6515--NX Defibrillators

Amendment 0001 Questions and Answers Document

Combined Synopsis/Solicitation Notice

Page 14 of 14

Page 1 of

Solicitation Number:

36C10G25R0012

Notice Type:

Combined Synopsis/Solicitation

Synopsis:

COMBINED SYNOPSIS/SOLICITATION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.

Solicitation number 36C10G25R0012 is issued for this combined synopsis/solicitation; this solicitation is being issued as a Request for Proposal (RFP). This combined synopsis/solicitation incorporates provisions and clauses in effect through Federal Acquisition Circular (FAC) 2025-03, dated 17 January 2025.

Requirement Description:

The Veterans Health Administration (VHA) Non-Expendable National Program has a requirement to purchase Defibrillators to deliver patient care at its VA Medical Centers around the country. Defibrillators, manual and automatic, deliver a high-voltage electrical impulse to the heart in order to restore normal rhythm and contractile function in patients who are experiencing ventricular fibrillation (VF), ventricular tachycardia (VT), or another shockable rhythm. An ECG monitor included with the unit is used to verify the presence of a shockable rhythm and the effectiveness of treatment.

A single award Requirements contract will be awarded IAW FAR 52.211-6 Brand Name or Equal in accordance with all terms, conditions, provisions, specifications, and schedule of this solicitation herein. Proposals shall contain the terms for cost/price and technical capabilities of the brand name or equal equipment. The Government reserves the right to award without discussions.

The associated North American Industrial Classification System (NAICS) code for this procurement is 334510 Electromedical and Electrotherapeutic Apparatus Manufacturing: 6515 Medical and Surgical Instruments, Equipment, and Supplies and the associated size standard is 1,250 employees. This procurement action is issued as full and open competition.

This acquisition is for a single award Requirements contract with firm-fixed priced (FFP) delivery orders in accordance with FAR Part 16.5 for Zoll brand name or equal Defibrillators and accessories as identified in ATTACHMENT A PRICE COST SCHEDULE - NX DEFIBRILLATORS. Offerors shall provide a proposal for all Contract Line-Item Numbers (CLINs) listed in ATTACHMENT A PRICE COST SCHEDULE NX DEFIBRILLATORS.

The ordering period is for one 12-month base year with four 12-month option years. Delivery is Free on Board (FOB) destination. FFP Orders will be placed against this contract in writing and will provide the delivery locations, delivery dates and exact quantities.Â

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The FAR provision at 52.212-1, Instructions to Offerors Commercial, applies to this acquisition including attached addenda to the provision (see ATTACHMENT D SOLICITATION PROVISIONS NX DEFIBRILLATORS).

The FAR provision at 52.212-2, Evaluation -- Commercial Items, and the specific evaluation criteria as attached addenda also applies to this acquisition (see ATTACHMENT D SOLICITATION PROVISIONS - NX DEFIBRILLATORS).

The Offeror is to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications -- Commercial Items, with Volume V: Offer, Amendments, and Certifications & Representations of its proposal (see ATTACHMENT D SOLICITATION PROVISIONS NX DEFIBRILLATORS).

Clause at 52.212-4, Contract Terms and Conditions -- Commercial Items, applies to this acquisition and a statement regarding any addenda to the clause. Addendum is attached (see ATTACHMENT C - CONTRACT CLAUSES NX DEFIBRILLATORS).

Clause at 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders -- Commercial Items, applies to this acquisition and a statement regarding which, if any, of the additional FAR clauses cited in the clause are applicable to the acquisition (see ATTACHMENT C - CONTRACT CLAUSES NX DEFIBRILLATORS).

All interested offerors must be registered in the System for Award Management (SAM) prior to submitting a proposal. You may access SAM at https://sam.gov/SAM/.

Questions regarding this combined synopsis/solicitation are due via email by 16:30 CST on May 12, 2025, to Contract Specialist, Courtney Chattman at Courtney.Chattman@va.gov and Contracting Officer, Jessica Edwards at Jessica.Edwards6@va.gov. No questions will be accepted after the due date. No calls will be accepted.

Proposals are due via email by 16:30 CST on May 26, 2025, to Contract Specialist, Courtney Chattman at Courtney.Chattman@va.gov and Contracting Officer, Jessica Edwards at Jessica.Edwards6@va.gov.

