36C25019Q0623-000.docx

FedBizOpps Combined Synopsis/Solicitation Notice

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* = Required Field FedBizOpps Combined Synopsis/Solicitation Notice Rev. March 2010 Cardiac, Thoracic, and Vascular Instruments 44131 36C25019Q0623 07-02-2019 N 339112 Department of Veterans Affairs Network Contracting Office (NCO) 10 6150 Oak Tree Blvd., Suite 300 Independence OH 44131 Department of Veterans Affairs Network Contracting Office (NCO) 10 Christopher A. Callihan Contracting Officer 6150 Oak Tree Boulevard Independence, OH 44131 Department of Veterans Affairs Louis Stokes Cleveland VA Medical Center 10701 East Boulevard Cleveland, OH 44106-1702 United States of America va.gov Department of Veterans Affairs Contracting Officer christopher.callihan@va.gov This is a combined synopsis/solicitation for 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; quotations are being requested, and a written solicitation document will not be issued.

This solicitation is a request for quotations (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular FAC 2019-01.

The associated North American Industrial Classification System (NAICS) code for this procurement is 339112, with a small business size standard of 1000 Employees.

The Network Contracting Office (NCO) 10 (Indiana, Ohio & Michigan) 6150 Oak Tree Blvd., Suite 300, Independence, OH 44131 is seeking to purchase multiple instruments for our Cardiac, Thoracic, and Vascular Surgery lines, due to increases in physician staff across all service lines.

All interested companies shall provide quotations for the following:

Supplies

SCANLAN® LEGACY Jacobson Micro Needle Holder, round handle, extended 10 mm diameter knurling, with ratchet, straight DIAMOND DUST™ jaws, regular boxlock, 9" / 23 cm (Item # 3003-346)

SCANLAN® LEGACY Jacobson Micro Needle Holder, round handle, extended 10 mm diameter knurling, with ratchet, straight DIAMOND DUST™ jaws, regular boxlock, 10" / 25.4 cm

MANUFACTURER PART NUMBER (MPN): 3003-348

SCANLAN® Jacobson Needle Holder (for large needles), round handle, with ratchet, straight DIAMOND DUST™ jaws, streamline box lock, 9" / 23 cm

MANUFACTURER PART NUMBER (MPN): 3003-530

SCANLAN® Jacobson Heavy Style Needle Holder (for large needles), round handle, with ratchet, straight DIAMOND DUST™ jaws, 10" / 25.4 cm

MANUFACTURER PART NUMBER (MPN): 6006-340

SCANLAN® Jacobson Micro Needle Holder, flat handle, with ratchet, straight DIAMOND DUST™ jaws, regular box lock, 8-1/4" / 21 cm

MANUFACTURER PART NUMBER (MPN): 6006-108

SCANLAN® Lillehei-Potts Scissors, curved Super Cut™ blades, tenotomy tips, black platinum ring handles, 6-1/2"/ 16.5 cm

MANUFACTURER PART NUMBER (MPN): 7007-263SC

SCANLAN® Premier Jacobson Micro Scissors, spring style, round handle, 45° angled micro fine blades, 8" / 20 cm

MANUFACTURER PART NUMBER (MPN): 7007-492-8

SCANLAN® Premier Jacobson Micro Scissors, spring style, round handle, 90° angled micro fine blades, 8" / 20 cm

MANUFACTURER PART NUMBER (MPN): 7007-496-8

SCANLAN® Premier ™ Jacobson Micro Scissors, spring style, round handle, V-neck, 125° angled micro fine blades, 8" / 20 cm

MANUFACTURER PART NUMBER (MPN): 7007-499-8

SCANLAN® LEGACY Micro Forceps, round handle, Never Shear™ Dual Guide™, straight 1.0 mm DIAMOND DUST™ platform ring tips, 9" / 23 cm

