SOURCES SOUGHT
65 -- Central Line Dressing Kits
- Notice Date
- 12/8/2009
- Notice Type
- Sources Sought
- NAICS
- 339113
— Surgical Appliance and Supplies Manufacturing
- Contracting Office
- Defense Logistics Agency, DLA Acquisition Locations, Defense Supply Center Philadelphia - Medical, 700 Robbins Avenue, Philadelphia, Pennsylvania, 19111-5096
- ZIP Code
- 19111-5096
- Solicitation Number
- APP01-0911-003
- Archive Date
- 1/13/2010
- Point of Contact
- Toni Massenburg, Phone: 202 782-3666, Tracy Martin-Tilghman, Phone: 2027823663
- E-Mail Address
-
toni.massenburg@us.army.mil, tracy.martintilghman@us.army.mil
(toni.massenburg@us.army.mil, tracy.martintilghman@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- 65-Medical Supplies-Potential Sources Sought A.General Information. The Northeast Region (TRBO Reg. 1), a military integrated delivery network, comprised of 47 Army, Navy, Air Force, Marine Corps, and U.S. Coast Guard Medical Treatment Facilities (MTFs) in the states of Maine, New Hampshire, Massachusetts, Rhode Island, Connecticut, New York, Pennsylvania, New Jersey, Delaware, Maryland, Virginia, and the District of Columbia including institutional and operational healthcare settings announces a Request for Regional Incentive Agreement Quotation (RFRIAQ) for the standardization of CENTRAL LINE DRESSING KITS. This product line includes but is not limited to the Central Line Dressing Kits which contain an antiseptic agent with rapid and persistent bactericidal activity; that allows for compliance with CDC guidelines for the prevention of central line–associated bloodstream infection (CABSI); a transparent, semi permeable polyurethane occlusive device securement dressing; a variety of components, and sizes, etc., to meet all of the infection control and securement needs. 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. 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 Northeast Region include, but are not limited to Walter Reed Army Medical Center (Washington, DC) and National Naval Medical Center (Bethesda, MD) Malcolm Grow Medical Center (Andrews AFB, MD), Dewitt Healthcare System (FT Belvoir, VA), Keller Army Community Hospital (West Point, NY), and Kimbrough Ambulatory Care Center (FT Meade, MD). This standardization action is part of the Medical/Surgical Prime Vendor program executed by the Defense Supply Center Philadelphia (DSCP), 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 Vendors for 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 products. This RFRIAQ will result in Regional Incentive Agreements (RIA’s) that supplement the Prime Vendor Program. The RFQ will not result in a contract award. For additional information regarding DSCP’s Prime vendor program please access their web site at https://dmmonline.dscp.dla.mil. The resulting Regional Incentive Agreement (RIA) will be for a base period of two years (24 months) from date of selection with three one year (12 months) option periods (not to exceed 5 years.) Anticipated selection date is March 2010. The evaluation will be based on clinical, technical, and pricing factors. Clinical/performance and technical/company factors will be weighted more heavily than price. 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: Toni Massenburg, (202) 782-3666, toni.massenburg@us.army.mil. B.Products & Performance Required. The Northeast Region is seeking product line items in the category of CENTRAL LINE DRESSING KITS which at a minimum includes the high volume lines below. Within this region, this product line has an estimated annual dollar requirement of $153,174. This forecast is based on historical prime vendor sales during a recent 12-month period. The top high volume usage lines for this project are shown in the Technical/Company Criteria below. At the request of the Northeast Regional MTFs, vendors will provide on-site support and in-servicing during implementation, conversion information, prime vendor order numbers, 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 detailed responses to the technical/company criteria and (1) Company name and address, (2) Company POC (Name and Phone Number, Fax Number, and E-mail address) to Toni Massenburg, (202) 782-3666, toni.massenburg@us.army.mil or Tracy Martin-Tilghman, (202) 782-3663, tracy.martintilghman@us.army.mil as a back-up. Submissions must be received by COB 5:00 PM EST on the specified closing date/time of this sources sought notice. Vendors that fail to meet this submittal deadline will be disqualified from participating in the standardization process. This process will include vendor requirements to provide electronic responses to technical criteria, no charge samples for clinical evaluation, and submission of electronic best price quotes. Due to the potential for email to be lost in transmission, from network security, etc., vendors are strongly encouraged to confirm with the Region that its initial submission, quote and literature actually arrived at the Region 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. Vendors that do not meet the deadline of COB 5:00PM EST on the date listed for closing (per the FBO RFQ), will be disqualified from further consideration in the standardization initiative. All email communications between vendors and the Region should be digitally signed by the issuer. D. Evaluation Criteria. The Tri-Service Product