| | Exhibit 300 (BY2010) for NIH CC Clinical Research Information System (CRIS)PART ONE
OVERVIEW
- 1. Date of Submission:
- 2009-03-12
- 2. Agency:
- 009
- 3. Bureau:
- 25
- 4. Name of this Capital Asset:
- NIH CC Clinical Research Information System (CRIS)
- 5. Unique Project Identifier:
- 009-25-01-02-01-3006-00
- 6. What kind of investment will this be in FY2010?
- Operations and Maintenance
- 7. What was the first budget year this investment was submitted to OMB?
- FY2002
- 8. Provide a brief summary and justification for this investment, including a brief description of how this closes in part or in whole an identified agency performance gap.
- The Clinical Research Information System (CRIS) was designed and implemented to support medical care and research support at the NIH Clinical Center. As the nation's largest research hospital, data collection and analysis for clinical trials is critical to improving the health of the nation. The CRIS supports over 1200 clinical trials at the hospital for the NIH through an enterprise of interfaced applications. As CRIS enters the O & M phase, the vision of multiple interfaced COTS systems is complete: The modules currently in production include: The hospital information core, radiology, nutrition, surgery, scheduling and admissions, Lab, transfusion medicine,EKG, Pharmacy, and Data Mart systems. Replacing a 25 year old legacy system, CRIS now offers a central source of data, images and reports for clinical researchers of the NIH intramural program. The project has mitigated the manual transfer of data, and has created electronic access to clinical and research data. The CRIS has been developed to meet multiple goals of the PMA. The key PMA is the e-government initiative. Clinical and research data including images are now ordered, documented and stored electronically. This has been critical to sustaining the research enterprise at the NIH, and allowed researchers access to larger datasets than in the past. A second PMA goal of human capital is also been addressed with this project. With the nursing shortage and decreased funding, there is decreased staffing. Therefore, the clinical care areas require efficient data capture into a system that accrues data once for care and for research. The CRIS system has reduced time for M.D.'s to enter orders (see performance measures) and also to make care decisions. This system has increased employee satisfaction with an electronic medical record system (see performance measures). The last PMA is R & D investment criteria. The core mission of the NIH is research. CRIS has enabled the intramural program to pool all patient data into one repository creating efficiencies and allowing researchers to analyze increasingly more complex data and results by protocol or across protocols. CRIS continues to meet goals set through a rigorous CPIC process. Budget requests are vetted through the project Steering Committee, the NIH IT Working Group, and evaluated through the NIH Budget and Management Working Group. CRIS became Steady in State with the begining of Fiscal Year 2007.
- 9. Did the Agency's Executive/Investment Committee approve this request?
- yes
- 9.a. If "yes," what was the date of this approval?
- 2007-06-26
- 10. Did the Project Manager review this Exhibit?
- yes
- 11.a. What is the current FAC-P/PM certification level of the project/program manager?
- Waiver Issued
- 11.b. When was the Program/Project Manager Assigned?
- 2008-03-07
- 11.c. What date did the Program/Project Manager receive the FACP/PM certification? If the certification has not been issued, what is the anticipated date for certification?
- 2009-07-31
- 12. Has the agency developed and/or promoted cost effective, energy-efficient and environmentally sustainable techniques or practices for this project.
- yes
- 12.a. Will this investment include electronic assets (including computers)?
- yes
- 12.b. Is this investment for new construction or major retrofit of a Federal building or facility? (answer applicable to non-IT assets only)
- no
- 13. Does this investment directly support one of the PMA initiatives?
- yes
- If yes, select the initiatives that apply:
| Initiative Name |
|---|
| Expanded E-Government | | Human Capital |
- 13.a. Briefly and specifically describe for each selected how this asset directly supports the identified initiative(s)? (e.g. If E-Gov is selected, is it an approved shared service provider or the managing partner?)
- CRIS supports the NIH electronic patient & research record. The PMA e-government initiative is supported directly with the creation of an electronic medical record and the creation of standardized databases that will be Interoperable with other medical information systems and allow for data-sharing across government & private health care providers.
- 14. Does this investment support a program assessed using the Program Assessment Rating Tool (PART)?
- yes
- 14.a. If yes, does this investment address a weakness found during the PART review?
- no
- 14.b. If yes, what is the name of the PARTed program?
- 10003522 - National Institutes of Health - Intramural Research
- 14.c. If yes, what rating did the PART receive?
- Effective
- 15. Is this investment for information technology?
- yes
- 16. What is the level of the IT Project (per CIO Council's PM Guidance)?
- Level 2
- 17. What project management qualifications does the Project Manager have? (per CIO Council's PM Guidance)
- (4) Project manager assigned but qualification status review has not yet started
- 18. Is this investment identified as high risk on the Q4 - FY 2007 agency high risk report (per OMB memorandum M-05-23)?
