Description of item statement of need items needed for instrument set for ent and plastic surgery services in the oper



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Combined Synopsis


DESCRIPTION OF ITEM



STATEMENT OF NEED

ITEMS NEEDED FOR INSTRUMENT SET FOR ENT AND PLASTIC SURGERY SERVICES IN THE OPERATING ROOM.



SALES REPRESENTATIVE MAY OR MAY NOT BE PRESENT IN THE OPERATING ROOM DURING THE USE OF INSTRUMENT TRAY.

DESCRIPTION OF ITEM:

Item #

Part Number

Description

Qty

1.008

04.503.435.05

2.4MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 5MM

2

1.009

04.503.436.05

2.4MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 6MM

2

1.010

04.503.438.05

2.4MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 8MM

6

1.011

04.503.440.05

2.4MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 10MM

4

1.012

04.503.442.05

2.4MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 12MM

4

1.013

04.503.444.05

2.4MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 14MM

2

1.014

04.503.446.05

2.4MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 16MM

2

1.015

04.503.448.05

2.4MM TI MATRIXMANDIBLE SCREW SELF-TAPPING 18MM

2

1.016

04.503.465.05

2.7MM TI MATRIXMANDIBLE EMERGENCY SCREW SLF-TPNG 5MM

2

1.017

04.503.466.05

2.7MM TI MATRIXMANDIBLE EMERGENCY SCREW SLF-TPNG 6MM

2

1.018

04.503.468.05

2.7MM TI MATRIXMANDIBLE EMERGENCY SCREW SLF-TPNG 8MM

2

1.019

04.503.470.05

2.7MM TI MATRIXMANDIBLE EMERGENCY SCREW SLF-TPNG 10MM

2

1.020

04.503.472.05

2.7MM TI MATRIXMANDIBLE EMERGENCY SCREW SLF-TPNG 12MM

2

1.021

04.503.474.05

2.7MM TI MATRIXMANDIBLE EMERGENCY SCREW SLF-TPNG 14MM

2

1.022

04.503.476.05

2.7MM TI MATRIXMANDIBLE EMERGENCY SCREW SLF-TPNG

16MM


2

1.023

04.503.478.05

2.7MM TI MATRIXMANDIBLE EMERGENCY SCREW SLF-TPNG 18MM

2

1.032

04.503.638.05

2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 8MM

6

1.033

04.503.640.05

2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 10MM

4

1.034

04.503.642.05

2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 12MM

4

1.035

04.503.644.05

2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 14MM

4

1.036

04.503.646.05

2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 16MM

2

1.037

04.503.648.05

2.4MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 18MM

2

1.038

04.503.668.05

2.9MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 8MM

4

1.039

04.503.670.05

2.9MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 10MM

4

1.040

04.503.672.05

2.9MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 12MM

2

1.041

04.503.674.05

2.9MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 14MM

2

1.042

04.503.676.05

2.9MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 16MM

2

1.043

04.503.678.05

2.9MM TI MATRIXMANDIBLE LOCKING SCREW SLF-TPNG 18MM

2

1.058

04.503.715

TI MATRIXMANDIBLE 6 HOLE PLATE 1.5MM THICK

4

1.060

04.503.717

TI MATRIXMANDIBLE 12 HOLE PLATE 1.5MM THICK

2

1.061

04.503.718

TI MATRIXMANDIBLE 20 HOLE PLATE 1.5MM THICK

2

1.062

04.503.721

TI MATRIXMANDIBLE 3X3 HOLE ANGLE PLATE 1.5MM THICK

2

1.063

04.503.722

TI MATRIXMANDIBLE 3X3 HOLE CRESCENT PLATE 1.5MM THICK

2

1.064

04.503.723

TI MATRIXMANDIBLE 2X2 HOLE DCP PLATE 1.5MM THICK

2

1.077

04.503.737

TI MATRIXMANDIBLE 12 HOLE RECON PLATE 2.5MM THICK

2

1.079

