SOLICITATION NOTICE
65 -- NX EQ Washers Lab Surgical Instrument Ultrasonic
- Notice Date
- 9/24/2024 2:27:25 PM
- Notice Type
- Combined Synopsis/Solicitation
- NAICS
- 339113
— Surgical Appliance and Supplies Manufacturing
- Contracting Office
- STRATEGIC ACQUISITION CENTER FREDERICKSBURG (36C10G) FREDERICKSBURG VA 22408 USA
- ZIP Code
- 22408
- Solicitation Number
- 36C10G24R0004
- Response Due
- 10/1/2024 8:59:00 PM
- Archive Date
- 10/26/2024
- Point of Contact
- Alex Beck, Contract Specialist, Phone: (360) 852-9892
- E-Mail Address
-
Alex.Beck1@va.gov
(Alex.Beck1@va.gov)
- Awardee
- null
- Description
- Combined Synopsis/Solicitation Notice *= Required Field Combined Synopsis/Solicitation Notice SUBJECT* NX EQ Washers Lab Surgical Instrument Ultrasonic GENERAL INFORMATION CONTRACTING OFFICE S ZIP CODE* 22408-2697 SOLICITATION NUMBER* 36C10G24R0004 RESPONSE DATE/TIME/ZONE 09-26-2024 11:59PM EASTERN TIME, NEW YORK, USA ARCHIVE 30 DAYS AFTER THE RESPONSE DATE RECOVERY ACT FUNDS N SET-ASIDE PRODUCT SERVICE CODE* 6515 NAICS CODE* 339113 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 Alex Beck Alex.Beck1@va.gov PLACE OF PERFORMANCE ADDRESS Nationwide POSTAL CODE COUNTRY United States ADDITIONAL INFORMATION AGENCY S URL https://www.va.gov/opal/sac/index.asp URL DESCRIPTION VA | OALC | OPAL | SAC AGENCY CONTACT S EMAIL ADDRESS Alex.Beck1@va.gov EMAIL DESCRIPTION Alex.Beck1@va.gov Combined Synopsis/Solicitation Notice Combined Synopsis/Solicitation Notice DESCRIPTION Solicitation Number: 36C10G24R0004 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 Products and Commercial Services as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. Solicitation number 36C10G24R0004 is issued for this combined synopsis/solicitation; this solicitation is being issued as a Request for Proposal (RFP). This combined synopsis/solicitation incorporates provisions and clauses in effect through Federal Acquisition Circular (FAC) 2024-05, dated 22 MAY 2024. Requirement Description: The Veterans Health Administration (VHA) Non-Expendable Equipment National Program has a requirement to purchase Washers Lab Surgical Instrument Ultrasonic to deliver patient care at its VA Medical Centers around the country. Washers Lab/Surgical Instrument Ultrasonic are designed for automatic removal of dirt, stains, and/or biological debris (i.e., washing) from labware (e.g., glass and plastic beakers, test tubes), surgical instruments, and/or other critical devices using ultrasonic energy. The process is performed by delivering ultrasonic waves to a tank filled with a warm cleaning solution (e.g., detergents formulated for ultrasonic cleansing). These systems typically include a radiofrequency generator (frequencies from 25 to 40 kHz are typical), ultrasonic transducers, a heating unit, and a stainless-steel tank with baskets and/or trays. Cleaning is performed by the scrubbing action of the ultrasonic vibration and also by the implosion of bubbles (i.e., cavitation effect). Surgical instrument ultrasonic washers may include two or three tanks to perform automatic cycles for washing, rinsing, and drying; they may also include heating capabilities. This equipment may provide some level of disinfection by killing and/or inactivating several microorganism species; it is commonly used after general cleaning and before thermal or chemical disinfection. A single award Requirements Contract will be awarded IAW FAR 52.211-6 Brand Name or Equal, accordance with all terms, conditions, provisions, specifications, and schedule of this solicitation herein. Proposals 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 800 employees. This procurement action is issued as a Full and Open Competition. This acquisition is for FAR Part 16.5 for Steris ® or equal Washers Lab Surgical Instrument Ultrasonic and related equipment and accessories as identified in ATTACHMENT A PRICE COST SCHEDULE - NX EQ Washers Lab Surgical Instrument Ultrasonic. All interested Offerors shall provide an offer for all Contract Line-Item Numbers (CLINs) listed in ATTACHMENT A PRICE COST SCHEDULE NX EQ Washers Lab Surgical Instrument Ultrasonic. 