6515--SPS surgical instruments

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Combined Synopsis Solicitation: SPS Surgical Instruments

General:

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR subpart 12.6 as supplemented with additional information included in this notice. This notice constitutes the only solicitation; quotations are being requested and a written solicitation will not be issued. The solicitation number is 36C25020Q0472 and is issued as a Request for Quote (RFQ). This solicitation document incorporates provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2020-04, effective January 15, 2020. The applicable North American Industry Classification System Code (NAICS) is 339113 and the small business size standard is 1,000 employees. This RFQ is for Brand Name or Equal.

Statement of Work (SOW):

Background

The Louis Stokes Department of Veterans Affairs Medical Center (CLE VAMC), Sterile Processing Service (SPS), is requesting the procurement of (3) surgical instrument sets.

Scope

CLE VAMC, SPS, is requesting the procurement of (3) sternal fixation systems. These sternal fixation systems are utilized on patients that have soft sternal bone or sternal separation that is not able to be approximated with sternal wires.

CLE VAMC, SPS, is looking for a system that is Brand Name or Equal to the Zimmer-Biomet Sterna lock Blu system. The contents of this system are listed below.

OEM

MODEL #

DESCRIPTION

TOTAL QTY NEEDED

ZIMMER BIOMET

01-7600

2.0/2.4 MM SCREWDRIVER HANDLE

6

ZIMMER BIOMET

01-9095

BEUSE PLATE HOLDING FORCEPS

3

ZIMMER BIOMET

01-9728

2.0 PLATE BENDING PLIERS

6

ZIMMER BIOMET

24-1186

2.4 PLATE HOLDING WAND

3

ZIMMER BIOMET

51-0960

WIRE CUTTING PLIER D-A 22CM TC

3

ZIMMER BIOMET

73-0006

SL BLU SCREW SIZER

3

ZIMMER BIOMET

73-1191

STERNALOCK PD BLADE

6

ZIMMER BIOMET

73-1194

STERNALOCK BLADE

6

ZIMMER BIOMET

73-1300

STERNALOCK BLU SMI MODLAR TRAY

3

ZIMMER BIOMET

73-2306

STERNALOCK BLU CONTAINER

3

ZIMMER BIOMET

24-1112

BONE REDUCTION FORCEPS

6

ZIMMER BIOMET

73-2597

SL REDUCTION FORCEP WIDE

3

ZIMMER BIOMET

74-1193

SL360 MANUBRIUM BONE PUNCH

3

ZIMMER BIOMET

74-1192

SL360 NEEDLE GUIDE

3

ZIMMER BIOMET

74-1195

PLATE BENDER STRGHT THREADED

6

ZIMMER BIOMET

73-1952

PLATE 8 HOLE STRAIGHT

9

ZIMMER BIOMET

73-2622

PLATE 4 HOLE SQUARE

9

ZIMMER BIOMET

73-2623

PLATE 8 HOLE X

24

ZIMMER BIOMET

73-2632

PLATE 12 HOLE LADDER

3

ZIMMER BIOMET

73-2634

PLATE 12 HOLE WIDE LADDER

3

ZIMMER BIOMET

73-2636

PLATE 4 HOLE WITH GAP

9

ZIMMER BIOMET

73-2643

PLATE 4 HOLE L 100 DEG

12

ZIMMER BIOMET

73-2645

PLATE 8 HOLE JL

9

ZIMMER BIOMET

73-2408

SCRW 2.4X8MM CANCELOUS LOCKING

24

ZIMMER BIOMET

73-2410

SCRW 2.4X10MM CANCELOUS LOCKNG

24

ZIMMER BIOMET

73-2412

SCRW 2.4X12MM CANCELOUS LOCKNG

96

ZIMMER BIOMET

73-2414

SCRW 2.4X14MM CANCELOUS LOCKNG

96

ZIMMER BIOMET

73-2416

SCRW 2.4X16MM CANCELOUS LOCKNG

72

ZIMMER BIOMET

73-2418

SCRW 2.4X18MM CANCELOUS LOCKNG

24

ZIMMER BIOMET

73-2420

SCRW 2.4X20MM CANCELOUS LOCKNG

24

ZIMMER BIOMET

73-2708

SCRW 2.7X8MM CANCELOUS LOCKING

24

ZIMMER BIOMET

73-2710

SCRW 2.7X10MM CANCELOUS LOCKNG

24

ZIMMER BIOMET

73-2712

SCRW 2.7X12MM CANCELOUS LOCKNG

24

ZIMMER BIOMET

73-2714

SCRW 2.7X14MM CANCELOUS LOCKNG

24

ZIMMER BIOMET

73-2716

