SOURCES SOUGHT
65 -- Tri-service Regional Business Office Northwest Region (Washington and Alaska) announcement for the evaluation and standardization of Epidural & Spinal Trays
- Notice Date
- 6/16/2008
- Notice Type
- Sources Sought
- Contracting Office
- Department of the Army, U.S. Army Medical Command, Western Regional Contracting Office, Western Regional Contracting Office, ATTN: MCAA W BLDG 9902, 9902 Lincoln Street, Tacoma, WA 98431-1110
- ZIP Code
- 98431-1110
- Solicitation Number
- W91YU0R11-08-08-001EPIDURALSPINAL
- Response Due
- 7/21/2008
- Archive Date
- 9/19/2008
- Point of Contact
- Wesley E. Burnett, 253-968-1869
- Small Business Set-Aside
- N/A
- Description
- A. General Information Northwest Region seeks to initiate the standardization process for Epidural & Spinal Trays for its 7 Army, Navy, and Air Force Medical Treatment Facilities (MTFs) in the states of Alaska & Washington. Standardization for this product line represents a previously standardized product line initiative for this Region. The Region originally completed this product line for standardization in 03/03, and it expired 06/07 This product line includes a full line of Epidural & Spinal Trays in various sizes and descriptions, as detailed in 1a of the Technical Criteria below, Usage Items. Vendors MUST provide a complete list of items supplied (catalog, etc.) and product literature in response to this Request for Quotes (RFQ). Vendors are required to supply all items listed in all sizes and styles listed. Vendors who do not have a complete product line, as detailed below in usage items, will be disqualified in Phase I. 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 (PV) Program. The major facilities in the Region include but are not limited to Bassett Army Community Hospital, Fort Wainwright, AK; Bremerton Naval Hospital, Bremerton, WA; Fairchild AFB Clinic, Fairchild AFB, WA; 354th Medical Group, Eielson Air Force Base, AK; 3rd Medical Group, Elmendorf AFB, AK; Madigan Army Medical Center, Tacoma, WA; Oak Harbor Naval Hospital, Oak Harbor, WA This standardization action is part of the Medical/Surgical PV program executed by the Defense Supply Center Philadelphia (DSCP), Directorate of Medical Materiel. To participate, your company must have a Distribution and Pricing Agreement (DAPA) and a separate commercial agreement with the PVs for the program. This is pursuant to the DAPA clause by which DAPA holders agree to the Standardization process and to allow PVs to distribute their items. This RFQ will result in Regional Incentive Agreements (RIAs) that supplement the PV Program. The RFQ will not result in a contract award. For additional information regarding DSCPs PV program, please access their web site at https://dmmonline.dscp.dla.mil. The resulting RIA will be for a base period of two (2) years (24 months) from date of selection with three (3) 12-month option periods for a maximum of 5 years. Anticipated selection date is 10/08. The evaluation will be based on clinical, technical, 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. The Point of Contact is Diane Mathews, phone: 253-968-3115, and e-mail diane.mathews@amedd.army.mil B. Products & Performance Required The Region is seeking Epidural & Spinal Trays which at a minimum include the product lines below. Within this region, this product line has an estimated annual demand of $166,594. This forecast is based on historical PV sales during a recent 12-month period. T he top high volume usage lines for this project include: Epidural Kit Anesthesia, Epidural Tray Continuous Perifix Fx, Sd20td Epidural Tray Sgl Dose P66, P25bk Spinal Tray, Spinal Tray With Pencan 25gx3.5in Needle, Ce18tkcd Epidural Tray Continuous, Epidural Cont Hustead 18g With Drugs, Epidural Anest Lor Pulsator Syringe, Spinal Anes Tray Whit25g3.5 L/L-D 2t2023, Spinal Epidural Tray Espocan Es1725kfx At the request of the Regional MTFs, vendors will provide on-site support and in-servicing during implementation, educational resources and tools for clinical use of the product, conversion information, PV order numbers, MSDS information, and itemization of the brands, types and packaging information of the products supplied by the vendor C. Instructions to Vendors DAPA holders interested in participating in this standardization initiative should email their (1) Company name and address, (2) POC (Name and Phone Number, Fax Number, and E-mail address) to diane.mathews@amedd.army.mil. All e-mail communication between