SOURCES SOUGHT
65 -- Blood Collection Tubes
- Notice Date
- 2/3/2009
- Notice Type
- Sources Sought
- NAICS
- 339113
— Surgical Appliance and Supplies Manufacturing
- Contracting Office
- Department of the Navy, Bureau of Medicine and Surgery, NMC San Diego, Bldg 1, 38400 Bob Wilson Drive, San Diego, California, 92134-5000
- ZIP Code
- 92134-5000
- Solicitation Number
- APP-9-10-0812-01
- Archive Date
- 3/11/2009
- Point of Contact
- Cynthia Ingrao,, Phone: 619-532-8517
- E-Mail Address
-
cynthia.ingrao@med.navy.mil
- Small Business Set-Aside
- N/A
- Description
- A.General Information The Southwest Region will be standardizing Blood Collection Tubes. This is a 5-year re-evaluation of this product group. A multiple selection is only a possibility if no single vendor can meet the total requirement of the Region and would be based on a combination of MTF preference and product availability. In order to meet the total requirements of the Region a vendor must be able to offer a comprehensive product line (all items within a product category) available in the necessary quantities to meet all of the DoD MTFs’ needs. That is, the required products must be available in the required quantities. As stated previously, it is not the preference of this standardization to make a multiple selection, however, if necessary due to non-availability from a single source, a multiple selection would be made based on a combination of Regional Clinical preference as determined by the Clinical Product Team (CPT) and vendor product availability. This product line includes blood collection tubes for adult, pediatric and neonatal populations for chemistry, hematology, coagulation and specialty studies and testing. The entire category of Blood Collection Tubes has an annual demand of over $162,000. The primary objective of this program is to standardize the quality of care across this region based on a best value determination that represents the clinically preferred product or source(s) at the best possible price. It is also intended that standardized product be obtained through the DoD Prime Vendor Program, Cardinal, currently serving Southwest Region. The secondary objective of this standardization initiative is the potential of decreasing the existing Stock Keeping Unit’s (SKUs) and thus dollars held as inventory. The below item detail of the products being purchased within the region will be used to target and cross-match product lists submitted by the vendor. This process will ensure the minimum requirements of the Region are met and help identify possible candidates for elimination (i.e. like product items), as well as potentially minimizing the number of SKUs included in a subsequent incentive agreement. The major facilities in the area include but are not limited to Naval Medical Center San Diego; David Grant Medical Center, Travis AFB; Naval Hospital Camp Pendleton; Robert E. Bush Hospital, Twenty-Nine Palms; Weed Army Community Hospital, Ft. Irwin; Naval Hospital Lemoore; 9th Medical Group, Beale AFB; 30th Medical Group, Vandenberg AFB; 61st Medical Squadron, Los Angeles AFB; 95th Medical Group, Edwards AFB. This standardization action is part of the Medical/Surgical Prime Vendor program executed by the Defense Supply Center Philadelphia, Directorate of Medical Materiel. In order to participate, your company must have a Distribution and Pricing Agreement (DAPA) and a separate commercial agreement with the Prime Vendor of the program. This is pursuant to the DAPA clause by which DAPA holders agree to the Standardization process and to allow Prime Vendors to distribute their items. This is a supplement to the Prime Vendor Program and it is not a contract. For additional information regarding DSCP’s Prime vendor program please access our web site at: https://dmmonline.dscp.dla.mil The Tri-Service Regional Business Office (TRBO) will provide anticipated volume (quantity) based on historical usage/forecasted requirements. The agreement will be for a base period of two (2) years (24 months) from date of award with three (3) 12-month option periods. Anticipated award date is April 2009. The evaluation will be based on technical, clinical and pricing factors. The Technical/Company and Clinical/Performance evaluation factors, when combined, are considered significantly more important than cost or price. As the technical and clinical evaluation results become more equal, price will become more important. The selection will be determined utilizing best value/trade off criteria. The selection of a single vendor is anticipated. However, if no single vendor can meet the total requirement of the Region, the Government reserves the right to make two or more selections for RIAs. In this event, selection would be based on a combination of MTF preference and product availability. Point of Contact: Cindy Ingrao, RN, MSN at (619) 532-8517; Email- cynthia.ingrao@med.navy.mil B.Products & Performance Required The Southwest Region is seeking product line items in the category of Blood Collection Tubes. This product line includes blood collection tubes for adult, pediatric