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Contract Opportunity

36C25024Q0469
SPECIAL NOTICE
NOTICE OF INTENT TO SOLE SOURCE

Defibrillators and Automated External Defibrillators (AEDs)

The Department of Veterans Affairs, The Chalmers P. Wylie Ambulatory Care Center, 420 North James Road, Columbus, Ohio 43219 intends to solicit and negotiate with only one source under the authority of FAR 6.302-1(a)(2), Only one responsible source and no other supplies or services will satisfy agency requirements. The VA intends to solicit and negotiate with the (OEM) ZOLL Medical Corporation, an Asahi Kasei company, 269 Mill Road, Chelmsford, MA and with After-Action Medical and Dental Supply, 4444 Decatur Boulevard. Suite 100, Indianapolis, IN 46241 an Authorized Service Disabled Veteran Owned Small Business (SDVOSB) distributor for Defibrillators and Automated External Defibrillators (AEDs) along with all necessary training.

The Chalmers P. Wylie Ambulatory Care Center is in need of a life cycle replacement of our existing Defibrillator and Automated External Defibrillator (AED) device fleet. The devices are in need of replacement due to age, technology obsolescence, and manufacturer s end of support. The acquisition of new devices will ensure that the organization has the necessary equipment and modern technology to respond to critical emergency events requiring lifesaving resuscitation equipment.

The ZOLL defibrillators have unique capabilities that the Chalmers P. Wylie Ambulatory Care Center have determined are clinically necessary to provide the safest and most effective clinical intervention necessary in the event of a medical emergency requiring this life resuscitating equipment. No other vendor's products have been identified that can meet all these requirements. Below are several clinically necessary features that comparable competitors do not have:

FIPS (Federal Information Processing Standards) compliance which is a requirement for future connectivity to the VA wireless network per VA Directive 6550. Procurement of systems using 802.11 wireless networking that are not FIPS 140-2 compliant is prohibited per VA Directive 6550 Appendix A section 2.2.
For defibrillator and AED: Real-time chest compression (depth and rate) feedback available directly on-screen to provide visual feedback about compression quality. This is consistent with current American Heart Association (AHA) guidelines which recommend "real-time use of audiovisual feedback" as a way to ensure chest compression quality. highlights 2020 ecc guidelines english.pdf (heart.org)
For defibrillator and AED: Visual feedback letting users know that they are appropriately releasing their chest compression fully, improving blood flow during chest compressions.
Cardiac monitoring that filters out chest compressions in order to show the underlying cardiac rhythm.
Pacing leads built into the hands-free defibrillation pads in order to minimize equipment setup time and complexity during an emergent patient encounter; simpler setup processes during medical emergencies are safer for both patients and staff due to the stress and time-critical nature of these encounters.
Rapidly changeable user interface between basic AED function to advanced ACLS functions.
Idle time display for users to know how long the patient has been without chest compressions and therefore blood flow during cardiac arrest.
Hands-free defib pads that both self-tests daily and are also ready to use in emergent patient encounters without having to change out equipment; again, simpler setup processes during medical emergencies are safer and more effective.
Same vendor for AED and Defibrillator so therapy cable is interchangeable.

The Government believes that only these businesses can satisfy the agency requirements and intends to negotiate with only one source under the authority of FAR 6.302-1(a)(2), Only one responsible source and no other supplies or services will satisfy agency requirements. Other persons may identify their interest and capability to respond to this requirement by Thursday, March 29, 2024, by 5:00PM EST. Such capabilities information will be used solely for the purpose of determining whether or not to conduct this procurement on a competitive basis. All information shall be furnished at no cost or obligation to the Government. A determination by the Government not to open the requirement to competition based upon responses to this notice is solely within the discretion of the Government. No solicitation is available at this time.  All inquiries must be submitted by email to DeJanee R. Evans at dejanee.evans@va.gov Enter RFQ 36C25024Q0469: Defibrillators and Automated External Defibrillators (AEDs) in the email subject line.


STATEMENT OF WORK (SOW)
Contract Number:

Task Order Number:

IFCAP Tracking Number:

Follow-on to Contract and Task Order Number:
PROGRAM REQUESTOR/MANAGER).

Name:

Section:
Healthcare Technology Management
Address:
420 N. James Road, Columbus, OH 43219
Phone Number:

Fax Number:

E-Mail Address:
2. Contract Title. Defibrillator and Automated External Defibrillator Fleet Replacement
3. Background. The VA Central Ohio Healthcare System is in need of a life cycle replacement of our exiting Defibrillator and Automated External Defibrillator (AED) device fleet. The devices are in need of replacement due to age, technology obsolescence, and manufacturer s end of support. The acquisition of new devices will ensure that the organization has the necessary equipment and modern technology to respond to critical emergency events requiring life saving resuscitation equipment.
4. Scope. Contractor shall provide a new fleet of Defibrillators, Automated External Defibrillators (AEDs), Training devices, Training Services for both Clinical and Technical (HTM/Biomed Support) staff, along with all necessary supplies and accessories as outlined within the specific tasks identified in this scope of work along with the salient characteristics identified and limited sources justifications.

