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FBO DAILY ISSUE OF JULY 09, 2011 FBO #3514
SOLICITATION NOTICE

65 -- Fingertip Pulse Oximeter - Vendor Responses to Technical Requirements

Notice Date

7/7/2011
 

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

MP-1105-36_Fingertip_Pulse_Oximeter
 

Point of Contact

Corazon Toledo, Phone: 808.433.2894, 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

Responses to this RFIAQ should include all the information as indicated in the FBO. Please use this document for all your responses. 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 Fingertip Pulse Oximeter. 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 (hereafter referred to as MMESOs) areas of responsibility (AOR) and operational assemblages based on the critical balance of clinical efficacy and value. This Standardization Action (SA) will apply to all MMESOs. 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 intended for this initiative to result in the reduction of Stock Keeping Units (SKUs) and National Stock Numbers (NSN). It is also intended that standardized products 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 requirements as a primary consideration. Among vendors who meet the technical requirements and the products that meet or exceed the clinical the clinical preferred threshold, best price will determine selection. It is intended that the selected vendor (s) for this 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 standardization action is part of the Medical/Surgical PV program executed by the Defense Logistics Agency (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 PV for each MMESOs Area of Responsibility (AOR), 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 PVs to distribute their products. The Incentive Agreement (IA) resulting from this RFIAQ is a supplement to the PV Program and is not a contract. For additional information regarding DLA Troop Support 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 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 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 October 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. Point of Contact: Ms. Mary Summers, MMESO Pacific, Team Leader, mary.summers1@us.army.mil 808-433-3686, and Ms. Cora Toledo, MMESO Pacific, Clinical Analyst, Corazon.m.toledo.ctr@us.army.mil, 808-433-2894. B. Products & Performance Required The MMESOs, are seeking product line items in the category of Fingertip Pulse Oximeter. Within the MMESOs, this product line has an estimated annual dollar requirement of $8,154,926.02. This forecast is based on historical Prime Vendor sales during a recent 12-month period. Based on the recent 12-month usage data, the four (4) total line items, account for 100% of the total volume in sales ($8,154,926.02) 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 Ms. Mary Summers, MMESO Pacific, Team Leader, mary.summers1@us.army.mil. AND Ms. Cora Toledo, MMESO Pacific, 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 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 e-mail to be lost in transmission, from network security, etc., vendor is strongly encouraged to confirm with the MMESO Pacific that its initial submission, quote and literature actually arrived at the MMESO Pacific 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 who 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 Designated Senior Logisticians (DSLs) and co-chaired by Designated Senior Clinicians (DSCs) in the MMESO AORs and include clinicians and logisticians for Medical Treatment Facilities (MTFs) within each MMESO. 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 Pacific 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 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 eleven (11) requirements below must be answered with the vendor's initial submittal 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 Fingertip Pulse Oximeter products that includes at a minimum the specific products identified below for Fingertip Pulse Oximeter as follows: • Reusable, latex free/safe, easy to operate, one-button key pad, pocket-size in dimension: 1.3"W x 1.3" H x 2.20" D (3.3 cm x 3.3 cm x 5.7 cm) to 1.7" W x 2.25" H x 1.5" D (4.3 cm x 5.7 cm x 3.8 cm), lightweight with batteries included (weight: 2- 3 ounces /62- 86 grams), enclosed in a high impact polycarbonate shell without sharp edges. • Replaceable battery requirement that has a battery life of 24- 30 hours on normal operation and up to 16 hours on continuous use. • Easy access to replaceable battery is fast and simple and has a built-in visual battery life indicator with an automatic shut off in 8 seconds when not in use. • Large, easy to read LED (light-emitting diodes) that displays pulse rate (30 - 300 beats per minute (bpm) range), pulse oxygen saturation (SP02) (0 - 100 % range), and vertical bar graph, and with high contrast display screen that is clear and easy to see, night or day. • Provides continuous, fast, accurate pulse oxygen saturation and pulse measurements on any patient, from neonates to adults, a sensor probe that accommodates a wide range (0.3 - 1.0 inch or 8 - 26 millimeters) of finger thickness for pediatric to adult patients, and reliable performance in monitoring conditions of low perfusion, motion and signal interference. • Conveniently operated by the deployed military units who will be using the product under different climate (extreme temperatures +32 ºF to 131 ºF/ 0ºC to 55 ºC), altitude (up to 40,000 feet/ 12,192 meters), light (display screen visibility day or night) conditions, and used during emergency transport. • Audible and visible alarms for high /low SP02 and pulse rate, low battery indicator and alerts when probe drops. • Additional accessory: at a minimum, provide a carrying case with neck/wrist cord. • Manufacturer list compatible cleaning agents recommended for the device. • Device incompatible with equipment cleaning agents without degradation of plastic encasing, connectors, or surfaces with long-term or prolonged use. a Required Items OXIMETER FINGER DIGITAL/SPO2/PULSE RATE AAA ALKALINE BATTERIES OXIMETER FINGER DIGITAL/SPO2/PULSE RATE/SPO2 WAVELENGTH INTEGRAL FINGER SENSOR AAA ALKALINE BATTERIES CARRYING CASE WITH NECK/WRIST CORD * Operational usage items are included in this list of Fingertip Pulse Oximeter. 