- no
- 19. Is this a financial management system?
- no
- 20. What is the percentage breakout for the total FY2009 funding request for the following? (This should total 100%)
| Area | Percentage |
|---|
| Hardware | 0 | | Software | 0 | | Services | 100 | | Other | 0 |
- 21. If this project produces information dissemination products for the public, are these products published to the Internet in conformance with OMB Memorandum 05-04 and included in your agency inventory, schedules and priorities?
- n/a
- 22. Contact information of individual responsible for privacy related questions.
| Name | Karen Pla | | Phone Number | 301-402-6201 | | Title | NIH Privacy Act Officer | | Email | plak@mail.nih.gov |
- 23. Are the records produced by this investment appropriately scheduled with the National Archives and Records Administration's approval?
- yes
- 24. Does this investment directly support one of the GAO High Risk Areas?
- no
SUMMARY OF SPEND
- 1. Provide the total estimated life-cycle cost for this investment by completing the following table. All amounts represent budget authority in millions, and are rounded to three decimal places. Federal personnel costs should be included only in the row designated Government FTE Cost, and should be excluded from the amounts shown for Planning, Full Acquisition, and Operation/Maintenance. The total estimated annual cost of the investment is the sum of costs for Planning, Full Acquisition, and Operation/Maintenance. For Federal buildings and facilities, life-cycle costs should include long term energy, environmental, decommissioning, and/or restoration costs. The costs associated with the entire life-cycle of the investment should be included in this report.
All amounts represent Budget Authority
Note: For the cross-agency investments, this table should include all funding (both managing partner and partner agencies).
Government FTE Costs should not be included as part of the TOTAL represented. | Cost Type | Py-1 & Earlier -2007 | PY 2008 | CY 2009 | BY 2010 |
|---|
| Planning Budgetary Resources | 4.180 | 0.000 | 0.000 | 0.000 | | Acquisition Budgetary Resources | 55.484 | 0.000 | 0.000 | 0.000 | | Maintenance Budgetary Resources | 10.825 | 7.140 | 3.380 | 5.570 | | Government FTE Cost | 16.730 | 3.250 | 3.520 | 3.740 | | # of FTEs | 38 | 30 | 30 | 30 |
- 2. Will this project require the agency to hire additional FTE's?
- no
PERFORMANCE
In order to successfully address this area of the exhibit 300, performance goals must be provided for the agency and be linked to the annual performance plan. The investment must discuss the agency's mission and strategic goals, and performance measures (indicators) must be provided. These goals need to map to the gap in the agency's strategic goals and objectives this investment is designed to fill. They are the internal and external performance benefits this investment is expected to deliver to the agency (e.g., improve efficiency by 60 percent, increase citizen participation by 300 percent a year to achieve an overall citizen participation rate of 75 percent by FY 2xxx, etc.). The goals must be clearly measurable investment outcomes, and if applicable, investment outputs. They do not include the completion date of the module, milestones, or investment, or general goals, such as, significant, better, improved that do not have a quantitative measure.
- Agencies must use the following table to report performance goals and measures for the major investment and use the Federal Enterprise Architecture (FEA) Performance Reference Model (PRM). Map all Measurement Indicators to the corresponding Measurement Area and Measurement Grouping identified in the PRM. There should be at least one Measurement Indicator for each of the four different Measurement Areas (for each fiscal year). The PRM is available at www.egov.gov. The table can be extended to include performance measures for years beyond FY 2009.