5. Specific Tasks.
5.1 Task 1. Provide a quantity of 46 Automated External Defibrillator devices with the following salient characteristics:
5.1.1 Visual CPR Feedback that includes the following.
5.1.1.1 Visual compression depth feedback with every compression in real time
5.1.1.2 Visual compression rate feedback with every compression in real time
5.1.1.3 Visual chest recoil feedback with every compression in real time
5.1.2 Pediatric Button
5.1.3 Semi-Automatic or Automatic
5.1.4 No option for manual mode
5.1.5 Resuscitation event review software connectivity
5.1.6 Biphasic
5.1.7 Metronome
5.1.8 Adult/Pediatric Pads/Electrodes (2 Sets per AED Device)
5.1.9 Battery (1 set per AED Device)
5.2 Task 2. Provide Training AED devices for use in both training clinical staff and demonstrating functionality/proper use.
5.2.1 4 Devices at a minimum must have full training capabilities and ability to deliver a shock to a training manakin.
5.2.2 5 Devices must at a minimum have the ability to demonstrate proper functionality and use but not deliver a shock.
5.2.3 Provide all necessary supplies and/or accessories to allow for proper training of clinical staff on the safety and proper use of the AED devices.
5.3 Task 3. Provide a quantity of 15 Defibrillator devices with the following salient characteristics:
5.3.1 Visual CPR Feedback that includes the following.
5.3.1.1 Visual compression depth feedback with every compression in real time
5.3.1.2 Visual compression rate feedback with every compression in real time
5.3.1.3 Visual chest recoil feedback with every compression in real time
5.3.2 AED Mode
5.3.3 Machine powers on in AED mode
5.3.4 Resuscitation event review software connectivity
5.3.5 Pulse oximetry (Masimo)
5.3.6 Automatic Blood Pressure
5.3.7 Capnography
5.3.8 Respiration Rate
5.3.9 3-5 lead telemetry
5.3.10 Pacing
5.3.11 Syncing
5.3.12 Manual Defibrillation
5.3.13 Self-testing
5.3.14 Portable
5.3.15 Battery backup
5.3.16 Biphasic
5.3.17 Shows underlying rhythm during compressions.
5.3.18 Battery set for each device.
5.3.19 All power cords, cables, and accessories required for proper use and operation.
5.4 Task 4. Provide one battery/conditioning station for Defibrillator batteries. This is to be used in HTM/Biomedical Engineering
5.5 Task 5. Provide at least 1 set of batteries for each defibrillator device along with 3 extra sets to be held by HTM/Biomedical engineering for backup.
5.6 Task 6. Provide one training defibrillator along with all supplies and accessories necessary to allow clinical trainers the ability to successfully train clinical staff on the full functionality and proper operation of the defibrillator devices acquired.
5.7 Task 7. Provide onsite instructor led Technical Training for HTM/Biomedical Engineering staff which will give them the full knowledge and capability to complete planned maintenance and repairs to the Defibrillator and AED devices in-house to the full extent possible or authorized by authorities having jurisdiction. Training should be included for at least 12 individuals. Number of days is to be determined by the vendor but must provide sufficient time to properly train at least 12 HTM/Biomedical staff members.
5.8 Task 8. Provide onsite clinical apps training for all clinical staff deemed necessary by the VA Central Ohio Healthcare System s Clinical Nurse Educators. Training must be sufficient to ensure all necessary clinical staff are properly versed and capable of using the defibrillators and AEDs in emergency situations.
5.9 Task 9. Provide a trade in allowance/option for a quantity of 15 Physio Control Lifepak 15 defibrillators.
6. Performance Monitoring
Vendor s performance will be monitored by the Contracting Officer s Representative and the Contracting Officer. The vendor will be held responsible for delivering and/or providing all equipment and services as outlined in this scope of work and contractually agreed upon.
7. Security Requirements
NA
8. Government-Furnished Equipment (GFE)/Government-Furnished Information (GFI).
No GFE/GFI will be provided.
9. Other Pertinent Information or Special Considerations.
NA
a. Identification of Possible Follow-on Work.
b. Identification of Potential Conflicts of Interest (COI).
c. Identification of Non-Disclosure Requirements.
d. Packaging, Packing and Shipping Instructions.
e. Inspection and Acceptance Criteria.
10. Risk Control
NA
11. Place of Performance.
Chalmers P. Wylie Ambulatory Care Center, Columbus, Ohio, 420 North James Road, Columbus, OH 43219