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. A vendor is required to supply all items listed in all sizes and device type. (A vendor who does not have a complete product line as stated above will be disqualified in Phase I). 2. Vendor must have a DAPA or be in the process of obtaining a DAPA for the Fingertip Pulse Oximeter product line. Vendor must provide 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 Fingertip Pulse Oximeter 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: 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. Vendor shall not quote FSS prices as the discounted price for purposes of this standardization initiative). Vendor who does not provide discounts off DAPA for ALL products in Phase III will be disqualified. 5. Vendor must provide literature that clearly identifies that the products' packaging are clearly labeled, has manufacturing lot number and expiration date on packaging with initial submittal. A vendor whose products cannot identify these features or vendor who does not provide documents to support this with initial submittal will be disqualified in Phase I. 6. Vendor must provide latex safe/free and hypoallergenic Fingertip Pulse Oximeter and accessory products. Vendor must provide a list of all latex safe/free hypoallergenic claims for the Fingertip Pulse Oximeter, and case via catalog or like-material in response to this RFIAQ with initial submittal. Vendor whose products cannot be identified with these features or vendor who does not provide documents to support this with initial submittal will be disqualified in Phase I. 7. Vendor must have an identified customer service representative available for on-site instructional sessions (in-services), and on-going clinical support as required at no cost to the government for the Fingertip Pulse Oximeter product line. Vendor must provide a list of customer service representatives with initial submittal. Vendor who cannot provide representatives to support these requirements will be disqualified in Phase I. 8. Vendor must provide documentation for all possible educational tools, materials, and ongoing support that are available for Fingertip Pulse Oximeter in response to this RFIAQ. The selected vendor(s) must be able to commit in training and installation of the product and must provide warranty statement on their posting. 9. Vendor must provide evidence of FDA 510(K) approval for Class II Devices, Oximeter, 21 CFR 870.270, and have a certificate of air worthiness demonstrating that deployed military units, or emergency transport medical personnel can use this device. 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 a statement confirming their products meet the industry production and safety standards (Occupational Safety & Health Association (OSHA) guidelines used in manufacturing Fingertip Pulse Oximetry products in response to this RFIAQ. 11. The evaluation of medical equipment may require service specific Biomedical Safety Checks and Bailment Documents to be completed before a clinical evaluation is undertaken. Vendors must be able to bring or deliver the required sample equipment to the identified clinical evaluation sites and complete all requirements before the clinical evaluation date identified in the Phase 2 invitations to participate. CPT site specific requirements will be identified in the letters of invitation. Phase II Acceptability Evaluation Clinical Performance Clinical Performance Requirements 1. 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) Express Mail AND to the rest of the continental United States via appropriate shipping method when requested in Phase II. Vendors who ship the sample devices MUST include a prepaid return shipping label in the package if they want their samples returned. Vendors MAY hand deliver the Fingertip Pulse Oximeter samples to the evaluation sites, and collect their samples in person following the completion of the clinical evaluation. Vendor must send the MMESO Pacific verification regarding the shipment of literature and samples. Thisinformation will include the date of shipment, final delivery date, and tracking numbers and the carrier used by the vendor. As stated in the Technical Requirements - The evaluation of medical equipment may require service specific Biomedical Safety Checks and Bailment Documents to be completed before a clinical evaluation is undertaken. Vendors must be able to bring or deliver the required sample equipment to the identified clinical evaluation sites and complete all requirements before theclinical evaluation date identified in the Phase 2 invitations to participate. CPT site specific requirements will be identified in the letters of invitation.Vendor who cannot or does not meet this requirement will be disqualified from the standardization process.Vendor will provide ONLY the following no cost product samples for clinical/performance evaluation.Two (2) Fingertip Pulse Oximeters as listed below are to be provided as samples to each of the evaluation sites as identified in the letters of invitation. Sample OXIMETER FINGER DIGITAL/SPO2/PULSE RATE AAA ALKALINE BATTERY X2 (each) The clinical/performance acceptability evaluation period will last for fourteen (14) calendar days. Theacceptability evaluation responses will be in a Likert scale format with a one (1) through five (5) scoringrange. 