SOURCES SOUGHT
65 -- GLUCOMETER AND TEST STRIP/REAGENT SUPPLIES
- Notice Date
- 5/9/2017
- Notice Type
- Sources Sought
- NAICS
- 339113
— Surgical Appliance and Supplies Manufacturing
- Contracting Office
- Department of the Air Force, Air Force Materiel Command, AFLCMC/PK - WPAFB (includes PZ, WL, WW, WI, WN, WK, LP, WF, WK), 2275 D Street, Wright-Patterson AFB, Ohio, 45433-7218, United States
- ZIP Code
- 45433-7218
- Solicitation Number
- FA860117T0161
- Archive Date
- 5/31/2017
- Point of Contact
- Kyle Hartlage, Phone: 9375224527
- E-Mail Address
-
kyle.hartlage@us.af.mil
(kyle.hartlage@us.af.mil)
- Small Business Set-Aside
- N/A
- Description
- GLUCOMETER AND TEST STRIP/REAGENT SUPPLIES The Government is conducting market research and identifying, as potential sources, companies that may possess the expertise, capabilities, and experience to meet the requirements as specified in the Program Description below. CAUTION: This Sources Sought is issued solely for information and planning purposes. In accordance with Part 10 of the Federal Acquisition Regulation, the U.S. Government is conducting market research. The intended purpose is to identify potential sources that may possess the expertise, capabilities, and experience to meet Lab Point of Care located at 88th Medical Group, Wright Patterson AFB requirement. It does not constitute a Request for Proposal (RFP) or a promise to issue an RFP in the future. Furthermore, Wright Patterson AFB, Medical Treatment Facility (MTF) is not at this time seeking proposals, and will not accept unsolicited proposals. Responders are advised that the Government will not pay for any information or administrative costs incurred in response to this sources sought. Please be advised that all submissions become Government property and will not be returned. All costs associated with responding to this sources sought will be solely at the responding party's expense. Not responding to this sources sought does not preclude participation in any future RFP, if any is issued. In accordance with Federal Acquisition Regulation 15.201(e), responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. It is the responsibility of the interested parties to monitor this FedBizOpps website for additional information pertaining to this source sought. INSTRUCTIONS: 1. Below is a document containing a description of the requirement and a Contractor Capability Survey, which allows you to provide your company's capabilities. 2. If, after reviewing these documents, you desire to participate in the market research, you should provide documentation that supports your company's capability in meeting these requirements. Failure to provide documentation may result in the government being unable to adequately assess your capabilities. If you lack sufficient experience in a particular area, please provide details explaining how you would overcome the lack of experience/capabilities in order to perform that portion of the requirement (i.e., teaming, subcontracting, etc.). 3. Both large and small businesses are encouraged to participate in this Market Research. Joint ventures or teaming arrangements are encouraged. 4. Questions relative to this market survey should be addressed via email to Kyle Hartlage (AFLCMC/PZIOA), kyle.hartlage@us.af.mil no later than 12:00 pm EST on 16 May 2017. Verbal questions will NOT be accepted. PROGRAM DESCRIPTION The Medical Treatment Facility (MTF) located at Wright-Patterson AFB requires Clinical Laboratory Improvement Act (CLIA)-waived blood glucose analyzer that is cleared by the Food and Drug Administration (FDA) for use in all types of hospital patients, including critically ill patients receiving intensive medical intervention. REQUIREMENTS The Contractor shall provide all management, tools, parts, materials (including all glucometers, Glucose Strips, Control Solutions, Strip Linearity Kits, reagents, quality control materials, and consumable parts and accessories), equipment, travel, and service (Operator Training, Initial Inspection, Removal of Equipment, Preventive maintenance and tech support) necessary to provide the instrumentation described below for the Lab Point of Care located at 88th Medical Group, Wright Patterson AFB. All patient and testing information must be accessible and accurate. All services provided shall be performed in accordance with all applicable laws, regulations, standards, local instructions, and commercial practices. Must be in compliance with Section 510(k) of the Federal Food, Drug, Cosmetic Act for those medical device products intended to be delivered to the Government. Only devices that have received Premarket Notification Approval from the U.S. Food and Drug Administration (FDA) shall be considered. Performance Specifics: • Test time must be 6 seconds or less • Sample volume must be 1.2 microliters or less • Linear range must be 10-600 mg/dl • Glucose result must have no interference due to the following substances (up to the indicated levels (mg/dl)) Acetaminophen 20 Acetoacetate 30 Ascorbic acid 10 Beta-hydroxy butyrate 30 Bilirubin 15 Cholesterol 500 Creatinine 