12. Period of Performance
One time purchase
13. Delivery Schedule.
SOW Task#
Deliverable Title
Format
Number
Calendar Days After CO Start
1
Automated External Defibrillators (AEDs)
Physical Device
46
90
2
Training/Demo AED
Physical Device
9
90
3
Defibrillators
Physical Device
15
90
4
Battery Station
Physical Device
1
90
5
Defibrillator Battery Sets
Physical Device
18
90
6
Training Defibrillator
Physical Device
1
90
7
Technical Biomed Training
Labor
At least 12 individuals
90
8
Clinical Training
Labor
Clinical Determined Sufficient Time
90
9
Trade-In Allowance
Credit
15
160

* Standard Distribution: 1 copy of the transmittal letter without the deliverable to the Contracting Officer shall be
Emailed.


LIMITED SOURCES JUSTIFICATION

ORDER >SAT

FAR PART 8.405-6

Acquisition Plan Action ID: 36C250-24-AP-2689

(1) Contracting Activity: Department of Veterans Affairs, Network Contracting Office 10, located at 3140 Governor s Place Boulevard Suite 210, Kettering OH 45409-1337, in support of VISN 10 VA Health Care System at 420 North James Road, Columbus, OH 43219-1834, using Transaction # 757-24-2-096-0191.

(2) Description of Action: This acquisition is conducted under the authority of the Multiple-Award Schedule Program (41 U.S.C. 152(3) and 40 U.S.C. 501).

This Action will be awarded as a new requirement.

The Contractor shall provide Defibrillators and Automated External Defibrillators along with all necessary accessories, supplies, and training outlined in the Statement of Work and meeting the salient characteristics provided. Quantities required will be as written in the Statement of Work. New devices will be replacing the existing fleet as a scheduled life cycle replacement.

Order against: FSS Contract Number: V737D-40135
Name of Proposed Contractor:
ZOLL Medical Corporation
Street Address:
269 Mill Road
City, State, Zip:
Chelmsford, MA 01284-4105
Phone:
800-348-9011
(3) Description of Supplies or Services:
.
Vendor is to provide Defibrillators and Automated External Defibrillators along with all necessary accessories, supplies, and training outlined in the Statement of Work and meeting the salient characteristics provided.

(4) Identify the Authority and Supporting Rationale (see below and if applicable, a demonstration of the proposed contractor s unique qualifications to provide the required supply or service.

FAR 8.405-6(a)(1)(A): An urgent and compelling need exists and following the ordering procedures would result in unacceptable delays:

FAR 8.405-6(a)(1)(B): Only one source is capable of providing the supplies or services required at the level of quality required because the supplies or services are unique or highly specialized:

The ZOLL defibrillators have unique capabilities that the Columbus VA's Clinical Team have determined are clinically necessary to provide the safest and most effective clinical intervention necessary in the event of a medical emergency requiring this life resuscitating equipment. No other vendor's products have been identified that can meet all these requirements. Below are several clinically necessary features that comparable competitors do not have:

FIPS (Federal Information Processing Standards) compliance which is a requirement for future connectivity to the VA wireless network per VA Directive 6550. Procurement of systems using 802.11 wireless networking that are not FIPS 140-2 compliant is prohibited per VA Directive 6550 Appendix A section 2.2.
For defibrillator and AED: Real-time chest compression (depth and rate) feedback available directly on-screen to provide visual feedback about compression quality. This is consistent with current American Heart Association (AHA) guidelines which recommend "real-time use of audiovisual feedback" as a way to ensure chest compression quality. hghlghts 2020 ecc guidelines english.pdf (heart.org)
For defibrillator and AED: Visual feedback letting users know that they are appropriately releasing their chest compression fully, improving blood flow during chest compressions.
Cardiac monitoring that filters out chest compressions in order to show the underlying cardiac rhythm.
Pacing leads built into the hands-free defibrillation pads in order to minimize equipment setup time and complexity during an emergent patient encounter; simpler setup processes during medical emergencies are safer for both patients and staff due to the stress and time-critical nature of these encounters.
Rapidly changeable user interface between basic AED function to advanced ACLS functions.
Idle time display for users to know how long the patient has been without chest compressions and therefore blood flow during cardiac arrest.
Hands-free defib pads that both self-tests daily and are also ready to use in emergent patient encounters without having to change out equipment; again, simpler setup processes during medical emergencies are safer and more effective.
Same vendor for AED and Defibrillator so therapy cable is interchangeable.

FAR 8.405-6(a)(1)(C): In the interest of economy and efficiency, the new work is a logical follow-on to an original Federal Supply Schedule order provided that the original order was placed in accordance with the applicable Federal Supply Schedule ordering procedures. The original order must not have been previously issued under sole source or limited source procedures.

