SOLICITATION NOTICE
65 -- Blood Collection Vacuum Tubes
- Notice Date
- 4/22/2011
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 339112
— Surgical and Medical Instrument Manufacturing
- Contracting Office
- Defense Logistics Agency, DLA Acquisition Locations, DLA Troop Support - Medical, 700 Robbins Avenue, Philadelphia, Pennsylvania, 19111-5096, United States
- ZIP Code
- 19111-5096
- Solicitation Number
- MN-1011-06_Blood_Collection_Vacuum_Tubes
- Archive Date
- 6/1/2011
- Point of Contact
- Toni Massenburg, Phone: 202 782-3663, Varnia Bryant, Phone: 202-782-4494
- E-Mail Address
-
toni.massenburg@us.army.mil, varnia.c.bryant.ctr@us.army.mil
(toni.massenburg@us.army.mil, varnia.c.bryant.ctr@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- The Defense Medical Materiel Program Office (DMMPO) Medical Materiel Enterprise Standardization Office (MMESO) announces a Request for Incentive Agreement Quotation (RFIAQ) for the standardization of Blood Collection Vacuum Tubes. The MMESO North is the lead MMESO for this project. The primary objective of this program is to standardize the quality of care across the MMESO North, South, West, Pacific, Europe (hereafter referred to as MMESOs) areas of responsibility (AOR) and operational assemblages based on the critical balance of clinical efficacy and value. This Standardization Action (SA) will apply to all MMESOs. It is intended for this initiative to result in the standardization of a technically and clinically preferred product (s) and source for institutional and operational medicine requirements at the best possible price. It is intended for this initiative to result in the reduction of Stock Keeping Units (SKUs) and National Stock Numbers (NSN). It is also intended that standardized products be obtained through the Department of Defense (DoD) Prime Vendor (PV) Program. As an enterprise-wide clinically driven program, vendors and products must meet specific technical requirements plus products must meet or exceed specific clinical performance requirements as a primary consideration. Among vendors who meet the technical requirements and the products that meet or exceed the clinical the clinical preferred threshold, best price will determine selection. It is intended that the selected vendor (s) for this SA support the enterprise goal of medical materiel standardization that combines operational and institutional requirements. The government is seeking a single award for this SA. The major facilities in the MMESOs include, but are not limited to MMESO North: Walter Reed Army Medical Center, National Naval Medical Center, Naval Medical Center Portsmouth, Wright-Patterson Medical Center; MMESO South: Wilford Hall Medical Center, Brook Army Medical Center, Naval Hospital Jacksonville, Martin Army Community Hospital; MMESO West: Naval Medical Center San Diego, Madigan Army Medical Center, Irwin Army Community Hospital, Mike O'Callaghan Federal Hospital; MMESO Pacific: Tripler Army Medical Center, Honolulu, HI, 18th Medical Group, Kadena AB, Okinawa, US Naval Hospital, Yokosuka, Japan; MMESO Europe: Landstuhl Regional Medical Center, Landstuhl, GE, US Naval Hospital, Naples, Italy, the 48th Medical Group, Lakenheath, UK; and Operational U.S. Forces. This standardization action is part of the Medical/Surgical PV program executed by the Defense Logistics Agency (DLA) Troop Support, Directorate of Medical Materiel. To participate, your company must have a Distribution and Pricing Agreement (DAPA) and a separate commercial agreement with the current Med-Surg PV for each MMESOs Area of Responsibility (AOR), i.e., Cardinal Health, and Owens & Minor. This requirement is pursuant to the DAPA clause by which DAPA holders agree to the standardization process and agree to allow PVs to distribute their products. The Incentive Agreement (IA) resulting from this RFIAQ is a supplement to the PV Program and is not a contract. For additional information regarding DLA Troop Support Medical's PV program please access its web site at https://dmmonline.dscp.dla.mil This IA standardization initiative will be a Three Phase IPP Process: vendor (s) who meets the technical / company requirements in Phase I will be invited to advance and participate Phase II where no-charge products will be provided for clinical evaluation and Phase III where pricing will be required for submittal. Phase II and Phase III will run concurrently. The resulting IA will be for a base period of two (2) years (24 months) from date of selection with three (3) 12-month "option" periods not to exceed a total of 5 years. Anticipated selection date is July 2011. The selection will be based on the product and vendor that provides the Best Value to the enterprise. Products and vendors that meet or exceed the technical and clinical performance requirements will be considered clinically preferred products and sources. Among vendors who meet the technical requirements and the products that meet or exceed the clinically preferred standard, best price (i.e. lowest Aggregate Post Standardization Cost) will determine selection. Point of Contact: Ms. Toni Massenburg, MMESO North, Team Leader, toni.massenburg@us.army.mil and 202-782-3663. B. Products & Performance Required The MMESOs, are seeking product line items in the category of Blood