Review Board (TPRB) is the governing body of the standardization process. This board includes clinicians and logisticians from the Military Treatment Facilities within the Northeast Region. They are the deciding officials for this initiative. The Region intends to evaluate quotes and select a vendor or vendors, on initial submissions/quotes. Vendor quotes should contain the vendor's best product matches for the products or product lines requested in this announcement. Vendor quotes 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). (Note: vendors that fail to submit a discount from DAPA will be disqualified. Note: 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.) However, the Region reserves the right to conduct discussions and request revised quotes, if determined necessary. The Region reserves the right to limit the number of quotes to the greatest number that will permit an efficient competition among vendors. The Region reserves the right to make a down-selection during the evaluation process based on considerations of efficient competition. The TPRB votes for the best value for a single or multiple vendor selection(s). 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. Phase I – Technical/Company Evaluation Process: Interested vendors are to respond to this FBO announcement by emailing their detailed responses and required documentation to toni.massenburg@us.army.mil by the required response date. 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 by the Clinical Product Team (CPT) and determine the acceptability of each vendor. After the review of the technical/company criteria, those vendors who meet the following technical/company criteria will be qualified/invited to participate in the clinical/performance evaluation process as well as the price analysis process and will be requested to submit their best product/price proposed package discount quotes via an email communication with each vendor. In general, “acceptability for the purposes of validation of technical/company criteria is defined as follows: Generally, responses to all questions in the technical/company criteria demonstrate that: (1) based on the vendors’ responses, the evaluators have reasonable confidence that the line of products and /or services submitted meet the medical standards of care of the community, applicable to such products and services; (2) the vendor’s information provided is factually correct. Any misrepresentation of information will disqualify the vendor from further consideration. NOTE: Specific technical/company criteria will require an additional, more-specific definition of “technical acceptability.” The specific standard for technical acceptability will be set forth with the individual statement of each criterion, as required. The following equally weighted Technical/Company Evaluation Criteria have been established for this standardization initiative: 1.Vendor MUST provide a complete line of Central Line Dressing Kit products. A ‘complete line of product’ is defined as the MTF’s 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. The ability for the vendor to provide these items is considered critical and failure by them to do so will result in the vendor not being included in this standardization effort. a. At a minimum, the Central Line Dressing Kit product line includes as follows: standard dressing kit configurations that include a clear occlusive device securement dressing; dressing size 2 in x 3 in; gauze size 2 in x 2 in, 8-ply; Nitrile gloves, powder-free, cuffed, size medium; dressing label; face masks; alcohol swabstick 3 in 1; skin protectant prep pads; 2% Chlorhexidine Gluconate (CHG) and 70% Isopropyl alcohol applicator; biopatch protective disk with Chlorhexidine Gluconate (CHG); wound closure strip; drape; tray; CSR wrap; and Drug Fact Insert (ChloraPrep); and any other products in this category. Vendors are required to supply items listed below. Product Kit to SendQuantityItem DescriptionCase Size 20kits/case Clear occlusive device securement dressingone 3.5 in x 6.5 in1 case Dressing one2 in x 3 in Gauze two2 in x 2 in, 8-ply Nitrile gloves, powder-free, cuffed 2prSize medium Label, change date and initials one1 in x 2 in Masks with ear loops2 Alcohol swabstick one3 in 1 Skin protectant prep pads2 2% Chlorhexidine Gluconate (CHG) and 70% Isopropyl alcohol applicator one3ml Biopatch® Protective Disk with Chlorhexidine Gluconate (CHG) one2.5 x 4.0mm Wound closure strip one0.5 in x 4 in Drape1 Tray1 CSR wrap1 Drug Fact Insert (ChloraPrep)1 b.Vendor MUST provide a complete list of items supplied (manufactured and/or distributed by brands) via catalog, and product literature in response to this RFQ with initial submittal. Vendors are required to supply items listed that contain an antiseptic agent with rapid and persistent bactericidal activity; that allows for compliance with CDC guidelines for the prevention of central line–associated bloodstream infection (CABSI); a transparent, semi permeable polyurethane occlusive device securement dressing; a variety of components, and sizes, etc., to meet all of the infection control and securement needs. (Vendors who do not have a complete product line as above will be disqualified in Phase I). 2.Vendor MUST have a DAPA for the Central Line Dressing Kits product line. Vendor MUST provide DAPA number with initial submittal. (Note that vendors without a DAPA number will be disqualified in Phase I). 