SOLICITATION NOTICE
65 -- Electrocautery Supplies - FBO Responses to Technical Requirements
- Notice Date
- 5/23/2011
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 339113
— Surgical Appliance and Supplies Manufacturing
- Contracting Office
- Defense Logistics Agency, DLA Acquisition Locations, DLA Troop Support - Medical, 700 Robbins Avenue, Philadelphia, Pennsylvania, 19111-5096, United States
- ZIP Code
- 19111-5096
- Solicitation Number
- MP-1103-13_Electrocautery_Supplies
- Archive Date
- 6/29/2011
- Point of Contact
- Corazon toledo, Phone: 808.433.3686, Mary Summers, Phone: 808-433-3686
- E-Mail Address
-
Corazon.M.Toledo.ctr@us.army.mil, mary.summers1@us.army.mil
(Corazon.M.Toledo.ctr@us.army.mil, mary.summers1@us.army.mil)
- Small Business Set-Aside
- N/A
- Description
- Utilize the attachment for FBO Technical/Company Requirements. The Defense Medical Materiel Program Office (DMMPO) Medical Materiel Enterprise Standardization Office (MMESO) announces a Request for Incentive Agreement Quotation (RFIAQ) for the standardization of Electrocautery Supplies. The MMESO Pacific is the lead MMESO for this project. The primary objective of this program is to standardize the quality of care across the MMESO North, South, West, Pacific, Europe and operational assemblages based on the critical balance of clinical efficacy and value. It is intended for this initiative to result in the standardization of a technically and clinically preferred product (s) and source for institutional and operational medicine requirements at the best possible price. It is also intended that standardized products be obtained through the Department of Defense (DoD) Prime Vendor Program. As an enterprise-wide clinically driven program, vendors and products must meet specific technical requirements plus products must meet or exceed specific clinical performance requirements as a primary consideration. Among vendors who meet the technical requirements and the products that meet or exceed the clinical preferred threshold, best price will determine selection. It is intended that the selected standardized vendor (s) for this Standardization Action (SA) support the enterprise goal of medical materiel standardization that combines operational and institutional requirements. The government is seeking a single award for this SA. The major facilities in the MMESO North, South, West, Pacific, and Europe include, but are not limited to MMESO North: Walter Reed Army Medical Center, Bethesda Naval Hospital, Portsmouth Naval Hospital, Womack Army Medical Center, Wright-Patterson Medical Center; MMESO South: Wilford Hall Medical Center, Brook Army Medical Center, Eisenhower Army Medical Center, Darnall Army Medical Center, Keesler Medical Center, Naval Hospital Jacksonville, Martin Army Community Hospital, Fort Benning, GA; MMESO West: Madigan Army Medical Center, William Beaumont Army Medical Center, Naval Medical Center San Diego, Irwin Army Community Hospital, Mike O'Callaghan Federal Hospital; MMESO Pacific: Tripler Army Medical Center, 18th Medical Group, Kadena AB, Okinawa, US Naval Hospital, Yokosuka, Japan; MMESO Europe: Regional Medical Command, Heidleberg, GE, Landstuhl Regional Medical Center, GE, US Naval Hospital, Naples, Italy, 48th Medical Group, RAF Lakenheath. This standardization action is part of the Medical/Surgical Prime Vendor program executed by the DLA Troop Support, Directorate of Medical Materiel. To participate, your company must have a Distribution and Pricing Agreement (DAPA) and a separate commercial agreement with the current Med-Surg Prime Vendor for each MMESO Region, i.e., Cardinal Health, and Owens& Minor. This requirement is pursuant to the DAPA clause by which DAPA holders agree to the standardization process and agree to allow Prime Vendors to distribute their products. The Incentive Agreement (IA) resulting from this RFIAQ is a supplement to the Prime Vendor Program and is not a contract. For additional information regarding DLA Troop Support Medical's Prime vendor program please access its web site at https://dmmonline.dscp.dla.mil This IA standardization initiative will be a Three Phase IPP Process: vendor (s) who meets the technical / company requirements in Phase I will be invited to advance and participate Phase II where no-charge products will be provided for clinical evaluation and Phase III where pricing will be required for submittal. Phase II and Phase III will be run concurrently. The resulting Incentive Agreement (IA) will be for a base period of two (2) years (24 months) from date of selection with three (3) 12-month "option" periods not to exceed a total of 5 years. Anticipated selection date is August 2011. The selection will be based on the product and vendor that provides the Best Value to the enterprise after consideration of technical requirements, clinical and pricing factors. Products and vendors that meet or exceed the technical and clinical performance expectations will be considered clinically acceptable products and sources. Among vendors who meet the technical requirements and the products that meet or exceed the clinically preferred standard, best price (i.e. lowest Aggregate Post Standardization Cost) will determine selection. Point of Contact: Mary Summers, MMESO Pacific Team Leader, mary.summers1@us.army.mil and Cora Toledo, Clinical Analyst, Corazon.m.toledo.ctr@us.army.mil B. Products & Performance Required. The MMESOs are seeking product line items in the category of Electrocautery Supplies. Within the MMESOs this product line has an estimated annual dollar requirement of $1,950,754.50. This forecast is based on Medical Product Data Base (MEDPDB) usage data over 12-months of recent usage. Based on the recent 12-month usage data, the top twenty (20) lines items of the total three hundred and four (304) line items, account for 75% ($1, 472,722.29) of the total volume in sales ($1,950,754.50) in the MMESOs and are procurement significant. The top high volume usage lines for this project are shown in the technical/company requirements below, consolidated by product type to reduce duplication within the top 20 lines. This represents the line item, or SKU, reduction that is an additional objective of this program. C. Instructions to Vendors Vendors interested in participating in this standardization initiative will provide an initial response to the FBO-posted RFAIQ to Mary Summers, MMESO Pacific Team Leader, mary.summers1@us.army.mil and Cora Toledo, Clinical Analyst, Corazon.m.toledo.ctr@us.army.mil. The vendor's initial responses will include detailed information requested in the technical/company requirements listed in the FBO RFAIQ and must also include: (1) Company name and address; (2) Company Point of Contact (POC) (Name and Phone Number, Fax Number, and E-mail address); and (3) Identification of the RFIAQ to which the vendor is responding. Due to the potential for e-mail to be lost in transmission, from network security, etc., vendors are strongly encouraged to confirm with the MMESO that its initial submission, quote and literature actually arrived at the MMESO 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 Hawaii Standard Time (HST) on the date listed for closing will be disqualified from further consideration in the standardization initiative. D. Source Selection Procedures The MMESO Joint Product Review Board (JPRB) will serve as the forum for clinical recommendations for product selection, seeking and evaluating opportunities for committed volume purchase agreements, and coordinating logistics efforts in support of DoD Components. The boards are chaired by the Designated Senior Logisticians (DSLs) and co-chaired by a Designated Senior Clinician (DSC) in the MMESO AORs and include clinicians and logisticians for Medical Treatment Facilities (MTFs) within each MMESO AOR. The Clinical Advisory Committee (CAC) members are the deciding officials for this initiative. The MMESO DSLs and DSCs intend to evaluate quotes and select a vendor on initial submissions/quotes. Vendor quotes should contain the vendor's best discounts off of the vendor's DAPA pricing (based on committed volume of 80% of the total requirements of the MTFs in the MMESOs. The MMESO reserves the right to conduct discussions and request revised quotes, if determined necessary. The MMESO Pacific reserves the right to limit the number of quotes to the greatest number that will permit an efficient competition among vendors. The MMESO Pacific reserves the right to conduct discussions and request revised quotes, if determined necessary. Technical Requirements The MMESO CPT will review the responses from the vendors and determine which vendors meet the technical/company requirements and determine acceptability. A vendor must meet the technical requirements for continued consideration in this initiative. A vendor who does not meet the requirements will be disqualified. Failure to provide any requested information or meet any of the technical requirements