FAR 8.405-6(b): Items peculiar to one manufacturer:

A patent, copyright or proprietary data limits competition. The proprietary data is:

These are direct replacements parts/components for existing equipment.

The material/service must be compatible in all aspects (form, fit and function) with existing systems presently installed/performing.

(5) Describe Why You Believe the Order Represents the Best Value consistent with FAR 8.404(d) to aid the contracting officer in making this best value determination:

This is the best value option because it allows the facility to continue using all other equipment associated with this requirement. In addition, this ensures that the latest technologies and newest equipment are available for the medical staff when treating Veterans Affairs Medical Center patients. The Contracting Officer has ensured that the requirements are consistent with GSA pricing. In accordance with FAR 8.404(d), GSA has determined pricing to be fair and reasonable; in addition, the pricing is in line with the Independent Government Cost Estimate (IGCE).

The Contracting Officer will seek price reductions prior to issuing the order.

(6) Describe the Market Research Conducted among schedule holders and the results or a statement of the reason market research was not conducted.

This new requirement is for a life cycle replacement of VA Central Ohio Healthcare System s existing Defibrillator and Automated External Defibrillator (AED) device fleet. Market research was conducted via VetCert, DSBS, GSA, FPDS and the Internet. The VetCert search using NAICS 334510 netted 310 SD/VOSB Vendors. The DSBS search using the same NAICS netted 1,622 Vendors; added keywords, separately, Defibrillator netted 11 Vendors; AED netted 13 Vendors and Automated External Defib netted 4 Vendors.

While only two manufacturers have been identified that meet or partially meet the requirements for this procurement, it is understood that both vendors may have SDVOSB partners who they may be able to work through for procurements.

During our market research it has been identified that Stryker has not yet released their new product line for Defibrillators and the current device available has been on the market for several years. Given that the device is nearing its end of life and the features available are not up to the latest technology standards of the defibrillator line that ZOLL Medical currently offers. This has put Stryker at a technological disadvantage. It has been determined that no other equipment is compatible except the defibrillator line by (OEM) ZOLL Medical.

ZOLL Medical s product line also better meets the clinical needs at this time as it provides the modern clinical features that the clinical teams have deemed a necessity to provide the safest and most effective clinical response in the event of a lifesaving emergency requiring resuscitation of patients.

ZOLL Medical Corporation does have an exclusive authorized Service-Disabled Veteran Owned Small Business (SDVOSB) Distributor for the sale of their products, After Action Medical and Dental Supply. Prior to completion of this action the VA will conduct new market research to determine if it would be beneficial to consider other types before entering any new agreements.

From November 2022 to December 2023, 22 mock codes were conducted within VA Central Ohio Healthcare System. All 22 mock codes included the use of an AED or Defibrillator from a comparable competitor. Due to the complexity of comparable competitor's defibrillator interface, several learners have been unable to operate the device appropriately. This interface issue leads to delays in appropriate treatment for mock patients (and potentially live patients) who are "dead" and require resuscitation. There were multiple instances in these mock codes where the "patient" did not receive any shock due to the complex interface.

876 users (76%) within VA Central Ohio Healthcare System are American Heart Association (AHA) BLS (Basic Life Support) trained and should only be using the AED mode functionality of the defibrillator. This user interface on the manual defibrillation device is difficult for learners to understand even with extra hands-on training; it is simply not intuitive enough for the hundreds of people who may need to use it. And while we have AEDs in the facility, the more advanced equipment is frequently needed in procedural and higher-risk areas. The manual mode functions still need to be available for the 267 users (24%) that are AHA ALS (Advanced Life Support) certified and caring for sicker Veterans who may go into cardiac arrest within the facility.

(7) Any Other Facts Supporting the Justification: NA
(8) A Statement of the Actions, if any, the agency may take to remove or overcome any barriers that led to the restricted consideration before any subsequent acquisition for the supplies or services is made:

Currently no barriers can be removed for this procurement, but the program office will continue to evaluate and monitor the market availability of other types which may be compatible and interchangeable with the existing Defibrillators and Automated External Defibrillators.

(9) Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge. I understand that processing of this limited sources justification restricts consideration of Federal Supply Schedule contractors to fewer than the number required by FAR Subpart 8.4. (This signature is the requestor s supervisor, fund control point official, chief of service or someone with responsibility and accountability.)
____________________________
Chief
Chalmers P. Wylie Veterans Outpatient Clinic
(10) Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.


___________________________
Contracting Officer
Network Contracting Office 10
b. One Level Above the Contracting Officer (Required over the SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.
__________________________________

Branch Chief
Network Contracting Office 10

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