A--Specialized Spirometry Quality Control Serivces VA Puget Sound Healthcare System To support a multi-site epdiemiologic study sponsored by the VA Cooperative Studies Program.

SPECIAL NOTICE: Intent to Sole source The Seattle Epidemiologic Research and Information Center (ERIC) located at the VA Puget sound Healthcare System, intends to negotiate on a sole-source basis with Robert L. Jensen, PhD, LLC. for Specialized Spirometry Quality Control Services. This procurement is being conducted in accordance with FAR 6.302-1(b)(1)(i) (only 1 responsible source), as it is believed that only Robert L. Jensen, PhD, LLC can provide this service. Description of Services: The Seattle ERIC requires the services of a contractor with experience conducting high-quality epidemiologic research studies leading to academic medicine peer reviewed publications related to pulmonary function and health. The contractor will oversee spirometry quality assurance and quality control efforts in a nationwide VA study assessing pulmonary function in Veterans. The contractor will train study personnel in performing spirometry using the Easy on-PC Spirometry System and serve as a central reading site for all pulmonary function data. The Easy on-PC Spirometry System is necessary because it collects reliable pulmonary function data without the need for calibration, and it is constructed to perform reliably in testing done outside of pulmonary function laboratories. In order to conduct statistical analyses, detect meaningful differences, and draw conclusions regarding the long-term impact of deployment on pulmonary function, the data must be assembled into datasets that have been reviewed for acceptability and reproducibility. It is not possible to use raw data received from the spirometry system. The contractor must have the knowledge and skills to train experienced and inexperienced study personnel in performing spirometry according to the study protocol and analyze and interpret data used in epidemiologic studies. The requirements of this contract are such that the contractor must have extensive experience with the Easy on-PC Spirometry System, including the software, and ATS and ERS standards, as well as experience providing spirometry training that is comparable to the National Institute for Occupational Safety and Health (NIOSH) spirometry training course. The contractor must have experience reviewing pulmonary function data for quality, including experience as a central reading site to large, multi-site epidemiologic studies. The contractor must have the specialized software, compatible with the Easy on-PC Spirometry System, to process the data collected, blinding each report before it is read to keep data confidential and not create any bias in the reading process, and a team of pulmonary specialists with the skills to review and grade spirometry for test values, graphical assessment, testing standards, test repeatability, test reproducibility, and overall quality control. The contractor must have a track record of completing quality reports within 24 hours in order to identify and address data quality or testing issues immediately. The contractor must be available to provide onsite training sessions based on the study timeline, ongoing training and direct support to improve and maintain data quality for the duration of the study, and regular communication and reports to investigators. Period of Performance (POP): Base Year: 3/1/2017 2/28/2018 Option Year 1: 3/1/2018 2/28/2019 Option Year 2: 3/1/2019 2/28/2020 Option Year 3: 2/29/2020 2/28/2021 Option Year 4: 3/1/2021 2/28/2022 Place of Performance: The contractor shall support this effort at contractor facilities. Trainings will be conducted at the recruitment sites, located at Veterans Health Administration (VHA) facilities: (1) Atlanta VA Medical Center; (2) VA Boston Healthcare System; (3) Michael E. DeBakey VA Medical Center (Houston); (4) Minneapolis VA Health Care System; (5) VA San Diego Healthcare System; and (6) VA Puget Sound Health Care System. This notice of intent to sole source is not a request for competitive quotes. The North American Industry Classification System (NAICS) number is 518210. This notice is NOT a request for competitive proposals/quotes and no solicitation document is available. However, parties may express their interest accompanied by supporting literature by email to Linda Buccigrossi, Contracting Officer, no later than 2/22/2107 at 11:00 AM EST. Responses should be sent to contact@example.gov. No telephone responses will be accepted. Information received will be for the purpose of determining whether or not to conduct a competitive procurement or proceed with sole source negotiations. The determination to conduct a competitive procurement based on responses to this notice is solely within the discretion of the VAPHS Contracting Officer.