6 Dopamine 10 Ephedrine 0.9 Galactose 350 Ibuprofen 48 L-dopa 100 Maltose monohydrate 240 Maltotetraose 240 Maltotetriose 240 Methyl-dopa 1 N-Acetylcysteine (NAC) 20 Salicylate 30 Tetracycline 30 Tolazamide 15 Tolbutamide 45 Triglycerides 750 Uric acid 20 Oxygen All concentation • Hct range must be 20%-65% with no limitations over the full glucose measurement range of 10-600 mg/dl (0.5-33.3 mmol/L) • Strips must require no calibration code and have no user calibration requirements • Manufacturer must be able to guarantee strips for an up to 12 month sequester period • Strip shelf life must be 24 months from date of manufacture • Open vial stability must be 6 months and not subject to immediate use open opening • Test must be reimbursable under CPT 82947 (Hospitals using StatStrip can bill at a 67% higher reimbursement rate for increased outpatient revenue and improved cost accounting for inpatient testing). • System must be FDA cleared for use throughout all hospital and all professional healthcare settings, including intensive care settings • Required operating range: Temp 15-40 °C Altitude up to 15,000 ft. Humidity 10 - 90% • Required display type: color, touch screen • Must be capable of reading both 1D and 2D barcodes • Must be able to send message to meters • Operator lockout required • QC lockout required • Ability to enter user free text comments required • Ability to flag TGC results required • Must have ability to enter at least 30 other test / manual test entry items • Must have an automatic strip ejector to minimize post sampling exposure to biohazards • Must support multiple, flexible connectivity options (direct to Ethernet, Ethernet to USB, wireless) • Must have 2-year standard warranty • Vendor must be able to provide a companion self-test glucose meter for non-hospital use • Must have data storage to meet or exceed: a. Patient Tests: 1,000 tests b. QC Tests: 200 tests c. Users: 4,000 users • Must have connectivity: a. Meter Data Output: RJ-45 Ethernet Port b. Protocol: TCP/IP Ethernet 10 Mbit c. Standard: POCT1-A Compliant d. Setup Program: NovaNet Web-Based Instrument Manager Software • Battery Information: a. Type: 3.7V Li Polymer Rechargeable Battery b. Feature: Rechargeable/Replaceable battery c. Life: 6-8 hours in use (approximately 40 tests w/barcode scans)/12-24 hours standby. • Docking Station: a. Desk or wall mount charging station with RJ-45 Ethernet jack 3 led indicator lights showing connection status, transmit/receive data, and charging status. Extra battery slot included for recharging and storage of spare battery. • Must have additional features: a. Color touch screen b. Built-in barcode scanner c. Traditional QC with target values assigned to QC materials d. Numeric or pass/fail QC e. QC prompting or QC lock out f. Abnormal and critical ranges flagged by color highlighting g. Canned or free text user comments h. Rejecting of results at meter (optional) for repeat testing i. Accepting patient ID or accession number j. Use of operator password (lockout) k. Entry of offline tests l. Entry of ICD-9 Diagnosis codes m. Ordering physicians I.D. n. On-screen training mode o. Correlation mode p. Slope and intercept adjustment q. Web-based meter configuration by location r. Custom meter configuration by medical unit s. Connect to all LIS/EMR t. POCT1-A data output • QC program must be flexible for optimum QC data interpretation and manipulation. • An expiration date tracking system is a must. It must have lot traceability for all QC material. • Must have FDA approval for testing designed critically ill patients. • The analyzer must meet the characteristics of performance for precision and accuracy defined by 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI) • All published operating specifications shall be abided by and are available in the operating sections, the MERC, and are matter of public record. • Monitoring: a. Must have an ease of maintenance. b. Easy to use and flexible software is one of the strong features for consideration. c. Must have 24/7 365 available technical support. d. The calibration frequency must always be monitored e. The analyzer shall alert the operator for sudden out of range quality control. Service: In the event that equipment becomes non-functional the Medical Equipment Repair Center (MERC) will call the contractor. Troubleshooting steps will be taken to address the issue. If the issue cannot be resolved the non-functional equipment will be returned to the contractor. An equipment replacement will be issued from the contractor and the Medical Equipment Repair Center (MERC) will ensure that function checks are performed prior to equipment issue. The contractor's standard quality control practices are expected to ensure services are performed in accordance with commonly accepted commercial practices, and include procedures to identify, prevent, and ensure non-performance and continual repeat of defective service does not occur. Procedures as set forth in the FAR 52.212-4 (a), Contract Terms and Conditions - Commercial Items, Inspection/Acceptance, will be used to remedy all