Sources Sought Notice – Follow-on Requirement: Molecular Diagnostics and Cytogenetics Rare Disorders Fellows Training

Notice Type: Sources Sought Notice

Posted Date: 02-DEC-13

Office Address: Department of Health and Human Services; National Institutes of Health; National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD; Office of Acquisitions6701 Rockledge Dr RKL2/6100 MSC 7902 Bethesda MD 20892-7902

Subject: Follow-on Requirement: Molecular Diagnostics and Cytogenetics Rare Disorders Fellows Training

Classification Code: U - Education & training services

Solicitation Number: HHS-NIH-NHLBI-CSB-(HG)-SBSS-2014-017-DLM

Contact: Dorothy Maxwell, Phone 301-435-0352, Fax 301-480-3345, Email [email protected]

Setaside: N/AN/A

Place of Performance (address): Vendors Training Facility Location and NIH

Place of Performance Country: US

Description: Department of Health and Human Services

National Institutes of Health

National Heart, Lung and Blood Institute, Rockledge Dr. Bethesda, MD

This is a Small Business Sources Sought (SBSS) notice. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The purpose of this notice is to obtain information regarding: (1) the availability and capability of qualified small business sources; (2) whether they are small businesses; HUBZone small businesses; service-disabled, veteran-owned small businesses; 8(a) small businesses; veteran-owned small businesses; woman-owned small businesses; or small disadvantaged businesses; and (3) their size classification relative to the North American Industry Classification System (NAICS) code for the proposed acquisition. Your responses to the information requested will assist the Government in determining the appropriate acquisition method, including whether a set-aside is possible. An organization that is not considered a small business under the applicable NAICS code should not submit a response to this notice." A. Background:

The National Institute of Health (NIH) is the nation's leading medical research agency and the primary Federal agency conducting, supporting and making medical discoveries that improve people's health and save lives. National Institutes of Health Undiagnosed Disease Program (UDP) is a trans-National Institute of Health (NIH) Division of Intramural Research (DIR) was established to serve as a hub where development of technology for the rapid isolation and analysis of disease genes will be carried out. The DIR's basic research laboratories and clinical branches develop and use the most advanced techniques to conduct research in medical genetics. Research includes identifying and understanding the molecular basis of human genetic disease and planning and carrying out clinical trials to test methods for the treatment.

The mission of the DIR includes the training of physicians and doctoral degree fellows in genetics and genomics through the Medical Genetics and Genomic Medicine Residency and Fellowship Training Programs. These programs are administered by the Office of the Clinical Director (OCD) and are accredited by the American Board of Medical Genetics (ABMG). Requirements for board certification of competency of trainees includes laboratory experiences in cytogenetics and molecular genetics, including genomics. To meet these requirements the Medical Genetics Branch and OCD seek nearby institutions to provide these components of training for board certification in Clinical Genetics, Clinical Molecular Genetics, Clinical Biochemical Genetics and Clinical Cytogenetics. The laboratory experience of the trainees must include a wide array of molecular diagnostic testing in the fields of neurodegenerative disorders, late onset disorders, imprinting disorders, mental retardation, neuromuscular disorders, and metabolic diseases, including prenatal diagnosis. In addition, the training in cytogenetics must include conventional karyotyping as well as FISH and microarrays in both pre- and post-natal settings.

The laboratory aspect of the training program will need to be conducted in diagnostic laboratories with equipment and personnel to provide the hands-on experience required for board certification by ABMB. The staff, which must include ABMG board certified laboratory directors, will be required to train fellows in applicable laboratory techniques and the clinical interpretation and implications of the test results. The staff must also participate in the comprehensive teaching of fellows; including participation in lecture series, journal clubs, and case conferences.

B. Purpose and Objectives

The purpose of this requirement is to provide DIR with access to CLIA/CAO and ABMG approved settings to train fellows in the laboratory techniques of cytogenetic and molecular genetics for the diagnosis of genetic disorders and the genetic implications of these test results. To maintain formal training program sites for the instruction of medical and doctoral fellows as part of the requirements for board certification in Clinical Genetics, Clinical Cytogenetics, Clinical Biochemical Genetics and Clinical Molecular Genetics.

The goals of the program are to:

1. Provide a training facility that will conduct two week training experiences in cytogenetics genetics for each of our Medical Genetics trainees seeking certification in Clinical Molecular Genetics and Clinical Biochemical Genetics as well as our Clinical Genetic trainees. 2. Provide a training facility that will conduct one month training experiences in cytogenetics genetics for each of our Medical Genetics trainees seeking certification in Clinical Cytogenetics. 3. Provide a training facility that will conduct one-month training experiences in molecular genetic testing for rare genetic conditions for each of our Medical Genetics trainees seeking certification in Clinical Molecular Genetics, Clinical Cytogenetics and Clinical Biochemical Genetics as well as our Clinical Genetic trainees. 4. Provide a training facility that will conduct two week training experiences in medical genomics for each of our Medical Genetics trainees seeking certification in Clinical Molecular Genetics, Clinical Cytogenetics and Clinical Biochemical Genetics as well as our Clinical Genetic trainees. 5. To provide a genetic counselor to assist in the training of the fellows in the genetic counseling implications of the diagnoses that have been made. 6. To participate in the comprehensive training of all trainees in genetics as part of the Medical Genetics and Genomic Medicine Residency and Fellowship Programs.