PRODUCT DESCRIPTION

1. SCOPE OF WORK

The VHA NX EQ National Program has identified the Defibrillators product line as a candidate for inclusion in the National Equipment Catalog (NEC).

Defibrillators, manual and automatic, deliver a high-voltage electrical impulse to the heart in order to restore normal rhythm and contractile function in patients who are experiencing ventricular fibrillation (VF), ventricular tachycardia (VT), or another shockable rhythm. An ECG monitor included with the unit is used to verify the presence of a shockable rhythm and the effectiveness of treatment.

The Offeror must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Defibrillators and accessories to be used throughout the VA medical centers and facilities CONUS and OCONUS. The period of performance is for a 12-month base period and four 12-month option periods.

2. REQUIREMENT

The objective of this procurement is to establish a single Requirements contract with firm-fixed priced (FFP) delivery orders for inclusion in the NEC and Enterprise-wide usage. VHA aims to ensure availability and consistency of NX EQ and to obtain volume-based, standardized pricing. VHA desires to continue the practice of achieving cost avoidance while simultaneously balancing clinician considerations for obtaining quality equipment. This requirement will be in accordance with FAR 52.211-6, Brand Name or Equal, which requires the Offeror to indicate that each product being offered as an equal product to Zoll Defibrillators and accessories.

The VHA is seeking four (4) types of defibrillators. All four (4) types of defibrillators shall be of the same brand name.

Critical Care Transport Monitor/Defibrillator with pacing capabilities, Pulse Oximetry options (i.e., Nellcor and Masimo), Non-invasive blood pressure, Invasive blood pressure, and End tidal CO2 monitoring with real-time CPR feedback.

Crash-cart ALS defibrillator with pacing capabilities, Pulse Oximetry options (i.e., Nellcor and Masimo), Non-invasive blood pressure, End Tidal CO2 monitoring with real-time CPR feedback with Federal Information Processing Standards (FIPS) compliant Wi-Fi capability.

Crash-cart Automated External Defibrillator (AED) with manual ALS override pacing, Pulse Oximetry options (i.e., Nellcor and Masimo), Non-invasive blood pressure, End Tidal CO2 monitoring with real-time CPR feedback with FIPS compliant Wi-Fi capability.

Public access AED with CPR feedback and guidance.

For each equal product, the offeror must include a description reflecting the salient characteristics and level of quality that will satisfy the salient physical, functional, or performance characteristics of the equal product(s) specified in the solicitation. The Offeror must also clearly identify the item by brand name (if any) and make/model number. In addition, the Offeror must include descriptive literature, such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the contracting officer, and clearly describe any modifications it plans to make to a product to make it conform to the salient characteristics.

The following line items comprise the Zoll Defibrillators product line:

Contract Line Item#

Brand

Part Number

Zoll

0001

Zoll

603-0221311-01

X Series Monitor/Defibrillator with Expansion Pack - SpO2(Masimo), Pacing, NIBP, IBP, EtCO2

Includes: 4 trace tri-mode display monitor/ defibrillator/ printer, advisory algorithm, advanced communications package (Wi-Fi, Bluetooth, USB cellular modem capable) USB data transfer capable and large 6.5in( 16.5cm) diagonal screen.

Accessories Included: Six (6) foot 3- Lead ECG cable, OneStep Patient Cable, AC Power Cord, one (1) roll printer paper, 6.6 Ah Li-ion battery, Operator Manual, Quick Reference Guide, and Five (5)-year Hospital warranty.

