Loren Data's SAM Daily™

FBO DAILY ISSUE OF APRIL 16, 2010 FBO #3065
SOURCES SOUGHT

65 -- Automated External Defibrillator (AED)

Notice Date

4/14/2010
 

Notice Type

Sources Sought
 

NAICS

339113 — Surgical Appliance and Supplies Manufacturing
 

Contracting Office

Defense Logistics Agency, DLA Acquisition Locations, Defense Supply Center Philadelphia - Medical, 700 Robbins Avenue, Philadelphia, Pennsylvania, 19111-5096
 

ZIP Code

19111-5096
 

Solicitation Number

APP01-1004-001
 

Archive Date

5/13/2010
 

Point of Contact

Toni Massenburg, Phone: 202 782-3666, Tracy Martin-Tilghman, Phone: 2027823663
 

E-Mail Address

toni.massenburg@us.army.mil, tracy.martintilghman@us.army.mil
(toni.massenburg@us.army.mil, tracy.martintilghman@us.army.mil)
 

Small Business Set-Aside

N/A
 

Description

65-Medical Supplies-Potential Sources Sought A.General Information. The Northeast Region (TRBO Reg. 1), a military integrated delivery network, comprised of 47 Army, Navy, Air Force, Marine Corps, and U.S. Coast Guard Medical Treatment Facilities (MTFs) in the states of Maine, New Hampshire, Massachusetts, Rhode Island, Connecticut, New York, Pennsylvania, New Jersey, Delaware, Maryland, Virginia, and the District of Columbia including institutional and operational healthcare settings announces a Request for Regional Incentive Agreement Quotation (RFRIAQ) for the standardization of AUTOMATED EXTERNAL DEFIBRILLATORS (AED). This product line includes but is not limited to the Automated External Defibrillators (AED) which includes a portable carrying case; a long-life disposable battery pack; adult and pediatric electrode pads; ECG tracing capability; instantaneous compression data to help the rescuer with the proper rate and depth; delivery of appropriate defibrillation energy levels; ability to distinguish between adult and pediatric rescue; graphical interface of pictures combined with text displays and/or voice prompts; internal memory and external USB memory technology for expanded data storage and transfer capacity; and an accessory kit that include Nitrile gloves, powder-free, cuffed; pocket breathing mask; paramedic scissors; disposable safety razor; and large, extra-absorbent paper towel. Additionally, this product line includes a Crash Cart Defibrillator that has a combination of programmable text prompts, audible alarms and visible indicators; biphasic escalating shock energy technology that automatically adjusts the magnitude of the defibrillation shock based upon each patient’s unique body type; a wide variety of electrodes and paddles for adults and pediatric patients; switch internal paddles for open-heart defibrillation; 3-lead patient cable with integral lead wires; universal cable; a rechargeable battery; event documentation/ data transfer capabilities via internal memory; and heart rhythm analysis and shock advice to effectively address life-threatening arrhythmias. 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. It is possible that the devices may have to be purchased direct from the vendor but all recurring accessories will be ordered through the Prime Vendor. It is also noted that the equipment is ordered cyclical or on an as-needed basis when budgeted to outfit a facility or specific area. 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 Northeast Region include, but are not limited to Walter Reed Army Medical Center, Washington, DC; Dewitt Health Care Network, Fort Belvoir, VA; and National Naval Medical Center, Bethesda, 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 (RIAs) 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 July 2010. The evaluation will be based on clinical, technical, and pricing factors. Clinical/performance and technical/company factors will be weighted more heavily than price. The Technical/Company and Clinical/Performance evaluation factors, when combined, are considered significantly more important than cost or price. As the technical and clinical evaluation results become more equal, price will become more important. The selection will be determined utilizing Best value/ trade-off criteria. The selection of a single vendor is anticipated. However, if no single vendor can meet the total requirement of the Region, the Government reserves the right to make two or more selections for RIAs. In this event, selection would be based on a combination of MTF preference and product availability. Point of Contact: Toni Massenburg, (202) 782-3666, toni.massenburg@us.army.mil. B.Products & Performance Required. The Northeast Region is seeking product line items in the category of AUTOMATED EXTERNAL DEFIBRILLATORS (AED) which at a minimum includes the high volume lines below. Within this region, this product line has an estimated annual dollar requirement of $90,113 for the accessories. This forecast is based on historical prime vendor sales during a recent 12-month period. The Northeast Region estimates needing 200 AED devices based on past purchases and future requirements for the new hospitals. The top high volume usage lines for this project are shown below: PHILIPS MEDICALM3716AHEARTSTREAM ADULT RADIOLUCENT PADS PHILIPS MEDICALM3717AHEARTSTREAM PEDIATRIC PLUS PADS MULTI-FUNCTION ZOLL MEDICAL8900-4003STAT