3.Vendor MUST have a separate agreement with the prime vendor (currently, the prime vendor is Owens & Minor) for Central Line Dressing Kits in the Northeast Region. (Note that vendors whose products are not available through the regional PV will be disqualified in Phase I.) Vendor MUST provide supporting documentation (four digit code) of agreement with Prime Vendor with initial submittal. 4.Vendors MUST submit discounts off DAPA for all products included in this standardization initiative. (Note: vendors that fail to submit a discount from DAPA will be disqualified. Note: 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.) Vendors who do not provide discounts off DAPA for ALL products in Phase II will be disqualified. 5.Vendor MUST provide all history of back orders and recalls that occurred during the most recent 12-month period for Central Line Dressing Kit products, including dates, duration, cause, and resolution. Vendors will not have an opportunity to provide additional information on back orders and recall during any subsequent stage in this evaluation. Vendors are encouraged to submit all information deemed relevant (i.e., positive resolutions, etc.) in response to this RFQ. The Government will not contact any provided points of contact in response to this question. Vendors should not provide point of contact information in response to this question. 6.Vendor MUST provide Central Line Dressing Kit products that are mandatory to infection control properties required to meet the CDC recommendations for the prevention of central line–associated bloodstream infection (CABSI) that are an integral part of the purpose for the Central Line Dressing Kits. Vendors MUST identify these features of their products and provide literature to support this in response to this RFQ with initial submittal. 7.Vendor MUST provide latex safe/free products. Vendor MUST provide a list of all latex safe/free items supplied via catalog or like-material in response to this RFQ with initial submittal. 8.Vendor MUST provide adhesive (securement dressing) that is non-allergenic, recommended for use with all skin types and populations, and which will remain in place with various degrees of skin moisture (dry to diaphoretic). Vendor MUST provide list of all adhesive items supplied via catalog or like-material in response to this RFQ with initial submittal. 9.Vendor MUST provide Central Line Dressing Kits that are in accordance with IHI and CDC 1A guidelines to provide maximum barrier protection and line securement during changes. Vendor MUST provide list of all barrier items supplied via catalog or like-material in response to this RFQ with initial submittal. Phase II Plan – Clinical/Performance Evaluations and Pricing Analysis Process: Clinical/Performance Evaluations 1.Following acceptability of the technical/company criteria, the TRBO, on behalf of the CPT, will request product sample sets from the product group to be sent directly to the to the CPT members at participating Medical Treatment Facilities (MTFs), and will be allowed 14 calendar days from the date of notification to complete the delivery. Product samples must be shipped to arrive at the participating MTF address by COB, 5:00PM EST, (14) calendar days after the notice to ship. Vendors who do not meet the deadline to deliver the product samples by the deadline will be disqualified from this standardization initiative. Note: all vendors must send the TRBO verification regarding the date of shipment from the vendor and final delivery date of the product sample sets. 2.Specific MTFs will evaluate the vendor’s product sample sets against the clinical/performance criteria in a clinical/patient care setting using a Likert scale, with a one to five scoring range. The scale descriptors are: one (1)-not acceptable, two (2)-minimally acceptable, three (3)-acceptable, four (4)-more acceptable, and five (5)-highly acceptable. 3.All clinical/performance criteria are weighted equally. The clinical/performance evaluation period will last for twenty-one (21) calendar days. The CPT has established a target threshold of 3.50 for the Clinical Acceptability of products for standardization. The CPT will determine the actual Acceptability threshold for this standardization initiative -- at or near 3.50 -- depending on the location of any "break" in vendors’ average scores (i.e., a gap between vendors’ average scores). In addition, the CPT may consider how closely scores are clustered near the Acceptability target threshold of 3.50, 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. Vendors that have been disqualified will be notified in writing at the conclusion of the evaluation process (DSCP approval). 4.To determine acceptability, the CPT, comprised of medical professionals from multiple disciplines from the Northeast Region will evaluate the products based on the evaluation criteria below in a clinical/patient care setting. 5.Vendors will ONLY provide sample products of the items that are requested and being evaluated. Vendors who bring in other product samples or literature on items that are not part of the evaluation process will be disqualified from the evaluation process. Vendor’s presence will not be required for in-servicing prior to the evaluations. Vendors WILL NOT BE ALLOWED TO BE PRESENT during the actual evaluation process of their products or their competitor’s products. 