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Combined Synopsis/Solicitation Notice Combined Synopsis/Solicitation Notice *= Required Field Solicitation Number: 36C10G22Q0073 Notice Type: Combined Synopsis/Solicitation Synopsis: COMBINED SYNOPSIS... 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