| Row | Fiscal Year | Strategic Goal Supported | Measurement Area | Measurement Grouping | Measurement Indicator | Baseline | Planned Improvement to the Baseline | Actual Results |
|---|
| 1 | 2006 | S.O. 1.3 - Improve health care quality, safety, cost and value | Customer Results | Service Efficiency | Prescriber electronic order entry time | 05 results - 34.11 min +/- 8.14 minutes | 29 minutes | Multiple order entry took 21.2 minutes, entry of same orders using order sets took 15.5 minutes, a decrease of 27%. Demonstrated efficiencies in creating order sets for patient care and research. | | 2 | 2006 | S.O. 1.3 - Improve health care quality, safety, cost and value | Processes and Activities | Errors | Number of missing lab specib specimens | Lost or missing lab specimens - 52 per year | 39 less missing specimens | Decreased from 52 to 21 lost or mislabeled specimens, a decrease of 60% | | 3 | 2006 | S.O. 1.3 - Improve health care quality, safety, cost and value | Mission and Business Results | Health Care Research and Practitioner Education | Perceived Usefulness, Perceived Ease of Use , Support of Clinical Care, Support Research, Customer Support, Training Satisfaction | Perceived usefulness - 52 %, Perceived Ease of Use 46%, Support of Clinical Care - 74%, Support Research 74%, Customer Support - 75%, Training satisfaction - 94% | Improve user satisfaction and ease of use of the medical information system by 10% | Perceived Usefulness - 73% (up 21%), Preceived Ease of Use - 57% (Up 11%), Support of Clinical Care - 85% (Increased 11%), Support Research - 78% (increased 4%), Customer Support - 85% (increased 10%), Training Satisfaction - 96% (increased 2%) | | 4 | 2006 | Effective Management of Human Capital/Information Technology/Resources | Technology | Interoperability | Number of interface systems | At beginning of project had 5 interfaced systems | 6 | Built and interfaced scheduling system, surgery system, ADT system | | 5 | 2007 | S.O. 1.3 - Improve health care quality, safety, cost and value | Processes and Activities | Errors | Percentage use of physician order entry | 05 results - 66.3 % of all orders | 70% | Percentage of use 66.6% normal orders 77% medication orders | | 6 | 2007 | S.O. 1.3 - Improve health care quality, safety, cost and value | Customer Results | Automation | Number of protocol order sets | Count of protocol order sets | Increase number of order sets by 10% | Protocol order sets added 256 | | 7 | 2007 | S.O. 1.3 - Improve health care quality, safety, cost and value | Mission and Business Results | Health Care Research and Practitioner Education | Perceived Usefulness, Perceived Ease of Use , Support of Clinical Care, Support Research, Customer Support, Training Satisfaction | Perceived usefulness - 73%, Perceived Ease of use - 57%, Support of Clinical Care - 85%, Support of Research - 78%, Customer Support - 85%, Training Satisfaction - 96%. | Increase user satisfaction with system across all measures by 5% | Perceived usefulness 77% (up .6%) | | 8 | 2007 | Effective Management of Human Capital/Information Technology/Resources | Technology | Interoperability | Number of interface systems | 5 | 6 | Added EKG and ProVation | | 9 | 2008 | S.O. 1.3 - Improve health care quality, safety, cost and value | Mission and Business Results | Health Care Research and Practitioner Education | Perceived Usefulness, Perceived Ease of Use , Support of Clinical Care, Support Research, Customer Support, Training Satisfaction | Use prior year results as baseline | Increase by 5% | Perceived usefulness 88% up 9% | | 10 | 2008 | Effective Management of Human Capital/Information Technology/Resources | Technology | Interoperability | Number of NIH systems interfaced to CRIS to improve efficiency | Use prior year results as baseline | Increase by 1 | Added CRIMSON and Theradoc | | 11 | 2008 | S.O. 1.3 - Improve health care quality, safety, cost and value | Customer Results | Automation | Percent of auditors satified with electronic medical record | Currently auditors request paper medical record | 100% | 100% | | 12 | 2008 | S.O. 1.3 - Improve health care quality, safety, cost and value | Processes and Activities | Errors | Number of systems using barcoding to decrease patient errors (lab, pharmacy, blood bank) | In FY 06 only lab has barcoding system | 3 | Lab, DTM, & Pharmacy use Barcoding | | 13 | 2009 | S.O. 1.3 - Improve health care quality, safety, cost and value | Mission and Business Results | Health Care Research and Practitioner Education | % of users indicating CRIS supports their health research at the 4 and above levels on a scale from 1 (unacceptable) to 5 (excellent) | Use prior year results as baseline | 80% at 4 and above | Survey is released in June | | 14 | 2009 | Effective Management of Human Capital/Information Technology/Resources | Technology | IT Contribution to Process, Customer, or Mission | % of users indicating CRIS' usefullness in their work is at the 4 and above levels on a scales from 1 (unacceptable) to 5 (excellent) | Use prior year results as baseline | 75% at 4 and above | Survey is released in June | | 15 | 2009 | S.O. 1.3 - Improve health care quality, safety, cost and value | Customer Results | Access | % of users indicating CRIS' ease of use is at the 4 or above levels on a scale from 1 (unacceptable) to 5 (excellent) | Use prior year results as baseline | 