SOLICITATION NOTICE
R -- Workshops on the Methods of Routine Documentation of Medical Device Use
- Notice Date
- 4/8/2005
- Notice Type
- Solicitation Notice
- NAICS
- 541990
— All Other Professional, Scientific, and Technical Services
- Contracting Office
- Department of Health and Human Services, Food and Drug Administration, Office of Acquisitions and Grants Services, 5630 Fishers Lane, Room 2129, Rockville, MD, 20857-0001
- ZIP Code
- 20857-0001
- Solicitation Number
- SOL-FDA-05-00040
- Response Due
- 4/29/2005
- Archive Date
- 5/14/2005
- Description
- This is a combine synopsis/solicitation for commercial items prepared in accordance with the format in FAR subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. Solicitation Number FDA-SOL-05-00040 and the solicitation are issued as a request for quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2001-27. This acquisition is unrestricted as to the size of the business. The NAICS Code is 541990 and size standard is $6 million. All interested parties are invited to submit a quotation for the following requirement: BACKGROUND: One of the missions of the Center for Devices and Radiological Health (CDRH) is to monitor the safety of marketed medical devices. The current monitoring systems in place rely on adverse event reporting. Several studies have shown significant rates of underreporting. New monitoring systems that could be developed include routine searches of various data sources such as hospital discharge codes, electronic hospital records, or emergency room records. Unfortunately, studies currently underway show that attempts to create such systems will all fail to capture rates of adverse device events because device-specific medical information is not routinely documented in medical records. In other words, both device use and problems related to device use are not adequately recorded in patient charts. For most of the instances when device use and device-related problems are recorded, information about the specific device and the nature of the problem is inadequate. Good documentation of both device use and device problems is necessary for scientifically investigating the safety of devices. For patient safety reporting of adverse device events, it is essential that information on device utilization be routinely documented. For improving patient safety, reports of adverse device events may be lead to analysis of the use of all or a sample of a particular device to obtain information about the likelihood of such events and may lead to patient follow-up by providers of their patients using such devices. In these cases, having unique device identification in the patients? medical records, and pointers to a data base for information about that specific device is necessary. There are many barriers to good routine documentation: lack of awareness of the need to document, lack of financial incentive, lack of knowledge of how to describe particular devices, and lack of time for documentation. Since the barriers are multi-factorial, a multifaceted solution to the problem of poor documentation will probably be required. Simple exhortations to busy providers to write down more information are unlikely to be effective. An example of new solutions to be considered includes the development of ?smart? technology as an effective and inexpensive way to set up automatic documentation of device use, especially in adverse event situations. One way to examine and facilitate potential solutions to the issue of medical device identification and routine documentation is to bring experts from the relevant fields together to discuss the problem and recommend actions. A separate effort is underway to improve the nomenclature and identification of devices. This current effort regards routine documentation. Because of the possibility that one or two dominant personalities could steer the course of a workshop, two workshops will be held to increase the range of ideas that are expressed by the participants. Participants will be chosen from the fields of drug epidemiology, health services research, health care insurance, information technology, clinical data standards and technology, human factors engineering, social science, medical device manufacture, medical device regulation, and high technology development and engineering. Sectors to be represented include non-FDA federal government, professional societies, consumer groups, academia, health care providers, health care payers, third party health research contractors, information technology firms, and technology development entrepreneurs. The workshops will need to be facilitated by people with a broad understanding of medical devices. Each workshop should have a relatively small number of participants to encourage conversation. PROJECT PURPOSE: The purpose of this project is to work with people and organizations who are interested in furthering device documentation, patient safety, and the exchange of device information, and who understand health care delivery and are developing new technologies. We want to stimulate and record their ideas regarding the encouragement and enabling of routine documentation of medical device use. The best vehicle for this work is through targeted workshops. SCOPE OF WORK: Provide professional services to organize, recruit non-CDRH participants, host, facilitate, and document two workshops to brainstorm and obtain feedback on ways to encourage and develop routine documentation of medical device use and medical device related problems. These workshops would be held with CDRH and invited members of industry, government and academia. Tasks for each of two workshops: (1) The length of each workshop will be one and one-half days. The dates will be determined by the contractor in consultation with the Project Officer. Each workshop will include approximately 10 to 15 invitees from outside CDRH and up to 6 from inside CDRH. The non-CDRH invitees will be different at each workshop. The distribution of background profiles of the invitees will be approximately similar for each of the workshops. The background profiles will be distributed among three dimensions in a way that maximizes the diversity of the participants. The first dimension is field: drug epidemiology, health services research, health care insurance, information technology, clinical data standards and technology, human factors engineering, social science, medical device manufacture, medical device regulation, and high technology development and engineering. The second dimension is economic sector: non-FDA federal government (including health care providers and health care payers), non-profit private organizations (including professional societies, consumer groups, health care providers, and academia), and for-profit private organizations (including academia, health care providers, health care payers, third party health research contractors, information technology firms, and technology development entrepreneurs). The third dimension is academic degree: bachelor, master, and doctoral. The fourth dimension is years of relevant work experience: less than 5, 5 to 19, and 20 or more. All invitees should exhibit evidence of being highly creative. (2) Working with the Project Officer, the contractor will identify invitees, issue invitations, offer travel advice, and, as appropriate, offer honoraria to cover reasonable travel expenses and induce attendance. Some invitees will not require an honorarium. The contractor will need to judge the appropriate