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Combined Synopsis/Solicitation Notice
| SUBJECT* |
| NX EQ Surgical Helmet System |
GENERAL INFORMATION
| CONTRACTING OFFICE’S ZIP CODE* |
| 22408-2697 |
| SOLICITATION NUMBER* |
| 36C10G22Q0073 |
| RESPONSE DATE/TIME/ZONE |
| 05-13-2022 11:59PM EASTERN TIME, NEW YORK, USA |
| ARCHIVE |
| 99 DAYS AFTER THE RESPONSE DATE |
SET-ASIDE
| PRODUCT SERVICE CODE* |
| 6515 |
| CONTRACTING OFFICE ADDRESS |
| U.S. Department of Veterans Affairs |
OPAL | Strategic Acquisition Center
10300 Spotsylvania Ave | STE 400 Fredericksburg VA 22408-2697
POINT OF CONTACT*
Contract Specialist Ninatile Bacote
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 |
| Ninatile.Bacote@va.gov |
| EMAIL DESCRIPTION |
| Ninatile.Bacote@va.gov |
DESCRIPTION
| *= Required Field |
| Combined Synopsis/Solicitation Notice |
Combined Synopsis/Solicitation Notice
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 |
See attached document: ATTACHMENT A - PRICE COST SCHEDULE - NX EQ SURGICAL HELMET SYSTEMS.
See attached document: ATTACHMENT B - CONTRACT ADMINISTRATION - NX EQ SURGICAL HELMET SYSTEMS.
See attached document: ATTACHMENT C - CONTRACT CLAUSES - NX EQ SURGICAL HELMET SYSTEMS.
See attached document: ATTACHMENT D - SOLICITATION PROVISIONS - NX EQ SURGICAL HELMET SYSTEMS.
See attached document: ATTACHMENT E - REPORTING TOOL - NX EQ SURGICAL HELMET SYSTEMS.
*= Required Field
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