60% at 4 and above | Survey is released in June | | 16 | 2009 | S.O. 1.3 - Improve health care quality, safety, cost and value | Processes and Activities | Innovation and Improvement | % of users indicating CRIS supports clinical care at the 4 and above levels on a scale of 1 (unacceptable) to 5 (excellent) | Use prior year results as baseline | 88% at 4 and above | Survey is released in June | | 17 | 2010 | S.O. 1.3 - Improve health care quality, safety, cost and value | Mission and Business Results | Health Care Research and Practitioner Education | % of users indicating CRIS supports their health research at the 4 and above levels on a scale from 1 (unacceptable) to 5 (excellent) | Use prior year results as baseline | 80% at 4 and above | TBD | | 18 | 2010 | Effective Management of Human Capital/Information Technology/Resources | Technology | IT Contribution to Process, Customer, or Mission | % of users indicating CRIS' usefulness in their work is at the 4 and above levels on a scale from 1 (unacceptable) to 5 (excellent) | Use prior year results as baseline | 75% at 4 and above | TBD | | 19 | 2010 | S.O. 1.3 - Improve health care quality, safety, cost and value | Customer Results | Access | % of users indicating CRIS' ease of use is at 4 or above levels on a scale from 1 (unacceptable) to 5 (excellent) | Use prior year results as baseline | 60% at 4 and above | TBD | | 20 | 2010 | S.O. 1.2 - Increase health care service availability and accessibility | Processes and Activities | Innovation and Improvement | % of users indicating CRIS supports clinical care at the 4 and above levels on a scale from 1 (unacceptable) to 5 (excellent) | Use prior year results as baseline | 88% at 4 and above | TBD | | 21 | 2011 | S.O. 1.3 - Improve health care quality, safety, cost and value | Mission and Business Results | Health Care Research and Practitioner Education | % of users indicating CRIS supports their health research at the 4 and above levels on a scale from 1 (unacceptable) to 5 (excellect) | Use prior year results as baseline | 85% at 4 and above | TBD | | 22 | 2011 | Effective Management of Human Capital/Information Technology/Resources | Technology | IT Contribution to Process, Customer, or Mission | % of users indicating CRIS' usefullness in their work is at the 4 and above levels on a scale from 1 (unacceptable) to 5 (excellent) | Use prior year results as baseline | 80% at 4 and above | TBD | | 23 | 2011 | S.O. 1.3 - Improve health care quality, safety, cost and value | Customer Results | Access | % of users indicating CRIS ease of use is at the 4 and above levels on a scale from 1 (unacceptable) to 5 (excellent) | Use prior year results as baseline | 65% at 4 and above | TBD | | 24 | 2011 | S.O. 1.3 - Improve health care quality, safety, cost and value | Processes and Activities | Innovation and Improvement | % of users indicating CRIS supports clinical care at the 4 and above levels on a scale from 1 (unacceptable) to 5 (excellent) | Use prior year results as baseline | 90% at 4 and above | TBD | | 25 | 2012 | S.O. 1.3 - Improve health care quality, safety, cost and value | Mission and Business Results | Health Care Research and Practitioner Education | % of users indicating CRIS supports their health research at the 4 and above levels on a scale from 1 (unacceptable) to 5 (excellent) | Use prior year results as baseline | 85% at 4 and above | TBD | | 26 | 2012 | Effective Management of Human Capital/Information Technology/Resources | Technology | IT Contribution to Process, Customer, or Mission | % of users indicating CRIS' usefullness in their work is at the 4 and above levels on a scale from 1 (unacceptable) to 5 (excellent) | Use prior year results as baseline | 80% at 4 and above | TBD | | 27 | 2012 | S.O. 1.3 - Improve health care quality, safety, cost and value | Customer Results | Access | % of users indicating CRIS' ease of use is at the 4 or above levels on a scale from 1 (unacceptable) to 5 (excellent) | Use prior year results as baseline | 65% at 4 and above | TBD | | 28 | 2012 | S.O. 1.3 - Improve health care quality, safety, cost and value | Processes and Activities | Innovation and Improvement | % of users indicating CRIS supports clinical care at the 4 and above levels on a scale of 1 (unacceptable) to 5 (excellent) | Use prior year results as baseline | 90% at 4 and above | TBD | | 29 | 2013 | S.O. 1.3 - Improve health care quality, safety, cost and value | Mission and Business Results | Health Care Research and Practitioner Education | % of users indicating CRIS supports their health research at the 4 and above levels on a scale from 1 (unacceptable) to 5 (excellent) | Use prior year results as baseline | 85% at 4 and above | TBD | | 30 | 2013 | Effective Management of Human Capital/Information Technology/Resources | Technology | IT Contribution to Process, Customer, or Mission | % of users indicating CRIS' usefullness in their work is at the 4 and above levels on a scale from 1 (unacceptable) to 5 (excellent) | Use prior year result as baseline | 80% at 4 and above | TBD | | 31 | 2013 | S.O. 1.3 - Improve health care quality, safety, cost and value | Customer Results | Access | % of users indicating CRIS' ease of use is at the 4 or above levels on a scale from 1 (unacceptable) to 5 (excellent) | Use prior year result as baseline | 65% at 4 and above | TBD | | 32 | 2013 | S.O. 1.3 - Improve health care quality, safety, cost and value | Processes and Activities | Innovation and Improvement | % of users indicating CRIS supports clinical care at the 4 and above levels on a scale of 1(unacceptable) to 5 (excellent) | Use prior year result as baseline | 90% at 4 and above | TBD | | 33 | 2014 | S.O. 1.3 - Improve health care quality, safety, cost and value | Mission and Business Results | Health Care Research and Practitioner Education | % of users indicating CRIS supports their health research at the 4 and above levels on a scale from 1 (unacceptable) to 5 (excellent) | Use prior year result as baseline | 85% at 4 and above | TBD | | 34 | 2014 | Effective Management of Human Capital/Information Technology/Resources | Technology | IT Contribution to Process, Customer, or Mission | % of users indicating CRIS' usefullness in their work is at the 4 and above levels on a scale of 1 (unacceptable) to 5 (excellent) | Use prior year result as baseline | 80% at 4 and above | TBD | | 35 | 2014 | S.O. 1.3 - Improve health care quality, safety, cost and value | Customer Results | Access | % of users indicating CRIS' ease of use is at the 4 or above levels on a scale from 1 (unacceptable) to 5 (excellent) | Use prior year result as baseline | 65% at 4 and above | TBD | | 36 | 2014 | S.O. 1.3 - Improve health care quality, safety, cost and value | Processes and Activities | Innovation and Improvement | % of users indicating CRIS supports clinical care at the 4 or above levels on a scale of 1 (unacceptable) to 5 (excellent) | Use prior year result as baseline | 90% at 4 and above | TBD |
Enterprise Architecture
In order to successfully address this area of the business case and capital asset plan you must ensure the investment is included in the agency's EA and Capital Planning and Investment Control (CPIC) process, and is mapped to and supports the FEA. You must also ensure the business case demonstrates the relationship between the investment and the business, performance, data, services, application, and technology layers of the agency's EA. - 1. Is this investment included in your agency's target enterprise architecture?
- yes
- 2. Is this investment included in the agency's EA Transition Strategy?
- yes
- 2.a. If yes, provide the investment name as identified in the Transition Strategy provided in the agency's most recent annual EA Assessment.
- NIH CC Clinical Research Information System (CRIS)
- 3. Is this investment identified in a completed (contains a target architecture) and approved segment architecture?
- no
- 4. Identify the service components funded by this major IT investment (e.g., knowledge management, content management, customer relationship management, etc.). Provide this information in the format of the following table. For detailed guidance regarding components, please refer to http://www.whitehouse.gov/omb/egov/.
Component: Use existing SRM Components or identify as NEW. A NEW component is one not already identified as a service component in the FEA SRM.
Reused Name and UPI: A reused component is one being funded by another investment, but being used by this investment. Rather than answer yes or no, identify the reused service component funded by the other investment and identify the other investment using the Unique Project Identifier (UPI) code from the OMB Ex 300 or Ex 53 submission.
Internal or External Reuse?: Internal reuse is within an agency. For example, one agency within a department is reusing a service component provided by another agency within the same department. External reuse is one agency within a department reusing a service component provided by another agency in another department. A good example of this is an E-Gov initiative service being reused by multiple organizations across the federal government.
Funding Percentage: Please provide the percentage of the BY requested funding amount used for each service component listed in the table. If external, provide the funding level transferred to another agency to pay for the service. | Row | Agency Component Name | Agency Component Description | Service Type | Component | Reused Component Name | Reused UPI | Internal or External Reuse? | Funding % |
|---|
| 1 | NIH CC Clinical Research Information System (CRIS) | CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition. | Routing and Scheduling | Outbound Correspondence Management | | | No Reuse | 8 | | 2 | NIH CC Clinical Research Information System (CRIS) | CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition. | Knowledge Management | Categorization | | | No Reuse | 4 | | 3 | NIH CC Clinical Research Information System (CRIS) | CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition. | Routing and Scheduling | Inbound Correspondence Management | | | No Reuse | 0 | | 4 | NIH CC Clinical Research Information System (CRIS) | CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition. | Visualization | Graphing / Charting | | | No Reuse | 3 | | 5 | NIH CC Clinical Research Information System (CRIS) | CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition. | Asset / Materials Management | Computers / Automation Management | | | No Reuse | 4 | | 6 | NIH IT Infrastructure | The NIH IT Infrastructure program consists of network infrastructure, cyber security, office automation, help desk support, and telecommunications for all of NIH. These tools