vendors and the region must be digitally signed. All communications of significant acquisition milestones (such as invitations to participate, or notices of disqualification) must be digitally signed as well. Submissions must be received by 4:00 PM PST on the specified closing date of this RFQ. Vendors that fail to meet this submittal deadline will be disqualified from participating. This process will include vendor requirements for providing electronic responses to technical criteria, no charge literature for clinical evaluation, and submission of electronic best price quotes. Due to the potential for e-mail to be lost in transmission from network security, etc., vendors are strongly encouraged to confirm with the Regional POC stated above their initial submission, best price submissions, and literature or other requested information have actually arrived at the Northwest Regional Tri-Service Business Office (TRBO) via e-mail. 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. D. Evaluation Criteria The Tri-Service Product Review Board (TPRB) is the governing board of the standardization process. This board includes clinicians and logisticians from the MTFs within the Region. They are the deciding officials for this initiative. The TPRB intends to evaluate price quotes and select a vendor or vendors without discussions. Vendor quotes should contain the vendors best product matches for the products or product lines requested in this announcement. Vendor quotes should contain the vendors best responses to all technical and/or company questions listed in this announcement. Vendor quotes should contain the vendors best tiered-pricing discounts off of the vendors DAPA pricing (based on committed volume of 80% of the total requirements of the MTFs in the Region). Additionally, the TPRB reserves the right to conduct discussions and request revised quotes, 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. Phase I - Technical/Company Evaluation Process. Interested vendors are to respond to this FBO announcement by emailing their intent to participate to the above POC by the required response date. The vendors initial responses will include information requested in the technical/company criteria listed in the FBO RFQ. Vendors are required to meet/provide responses to the technical/ company criteria stated below. All technical/company criteria are weighted equally. The responses will be reviewed under the purview of the TPRB and the Clinical Product Team (CPT) to determine acceptability of each vendor. After review of the technical/company criteria, those vendors who meet these criteria will be qualified/invited to participate in the clinical/performance evaluation. 1. In general, acceptability for purposes of evaluation of technical/company criteria is defined as follows: a. Based on the vendors 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. b. The vendors information provided is factually correct. Any misrepresentation of information will disqualify the vendor from further consideration. 2. Each technical/company criteria below requires additional, more specific definition of technical acceptability. This specific standard for technical acceptability will be set forth with the individual criterion. The following Technical/Company Evaluation Criteria have been established for the standardization initiative: 1.Vendors must provide a complete line of Epidural and Spinal products. A complete line of product is defined as the MTFs requirements for usage items in the product line. Usage items are defined in the Medical/Surgical Prime Vendor contract statement of work, as DAPA items ordered at least once per month, and at least one unit per order. At a minimum, a complete product line includes: a.Standard epidural trays must be capable of meeting the diverse patient and clinician needs in the Region. In addition to the typical items in a standard epidural tray (i.e.: sterile outer wrap, injection needles and syringes, fenestrated and towel drapes, gauze pads, etc.), the users should be able to choose a standard set that gives them choices from among the following options: i.Epidural needles in sizes from 16 gauge to 20 gauge, from 3.5 to 6 long, with centimeter markings. ii.Flexible regular or coil-spring wire interior epidural catheters, open-tip or closed-tip, in sizes from 18 gauge to 20 gauge, sized to fit the needle provided in the tray. iii.LOR (loss of resistance) syringe, 5cc to 10 cc, plastic or glass, Luer-lock or