will disqualify the vendor from further consideration. A vendor who meets the following technical/company requirements will be qualified/invited to participate in the clinical/performance selection and will be requested to submit their best product/price discount quotes via an email communication. All communications of significant acquisition milestones (such as invitations to participate, or notices of disqualification) should be digitally signed. Technical/Company Requirements: During the acquisition planning process, the MMESO CPT validated/approved the technical/ company requirements outlined below. The five (5) requirements below must be answered with the vendor's initial submittal by the response date stated in the FBO announcement: 1. Vendor MUST provide a complete line of Electrocautery Supplies products that includes at a minimum the specific products identified below are designed to be easy to use, sterile, latex free/safe, disposable and/ or reusable, and offer monopolar and/ or bipolar output. a. REQUIRED ITEMS PAD GROUNDING ADULT ADHESIVE SPLIT DISPOSABLE with CORD PENCIL CAUTERY CORDLESS DISPOSABLE FINE HI-TEMP STERILE PENCIL CAUTERY HAND CONTROL ROCKER NEEDLE TIP W/HOLSTER DISPOSABLE STERILE with CORD ELECTRODE CAUTERY BLADE 6.5INL DISPOSABLE STERILE ELECTRODE CAUTERY NEEDLE 1.0INL DISPOSABLE ELECTRODE LAPAROSCOPY MONOPOLAR DISPOSABLE L-HOOK WIRE 5MM DIA PTFE COATED STERILE CAUTERY TIP CLEANER * Operational usage items are included in this list of Electrocautery Supplies b. Vendor MUST provide a complete itemized list of items supplied (manufacture and/or distribute by brands and descriptions) via excel sheet, and product catalog & literature in response to this RFIAQ with initial submittal. Vendor is required to supply all items listed in all sizes and device type. (A vendor who does not have a complete product line will be disqualified in Phase I). c. Additionally, the government is seeking full body gel grounding pads. Failure to have a full body gel grounding pad will not eliminate a vendor from participating in the standardization effort. Vendor must identify whether they can supply full body gel grounding pads. 2. Vendor MUST have a DAPA or be in the process of obtaining a DAPA for the Electrocautery Supplies product line. Vendor MUST provide the DAPA number with initial submittal or provide documentation that DAPA has been applied for with response submittal. A vendor without a DAPA number or who has not applied for a DAPA will be disqualified in Phase I. 3. Vendor MUST have agreements with the current Med/Surg Prime Vendors for each MMESO AOR, i.e. Cardinal Health and Owens & Minor for Electrocautery Supplies or be in the process of obtaining Prime Vendor agreements. Vendor must provide documentation to support agreements with initial submittal. A vendor whose products are not available through the Prime Vendors or who has not applied for PV distribution will be disqualified in Phase I. 4. Vendor MUST submit discounts off of DAPA for all products included in this standardization initiative. (Note: a vendor who fails to submit a discount off of DAPA will be disqualified. Where lower FSS prices are available, DAPA holders are required by previous agreement to provide the FSS price as the DAPA price. A vendor shall not quote FSS prices as the discounted price for purposes of this standardization initiative). A vendor who does not provide discounts off DAPA for ALL products in Phase III will be disqualified. 5. Vendor MUST provide Electrocautery products that are approved for use by ASA Standards, Guidelines and Policies in all clinical settings, and provide literature to support this requirement with the initial submittals. Phase II Plan - Selection Process Clinical/Performance Selection Process Following acceptability of the technical/company requirements, the MMESO Pacific, on behalf of the CPT, will request product sample sets from the product group to be sent to the CPT members at the participating MTFs. Vendor will be given 30 calendar days from the issue of the notice in which to deliver the product samples for clinical evaluation at Phase II. Product samples must be shipped to arrive at the designated addresses by 5:00PM local time for each MTF on the 30th calendar day after the notice to ship. Vendor MUST be able to deliver product literature, training materials and evaluation samples to the MMESO Pacific via FedEx or UPS AND to the MMESO Europe via United States Postal Service (USPS) and throughout the