Collection Vacuum Tubes. Within MMESOs, this product line has an estimated annual dollar requirement of $2,538,490.25. This forecast is based on historical prime vendor sales during a recent 12-month period. Based on the recent 12-month usage data, the top sixteen (16) line items of the total one hundred and thirty one (131) line items purchased, account for 79.7% ($2,024,927.35) of the total volume in sales ($2,538,490.25) in the MMESOs and are procurement significant. The top high volume usage lines for this project are shown in the Technical/Company Requirements below, consolidated by product type to reduce duplication within the top 15 lines. This represents the line item, or SKU, reduction that is an additional objective of this program. C. Instructions to Vendors Vendors interested in participating in this standardization initiative will provide an initial response to the FBO-posted RFIAQ to Ms. Toni Massenburg, Team Leader, toni.massenburg@us.army.mil. The vendor's initial response will include detailed information requested in the technical/company requirements listed in the FBO RFIAQ and must also include: (1) Company name and address; (2) Company Point of Contact (POC) (Name and Phone Number, Fax Number, and E-mail address); and (3) Identification of the RFIAQ to which the vendor is responding. Due to the potential for e-mail to be lost in transmission, from network security, etc., vendor is strongly encouraged to confirm with the MMESO North that their initial submission, quote and literature actually arrived at the MMESO North via email. Each submitting vendor is advised to confirm receipt, allowing adequate time for resubmission before the due date / time, should a problem occur with the first submission. A vendor that does not meet the deadline of COB 5:00PM Eastern Standard Time (EST) on the date listed for closing (per the FBO RFIAQ), will be disqualified from further consideration in the standardization initiative. D. Source Selection Procedures The MMESO Tri-Service Product Review Board (TPRB) will serve as the forum for clinical recommendations for product selection, seeking and evaluating opportunities for committed volume purchase agreements, and coordinating logistics efforts in support of DoD Components. The boards are chaired by Designated Senior Logisticians (DSLs) and co-chaired by Designated Senior Clinicians (DSCs) in the MMESO AORs and include clinicians and logisticians for Medical Treatment Facilities (MTFs) within each MMESO. The Clinical Advisory Committee (CAC) members are the deciding officials for this initiative. The MMESO DSLs and DSCs intend to evaluate quotes and select a vendor on initial submissions/quotes. Vendor quotes should contain the vendor's best discounts off of the vendor's DAPA pricing based on committed volume of 80% of the total requirements of the MTFs in the MMESOs. The MMESO North reserves the right to conduct discussions and request revised quotes, if determined necessary. Phase I Technical / Company Requirements The MMESO CPT will review the responses from the vendor and determine whether vendor meets the technical/company requirements and determine acceptability. Vendor must meet the technical requirements for continued consideration in this initiative. A vendor who does not meet the requirements will be disqualified. Failure to provide any requested information or meet any of the technical requirements will disqualify the vendor from further consideration. A vendor who meets the following technical/company requirements will be qualified/invited to participate in the clinical/performance selection and will be requested to submit their best product/price discount quotes via an email communication. All communications of significant acquisition milestones (such as invitations to participate, or notices of disqualification) should be digitally signed. Technical/Company Requirements: During the acquisition planning process, the MMESO CPT validated/approved the technical/company requirements outlined below. The twenty (20) requirements below must be answered with the vendor's initial submittal by the response date stated in the FBO announcement. A vendor who does not meet these requirements or who does not submit documentation to support these requirements with initial submittal will be disqualified in Phase I. 1. Vendor MUST provide a line of Blood Collection Vacuum Tube products that includes at a minimum the specific products identified below for evacuated tubes of plastic material; without additives and other collection tubes that have some type of additive that range from those that promote faster clotting of the blood, those that enable anticoagulation, and those that preserve or stabilize certain analytes or cells; and a range of sizes or draw volumes as follows: 5.0 mL draw Pearlescent White plastic molecular diagnostics Plasma Preparation Tube with see thru label. Additive: Polymer gel and K2EDTA. 5.0 mL draw Gold plastic serum tube, with serum separator and clot activator gel, paper label with conventional closure. 4.0 mL draw Lavender plastic serum tube, paper label with conventional closure. Additive: K2EDTA 4.5 mL draw Lt. green plastic plasma tube. Lithium heparin (spray-coated) and polymer separator gel conventional closure 8.5 mL draw Gold plastic serum tube, serum separator and clot activator gel, paper label with conventional closure; silicone coated interior. 