Luer-slip hub. iv.Skin antiseptic of iodine solution, iodine/alcohol solution, tinted chlorhexidine, or tinted chlorhexidine/alcohol solution. v.Labels to identify epidural catheter and medications drawn into syringes. vi.Medications: Lidocaine HCl, 1.5% with epinephrine; Lidocaine HCl, 1%; Sodium Chloride 0.9% vii.Filter needle or filter straw for drawing up ampoule medications. b.Standard spinal trays must be capable of meeting the diverse patient and clinician needs in the Region. In addition to the typical items in a standard spinal tray (i.e.: sterile outer wrap, 20 gauge introducer needle, injection needles and syringes, fenestrated and towel drapes, gauze pads, etc.), the users should be able to choose a standard set that gives them choices from among the following options: i.Pencil-point spinal needles in sizes from 24 gauge to 27 gauge, and lengths from 3.5 to 5.5. ii.Skin antiseptic of iodine solution, iodine/alcohol solution, tinted chlorhexidine, or tinted chlorhexidine/alcohol solution. iii.Labels to identify medications drawn into syringes. iv.Medications: Lidocaine HCl 1%, Epinephrine 0.1%; Sodium Chloride 0.9%; Bupivacaine 0.75% MPF, Bupivacaine 0.75% with Dextrose 8.25%. v.Filter needle or filter straw for drawing up ampoule medications. c.Vendors are to provide a complete list of items supplied (catalog, etc.) and product literature in response to this RFQ. 2.Vendors must have a DAPA, or be in the process of applying for a DAPA, for the Epidural and Spinal Product line. Provide the DAPA number or proof of the application process with the initial submittal. (Note that vendors that fail to have a DAPA or show a lack of progress in obtaining a DAPA will be disqualified.) 3.Vendors must have a separate agreement with the Regions Prime Vendor (currently, Cardinal Health is the PV for distribution in Region 11.) Please provide documentation of agreement with Prime Vendor. (Note that vendors whose products are not available through the Regional PV will be disqualified.) 4.Vendors must submit discounts off DAPA for all products included in this standardization initiative. a.Vendors that fail to submit a discount from DAPA will be disqualified. b.Where lower FSS prices are available, DAPA holders are required by previous agreement to provide the FSS price as the DAPA price. Vendors shall not quote FSS prices as the discounted price for purposes of this standardization initiative. c.Vendors are to provide a quote on discounts, in response to this RFQ. 5.Vendors must have a local vendor representative in the Northwest Region. Provide contact information, i.e. name, address, phone number, and e-mail address. 6.Vendors must provide any history of back orders and/or recalls that occurred during the most recent 12-month period for items in their epidural/spinal product line, including dates, duration, cause, and resolution. a.Vendors will not have an opportunity to provide additional information on back orders and recalls during any subsequent stage in this evaluation. b.Vendors are encouraged to submit all information deemed relevant (i.e., positive resolutions, etc.) in response to this RFQ. c.Vendors should not provide point of contact information in response to this question. Additionally, the Government will not contact any points of contact that are provided in response to this question. 7.Vendors must provide in-service staff training and identify company resources for such requirements with the initial submittals. (Provide literature on the training, if available.) Phase II - Clinical/Performance Evaluation Process: The CPT developed a list of items from the product group to evaluate. The determination of the sample set was based on advances in technology, patient safety, and on historical usage for the product line. The CPT also determined that the clinical/performance evaluation will be performed in a clinical, patient care setting. 