C. Scope of Work

A. Specific tasks to be performed are:

Each year the training program will enroll up to four (4) clinical genetics fellows, (2) clinical biochemical genetics fellows, and (4) clinical molecular genetics fellows. Each fellow will spend one (1) month each in the molecular genetics laboratory, two (2) weeks in the cytogenetics laboratory, and two (2) weeks in the genomics rotation. Each year the training program will enroll up to one (1) clinical cytogenetic fellow who will spend one (1) month each in the cytogenetic and molecular genetic laboratories, and two (2) weeks in the genomics rotation.

1. Track the progress of each fellow to insure that they will have had necessary experiences for AMGB certification.

B. Capability of Contractor Evaluation:

The Contractor shall describe procedures needed to successfully train the fellows in required laboratory techniques and the genetic implications of the molecular diagnostic tests.

C. Facilities:

The Contractor shall arrange to have suitable facilities, which include dedicated space for performance of administrative duties associated with tracking the progress of the medical fellows through the training.

D. Quality Control:

The Contractor shall establish and adhere to time lines for:

1. Providing the fellow with up-to-date protocols at the start of the rotation, and providing protocol modifications that occur during the rotation. 2. Providing all the required experiences for board certification within each rotation period. 3. Following the guidelines established by the American College of Medical Genetics for conducting genetic diagnostic tests. 4. Evaluate each medical fellow to insure they have a full understanding of all the techniques taught during training experiences. 5. Have sufficient samples submitted to the laboratory so that the fellows can have first-hand involvement in 150 cases of sufficient variety to qualify for ABMG Board eligibility. 6. Have the fellow participate in the interpretation of proficiency tests if such tests are conducted during the rotation period. 7. Personnel qualifications are to be provided by the Contractor to the Project Officer for review and approval prior to the award of the contract. E. Required Reports/Deliverables:

The Contractor shall prepare and deliver quarterly progress reports in the quantities specified to the recipients designated:

Quantity to Quantity Item Due Date

P.O.C.O. 2 Progress Quarterly 1 each Reports

Description of Reports:

Quarterly Progress Report - A Quarterly Progress Report shall be submitted to the Project Officer within 30 calendar days after each three (3) month reporting period. This report shall include the following information:

1. Number of fellows instructed in each rotation. 2. Number of fellows recommended repeating all or parts of the training sessions and why. 3. A narrative explaining any problems encountered that quarter, when they occurred and how they were resolved.

F. Government Property:

There will be Government furnished property as part of this contract if needed by competing institutions.

D. Anticipated Period of Performance:

Period of Performance will begin upon award. This contract will have one base year for 12-Months and two options year periods for 12-Months each.

E. Capability Statement /Information: Interested parties are expected to review this notice to familiarize itself with the requirements of this project. Failure to do so will be at your firm's own risk. The following information shall be included in the capability statement: 1. A general overview of the respondents' opinions about the difficulty and /or feasibility of the potential requirement, and any information regarding innovative ideas or concepts.

2. Information in sufficient details of the respondents' (a) staff expertise, including their availability, experience, and formal and other training; (b) current in-house capability and capacity to perform the work; (c) prior completed projects of similar nature; (d) corporate experience and management capability; and (e) examples of prior completed Government contracts, references, and other related information.

3. The respondents' DUNS number, organization name, address, point of contact, and size and type of business (e.g., 8(a), HUBZone, etc.) pursuant to the North American Industry Classification System (NAICS) code 611430, Professional and Management Development Training, small business size standard in millions: $10.0M.

4. Any other information that may be helpful in developing or finalizing the requirements of the potential acquisition.

5. The capability statement shall not exceed 20 single-sided pages (including all attachments, resumes, charts, etc.) presented in single-space and using a 12-point font size minimum, in either Microsoft Word or Adobe Portable Document Format (PDF), with 8-1/2 by 11 inch paper size, and 1 inch top, bottom, left and right margins.

6. All proprietary information should be marked as such. Statements should also include an indication of current certified small 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.

F. Closing Statement:

The capability statement should be submitted electronically (via email) to Dorothy Maxwell, Contract Specialist, at [email protected], Sources Sought Notice Number: HHS-NIH-NHLBI-CSB-(HG)-SBSS-2014-017-DLM on December 9, 2013, 7:30 A.M., Eastern Time. All responses must be received by the specified due date and time in order to be considered.

This notice is for information and planning purposes only and shall not be construed as a solicitation or as an obligation on the part of the National Heart, Lung, and Blood Institute (NHLBI). 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 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 notice or the NHLBI's use of such information as either part of our evaluation process or in developing specifications for any subsequent requirement.

"Disclaimer and Important Notes. This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre-solicitation synopsis and solicitation may be published in Federal Business Opportunities. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality. No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non-proprietary technical information in any resultant solicitation(s)."

Link/URL: https://www.fbo.gov/spg/HHS/NIH/NHLBI/HHS-NIH-NHLBI-CSB-(HG)-SBSS-2014-017-DLM/listing.html