SOLICITATION NOTICE
65 -- SYNOPSIS: Nova BioMedical Stat Strip Glucometer Kits and Service
- Notice Date
- 6/6/2017
- Notice Type
- Presolicitation
- 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
- FA8601-17-T-0161
- Archive Date
- 6/28/2017
- 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
- SYNOPSIS: Nova BioMedical Stat Strip Glucometer Kits and Service This synopsis is issued in accordance with FAR 5.101(a)(1) and FAR 5.207. This proposed action is for the procurement of Nova BioMedical Stat Strip Glucometer Kits and Service. The Government intends to solicit and negotiate with only one source under the authority of FAR 13.106-1(b)(1). This proposed procurement will be a sole source award under North American Industry Classification System Code (NAICS) 339113-Surgical Appliance and Supplies Manufacturing, with a size standard of 750 employees. PSC code: 6515- Medical, dental & veterinary equipment & supplies. Delivery Schedule: Supplies will be sent on one time yearly basis for the first year by June 2017 and on quarterly basis for the option years on the following dates: 15 October, 15 January, 15 April, and 15 July. Delivery Destination: Medical Materiel Bldg 830 Area A 4881 Sugar Maple Dr Wright Patterson AFB, Ohio 45433 Requirement: The Contractor shall provide all management, tools, parts, materials (including all glucometers, Nova BioMedical Nova BioMedical 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. Warranty: Must have 2-year standard warranty. The Government will award a contract to the responsible Offeror whose offer conforms to the solicitation and is most advantageous to the Government, price and other factors considered. Technical Capability and Price will be used to evaluate all offers. The Department of Defense (DoD) has determined the System for Award Management (SAM) to be the single point of DoD registration for contractors who conduct business or who are interested in conducting business with the government. Contractors must be registered in SAM prior to award for solicitations issued after 29 May 2012. You may contact SAM by telephone at 866-606-8220 or online at https://www.sam.gov. POC Information: Kyle Hartlage AFLCMC/PZIOAA Building 1 1940 Allbrook Drive, Suite 3 Wright-Patterson AFB, OH 45433 Telephone: 937-522-4527 kyle.hartlage@us.af.mil Be advised that all correspondence sent via e-mail shall contain a subject line that reads "Globus Medical TLIF Spinal Implant System." Note that e-mail filters at Wright-Patterson AFB are designed to filter e-mails without subject lines or with suspicious subject lines or contents (i.e.,.exe, or.zip files). Therefore, if this subject line is not included, the e-mail may not get through the e-mail filters. Also be advised that.zip or.exe files are not allowable attachments and may be deleted by the e-mail filters at Wright-Patterson AFB. If sending attachments with e-mail ensure only.PDF,.doc, or.xls documents are sent. The e-mail filter may delete any other form of attachments.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/USAF/AFMC/ASC/FA8601-17-T-0161 /listing.html)
- Place of Performance
- Address: Medical Materiel, Bldg 830 Area A, 4881 Sugar Maple Dr, Wright Patterson AFB, Ohio 45433, Wright Patterson AFB, Ohio, 45433, United States
- Zip Code: 45433
- Zip Code: 45433
- Record
- SN04534639-W 20170608/170607000013-fd0b1b4cb2244b228bb02d497580ae45 (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
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