Parameter Details: Real CPR Help Dashboard display of CPR Depth and Rate for Adult and Pediatric patients, Visual and audio prompts to coach CPR depth (Adult patient only), Release bar to ensure adequate release off the chest, Metronome to coach rate for Adult and Pediatric patients. See-Thru ® CPR artifact filtering ZOLL Noninvasive Pacing Technology

Welch Allyn NIBP with Smartcuff. 10-foot Dual Lumen hose and SureBP Reusable Adult Medium Cuff Masimo Pulse Oximetry with Signal Extraction Technology (SET), Rainbow SET®, EtCO2 Oridion, Microstream Technology. Microstream tubing set sold separately, Invasive, pressure waveform capability with display and digital monitoring. Invasive pressure cable/ transducer sold separately

0002

Zoll

603-0211511-01

X Series Monitor/Defibrillator with Expansion Pack - SpO2 (Nellcor), Pacing, NIBP, IBP, EtCO2 X Series Monitor/Defibrillator with Expansion

Includes: 4 trace tri-mode display monitor/defibrillator/ printer, advisory algorithm, advanced communications package (Wi-Fi, Bluetooth, USB cellular modem capable) USB data transfer capable and large 6.5in( 16.5cm) diagonal screen.

Accessories Included: Six (6) foot 3- Lead ECG cable, OneStep Patient Cable, AC Power Cord, one

(1) roll printer paper, 6.6 Ah Li-ion battery, Operator Manual, Quick Reference Guide, and Five (5)-year

Hospital warranty. Parameter Details: Real CPR Help - Dashboard display of CPR Depth and Rate for Adult and Pediatric patients, Visual and audio prompts to coach CPR depth (Adult patient only), Release bar to ensure adequate release off the chest, Metronome to coach rate for Adult and Pediatric patients. See-Thru ® CPR artifact filtering ZOLL Noninvasive Pacing Technology Welch Allyn NIBP with Smartcuff. 10-foot Dual Lumen hose and SureBP Reusable Adult Medium Cuff Masimo Pulse Oximetry with Signal Extraction Technology (SET), Rainbow SET® EtCO2 Oridion Microstream Technology. Microstream tubing set sold separately Invasive pressure waveform capability with display and digital monitoring. Invasive pressure cable/ transducer sold separately

0003

Zoll

30720005201310012

R Series ALS Defibrillator with Expansion Pack -

SpO2 (Masimo), OneStep Pacing, EtCO2 (mainstream),

NIBP

Includes: Guidelines 2020 compatible, Code Readiness testing system, High current Rectilinear Biphasic Waveform, OneStep 3 lead ECG cable, Advisory Defibrillation, Built-in test port, AC Power Cord, Operators manual, and 5-year hospital warranty. Parameter Details: Real CPR Help ® - Numeric display of CPR Depth and Rate for Adult and Pediatric patients, Visual and audio prompts to coach CPR depth (Adult patient only), Release bar to ensure adequate release off the chest, Metronome to coach rate for Adult and Pediatric patients. See-Thru ® CPR artifact filtering, Defib Mentor OneStep Pacing with OneStep Pacing Cable (also supports CPR) NIBP with 23-33cm reusable cuff & 3-meter air hose Masimo Pulse Oximetry with Signal Extraction Technology (SET) and Reusable adult sensor & reusable 4 ft ext. cable EtCO2 CAPNOSTAT ® 5 Mainstream CO2 Cable and

sensor. For use with adult, pediatric, and neonatal patients. Airway adapter sold separately

0004

Zoll

30120007201310012

R Series ALS Defibrillator with Expansion Pack - SpO2 (Nellcor), OneStep Pacing, EtCO2 (mainstream), NIBP

Includes: Guidelines 2020 compatible, Code Readiness testing system, High current Rectilinear

Biphasic Waveform, OneStep 3 lead ECG cable, Advisory Defibrillation, Built-in test port, AC Power Cord, Operators manual, and 5-year hospital warranty.

Parameter Details: Real CPR Help ® - Numeric display of CPR Depth and Rate for Adult and Pediatric patients, Visual and audio prompts to coach

CPR depth (Adult patient only), Release bar to ensure adequate release off the chest, Metronome to coach rate for Adult and Pediatric patients. See-Thru ® CPR artifact filtering, Defib Mentor OneStep Pacing with OneStep Pacing Cable (also supports CPR) NIBP with 23-33cm reusable cuff & 3-meter air hose Nellcor Pulse Oximetry with Signal Extraction Technology (SET) and Reusable adult sensor & reusable 4 ft ext. cable EtCO2 CAPNOSTAT ® 5 Mainstream CO2 Cable and sensor. For use with adult, pediatric, and neonatal patients. Airway adapter sold separately.