PADZ HVP MULTI-FUNCTION ELECTRODES ZOLL MEDICAL8900-2065PAD ELECTRODE PED 6S PK/6 PHILIPS MEDICALM1625ASHIELDED 5-LEAD SET; SNAPS PHYSIO-CONTROL11141-000026LIFEPAK NiCd BATTERY PHILIPS MEDICAL989803158211 PAD ADULT DEFIBRILLATION FR2 PHILIPS MEDICALM3863ABATTERY, LONG LIFE LIMNO PHILIPS MEDICALM1520ATRUNK CABLE, 5 LEAD, SAFETY ZOLL MEDICAL8000-0294LNCS ADULT REUSABLE SENSOR 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 who 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 who 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 who 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 Automated External Defibrillator (AED) 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 includes an AED device that automatically diagnoses the heart rhythm and determines if a shock is needed; has real time spoken and visual CPR and shock prompts and/or visual ECG readout displays to instruct the rescuer; has both adult and pediatric defibrillation capability and per-gelled, self-adhesive, disposable pads; has biphasic technology; is simple to use; has built in event memory data storage; has a long-life disposable battery; performs self tests; is lightweight, portable, and can withstand drops and environmental conditions that meet our specifications; and any other products in this category. b.At a minimum this also includes a Crash Cart Defibrillator that has a combination of programmable text prompts, audible alarms and visible indicators; biphasic escalating shock energy technology that automatically adjusts the magnitude of the defibrillation shock based upon each patient’s unique body type; a wide variety of electrodes and paddles for adults and pediatric patients; switch internal paddles for open-heart defibrillation; 3-lead patient cable with integral lead wires; universal cable; a rechargeable battery; event documentation/ data transfer capabilities via internal memory; and heart rhythm analysis and shock advice to effectively address life-threatening arrhythmias and any other products in this category. Vendors are required to supply the items listed below only if approved to progress to Phase II – Clinical Evaluation Phase. Product requestedNumber of ItemsBest product description Automated External Defibrillator (AED)1Automated, external, defibrillator with adult and pediatric capability Crash Cart Defibrillator1Biphasic defibrillator with a wide variety of defibrillation and monitoring functions c.Vendor MUST provide a complete list of items supplied (manufactured and/or distributed by brands) via catalog, and product literature in response to this RFQ with initial submittal. Vendors are required to supply items listed in all product ranges, configurations, capabilities, sizes, and durability. (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 Automated External Defibrillator (AED) 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 (PV) (currently, the prime vendor is Owens & Minor) for Automated External Defibrillators (AED) 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 of DAPA for all products included in this standardization initiative. (Note: vendors who fail to submit a discount off of 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 Automated External Defibrillator (AED) products, including dates, duration, cause, and resolution. Vendors will not have an opportunity to provide additional information on back orders and recalls 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 Automated External Defibrillator (AED) products that have a lifesaving pulse of electricity (defibrillation) that can be delivered quickly in order to be effective in first aid efforts to restore the heart to its normal rhythm. Vendors MUST identify these features of their products and provide literature to support this in response to this RFQ with initial submittal. 7.Vendor MUST provide latex safe/free products. Vendor MUST provide a list of all latex safe/free items supplied via catalog or like-material in response to this RFQ with initial submittal. 8.Vendor MUST provide Automated External Defibrillator (AED) products that meet the cardiopulmonary resuscitation protocol in Guidelines 2005 for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care, International Consensus on Science, published by the American Heart Association (AHA) and the International Liaison Committee on Resuscitation (ILCOR). 9.Vendor MUST provide Automated External Defibrillator (AED) products that deliver a high-current/low energy therapy for appropriate defibrillation dose, while at the same time, minimizing/safe guarding against side effects that are harmful to the heart. 10.Vendor MUST provide Automated External Defibrillator (AED) products that can differentiate between shockable and non-shockable events. 11.Vendor MUST provide Automated External Defibrillator (AED) products that automatically conducts self-tests daily. 12.Vendor MUST provide Automated External Defibrillators (AED) products whose long-life disposable battery options (long-life disposable or rechargeable) to deliver 100 shocks per minute or 8 hours of continuous monitoring that meet our specifications. 13.Vendor MUST provide Automated External Defibrillator (AED) products that have a five (5) year warranty that meet our specifications. 