and neonatal populations for chemistry, hematology, coagulation and specialty studies and testing. Within this region, this product line has an estimated annual dollar requirement of $162,000. This forecast is based on historical prime vendor sales during a recent 12-month period. At the request of the Southwest Region Military Treatment Facilities vendors will provide on-site support and in-servicing, educational resources and tools for clinical use of the product, conversion information, prime vendor order numbers, MSDS information, and itemization of the brands, types and packaging information of the products offered by the vendor. C.Instructions to Vendors If you are interested in participating in this standardization initiative, email your (1) Company name and address, (2) POC (Name and Phone Number, Fax Number, E-mail address, (3) your answers to the technical questions/criteria below and product literature to cynthia.ingrao@med.navy.mil no later than February 24, 2009. Submissions must be received by 5:00 PM PST on the specified closing date/time of this sources sought notice. Vendors that fail to meet the submittal deadline will be disqualified. If your product literature is more than 4MB in size, please mail your product literature to: Cindy Ingrao, RN, MSN Tri-Service Regional Business Office MSMMO - Southwest Region 34800 Bob Wilson Drive, Suite 110 San Diego, CA 92134 Phone: (619) 532-8517 This process will include vendor requirements of electronic responses to technical criteria, no charge samples for clinical evaluation, and submission of electronic best price offers. Due to the potential for email to become lost in transmission due to network security, etc., the vendor is strongly encouraged to confirm with the Region that its quote and literature actually arrived at the Region via email. All e-mail communication between vendors and the region will be digitally signed by the issuer. We strongly recommend that each submitting vendor confirm receipt, allowing enough time for re-submission before the due date, if a problem should occur with the first transmission. D.Evaluation Criteria Phase I - Technical/Company Evaluation Process. Vendors will be required to provide responses to the technical/company criteria. Amplifying information about your products may be requested by the Government. The responses will be reviewed under the purview of the TPRB to determine acceptability. All technical/company criteria are weighted equally. The vendors who meet the following technical/company criteria will be qualified/invited to participate in the clinical/performance evaluation process via e-mail communication with each vendor. All communications of significant milestones, such as invitations to participate, notices of disqualification, etc. must be digitally signed. The TPRB will review the responses from the vendors and determine which vendors meet the criteria and determine acceptability. Acceptability for purposes of evaluation of technical/company criteria: Generally, responses to all questions in this section demonstrate: (1) the vendor is a distributor or manufacturer of a complete line of the subject medical/surgical consumables; (2) based on the vendor’s responses, the evaluators have reasonable confidence that the line or products and/or services submitted meet the medical standards of care of the community, applicable to such products or services; (3) the vendor has, or is obtaining a DAPA for the items (vendors that fail to have a DAPA will be disqualified); (4) the vendor has, or is obtaining, an agreement covering the items, with Cardinal, the Prime Vendor for the region (vendors whose products are not available through the regional PV will be disqualified); (5) the vendor intends to provide discounts off DAPA for all products included in this standardization initiative (vendors that fail to provide a discount from DAPA will be disqualified); and (6) the vendor’s information provided is factually correct. Any misrepresentation of information will disqualify the vendor from further consideration. Technical/Company Criteria 1.Vendors must manufacture and/or distribute a complete line of blood collection tubes for adult, pediatric and neonatal populations for chemistry, hematology, coagulation and specialty studies. The volumes of these tubes must include those less than 2.0 ml as well as greater than 2.0 ml for small volume testing. 2.Provide the brand(s) under which vendor manufactures or distributes products. 3.Provide the size for each type of product, how the product is packaged and how the sizes are identified. 4.Vendor’s blood collection tubes must be FDA approved for use in all laboratory testing. Please provide documentation stating that they meet the standards. 5.Vendor’s blood collection tube stated volumes must be accurate. Please provide documentation that states your tubes stated volumes are accurate and to what degree. 6.Vendor’s blood collection tubes must be made from material that allows an undistorted view of the contents, has sufficient strength for normal use, and capable of retaining a vacuum for a shelf life of no less than one year. 7.Vendor’s blood collection tubes must be made of plastic or a shatterproof material. 