MANUFACTURER PART NUMBER (MPN): 3003-926

SCANLAN® DeBakey Forceps, flat handle, 2 mm tips, 9-1/2" / 24 cm

MANUFACTURER PART NUMBER (MPN): 4004-50

SCANLAN® DeBakey Forceps, flat handle, 2.7 mm tips, 9-1/2" / 24 cm

MANUFACTURER PART NUMBER (MPN): 4004-50-A

SCANLAN® Omni Tract Style Retractor Blade #1 FLEX/ROTATE

MANUFACTURER PART NUMBER (MPN): Q38037-01

SCANLAN® Omni Tract Style Retractor Blade #2 FLEX/ROTATE

MANUFACTURER PART NUMBER (MPN): Q38037-02

SCANLAN® Omni Tract Style Retractor Blade #3 FLEX/ROTATE

MANUFACTURER PART NUMBER (MPN): Q38037-03

SCANLAN® Omni Tract Style Retractor Blade #4 FLEX/ROTATE

MANUFACTURER PART NUMBER (MPN): Q38037-04

SCANLAN® Omni Tract Style Retractor Blade #5

MANUFACTURER PART NUMBER (MPN): Q38037-05

SCANLAN® Satinsky Clamp, with custom jaw dimensions, 10" / 25.4cm

MANUFACTURER PART NUMBER (MPN): 3003-80-01

SCANLAN® Dennis Clamp, with custom jaw dimensions, 6 1/2" / 16.5cm

MANUFACTURER PART NUMBER (MPN): 2002-92-01

SCANLAN® Lengthen instrument each additional inch - Lengthen 1 X 3003-442 by two (2) inches on the shaft so the length is twelve (12) inches.

MANUFACTURER PART NUMBER (MPN): 971

SCANLAN® Lengthen instrument each additional inch - Lengthen 1 X 3003-442 by two (2) inches on the shaft so the length is twelve (12) inches.

MANUFACTURER PART NUMBER (MPN): 971A

SCANLAN® Cardiovascular Needle Holder, ring handle, DIAMOND DUST™ jaws, 10" / 25.4 cm

MANUFACTURER PART NUMBER (MPN): 3003-442

SCANLAN® Cardiovascular Needle Holder, ring handle, DIAMOND DUST™ jaws, 8" / 20 cm

MANUFACTURER PART NUMBER (MPN): 3003-438

SCANLAN® Cardiovascular Needle Holder, ring handle, DIAMOND DUST™ jaws, 10" / 25.4 cm

MANUFACTURER PART NUMBER (MPN): 3003-442

SCANLAN® LEGACY Jacobson Micro Needle Holder, Scan-II™ handle, extended 10 mm knurling, with ratchet, straight DIAMOND DUST™ jaws, regular boxlock, 8" / 21 cm

MANUFACTURER PART NUMBER (MPN): 3003-374

SCANLAN® LEGACY Jacobson Micro Needle Holder, Scan-II™ handle, extended 10 mm knurling, with ratchet, straight DIAMOND DUST™ jaws, streamline boxlock, 10" / 25.4 cm

MANUFACTURER PART NUMBER (MPN): 3003-388

SCANLAN® Thoracoscopic Foerster Clamp (5 mm tapered to 7 mm), ring handle, curved left 20 mm oval ring jaws, with ratchet, 9-1/4" / 23.5 cm working length, 13-1/4" / 33.5 cm total length

MANUFACTURER PART NUMBER (MPN): 9009-229

SCANLAN® Thoracoscopic Foerster Clamp (10 mm), ring handle, curved left 20 mm oval ring jaws, 12-1/2" / 32 cm working length, 16-3/4" / 42.4 cm total length

MANUFACTURER PART NUMBER (MPN): 9909-925

SCANLAN® Thoracoscopic DeBakey Forceps (5 mm), round axial handle, 3.5 mm width straight DeBakey jaws, without ratchet, working length 8” / 20 cm, total length 14-1/4" / 36 cm

MANUFACTURER PART NUMBER (MPN): 9009-524

SCANLAN® Thoracoscopic Khan Decortication Grasper (10 mm), ring handle with 1-gold ring, 20 mm oval ring jaws with enhanced serrations , with ratchet, 9-1/2" / 24 cm working length, 13-1/4" / 33.5 cm total length

MANUFACTURER PART NUMBER (MPN): 9909-940

SCANLAN® Thoracoscopic Resano Forceps (5 mm), round axial handle, 2.5 mm width multi-tooth Resano jaws, without ratchet, working length 8” / 20 cm, total length 14-1/4“ / 36 cm

MANUFACTURER PART NUMBER (MPN): 9009-510

SCANLAN® Thoracoscopic Gonzalez-Rivas Dissector (5 mm), ring handle, fine mixter-style 1x2 DeBakey jaws, without ratchet, 19 cm working length, 11-1/2" / 29 cm total

MANUFACTURER PART NUMBER (MPN): 9009-213

SCANLAN® Thoracoscopic Node Grasper (5 mm tapered to 7 mm), ring handle, curved left 11 mm oblong ring jaws, with ratchet, 12-1/2" / 32 cm working length, 16-3/4" / 42.4 cm total length