3.5 mL draw red/grey plastic serum separator tube, paper label with conventional closure. Clot activator and gel for serum separation; silicone coated interior. 3.0 mL draw Lavender plastic serum tube, paper label with conventional closure. Additive: K2EDTA 5.0 mL draw serum separator tube, Clot activator and gel for serum separation; silicone coated interior; paper label with conventional closure. 6.0 mL draw Red plastic serum tube, paper label with conventional closure. 2.7 mL draw Lt. blue plastic serum tube, paper label with conventional closure. Additive: 0.109 Molar / 3.2% Sodium citrate. 3.0 mL draw Lt Green plastic plasma tube, paper label with conventional closure. 7.0 mL draw tube, paper label with conventional closure. Clot activator and gel for serum separation; silicone coated interior. 5.0 mL draw plastic plasma tube, lithium Heparin with gel separator, paper label with conventional closure. 8.0 mL draw serum clot activator with gel separator, paper label with conventional closure. 6.0 mL draw Pink plastic whole blood tube paper with K2EDTA, 10.8 mg label with conventional closure. * Operational usage items are included in this list of Blood Collection Vacuum Tubes b. Vendor MUST provide a complete itemized list of items supplied (manufacture and/or distribute by brands and descriptions) via excel sheet, and product catalog & literature in response to this RFIAQ with initial submittal. Vendor is required to supply all items listed in all sizes, colored tops, and additives/non-additive types. (Vendor who does not have a complete product line as stated above will be disqualified in Phase I). 2. Vendor MUST have a DAPA or be in the process of obtaining a DAPA for the Blood Collection Vacuum Tubes product line. Vendor MUST provide DAPA number with initial submittal or provide documentation that DAPA has been applied for with response submittal. Vendor without a DAPA number or who has not applied for a DAPA will be disqualified in Phase I. 3. Vendor MUST have agreements with the current Med/Surg Prime Vendors for each MMESO AOR, i.e. Cardinal Health and Owens & Minor for Blood Collection Vacuum Tubes or be in the process of obtaining Prime Vendor agreements. Vendor must provide documentation to support agreements with initial submittal. Vendor whose products are not available through the Prime Vendors or who has not applied for PV distribution will be disqualified in Phase I. 4. Vendor MUST submit discounts off of DAPA for all products included in this standardization initiative. (Note: vendor who fails to submit a discount off of DAPA will be disqualified. Where lower FSS prices are available, DAPA holder is required by previous agreement to provide the FSS price as the DAPA price. Vendor shall not quote FSS prices as the discounted price for purposes of this standardization initiative). Vendor who does not provide discounts off DAPA for ALL products in Phase III will be disqualified. 5. Vendor MUST provide literature that clearly identifies that the products' packaging is clearly labeled, has manufacturing lot number and expiration date on packaging with initial submittal. Vendor whose products cannot identify these features or vendor who does not provide documents to support this requirement with initial submittal will be disqualified in Phase I. 6. Vendor MUST supply "instructions/directions for use" for all products to be supplied. Provide this information with the product literature submitted in response to this RFIAQ. Vendor whose products do not provide these features or vendor who does not provide documents to support this requirement with initial submittal will be disqualified in Phase I. 7. Vendor MUST provide Blood Collection Vacuum Tube products that have a shelf life determined by functional testing and the stability of the additives as well as vacuum retention that is clearly marked/printed on each tube in an easy to read font. Vendor MUST identify these features of products and provide literature to support this requirement in response to this RFAIQ with initial submittal. Vendor who cannot provide documentation or requested info to support this requirement with initial submittal will be disqualified in Phase I. 8. Vendor MUST provide Blood Collection Vacuum Tube products that have color coded crowns as per ISO-6710 International color coding standard and which are compatible with all kinds of diagnostic systems and tests. Vendor MUST identify these features of products and provide literature to support this requirement in response to this RFAIQ with initial submittal. Vendor who cannot provide documentation or requested info to support this requirement with initial submittal will be disqualified in Phase I. 9. Vendor MUST be able to furnish a chart that identifies the various color coded tubes used with safety and conventional blood collection vacuum tubes according to the additive, additive function, volume, and specimen considerations to be followed. Vendors who cannot provide documentation or requested info to support this with initial submittal will be disqualified in Phase I. 10. Vendor MUST provide products and supporting documentation indicating that products reduce the potential for tube breakage and specimen spillage, thereby reducing the potential for exposure to blood borne pathogens. 