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 JPRBhas 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 thisstandardization initiative. Of those vendors who 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. Each requirement for Fingertip Pulse Oximeter will be evaluated by two (2) trials perevaluator (each clinical trial site will have at least two (2) clinical evaluators who will each evaluate all samples), in a clinical/patient care setting. Vendor WILL BE required for in-servicing prior to the evaluations. Vendor will be given 14 calendar days from the issue of the notice in which to make demonstration/in-service arrangements/appointments with the participating MTFs so that the instructions are available for clinical evaluation at Phase II. Vendor in-servicing must be completed NLT two (2) days before the scheduled start of the clinical evaluations. Vendor who does not make the before mentioned arrangements by the deadline will be disqualified from this standardization initiative. Note: vendor must send the MMESO Pacific verification regarding the dates of the in-services for the participating MTFs. The vendor must coordinate all in-services so that all MTFs are in-serviced before the evaluation starts. There will be approximately fifteen (15) 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 audible and visible alarms perform effectively. (Improve recognition and response to changes in a patient's condition) NPSG.16.01.01, IC.02.02.01 a. The device must be reliable and be able to demonstrate the safety and efficacy of the alarm when it cannot detect the peripheral pulse even under the most challenging patient motion conditions. Critical values are displayed, and warning sign is given prior to a clinical deterioration event on a patient. Early response to changes in patient's condition may increase survivability. b. The evaluator will apply the sensor probe directly to the patient's finger and demonstrate in a variety of positions that the device warns you when accurate readings are not possible. Have patient raise arm above the head, hang dependent on the side, at rest, and wave arm and hand erratically while evaluating the device and the alarm system. 2. The pulse oximeter device has a high quality display screen. (User Visibility and Device Reliability) NPSG 02.03.01, EC.02.04.01 a. The pulse oximeter device has a high contrast display screen that is clear, easy to read, large numbers, easy to see at night or day and in weather conditions. b. The evaluator will turn the pulse oximeter device on and determine the visibility in different light conditions ranging from no light to full day light to determine that the evaluator has no difficulty reading the numbers that are being displayed. 3. The battery is easily accessed and replaced. (Device Reliability and Performance) EC.02.04.01 a. The battery is protected from water and dirt, yet easily accessed. It has a tightly sealed compartment that even when batteries are changed numerous times, it is water and dirt resistant. b. The evaluator will have easily remove the old battery and replace with a new battery. Then, the evaluator will visually inspect the battery compartment cover to see that it is tightly sealed. 4. The signal is picked up and displayed within 8 seconds of being applied to the patient. (Patient Safety and Device Reliability) NPSG.02.03.01, EC.02.04.01 a. Critical result must be available within 8 seconds of proper application to help assess and take appropriate action for safe care delivery and increase survivability. Accuracy and reliability of medical device could directly impact patient care delivery. b. The evaluator will turn the pulse oximeter device on, place the patient's finger in the sensor probe and result will display in 8 seconds after application to the finger. 5. All surfaces and edges of the clip sensor probes are smooth. (Patient Safety and Comfort) IC.02.02.01 a. The sensor probe is smooth and easy to apply. The sensor probe has rigid structure, no rough edges, comfortable, and fosters proper alignment of the LED (light emitting diodes) with the photo detector. b. The evaluator will inspect the sensor probe by running the finger along the edges and should not feel any rough or sharp edges which could cut, tear or disrupt skin integrity and cause pain to patient. To avoid injury to the patient, check the integrity and condition of the skin in monitoring the site and in repositioning of the probe to prevent damage on the surface of the skin. 6. The pulse oximeter device performs and accurately. (Patient Safety and Device Accuracy) NPSG.02.03.01, IC.02.02.01 a. The patient's pulse from the pulse oximeter device correlates with the patient's actual pulse which simultaneously validates the accuracy of the device. b. The evaluator will place the sensor probe on the patient's finger and simultaneously palpating the patient's actual pulse and match the audible pulse rate and waveform from the device to validate the accuracy of the device. Phase III Pricing Analysis Price 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 Pacific and must be received 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 vendors' 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-1105-36_Fingertip_Pulse_Oximeter/listing.html)
 

Place of Performance

Address: Tripler Army Medical Center, 1 Jarrett White Road, Honolulu, Hawaii, 96859-5000, United States

Zip Code: 96859-5000
 

Record

SN02491779-W 20110709/110707234944-8d2ae7b235ce87f23ed9304b94b6b372 (fbodaily.com)
 

Source

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

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