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FBO DAILY ISSUE OF AUGUST 07, 2011 FBO #3543
SOLICITATION NOTICE

65 -- Sequential Compression Devices, Sleeves and Tubing - Technical / Company Requirement Response Document

Notice Date

8/5/2011
 

Notice Type

Combined Synopsis/Solicitation
 

NAICS

339112 — Surgical and Medical Instrument 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

MW-1104-27_Sequential_Compression_Devices_Sleeves_Tubing
 

Archive Date

9/10/2011
 

Point of Contact

Cheryl Janus, Phone: (619) 532-7554, Ricardo Orias, Phone: 619-532-8537
 

E-Mail Address

cheryl.janus.ctr@med.navy.mil, ricardo.orias.ctr@med.navy.mil
(cheryl.janus.ctr@med.navy.mil, ricardo.orias.ctr@med.navy.mil)
 

Small Business Set-Aside

N/A
 

Description

Responses to this RFIAQ should include all the information as indicated in the FBO. The Defense Medical Materiel Program Office (DMMPO) announces a Request for Incentive Agreement Quotation (RFIAQ) for the standardization of Sequential Compression Devices, Sleeves and Tubing. The MMESO West 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 (hereafter referred to as MMESOs) areas of responsibility (AOR) and operational assemblages based on the critical balance of clinical efficacy and value. The intent for this initiative is the standardization of a clinically preferred product(s) and source for institutional and operational medicine requirements at the lowest price. It is also intended for this initiative to result in the reduction of Stock Keeping Units (SKUs) and National Stock Numbers (NSN). Standardized products must be obtained through the Department of Defense (DoD) Prime Vendor (PV) 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 expectations as a primary consideration. Among vendors who meet the technical requirements and the products that meet or exceed the clinical acceptability, then clinically preferred, best value 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 MMESOs include, but are not limited to MMESO North: Walter Reed Army Medical Center, National Naval Medical Center, Naval Medical Center Portsmouth, Wright-Patterson Medical Center; MMESO South: Wilford Hall Medical Center, Brooke Army Medical Center, Naval Hospital Jacksonville, Martin Army Community Hospital; MMESO West: Naval Medical Center San Diego, Madigan Army Medical Center, Irwin Army Community Hospital, Mike O'Callaghan Federal Hospital; MMESO Pacific: Tripler Army Medical Center, Honolulu, HI, 18th Medical Group, Kadena AB, Okinawa, US Naval Hospital, Yokosuka, Japan; MMESO Europe: Landstuhl Regional Medical Center, Landstuhl, GE, US Naval Hospital, Naples, Italy, the 48th Medical Group, Lakenheath, UK; and Operational U.S. Forces. This SA is part of the Medical/Surgical Prime Vendor program executed by the Defense Logistics Agency (DLA) Troop Support, Directorate of Medical Materiel. To participate in this SA your company must have a Distribution and Pricing Agreement (DAPA) and a separate commercial agreement with the current Med-Surg PV 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 initiative and agree to allow PVs to distribute their products. The IA resulting from this RFIAQ is a supplement to the PV Program and is not a contract. For additional information regarding DLA TS Medical's PV 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 participate in 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 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 December 2011. The selection will be based on the product and vendor that provides the Best Value to the enterprise. Products and vendors that meet or exceed the technical and clinical performance requirements will be considered clinically preferred 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. Points of Contact: Ricardo Orias, MMESO West Team Leader, Ricardo.orias.ctr@med.navy.mil, (619) 532-8537 and Cheryl Janus, MMESO West Clinical Analyst, Cheryl.janus.ctr@med.navy.mil, (619) 532-7554. B. Products & Performance Required The MMESOs are seeking product line items in the category of Sequential Compression Devices, Sleeves and Tubing. Within the MMESOs, this product line has an estimated annual dollar requirement of $5,851,921, of which $285,928 or 4.89% were reprocessed. This forecast is based on historical Prime Vendor sales during a recent 12-month period. Based on usage data, the top forty three (43) line items of the total fifty three (53) line items, account for 99% ($5,810,492) of the total volume in sales $5,851,921 in the MMESOs and are procurement significant. The top high volume usage lines for this project are shown in the Technical/Company Requirements below. C. Instructions to Vendors Vendors interested in participating in