04.503.739

TI MATRIXMANDIBLE 7X23 ANGLE RECON PL LEFT 2.5MM THICK

4

1.080

04.503.740

TI MATRIXMANDIBLE 7X23 ANGLE RECON PL RIGHT 2.5MM THICK

4

1.081

04.503.741

TI MATRIXMANDIBLE DOUBLE ANGLE RECON PL SMALL 2.5MM THICK

2

1.082

04.503.742

TI MATRIXMANDIBLE DOUBLE ANGLE RECON PL MEDIUM 2.5MM THICK

2

1.083

04.503.743

TI MATRIXMANDIBLE DOUBLE ANGLE RECON PL LARGE 2.5MM THICK

2

1.092

04.503.900

TI MATRIXMANDIBLE PREFORMED RECON PL/SMALL/RIGHT/2.5MM THK

2

1.093

04.503.901

TI MATRIXMANDIBLE PREFORMED RECON PL/SMALL/LEFT/2.5MM THK

2

1.094

04.503.902

TI MATRIXMANDIBLE PREFORMED RECON PL/MED/RIGHT/2.5MM THK

2

1.095

04.503.903

TI MATRIXMANDIBLE PREFORMED RECON PL/MEDIUM/LEFT/2.5MM THK

2

1.096

04.503.904

TI MATRIXMANDIBLE PREFORMED RECON PL/LARGE/RIGHT/2.5MM THK

2

1.097

04.503.905

TI MATRIXMANDIBLE PREFORMED RECON PL/LARGE/LEFT/2.5MM THK

2

INSTRUMENTS

 

1.098

03.503.034

MINI PLATE HOLDER LONG

2

1.099

03.503.036

MATRIXMANDIBLE DEPTH GAUGE

2

1.100

03.503.040

MATRIXMANDIBLE PLATE BENDING PLIERS-RIGHT

2

1.101

03.503.041

MATRIXMANDIBLE PLATE BENDING PLIERS-LEFT

2

1.102

03.503.043

MATRIXMANDIBLE 1.5MM THREADED DRILL GUIDE-SHORT

2

1.103

03.503.044

MATRIXMANDIBLE 1.8MM THREADED DRILL GUIDE-SHORT

2

1.104

03.503.045

MATRIXMANDIBLE TROCAR DRILL GUIDE FOR 397.213

2

1.105

03.503.046

MATRIXMANDIBLE 2.4MM THREADED DRILL GUIDE-SHORT

2

1.106

03.503.047

MATRIXMANDIBLE THREADED TROCAR DRILL GUIDE FOR 397.213

2

1.107

03.503.056

MATRIXMANDIBLE COMBINATION BENDER

2

1.108

03.503.057

MATRIXMANDIBLE SHORT CUT PLATE CUTTER

4

1.109

03.503.062

MATRIXMANDIBLE PLATE INTRODUCING FORCEPS

2

1.110

03.503.070

MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-SHORT

2

1.111

03.503.071

MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-MEDIUM

2

1.112

03.503.072

MATRIXMANDIBLE/THORAX SCRWDRVR BLADE SELF RETAINING-LONG

2

1.113

03.503.073

MATRIXMANDIBLE/THORAX SCRWDRVR FIXED HANDLE/SELF-RETAINING

2

1.114

03.503.079

MATRIXMANDIBLE SMALL PLATE CUTTER

2

1.115

03.503.080

MATRIXMANDIBLE BENDING INSERT

16

1.116

03.503.168

MATRIXMANDIBLE BENDNG TEMPLATE F/1.5MM THICK STRAIGHT PLATES

4

1.117

03.503.172

MATRIXMANDIBLE BENDNG TEMPLATE F/1.5MM BROAD 2X2/3X3 PLATES

2

1.118

03.503.180

MATRIXMANDIBLE BENDNG TEMPLATE F/2.5/2.8MM STRAIGHT RECON PL

2

1.119

03.503.181

MATRIXMANDIBLE BENDNG TEMPLATE F/2.5/2.8MM ANGLE RECON PLATES

4

1.120

03.503.182

MATRIXMANDIBLE BENDNG TEMPLATE F/2.5MM DBL ANGLE RECON PL/SM

2

1.121

03.503.183

MATRIXMANDIBLE BENDNG TEMPLATE F/2.5MM DBL ANGLE RECON PL/MED

2

1.122

03.503.184

MATRIXMANDIBLE BENDNG TEMPLATE F/2.5MM DBL ANGLE RECON PL/LRG

2

1.123

03.503.408

MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH W/8MM STOP/50MM

4

1.124

03.503.451

MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH/90MM FOR 03.503.043

4

1.133

03.503.461

MATRIXMANDIBLE 1.8MM DRILL BIT J-LATCH/90MM FOR 03.503.044

4

1.137

03.503.471

MATRIXMANDIBLE 2.4MM DRILL BIT J-LATCH/90MM FOR 03.503.046

4

1.145

03.503.476

MATRIXMANDIBLE 1.5MM DRILL BIT J-LATCH FOR 03.503.045/.047

4

1.146

03.503.477

MATRIXMANDIBLE 1.8MM DRILL BIT J-LATCH FOR 03.503.045/.047

4

1.147

03.503.478

MATRIXMANDIBLE 2.4MM DRILL BIT J-LATCH FOR 03.503.045/.047

4

1.148

03.503.900

SIZER F/MATRIXMANDIBLE PREFORMD RECON PL(04.503.900)