SCRW 2.7X16MM CANCELOUS LOCKNG

24

ZIMMER BIOMET

73-2718

SCRW 2.7X18MM CANCELOUS LOCKNG

24

ZIMMER BIOMET

73-2720

SCRW 2.7X20MM CANCELOUS LOCKNG

24

Requirements

Contractor shall provide all appropriate Manufacturer s Indications for use;

Contractor shall provide onsite education to all Sterile Processing Service Technicians and Operating Room staff;

Plates shall be double sided and are able to be contoured to fit the patient s anatomy;

Plates shall be considered low-Profile and range from less than 1.8 mm;

Plates shall have a variety of different plate types to include L-Plates, Square plates, X-Plates, JL Plates, straight plates, and ladder plates ;

Screws shall range in size from 8-20 mm in length and 2.4 to 2.7 mm in diameter;

Plates and screws shall be made of surgical grade equal to TI-6AL-4V/GRADE 5 OR TI-6AL-4V ELI/GRADE 23;

Surgical Stainless-steel instrumentation shall be made from either martensitic 420/2303, 440 or strong;

Stainless steel instruments shall follow the following standards:

ASTM F1089-10 STANDARD TEST METHOD FOR CORROSION OF SURGICAL INSTRUMENTS

ASTM F899-12B STANDARD SPECIFICATION FOR WROUGHT STAINLESS STEELS FOR SURGICAL INSTRUMENTS

ASTM F1744-96 (2016) STANDARD GUIDE FOR CARE AND HANDLING OF STAINLESS-STEEL SURGICAL INSTRUMENTS

All surgical instruments and implants shall be forged, assembled and finished in Germany, Belgium, Sweden or United States;

Surgical instruments who s blanks from Pakistan, China, India, Malaysia, North Korea, or another TAA non-compliant country will not be considered;

All items shall be able to be sterilized at a minimum of 273 degrees Fahrenheit for 5 minutes in a pre-vacuum sterilizer.

Samples, Inspection, Testing

All surgical instrument/implant proposals shall be subject to technical review. All vendors are required to provide the following documentation prior to technical review:

DOCUMENT LISTING THE REQUESTED ITEMS ABOVE, THEIR EQUIVALENT MODEL #, AND PROVIDE A FULL AND COMPLETE DESCRIPTION OF THE PRODUCT BEING OFFERED (INCLUDING SIZE AND SPECS OF EACH INSTRUMENT).

INDICATIONS FOR USE (IFU) THAT WILL DESCRIBE THE COMPLETE DISASSEMBLY, CLEANING, DECONTAMINATION, ASSEMBLY, AND STERILIZATION PARAMETERS.

PICTURES OF EACH PIECE OF INSTRUMENTATON BEING REQUESTED

Upon CLE VAMC, SPS request, vendor may be required to send up to 5 different instruments of their choosing for preliminary inspection under a digital microscope before the order is placed. These instruments will be checked for

PITTING, RUST,

CORRECT SIZE OF INSTRUMENTATION

WELDS OF THE INSTRUMENTS

APPROXIMATION OF JAWS

FINISHING PROCESS OF JAWS AND OVERALL INSTRUMENT

TEETH WITHIN THE JAWS OF THE INSTRUMENT

Upon Delivery, surgical instrumentation and implants will be inspected for quality by SPS management. Any deficiencies will be communicated to the contracting officer to include:

PITTING, RUST,

CORRECT SIZE OF INSTRUMENTATION

WELDS OF THE INSTRUMENTS

APPROXIMATION OF JAWS

FINISHING PROCESS OF JAWS AND OVERALL INSTRUMENT

TEETH WITHIN THE JAWS OF THE INSTRUMENT

Packaging and Delivery

Completed units will be delivered within 30 days after contract has been awarded to :

Louis Stokes Cleveland VAMC

c/o Sterile Processing Service 1-w-122

10701 East Blvd

Cleveland, Ohio 44106

Contractor shall assemble all instruments/implant trays within 2 weeks of arrival.