this standardization initiative will provide an initial response to the FBO-posted RFIAQ to Ricardo Orias, MMESO West Team Leader, ricardo.orias.ctr@med.navy.mil and Ms. Cheryl Janus, Clinical Analyst, cheryl.janus.ctr@med.navy.mil. The vendor's initial responses will include detailed information requested in the technical/company requirements listed in the FBO RFIAQ 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 email to be lost in transmission, from network security, etc., vendors are strongly encouraged to confirm with the MMESO West that their initial submissions, quote and literature arrived at the MMESO West 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. Vendor should complete and submit the attached document. A vendor who cannot open the attachments, may contact the POC as noted in the FBO RFIAQ and a copy will be provided via an alternate method (fax, email or hard copy). Vendors that do not meet the deadline of COB 5:00 PM Pacific Daylight Savings Time (PDST) 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 Designated Senior Logisticians (DSLs) and co-chaired by Designated Senior Clinicians (DSCs) in the MMESO AORs and include clinicians and logisticians for MTFs within each MMESO. The Clinical Advisory Committee (CAC) members are the deciding officials for this initiative. 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 West reserves the right to conduct discussions and request revised quotes, if determined necessary. Phase I Technical / Company Requirements The MMESO CPT will review the responses from the vendors and determine which vendors meet the technical/company requirements. A vendor must meet the technical requirements for continued consideration in this initiative. 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 and invited to participate in the clinical/performance selection process and will be requested to submit products for testing and their best price discount quotes via an e-mail 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 pre-source selection procedures, the CPT approved the company/technical requirements outlined below. The eleven (11) requirements below must be answered with the vendor's initial submittal and required documents by the response date stated in the FBO announcement. A vendor who does not meet these requirements or who does not submit documentation to support these requirements with initial submittal will be disqualified in Phase I. 1. Vendor must provide a line of Sequential Compression Devices, Sleeves and Tubing made of latex free, non-abrasive, non-irritating materials, securely fastening limb sleeves and low noise level emitting pumps that hang securely off a gurney or bed that includes at a minimum the specific products identified below: a. SLEEVE SEQUENTIAL COMPRESSION DEVICE CALF STANDARD/MEDIUM OR NEAREST EQUIVALENT DISPOSABLE WITH LOCKING MECHANISM PAIR NON-STERILE SLEEVE SEQUENTIAL COMPRESSION DEVICE THIGH STANDARD/MEDIUM OR NEAREST EQUIVALENT DISPOSABLE W/LOCKING MECHANISM PAIR NON-STERILE * Operational usage items are included in this list of Sequential Compression Devices, Sleeves and Tubing. b. Vendor must provide a complete itemized list of products supplied (manufacture and/or distribute by brand) via Microsoft Excel sheet, and a product catalog and literature in response to this RFIAQ that includes the following information: (1) product packaging is clearly labeled with size, latex content and lot number (2) list of latex free products of varying sizes (3) list of pump performance characteristics including number of inflation bladders, hose features (lengths, quick disconnect for replacement or increasing length) and if "single limb mode" is a standard option (4) instructions for sizing sleeves/garments. The type of literature is not a disqualifier; however, the failure to provide the requested information will result in disqualification in Phase I. 2. Vendor must have a DAPA or be in the process of obtaining a DAPA for the Sequential Compression Devices, Sleeves and Tubing product line. Vendor must provide the DAPA number or provide documentation the DAPA number has been applied for. 3. Vendor must have agreements with the current Med/Surg Prime Vendors for each MMESO AOR, i.e. Cardinal Health and Owens & Minor for Sequential Compression Devices, Sleeves and Tubing or be in the process of obtaining Prime Vendor agreements. 4. Vendor will be required to submit discounts off of DAPA for all products included in this standardization initiative when pricing is requested in Phase III. 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 in Phase II for all products will be disqualified. 