United States when requested in Phase II. Vendor who cannot or does not meet this requirement will be disqualified from the standardization process. Vendor must send the MMESO Pacific verification regarding the shipment of literature and samples. This information will include the date of shipment, final delivery date, tracking numbers and the carrier used by the vendor. Vendor will provide ONLY the following no cost product samples for clinical/performance evaluation. (Unused samples will not be returned. Two (2) samples of each specific disposable product in the sizes listed below are to be provided to each of the evaluation sites as identified in the letters of invitation, except for Naval Medical Center San Diego, Naval Hospital Bremerton, William Beaumont Army Medical Center, and Naval Hospital Camp Pendleton that will each require four (4) samples of each product in the sizes listed below. Item to Send Number Each to send per MTF Size Item Description Grounding Pads 2 Adult PAD GROUNDING ADULT ADHESIVE SPLIT DISPOSABLE WITH CORD Cautery Pencil 2 N/A PENCIL CAUTERY HAND CONTROL ROCKER NEEDLE TIP DISPOSABLE/ STERILE W/CORD AND HOLSTER Cautery Pencil 2 N/A ELECTRODE CAUTERY NEEDLE 1.0INL DISPOSABLE Each evaluator will evaluate the Electrocautery Supplies product samples from each vendor against the established requirements. A trial will consist of evaluating all sample products from a single vendor, evaluated against the requirements and recorded on a single evaluation form per vendor. Each evaluator will evaluate or trial each participating vendor's product line in a clinical/patient care setting. The clinical/performance evaluation period will last for fourteen (14) calendar days. The evaluation responses will be in a Likert scale format with a one (1) through five (5) scoring range. The scale descriptors are: one (1)- Completely unacceptable, two (2)- Overwhelmingly unacceptable, three (3)- Partially unacceptable, four (4)- Acceptable, and five (5)- Highly acceptable. The MMESO JPRB has established a target threshold of 4.0 as the clinically preferred threshold of products for standardization. Vendors scoring below the clinically preferred threshold will be disqualified from selection for this standardization initiative. Of those Vendors that are qualified as clinically preferred, selection will be based on best price. A vendor who has been disqualified will be notified in writing upon disqualification. Clinical /performance acceptability evaluations by the participating CPT facilities will be tabulated resulting in one score per participating MMESO per vendor. The participating MMESOs' scores by vendor will then be combined resulting in one final vendor performance evaluation score. All clinical/performance acceptability evaluations will be tabulated by the MMESO Pacific, and results will be forwarded to the MMESO CPT for final review. There will be approximately seventeen (17) MTFs enterprise wide that will be evaluating products. Clinical Performance Requirements During the acquisition planning process the MMESO CPT validated/approved the clinical/performance requirements outlined below: 1. The cautery pencil is easily held and used by either hand. ( Non slip grip provides improved control and efficiency) (Clinician Efficiency of Care/ Patient Safety - NPSG 07.0201), OSHA 1910.132 ( c) (Patient and Healthcare Provider Safety) Evaluator will hold the non-slip grip cautery pencil in their dominant, gloved hand. Evaluator should be able to easily hold and maneuver the cautery pencil with control and efficiency, throughout the procedure, in order to avoid patient injury. 2. Electrode and needle tip are easily loaded and remain in place without adjustment. (World Health Organization 2003, Surgical Care at the District Hospital, 2.3; Health Devices, 1994). OSHA 1910.1030 (Patient and Healthcare Provider Safety). The electrode and needle tip must be easily loaded and will remain in place without adjustment allowing for safe passing of sharps to prevent injuries in operating rooms. 3. Length of cord for pencil and grounding pad is adequate for general procedures. (World Health Organization 2003, Surgical Care at the District Hospital, 2.3; Health Devices, 1994). OSHA 1910.333 (a) (Patient and Healthcare Worker Safety.) Cords will comfortably reach the operative site and minimize the risk of tripping or contamination of the surgical field. Cord length should be approximately 4 to 10 feet in length, long enough to provide adequate length of cord that is not cumbersome while doing the procedure. 