Place of Performance (place of delivery)-Destination

Louis Stokes Cleveland VAMC

c/o Sterile Processing Service 1-w-122

10701 East Blvd

Cleveland, Ohio 44106

Applicable Provisions and Clauses:

The following clauses apply to this acquisition: FAR Addendum to 52.212-4 Contract Terms and Conditions-Commercial Items; 852.203-70; 852.211-70; 852.232-72; 852.246-71; http://www.acquistion.gov/far/index.html, and http://www.va.gov/oal/library/vaar/index.asp/ ; 52.232-40 (end of addendum 52.212-4) 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders (of which 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.223-18, 52.225-1, 52.225-13, and 52.232-33 are applicable).

The following provisions apply to this acquisition: Addendum to 52.212-1, Instructions to Offerors-Commercial; http://www.acquistion.gov/far/index.html, and http://www.va.gov/oal/library/vaar/index.asp/ ; 52.204-7 (end of addendum 52.212-1) 52.212-3.

Offer Evaluation and Award:

This is a competitive Request for Quotations (RFQ) that will be evaluated and awarded following the procedures in FAR Part 12 and 13 using price and other factors. The Government will issue/award a Firm-Fixed Price Purchase Order or delivery order for Brand Name or Equal to the responsible vendor/contractor/offeror whose quote/offer best conforms to the requirements within the solicitation and is considered to provide the best value to the Government. The Government reserves the right to select a response that provides benefit to the Government that exceeds the minimum but is not required to do so. In addition to a price comparison, the other following factors will be evaluated:

Technical (Brand Name or Equal);

Delivery;

Past Performance (CPARS);

Special Features of the Supply Required for effective program performance;

Probable life of the item selected as compared with that of a comparable item;

Warranty Considerations;

Maintenance Availability;

Delivery Terms; and

Sample/Inspection Testing.

A Price Comparison will be completed.

An Offeror s initial quote shall contain the best terms from a price and technical standpoint. Offerors are reminded that representatives from your company SHALL NOT contact any Cleveland VAMC personnel to discuss this RFQ during the solicitation and evaluation process.

In addition to providing a quote, please provide literature to be able determine the product meeting the requested specifications must be provided.

5. Procedure for submitting documents to the Department of Veterans Affairs:

DOCUMENTS THAT ARE TO BE PROVIDED TO THE CONTRACTING OFFICER WILL BE SUBMITTED USING THE APPROPRIATE VEHICLE BELOW.

email: rachelle.hamer@va.gov

6. Submission of Offer.

All information shall be submitted in the manner described below and offerors who do not submit all information may not be considered for award.

The vendor/contractor/offeror shall be an Original Equipment Manufacturer (OEM). If not the OEM, then an authorized OEM distributor, dealer, reseller letter for the proposed equipment/system, such that the provided OEM warranty and service are maintained and remain enforceable, must be provided with your response. All warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions. The Contractor shall provide new items ONLY; no remanufactured or "gray market" items. All items must be covered by the manufacturer's warranty.

F.O.B. shall be destination.

This solicitation requires registration with the System for Award Management (SAM) prior to award, pursuant to applicable regulations and guidelines. Registration information can be found at www.sam.gov.

Quotes are to be broken out to include line item pricing for each item, and installation including any premium time required.

RESPONSES ARE DUE: Wednesday, April 1, 2020 at 5:00 PM EST. Offers will only be accepted electronically via e-mail to rachelle.hamer@va.gov. Enter RFQ 36C25020Q0472| SPS Surgical Instruments in the email subject line.