14.Vendor MUST provide Automated External Defibrillator (AED) products that are easy to inspect without removing the unit from the wall bracket that meet our specifications. 15.Vendor MUST provide Automated External Defibrillator (AED) products that have an Ingress Protection (IP) code of greater (>) than 55 that meet our specifications. 16.Vendor MUST provide Automated External Defibrillators (AED) products that can also be utilized for training without the need to purchase different training units that meet our specifications. 17.Vendor MUST provide Crash Cart Defibrillators that meets or exceeds UL 2601, AAMI DF-39, AAMI DF-2, and IEC 601-2-4 that meet our specifications. 18.Vendor MUST provide Crash Cart Defibrillators that has a multi-function cable and battery that meet our specifications. 19.Vendor MUST provide Crash Cart Defibrillators that can offer external pacing capability to allow external pacing of bradycardias and SPO2 to monitor the oxygenation level of the patient via an external sensor. 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 no-cost product sample sets from the product group to be hand carried directly to the participating Medical Treatment Facilities (MTFs) where the evaluations are to occur. Vendors will be allowed 7 calendar days from the date of notification to complete the arrangements for inservice/demonstration. Product samples must be hand delivered to the participating MTF addresses and points of contact by the morning of the appointed demonstration/inservice day. Vendors who do not meet the deadline to hand deliver the product samples by the deadline will be disqualified from this standardization initiative. Note: Vendors are required to make these arrangements only if approved to progress to Phase II – Clinical Evaluation Phase and then vendors must send the TRBO verification regarding the date of inservice/demonstration with the MTF and final return 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 one day at the selected sites. The CPT has established a target threshold of 3.50 for the Clinical Acceptability of products for standardization. The CPT will determine the actual Acceptability threshold for this standardization initiative -- at or near 3.50 -- depending on the location of any "break" in vendors’ average scores (i.e., a gap between vendors’ average scores). In addition, the CPT may consider how closely scores are clustered near the Acceptability target threshold of 3.50, in determining the actual Acceptability threshold. Vendors scoring below the actual Acceptability threshold will be determined to be clinically Unacceptable, and be disqualified from further consideration for this standardization initiative. Vendors that have been disqualified will be notified in writing at the conclusion of the evaluation process (DSCP approval). 4.To determine acceptability, the CPT, comprised of medical professionals from multiple disciplines from the Northeast Region will evaluate the products based on the evaluation criteria below in a clinical/patient care setting. 5.Vendors will ONLY provide sample products of the items that are requested and being evaluated. Vendors who bring in other product samples or literature on items that are not part of the evaluation process will be disqualified from the evaluation process. Vendor’s presence will 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 Standards: 1.The CPT identified the standards of care that the Northeast Region medical communities adhere to, specifically related to Automated External Defibrillators (AED), and those will form the basis for specific technical/company and clinical/performance criteria. The standards are set forth by the following: a. OSHA does not have standards specific to automated external defibrillators (AEDs). However, exposures to first-aid hazards are addressed in specific standards for the general industry. The following highlights standards, Federal Registers (rules, proposed rules, and notices), directives instructions for compliance officers), and standard interpretations (official letters of interpretation of the standards) related to AEDs. i. Section 5(a)(1) of the OSH Act, often referred to as the General Duty Clause, requires employers to "furnish to each of his employees employment and a place of employment which are free from recognized hazards that are causing or are likely to cause death or serious physical harm to his employees." ii. Section 5(a)(2) requires employers to "comply with occupational safety and health standards promulgated under this Act." Public access defibrillation programs that place automated external defibrillators (AEDs) in areas where cardiac arrests may occur can reduce the response time up to three to five minutes. iii. Working Against Time. American Heart Association (AHA), (2003), 504 KB PDF summarizes the importance of AEDs and training in saving lives, as well as an overview of the steps necessary to implement an AED program. iv. The Sudden Cardiac Arrest Association, with numerous scientific studies conducted during the past two decades, has proven that rapid defibrillation is the single most important factor affecting survival from sudden cardiac arrest in adults. This research, coupled with important technological advances, has driven an international movement to increase access to early defibrillation. v. 2005 American Heart Association Guidelines for Cardiopulmonary Resuscitation and Emergency Cardiovascular Care Part 5: Electrical Therapies (Circulation. 