2

1.149

03.503.901

SIZER F/MATRIXMANDIBLE PREFORMD RECON PL(04.503.901)

2

1.150

03.503.902

SIZER F/MATRIXMANDIBLE PREFORMD RECON PL(04.503.902)

2

1.151

03.503.903

SIZER F/MATRIXMANDIBLE PREFORMD RECON PL(04.503.903)

2

1.152

03.503.904

SIZER F/MATRIXMANDIBLE PREFORMD RECON PL(04.503.904)

2

1.153

03.503.905

SIZER F/MATRIXMANDIBLE PREFORMD RECON PL(04.503.905)

2

1.154

03.503.910

MATRIXMANDIBLE BNDNG TEMPLATE F/PREFORMED RECON PL/SMALL

2

1.155

03.503.911

MATRIXMANDIBLE BNDNG TEMPLATE F/PREFORMED RECON PL/MEDIUM

2

1.156

03.503.912

MATRIXMANDIBLE BNDNG TEMPLATE F/PREFORMED RECON PL/LARGE

2

1.157

304.105

SCREW LENGTH MARKER-5MM

2

1.158

304.106

SCREW LENGTH MARKER-6MM

2

1.159

304.108

SCREW LENGTH MARKER-8MM

2

1.160

304.110

SCREW LENGTH MARKER-10MM

2

1.161

304.112

SCREW LENGTH MARKER-12MM

2

1.162

304.114

SCREW LENGTH MARKER-14MM

2

1.163

304.116

SCREW LENGTH MARKER-16MM

2

1.164

304.118

SCREW LENGTH MARKER-18MM

2

1.165

306.701

GRAPHIC CASE FOR MATRIXMANDIBLE SYSTEM

2

1.166

306.704

LABEL SHEET SMALL PLATE MODULE FOR MATRIXMANDIBLE SYSTEM

2

1.167

306.705

LABEL SHEET SCREW MODULE FOR MATRIXMANDIBLE SYSTEM

2

1.168

306.706

LABEL SHEET LARGE PLATE MODULE FOR MATRIXMANDIBLE SYSTEM

2

1.169

306.731

INSTRUMENT TRAY MATRIXMANDIBLE

2

1.170

306.732

INSTRUMENT TRAY MATRIXMANDIBLE

2

1.171

306.733

TROCAR INSTRUMENT MODULE MATRIXMANDIBLE

2

1.172

306.735

LABEL SHEET FOR 306.731 MATRIXMANDIBLE INSTRUMENTS

2

1.173

306.736

LABEL SHEET FOR 306.732 MATRIXMANDIBLE INSTRUMENTS

2

1.175

306.740

SMALL PLATE MODULE FOR MATRIXMANDIBLE SYSTEM

2

1.176

306.742

SCREW MODULE FOR MATRIXMANDIBLE SYSTEM

2

1.001

306.744

LABEL SHEET FOR 306.733 MATRIXMANDIBLE INSTRUMENTS

2

1.002

306.749

LARGE PLATE MODULE FOR MATRIXMANDIBLE SYSTEM

2

1.003

306.762

STRENGTH GRADIENT LABEL SHEET MATRIXMANDIBLE SYSTEM

2

1.004

311.007

SCREWDRIVER HANDLE WITH HEX COUPLING-LARGE

2

1.005

311.023

RATCHETING SCREWDRIVER HANDLE

2

1.006

323.204

2.0/2.4MM UNIV DRILL GUIDE

2

1.007

397.211

UNIVERSAL TROCAR HANDLE

2

1.008

397.213

2.0MM CANNULA & OBTURATOR

2

1.009

397.232

MALLEABLE C-RETRACTOR

2

1.010

397.42

2.0MM CHEEK RETRACTOR BLADE

2

1.011

397.43

2.0MM CHEEK RETRACTOR RING

2

1.012

398.985

BONE REDUCTION FORCEPS-LARGE

2

1.013

398.986

BONE REDUCTION FORCEPS-SMALL

2

1.014

398.987

BONE REDUCTION FORCEPS SMALL STRAIGHT

2

1.015

60.503.900

MODULE FOR MATRIXMANDIBLE PREFORMED RECON PLATES/INSTR

2

1.016

690.612

SCREW LENGTH LABEL SHEET FOR CALIBRATED DRILL BITS

2

1 KIT $__________________ $__________________

Grand Total

$__________________



DELIVERY:

  1. Delivery of items under the contract shall be no later than fifteen (15) days from notice of award.

QUOTES:

  1. All quotes received as a result of this solicitation shall be valid for a period of 100 days from the closing of this solicitation.

CHANGES TO STATEMENT OF WORK:

  1. Any changes to this SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor.

STATEMENT OF AWARD:

  1. The Government intends to award to one (1) or contract as a result of an unrestricted solicitation.

B. In order to be awarded this delivery order the offorer shall not be listed as derogatory on the following data base.

a. http://www.fda.gov/ora/compliance_ref/debar/default.htm

b. http://exclusions.oig.hhs.gov/

C. In order to be awarded this delivery order the offorer shall be compliant with the data base.

a. http://www.dol.gov/vets/programs/fcp/main.htm

b. http://www.vip.vetbiz.gov/general_user/register/default.asp



c. https://www.sam.gov/portal/public/SAM/

EVALUATION CRITEREA:

  1. The solicitation is a Request for Quote (RFQ) and will be awarded to the offeror or offers who is considered Lowest Price Technically Acceptable (LPTA) in accordance with FAR 15.101-2. A pass /fail system will be used to assess an offeror’s technical capability. An offeror must receive 100% “pass” rating in the technical portion to be considered for award. Based on this determination and display of relevant and satisfactory past experience, the award will be made to the offeror or offers that propose the lowest price.



  1. SUBMISSION OF OFFERS



  1. Offers shall not exceed fifteen (15) pages; include a coversheet and table of contents.

  2. Contra



  1. The following factors are listed below that shall be used to evaluate offers:



  1. Price/Cost



  1. Salient Characteristics

  • Facilitates treatment of panfacial fractures

  • Eliminates need to pull separate sets to treat mandible and midface cases

  • Modular system allows set to be configured per surgeon and hospital needs

  • Side-loading graphic case for complete set visibility

  • One screw diameter and one blade works with all plates for the midface system-1.55mm

  • Preformed Orbital plates (small and large) 0.4mm thick with contoured edges for easier plate insertion

  • Self-retaining screws/blades that reduce cam-out

  • Self-drilling threaded reduction tool for zygomatic arch fractures

  • Articulating plate introducer which allows for access to the sub condylar ramus inter orally

  • Pre formed mandible plates which saves time in the operating room and reduces the number of bends required to fit the plate

  • All screws work with all plates within each system

  • One screwdriver blade for all screws within each system

  • Color-coding by strength for easy identification

  • Reduced plate screw profile, where applicable

  • Rounded edges on plates

  • Standardized instrumentation

  • Preformed three-dimensional shape



  1. Past performance – offeror shall submit three (3) past performances. Past performance shall be relevant to this solicitation in regards to products, and cost. Past performance shall at a minimum contain:



    1. Name, Current Contact Information, and Address of the Agency/Company

    2. Contact Number

    3. Total Cost of the Contract

    4. Period of Performance



  1. Delivery Schedule to be delivered within fifteen (15) days of award.



  1. Technical Capability and Subfactors:

    1. Used for treatment of Craniofacial and Mandibular trauma and reconstruction.

    2. Craniofacial and Mandibular modules contained in a single graphic case for easier use in the operating room and easier accessibility.

    3. The set contains all components identified in the salient characteristics.

    4. Components shall be compatible with current and previous Synthes Matrix Sets.



  1. Equals shall have certified proof via medical board or FDA of “equal” testing and approval.



  1. As a result of this solicitation all evaluation factors other than cost or price, when combined, are:



  1. Significantly less important than cost or price (10 U.S.C. 2305(a)(3)(A)(iii) and 41 U.S.C. 253a(c)(1)(C)).

CONTRACT ADMINISTRATION:

  1. The contract will be administered by the contracting officer (CO), and by the contracting officer’s representative (COR), as delegated by the CO. The COR will recommend to the CO contract modification, if necessary. The CO will approve and process contract modifications as appropriate. The COR will review contractor’s invoices and will then submit them to the CO with a recommendation for approval or denial.

