SRCSGT | 65 | Safety Scalpels and Blades

FBO DAILY ISSUE OF JUNE 07, 2009 FBO #2750
SOURCES SOUGHT

65 -- Safety Scalpels and Blades

Notice Date: 6/5/2009
Notice Type: Sources Sought
NAICS: 339113 — Surgical Appliance and Supplies Manufacturing
Contracting Office: Department of the Army, U.S. Army Medical Command, MEDCOM, North Atlantic Regional Contracting Office, ATTN: MCAA NA Bldg T20, 6900 Georgia Avenue NW, Washington, District of Columbia, 20307-5000
ZIP Code: 20307-5000
Solicitation Number: APP1-0904-001
Archive Date: 7/10/2009
Point of Contact: Toni Massenburg, Phone: 202 782-3666, Tracy Martin-Tilghman, Phone: 202 782-3663
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: 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 SAFETY SCALPELS AND BLADES. This product line consists of sterile, disposable and safety engineered scalpels with blades that are round-tipped and/or retractable; quick-release and/or shielded; separate and/or attached blades to handles; scalpel handles of various lengths and sizes with handles that must have a slip-resistant feature. Also included in this product line are carbon steel and stainless steel blades and disposable blade handles that are flash/steam autoclavable. At a minimum vendors are required to supply the surgical blades listed in the sizes listed below. 1.Safety blade, rib-back, carbon steel, disposable, sterile, individually packaged, 10 2.Safety scalpel, disposable, sterile, #10 3.Safety scalpel, disposable, sterile, #11 4.Non-safety blade, disposable, sterile, #15 5.Non-safety blade, rib-back, carbon steel, disposable, sterile, #15 and #11 6.Non-safety blade, 2.5mm, 60 degree, bevel down, disposable, sterile 7.Non-safety blade, disposable, non-sterile, #10 8.Non-safety blade, disposable, non-sterile, #11 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), 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 August 2009. 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. 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 SAFETY SCALPELS AND BLADES, which at a minimum includes the high volume lines below. Within this region, this product line has an estimated annual dollar requirement of $57,217. 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 Safety Scalpels & Blades 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 this product line consists of sterile, disposable and safety engineered scalpels with blades that are round-tipped and/or retractable; quick-release and/or shielded; separate and/or attached blades to handles; scalpel handles of various lengths and sizes with handles that must have a slip-resistant feature. Also included in this product line are carbon steel and stainless steel blades and disposable blade handles that are flash/steam autoclavable. At a minimum vendors are required to supply the surgical blades listed in the sizes listed below. i. Safety blade, rib-back, carbon steel, disposable, sterile, individually packaged, #10 ii.Safety scalpel, disposable, sterile, #10 iii.Safety scalpel, disposable, sterile, #11 iv.Non-safety blade, disposable, sterile, #15 v.Non-safety blade, rib-back, carbon steel, disposable, sterile, #15 and #11 vi.Non-safety blade, 2.5mm, 60 degree, bevel down, disposable, sterile vii.Non-safety blade, disposable, non-sterile, #10 viii.Non-safety blade, disposable, non-sterile, #11 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 all items listed in all sizes and device type. (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 Safety Scalpels & Blades 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 Safety Scalpels & Blades 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 Safety Scalpels & Blades 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 Safety Scalpels and Blades systems that have safety features that are an integral part of the safety scalpels. Vendors MUST identify their safety 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 list of all latex safe/free items supplied such as catalogs, etc. 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 3.00 for the Clinical Acceptability of products for standardization. The CPT will determine the actual Acceptability threshold for this standardization initiative -- at or near 3.00 -- 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 3.00, 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 that 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 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 Safety Scalpels and Blades, are those that will be the basis for specific technical/company and clinical/performance criteria. The standards are set forth by the following: a.The Joint Commission - Requires compliance with "applicable law and regulation" standards in the Governance (GO.2.4) and the Management (MA.2) chapters, The Needlestick Safety and Prevention Act. b.Federal Needlestick Safety and Prevention Act (PL 106-430), (November 6, 2000), which mandates revision of the 1991 OSHA Bloodborne Pathogens Standard to require the use of engineered sharps injury prevention devices. c.Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens Standard (29 CFR 1910.1030) and its related field directive, Inspection Procedures for the Occupational Exposure to Bloodborne Pathogens Standard (CPL 2-2.44, November 5, 1999) requiring use of engineered sharps injury prevention devices as a primary prevention strategy. The standards are located in the guidance set forth by the Occupational Safety & Health Administration (OSHA’s) Directorate of Enforcement Programs (DEP) - i.