are used by internal and external researchers, patients, and the public. | Security Management | Digital Signature Management | Digital Signature Management | 009-25-02-00-01-3109-00 | Internal | 0 | | 7 | NIH CC Clinical Research Information System (CRIS) | CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition. | Development and Integration | Data Integration | | | No Reuse | 2 | | 8 | NIH IT Infrastructure | The NIH IT Infrastructure program consists of network infrastructure, cyber security, office automation, help desk support, and telecommunications for all of NIH. These tools are used by internal and external researchers, patients, and the public. | Security Management | Intrusion Prevention | Intrusion Prevention | 009-25-02-00-01-3109-00 | Internal | 9 | | 9 | NIH CC Clinical Research Information System (CRIS) | CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition. | Data Management | Data Warehouse | | | No Reuse | 9 | | 10 | NIH IT Infrastructure | The NIH IT Infrastructure program consists of network infrastructure, cyber security, office automation, help desk support, and telecommunications for all of NIH. These tools are used by internal and external researchers, patients, and the public. | Organizational Management | Network Management | Network Management | 009-25-02-00-01-3109-00 | Internal | 0 | | 11 | NIH IT Infrastructure | The NIH IT Infrastructure program consists of network infrastructure, cyber security, office automation, help desk support, and telecommunications for all of NIH. These tools are used by internal and external researchers, patients, and the public. | Management of Processes | Configuration Management | Configuration Management | 009-25-02-00-01-3109-00 | Internal | 4 | | 12 | NIH CC Clinical Research Information System (CRIS) | CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition. | Tracking and Workflow | Process Tracking | | | No Reuse | 3 | | 13 | NIH CC Clinical Research Information System (CRIS) | CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition. | Knowledge Management | Information Retrieval | | | No Reuse | 5 | | 14 | NIH CC Clinical Research Information System (CRIS) | CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition. | Development and Integration | Enterprise Application Integration | | | No Reuse | 9 | | 15 | NIH IT Infrastructure | The NIH IT Infrastructure program consists of network infrastructure, cyber security, office automation, help desk support, and telecommunications for all of NIH. These tools are used by internal and external researchers, patients, and the public. | Security Management | Identification and Authentication | Identification and Authentication | 009-25-02-00-01-3109-00 | Internal | 0 | | 16 | NIH CC Clinical Research Information System (CRIS) | CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition. | Knowledge Management | Information Sharing | | | No Reuse | 4 | | 17 | NIH CC Clinical Research Information System (CRIS) | CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition. | Management of Processes | Business Rule Management | | | No Reuse | 2 | | 18 | NIH CC Clinical Research Information System (CRIS) | CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition. | Knowledge Management | Information Mapping / Taxonomy | | | No Reuse | 11 | | 19 | NIH CC Clinical Research Information System (CRIS) | CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition. | Reporting | Standardized / Canned | | | No Reuse | 0 | | 20 | NIH CC Clinical Research Information System (CRIS) | CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition. | Management of Processes | Quality Management | | | No Reuse | 2 | | 21 | NIH CC Clinical Research Information System (CRIS) | CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition. | Systems Management | Remote Systems Control | | | No Reuse | 5 | | 22 | NIH CC Clinical Research Information System (CRIS) | CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition. | Reporting | Ad Hoc | | | No Reuse | 3 | | 23 | NIH CC Clinical Research Information System (CRIS) | CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition. | Organizational Management | Network Management | | | No Reuse | 0 | | 24 | NIH CC Clinical Research Information System (CRIS) | CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition. | Systems Management | Issue Tracking | | | No Reuse | 6 | | 25 | NIH CC Clinical Research Information System (CRIS) | CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition. | Records Management | Document Classification | | | No Reuse | 4 | | 26 | NIH CC Clinical Research Information System (CRIS) | CRIS is a core system with hospital functions of medical order entry, clinical documentation and results retrieval. Multiple ancillary systems will support clinical data collection for labs, radiologic images, blood bank and nutrition. | Knowledge Management | Knowledge Distribution and Delivery | | | No Reuse | 3 |
- 5. To demonstrate how this major IT investment aligns with the FEA Technical Reference Model (TRM), please list the Service Areas, Categories, Standards, and Service Specifications supporting this IT investment.
FEA SRM Component: Service Components identified in the previous question should be entered in this column. Please enter multiple rows for FEA SRM Components supported by multiple TRM Service Specifications.