8.Due to the increasing number of latex sensitive beneficiaries in our health system, our region requires latex-free versions of products in this product line where available. Additionally, products must be clearly labeled as latex free. 9.Vendor’s blood collection tubes must be made from materials or contain materials, lubricants, coating, or additives that do not adversely influence the results obtained when the container is used as intended. 10.Vendor’s blood collection tubes must provide a closed system for needle punctures and reseal itself. 11.Vendor’s blood collection tubes must be capable of withstanding an acceleration of up to 3500 RPM when they contain a specimen. 12.Vendor’s blood collection tubes must contain a closure that can be removed by gripping with fingers or by mechanical extractors. 13.Vendor’s blood collection tubes must have markings that identify the product as shown on the package label. 14.Vendor’s blood collection tubes must have a surface that can be marked with a ballpoint pen for patient identification information. 15.Vendor’s blood collection tubes must have the tubes shelf life or expiration date clearly marked/printed on each tube in an easy to read font. 16.Vendor’s blood tubes must be compatible with the Beckman-Coulter LX20, Roche Cobas 6000 Series, Roche Modular System, Roche Cobas AmpliPrep/Taqman System, Stago STA-R Evolution, DiaSorin Eti-Max 3000, Ortho Vitros 250, Siemens Immulite 1000, Siemens Centaur, Beckman Coulter LH 755 system, Beckman Coulter LH 500, Beckman Coulter LH 785, Beckman Coulter AcT Diff, Immucor Galileo, Ortho ProVue, Dade Dimension, Dade Sysmex CA 500, Abbott Ruby 3200, Abbot Cell Dyn 3200,Vitros 350, MTS Gel System by Ortho, Act-5-Diff, Johnson & Johnson Ortho-Clinical Diagnostics Vitros 250, Abbott Architect c8000, ci8200, i2000SR, Sysmex CA-1500 and Sysmex CA-500. 17.Vendor’s coagulation tubes must contain 3.2% sodium citrate. 18.Vendor’s products must be available through the Prime Vendor, Cardinal Health, or you will be disqualified from the standardization process. Please acknowledge and identify that you have such an agreement with Cardinal Health. 19.Vendors must have a DAPA number for this product line or you will be disqualified from the standardization process. Please provide the DAPA number for this product line. 20.Vendors must offer volume discounts off DAPA for all products included in this standardization initiative. Where FSS prices are available, DAPA holders are required by previous agreement to provide the FSS price as their DAPA price. Therefore, FSS prices do not represent a discount off the DAPA. Vendors that fail to offer a discount off the DAPA price will be disqualified. 21.Educational tools or materials in the form of written, audio and/or visual must be provided for this product line. Please state how vendor will meet this requirement. 22.Vendors must provide staff training for this product line. Please state how vendor will meet this requirement. 23.Please provide a list of product representatives for each account in the Southwest Region. 24.Please provide vendor’s returned goods policy. 25.Please provide an implementation plan for servicing the supply requirements of the Southwest region. 26.Please annotate the hours that customer service support is accessible via a toll-free number. 24 hours/day, 7 days/week support is preferable. If vendor does not provide preferable level of support, state the hours support is provided. 27.Please provide any history off backorders, recalls, and/or adverse events for this product line stating dates and duration, cause, and resolution. Vendors should put their best foot forward, that is, provide a context to include any mitigating factors for these situations and any relief or resolution which may have been provided since there will be no further opportunity to explain these incidents. If vendor has not had any of the above, so state. Phase II - Clinical/Performance Evaluation Process. The TPRB will request samples from the product group to be clinically evaluated at selected Military Treatment Facilities. Vendors are required to ship samples directly to the designated MTFs. Vendors will be given 14 calendar days to ship samples. Samples with literature must arrive at the MTF by COB, 5PM local time, on the 14th calendar day after the notice to ship. Vendors failing to deliver by the deadline will be disqualified from further consideration in the standardization process. The MTFs will evaluate the clinical/performance criteria using a scale from one (1) to five (5) where 1 = Strongly Disagree, 2 = Disagree, 3 = Neutral, 4 = Agree and 5 = Strongly Agree. All clinical/performance criteria are weighted equally. The Government reserves the right to conduct evaluations in either a non-clinical or clinical setting or both. The CPT has established a target threshold of 3.0 for clinical acceptability of product for standardization. The CPT will analyze acceptability as being