4. All connectors on pad, pencils, and cords are secure. ( AORN Standards and Recommended Practices for Perioperative Nursing III; 2011; Health Devices, 1994). OSHA 1910.333, 1926.416 (Patient and Healthcare Provider Safety) Direct observation and manipulation of the instrument will help ensure that components are operationally intact and secure connectors help prevent shock or other injuries from either direct or indirect electrical contacts, when work is performed. 5. Pad conforms to patient's anatomy for maximum safety and is adequately pre-gelled. (ECRI Institute Health Devices, Jan 1980) (Patient Safety) OSHA 1910.132 ( c) (Patient and Healthcare Provider Safety) Adequately pre-gelled pad will reduce the risk of injury, fight pad burns and increase patient safety. 6. The non-conductive holster is easily secured to the sterile field. (World Health Organization 2003, Surgical Care at the District Hospital, 2.3; Health Devices, 1994; ECRI Los Angeles Fire Marshall). (Patient and Healthcare Provider Safety) When not in use, the cautery pencil should be placed in a clean, dry, non-conductive holster. This will prevent inadvertent activation of the cautery pencil that can cause fire. 7. Packaging is clearly marked as to content and allows for safe delivery to the sterile field. Global Harmonization Task Force SG1/N020R5 (Medical Device Safety and Patient Safety), Patient Safety and Infection Prevention- NPSG 07.02.01 Packaging must be easy to open and allows safe delivery to the sterile field to prevent the risk of contamination. 8. Packaging of the grounding pad is easily identifiable by color code with the size of the pad that is specific for adult, pediatric, and neonate. (Patient and Healthcare Provider Safety) OSHA 1910.333, 1910.132. AORN Standards and Recommended Practices for Perioperative Nursing 2010. Association for the Advancement of Medical Instrumentation. ANSI/AAMI HF18:2001. Electrosurgery checklist. Operating Room Risk Management. 2007; 2 (Surgery 10) ECRI Institute. The grounding pad packaging easily identifies the color coded product with the correct size and quickly visualizes the clearly marked expiration date and lot number. Using an appropriate sized grounding pad reduces the concentration of current and minimizes the potential for electrosurgical injuries. Phase III Pricing Analysis Price Analysis Upon completion of the Phase I - Technical/Company Requirements Evaluation, a vendor who is found technically acceptable will be qualified /invited to provide their product samples and price discount quotes concurrently. Vendors will be given 30 calendar days from the date of pricing requests to submit IA pricing quotes, in a prescribed electronic spreadsheet format, based upon the requirements of the MMESOs. Pricing must be received at the MMESO Pacific by 5:00 PM HST, thirty (30) calendar days after the issue date of the vendor notice to submit best price quotes. Vendor quotes should contain the vendor's best product matches for the specific products requested in this announcement. The MMESO DSLs and DSCs intend to evaluate quotes and select a vendor on initial submissions/quotes. Vendor quotes should contain the vendor's best discounts off of the vendor's DAPA pricing for the products identified in this announcement based on committed volume of 80% of the total requirements of the MTFs in the MMESOs. Price will be analyzed based on the projected Aggregate Post-Standardization costs for each vendor. Aggregate Post-Standardization Cost will be calculated for each vendor by applying the vendor's offered prices to the anticipated annual usage of the enterprise. Unmatched items will be represented in the Post-Standardization Cost at a baseline non-discounted price (current DAPA price of product with highest procurement). Among the products and sources that were determined to be clinically preferred, the best price Aggregate Post-Standardization Cost will be selected.
- Web Link
-
FBO.gov Permalink
(https://www.fbo.gov/spg/DLA/J3/DSCP-M/MP-1103-13_Electrocautery_Supplies/listing.html)
- Place of Performance
- Address: Tripler Army Medical Center, 1 Jarrett White Road, United States, Honolulu, Hawaii, 96859-5000, United States
- Zip Code: 96859-5000
- Zip Code: 96859-5000
- Record
- SN02454066-W 20110525/110523233957-b9f2c6045b221b6960f47e5a3039fc4f (fbodaily.com)
- Source
-
FedBizOpps Link to This Notice
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