The purpose of this SS is to identify businesses that are interested in a study on "Genetic Testing Services" for Undiagnosed Diseases program (UDP) under protocol 76-HG-0238, providing biochemical and molecular testing for genetic syndromes, inborn errors of metabolism, and mitochondrial diseases for clinical and research programs.

The NHLBI does not intend to award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted. As a result of this Sources Sought notice, the NHLBI may issue a Request for Quote (RFQ).

THERE IS NO SOLICITATION AVAILABLE AT THIS TIME. However, should such a requirement materialize, no basis for claims against NHLBI shall arise as a result of a response to this Sources Sought notice or the NHLBI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement.

The NHLBI is seeking capability statements from all eligible businesses, under the North American Industry Classification System (NAICS) code 621111, Office of Physicians (except Mental Health Specialists), with size standard of $10.0M.

The National Human Genome Research Institute (NHGRI), Undiagnosed Disease Program (UDP) is a pilot program designed to address the needs of persons with debilitating medical conditions for which no diagnosis has been found despite an extensive workup. The UDP requires the services of a Clinical Laboratory Improvement Amendments (CLIA)-certified biochemical and molecular testing laboratory with expert interpretations, and prompt reporting of rare or new genetic disorders, specifically mitochondrial disorders. The goals of the UDP include finding accurate diagnoses and discovering new diseases that provide insight into human physiology and genetics. The objectives of UDP are to provide the following under NIH protocol number: 76-HG-0238:

• Provide cutting edge mitochondrial DNA analysis
• Provide highly specialized mitochondrial electron transport chain enzymology testing on fibroblasts.
• Provide assessment of muscle mitochondrial DNA copy number

STATEMENT OF WORK

Purpose:

The Contractor shall provide Clinical Laboratory Improvement Amendments (CLIA) - certified biochemical and mitochondrial testing for patients within the National Human Genome Research Institute (NHGRI), Undiagnosed Disease Program (UDP). Specifically, the Contractor laboratory shall provide highly specialized mitochondrial testing and supports the research needs of the UDP by collaborating on clinically identified new and rare diseases.

Contractor Requirements:

1. The Contractor shall provide cutting edge mitochondrial DNA analysis.
2. The Contractor shall provide highly specialized mitochondrial electron transport chain
enzymology testing on fibroblasts.
3. The Contractor shall provide assessment of muscle mitochondrial DNA copy number.
4. The Contractor shall add new tests as available

Desired Results/Functions/End Items:

1. CLIA-certified test results with qualified interpretations in a timely way given the
requirements of the particular test the UDP Clinicians request.
2. Research collaborations will be conducted via Teleconferences, email communications,
shared professional presentations, posters and publications. Grand Round presentations
at the Contractor's location and in-house may also occur.

Technical Specifications/Standards/Methods:

The Contractor shall supply CLIA-certified test results with qualified interpretations.

Period of Performance:

This contract will have a base for 12 Months with 4 options year period for 12 Months each.

Base Year: October 2012 through October 2013
Option year 1: October 2013 - October 2014
Option year 2: October 2014 - October 2015
Option year 3: October 2015 - October 2016
Option year 4: October 2016 - October 2017

Special Handling or Handling Requirements:

The Contractor shall provide Result Reports in a secure HIPAA compliant manner.

Government Requirements:

Appropriate handling, packaging and shipping of specimens per requirements of the particular test the UDP Clinicians order and the terms of outlined by the Contractor for the given test.

Reporting Requirements and Deliverables:

1. The Contractor supply CLIA-certified test results with qualified interpretations in a timely
way given the requirements of the particular test the UDP Clinicians request. This
usually takes 2-8 weeks depending on the test ordered.

2. Billing will be within 30 days of issuance of the result report and include a 15% discount
on all CLIA tests ordered through the UDP.

3. Research collaborations will be ongoing as new disorders are identified or confirmed by
the Contractor.

Inspection and Acceptance Requirements:

The Contractor supplies CLIA-certified test results with qualified interpretations.

Interested parties are expected to review this notice to familiarize yourself with the requirements of this project; failure to do so will be at your firm's own risk. Interested parties should submit a tailored capability statement for this requirement, not to exceed 20 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space and using a 12-point font size minimum, that clearly details the ability to perform the aspects of the notice described above and in the attached draft statement of work. All proprietary information should be marked as such. Statements should also include an indication of current certified business status; this indication should be clearly marked on the first page of your capability statement (preferably placed under the eligible small business concern's name and address). Responses will be reviewed only by NIH personnel and will be held in a confidential manner.

All capability Statements sent in response to this SOURCES SOUGHT notice must be submitted electronically (via email) to Dorothy Maxwell, Contract Specialist, at [email protected] in either MS Word or Adobe Portable Document Format (PDF), August 16 , 2012, 7:30 AM, EST. All responses must be received by the specified due date and time in order to be considered.