6515--NX EQ Surgical Helmet System

Combined Synopsis/Solicitation Notice

Combined Synopsis/Solicitation Notice

*= Required Field

Solicitation Number:

36C10G22Q0073

Notice Type:

Combined Synopsis/Solicitation

Synopsis:

COMBINED SYNOPSIS/SOLICITATION

This is a combined synopsis/solicitation for brand name or equal 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 36C10G22Q0073 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) 2022-04, dated 30 January 2022.

Requirement Description:

VA has a requirement to purchase Surgical Helmet Systems to deliver patient care at its VA Medical Centers around the country. Surgical Helmet Systems (SHS) are used by surgical staff during orthopedic procedures to decrease the patient's risk of deep wound infection (e.g., Staphylococcus aureus) by keeping skin and other particles from falling into the open surgical site. They are also used to protect the surgical staff from potentially infectious aerosols generated by power tools during orthopedic procedures, particularly total knee and hip replacements, and long procedures such as spinal surgery. Aerosols may contaminate mucous membranes (e.g., eyes, nose, mouth) or the respiratory tract. SHSs can also protect the surgical staff from infectious blood splashes that may carry hepatitis B and C viruses as well as HIV (Human Immunodeficiency Virus).

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 339113 Surgical Appliance and Supplies Manufacturing, Product Service Code: 6515 Medical and Surgical Instruments, Equipment, and Supplies and the associated size standard is 750 employees. This procurement action is issued as full and open competition.

This acquisition is for a single award Requirements contract in accordance with FAR Part 16.5 for Stryker brand name or equal Surgical Helmet Systems and related equipment and accessories as identified in ATTACHMENT A NX EQ SURGICAL HELMET SYSTEMS PRICE COST SCHEDULE. All interested companies shall provide a quote for all Contract Line Item Numbers (CLINs) listed in ATTACHMENT A NX EQ SURGICAL HELMET SYSTEMS PRICE COST SCHEDULE.

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 Terms and Conditions -- Commercial Items, applies to this acquisition and a statement regarding 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 11:59PM EST on April 28, 2022, to Contract Specialist, Ninatile Bacote at Ninatile.Bacote@va.gov and Contracting Officer, David Barber at David.Barber@va.gov. No calls will be accepted.

Quotes are due via email by 11:59PM EST on May 13, 2022, to Contract Specialist, Ninatile Bacote at Ninatile.Bacote@va.gov and Contracting Officer, David Barber at David.Barber@va.gov.

1. BACKGROUND:

The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has identified the Surgical Helmet Systems (SHS) product line as a candidate for a VA-wide (otherwise referred to as national ) single Requirements contract.

Surgical Helmet Systems are used by surgical staff during orthopedic procedures to decrease the patient's risk of deep wound infection (e.g., Staphylococcus aureus) by keeping skin and other particles from falling into the open surgical site. They are also used to protect the surgical staff from potentially infectious aerosols generated by power tools during orthopedic procedures, particularly total knee and hip replacements, and long procedures such as spinal surgery. Aerosols may contaminate mucous membranes (e.g., eyes, nose, mouth) or the respiratory tract. SHSs can also protect the surgical staff from infectious blood splashes that may carry hepatitis B and C viruses as well as HIV (human immunodeficiency virus).

The Contractor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Surgical Helmet Systems to be used by clinicians throughout the VA medical centers and facilities. The period of performance is for a base of 12-months 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 offeror indicate that each product being offered as an equal product to the Stryker® Surgical Helmet System. 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 offeror must also clearly identify the item by brand name (if any) and make/model number. Finally, 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 solicitation requirements.

Contract Line Items

Brand

Part Number

Description

0001

Stryker

0408-645-000

Helmet, Flyte W/ LED Light

0002

Stryker

0408-210-000

Flyte Comfort Pads (8/Pk)

0003

Stryker

0408-600-300

Power Cord, Flyte

0004

Stryker

0408-660-000

Power Pack

0005

Stryker

0408-830-000

Toga, Zippered, X Large (9/Pk)

0006

Stryker

0408-840-000

Toga, Zippered, 2X Large (8/Pk)

0007

Stryker

0408-800-400

Hood, Flyte (28/Pk)

0008

Stryker

0408-800-000

Flyte Hood (32/Pk)

0009

Stryker

0408-800-100

Flyte Hood W/ Peelaway (32/Pk)

0010

Stryker

0408-800-500

Extended Length Flyte Hood W/ Peelaway

0011

Stryker

0408-720-000

Flyte Toga, Pullover, L

0012

Stryker

0408-730-000

Flyte Toga, Pullover, XL

0013

Stryker

0408-740-000

Flyte Toga, Pullover, 2X

0014

Stryker

0408-820-100

Flyte Toga, Peelaway, L

0015

Stryker

0408-830-100

Flyte Toga, Peelaway, XL

0016

Stryker

0408-840-100

Flyte Toga, Peelaway, 2X

0017

Stryker

0408-850-100

Flyte Toga, Peelaway, 3X

0018

Stryker

0408-801-400

Flyte Surgicool Hood (28/Pk)