11. Vendor MUST provide blood collection tubes and supporting documentation indicating that products have a closed system for needle punctures and the ability to reseal themselves. 12. Vendor MUST provide blood collection tubes and supporting documentation indicating that products are capable of withstanding an acceleration of up to 3500 RPM when they contain a specimen. 13. Vendor MUST provide tubes with an internal tube diameter that cannot be smaller than 13mm and provide supporting documentation that tube diameter is not smaller than 13mm. 14. Vendor MUST provide blood collection tubes that contain a closure that can be removed by gripping with fingers or by mechanical extractors and provide supporting documentation of this capability. 15. Vendor MUST provide blood collection tubes, and supporting documentation indicating that blood collection tubes have plastic or rubber caps that can be punctured or pulled off providing a firm and leak-resistant seal and protecting the samples from evaporation and contamination. 16. Vendor MUST provide tubes that are the external closure type with the cap closure on the outside of the tube and not on the inside of the tube and provide supporting documentation of this feature. 17. Vendor MUST provide blood collection tubes that have a surface that can be marked with a ballpoint pen for patient identification and provide supporting documentation of this feature. 18. Vendors MUST provide Blood Collection Vacuum Tubes that contain 3.2% (.105 to.109 mol/L) buffered sodium citrate and provide documentation to support this requirement. 19. Vendor MUST provide tubes and supporting documentation indicating that tubes have an inert gel barrier that cannot interfere with or absorb analyte. 20. Vendor MUST have an identified customer service representative available for on-site assessment, on-site instructional sessions (in-services), and on-going clinical support as required at no cost to the government for the Blood Collection Vacuum Tube product line. Vendor must provide a list of customer service representatives with initial submittal. Phase II Acceptability Evaluation Clinical Performance Clinical Performance Requirements Following acceptability of the technical/company requirements, the MMESO North, on behalf of the CPT, will request product sample sets from the product group to be sent to the CPT members at the participating MTFs. Vendor will be given 30 calendar days from the issue of the notice in which to deliver the product samples for clinical evaluation at Phase II. Product samples must be shipped to arrive at the designated addresses by 5:00PM local time for each MTF on the 30th calendar day after the notice to ship. Vendor MUST be able to deliver product literature, training materials and evaluation samples to the MMESO Pacific via FedEx or UPS AND to the MMESO Europe via United States Postal Service (USPS) and throughout the United States when requested in Phase II. Vendor who cannot or does not meet this requirement will be disqualified from the standardization process. Vendors must send the MMESO North verification regarding the shipment of literature and samples. This information will include the date of shipment, final delivery date, tracking numbers and the carrier used by the vendor. Vendor will provide ONLY the following no cost product samples for clinical/performance evaluation. (Unused samples will not be returned). One hundred (1box/100) samples of each type and size listed below are to be provided to each of the evaluation sites as identified in the letters of invitation. 5.0 mL draw Pearlescent White plastic molecular diagnostics Plasma Preparation Tube with see thru label. Additive: Polymer gel and K2EDTA. 2.7 mL draw Lt. blue plastic serum tube, paper label with conventional closure. Additive: 0.109 Molar / 3.2% Sodium citrate. 3.5 mL draw red/grey plastic serum separator tube, paper label with conventional closure. Clot activator and gel for serum separation; silicone coated interior. 3.0 mL draw Lavender plastic serum tube, paper label with conventional closure. Additive: K2EDTA 5.0 mL draw serum separator tube, Clot activator and gel for serum separation; silicone coated interior; paper label with conventional closure. 6.0 mL draw Red plastic serum tube, paper label with conventional closure. The clinical/performance acceptability evaluation period will last for fourteen (14) calendar days. The acceptability evaluation responses will be in a Likert scale format with a one (1) through five (5) scoring range. The scale descriptors are: one (1)-Completely unacceptable, two (2)-overwhelmingly unacceptable, three (3)-partially unacceptable, four (4)-acceptable, and five (5)-highly acceptable. The MMESO TPRB has established a 4.0 as the Clinically Preferred threshold of products for standardization. A vendor scoring below the clinically preferred threshold will be disqualified from selection for this standardization initiative. Of those vendors that are qualified as clinically preferred, selection will be based on best price. A vendor that has been disqualified will be notified in writing upon disqualification. Clinical /performance evaluations by the participating CPT facilities