NOTICE OF INTENT TO NEGOTIATE ON A SOLE SOURCE BASIS - 2ND NOTICE FOR SOLICITATION NO. NIHCL2012120, ENTITLED THERADOC MAINTENANCE AND SUPPORT
National Institutes of Health, Clinical Center Office of Purchasing and Contracts, intends to negotiate on a sole source basis with TheraDoc, 257 East 200 South, Suite 600, Salt Lake City, Utah 84111, pursuant to 41 U.S.C.253(c)(1)--Only one responsible source and no other supplies or services will satisfy agency requirements.
This procurement is for TheraDoc maintenance and support. 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. An IDIQ contract is anticipated with a base period of performance of 12 months and four 12 month options to extend the period of performance.
Interested parties may identify their interest and capability. Interested parties may respond to this requirement by submitting written capabilities/specifications to the Contract Specialist at the National Institutes of Health, Clinical Center, Office of Purchasing and Contracts, 6707 Democracy Blvd., Suite 106, Bethesda, MD 20892-5480, Attention: Rieka Plugge, or by email to
[email protected].
Specific information the Government requires to make a determination of acceptability include the following:
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 Contractor shall provide maintenance for the system application software as specified in this contract. The Contractor 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 Contractor 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 Contractor; custom software products will remain the intellectual property of the Contractor, but will be perpetually licensed to NIH under the same terms as the generally released software products.
This notice of intent is not a request for competitive proposals; however, all responses received within 8 days from the date of publication of this synopsis will be considered by the Government. A determination by the Government not to compete this proposed contract action based upon responses to this notice is solely with the discretion of the Government. Information received will normally be considered for the purpose of determining whether to conduct a competitive procurement. If no affirmative responses are received within 8 days of this notice to determine whether a qualified source is more advantageous to the Government, the order will be issued to TheraDoc. The NAICS Code/Size is 511210/$25.0 Million. This procurement is to be processed using Simplified Acquisition Procedures-Commercial Item Acquisition in conjunction with FAR Part 12 Commercial Item Acquisition of Commercial Items. There is no solicitation package available. For any questions regarding this announcement, please contact Rieka Plugge via email at
[email protected].
Bid Protests Not Available