0019

Stryker

0408-801-500

Flyte Surgicool Hood W/ Peelaway (28/Pk)

0020

Stryker

0408-721-000

Flyte Surgicool Toga, Pullover, L

0021

Stryker

0408-731-000

Flyte Surgicool Toga, Pullover, XL

0022

Stryker

0408-741-000

Flyte Surgicool Toga, Pullover, 2X

0023

Stryker

0408-821-000

Flyte Surgicool Toga, Zipper, L

0024

Stryker

0408-821-100

Flyte Surgicool Toga, Peelaway, L

0025

Stryker

0408-831-000

Flyte Surgicool Toga, Zipper, XL

0026

Stryker

0408-831-100

Flyte Surgicool Toga, Peelaway, XL

0027

Stryker

0408-841-000

Flyte Surgicool Toga, Zipper, 2X

0028

Stryker

0408-841-100

Flyte Surgicool Toga, Peelaway, 2X

0029

Stryker

0408-851-000

Flyte Surgicool Toga, Zipper, 3X

0030

Stryker

0408-600-000

Helmet, Flyte

0031

Stryker

0408-635-000

Helmet, Flyte W/ Fiber Optic Light

0032

Stryker

0416-210-000

T7 Comfort Pads

0033

Stryker

0416-600-000

T7 Surgical Helmet

0034

Stryker

0416-610-000

T7 Surgical Helmet W/LED

0035

Stryker

0416-720-200

T7 Pullover Toga L

0036

Stryker

0416-721-200

T7 Plus Pullover Toga L

0037

Stryker

0416-730-200

T7 Pullover Toga XL

0038

Stryker

0416-731-200

T7plus Pullover Toga XL

0039

Stryker

0416-740-200

T7 Pullover Toga 2X

0040

Stryker

0416-741-200

T7plus Pullover Toga 2X

0041

Stryker

0416-800-100

T7 Hood W Peelaway Shield

0042

Stryker

0416-800-200

T7 Hood

0043

Stryker

0416-801-100

T7Plus Hood W Peelaway Shield

0044

Stryker

0416-801-200

T7plus Hood

0045

Stryker

0416-820-100

T7 Zipper Toga W Peelaway L

0046

Stryker

0416-821-100

T7Plus Zipper Toga W Peelaway L

0047

Stryker

0416-821-200

T7plus Zipper Toga L

0048

Stryker

0416-830-100

T7 Zipper Toga W Peelaway XL

0049

Stryker

0416-830-200

T7 Zipper Toga XL

0050

Stryker

0416-831-100

T7Plus Zipper Toga W Peelaway XL

0051

Stryker

0416-831-200

T7plus Zipper Toga XL

0052

Stryker

0416-840-100

T7 Zipper Toga W Peelaway 2X

0053

Stryker

0416-840-200

T7 Zipper Toga 2X

0054

Stryker

0416-841-100

T7Plus Zipper Toga W Peelaway 2X

0055

Stryker

0416-841-200

T7plus Zipper Toga 2X

0056

Stryker

0416-850-100

T7 Zipper Toga W Peelaway 3X

0057

Stryker

0416-851-200

T7plus Zipper Toga 3X

0058

Stryker

0408-655-000

Flyte 120v Charger

The Department of Veterans Affairs (VA) is seeking vendors who can provide Stryker® Surgical Helmet System or equal as listed above which meet all of 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.

SC #

SALIENT CHARACTERISTICS

METHOD OF EVALUATION

APPLICABLE CLINs

PAGE # WHERE SC IS FOUND IN TECHNICAL LITERATURE

SC 1

Shall meet a minimum AAMI Level 4 Testing (Toga)

(Association for Advancement of Medical Instrumentation)

Literature Review

0005-0028, 0034-0057

SC 2

Basic system components must include Helmet w/ light, Hood, Toga, Battery with Charging ability

Literature Review

0001-0058

SC 3

Helmet must include a variable speed fan for ventilation

Literature Review

0001, 0030, 0032, 0033, 0034

SC 4

Headband in helmet must be adjustable for custom fitting

Literature Review

0001, 0030, 0032, 0033, 0034

SC 5

All areas of the helmet must be accessible for cleaning to prevent cross-contamination

Literature Review

0001, 0030, 0032, 0033, 0034

SC 6

Hood/Toga must be constructed of splash and fluid resistant fabric

Literature Review

0005-0029, 0035-0057

SC 7

Batteries must have operating life of >= 5 hours

Literature Review

0001, 0004, 0030, 0032, 0033, 0034, 0058