1.The following procedures will apply. a.The TRBO office will request a no charge clinical evaluation sample set from each of the vendors with a required delivery date 30 days from date of request. b.Each vendor will send the samples directly to the participating MTFs at the addresses listed at the end of this announcement. c.All email communications between vendors and the region concerning sample set shipment will be digitally signed. d.Vendors who do not meet the deadline for sample arrival will be disqualified from the standardization process. e.Due to the potential for samples to become lost or delayed in shipping, all vendors must send the TRBO verification regarding the date of shipment from the vendor, and anticipated delivery date. 2.The samples to be provided are as follows: a.Epidural catheterization tray that includes a 19 Ga. epidural catheter with interior coil-spring and open-end tip, 17 Ga. x 3.5 winged Tuohy needle with centimeter markings, 5cc Luer-slip glass LOR syringe, and a clear fenestrated drape b.Epidural catheterization tray that includes a 19 Ga. epidural catheter with interior coil-spring and closed-end tip, 17 Ga. x 3.5 winged Tuohy needle with centimeter markings, 5cc Luer-slip glass LOR syringe, and a clear fenestrated drape. c.Epidural catheterization tray that includes a 20 Ga. epidural catheter and closed-end tip, 18 Ga. x 3.5 winged Tuohy needle with centimeter markings, 5cc Luer-slip glass LOR syringe, and a clear fenestrated drape. d.Combined spinal/epidural catheterization tray that includes a 19 Ga. epidural catheter with interior coil-spring and open-end tip, 17 Ga. x 3.5 winged Tuohy needle with centimeter markings, 26 Ga. x 5 pencil-point spinal needle, 5cc Luer-slip glass LOR syringe, and a clear fenestrated drape. e.Spinal anesthesia tray that includes 25 Ga. x 3.5 pencil-point spinal needle, Bupivacaine 0.75% Methyl Paraben Free (MPF), and a clear fenestrated drape. f.10cc plastic LOR syringe. g.5cc Luer-lock glass LOR syringe. h.17 Ga. x 4.5 winged Tuohy needle. i.25 Ga. x 5.5 pencil-point spinal needle. j.27 Ga. x 3.5 pencil-point spinal needle. 3.The CPT will evaluate each product against the clinical/performance criteria. All criteria will carry equal weight. The evaluation will take place in a clinical patient care setting. 4.The evaluation responses will represent a clinical value judgment placed in a Likert-like scale with a 1 to 5 scoring format (1 = Strongly Disagree; 2 = Disagree or no; 3 = Undecided; 4 = Agree or yes; 5 = Strongly Agree). Comments will be invited and recorded on the evaluations.. 5.The CPT has set a clinical acceptability threshold target at 3.1. The CPT will determine the actual acceptability threshold for this standardization initiative at or near 3.1 depending on the location of any break (or gap) in vendors average scores. In addition, the CPT may consider how closely scores are clustered near the acceptability target threshold of 3.1, in determining the actual acceptability threshold. Vendors scoring below the actual acceptability threshold will be determined to be clinically unacceptable, and be disqualified from further consideration for this standardization initiative. Clinical/Performance Criteria: During the pre-source selection procedures, the CPT validated/ approved the following equally weighted clinical/performance criteria. All criteria will be evaluated in a patient care setting, during the process of establishing an epidural and/or spinal block. Practitioners will perform at least 2 blocks in order to evaluate each criterion: 1. Sterile patient fenestrated drape provided does not obscure anatomical landmarks. a.Rationale: with patient in a side-lying or seated position for epidural cannulation, it is essential to see the anatomical landmarks to insure the appropriate needle insertion site and trajectory. Otherwise, the incorrect intra-spinous space may be entered or the needle may travel askew. b.Method: The practitioner will place the fenestrated drape and observe whether the anatomical landmarks are obscured. 2.Compartments in tray are configured to hold contents firmly, in an intuitive order, and in a ready-to-use layout. a.Rationale: Clinician time is wasted and efficiency decreased if they must reorganize a tray if the prepping products, needles, syringes, catheters and medications in the tray get displaced during shipping, or are packaged haphazardly in the tray. b.Method: The practitioner will open an epidural tray, establish a sterile field, and use the products in the tray in order to assess if the tray is configured to hold contents firmly, in an intuitive order, and in ready-to-use layout. 3.Epidural needle is sturdy, has a smooth end curve, and has an aperture that allows drag-free passage of epidural catheter into epidural space. a.Rationale: The needle must be sturdy enough to pass through a variety of soft and ligamentous tissue before reaching the epidural space, it must be curved appropriately to direct the catheter into the space, and it must not damage the catheter as it passes through. b.Method: The practitioner will insert the epidural needle and thread the epidural catheter into the epidural space in order to assess if the needle is sturdy, has a smooth end curve, and has an aperture that allows drag-free passage of the catheter into the space. 