0005

Zoll

30520005201310013

R Series Plus Defibrillator with Expansion Pack - SpO2 (Masimo), OneStep Pacing, EtCO2 (mainstream), NIBP

Includes: Guidelines 2020 compatible, AED w/ manual override, Code Readiness testing system, High current Rectilinear Biphasic Waveform, OneStep 3 lead ECG cable, Advisory Defibrillation, Built-in test port, AC Power Cord, Operators manual, and 5-year hospital warranty.

Parameter Details: Real CPR Help ® - Numeric display of CPR Depth and Rate for Adult and Pediatric patients, Visual and audio prompts to coach CPR depth (Adult patient only), Release bar to ensure adequate release off the chest, Metronome to coach rate for Adult and Pediatric patients. See-Thru ® CPR artifact filtering, Defib Mentor OneStep Pacing with OneStep Pacing Cable (also supports CPR) NIBP with 23-33cm reusable cuff & 3 meterair hose Masimo Pulse Oximetry with Signal Extraction Technology (SET) and Reusable adult sensor & reusable 4 ft ext. cable EtCO2 CAPNOSTAT ® 5 Mainstream CO2 Cable and sensor. For use with adult, pediatric, and neonatal patients. Airway adapter sold separately

0006

Zoll

30520007201310013

R Series Plus Defibrillator with Expansion Pack - SpO2 (Nellcor), OneStep Pacing, EtCO2 (mainstream), NIBP

Includes: Guidelines 2020 compatible, AED w/ manual override, Code Readiness testing system, High current Rectilinear Biphasic Waveform, OneStep 3 lead ECG cable, Advisory Defibrillation, Built-in test port, AC Power Cord, Operators manual, and 5-year hospital warranty.

Parameter Details: Real CPR Help ® - Numeric display of CPR Depth and Rate for Adult and Pediatric patients, Visual and audio prompts to coach CPR depth (Adult patient only), Release bar to ensure adequate release off the chest, Metronome to coach rate for Adult and Pediatric patients. See-Thru ® CPR artifact filtering, Defib Mentor OneStep Pacing with OneStep Pacing Cable (also supports CPR) NIBP with 23-33cm reusable cuff & 3-meter air hose Nellcor Pulse Oximetry with Signal Extraction Technology (SET) and Reusable adult sensor & reusable 4 ft ext. cable EtCO2 CAPNOSTAT ® 5 Mainstream CO2 Cable and sensor. For use with adult, pediatric, and neonatal patients. Airway adapter sold separately

0007

Zoll

8050-0030-01

SurePower Charging Station 4 Charging bays, Multiple chemistry compatible, 200-watt capacity, Graphic driven user interface, RS-232 Communication port, Standard one (1) year warranty

0008

Zoll

8300-0250-01

SurePower Charger Adapter

0009

Zoll

8503-001103-01

ZOLL AED 3® BLS Hospital

Package Includes: Product Documentation and ZOLL AED 3 Battery Pack

0010

Zoll

8000-001257

Semi-recessed Wall Cabinet (Device Only).

Includes: alarm, set-up instructions and ILCOR label set

0011

Zoll

8000-001250

ZOLL AED 3 Carry Case

The VA is seeking offerors who can provide Zoll Defibrillators or equal as listed above which meet all salient characteristics listed below. Offerors may offer any product solution or configuration so long as they meet the salient characteristics.

Offerors may propose an alternative contract line-item number (CLIN) structure IAW FAR 4.1003 and 4.1004. Products proposed in the technical volume must be appear on and correspond with the Offeror s pricing volume (Attachment A - Price Cost Schedule - NX EQ Defibrillators).

Offerors may propose any additional ancillary products which they deem to be essential to the functionality of the proposed solution; these ancillary items must be quantified in the Offeror s pricing volume with an estimated quantity of zero (0).

Only new equipment is acceptable; no remanufactured or "gray market" items. No product in development shall be considered. All items must be covered by the manufacturer's warranty.

Distributors must be authorized distributors/resellers as certified by the Original Equipment Manufacturer (OEM) (i.e., OEM letter dated within 12 months of the solicitation close date and duly signed by OEM s authorized representative) to be eligible for award. The OEM letter must be valid for the life of the contract. Failure to include the OEM letter with the Offer will render the Offer non-compliant and will not be considered for award.