6.Vendors will not be allowed to speak to any hospital staff member regarding the product evaluation, product pricing or price–related factors. Vendors that speak to hospital staff members regarding the product evaluation; pricing or price–related factor will be disqualified from this evaluation process. Clinical/Performance Criteria: 1.The CPT identified that the standards of care that the Northeast Region medical communities adhere to, specifically related to Central Line Dressing Kits, are those that will be the basis for specific technical/company and clinical/performance criteria. The standards are set forth by the following: a.Prevention of Central Line-Associated Bloodstream Infection, Institute for Healthcare Improvement: Background i. Forty-eight percent of ICU patients have central venous catheters, accounting for about 15 million central venous catheter days per year in ICUs. ii. There are approximately 5.3 CR-BSIs per 1,000 catheter-days in ICUs. iii. The attributable mortality for CR-BSIs is approximately 18%. Thus, there are probably about 14,000 deaths annually due to CR-BSIs in ICUs. Some estimates have put this figure as high as 28,000 deaths per year. iv. The Centers for Disease Control and Prevention (CDC) issued a guideline for prevention of CR-BSI in 2002. v. The Institute of Medicine has identified the prevention of nosocomial infections, including CR-BSI, as a priority area for national action. vi. The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) has included reducing the risk of health-care associated infections, including CR-BSI, in its 2005 National Patient Safety Goals. b.Failure Mode and Effects Analysis Central Line Catheter-Related Bloodstream Infections: Insertion and Maintenance Practices, Partnership for Patient Care, Healthcare Improvement Foundation, 2006. i.This topic was chosen based on its broad application across regional hospitals, regional advisory group input, synergy with national patient safety/quality initiatives, and evidence base related to the effectiveness of insertion and maintenance practices to reduce central line catheter related bloodstream infections. ii. Mitigation strategies to reduce risk associated with potential failure modes varied from hospital to hospital, depending on their unique circumstances. However, the following mitigation strategies were most frequently implemented amongst participating hospitals. In addition, hospitals indicated that implementing these mitigation strategies seemed to have the greatest impact on strengthening infection control and patient safety (3 of 14 listed). 1.Standardizing central line insertion kits with pre-approved products thus ensuring appropriate supplies (e.g., 2% chlorhexidine, large drape) are readily available. 2.Providing central line insertion carts on all units to support ready availability and standardization of insertion supplies. 3.Standardizing site maintenance supplies (e.g., flush, antiseptic, dressing). c.The Joint Commission Perspectives on Patient Safety, March 2009, Volume 9 Issue 3. i. The Joint Commission’s National Patient Safety Goal 7 requires accredited organizations to take steps to reduce the risk of HAIs. The goal’s five requirements include provisions related to hand hygiene, surgical site infections, central line–associated bloodstream infections, multiple-drug-resistant organisms, and managment of identified HAI cases as sentinel events. ii. NPSG.07.04.01 applies to short- and long-term central venous catheters as well as peripherally inserted central catheter (PICC) lines. The elements of performance (EPs) for this goal focus on four main points: (1) educating staff, patients, and their families regarding guidelines for preventing CABSIs; (2) measuring compliance with the guidelines and CABSI rates; (3) maintaining aseptic technique during central line insertion, and (4) properly maintaining the central line and continuously evaluating the necessity of the central line. 1. These interventions include use of alcohol-based hand gel (10 seconds), maximum sterile barriers including sterile gloves, large sterile drape, sterile gown, mask with face shield, and hat (50 seconds); application of chlorhexidine-based antiseptic (30 seconds); and appropriate drying time for antiseptic (30 seconds). d.Centers for Disease Control and Prevention. Guidelines for the prevention of intravascular catheter-related infections. MMWR Morb Mortal Wkly Rep. 2002;51(RR- 10):3–36. i.In the United States, povidone iodine has been the most widely used antiseptic for cleansing arterial catheter and CVC insertion sites. However, in one study, preparation of central venous and arterial sites with 2% aqueous chlorhexidine gluconate reduced BSI rates compared with site preparation with 10% povidone iodine or 70% alcohol. ii. Sutureless fixation devices may be preferable to sutures in preventing CR-BSIs. One study, which involved only a limited number of patients and was underpowered, compared a sutureless device to suture for securing PICCS; in this study, CR-BSI was reduced in the group of patients that received the sutureless device. Clinical/Performance Criteria: During the pre-source selection procedures, the CPT validated/approved the equally weighted clinical/performance criteria outlined below: 1. (Staff Efficiency of Care/ Infection Control) The skin prep wand will be easily activated by pinching or gently pressing the side wings until liquid is seen and will remain moist during the 30 second cleansing. a. Clinicians require the product to release it antiseptic solution easily. b. This criterion will be evaluated in a clinical setting by use of the product on at least (3) patients. c. Evaluator will open/remove product from packaging, easily pinch the wings and use a circular motion from the catheter insertion site outward. d. Evaluator will observe that the swab remains wet during the 30 second cleansing procedure. 