2005;112:IV- 35 – IV-46.). 1. To treat VF SCA, rescuers must be able to rapidly integrate CPR with use of the AED. To give the victim the best chance of survival, 3 actions must occur within the first moments of a cardiac arrest: (1) activation of the emergency medical services (EMS) system or emergency medical response system, (2) provision of CPR, and (3) operation of an AED. b. It's a Matter of Time, Would your employees rise to the AED challenge? ShopRite's experience proves they will. Jerry Laws. Oct 01, 2003. Occupational Health & Safety (OH&S). i. OSHA in 2001 estimated as many as 120 workers' lives would be saved each year by placing AEDs in workplaces, especially at sites where workers are involved in shift work, hold high-stress jobs, or are exposed to certain chemicals or electrical hazards. These workers face a higher risk of heart disease and cardiac arrest, according to the agency. ii. About 240,000 people in the United States die of sudden cardiac arrest per year, although as many as 90 percent could be saved if defibrillators reached them in time. Each minute that passes before defibrillation decreases an SCA victim's chance for survival by about 10 percent. Few attempts are successful after 10 minutes. iii. With liability and cost barriers to AED deployment disappearing, the time factor--how many minutes it takes EMS responders in any given location to arrive after a 911 call--will cause many more employers to buy them. c. Automatic External Defibrillators for Public Access Defibrillation: Recommendations for Specifying and Reporting Arrhythmia Analysis Algorithm Performance, Incorporating New Waveforms, and Enhancing Safety. A Statement for Health Professionals From the American Heart Association Task Force on Automatic External Defibrillation, Subcommittee on AED Safety and Efficacy. Richard E. Kerber, MD, Chair; Lance B. Becker, MD; Joseph D. Bourland, EE, PhD; Richard O. Cummins, MD, MPH; Alfred P. Hallstrom, PhD; Mary B. Michos, RN; Graham Nichol, MD; Joseph P. Ornato, MD; William H. Thies, PhD; Roger D. White, MD; Bram D. Zuckerman, MD; Members Endorsed by the Board of Trustees of the American College of Cardiology (Circulation. 1997; 95:1677-1682.) i. Safe and effective use of AEDs that are widely available and easily handled by nonmedical personnel has the potential to dramatically increase survival from cardiac arrest. d. Ventricular Fibrillation and the Use of Automated External Defibrillators on Children David Markenson, Lee Pyles, Steve Neish and the Committee on Pediatric Emergency Medicine and Section on Cardiology and Cardiac Surgery Pediatrics 2007;120;e1368- e1379; originally published online Oct 29, 2007; DOI: 10.1542/peds.2007-2679. i. Although the incidence of VF in the pediatric population is low, there is a need for developing strategies to provide early defibrillation to patients younger than 8 years. ii. The most important safety feature of an AED is specificity. As long as there is a very high level of assurance that shocks will be advised only for appropriate rhythms in the pediatric population, then the risk of myocardial damage from defibrillation likely is significantly less than the risk of not delivering a shock (probable death). However, the potentially toxic effects of delivering too much energy must be minimized whenever possible. e. Part 5: Electrical Therapies: Automated External Defibrillators, Defibrillation Cardioversion, and Pacing Circulation 2005;112;IV-35-IV-46; originally published online Nov 28, 2005; DOI: 10.1161/CIRCULATIONAHA.105.166554 i. AEDs have been tested extensively, both in vitro against libraries of recorded cardiac rhythms and clinically in many field trials in adults63,64 and children.65,66 They are extremely accurate in rhythm analysis. Although AEDs are not designed to deliver synchronized shocks (ie, cardioversion for VT with pulses), AEDs will recommend a (nonsynchronized) shock for monomorphic and polymorphic VT if the rate and R-wave morphology exceed preset values. ii. The high first-shock efficacy of newer biphasic defibrillators led to the recommendation of single shocks plus immediate CPR instead of 3-shock sequences that were formerly recommended to treat VF. Clinical/Performance Criteria: During the pre-source selection procedures, the CPT and lay person validated/approved the equally weighted clinical/performance criteria outlined below: 1. (Bystander Efficiency of Care) The AED is lightweight and portable. a. Bystanders require the device be lightweight and portable to accommodate all sizes and health conditions of the people who will be using it. b. The criterion will be evaluated in a non-clinical setting by use of the product on a mannequin at least 2 times. c. Evaluator will lift the device to determine its weight and portability. 