there are data exclusions Provide any details of testing irregularities or issues that affected data collection or interpretation of the results Present data in a form such as a table to easily identify performance results and comparing of results Task Success (ean) Path Deviations (Observed/Optimal) Task Time (ean, Observed/Optimal) Errors (ean) Task Ratings (ean) Narrative information of the finding shown in the table Effectiveness Description of the effectiveness of the system under test Efficiency Description of the efficiency of the system under test Satisfaction Description of the satisfaction data of the system under test ajor Findings Description of interpretation of quantitative findings, verbal report of the participants, and observations from the administrators and data loggers. Areas for Improvement Description of interpretation of quantitative findings, verbal report of the participants, and observations from the administrators and data loggers InfoGard. ay be reproduced only in its original entirety, without revision 9

10 Productive Programming, Inc. This statement applies to the following ONC requirements for EHR certification: (a)(6) edication list (g)(3) Safety-enhanced design PPi developed Care Compass using a homegrown UCD process. The initial design/blue print of the software was determined in a Statement of Work (SOW). A project plan assigning resources and date ranges was developed. The project plan was broken down into small focus groups that included our customers (AXIS and ICS). These small focus groups reviewed the design at a granular level and helped provide requirements and detailed specifications in a Wire Frame. Programmers then built the functionality using the wire frame as a blue print. After initial programming was complete the customers reviewed the functionality and made design change requests in an iterative process until all parties were satisfied. S:\easure Requirements\PPi UCD Document.docx Page 1 of 1

11 EHR Usability Test Report of Care Compass Version , edication List Feature 1 Report based on ISO/IEC 25062:2006 Common Industry Format for Usability Test Reports Date of Usability Test: 10/2/2014 Date of Report: [10/5/2014] Report Prepared By: [Scott Dilts Implementation and Regulatory Requirements Specialist Productive Programming, Inc. Scott.dilts@ppi.com Contents EXECUTIVE SUARY... 2 INTRODUCTION... 3 ETHOD... 3 APPENDIX A... 5

12 2 EXECUTIVE SUARY A usability test of Care Compass, a care management system, was conducted from October 2, 2014 in New York, New York by our client, ICS New York at their facility 257 Park Avenue South, 2nd Floor, New York, New York The purpose of this test was to test and validate the usability of the medications list feature in Care Compass. The version tested was , the version which ICS currently operates prior to our release of in late 2014/early 2015 (exact date TBD). The feature being tested, the medications list, is not being altered in any way between and so this test serves as an accurate test of medications list feature for During the usability test, an Application Specialist and a Director served as participants and used the EHR in simulated, but representative tasks. These testers are representatives of the users who would use this feature of the software in performing their daily activities. This study collected data on tasks typically conducted in a medications list, such as: Provide the ability to record member medications, whether prescribed or OTC Provide the ability to record start and end date for taking a medication. When adding a medication, be able to add dose, route and frequency. Provide ability to sign off as reviewed on a single medication, or on a complete list of medications for ember. Provide ability to link a medication to a member diagnosis. During the test, each participant logged on to the EHR in ICS Care Compass UAT testing environment and attempted to record/modify medications on member records. The participants recorded their success/failure and thoughts on the testing. This was provided to PPi to assist the development process.

13 3 INTRODUCTION The EHR tested for this study was Care Compass, a care management system. The purpose of this test was to test and validate the usability of the medications list feature in Care Compass. The version tested was , the version which ICS currently operates prior to our release of in late 2014/early 2015 (exact date TBD). The feature being tested, the medications list, is not being altered in any way between and so this test serves as an accurate test of medications list feature for ETHOD Designed to present insurance and some medical information to care managers in a managed long-term care setting, the EHR consists of a care management model used by the LTC provider and a web portal that may be used to communicate with members and supports or healthcare providers. The purpose of this test was to test and validate the usability of the medications list. The intended users of this feature are nurses and care managers employed by the managed care plan to monitor plan members. To this end ICS was asked to evaluate this function of the EHR against their requirements for the medication list feature. ICS prepared a requirements document based on their requirements for this feature and used this document to record test results. PARTICIPANTS The two participants in the test were an Application Specialist and a Director. Participants were employees of ICS New York, a care management group and client of PPi with which PPi partnered to develop its software by assisting with requirements and user testing. These employees represent our client s users when PPi and ICS work together on system features. Allison Ansell - 3 years in medical software business. Allison was an Account Executive for ediware where she assisted clients with management and support of their ediware software. Allison is currently the Care Compass Application Specialist at ICS and handles day to day support and training for all ICS employees. egan. 11 years Healthcare/IS experience. egan was a key member of the Care Compass software design team (ICS side) during PPi s collaboration with ICS and was involved in all phases of the software design life cycle. egan is