will be tabulated resulting in one score per participating MMESO per vendor. The participating MMESOs' scores by vendor will then be combined resulting in one final vendor performance evaluation score. All clinical/performance evaluations will be tabulated by the MMESO North, and results will be forwarded to the MMESO CPT for final review. Each requirement for Blood Collection Tubes will be evaluated by four (4) trials (each clinical trial site will have three (3) clinical evaluators who will each evaluate all samples), in a clinical/ patient care setting. There will be approximately fourteen (14) MTFs enterprise wide that will be evaluating products. Clinical/Performance Requirements: During the acquisition planning process, the CPT validated/approved the clinical/performance requirements outlined below. 1. (Clinician Efficiency of Care/Patient and Staff Safety, International Standards Organization (ISO): Quality System - Medical Devices-particulate requirements for the application of EN ISO 9001, EN ISO 13485, 2001.) Plastic evacuated blood collection tubes are resistant to breakage to minimized risk of injury and infection for staff responsible for collecting and processing blood samples. 2. (Clinician Efficiency of Care/ Laboratory Services National Patient Safety Goals, International Standards Organization (ISO): Quality System - Medical Devices-particulate requirements for the application of EN ISO 9001, EN ISO 13485, 2001.) The blood collection tubes will be easily identified by color to help correctly decide the type of blood specimen to be obtained. 3. (Clinician Efficiency of Care/Patient Safety, International Standards Organization (ISO): Quality System - Medical Devices-particulate requirements for the application of EN ISO 9001, EN ISO 13485, 2001.) All blood collection tubes that are vacuum sealed must have the expiration date listed on the label. 4. (Clinician Efficiency of Care/Patient Safety, International Standards Organization (ISO): Quality System - Medical Devices-particulate requirements for the application of EN ISO 9001, EN ISO 13485, 2001.) The top of the blood collection tube is easily pierced after it is inserted into the tube holder. 5. (Clinician Efficiency of Care/Patient Safety, International Standards Organization (ISO): Quality System - Medical Devices-particulate requirements for the application of EN ISO 9001, EN ISO 13485, 2001.) Once the patient has been prepped and the venipuncture is performed, the vacuum draw is consistent and reliable. 6. (Clinician Efficiency of Care/Patient Safety, International Standards Organization (ISO): Quality System - Medical Devices-particulate requirements for the application of EN ISO 9001, EN ISO 13485, 2001.) The blood collection tube is easily disengaged so that multiple vacuum tubes can be attached to and removed in turn from a single needle. 7. (Clinician Efficiency of Care/Patient Safety, International Standards Organization (ISO): Quality System - Medical Devices-particulate requirements for the application of EN ISO 9001, EN ISO 13485, 2001.) Blood collection tubes can be utilized with current automated laboratory instrumentation designed for chemistry, hematology, microbiology and decappers. Phase III Pricing Analysis Price Analysis Upon completion of the Phase I - Technical/Company Requirements, vendors who are found technically acceptable will be qualified /invited to provide their product samples and price discount quotes concurrently. Vendor will be given 30 calendar days from the date of pricing requests, to submit IA pricing quotes, in a prescribed electronic spreadsheet format, based upon the requirements of the MMESOs. Pricing must be received at the MMESO North by 5:00 PM EST, thirty (30) calendar days after the issue date of the vendor notice to submit best price quotes. Vendor quotes should contain the vendor's best product matches for the specific products requested in this announcement. The MMESO DSLs and DSCs intend to evaluate quotes and select a vendor on initial submissions/quotes. Vendor quotes should contain the vendor's best discounts off of the vendor's DAPA pricing for the products identified in this announcement (based on committed volume of 80% of the total requirements of the MTFs in the MMESOs). Price will be analyzed based on the projected Aggregate Post-Standardization costs for each vendor. Aggregate Post-Standardization Cost will be calculated for each vendor by applying the vendors' offered prices to the anticipated annual usage of the enterprise. Unmatched items will be represented in the Post-Standardization Cost at a baseline non-discounted price (current DAPA price of product with highest procurement). Among the products and sources that were determined to be clinically preferred, the best price Aggregate Post-Standardization Cost will be selected.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DLA/J3/DSCP-M/MN-1011-06_Blood_Collection_Vacuum_Tubes/listing.html)
- Place of Performance
- Address: Walter Reed AMC, 6900 Georgia Ave N.W., ATTN: WR-NARMC, Bldg 1 Rm C330, Washington, District of Columbia, 20307, United States
- Zip Code: 20307
- Zip Code: 20307
- Record
- SN02431818-W 20110424/110422234744-03652ce25851e5b7546564d0e967b51c (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's FBO Daily Index Page |