5. Vendor must provide pumps and the necessary hoses at no cost if awarded the Incentive Agreement. Vendor must state the ratio of number of sleeves/garments for every pump provided to each facility at no cost with initial submittal. Vendor must keep in mind that DoD facilities use reprocessing as part of their "going green" mission. 6. Vendor must submit a detailed written conversion/implementation plan that includes a plan for the replacement of existing pumps and hoses at each facility with initial submittal. 7. Vendor must have an identified customer service representative available for on-site assessment, on-site instructional sessions (in-services), and on-going clinical support as required at no cost to the government for the Sequential Compression Devices, Sleeves and Tubing product line. A vendor must provide a list of customer service representatives with initial submittal. 8. Vendor must provide, at no charge to the government, a trial compressor/pump to each of the evaluating facilities. The compressor/pump will be returned to the vendor after completion of the evaluation phase. The vendor will be asked to provide a return prepaid shipping label or have a local vendor representative pick up the compressor/pump. 9. Vendor must provide evidence of FDA 510(K) approval for Sequential Compression Devices - Pumps, sleeves and tubing. Class II Devices, FDA requirements (21CFR820). Vendor must provide documentation to support this request with initial submittal. Vendor whose products do not meet requirements or who does not provide supporting documentation will be disqualified in Phase I. 10. Vendor must provide an instructional DVD to be used by all evaluating CPT members prior to the evaluation of the Sequential Compression Devices Sleeves and Tubing. A vendor who cannot provide an instructional DVD in support of these requirements will be disqualified in Phase I. 11. The evaluation of medical equipment may require service specific Biomedical Safety checks and Bailment / loaner equipment documents to be completed before a clinical evaluation is undertaken. Vendors must be able to deliver the required sample equipment to the identified clinical evaluation sites and complete all requirements before the clinical evaluation start date identified in the Phase II invitations to participate. CPT site specific requirements will be identified in the letter of invitation. Invited vendors will support each evaluating MTF's requirements for any Biomedical safety checks and equipment loaner documents. This requirement will be conducted in a 15-day period, which will commence on the deadline date for sample delivery. Phase II Clinical Performance Evaluation Following acceptability of the technical/company requirements, the MMESO West, on behalf of the CPT, will request product sample sets from the product group to be sent to the specific 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 in Phase II. Product samples must be shipped to arrive at the designated addresses for each MTF by 5:00PM local time on the 30th calendar day after the notice to ship. Vendor must be able to deliver product literature, training materials and evaluation samples as requested to the MMESO Pacific via FedEx or UPS AND to the MMESO Europe via United States Postal Service (USPS) Express Mail AND throughout the United States by selected shipping method when requested in Phase II. Vendor must send the MMESO West 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 (sleeves and tubing) will not be returned. Two (2) pairs of the item listed below with one (1) pump/compressor and the necessary hoses are to be provided to each of the evaluation sites as identified in the letter of invitation. SLEEVE SEQUENTIAL COMPRESSION DEVICE CALF STANDARD/MEDIUM OR NEAREST EQUIVALENT DISPOSABLE WITH LOCKING MECHANISM PAIR NON-STERILE Each evaluator will evaluate each product sample from each vendor against the established requirements. A trial will consist of evaluating 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. The clinical/performance acceptability evaluation period will last for fourteen (14) calendar days. The acceptability 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 4.0 as the Clinically Preferred threshold of products for standardization. A vendor scoring below the clinically preferred threshold will be disqualified from selection for this standardization initiative. A vendor who has been disqualified will be notified in writing upon disqualification. Of those vendors that are qualified as clinically preferred, selection will be based on best price. 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 West and results will be forwarded to the MMESO CPT for final review. There will be approximately eleven (11) MTFs enterprise wide that will be evaluating products. Clinical/Performance Requirements During the acquisition planning process, the CPT approved the clinical/performance requirements outlined below. 