The Division of Computer Research Informatics (DCRI) in the Clinical Research Center at the National Institutes of Health located in Bethesda, Maryland has a need for computer software maintenance; computer software publishing or publishing and reproduction. The Contractor may be required to provide necessary supplies, personnel, and support necessary for producing and distributing computer software, such as designing, providing documentation, assisting in installation, and providing support services to software purchasers including software maintenance support.
General Requirements
Independently, and not as an agent of the Government, the Offeror shall furnish all necessary software, labor, materials, supplies, equipment, and services (except as otherwise specified herein) and perform the work set forth below. The Project Officer shall monitor all work performed under this contract.
Scope and Objectives
The National Institutes of Health Clinical Center's requirement is for an Offeror to provide the following:
Ongoing maintenance and support services
New Modules, Features, Training, and implementation Services
Applicable Government Publications and Forms
The Offeror is required to comply with the legislative, regulatory, guidelines, policies, standards, and procedures specified in this section.
Federal Legislation and Implementing Regulations
Computer Security Act of 1987 (P.L. 100-235) - Requires agencies to conduct security training, identify sensitive systems, and implement system security plans.
http://www.gsa.gov/attachments/GSA_PUBLICATIONS/extpub/4.pdf
Information Technology Accessibility Act of 1998. Electronic and Information Technology PL: 105-220. August 7, 1998. http://www.gsa.gov/attachments/GSA_PUBLICATIONS/extpub/15.pdf
Privacy Act (P.L. 93-579) of 1974 and 45 CFR Part 5b - Provides for the protection and accuracy of information about individuals. http://www.fs.fed.us/im/foia/patxt.htm
Electronic Communications Privacy Act (P.L. 99-508) - Provides for the protection of transmissions of various communications technology. http://www.gsa.gov/attachments/GSA_PUBLICATIONS/extpub/5.pdf
Revision of OMB Circular No. A-130, Transmittal No. 3, Appendix III, Security of Federal Automated Information Resources. http://www.whitehouse.gov/omb/circulars/a130/a130.html and http://www.whitehouse.gov/omb/circulars/a130/a130pre.html
Health Insurance Portability and Accountability Act Of 1996 (HIPAA) (proposed regulations) 104th Congress. August 21, 1996. Public Law 104-191. Health Insurance Portability and Accountability Act of 1996. http://aspe.os.dhhs.gov/admnsimp/pl104191.htm
Federal Information Security Management Act of 2002 (FISMA), Title III, E-Government Act of 2002, Pub. L. No. 107-347 (Dec. 17, 2002); http://csrc.nist.gov/policies/FISMA-final.pdf
DHHS Guidelines
Health Insurance Portability and Accountability Act Of 1996 (HIPAA) Resources DHHS Issues First Guidance on New Patient Privacy Protections. Friday, July 6, 2001. http://www.hhs.gov/news/press/2001pres/20010706a.html
HIPAA Administration Simplification http://aspe.os.dhhs.gov/admnsimp/
DHHS Information Systems Security Handbook. The DHHS Information Security Program Handbook is provided as an attachment.
