Combined Synopsis_Solicitation_36C10X24Q0221.pdf

Combined Synopsis/Solicitation Notice

*= Required Field Combined Synopsis/Solicitation Notice

SUBJECT NX EQ SCALP COOLING SYSTEMS

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 21703

SOLICITATION NUMBER* 36C10X24Q0221

RESPONSE DATE/TIME/ZONE 05-23-2024 4:00 PM EASTERN TIME, NEW YORK, USA

ARCHIVE 90 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

SET-ASIDE SDVOSB

PRODUCT SERVICE CODE* 6515

NAICS CODE* 339112

CONTRACTING OFFICE ADDRESS U.S. Department of Veterans Affairs

OPAL | Strategic Acquisition Center | Frederick

5202 Presidents Court | STE 103 Frederick MD 21703

POINT OF CONTACT*

Contract Specialist Angela Ayers Angela.Ayers@va.gov 202-763-9576

PLACE OF PERFORMANCE

ADDRESS Nationwide

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL https://www.va.gov/opal/sac/index.asp

URL DESCRIPTION VA | OALC | OPAL | SAC

AGENCY CONTACT’S EMAIL ADDRESS Angela.Ayers@va.gov EMAIL DESCRIPTION Angela.Ayers@va.gov

DESCRIPTION

Number:

36C10X24Q0221

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; quotes are being requested and a written solicitation will not be issued.

Solicitation number 36C10X24Q0221 is issued for this combined synopsis/solicitation;

this solicitation is being issued as a Request for Quote (RFQ). This combined synopsis/solicitation incorporates provisions and clauses in effect through Federal

Acquisition Circular (FAC) 2024-03, dated 23 February 2024.

Requirement Description:

VA has a requirement to purchase Scalp Cooling Systems to deliver patient care at its

VA Medical Centers around the country. The Scalp Cooling System: Medical device that circulates a refrigerated liquid coolant, at low pressure, through a special cooling cap that is positioned on the patient’s head during and after chemotherapy infusion treatments to help prevent or reduce hair loss. This is possible based on the scalp cooling system’s ability to reduce the patient’s scalp temperature in turn preventing hair follicles from absorbing as much chemotherapy. This scalp cooling system is a compact, mobile refrigeration unit intended to be used in hospital and healthcare facilities that treat cancer patients receiving chemotherapy.

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. Quotes 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 339112 – Surgical and Medical Instrument Manufacturing: 6515 –

Medical and Surgical Instruments, Equipment, and Supplies and the associated size standard is 1,000 employees. This procurement action is issued as SDVOSB set aside.

This acquisition is for a single award requirements contract in accordance with FAR Part

16.5 for Cooler Heads® Amma Scalp Cooling Unit or equal Scalp Cooling System:

Scalp Cooling System and related equipment and accessories as identified in

ATTACHMENT A – PRICE COST SCHEDULE – NX EQ SCALP COOLING SYSTEMS.

All interested companies shall provide a quote for all Contract Line-Item Numbers

(CLINs) listed in ATTACHMENT A – PRICE COST SCHEDULE – NX EQ SCALP

COOLING SYSTEMS. The ordering period is for one 12-month base year with four 12-month option years. Delivery is FOB destination. Firm-Fixed Price Orders will be placed against this contract in writing and will provide the delivery locations, delivery dates, and exact quantities.

The FAR provision at 52.212-1, Instructions to Offerors – Commercial, applies to this acquisition including attached addenda to the provision.

The FAR provision at 52.212-2, Evaluation -- Commercial Items, and the specific evaluation criteria as attached addenda also applies to this acquisition.

The Offeror is to include a completed copy of the provision at 52.212-3, Offeror

Representations and Certifications -- Commercial Items, with its offer.

Clause at 52.212-4, Contract and Conditions -- Commercial Items, applies to this acquisition and a statement regarding Terms any addenda to the clause. Addendum is attached.

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. Addendum is attached.

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

Questions regarding this combined synopsis/solicitation are due via email by 4:00PM EST on May 14, 2024, to Contract Specialist, Angela Ayers at Angela.Ayers@va.gov and Contracting Officer, Andrew Montgomery at Andrew.Montgomery@va.gov. No calls will be accepted.

Quotes are due via email by 4:00PM EST on May 23, 2024, to Contract Specialist, Angela Ayers at Angela.Ayers@va.gov and Contracting Officer, Andrew Montgomery at

Andrew.Montgomery@va.gov.

https://sam.gov/SAM/ mailto:Angela.Ayers@va.gov mailto:Andrew.Montgomery@va.gov mailto:Angela.Ayers@va.gov mailto:Andrew.Montgomery@va.gov

1. SCOPE OF WORK:

The Veterans Health Administration (VHA) Non-Expendable Equipment National

Program has identified the Cooler Heads® Amma or Scalp Cooling Unit product line as a candidate for a VA-wide (otherwise referred to as “national”) single requirements contract award.