1. US FDA Medical Devices Regulations and Guidance - Patient Safety and Comfort - The inner lining and all adjoining seams of the sleeve/cuff are made of breathable material that is smooth, soft and nonabrasive to the patient's skin. Skin integrity can be fragile and a rough material can be abrasive and scratch the skin, breaking the first defensive barrier of the body. 2. U.S. FDA Medical Devices Regulation and Guidance -Patient Safety and Clinical Efficiency - The connection tubing has a length that will not hamper position changes or movement of short distances from device. Tubing that is too short can disconnect and cause interruption in prescribed therapy. Tubing that is too long can be tripped over, become kinked or tied up, thus affecting the integrity of the tubing and causing the device to malfunction. 3. U.S. FDA Medical Devices Regulations and Guidance - Patient Safety and Patient Comfort, and Therapeutic Effectiveness - The sleeve/cuff will fasten to limb (thigh, calf or foot) and can be adjusted. The correct alignment of the devices is critical for the overall effectiveness of the device. 4. AORN Standard III and FDA Medical Devices Regulations and Guidance - Patient Safety and Clinical Efficiency - Pump emits low level of noise and low level of vibration. Vibration conducted through the bed frame or a loud humming machine noise can disturb the patient's ability to sleep/rest. Sleep and rest are critical elements to successful patient recovery. 5. IC.02.02.01 - Patient Safety - The pump and tubing are easy to clean. The pump is to be cleaned between patient applications. Residue of debris is a contaminant and can be harmful to a patient. 6. FDA Medical Devices Regulations and Guidance - Patient Safety, Longevity of the Pump and Cost of Care - The pump hangs securely off the end or side of the bed; or the end of the gurney. An insecure pump can fall, break and interrupt the therapeutic process to the patient; and, a pump on the floor is a potential for hospital-acquired infection. 7. AORN Standard III and FDA Medical Devices Regulations and Guidance - Patient Safety and Clinical Efficiency - The pump is easy to operate and requires minimal training. All buttons on the pump are identified as to their function; alarm systems are automatically activated w/out clinician initiation and inflation/deflation action is accomplished with one single action. 8. FDA Medical Devices Regulations and Guidance - Patient Safety, Longevity of the Pump and Cost of Care - The device will have an alarm that is seen, heard and silenced. The problem area will be identified. The alarm instructions will be analyzed for information/corrective action. Clinicians should be able to readily determine whether problem is an easy fix or device needs to be replaced. An alarming pump will disturb patient's rest and involve clinicians in the additional duty of stopping their activities and analyzing the alarm incident. 9. AORN Standard III and FDA Medical Devices Regulations and Guidance - Patient Safety and Clinical Efficiency - The sleeve attaches to the tubing securely. The tubing has an easy and quick way to be released/detached from the sleeve and pump. The sleeve must attach securely to maximize clinical effectiveness and patient safety. The tubing must have a quick release attachment to facilitate cleaning and replacement of the defective/worn hose. 10. FDA Medical Devices Regulations and Guidance - Patient Safety and Usage Cost - The size and type of the sleeve can be identified from the packaging. The packaging will clearly identify the type and size of the sleeve. The wrong sized sleeve can be injurious to the patient; and, increase the usage cost through wastage. Phase III Pricing Analysis Upon completion of the Phase I - Technical/Company Requirements, a vendor who is found technically acceptable will be qualified / invited to provide product samples and price discount quotes concurrently. A vendor 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 will be submitted to MMESO West and must be received by 5:00 PM PDST, 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. 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/MW-1104-27_Sequential_Compression_Devices_Sleeves_Tubing/listing.html)
 

Place of Performance

Address: Medical Materiel Enterprise Standardization Office (MMESO) West, 34960 Bob Wilson Dr., San Diego, California, 92134, United States

Zip Code: 92134
 

Record

SN02523576-W 20110807/110805234853-e65f9f17318ba0bab3af11df1da29d97 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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