The following salient characteristics apply to CLINs 0001-0006:

SC #

Salient Characteristics

Method of Evaluation

SC Literature Map

SC 1

FDA Approved

Literature Review

Brand Name:

Page #:Â

SC 2

Must have Automatic External Defibrillation mode

Literature Review

Brand Name:

Page #:Â

SC 3

Voice Prompting

Literature Review

Brand Name:

Page #:Â

SC 4

Must delivery electric current by biphasic waveform

Literature Review

Brand Name:

Page #:Â

SC 5

Real Time CPR Feedback

Literature Review

Brand Name:

Page #:Â

SC 6

ECG Monitoring

Literature Review

Brand Name:

Page #:Â

SC 7

Lead Fault Indicator

Literature Review

Brand Name:

Page #:Â

The following salient characteristics apply to CLINs 0007:

SC #

Salient Characteristics

Method of Evaluation

SC Literature Map

SC 11

Must be compatible with CLINS 0001-0006

Literature Review

Brand Name:

Page #:Â

The following salient characteristics apply to CLINs 0008:

SC #

Salient Characteristics

Method of Evaluation

SC Literature Map

SC 12

Must be compatible with CLIN 0007

Literature Review

Brand Name:

Page #:Â

The following salient characteristics apply to CLIN 0009:

SC #

Salient Characteristics

Method of Evaluation

SC Literature Map

SC 1

FDA Approved

Literature Review

Brand Name:

Page #:Â

SC 3

Voice Prompting

Literature Review

Brand Name:

Page #:Â

SC 5

Real Time CPR Feedback

Literature Review

Brand Name:

Page #:Â

SC 8

CPR Technique Instruction

Literature Review

Brand Name:

Page #:Â

SC 9

Visual Prompts

Literature Review

Brand Name:

Page #:Â

SC 10

Self-Test

Literature Review

Brand Name:

Page #:Â

The following salient characteristics apply to CLINs 0010-0011:

SC #

Salient Characteristics

Method of Evaluation

SC Literature Map

SC 13

Must be compatible with CLINS 0001-0006

Literature Review

Brand Name:

Page #:Â

3. PRODUCT REFRESHÂ Â

Product refresh is when a current CLIN is no longer being manufactured due to

obsolescence and the product item is being replaced with a newer, and more often, a

superior version of the same item. The current CLIN product will be revised to reflect the

refreshed product information, manufacturer s part number, IDIQ price (inclusive of

Service Level Agreement (SLA) fee), etc.

The Government reserves the right to not accept the products offered under

product refresh. The contractor will be notified in writing if a product refresh is not

accepted. All products offered shall be provided with the warranty that is agreed upon

for this contract.

The Contractor agrees to ensure that all upgraded improved/replaced products

meet American with Disabilities Act (ADA) and Health Information Portability and

Accountability Act (HIPAA) Federal requirements, see attachment 5.

The contractor shall provide the Contracting Officer s Representative and Contracting Officer the following information for product refresh:

(1) A list of specific awarded item(s) being refreshed in the Price/Cost Schedule

(to include commercial pricing, discount offered, and IDIQ price (inclusive of SLA

fee));

(2) Product literature for the item(s) refreshed.

(3) A detailed description of the differences or benefits of refreshed as compared

to the item(s) being discontinued or added.

(4) Proper identification of any product requirements and/or procedures related to

those product(s) proposed to be refreshed or upgraded.

(5) FDA approval, if applicable.

(6) Provide historical sales to VA by item(s), if applicable

(7) Copy of Commercial Warranty.

The request shall be submitted to the Contracting Officer s Representative, copy to the Contract Specialist and Contract Officer, for review and recommendation of approval to be submitted to the Contracting Officer. The Contracting Officer shall prepare a bilateral modification for execution.

4. PRODUCT REMOVAL OR RECALL

For any product awarded under this contract removed or recalled by the manufacturer due to defects in the product or potential dangers to patients, or if any required removal or recall is suggested or mandated by a regulatory or official agency, the manufacturer agrees to take following steps immediately:

Notify the Contracting Officer at the Strategic Acquisition Center in writing, by the most expeditious manner possible.