MANUFACTURER PART NUMBER (MPN): 9009-220

SCANLAN® Thoracoscopic DeBakey Cooley Forceps, (10 mm), ring handle, 90° angled jaw, without ratchet, 9-1/2" / 24 cm working length, 13-1/2" / 34 cm

MANUFACTURER PART NUMBER (MPN): 9909-203

SCANLAN® Thoracoscopic Wolf Suction Instrument, (3.2 to 5 mm curved tapered shaft), 6 mm width blunt tip, 8-3/4" / 22 cm working length, 14-1/4” / 36 cm total length. 1 brush included

MANUFACTURER PART NUMBER (MPN): 9009-912

Delivery

Delivery shall be provided no later than 150 days after receipt of order/award of contract. delivery terms—FOB destination—and any special delivery requirements]. The contractor shall deliver all line item to the Louis Stokes Cleveland VA Medical Center 10701 East Boulevard, Cleveland 44106-1702 Attention: Shawn Huelsman.

Contractor shall deliver a complete set of indications for use (IFU) along with detailed cleaning sterilization instructions.

Contractor Shall provide in-service training to all operating room and SPS personnel when requested within two weeks after delivery.

Award shall be made to the quote whose quotation offers the best value to the government, considering Past Performance, Life cycle and life cycle cost (Contractor shall supply any documentation regarding longevity if available.), Warranty, Maintenance Availability, and delivery terms. The government will evaluate information based on the following evaluation criteria: technical capability factor "meeting or exceeding the requirement, past performance, and price.

Products offered shall meet the following requirements:

ALL SURGICAL INSTRUMENTS OFFERED SHALL BE MADE OF SURGICAL GRADE STAINLESS-STEEL AND TITANIUM FORGED IN SWEDEN OR THE UNITED STATES.

SURGICAL STAINLESS-STEEL SHALL BE MADE FROM EITHER MARTENSITIC 420/2303, 440 STAINLESS STEEL OR STRONGER.

STAINLESS STEEL SHALL FOLLOW

o ASTM F1089-10 STANDARD TEST METHOD FOR CORROSION OF SURGICAL INSTRUMENTS o ASTM F899-12B STANDARD SPECIFICATION FOR WROUGHT STAINLESS STEELS FOR SURGICAL INSTRUMENTS.

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

All TITANIUM IMPLANTS SHALL BE MADE OF SURGICAL GRAD EQUAL TO TI-6AL-4V/GRADE 5 OR TI-6AL-4V ELI/GRADE 23

ALL SURGICAL INSTRUMENTS OFFERED SHALL BE ASSEMBLED AND FINISHED IN SWEDEN OR THE UNITED STATES.

ALL SURGICAL INSTRUMENTS OFFERED SHALL INCLUDE SPECIFIC INDICATIONS FOR USE (IFU) THAT WILL DESCRIBE THE COMPLETE DISASSEMBLY, CLEANING, DECONTAMINATION, ASSEMBLY, AND STERILIZATION PARAMETERS.

ALL ITEMS SHALL BE ABLE TO BE STERILIZED AT A MINIMUM OF 273 DEGREES FAREINHEIHT FOR 5 MINUTES ON A PREVACUM STERRILIZER.

ALL SURGICAL INSTRUMENT PROPOSALS WILL BE SUBJECT TO TECHNICAL REVIEW.

ALL CONTRACTORS SHALL PROVIDE THE FOLLOWING DOCUMENTATION PRIOR TO TECHNICAL REVIEW o 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).

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

o PICTURES OF EACH PIECE OF INSTRUMENTATON BEING REQUESTED

UPON REQUEST POST SOLICITATION, CONTRACTOR SHALL SEND 5 DIFFEENT INSTRUMENTS TO VAMC CLEVELAND FOR PRELIMINARY INSPECTION UNDER A DIGITAL MICROSCOPE AS PART OF THE EVALUATION. THESE INSTRUMENTS WILL BE CHECKED FOR;

o PITTING, RUST, o CORRECT SIZE OF INSTRUMENTATION o WELDS OF THE INSTRUMENTS o APPROXIMATION OF JAWS o FINISHING PROCESS OF JAWS AND OVERALL INSTRUMENT o TEETH WITHIN THE JAWS OF THE INSTRUMENT