2. (Bystander Efficiency of Care/Patient Safety) After the AED is turned on, it is easy to use and understand/follow the directions/instructions. a. Bystanders require the device to be easily turned on (activated) and guided by the prompts. b. The criterion will be evaluated in a non-clinical setting by use of the product on a mannequin at least 2 times. c. Evaluator will turn the device on and listen for prompts. The device will require minimal training to use and it will automatically instruct the user on how to proceed. 3. (Bystander Efficiency of Care/Patient Safety) The AED utilizes hands free pads that indicate the appropriate placement and are simple to use and understand. a. Bystanders require the device to simplify the electrode placement during an emergency, preventing confusion and incorrect placement. b. The criterion will be evaluated in a non-clinical setting by use of the product on a mannequin at least 2 times. c. Evaluator will take the pads out of the case and be able to place them in the correct positions easily. The device will be simple to use and understand. 4. (Bystander Efficiency of Care/Patient Safety) The AED uses voice, text, and/or graphic prompts to guide me through the appropriate BLS sequence. a. Bystanders require the device to guide them properly through the sequence of actions. b. The criterion will be evaluated in a non-clinical setting by use of the product on a mannequin at least 2 times. c. Evaluator will listen to the device prompts and follow the instructions. 5. (Bystander Efficiency of Care/Patient Safety) The AED monitors my actions and provides me with feedback to ensure I am performing the proper rate and depth of compressions during CPR. a. Bystanders require the device to monitor their actions and that the voice prompts will inform them on how well they are performing compressions and if not how to correct their actions. b. The criterion will be evaluated in a non-clinical setting by use of the product on a mannequin at least 2 times. c. Evaluator will perform compressions and follow the voice prompts to the proper way of performing CPR. 6. (Bystander Efficiency of Care/Patient Safety) The AED automatically determines whether defibrillation (unsynchronized shock) is indicated. a. Bystanders require the device to determine whether the mannequin’s condition warrants a shock and if so, that the device will automatically deliver a defibrillation shock. b. The criterion will be evaluated in a non-clinical setting by use of the product on a mannequin at least 2 times. c. Evaluator will listen for prompts from the device. If the device determines that a shock is warranted, it will use the battery to charge its internal capacitor in preparation to deliver the shock. 7. (Bystander Efficiency of Care/Patient Safety) The AED rapidly delivers a shock if needed with little input from me. a. Bystanders require the device to determine whether the mannequin’s condition warrants a shock and if so, that the device will automatically deliver a defibrillation shock with only minimal input from the operator. b. The criterion will be evaluated in a non-clinical setting by use of the product on a mannequin at least 2 times. c. Evaluator will listen for prompts from the device. The device will instruct the user to ensure no one is touching the patient and then to press a button to deliver the shock with little input from the user. 8. (Bystander Efficiency of Care/Patient Safety) The AED continuously records the EKG tracing and CPR event information and that information is easily downloaded or transferred to a work computer. a. Bystanders require the device to record continuous ECG and critical resuscitation events with time stamped entries reflecting the rescuer and device activity. b. The criterion will be evaluated in a non-clinical setting by use of the product on a mannequin at least 2 times. c. Evaluator will transfer/download the recorded data to a computer so that the providing facility is able to see the effectiveness of both CPR and defibrillation. 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 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. (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 who can supply the complete range of clinically-required products, without unnecessary numbers of SKUs for minimally-differentiated products, will be more likely to provide the best-value solution for the Government in this standardization initiative. (4) Potential Cost Avoidance. Cost avoidance is calculated by subtracting the RIA price from the Distribution and Pricing Agreement (DAPA) price and multiplying by 12-months of usage. This is included as a reporting Matrix. Operational Impact of RIA prices on the Northeast Region are considered more important than other pricing elements. _____________________________________________________________________________ END
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/DLA/J3/DSCP-M/APP01-1004-001/listing.html)
 

Place of Performance

Address: ATTN: MCAA NA Bldg T20, 6900 Georgia Avenue, NW, Washington, District of Columbia, 20307, United States

Zip Code: 20307
 

Record

SN02121402-W 20100416/100414234738-f048efebc906ab3129b924c1cbb8f82f (fbodaily.com)
 

Source

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

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