2. (Staff Efficiency of Care/ Infection Control) The biopatch disk dressing will be correctly and easily placed around the central venous catheter at the insertion site where it will provide a sustained release of CHG. a. Clinicians require that the product effectively inhibits bacterial growth under the dressing when the product's impregnated foam side releases Chlorhexidine Gluconate (CHG) when in contact with the patient's skin. b. This criterion will be evaluated in the clinical setting by use of the product on at least (3) patients. c. The evaluator will examine the patch with the naked eye and determine how clearly marked the arrows or grids are to signify correct application with respect to skin orientation of the product (blue, shiny, grid side faces up and the foam side faces down towards the skin). 3.(Staff Efficiency of Care/ Patient Safety) The clear occlusive device securement dressing covers, protects and secures the catheter while allowing visualization of the insertion site. a. Clinicians require that the product is engineered with a secure-fit transparent adhesive on all sides to provide an optimal seal and visualization of the insertion site, while preventing germs and bacteria from getting to the wound site. b. This criterion will be evaluated in the clinical setting by use of the product on at least (3) patients. c. After removing the paper backing and applying the dressing, the evaluator will examine the dressing to see how well it stabilizes and secures the catheter and visualizes the site, noting any moisture or looseness. 4. (Staff Efficiency of Care) The kit contains all of the necessary components for aseptic catheter insertion and site maintenance and is easily accessible. a. Clinicians require that products come in a complete kit reducing the necessity to gather and assemble extra components. b. This criterion will be evaluated in a clinical setting by use of the product on at least (3) patients. c. The evaluator will open/remove products from the packaging without having to assemble any of the components. Evaluator will observe the ease of performing the task. Pricing Analysis Process. Upon completion of the Phase I – Technical/Company Criteria Evaluation, vendors who are found technically acceptable will be qualified/invited to provide their their product samples and price discount quotes concurrently. Vendors will be given 14 calendar days from the date of pricing requests, to submit RIA pricing quotes, in a prescribed electronic spreadsheet format, based upon the requirements of the Northeast Region. Pricing must be received at the TRBO by COB 5:00 PM (EST), fourteen (14) calendar days after the issue date of the vendor notice to submit best product and price quotes. 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 consideration/ participation. The Region intends to evaluate quotes and select a vendor on initial submissions/quotes. Vendor quotes should contain the vendor's best product matches for the products or product lines requested in this announcement. Vendor quotes 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). The Region intends to evaluate quotes and select a vendor or vendor(s), without discussions as noted above. However, the Region 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. Clinical/performance and technical/company factors will be weighted more heavily than price. 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. Pricing will be evaluated based on best value to the government and will be based on a committed volume for a two year (24 months) from date of selection with three one year (12 months) 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). This represents the new estimated annual cost or the total cost post standardization and includes the vendor’s products, and the products that could not be matched. The unmatched lines make it difficult to compare the prices of the various vendors, because the evaluator cannot compare similar product lines for each vendor. Those items that are considered in the high usage category will have a higher impact to the region for the unmatched product line and the end post-standardization costs. (3) Consideration of 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. (4) Potential Cost Avoidance. Cost avoidance is calculated by subtracting the RIA price from the Distribution and Pricing Agreement (DAPA) price and multiplying by 12-months of usage. This is included as a reporting Matrix. Operational Impact of RIA prices on the Northeast Region are considered more important than other pricing elements. _____________________________________________________________________________ END
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