UPON AWARD/DELIVERY, SURGICAL INSTRUMENTATION WILL BE INSPECTED FOR QUALITY BY SPS MANAGEMENT. ANY DEFICIENCIES WILL BE COMMUNICATED TO THE CONTRACTING OFFICER.

o PITTING, RUST, o CORRECT SIZE OF INSTRUMENTATION o WELDS OF THE INSTRUMENTS o APPROXIMATION OF JAWS o FINISHING PROCESS OF JAWS AND OVERALL INSTRUMENT o TEETH WITHIN THE JAWS OF THE INSTRUMENT

INSTRUMENT EXAMINATION MAY INCLUDE STERILIZATION OF EACH LOT NUMBER OF INSTRUMENT. EACH INSTRUMENT WILL BE PROCESSED IN COLLABORATION WITH THE INSTRUMENTATION IFU, VHA DIRECTIVE 1116 (2), AAMI ST-79, STERILIZER INSTRUCTIONS, AND MEDLINE CONTAINER IFUS.

o INSTRUMENTS ARE SOAKED MINIMUM 5 MINUTES IN NEUTRAL PH ENZYMATIC OR DETERGENT AND RINSED WITH REVERSE OSMOSIS/DEIONIZED WATER o INSTRUMENTS ARE THEN ULTRASONICED IN NEUTRAL PH ENZYMATIC OR DETERGENT FOR MINIMUM OF 28 MINUTES o INSTRUMENTS ARE THEN RUN THROUGH A MECHANICAL WASHER FOR A MINIMUM OF 30 MINUTES o INSTRUMENTS ARE ASSEMBLE AND THEN STERILIZED BETWEEN 270-275 DEGREES FOR A MINIMUM OF 5 MINUTES WITH A 45 MINUTE DRY TIME.

The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html.

The following solicitation provisions apply to this acquisition:

1. FAR 52.212-1, “Instructions to Offerors–Commercial Items” [Oct 2018]

2. FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items” [Oct 2018]

Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, “Offerors Representations and Certifications–Commercial Items.” If paragraph (j) of the provision is applicable, a written submission is required.

The following contract clauses apply to this acquisition:

· FAR 52.212-4, “Contract Terms and Conditions–Commercial Items” JAN 2017 ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

· The following clauses are incorporated into 52.212-4 as an addendum to this contract:

VAAR 852.219-10 VA NOTICE OF TOTAL SERVICE-DISABLED VETERAN-OWNED SMALL BUSINESS SET-ASIDE (JUL 2016)

VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2012)

VAAR 852.246-70 GUARANTEE (JAN 2008) (1 Year)

VAAR 852.246-71 INSPECTION (JAN 2008)

VAAR 852.215-70 Service-disabled veteran-owned and veteran-owned small business evaluation factors. (JUL 2016) (DEVIATION)

· FAR 52.212-5, “Contract Terms and Conditions Required to Implement Statutes or Executive Orders” AUG 2018

The following subparagraphs of FAR 52.212-5 are applicable:

52.203-6, 52.204-10, 52.209-6, 52.211-6, 52.219-8, 52.219-14, 52.219-27, 52.219-28, 52.222-3, 52.222-19, 52.222-21, 52.222-26, 52.222-35, 52.222-36, 52.222-37, 52.222-40, 52.222-50, 52.223-18, 52.225-1, 52.225-13, and 52.232-33.

All quoters shall submit the following: one copy of their quote electronically to the email provided below.

All quotations shall be sent to the christopher.callihan@va.gov.

This is an open-market combined synopsis/solicitation for products as defined herein. The government intends to award a purchase order as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. To facilitate the award process, all quotes must include a statement regarding the terms and conditions herein as follows:

"The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition."

OR

"The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:"

Quoter shall list exception(s) and rationale for the exception(s).

Submission shall be received not later than 1200 EST Tuesday 2 July 2019 at Contracting Office (NCO) 10 (Ohio, Indiana, & Michigan) 6150 Oaktree Boulevard Suite 300, Independence, OH 44131. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f).

Quotes are to be emailed to Christopher Callihan at Christopher.Callihan@va.gov

No telephone inquiries will be accepted.

All Questions Shall be submitted in writing no later than 1200 EST 20 June 2019 in response to the Solicitation via email to christopher.callihan@va.gov.

Any Government responses, answers, and or/comments will be issued via amendment to this solicitation.

Point of Contact Christopher A. Callihan Contract Specialist Network Contract Office (NCO) 10 Office: 216-447-8300 x3796 Email: christopher.callihan@va.gov