A Scalp Cooling System is a medical device that circulates a refrigerated liquid coolant, at low pressure, through a special cooling cap that is positioned on the patient’s head during and after chemotherapy infusion treatments to help prevent or reduce hair loss.

This is possible based on the scalp cooling system’s ability to reduce the patient’s scalp temperature in turn preventing hair follicles from absorbing as much chemotherapy. This scalp cooling system is a compact, mobile refrigeration unit intended to be used in hospital and healthcare facilities that treat cancer patients receiving chemotherapy.

The Contractor must demonstrate the ability to meet all requirements for the solicitation.

The objective is to provide Scalp Cooling Systems to be used by clinicians throughout the VA medical centers and facilities. The period of performance is for one 12-month base period with four 12-month option periods.

2. REQUIREMENT

This requirement will be IAW FAR clause 52.211-6, “Brand Name or Equal” which requires the quoter indicate that each product being offered as an “equal” product to the

Cooler Heads® Amma Scalp Cooling Unit. For each equal product, the offeror must include a description reflecting the salient characteristics (SC) and level of quality that will satisfy the salient physical, functional, or performance characteristics of the equal product(s) specified in the solicitation. The quoter must also clearly identify the item by brand name (if any) and make/model number. Finally, the quoter 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 solicitation requirements.

CLIN

# Manufacturer Part Number Description

0001 Cooler Heads ISO-Cooler Heads

Cooler Heads Care Kit -Cooler Heads Care - (2/EA) Amma - Scalp Cooling Devices (830771); (1 BX of 4) Disposable Capping System - Small (530100-S); (1 BX of 4) Disposable Capping System - Medium (530100-M); (1 BX of 4) Disposable Capping System - Large (530100-L); and Starter Kit which includes: Connector Hose (1/EA)(830941), Power Cord (1/EA) (830962), Measuring Cup (1/EA), Box of Hairnets (1/EA), and Mirrors (2/EA).

0002 Cooler Heads 830771 Cooler Heads Care - Amma - Scalp Cooling Device, 1/EA

0003 Cooler Heads 530100-S Cooler Heads Care - Disposable Capping System - Small, 4/BX

0004 Cooler Heads 530100-M "Cooler Heads Care - Disposable Capping System - Medium, 4/BX"

The Department of Veterans Affairs (VA) is seeking vendors who can provide Cooler

Heads® Amma or Scalp Cooling Unit or equal as listed above which meet all the following salient characteristics: Vendors may quote any product solution or configuration so long as they meet the salient characteristics. Products quoted in the technical volume must be captured on the Vendor’s pricing volume (Attachment A, Price

Cost Schedule) of the solicitation.

Vendors may quote any additional ancillary products which they deem to be essential to the functionality of the proposed solution; these items must be captured in the Vendor’s pricing volume with a quantity of zero.

CLIN’s 0001-0002 apply to the following SC’s

SC # SALIENT CHARACTERISTICS METHOD OF

EVALUATION

SC 1 Must have FDA Clearance Literature Review SC 2 Must have a Power Supply: 100-110V 50 Hz or 100-120 V 60

Hz single phase power Literature Review

SC 3 Must be Portable Unit (4 Wheels for easy maneuverability) Literature Review SC 4 Must have a Fluid Temperature Range of: 23ºF-86ºF (-5°C -

30°F) Literature Review

SC 5 Capable of providing multiple Cap Sizes Literature Review

Vendors may quote any product solution or configuration so long as they meet the salient characteristics.

The following attachments are incorporated by reference. All criteria outlined in the attachments are applicable to this combined synopsis/solicitation.

See attached document: ATTACHMENT A - PRICE COST SCHEDULE - NX EQ

SCALP COOLING SYSTEMS.

See attached document: ATTACHMENT B - CONTRACT ADMINISTRATION NX

EQ SCALP COOLING SYSTEMS.

See attached document: ATTACHMENT C - CONTRACT CLAUSES - NX EQ

SCALP COOLING SYSTEMS.

See attached document: ATTACHMENT D - SOLICITATION PROVISIONS - NX EQ

SCALP COOLING SYSTEMS.

See attached document: ATTACHMENT E - REPORTING TOOL - NX EQ SCALP COOLING SYSTEMS (available at award).

See attached document: ATTACHMENT F – NMR INDIVIDUAL WAIVER - NX EQ

SCALP COOLING SYSTEMS.