“bloodborne pathogens standards 29 CFR 1910.1030, “any contaminated object that can penetrate the skin, including but not limited to needles, scalpels, broken glass, broken capillary tubes, and exposed ends of dental wires,” 1910.1030 (b). ii.OSHA’s blood borne pathogens standard at 29 CFR 1910.1030 (c) (1) (iv) (B) requires employers to evaluate safer medical devices to eliminate/minimize employee exposure to blood or other potentially infectious materials (OPIM). iii.Solicit input from non-managerial employees in the election process [29 CFR 1910.1030 (c) (1) (v)]. iv.Engineering controls, including safety scalpels, must be implemented where their use is feasible [29 CFR 1910.1030 (d) (2) (i)]. Clinical/Performance Criteria: During the pre-source selection procedures, the CPT validated/approved the equally weighted clinical/performance criteria outlined below: Safety Scalpel Blade System: 1.The Safety Scalpel is ergonomically designed and comfortable to hold and use in either hand. a.Determining safety scalpel products that are comfortably engineered by the surgical staff not only will increase the potential for the safety scalpels to be utilized but it will put to work controls that can effectively minimize the hazards of operating room injuries related to scalpels. This also provides for the surgical staff to identify the products they will use so that the facility and region will be in compliance with the Joint Commission and OSHA’s requirements. b.The evaluator will gently grip/hold the safety scalpel between the thumb and index fingers, while gently balancing the scalpel handle in the remainder of the fingers in the same hand. 2.The safety feature of the Scalpel Blade System can be easily activated with one hand. a.The safety feature must be able to be easily activated with one hand in order to decrease operating room sharp incidents while passing instrument hand-to-hand, as well as protect employees who may be at risk for getting injured by an unprotected device. b.Per the manufacturer guidelines the evaluator is to grip/hold the safety scalpel between the thumb and index finger and release the safety mechanism as per manufacturer’s guidelines. 3.There is a clear and unmistakable change (audible / tactile / visible) that occurs when the safety feature is activated. a.The safety mechanism must be in place to assure that it is locked and that there is no compromise to the technique of providing a safety scalpel when related to the locking device. This will assist in minimizing potential sharp injuries in the operating room related to scalpels. b.The evaluator will activate the safety feature and hear, feel, and see a clear and unmistakable change or "clicks" that will help identify the blade's open and locked position. 4.The Safety Blade position is visible at all times on the sterile field. a.This will reduce the risk of blade and scalpel injuries by allowing clinicians to focus first on the surgical site, rather than on the instrument. b.The evaluator will have full visibility of the blade position at all times while on the sterile field to help reduce the risk of accidentally injury. Safety Scalpels with Handles 1.Safety blade is easily mounted onto blade handle. a.The Safety Blade System is easily assembled or mounted by grasping the protective shield with thumb and index finger with the blade tip pointing up. b.The handle cleat is inserted into the scalpel blade until the blade is up to the indicator line. c.The handle allows for the retraction of the scalpel blade inside the handle before passing, which helps reduce the risk of sharps injuries. d.The slider activation allows for the touchless disposal of used blades into a needle counter box. e.The two-piece handle uses standard protocol for sterilization. f.While following manufacturers guidelines, the evaluator will mount the safety scalpel to the handle provided. 2.The scalpel handle slip-resistant feature provides a secure hold in surgical gloved hands, accommodating to a variety of hand positions. a. The sure-grip sides on the handles allow for stable handling, preventing slippage, and allowing for easy loading, opening, and closing. b.The ability to hold the scalpel firm, yet gently enough to provide the delicate incisions of a traditional scalpel handle for surgeons’ increase not only their comfort in usage but also will assist in identifying a scalpel handle that meets their needs. c.The evaluator will hold the scalpel handle as per manufacturer guidelines while wearing surgical gloves and feel the slip-resistant feature through the gloves to help prevent risk of injury during use, passing and disposal. 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. Specifically it reflects the amount the Region would pay the vendor using the RIA pricing with the Non-Safety Scalpels and Blades converted to Safety Scalpels and Blades, including the current Safety Scalpels and Blades the region currently utilizes. (2) Impact of Unmatched Lines. 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.
Web Link: FBO.gov Permalink
(https://www.fbo.gov/spg/USA/MEDCOM/DADA15/APP1-0904-001/listing.html)
Place of Performance: Address: North Atlantic Regional Medical Command, ATTN: ACSLA (MCAT-LA), 6900 Georgia Avenue, NW, Washington, District of Columbia, 20307, United States; Zip Code: 20307
Record: SN01837593-W 20090607/090605235511-fe3e7de467547e92997fb4041b509375 (fbodaily.com)
Source: FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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65 -- Safety Scalpels and Blades