4.Epidural catheter that features a coil-spring wire interior is flexible to allow atraumatic cannulation of the epidural space. a.Rationale: If catheter is not flexible enough, it may increase incidence of paresthesia and vessel or dural puncture. b.Method: The practitioner will insert the epidural needle and thread the epidural catheter into the epidural space in order to assess if the catheter is flexible enough to allow non-traumatic cannulation of the epidural space. 5.LOR syringe (glass or plastic) has plunger that seals effectively, but slides smoothly without requiring lubrication. a.Rationale: LOR [loss-or-resistance] syringe must provide a drag-free, smooth plunger action to avoid accidental dural puncture. b.Method: The practitioner will insert the epidural needle and attach the LOR syringe. As the needle/syringe unit is advanced, the practitioner will evaluate how well the plunger seals and slides as the syringe is used to identify the moment the loss of resistance occurs. 6.Catheter-hub assembly holds securely without leaking. a.Rationale: The connection between the epidural catheter and the source of the medication must be secure to avoid diversion of the medication intended to be instilled into the epidural space, and therefore failing to provide the desired anesthetic block. Loose connections also provide an entry for bacteria into the epidural space. b.Method: The practitioner will insert the epidural catheter, inject fluid through hub assembly into the catheter, and observe for leaks. 7.Spinal pencil-point needle is sturdy in small-gauge sizes (26-27 Ga). a.Rationale: The needle must be sturdy to pass through a variety of soft and ligamentous tissue before reaching the dura, yet small enough gauge to aid in the prevention of PDPH (post-dural puncture headache). b.Method: The practitioner will insert a 26 Ga or 27 Ga spinal needle and assess its sturdiness as it passes through soft and ligamentous tissue. Phase III - Pricing Analysis Process. After the clinical/performance evaluations are completed and analyzed, all vendors in the clinical evaluation group who met the minimum 3.1 clinical threshold (depending on the break in the average scores and how closely scores are clustered near the Acceptability Target Threshold as determined by the CPT) will be contacted to submit their lowest pricing quotes as well as product cross-reference data based on a committed volume of 80% of the total Regional requirement. Vendors will be given fourteen (14) calendar days to submit their price quotes in the prescribed format as above via email. Price quotes must be received by 4:00 PM PST on the 14th calendar day. Failure to respond within this timeframe or failure to submit incentive discounts from their DAPA prices will result in the vendor being disqualified from further participation in this RIA initiative. The Region intends to evaluate quotes and select a vendor or vendors, without discussions as noted above. However, the Region reserves the right to conduct discussions and request revised pricing, if determined to be necessary. Clinical/performance and technical/company factors will be weighted more heavily than price. As the technical and clinical evaluation results become more equal, price will 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 three (3) one-year option periods. The following elements will be considered in the pricing analysis: (1) The impact of RIA prices on the Region (Post-Standardization Costs) is considered more important than the other pricing elements. (2) Impact of Unmatched Lines. (3) Consideration of stock keeping units (SKUs) by each vendor. The Region intends to reduce the number of SKUs that must be handled per period. Vendors that can supply the complete range of clinically required product, without unnecessary numbers of SKUs for minimally differentiated products, will be more likely to provide the best value solution for the Government in this standardization initiative.
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- Place of Performance
- Address: Western Regional Contracting Office ATTN: MCAA W BLDG 9902, 9902 Lincoln Street Tacoma WA
- Zip Code: 98431-1110
- Zip Code: 98431-1110
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