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 Requirements 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 a proposal. You may access SAM at https://sam.gov/SAM/. Proposals shall contain the terms for cost/price and technical capabilities of the equipment. The Government reserves the right to award without discussions. Questions regarding this combined synopsis/solicitation are due via email by 11:59 PM EST on September 13, 2024, to Contract Specialist, Alex Beck at Alex.Beck1@va.gov and Contracting Officer, Sara Vickroy at Sara.Vickroy@va.gov. No calls will be accepted. Proposals are due via email by 11:59 PM EST on September 26, 2024, to Contract Specialist, Alex Beck at Alex.Beck1@va.gov and Contracting Officer, Sara Vickroy at Sara.Vickroy@va.gov. SCOPE OF WORK The Veterans Health Administration (VHA) Non-Expendable Equipment (NX) National Program has identified the Washers Lab Surgical Instrument Ultrasonic product line as a candidate for a VA-wide (otherwise referred to as ""national"") single Requirements contract award. The Washers Lab Surgical Instrument Ultrasonic is designed for the automatic removal of dirt, stains, and/or biological debris (i.e., washing) from labware (e.g., glass and plastic beakers, test tubes), surgical instruments, and/or other critical devices using ultrasonic energy. The process is performed by delivering ultrasonic waves to a tank filled with a warm cleaning solution (e.g., detergents formulated for ultrasonic cleansing). These systems typically include a radiofrequency generator (frequencies from 25 to 40 kHz are typical), ultrasonic transducers, a heating unit, and a stainless-steel tank with baskets and/or trays. Cleaning is performed by the scrubbing action of the ultrasonic vibration and by the implosion of bubbles (i.e., cavitation effect). Surgical instrument ultrasonic washers may include two or three tanks to perform automatic cycles for washing, rinsing, and drying; they may also include heating capabilities. This equipment may provide some level of disinfection by killing and/or inactivating several microorganism species; it is commonly used after general cleaning and before thermal or chemical disinfection. The Vendor must demonstrate the ability to meet all requirements for the solicitation. The objective is to provide Washers Lab Surgical Instrument Ultrasonic 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. 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 STERIS® Washers Lab Surgical Instrument Ultrasonic. For each product, the offeror must include a description reflecting the salient characteristics (SC) and level of quality that will satisfy the 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. The following line items comprise the Washers Lab Surgical Instrument Ultrasonic product line: Contract Line Item# Brand Part Number Description lnnoWave PCF 0001 Steris IWPCF InnoWave PCF Sonic Irrigator Unit comes with standard tray(s), instrument tubing, and distal connectors for reverse flushing 0002 Steris IW1046 InnoWave PCF Seismic Anchoring Kit (required to install IWPCF) Steris lnnoWave PCF Baskets / Tubing 0003 Steris IW1062 Basket and Tubing Set - Standard Instrument Basket, Standard Tubing x20 0004 Steris IW1038 Basket and Tubing