INVOICING AND OB10 MANDATE INSTRUCTIONS:

  1. All packages, invoices, boxes, pallets, packing list, ect. shall be marked with the appropriate DEPARTMENT OF VETERANS AFFAIRS STATION 646 PUCHASE ORDER NUMBER. The purchase order number for this contract is listed on page one (1) block twenty (20) of the 1449. By not complying or conforming to these instructions may result in packages being refused, returned, delayed payment and acceptance and returned to the contractor. Any packages refused or returned to the contractor shall be re-performed at the contractors own expense. Any late charges for payments, restocking stocking fees, and interest accrued for non-paid invoices shall not be paid by the VA Pittsburgh Healthcare System 646 if the delivery is not compliant with this section.



  1. Mandatory Electronic Invoicing

VA published the final rule requiring vendors to submit invoices electronically to the Financial Services Center (FSC) in the November 27, 2012 Federal Register. The rule became effective December 27, 2012. The rule includes a new contract clause to be inserted in all solicitations and contracts by the contracting officer. Vendors can comply with the rule by using either of the two methods below:

  1. The FSC uses a third-party contractor, OB10, to transition vendors from paper to electronic invoice submission. Vendors can go to the following website to find out additional information on use of OB10 http://www.ob10.com/us/en/veterans-affairs/ For information on OB10 electronic invoicing set-up, vendors should call 877-752-0900, or email USClientServices@ob10.com .




  1. A system that conforms to the X12 electronic data interchange (EDI) format established by the Accredited Standards Center. For FSC e-Invoicing information, please call 877-353-9791 or email vafsccshd@va.gov. The X12 EDI Web site (http://www.x12.org).




  1. The FSC’s electronic invoicing system provides a variety of flexible solutions for all vendor types, including small businesses, and does not require any vendor transaction fees. More information on the FSC electronic invoicing process can be found at http://www.fsc.va.gov/einvoice.asp.

http://www.ob10.com/us/en/veterans-affairs/

OB10 Client Services

Phone: 1.877.752.0900, Option #2

E-mail: VA.Registration@OB10.com

CPARS REQUIREMENTS:

a. As prescribed in Federal Acquisition Regulation (FAR) Part 42.1502 and 42.1503, the Department of Veterans Affairs (VA) evaluates contractor past performance on all contracts that exceed $150,000. The FAR requires that the Contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database, Contractor Performance Assessment System (CPARS), which is maintained by the Naval Sea Logistics Center in Portsmouth, Virginia. CPARS has connectivity with the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies. PPIRS is the system used to collect and retrieve performance assessment reports used in source selection determinations and completed CPARS report cards transferred to PPIRS. CPARS also includes access to the Federal Awardee Performance and Integrity Information System (FAPIIS). FAPIIS is a web-enabled application accessed via CPARS for contractor responsibility determination information.

b. The Contractor will have an opportunity to review their ratings/comments, under the step “Contractor Comments” in CPARS.  You will be notified via email by the CPARS system to review the report and provide comments. Each contractor whose contract award is estimated to exceed $100,000 may register with CPARS database at the following web address: www.cpars.gov in order to review the past performance evaluations. Help in registering can be obtained by contacting Customer Support Desk

@ DSN: 684-1690 or COMM: 207- 438-1690. Registration should occur no later than thirty days after contract award, and must be kept current should there be any change to the Contractor's registered representative.



CONFIDENTIALITY AND NONDISCLOSURE

It is agreed that:

1. The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order.

2. The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order. No information shall be released by the contractor. Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO for response.



3. Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO.

INFORMATION SERCURITY:

  1. The Contracting Officer Representative (COR) is responsible for ensuring that all Contractors comply with physical security policies. A compliant ID badge shall be worn by Contractors at all times while on VA premises.

  2. Contractor shall not have access to the VA network or any VA sensitive information under this contract.

  3. All Contractors must receive Privacy training annually using one of the following

methods:

    1. Complete “VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information” training by using VA’s TMS system (https://www.tms.va.gov/). Contractors may use the TMS Managed Self Enrollment method to complete the training in TMS. The COR must ensure that all contractors are validated in the PIH domain.



    1. Complete the hard copy version of “VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or Use to VA Sensitive Information”. Signed training documents must be submitted to the COR.



    1. Training shall be completed prior to the performance of the contract and annually thereafter. Proof of training completion shall be verified and tracked by the COR.

End of Document


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