Federal Information Processing Standards (FIPS)
FIPS PUB 112, Standard on Password Usage, May 30, 1985. http://www.itl.nist.gov/fipspubs/fip112.htm
FIPS PUB 190, Guideline For The Use Of Advanced Authentication Technology Alternatives, September 28, 1994. http://www.itl.nist.gov/fipspubs/fip190.htm
Data Standards
Arden Syntax for Medical Logic Systems. A standard language for representing and sharing medical knowledge designed to assist clinicians in decisions and alerts. Approved as an ANSI Standard on July 26, 1999. http://www.hl7.org
The Clinical Document Architecture is a model for clinical documents. Approved as an ANSI Standard in November 2000. http://www.hl7.org
Health Level 7 (HL7) Version 2.3. Approved as an ANSI Standard on May 13, 1997. http://www.hl7.org
HL7 Clinical Context Object Workgroup (CCOW) Version 1.3. Approved as an ANSI Standard on June14, 2001. http://www.hl7.org/special/committees/visual/visual.cfm
Structured Query Language (SQL) - SQL/99 ISO/IEC 9075:1992, "Information Technology --- Database Languages --- SQL" or ANSI X3.135-1992, "Database Language SQL" http://www.ansi.org/
Regulatory Bodies
FDA - Title 21 Code of Federal Regulations (21 CFR Part 11). Electronic Records; Electronic Signatures. Industry Experience Implementing Technical Provisions of 21 CFR Part 11, Federal Register (FR), February 22, 2000 http://www.fda.gov/ora/compliance_ref/part11/FRs/updates/2k0222pubmtg.pdf
FDA - Guidance for Industry: General Principles of Software Validation; Final Guidance for Industry and FDA Staff - 1/11/2002 - (PDF), (Text) http://www.fda.gov/cber/guidelines.htm
FDA - Draft Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures; Glossary of Terms - 9/24/2001 - (PDF), (Text) http://www.fda.gov/cber/guidelines.htm
FDA - Draft Guidance for Industry: 21 CFR Part 11; Electronic Records; Electronic Signatures; Validation - 9/24/2001 - (PDF), (Text) http://www.fda.gov/cber/guidelines.htm
JCAHO Standards - http://www.jcaho.org/standards_frm.html
Electronic and Information Technology Accessibility Standards
As set forth in Section 508 amendments of the Rehabilitation Act, the following Electronic and Information Technology Accessibility Standards (36 CFR Part 1194) are applicable to this contract:
(a) Section 1194.21 - Software Applications and Operations Systems Technical Standard.
(b) Section 1194.22 - Web-based Intranet and Internet Information and Applications Technical Standard.
(c) Section 1194.23 - Telecommunications Products Technical Standard.
(d) Section 1194.24 - Video or Multimedia Products Technical Standard.
(e) Section 1194.25 - Self-Contained, Closed Products Technical Standard.
(f) Section 1194.26 - Desktop and Portable Computers Technical Standard.
(g) Section 1194.31 - Functional Performance Criteria Technical Standard.
(h) Section 1194.41 - Information, Documentation, and Support Technical Standard.
These standards may be found at http://www.section508.gov/final_text.html.
Maintenance and Support Requirements
General Maintenance Requirements
The Offeror shall provide maintenance for the system application software as specified in this contract. The Offeror shall provide Service Level Agreements (SLAs) to meet the maintenance terms and conditions. The SLAs shall address, but are not limited to the following elements: Service policies and procedures including security and software support, on call/on site service priorities, thresholds, response time, resolution/fix time, reporting and escalation procedures.
The Offeror shall grant, in accordance with the terms and conditions contained in this contract, a non-exclusive, irrevocable and perpetual license to use the Software. This includes custom software products, e.g., interfaces, developed by the Offeror; custom software products will remain the intellectual property of the Offeror, but will be perpetually licensed to NIH under the same terms as the generally released software products.
The NIH seeks a contractor for a base period of twelve months, with four, twelve month unilateral options available to extend the term of services, who provide the time, labor, and manufacturer approved parts to keep the equipment operating in accordance with the manufacturer's standards. The North American Industry Classification System (NAICS) code is 511210, Size Standard - $25.0 million dollars.
The vendor responses must demonstrate their expertise in the areas described above. Please note that failure to specifically demonstrate capability to provide the required services in your response to this market survey may affect the Government's review of industry's ability to perform these services. The vendor's response shall be in sufficient detail to allow the Government to assess the capability of your firm.
The vendor response shall also include any other specific and relevant information related to the requirements of this project that will enable the Government to determine the capabilities of the company to perform the maintenance requirements described in this synopsis. Interested organizations must demonstrate and document in any response submitted, to this market survey extensive experience with and the ability to perform the maintenance requirements.
This notice is a market survey and is for information and planning purposes only and does not commit the Government to any contractual agreement. THIS IS NOT A REQUEST FOR PROPOSALS. The Government will not award a Purchase Order or Contract based upon Vendor responses to this announcement. The Government shall not assume any costs for preparing or submitting any information in response to the market survey or the Government's use of the information. Any proprietary information should be clearly identified as "proprietary information".
Vendors must send written capability responses by July 16, 2012 to Ms. Rieka Plugge, Contract Specialist at the following e-mail address [email protected]. For any questions, please contact Ms. Rieka Plugge at (301) 496-1199.