Hispanic Community Health Study – Study of Latinos (HCHS-SOL)

Coordinating Center –RFP Number NHLBI-HV-13-05

Small Business Sources Sought Notice





The Division of Cardiovascular Sciences of the National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH), is conducting a market survey to assess the availability and potential technical capability of small business firms to perform as the Coordinating Center of the program entitled “Hispanic Community Health Study-Study of Latinos (HCHS-SOL)”. The applicable NAICS Code is 541712 and the size standard is 500 employees. It is anticipated that one award will be made in April 2013 for a period of six years.

The HCHS-SOL began in 2006 in four U.S. communities (San Diego, CA; Chicago, IL; Bronx, NY; and Miami, FL). Approximately 16,000 Hispanic/Latino men and women between 18 and 74 years of age were recruited between 2008 and 2011 across communities. A baseline examination (Visit 1) was performed during that period of time.



The objectives of the renewal of the HCHS-SOL program are to 1) further investigate the apparent paradox of high socioeconomic adversity, substantial cardiovascular and pulmonary disease (CVPD) risk factor burden, and low CVPD prevalence and mortality in Hispanics; 2) identify putative causes for diseases and conditions highly prevalent in Hispanics (e.g. diabetes, asthma, chronic obstructive pulmonary disease (COPD), left ventricular hypertrophy, and gestational diabetes mellitus); 3) describe the transformation of health-related risk and protective factors related to migration, acculturation, and length of time living in the U.S.; 4) assess the impact of socioeconomic factors, cultural values, risk behaviors, and medical care access on health in Hispanics; and 5) investigate genetic effects, gene-gene interactions, and gene-environment interactions in relation to measured phenotypes in this uniquely admixed population. These objectives will be accomplished through annual follow-up and a second examination (Visit 2) of the existing cohort.



NHLBI plans to support one (1) Research Coordinating center, four (4) Field Centers, and one (1) Echocardiography Reading Center. THIS NOTICE ADDRESSES THE COORDINATING CENTER ONLY.

The Field Centers and the Echocardiography Reading Center shall be supported by a Coordinating Center which shall be responsible for overall coordination, communications, data management, and analytical/statistical support.

The important overall technical requirements associated with this acquisition for the HCHS-SOL include the following:



• Demonstrated ability to lead, coordinate, and participate in all aspects of planning of Visit 2 components of HCHS-SOL;



• Establish and finalize subcontracts with an Electrocardiogram (ECG) Reading Center, Pulmonary Reading Center, Neurocognitive Reading Center and a Central Laboratory;



• Establish and finalize working agreements with the Echocardiography Reading Center associated with HCHS-SOL;



• Establish data entry systems to collect measures from the Visit 2 as specified in the protocol;



• Monitor recruitment of participants and completion of Visit 2 interviews and procedures;



• Provide central training and certifications of cohort follow-up interviewers, medical record acquisition staff, medical record abstractors and physician reviewers;



• Identify an ECG Reading Center that will oversee the acquisition and reading of ECGs on all HCHS-SOL cohort participants; a Pulmonary Reading Center that will oversee the training, acquisition, quality assurance, and quality control of the spirometry measurements in all HCHS-SOL participants; a Neurocognitive Reading Center that will oversee the acquisition and reading of neurocognitive tests performed by HCHS-SOL participants ages 45 years and older (approximately 3,000 per Field Center) that had these tests done at Visit 1; and a Central Laboratory that will oversee the training for the venipuncture, acquisition, process, aliquoting, and shipping of blood, serum, plasma and urine samples, and laboratory analyses;



• Provide statistical analyses appropriate to epidemiology studies with complex designs; and



• Provide a plan for transition of responsibilities, data and materials from the existing Coordinating Center to the new Offeror.



Small business firms having demonstrated experience in performing tasks as articulated above are invited to submit capability statements.



The capability statements shall include: (1) professional qualifications of scientific, managerial and technical personnel including medical, technical, statistical, computer, and administrative staff with relevant expertise in epidemiologic research; (2) the organizational flexibility to modify the labor mix to meet the changing demand on the resource; (3) evidence of prior administrative and scientific leadership as a multi-center epidemiology study coordinating center managing a study of this size (approximately 16,000 participants); (4) evidence of leadership in first-authoring and publishing scientific papers in a collaborative study; (5) experience and expertise in design, implementation and maintenance of quality control procedures including assessment of reproducibility, validity, and bias and drift in laboratory measurements in large multi-center studies; (6) substantial experience pertinent to the development of protocols and management of a wide variety of large-scale multi-center epidemiology studies; (7) experience and expertise in the epidemiology of cardiovascular and lung diseases; (8) expertise to determine appropriate levels for participant alerts and referrals, and actions required for participant safety; (9) experience in generation and enhancement of applications of appropriate statistical methods of analysis and interpretation of medical data; (10) access to a large capacity computer facility and networking to remote terminals, and experience in installing and maintaining such networks; (11) capability to subcontract to laboratories and reading centers; and (12) the firm’s status as a small business under NAICS Code 541712. Evaluation of the capability statements shall be based on the technical capabilities listed above. Each technical point (criterion) shall be weighted equally.



Capability statements submitted in response to this notice that do not provide sufficient information for review will not be considered. This is NOT a Request for Proposals (RFP), and responses should NOT include budgetary information. The Government intends to negotiate one contract for the period of six years with an approximate award date of April 01, 2013. Firms responding to this notice shall provide capability statements (original and three copies) no later than 04:00 pm EST on the fifteenth (15th) calendar day from the date of this announcement to the address shown above.



Your submission shall include the name and telephone number of a point of contact. Please reference this notice number. Electronic copies of capability statements will be accepted and shall be sent to Michael White, Contract Specialist (email address: michael.white2@nhlbi.nih.gov) and Tara Knox, Contracting Officer (email address: tara.knox@nhlbi.nih.gov).

See Attached Solicitation Notice NHLBI-HV-13-05 Amendment No.: 1

Date of Issuance: July 13, 2012

The above numbered Request For Proposal (RFP) is amended as set forth below. The hour and date specified for receipt of proposals remains unchanged.

Offerors must acknowledge receipt of the amendment prior to the hour and the date specified in the solicitation or as amended, by (1) acknowledging receipt of this amendment on each copy of the proposal submitted (please note that this is the preferred method); or (2) separate letter or Electronic Mail which includes a reference to the RFP and Amendment number(s). For your convenience, the Proposal Intent Response Form is provided in SECTION J - List of Attachments of this RFP, for this purpose.

FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERORS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR PROPOSAL.

The purpose of this amendment is to provide Attachments, 1 - 4 and 15, in SECTION J - List of Attachments.