at or near 3.0 depending on the “break”, in the average scores and how closely the scores are clustered near the Acceptability Target Threshold of 3.0. Subject to this review, products below this threshold will be clinically unacceptable and be disqualified from further consideration for standardization. A Clinical Product Team (CPT) comprised of medical professionals from several disciplines will evaluate the products based upon on the following evaluation criteria to determine acceptability. Clinical/Performance Criteria 1.The tube is easily identified outside of its package. a.Technicians require the tube be easily identified outside of its package because tubes come in large volume packages and are stocked in each technicians caddy without the packaging. They must be able to identify the tube outside of its packaging to be able to select the correct tube for the draw. b.This criterion will be evaluated in the clinical setting at least (2) times. c.Evaluator will be given tubes outside of their normal packaging and be able to identify the tube correctly using the information contained on the tube. 2.The tube’s closure can be removed with fingers or an extractor. a.Technicians require the tube’s closure be removed with fingers or an extractor for withdrawal of the tube’s contents for analysis. Withdrawing the contents with a needle puts the technician at risk for a needlestick injury and may damage the contents. b.This criterion will be evaluated in the clinical setting at least (2) times. c.Evaluator will be given an unused tube and will attempt removal of the closure with fingers and/or an extractor. 3.The tube has a surface that can be written on with a ballpoint pen with patient identification information. a.Technicians require the tube have a surface that can be written on with a ballpoint pen with patient identification information. b.This criterion will be evaluated in the clinical setting at least (2) times. c.Evaluator will be given an unused tube and will attempt to write on the surface provided on the tube with a ballpoint pen. 4.The tube is compatible with the cap piercing capabilities of current analyzers. a.Technicians require the tube be compatible with the cap piercing capabilities of their analyzers so the contents of the tube can be withdrawn and analyzed. b.This criterion will be evaluated in the clinical setting at least (2) times. c.Evaluator will be given tubes they can use with their analyzers and perform the skill set necessary to perform and visualize the cap being pierced by the analyzer. 5.The expiration date is easily visible on the tube packaging and individual tube. a.Clinicians require the expiration date be easily visible on the tube package and individual tube to insure expired product is not used on patients. b.This criterion will be evaluated in the clinical setting at least (2) times. c.Evaluator will inspect the tube package and individual tube and verify the expiration date is clearly printed on it. Phase III – Pricing Analysis Process. All vendors who provide samples with literature for clinical evaluation will be asked to submit best value pricing for analysis. Vendors will be given 14 calendar days from the date of request to submit their best pricing, in a prescribed format, based upon the total requirements of the Southwest Region. The Region intends to evaluate pricing and select a vendor or vendor(s), without discussions. Vendor pricing should contain the vendor's best product matches for the products or product lines requested in this announcement. Vendor pricing should contain the vendor's best tiered-pricing discounts off of the vendor's DAPA pricing (based on committed volume of 80% of the total requirements of the MTFs in the Region). Additionally, the Region reserves the right to conduct discussions and request revised pricing, if it is determined to be necessary. If a down-selection is made during the evaluation process, the Region may limit the number of quotes to the greatest number that will permit an efficient competition among vendors Pricing will be evaluated based on best value to the government and will be based on a committed volume for a two-year period with possible one-year option periods (not to exceed 5 years). The following elements will be considered in the pricing analysis: (1) Impact of RIA prices on the Region (Post-Standardization Costs), (2) Potential Cost Avoidance, (3) Impact of Unmatched Lines, and (4) Consideration of stockage keeping units (SKUs) by each vendor. The Impact of RIA prices on the Region is considered more important than other pricing elements. Clinical/performance and technical/company factors will be weighted more heavily than price. As the evaluation results become more technically equal, price may become more important. Pricing will be evaluated based on best value to the government and will be based on a committed volume for a two-year period with possible one-year option periods (not to exceed 5 years). Failure to submit a discount off the DAPA price will result in exclusion.
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