Set - Xi Multi-Basket, Xi EndoWrist Tubing x4, Stapler Tubing x2 0005 Steris IW1064 Basket and Tubing Set - Si Standard Basket, EndoWrist Tubing x10 0006 Steris IW1065 Basket and Tubing Set - Si Multi-Basket, EndoWrist Tubing x8, Stapler Tubing x2 0007 Steris IW1006 Basket Only - Orthopedic / Heavily Soiled Instrument Basket 0008 Steris IW1066 Tubing Set Only - Standard Instrument Tubing x20 0009 Steris IW1039 Tubing Set Only - Xi Basket Tubing x6 0010 Steris IW1017 Tubing Set Only - Si Standard Basket Tubing x10 0011 Steris IW1068 Tubing Set Only - Si Multi-Basket Tubing x10 0012 Steris IW1069 Tubing Set Only - S/Si Single Site Tubing x10 0013 Steris IW1005 Flush Nozzle Set - Si, S/Si Single Site, or Si Stapler Flush Nozzle Set x10 lnnoWave PCF Accessories 0014 Steris M10003 1-gallon Pick-Up Tube x1 0015 Steris MED8557 2.5-gallon Pick-Up Tube x1 0016 Steris MED3088 Elbow Connectors x1 0017 Steris IW1025 InnoWave PCF Instrument Organizer Steris lnnoWave Pro Sonic irrigator 0018 Steris IWPRO60 InnoWave Pro Sonic Irrigator (60 Lumens) (Unit comes with standard tray(s), instrument tubing, and distal connectors for reverse flushing) Steris lnnoWave Pro Sonic irrigator Required installation Accessories 0019 Steris MED1496 Eliminizer Combo Dryer / Filter (required when medical grade air is not available) 0020 Steris M12594 Eliminizer First Stage Filter - Change 1x/Year 0021 Steris M12595 Eliminizer Second Stage Filter - Change 1x/Year 0022 Steris IW1047 InnoWave Pro Seismic Anchoring Kit lnnoWave Pro Sonic irrigator Baskets/Tubing 0023 Steris IW1049 Basket and Tubing Set - Standard Instrument Basket, Standard Tubing x20 0024 Steris IW1053 Basket and Tubing Set - Xi Basket, Xi EndoWrist Tubing x6 0025 Steris IW1051 Basket and Tubing Set - Xi Multi-Basket, Xi EndoWrist Tubing x4, Stapler Tubing x2 0026 Steris IW1055 Basket and Tubing Set - Si Multi-Basket, EndoWrist Tubing x8, Stapler Tubing x2 0027 Steris IW1050 Tubing Set Only - Standard Instrument Tubing x20 0028 Steris IW1052 Tubing Set Only - Xi Basket Tubing x6 0029 Steris IW1056 Tubing Set Only - Si Multi-Basket Tubing x10 0030 Steris IW1005 Flush Nozzle Set - Si, S/Si Single Site, or Si Stapler Flush Nozzle Set x10 lnnoWave Pro Sonic irrigator Accessories 0031 Steris MED8557 2.5-gallon Pick-Up Tube x1 0032 Steris MED3088 Elbow Connectors x1 InnoWave Unity Sonic Irrigators 0033 Steris IW523046NPR InnoWave Unity Sonic Irrigators Unity 15 200-208V, 3 Ph, 60 Hz 0034 Steris IW523036NPR InnoWave Unity Sonic Irrigators Unity 15 230V/60hZ 0035 Steris IW523546NPR InnoWave Unity Sonic Irrigators Unity 20 200-208V, 3 Ph, 60 Hz 0036 Steris IW523536NPR InnoWave Unity Sonic Irrigators Unity 20 230V/60hZ 0037 Steris MP22699 InnoWave Unity Seismic Anchoring Kit InnoWave Unity Sonic Irrigators Accessories 0038 Steris MP22845 Unity 15 Basket and Tubing Set - Standard Basket and Tubing Set (8 Pack) 0039 Steris MP23284 Unity 20 Basket and Tubing Set - Standard Basket and Tubing Set (8 Pack) 0040 Steris MP22716 Tubing Only - Standard or S/Si Tubing Set (8 Pack) 0041 Steris MP22683 Tubing Only - Xi Tubing Set (8 Pack) 0042 Steris MP22542 Instrument Organizer lnnoWave Ultra+ Ultrasonic irrigator 0043 Steris IWULTRAPL lnnoWave Ultra+ 0044 Steris IWULTRAPLCAB lnnoWave Ultra+ with Cabinet lnnoWave Ultra+ Required installation Accessories 0045 Steris IW1048 InnoWave Ultra+ Seismic Anchoring Kit (only when installed with the cabinet/trolley) lnnoWave Ultra+ Required Baskets / Tubing 0046 Steris IW1070 Basket and Tubing Set - Standard Instrument Basket, Standard Tubing x6 0047 Steris IW1071 Tubing Set Only - Standard Instrument Tubing x6 lnnoWave Ultra Ultrasonic irrigator 0048 Steris IWULTRA InnoWave Ultra (Unit comes