B -- Occupational Exposures/ Nurses Health Study

Notice of intent to issue a purchase order. The Centers for Disease Control and Prevention/National Institute for Occupational Safety and Health, (NIOSH), Cincinnati, Ohio, intends to issue a purchase order on a sole source basis to Brigham and Women?s Hospital for Occupational Exposures in the Nurses Health Study (NHS). The NHS-III pilot study will include 3 selected states that are able to provide a computer file with names and mailing addresses for all licensed nurses in that state, as well as either their date of birth or the date of issue of their original nursing license; this information is necessary to target nurses in the correct age range. To improve minority participation, states that have a high proportion of minorities will be included, if possible, and Licensed Practial / Vocational Nurses (LPNs) as well as Registered Nurses (RNs) will be included; LPNs have a much higher proportion of minorities than RNs. The states that meet these criteria and are being considered for selection in the full study include Florida, Texas, North Carolina, Illinois, Ohio, Michigan, Massachusetts, New Jersey, Georgia, Virginia, Tennessee, South Carolina, Maryland, Alabama, and Missouri. Three of these states, Illinois, Florida, and North Carolina, have already been selected for the pilot study. Participants must have access to a computer with an Internet connection to complete the web-based questionnaire. However, the pilot study will assess whether participation would be maximized by offering a mailed questionnaire.Sub-Task A. To develop occupational question modules for the baseline and pregnancy questionnaires. The purpose of this sub-task is to create occupational exposure modules for the baseline and pregnancy questionnaires (Specific Aim 1). Occupational exposures and activities on the baseline and pregnancy questionnaires shall include work schedule, night work, and average hours worked per week over the previous year. There shall also be two lifetime shift work questions. Data shall also be collected on physical factors, such as lifting at work and hours spent standing or walking at work, on average, over the previous year. Separate exposure modules shall be developed to collect information on lifetime occupational chemical exposures to anti-viral and antineoplastic medication administration, high-level disinfectants, and anesthetic gases. The occupational exposure modules shall also collect information on exposure controls, such as ventilation and use of personal protective equipment. Each exposure module shall begin with a ?gateway? question about lifetime exposure that will be programmed to skip to the next module if the participant has never worked with the substance in question, thus reducing participant burden. The web-based interview shall be tested to ensure that skip patterns and gateway questions are properly programmed. Sub-Task B: To collect data in a pilot study. This sub-task will involve recruitment and data collection of a pilot phase of the NHS-III. An introductory letter, which has previously been approved by NIOSH, from the Principal Investigator explaining the study?s purpose and procedures shall be prepared and mailed by the contractor to subjects in the pilot study. A sample of approximately 6,000 nurses (3,000 RNs, 3,000 LPNs) shall be included in the mailing for the pilot phase. The mailings shall include a return postcard to assess whether non-participants would be willing to participate if given the option of a mailed questionnaire. In addition, a ?warning? postcard shall be mailed to all potential participants indicating that a letter will be arriving in a week. At the same time, half of those who are mailed an invitation shall receive a ?warning? phone message also indicating that the letter is being sent. Sub-task C: To evaluate the pilot study. Before conducting the full cohort study and to make improvements to the study design, questionnaires, or recruitment strategies, the contractor shall evaluate the pilot phase (Specific Aim 2). We conservatively estimate that 10% of those invited to participate will respond, based on the response rate to the NHS-II, factoring in the web-based nature of the study. If the actual response rate is less than 10%, NIOSH will collaborate with the contractor to evaluate whether the full study is feasible. The amount of time spent on the questionnaires and ease of use of the web-based questionnaire will be evaluated based on participant feedback, which will be collected on the questionnaire. The contractor shall provide summary statistics to NIOSH of key variables from the baseline and pregnancy questionnaires, including occupational variables, demographic variables, and other health outcomes. The summaries shall include frequency statistics for categorical variables and means and range of continuous variables, as well as the percent missing data. The accuracy and completeness of data and feasibility of data analysis shall also be evaluated by the contractor, with input from NIOSH investigators. The contractor shall evaluate whether mailed questionnaires would improve participation, and by how much and shall also evaluate the effectiveness of the ?warning? phone message. If we determine that the study is not feasible, we will consider other options, such as a second pilot study using a combination of web and paper questionnaires. Contract staff should include an epidemiologist, a computer programmer, and a web-programmer. The epidemiologist should have experience in reproductive epidemiology, epidemiology methods, and statistical analysis, and should have familiarity with the methods of the Nurses? Health Studies. The computer programmer should have experience with the Nurses? Health Studies data and be familiar with using SAS. The web-programmer associated with the NHS-III is necessary to the contract to facilitate programming the occupational modules. The contractor shall submit monthly progress reports. These reports shall include information on enrollment, demographic information on participants, and progress of data analyses, when applicable. In addition, the contractor shall communicate regularly (via bi-weekly conference calls) with the NIOSH technical monitor to resolve problems and discuss progress. References: Information on the Nurses? Health Studies: http://www.channing.harvard.edu/nhs/ The following publication resulted from our ongoing collaboration with the Nurses? Health Study II: Work schedule during pregnancy and spontaneous abortion.Whelan EA, Lawson CC, Grajewski B, Hibert EN, Spiegelman D, Rich-Edwards JW. Epidemiology. 2007 May;18(3):350-5. Deliverables The following deliverables shall be transmitted to NIOSH in the timeframe indicated: 1. Electronic file containing the occupational and pregnancy questionnaires (3 months after award). 2. A report summarizing the mailing of introductory letters and postcards to potential participants of the pilot study. The report shall include number of mailings, participation status, and known demographic information on the target population (3 months after award). 3. A report summarizing the evaluation of the pilot phase, including number of mailings, number of participants, summary statistics of data from the baseline and pregnancy questionnaires, summary results of non-participant surveys, effectiveness of the warning telephone message, estimated average time spent on survey, participant feedback, and completeness of occupational, reproductive, and demographic data. (8 months after award). Responsible sources that believe they possess the expertise and capabilities identified above are encouraged to submit to the Contracting Officer within 15 days from the posting date of this notice their capabilities statemetn and supporting information in the format they choose, not to exceed 10 pages. Please forward capabilities and supporting information to: Jennifer Bayer, Reference #000HCCKE-2008-50808, CDC/NIOSH, 4676 Columbia Parkway, Cincinnati, OH 45226, Mail Stop C-4, or email to: Jbayer@cdc.gov . The Government shall review any/all capabilities statements and supporting information submitted and determine if other qualified sources do exist that could provide the requirement. Information received in response to this notice shall be used solely for the purpose of determining whether to conduct a competitive procurement. All vendors must be registered in the Central Contractor Registry (CCR) prior to award of a federal purchase order/contract. Vendors may register at www.ccr.gov. If no affirmative responses are received within 15 days of this announcement, in accordance with FAR 13.106-1(b)(1), negotiations will be conducted with Brigham and Women?s Hospital as the only source, and a purchase order shall be issued without any additional notices being posted.