deficiencies. • Operator Training. Contractor shall provide instructions and training to 88th Medical Group equipment operators on the daily, weekly and monthly cleaning requirements when required or requested by the Lab. Must also be able to train on processing samples and other basic troubleshooting as needed. • Initial Inspection. All contractor owned equipment will be inspected and approved by the Biomedical Equipment Maintenance Section prior to use in the Medical Treatment Facility. Contactor will contact POC- to schedule inspection. Vendor provides a specialist to perform/oversee system installation, correlation, validation. Vendor also provides all validation reagent, calibrators, controls, and consumables needed to perform these tasks free of charge during the validation period. • Removal of Equipment. Should the equipment or any component listed herein require repair at the contractor's plant, contractor shall obtain a signed authorization from the COR authorizing removal of government equipment. Contractor shall not remove any equipment until loaner/replacement installed on-site. Contractor shall be responsible for damage or loss of equipment while in contractor's possession. • Preventive Maintenance and Tech Support. Should the equipment or any component listed herein require repair, or technical support the Biomedical Equipment Maintenance Section shall perform a function check while calling the contractor technical support line. Contractor shall be responsible for damage or loss of equipment while in contractor's possession. Contractor will replace nonfunctioning Glucometer with a working one. Period of Performance: The award will be a Firm-Fixed Priced contract with 1 base year and 2 option years. Delivery: Supplies will be sent on one time yearly basis for the first year by 1 June 2017 and on quarterly basis for the option years on the following dates: 15 October, 15 January, 15 April, and 15 July. Below is the ordering schedule to include all items and their quantities. Warranty: Must have 2-year standard warranty. CONTRACTOR CAPABILITY SURVEY Part I. Business Information Please provide the following business information for your company/institution and for any teaming or joint venture partners: • Company/Institute Name: • Address: • Point of Contact: • CAGE Code: • Phone Number: • E-mail Address: • Web Page URL: • Size of business pursuant to North American Industry Classification System (NAICS) Code: 339113- Surgical Appliance and Supplies manufacturing, 6515- Medical and Surgical Instruments, Equipment, and Supplies. Based on the above NAICS Code, state whether your company is: Small Business, (Self-Certified or Third Party Certified) (Yes / No) Small Disadvantaged Business, (Self -Certified or Third Party Certified) (Yes / No) o Woman Owned Small Business, (Self -Certified or Third Party Certified) (Yes / No) o Economically Disadvantaged Woman Owned Small Business, (Self -Certified or Third Party Certified) (Yes / No) o 8(a) Certified, (Self -Certified or Third Party Certified) (Yes / No) o HUBZone Certified, (Self -Certified or Third Party Certified) (Yes / No) o Veteran Owned Small Business, (Self -Certified or Third Party Certified) (Yes / No) o Service Disabled Veteran Small Business, (Self -Certified or Third Party Certified) (Yes / No) *All interested contractors must be registered in SAM in order to be eligible for award of Government contracts. The government reserves the right to consider a small business set-aside based upon responses hereto for any subsequent action. • A statement as to whether your company is domestically or foreign owned (if foreign, please indicate the country of ownership). • Please provide a statement that the respondent will allow or will not allow the Government to release proprietary data. • Please provide a statement to acceptability of the following proposed non-commercial provisions and clauses, as they are determined to be consistent with customary commercial practice. FAR 52.204-7, System for Award Management FAR 52.204-13, System for Award Management Maintenance FAR 52.204-16, Commercial and Government Entity Code Reporting FAR 52.204-18, Commercial and Government Entity Code Maintenance FAR 52.232-39, Unenforceability of Unauthorized Obligations FAR 52.242-13, Bankruptcy FAR 52.252-1, Solicitation Provisions Incorporated by Reference FAR 52.252-2, Clauses Incorporated by Reference FAR 52.252-5, Authorized Deviations in Provisions FAR 52.252-6, Authorized Deviations in Clauses DFARS 252.203-7002, Requirement to Inform Employees of Whistleblower Rights DFARS 252.204-7003, Control of Government Personnel Work Product DFARS 252.225-7002, Qualifying Country Sources as Subcontractors DFARS 252.225-7048, Export-Controlled Items DFARS 252.243-7001, Pricing on Contract Modifications AFFARS 5352.201-9101, Ombudsman AFFARS 5352.223-9000, Elimination of Use of Class I Ozone Depleting Substances (ODS) AFFARS 5352.223-9001 Health and Safety on Government Installations AFFARS 5352.242-9000, Contractor Access to Air Force Installations ATTENTION small business respondents who are interested in submitting