Provide copies of the notification to the Contracting Officer, Contracting Specialist, Contracting Officer s Representative, and Manager at Product Recall Office, all Agencies and VA Facilities who purchased the product, which include, but not be limited to the following:

(1) Complete item description and/or identification, order numbers from

customers and the contract number assigned as a result of an issuance on

the solicitation;

(2) Reasons for modifications, removal or recall; and

(3) Necessary instructions for return for credit, replacement or corrective

action.

A copy of the notification will be provided to:

Manager, Product Recall Office

National Center for Patient Safety

Veterans Health Administration

24 Frank Lloyd Wright Drive, Lobby M

Ann Arbor, MI 48106

5. DELIVERY

The Period of Performance will be from date of award for a base of 12-months with four 12-month option periods. Contractors will be required to deliver Defibrillators and accessories to VHA facilities, CONUS AND OCONUS, IAW the terms and conditions of the contract. Delivery requirements shall be specified under each individual order. All shipments shall be FOB Destination. The Contractor must coordinate delivery with the ordering facility point of contact.

6. TRAINING

The ordering facility and the Contractor will schedule any required training. When training is not required, the Contractor shall note if there are instructions for use.

7. DATA RIGHTS

Commercial license agreements may be made a part of this Contract/Order but only if both parties expressly make them an addendum hereto, as permitted by FAR 12.212. If the commercial license agreement is not made an addendum, it shall not apply, govern, be a part of or have any effect whatsoever on the Contract/Order; this includes, but is not limited to, any agreement embedded in the computer software (clickwrap), any agreement that is otherwise delivered with or provided to the Government with the commercial computer software or documentation (shrinkwrap), or any other license agreement otherwise referred to in any document. If a commercial license agreement is made an addendum, only those provisions addressing data rights regarding the Government s use, duplication and disclosure of data (e.g., restricted computer software) are included and made a part of this Contract/Order, and only to the extent that those provisions are not duplicative or inconsistent with Federal law, Federal regulation, the incorporated FAR clauses and the provisions of this Contract/Order; those provisions in the commercial license agreement that do not address data rights regarding the Government s use, duplication and disclosure of data shall not be included or made a part of the Contract/Order. Federal law and regulation including, without limitation, the Contract Disputes Act (41 U.S.C. § 7101 et seq.), the Anti-Deficiency Act (31 U.S.C. § 1341 et seq.), the Competition in Contracting Act (41 U.S.C. § 3301 et seq.), the Prompt Payment Act (31 U.S.C. § 3901 et seq.), Contracts for Data Processing or Maintenance (38 USC § 5725), and FAR clauses 52.212-4, 52.227-14, 52.227-19 shall supersede, control, and render ineffective any inconsistent, conflicting, or duplicative provision in any commercial license agreement. In the event of conflict between this clause and any provision in the Contract/Order or the commercial license agreement or elsewhere, the terms of this clause shall prevail. The Contractor shall deliver to the Government all data first produced under this Contract/Order with unlimited rights as defined by FAR 52.227-14. Claims of patent or copyright infringement brought against the Government as a party shall be defended by the U.S. Department of Justice (DOJ) in accordance with 28 U.S.C. § 516; at the discretion of DOJ, the Contractor may be allowed reasonable participation in the defense of the litigation. Any additional changes to the Contract/Order must be made by modification (Standard Form 30) and shall only be made by a warranted Contracting Officer. Nothing in this Contract/Order or any commercial license agreement shall be construed as a waiver of sovereign immunity.Â

ATTACHMENT A - PRICE COST SCHEDULE - NX DEFIBRILLATORS

ATTACHMENT B - CONTRACT ADMINISTRATION - NX DEFIBRILLATORS

ATTACHMENT C - CONTRACT CLAUSES - NX DEFIBRILLATORS

ATTACHMENT D - SOLICITATION PROVISIONS - NX DEFIBRILLATORS

ATTACHMENT E - QUARTERLY SALES REPORT - NX DEFIBRILLATORS

ATTACHMENT F - PAST PERFORMANCE REFERENCES - NX DEFIBRILLATORS

ATTACHMENT G - PAST PERFORMANCE QUESTIONAIRE - NX DEFIBRILLATORS