Service Specification: In the Service Specification field, Agencies should provide information on the specified technical standard or vendor product mapped to the FEA TRM Service Standard, including model or version numbers, as appropriate. | Row | SRM Component | >Service Area | Service Category | Service Standard | Service Specification (i.e., vendor and product name) |
|---|
| 1 | Outbound Correspondence Management | Service Access and Delivery | Access Channels | Collaboration / Communications | Microsoft Exchange by: Microsoft Corporation | | 2 | Categorization | Service Platform and Infrastructure | Database / Storage | Database | Microsoft SQL Server by: Microsoft Corporation | | 3 | Categorization | Component Framework | Data Management | Reporting and Analysis | Eclipsys Sunrise Clinical Manager by: Eclipsys | | 4 | Inbound Correspondence Management | Service Access and Delivery | Access Channels | Collaboration / Communications | Microsoft Exchange by: Microsoft Corporation | | 5 | Graphing / Charting | Component Framework | Data Management | Reporting and Analysis | Eclipsys Sunrise Clinical Manager by: Eclipsys | | 6 | Computers / Automation Management | Service Platform and Infrastructure | Hardware / Infrastructure | Servers / Computers | Sun Server by: TBD | | 7 | Computers / Automation Management | Service Platform and Infrastructure | Hardware / Infrastructure | Servers / Computers | IBM RISC by: IBM | | 8 | Digital Signature Management | Service Access and Delivery | Service Transport | Supporting Network Services | SiteMinder, Netegrity by: CA, Inc. | | 9 | Data Integration | Service Interface and Integration | Interoperability | Data Format / Classification | HL7 Messaging Standard Version 3.0 by: Health Level Seven, Inc. | | 10 | Data Integration | Service Interface and Integration | Integration | Enterprise Application Integration | QDX Interface Engine by: QDX | | 11 | Data Integration | Service Interface and Integration | Interoperability | Data Format / Classification | Microsoft Message Queuing by: Microsoft Corporation | | 12 | Intrusion Prevention | Service Access and Delivery | Service Transport | Supporting Network Services | SiteMinder, Netegrity by: CA, Inc. | | 13 | Data Warehouse | Service Interface and Integration | Integration | Middleware | Tivoli Storage Manager by: Tivoli | | 14 | Data Warehouse | Service Platform and Infrastructure | Database / Storage | Storage | EMC SAN Products by: EMC Corporation | | 15 | Data Warehouse | Service Platform and Infrastructure | Database / Storage | Database | Microsoft SQL Server by: Microsoft Corporation | | 16 | Data Warehouse | Service Interface and Integration | Integration | Middleware | Quest Central by: TBD | | 17 | Data Warehouse | Service Platform and Infrastructure | Database / Storage | Database | SYBASE 4D by: Sybase | | 18 | Network Management | Service Platform and Infrastructure | Hardware / Infrastructure | Local Area Network (LAN) | Ethernet by: Institute of Electrical and Electronics Engineers | | 19 | Network Management | Service Platform and Infrastructure | Hardware / Infrastructure | Servers / Computers | Microsoft Systems Management Server by: Microsoft Corporation | | 20 | Network Management | Service Access and Delivery | Service Transport | Supporting Network Services | SiteMinder, Netegrity by: CA, Inc. | | 21 | Configuration Management | Service Platform and Infrastructure | Hardware / Infrastructure | Servers / Computers | Microsoft Systems Management Server by: Microsoft Corporation | | 22 | Configuration Management | Service Access and Delivery | Access Channels | Collaboration / Communications | BMC Remedy Service Management by: BMC Software, Inc. | | 23 | Process Tracking | Component Framework | Data Management | Reporting and Analysis | Eclipsys Sunrise Clinical Manager by: Eclipsys | | 24 | Information Retrieval | Service Access and Delivery | Access Channels | Web Browser | Windows Internet Explorer by: Microsoft Corporation | | 25 | Enterprise Application Integration | Service Platform and Infrastructure | Delivery Servers | Web Servers | Apache by: Apache Software Foundation | | 26 | Enterprise Application Integration | Service Interface and Integration | Integration | Enterprise Application Integration | Visual Studio 6.0 by: Microsoft Corporation | | 27 | Enterprise Application Integration | Service Interface and Integration | Integration | Enterprise Application Integration | QDX Interface Engine by: QDX | | 28 | Enterprise Application Integration | Service Platform and Infrastructure | Support Platforms | Dependent Platform | .NET 2.0 Framework by: Microsoft Corporation | | 29 | Enterprise Application Integration | Component Framework | Data Management | Reporting and Analysis | Eclipsys Sunrise Clinical Manager by: Eclipsys | | 30 | Enterprise Application Integration | Service Platform and Infrastructure | Software Engineering | Integrated Development Environment | Merant Collage by: Merant | | 31 | Enterprise Application Integration | Component Framework | Data Management | Database Connectivity | Open Database Connectivity by: Microsoft Corporation | | 32 | Enterprise Application Integration | Service Platform and Infrastructure | Delivery Servers | Web Servers | Microsoft Internet Information Services by: Microsoft Corporation | | 33 | Enterprise Application Integration | Service Platform and Infrastructure | Delivery Servers | Application Servers | Orion Application Server by: TBD | | 34 | Enterprise Application Integration | Service Platform and Infrastructure | Support Platforms | Independent Platform | Java 2 Enterprise Edition by: Sun Microsystems, Inc. | | 35 | Identification and Authentication | Service Access and Delivery | Service Requirements | Authentication / Single Sign-on | Microsoft Active Directory by: Microsoft Corporation | | 36 | Identification and Authentication | Component Framework | Security | Supporting Security Services | Hypertext Transfer Protocol with SSL by: The Internet Engineering Task Force | | 37 | Identification and Authentication | Component Framework | Data Interchange | Data Exchange | Lightweight Directory Access Protocol by: The Internet Engineering Task Force | | 38 | Identification and Authentication | Service Platform and Infrastructure | Database / Storage | Database | Oracle by: Oracle Corporation | | 39 | Identification and Authentication | Service Access and Delivery | Service Transport | Supporting Network Services | SiteMinder, Netegrity by: CA, Inc. | | 40 | Information Sharing | Service Platform and Infrastructure | Database / Storage | Storage | EMC SAN Products by: EMC Corporation | | 41 | Business Rule Management | Component Framework | Data Management | Reporting and Analysis | Eclipsys Sunrise Clinical Manager by: Eclipsys | | 42 | Information Mapping / Taxonomy | Component Framework | Data Management | Reporting and Analysis | Eclipsys Sunrise Clinical Manager by: Eclipsys | | 43 | Information Mapping / Taxonomy | Service Interface and Integration | Integration | Enterprise Application Integration | QDX Interface Engine by: QDX | | 44 | Standardized / Canned | Service Platform and Infrastructure | Database / Storage | Database | Microsoft SQL Server by: Microsoft Corporation | | 45 | Standardized / Canned | Component Framework | Data Management | Reporting and Analysis | Eclipsys Sunrise Clinical Manager by: Eclipsys | | 46 | Quality Management | Service Platform and Infrastructure | Software Engineering | Test Management | Serena TeamTrack by: Serena | | 47 | Remote Systems Control | Service Access and Delivery | Access Channels | Wireless / PDA | 802.11g by: Institute of Electrical and Electronics Engineers | | 48 | Ad Hoc | Service Interface and Integration | Integration | Middleware | Quest Central by: TBD | | 49 | Ad Hoc | Component Framework | Data Management | Reporting and Analysis | Hummingbird BI Query Admin by: TBD | | 50 | Ad Hoc | Component Framework | Data Management | Reporting and Analysis | Crystal Reports by: SAP AG | | 51 | Ad Hoc | Service Platform and Infrastructure | Database / Storage | Database | Microsoft SQL Server by: Microsoft Corporation | | 52 | Ad Hoc | Component Framework | Data Management | Reporting and Analysis | Eclipsys Sunrise Clinical Manager by: Eclipsys | | 53 | Ad Hoc | Component Framework | Data Management | Reporting and Analysis | Surgical Information Systems by: TBD | | 54 | Network Management | Service Access and Delivery | Delivery Channels | Intranet | Hypertext Transfer Protocol -- HTTP/1.1 by: The Internet Engineering Task Force | | 55 | Network Management | Component Framework | Security | Supporting Security Services | Blue socket by: TBD | | 56 | Network Management | Component Framework | Security | Supporting Security Services | Secure Sockets Layer by: Netscape Communications Corporation | | 57 | Network Management | Service Platform and Infrastructure | Hardware / Infrastructure | Network Devices / Standards | CA Unicenter by: Computer Associates | | 58 | Network Management | Service Access and Delivery | Service Transport | Supporting Network Services | SItescope by: TBD | | 59 | Network Management | Service Access and Delivery | Service Transport | Supporting Network Services | TCP/IP by: The Internet Engineering Task Force |
- 6. Will the application leverage existing components and/or applications across the Government (i.e., FirstGov, Pay.Gov, etc)?
- no
PART THREE
RISK
You should perform a risk assessment during the early planning and initial concept phase of the investment's life-cycle, develop a risk-adjusted life-cycle cost estimate and a plan to eliminate, mitigate or manage risk, and be actively managing risk throughout the investment's life-cycle.
Answer the following questions to describe how you are managing investment risks. - 1. Does the investment have a Risk Management Plan?
- yes
- 1.a. If yes, what is the date of the plan?
- 2008-12-13
- 1.b. Has the Risk Management Plan been significantly changed since last year's submission to OMB?
- no
- 2.b. If no, what is the strategy for managing the risks?
COST & SCHEDULE
- 1. Was operational analysis conducted?
- yes
- 1.a. If yes, provide the date the analysis was completed.
- 2008-12-13
- What were the results of your operational analysis?
- The first ORR was performed In August 2004 prior to the original go-live for CRIS CORE. In addition, before each of the ancillary go-lives, or Eclipsys upgrades, an Operational Readiness Review is also performed. This review typically consists of a checklist of readiness objectives that need to be achieved before the system go live, responsible staff member, date, etc. An Operational Analysis will be performed for the entire system each year covering costs, schedule and performance as requested by NIH management (the IT Working Group). As the system has moved into Steady State or Operations and Maintenance reviews are performed when there is a significant event such as a version upgrade. The reveiw consists of preplanning the activation, preperation of a go-live activation check list of tasks and the person or persons responsible for performing the tasks. Minor reviews are perfomed with the installation of vendor based "hot fixes" or other changes to the system. These are captured in our Configuration Management System through the use of System Change Requests or SCRS. We went live on version 5.0 on 12/13/2009.
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