6515--NX EQ Surgical Helmet Systems

Solicitation Number:

36C10G20Q0035

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 36C10G20Q0035 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) 2020-04, dated 15 January 2020.

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 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 Firm-Fixed Price Requirements contract will be awarded for the purchase of brand name or equal equipment 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 band 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, Product Service Code: 6515 Medical and Surgical Instruments, Equipment, and Supplies and the associated size standard is 1,000 employees. This procurement action is issued as full and open competition.

This acquisition is for a single-award Firm-Fixed Price 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 year with two 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 Offerors must be registered in the System for Award Management (SAM) prior to submitting an offer or quotation. You may access SAM at https://sam.gov/SAM/.

Questions regarding this combined synopsis/solicitation are due via email by 11:59 PM EST on

April 23, 2020 to Contract Specialist, Ninatile Bacote at Ninatile.Bacote@va.gov and Contracting Officer, Timothy Johnson at Timothy.johnson13@va.gov. No calls will be accepted.

Quotes are due via email by 11:59 PM EST on May 11, 2020 to Contract Specialist, Ninatile Bacote at Ninatile.Bacote@va.gov and Contracting Officer, Timothy Johnson at Timothy.johnson13@va.gov.

Product Description

Salient Characteristics

Literature Review

1. SCOPE OF WORK:

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

Surgical Helmet Systems (SHSs) 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 one 12-month base period with two 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 Stryker® brand name 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 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.

Contract Line Item#

Brand

Part Number

Description

0001

Stryker

0408-645-000

Helmet, Flyte w/ LED Light

0002

Stryker

0408-210-000

Flyte Comfort Pads

0003

Stryker

0408-600-300

Power Cord, Flyte

0004

Stryker

0408-666-000

Power Pack

0005

Stryker

0408-820-000

Toga, Zippered, Large

0006

Stryker

0408-830-000

Toga, Zippered, X Large

0007

Stryker

0408-840-000

Toga, Zippered, 2X Large

0008

Stryker

0408-850-000

Toga, Zippered, 3X Large

0009

Stryker

0408-800-400

Hood, Flyte (32 per case)

The Department of Veterans Affairs (VA) is seeking vendors who can provide Stryker® brand name Surgical Helmet Systems as listed above or equal commodities which meet all the following salient characteristics:

SC #

SALIENT CHARACTERISTICS

METHOD OF EVALUATION

CLINs

SC 1

Shall meet a minimum AAMI Level 3 Testing

(Association for Advancement of Medical Instrumentation)

Literature Review

0001-0009

SC 2

Basic System Components Must Include Helmet with/Light, Hood, Toga, Battery with Charging Ability

Literature Review

0001-0009

SC 3

Helmet Must Include a Variable Speed Fan for Ventilation

Literature Review

0001

SC4

Headband in Helmet Must be Adjustable for Custom Fitting

Literature Review

0001