AFMRA Point of Care Integrated Blood Analyzer

Disclaimer THIS IS A SOURCES SOUGHT AND REQUEST FOR INFORMATION (RFI) FOR MARKET RESEARCH PURPOSES ONLY. IN ACCORDANCE WITH (IAW) FEDERAL ACQUISITION REGULATION (FAR) 15.201(e), THIS IS NOT A SOLICITATION ANNOUNCEMENT FOR PROPOSALS AND NO CONTRACT WILL BE AWARDED FROM THIS ANNOUNCEMENT. ALL INFORMATION INCLUDED IN THIS RFI IS CONFIDENTIAL AND ONLY FOR THE RECIPIENT'S KNOWLEDGE AND MARKET RESEARCH PURPOSES. NO INFORMATION INCLUDED IN THIS DOCUMENT OR IN DISCUSSIONS CONNECTED TO IT MAY BE DISCLOSED TO ANY OTHER PARTY. Introduction and Purpose of the RFI The purpose of this RFI is to request information to determine if your company's products, services, and capabilities may meet the Government's requirement for a point-of-care integrated blood analyzer (POCIBA). The information gathered from all companies that answer the RFI will be analyzed against the requirements in order to effectively identify capabilities that are available in the marketplace/ industry. Both large business concerns and all categories of small business are encouraged to respond to this request. The following North American Industry Classification System (NAICS) codes may possibly be used for this requirement: 334516 - Analytical Laboratory Instrument Manufacturing 423450 - Medical, Dental, and Hospital Equipment and Supplies Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. Background Description of Information Requested The Air Force Medical Service (AFMS) provides medical care throughout a wide range of environments, including the various roles of care in the military theater. Operational challenges surrounding prolonged field care, before transport to definitive care, is expected to become increasingly common with the loss of the - golden hour. Recent contingency operations have called for smaller-scale, targeted deployment of specific small medical teams rather than full Expeditionary Medical Systems (EMEDS) configurations. The Air Combat Command Surgeon General's office (ACC/SG) anticipates that these mission sets will continue as the AFMS attempts to address health service support in contested and operationally limited environments. Hence, there is an identified need to develop smaller and lighter diagnostic tools that can be easily transported and maintained, while reducing cold-chain and logistical burden. To date, complete blood count (CBC) analyzers are large and take up significant space in the shelter. They require cold-chain management for storing reagents and controls, and most significantly, they require a skilled laboratory technician to perform the testing. For this reason, there has historically been no CBC diagnostic capability below Role 2 (EMEDS +10). Technology has improved significantly over the last several years making it possible to provide a solution at lower roles of care. Scope Specific information is requested according to the forms below. Please complete as much information as possible. Context in which the product or service will be used Statement of need The AFMS lacks the capability to quickly and accurately assess disease severity in Role 2 care and below, without extensive logistical and base operations support, to include non-cold-chain management, ease of use and minimal maintenance. A point-of-care integrated blood analyzer (POCIBA) is needed to fulfill this capability gap. Requirements The response should describe the company's capability to provide, field, and sustain the POCIBA as characterized by the requirements addressed in this RFI. If unable to provide a device capable of meeting all requirements, the respondent should provide trade-off considerations to meet the requirements addressed in this RFI. Please provide a brief commentary on how the device meets or does not meet the requirements. The requirements below are mandatory Key Performance Parameters (KPP) of the device's capability: Cleared by the U.S. Food and Drug Administration (FDA) as a medical device in accordance with (IAW) applicable regulations and standards Clinical Laboratory Improvement Amendments (CLIA) waived - Certificate of Waiver (COW) Meet Safe-to-Fly/Air Worthiness criteria for all aircraft used for medical missions A total of three KPPs were identified along with 40 Key System Attributes (KSA). KSAs were prioritized using a priority scale broken down into four key areas: Level 1: Failure to meet requirement prevents accomplishment of an operational or mission-essential capability Level 2: Failure to meet requirement adversely affects accomplishment of an operational or mission-essential capability and no known work-around solution exists Level 3: Failure to meet requirement adversely affects accomplishment of operational or mission-essential capability, but work around exists Level 4: Failure to meet requirements results in user inconvenience but does not affect required operational or mission-essential capability These KPPs and KSAs are listed in the attached RFI Form #2 document: RFI_Form_2_POCIBA.xlsx. Manufacturers are encouraged to submit a response to this RFI, even if the device/system does not meet all the requirements at this time. For requirements that are not met, please provide commentary as trade-off considerations will still be reviewed. Acronym List ACC/SG: Air Combat Command Surgeon General AFMRA: Air Force Medical Readiness Agency AFMS: Air Force Medical Service BMET: Biomedical Equipment Technician CAP: The College of American Pathologists CBC: Complete Blood Count CLIA: Clinical Laboratory Improvement Amendments COW: Certificate of Waiver DOD: Department of Defense EMEDS: Expeditionary Medical Support FAR: Federal Acquisition Regulation FDA: U.S. Food and Drug Administration GST: Ground Surgical Team IAW: In Accordance With ISO: International Organization for Standardization KPP: Key Performance Parameter KSA: Key System Attribute OSHA: Occupational Safety and Health Administration POCIBA: Point of Care Integrated Blood Analyzer RFI: Request for Information SMEED: Special Medical Emergency Evacuation Device Instructions to Respondents To answer this RFI, please See Attachments fill in the attached forms (RFI response Form #1 and #2 [attached Excel requirements spreadsheet]). The contact person listed below is available for assistance, if needed. The answers to this RFI will be evaluated by staff from different functions in AFMRA. Response to this RFI must be submitted via email to Captain Kelsie Hughes, Test Director, AFMSA.SG5T.Market@us.af.mil. Email responses should be no larger than 10 MB in size. If larger attachments are required, please notify AFMRA at the above listed email address. Please include a point of contact, phone number, email address, website information, and indicate whether the company is a foreign or domestic entity in the contents of the email. Each RFI response will receive a confirmation email; if a confirmation is not received, please call 301-619-8600. The Government will not pay for any information submitted, or for any costs associated with providing the information. How to deliver the answer Send the attached Word (RFI Response Form #1) and Excel (RFI Response Form #2) forms, format unchanged, by email to: AFMSA.SG5T.Market@us.af.mil Timeframe This is the timeframe for Q&As and responses: 17 April 2020 - The RFI is sent out 1 May 2020 - No later than 5:00PM CST - Last date for questions and answers 17 May 2020 - No later than 5:00PM CST - Last date for response Point of Contact For questions regarding this RFI, you are welcome to contact: Captain Kelsie Hughes Test Director Air Force Medical Readiness Agency 1270 Montevue Lane (Area B) Fort Detrick, MD 21702 301-619-8600 AFMSA.SG5T.Market@us.af.mil To answer this RFI, please See Attachments fill in the attached forms (RFI response Form #1 and #2 [attached Excel requirements spreadsheet]).