The U.S. Food and Drug Administration (FDA) intends to award, using Simplified Acquisition Procedures, in accordance with FAR Part 13, a sole source award to The Department of Obstetrics and Gynecology, Division of Female Pelvic Medicine and Reconstructive Surgery of the Kaiser Permanente Southern Region, under authority of FAR 6.302-1 41 U.SC. 253 ( C )( 1 ) which states that only one responsible source and no other supplies or services will satisfy agency requirements. The Government anticipates the issuance of Award within (5) days after the response date of this notice. It is anticipated that the period of performance will be September 1, 2010 through August 31, 2011. This group has access to the system-wide deployment of a comprehensive electronic medical record (HealthConnect® - Epic Systems Corp, Verona WI) that can be modified to collect information critical for this study. KPSC uses HealthConnect® and it has been in place for over 2 years. The system can be modified for prospective data collection by the addition of a module that specifically collects information on the data needed for this study. The urogynecologists at KPSC are already using HealthConnect, to evaluate and record observations on their patients. They are familiar with the use of additional modules for specific purposes, minimizing the need for extensive training. The HealthConnect system has already been tested and validated and has a specific methodology for addition of modules for specific research purposes. The module can be designed and pretested on the system before launch into regular practice. KPSC computer programmers have specialized skills in module development using the HealthConnect system. This will allow ease in development and assurance of confidentiality of both the system and health care information. This will allow pilot testing within the live system.

FDA previously used KPSC for the Phase I of the Mesh study and has collaborated with KPSC urogynecologists during Phase I. KPSC has used the Health Connect® for two years. The urogynecologists at KPSC are already using HealthConnect to evaluate and record observations on their patients. They are familiar with the use of additional modules for specific purposes, minimizing the need for extensive training; decreasing the cost for Phase II of the study. It would not be in the best interest for the Government to have another electronic system redeveloped by another contractor, not only in terms of money, but also in terms of the time and efforts that have already been put into the development of HealthConnect® and FDA's evaluation of the safety and effectiveness of surgical mesh.

All responsible sources may submit a response by the due date of this posting to [email protected] and all questions regarding the post should be sent to the same e-mail address. Responses must be received within five days from the published date of this notice. All responses must be sent electronically, no faxes will be accepted.

 

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