14 currently the at ICS and oversees all reporting and software content needs for ICS. egan has an BA in Information and anagement. 4 STUDY DESIGN Overall, the objective of this test was to uncover areas where the application performed well that is, effectively, efficiently, and with satisfaction and areas where the application failed to meet the needs of the participants. The data from this test will serve as a guide for development of Care Compass and may serve as a baseline for future tests with an updated version of Care Compass. During the usability test, each participant was provided with the same instructions. The system was evaluated by each participant against the clients stated requirements, which were provided in a checklist created by the client. The tests marked each requirement as pass or fail, and entered a description of their action and any comments in the Rule and Test description columns of their requirements testing document, copied in Appendix A below. TASKS The users attempted to perform tasks centering on entering medications on patients with all necessary information about the medication recorded, modifying or discontinuing the medications, and marking medications as reviewed. The full list is included in Appendix A below. PROCEDURES The testers performed each task in the requirements testing document. They then used the document to mark the task pass or fail, along with a description/comments from the testers in the Rule and Test Descriptions column. This is included in Appendix A. TEST LOCATION The test was conducted at the client s normal place of work on their business computers. RESULTS The results of the test were communicate to PPi for further development in the form of the requirements spreadsheet filled out by the testers. The document recorded all tested areas as a pass. However, there are several follow-ups. Two requirements ED1.7 and ED2.1 were marked pass by the client because they have a business process in place that accomplishes this goal currently, not because the software performs the task. The task in question for both is drug interaction checking.

15 The testers also noted that there might be situations in which they would want to link a medication to more than one diagnosis. 5 APPENDIX A Therefore these items drug interaction checking and linking multiple diagnoses - are areas that PPi notes as possible avenues for new development. Such a decision would be based on further discussions with ICS and other clients. This table is copied from the customer s requirements and testing document, prepared by them and filled out by the two testers. Reqt. # Description Rule Test Description /Fail ember edications ED1.0 ED1.1 ED1.2 ED1.3 Provide ability to record ember edications, prescribed or non prescribed, with effective dating for the edication. Provide ability to link a medication to a member diagnosis. Provide ability to note 'Prescribed by', from a list of Ds and Specialists Provide ability to sign off as reviewed on a single medication, or on a complete list of medications for ember. Perhaps more than one diagnosis code Added Ocella to ember XXXX as of 10/1/14 Linked Above medication to Chronic Pain Added Prescribed by Family Practice to above medication Was able to mark Ocella reviewed on its own and all other medications listed in batch Tested By A Ansell A Ansell A Ansell A Ansell Role Application Specialist Application Specialist Application Specialist Application Specialist

16 ED1.4 ED1.5 ED1.6 ED1.7 ED1.8 ED1.9 Provide ability to inactivate a medication, and choose a 'Reason for Discontinue of edication' (list maintainable by administrator) Provide ability to select Allergies from a drop down list, or check a box of KNDA. (list maintainable by administrator) Provide ability to indicate the nature of the reaction, selectable from a drop down (maintainable by administrator) Provide ability to reconcile drug interactions within a member medications list, and alert the user when a conflict is raised Require a ember Diagnosis to be selected for any medication unless the PRN box is checked Reviewed medications cannot be changed, and can only be ended with an End Reason selected. e.g. side effects, treatment failure etc Was able to end Gabapentin as of 10/3/14 with a reason of No Longer Needed Was able to add a fish allergy Was able to select reaction type of Itching The pharmacy benefits manager will check for drug interactions upon claims payment. can be configured by administrator Was not able to change reviewed medication, only set end date and reason. A Ansell A Ansell A Ansell Application Specialist Application Specialist Application Specialist 6

17 ED2.0 ED2.1 When adding a medication, pull all brand related information (name, dose, route and frequency) from PDR. If user updates, they must confirm that they are changing to off brand information. Provide ability to pull drug interactions, counter indications and other alerts at time medications are entered. Will be necessary when we manage medications. medication list is managed by system administrator The pharmacy benefits manager will check for drug interactions upon claims payment. 7

18 Appendix B: Quality anagement System 2016 InfoGard. ay be reproduced only in its original entirety, without revision 10

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20 Appendix C: Privacy and Security 2016 InfoGard. ay be reproduced only in its original entirety, without revision 11

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23 Test Results Summary Document History Version Description of Change Date V1.0 Initial release November 12, 2014 V1.1 Updated Safety Enhanced Design report February 28, 2016 END OF DOCUENT 2016 InfoGard. ay be reproduced only in its original entirety, without revision 12