a proposal as the prime contractor for this effort: No set aside decision has been made; however, the Air Force is contemplating setting this acquisition aside for Small Businesses if there is sufficient demonstrated interest and capability. Note that a key factor in determining an acquisition to be a Small Business Set Aside is that two or more small business prime contractors must be capable of performing at least 50% of the entire scope of the effort, as defined in Federal Acquisition Regulation (FAR) clause 52.219-14, Limitations on Subcontracting. The clause reads, in part, as follows: "Limitations on Subcontracting (Nov 2011)... (c) By submission of an offer and execution of a contract, the Offeror/Contractor agrees that in performance of the contract in the case of a contract for - (1) Services (except construction). At least 50 percent of the cost of contract Performance incurred for personnel shall be expended for employees of the concern... ". Provide specific details and rationale as to how compliance with FAR clause 52.219-14 would be achieved, including specific details regarding teaming arrangements, etc. If subcontracts are to be used, provide anticipated percentage of effort to be subcontracted and whether small or large businesses will be used. Teaming and/or subcontracting arrangements should be clearly delineated and previous experience in teaming must be provided. ATTENTION all potential respondents: The acquisition strategy for this program has not been finalized. If this acquisition is not set aside for small business, it is anticipated that the contract may contain a small business utilization requirement. Please provide feedback on the requirement and what areas are likely candidates for SB subcontracting. Part II. Capability Survey Questions 1. Is your firm registered in the System for Award Management (SAM), formally known as Central Contractor Registration (CCR)? In accordance with federal regulations, all contractors doing business with the federal government must be registered in the SAM database. 2. Describe briefly the capabilities of the nature of the services you provide. 3. Describe your company's past experience on previous with similar services. Include contract numbers, a brief description of the work performed, period of performance, agency/organization supported, and individual point of contact (Contracting Officer or Program Manager). 4. Are there specific requirements in the documentation that we provide that would currently preclude your product/service from being a viable solution to our requirement? 5. Are there established market prices for our requirement? If you offer this product and/or service to both U.S. Government and commercial sources, is the same workforce used for both the U.S. Government and general public? Is our requirement offered to both under similar terms and conditions? Briefly describe any differences. If your company is interested, e-mail your responses to kyle.hartlage@us.af.mil. E-mail responses should be received no later than 12:00 pm EST on 16 May 2017. Direct and succinct responses are preferred. Marketing materials are considered an insufficient response. Also, please mail two original signed copies of your response, on or before the same date, to: AFLCMC/PZIOA, Bldg. 1, Room 109 Attn: Kyle Hartlage 1940 Allbrook Dr Wright-Patterson AFB OH 45433-5344 (937) 522-4527 All responses must be UNCLASSIFIED; no classified material will be accepted or considered with this Sources Sought Synopsis. The response to Part I. Business Information should be single spaced, 12pt font. The response to Part II. Capabilities should be limited to no more than 10 pages (8.5x11 inches), single spaced, 12pt font. In addition, identify a representative to support further Government inquiries and requests for clarification of the information provided, if needed. Respondents should indicate which portions of their response are proprietary and should mark them accordingly. The Air Force will handle proprietary items in accordance with FAR 2.101 and 3.104. Responses to questions from interested parties will be promptly answered and posted on this FedBizOps website, unless some release of proprietary information is involved or the answer addresses a question peculiar to a company or that company's response. Information feedback sessions may be offered to respondents after the sources sought assessments are completed. An Industry Day (date to be determined) with one-on-one information sessions with respondents may be offered to clarify the Government's understanding of their submittal, the capability ramifications, or to discuss their business approach.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USAF/AFMC/ASC/FA860117T0161/listing.html)
- Place of Performance
- Address: Medical Materiel, Bldg 830 Area A, 4881 Sugar Maple Dr, Wright Patterson AFB, Ohio, 45433, United States
- Zip Code: 45433
- Zip Code: 45433
- Record
- SN04501780-W 20170511/170509235504-c9babd9d280e684a797c1e816644a753 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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