with a standard tray, instrument tubing, and distal connectors for reverse flushing) InnoWave Ultra is verified with 3E-Zyme, P2X, and Prolystica HP lnnoWave Ultra Ultrasonic irrigator Basket / Tubing 0049 Steris IW1070 Basket and Tubing Set - Standard Instrument Basket, Standard Tubing x6 0050 Steris IW1011 Basket Only - Standard Instrument Basket 0051 Steris IW1071 Tubing Set Only - Standard Instrument Tubing x6 lnnoWave PCF Sonic irrigator (ECO) 0052 Steris IWECO2 InnoWave ECO 2.6 Gallon units come with standard tray 0053 Steris IWECO5 InnoWave ECO 5.3 Gallon units come with standard tray lnnoWave ECO Sonic irrigator Baskets 0054 Steris IW1075 Basket Only - InnoWave ECO 2.6 Gallon Standard Instrument Basket 0055 Steris IW1061 Basket Only - InnoWave ECO 5.3 Gallon Standard Instrument Basket lnnoWave, Inno Wave Ultra+, and ECO Sonic irrigator Accessories 0056 Steris IW1022 Disposable Drain Filters x100 0057 Steris IW1041 Disposable Drain Filters x24 Additional Accessories for lnnoWave PCF, lnnoWave Pro Sonic, lnnoWave Ultra, and Inno Wave Ultra+ Ultrasonic irrigator 0058 Steris MET110 InnoWave Ultra Add-On Cabinet 0059 Steris MED4817 1-gallon Pick-Up Tube x1 0060 Steris MED3088 Elbow Connectors x1 0061 Steris IW1020 Tubing Y-Connectors x6 0062 Steris IW1072 Tubing Y-Connectors x20 0063 Steris IW1026 Distal Connector 1mm x10 0064 Steris IW1027 Distal Connector 5mm Blue x10 0065 Steris IW1028 Distal Connector 8mm Yellow x10 0066 Steris IW1029 Distal Connector 12mm Green (10) 0067 Steris IW1032 Distal Connector Non-Ported 8mm The Department of Veterans Affairs (VA) is seeking vendors who can provide STERIS® Washers Lab Surgical Instrument Ultrasonic or equal identified above which meet all the Salient Characteristics (SC's) listed below. The Government intends for offerors to include all ancillary items, to ensure the equipment can function as designed by the OEM and as clinically required. Products quoted in the technical volume must be captured on the Vendor s pricing volume (Attachment A - Price Cost Schedule) of the solicitation. Additionally, responses can include any additional product and other product-related services necessary to obtain the supplies as required that may be beneficial and essential to the functionality of the proposed solution. These items must be clearly identified by brand name and part number. When offerors include their additional proposed product items/services, these items may be considered for evaluation, and must be captured in the vendor s pricing volume with an estimated quantity of zero. CLINS 0001, 0018, 0033-36 apply to SC 1 - 8 CLINS 0043-44, 0048 apply to SC 1 - 4, 6 - 7 SC # SALIENT CHARACTERISTICS METHOD OF EVALUATION PAGE # WHERE are the SC located IN TECHNICAL LITERATURE SC 1 Utilizes Sonic or Ultrasonic Frequencies Literature Review SC # SALIENT CHARACTERISTICS METHOD OF EVALUATION PAGE # WHERE are the SC located IN TECHNICAL LITERATURE SC 2 Weight Per Load Range Minimum 5 lbs. Maximum 80lbs. Literature Review SC 3 Touch Screen Controls Literature Review SC 4 Data Recording Capability Literature Review SC 5 Temperature Display Literature Review SC 6 Remaining Time Display Literature Review SC 7 Custom Cycles Literature Review SC 8 Robotic Instrument Compatible Literature Review 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. PRODUCT REFRESH Product refresh is when a current CLIN is no longer being manufactured due to obsolescence and the product item is being replaced with a newer, and more often, a superior version of the same item. The current CLIN product will be revised to reflect the refreshed product information, manufacturer s part number, IDIQ price (inclusive of Service Level Agreement (SLA) fee), etc. The Government reserves the right to not accept the products offered under product refresh. The contractor will be notified in writing if a product refresh is not accepted. All products offered shall be provided with the warranty that is agreed upon for this contract. The contractor agrees to ensure that all upgraded improved/replaced products meet American with Disabilities Act (ADA) and Health Information Portability and Accountability Act (HIPAA) Federal requirements, see attachment 5. The contractor shall provide the COR and CO the following information for product refresh: A list of specific awarded item(s) being refreshed in the Price/Cost Schedule (to include commercial pricing, discount offered, and IDIQ price (inclusive of SLA fee)); Product literature for the item(s) refreshed. A detailed description of the differences or benefits of refreshed as compared to the item(s) being discontinued or added, noting how the replacement item meets or exceeds all original, applicable salient characteristics of the original offered item. Proper identification of any product requirements and/or procedures related to those product(s) proposed to be refreshed or upgraded. FDA approval, if applicable Provide historical sales to VA by item(s), if applicable Copy of Commercial Warranty. The request shall be submitted to the COR, copy to the Contract Specialist and Contract Officer, for review and recommendation of approval to be submitted to the CO. The CO shall prepare a bilateral modification for execution. PRODUCT REMOVAL OR RECALL For any product awarded under this contract removed or recalled by the manufacturer due to defects in the product or potential dangers to patients, or if any required removal or recall is suggested or mandated by a regulatory or official agency, the manufacturer shall resolve any defects or potential dangers by repairing or replacing the product at no cost to the government. The manufacturer agrees to take following steps immediately: Notify the Contracting Officer (CO) at the Strategic Acquisition Center in writing, by the most expeditious manner possible. Provide copies of the notification to CO, Contracting Specialist, Contracting Officer Representative, and Manager at Product Recall Office, all Agencies and VA Facilities who purchased the product, which include, but not be limited to the following: Complete item description and/or identification, order numbers from customers and the contract number assigned as a result of an issuance on the solicitation; Reasons for modifications, removal or recall; and Necessary instructions for return for credit, replacement or corrective action. A copy of the notification will be provided to: Manager, Product Recall Office National Center for Patient Safety Veterans Health Administration 24 Frank Lloyd Wright Drive, Lobby M Ann Arbor, MI 48106 See attached document: ATTACHMETN A - PRICE COST SCHEDULE - NX EQ WASHERS LAB SURGICAL INSTRUMENT ULTRASONIC See attached document: ATTACHMENT B CONTRACT ADMINISTRATION NX EQ WASHERS LAB SURGICAL INSTRUMENT ULTRASONIC See attached document: ATTACHMENT C - CONTRACT CLAUSES - NX EQ WASHERS LAB SURGICAL INSTRUMENT ULTRASONIC See attached document: ATTACHMENT D - SOLICITATION PROVISIONS - NX EQ WASHERS LAB SURGICAL INSTRUMENT ULTRASONIC See attached document: ATTACHMENT E SALES REPORTING TOOL - NX EQ WASHERS LAB SURGICAL INSTRUMENT ULTRASONIC See attached document: ATTACHMENT F PAST PERFORMANCE REFERENCE - NX EQ WASHERS LAB SURGICAL INSTRUMENT ULTRASONIC See attached document: ATTACHMENT G - PAST PERFORMANCE QUESTIONNAIRE - NX EQ WASHERS LAB SURGICAL INSTRUMENT ULTRASONIC
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