level of honorarium to offer each invitee. (3) At least two weeks prior to the workshop, participants of the workshop will be sent background material to review. The material will describe the current state of routine documentation of device use and device related problems, explain the need for improvement, include a preliminary agenda, and provide travel information. One copy of the background materials will be provided to the contractor by the Project Officer. (4) The contractor will set up an appropriate meeting space large enough to comfortably accommodate all participants for formal presentations and group discussion. The meeting space must be in the Washington, DC, Metropolitan area and within 3 city blocks of a Metro stop. If the proposed meeting space is further from a Metro stop, the contractor will provide transportation from a Metro stop. (5) The contractor will provide, set up, and troubleshoot the required audiovisual equipment (at least two microphones and a Windows-based laptop-projector combination) and printed agendas. (6) Each workshop will begin in the morning with prepared presentations covering the background materials. In the first afternoon, the contractor will facilitate 2 simultaneous brainstorming groups, each in separate rooms, to address specific questions. The specific questions will have been developed in advance by the Project Officer and the contractor. In the evening, the contractor will prepare synopses of the brainstorm results. The second morning will begin with contractor presentation of the brainstorm results, and conclude with discussion by all the attendees. (7) Since work will continue through both morning breaks, afternoon break, and lunch on the first day, meals and break refreshments will be provided by the contractor. The contractor will accommodate special dietary needs. (8) The contractor will deliver a transcript (PDF format) and report (PDF and Microsoft Word formats) of each workshop to the Project Officer within one month of the workshop. The report will include the findings, proposed ideas, and decisions, if any. The contractor will have the option of including their own recommendations. The contractor will send to each participant and post on its website an FDA-approved PDF-format electronic report of the two workshops. Any further publication will be jointly agreed to by the Project Officer and contractor. PROVISIONS/CLAUSES: The following provisions and clauses apply to this acquisition: FAR 52.212-1, Instructions to Offerors, Commercial Items (JAN 2005). FAR 52.212-2, Evaluation ? Commercial Items (tailored) (JAN 1999). Paragraph (a) is tailored as follows: the Government will award an order resulting from this request for quotation to the Offeror whose quote represents the best value to the Government, price and other factors considered (Past Performance, Technical). Offerors will be evaluated based on the following evaluation criteria (maximum points for each evaluation criteria is shown after each evaluation criteria: Technical: (1) Ability to identify invitees that meet the requirements in Task 1, in enough numbers that the actual participants will represent all the fields, sectors, and credentials listed, for each workshop [10]; (2) Ability to successfully invite workshop participants and successfully negotiate honoraria that induce invitees to participate, relevant to Task 2 [15]; (3) For each workshop, ability to successfully distribute materials beforehand, relevant to Task 3 [5]; (4) Ability to select appropriate meeting spaces. The offeror should describe and justify the meeting space, including size and layout, to meet the requirements of Task 4 [5]; (5) Ability to select appropriate audiovisual equipment. The offeror should describe and justify the equipment and the experience of personnel who will be on site to set up and troubleshoot the equipment, to meet the requirements of Task 5 [5]; (6) For the requirements of Task 6; (6) (a) Ability to moderate formal presentations, brainstorming sessions, and discussion sessions when the participants are quite diverse [10]; (6)(b) Knowledge of the broad range of medical devices, use of medical devices, and problems related to medical devices [20]; (6)(c) Knowledge of health care delivery systems [20]; (6)(d) Ability to quickly and accurately summarize technical discussions regarding medical devices, use of medical devices, problems related to medical devices, health care documentation, information technology, social science, medical device education, and advanced technology [15]; (6)(e) Ability to present a summary of technical discussions regarding medical devices, use of medical devices, problems related to medical devices, health care documentation, information technology, social science, medical device education, and advanced technology to an audience composed of experts in these areas, and then moderate further discussion by those experts on these topics [15]; (7) Ability to plan the provision of healthful and enjoyable refreshments and lunch, and plan and provide for the accommodation of specific dietary needs of the participants, in reference to Task 7 [5]; In reference to Task 8; (8)(a) Ability to write a final report of the discussion and findings from the two workshops, including technical aspects of medical devices, use of medical devices, problems related to medical devices, health care documentation, information technology, social science, medical device education, and advanced technology [10]; (8)(b) Ability to provide the offeror?s recommendations [5]; (8) (c) Ability to create and deliver PDF and Microsoft Word files [5]; (9) In reference to Task 9, ability and willingness to post the final report on the offeror?s website and to pursue further dissemination options with the Project Officer [5]. The scoring is based on a total of 150 points. Past Performance: Provide information for 3 past or current projects completed within the past 3 years that are similar in size, scope and complexity to the work required. Each reference shall include: A) Name, Address of clients organization; B) Contract Number, if applicable; C) Name, Title, Telephone Number and Fax Numbers and email address of a currently available client point of contact/reference; D) Description of the work performed; E) Performance Period, and F) Dollar value. All Technical and Past Performance proposals shall be limited to 50 pages, 8 x 11 paper, single spaced, Size 12 font. FAR 52.212-3, Offerors Representations and Certifications ? Commercial Items (JAN 2005). Quoters must complete the annual representations and certifications electronically via the ORCA website at http://orca.bpn.gov. FAR 52.212-4, Contract Terms and Conditions Commercial Items (OCT 2003). FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders ? Commercial Items (JAN 2005). Responses must be submitted by 12:00 p.m. Eastern Standard Time, April 29, 2005, addressed to the Food and Drug Administration, Office of Acquisition and Grants Services, Attention: Kim Clark, Room 2090, 5630 Fishers Lane, Rockville, Maryland 20857, or e-mailed to Kim.Clark@fda.gov., or faxed to Kim Clark at 301-827-7106. All responsible offerors may submit a quotation that shall be considered by the Agency.
- Place of Performance
- Address: Vendor is responsible for obtaining and setting up a site to host trainings and workshops
- Record
- SN00784948-W 20050410/050408212048 (fbodaily.com)
- Source
-
FedBizOpps.gov Link to This Notice
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