J A_Sole_Source_CarticelCuluted_Autologous.pdf

Control No: 16-002

Contracting Activity~ Southern Regional Contracting Office, William Beaumont Army Medical Center, (WBAMC) Contracting Cell

Description of Action: This Justification and Approval is requested for a new Sole Source Firm Fixed Price Contract Carticel Care (autologous cultured Chondrocytes). To be funded for the current fiscal year {FY-16).

Description of Supplies/Services: .This supply requirement is for surgery for Cartlcel Care (autologous cultured Chondrocytes). Total Contract Value is $1,862,500.00 for 50 vial procedures.

Authority Cited: JAW FAR 6.302-1 (2), Only one responsible source and no other supplies or services will satisfy agency requlrements.10 U.S.C 2304 (c) (1).

Reason for Authority Cited~ This requirement is for Carticel (autologous cultured chondrocytes) for repair of symptomatic cartilage defect of the femoral condyle (medial, lataeral or trochlea), caused by acute or repetitive trauma at WBAMC, In the Operating Room. It Is determined that US Bio Services Carticel Care (autologous cultured chondrocytes) Is only source that can supply this Service. There is no other source for this requirement.

Effort to Obtain Competition: Market research will be conducted on a continual basis for new products that will provide the best value and the most benefit to both surgeons and patients.

Actions to Increase Competition: There is currently no effort to increase competition as there is only one source capable to meeting the requirement US Bio Services Carticel Care, (autologous cultured chondrocytes). The carticel procedure involve three distinct phrases: biopsy, implantation and rehabllltatlon.

US Bio Services Carticel Care (autologous cultured chondrocytes), is the only company that is capable of providing the service requirement. Based on the Information, there Is no effort to increase competition at this time.

Market Research: Market Research has been conducted on the open market to determine If there were ariy available sources readily available that could provide the requested supplies or service. It has been determined that there are no other companies available that can provide products. US Bio Services Carticel Care (autologous cultured chondrocytes), is the only company that can provide the service required, In September 1997, the Food and Drug Administration approved the first and only procedure, CARTICEL (autologous cultured chondrocytes), cell therapy used to repair articular cartilage in knee of adults. Effective 5 July 2004, US Bio Services Is the sole vendor for the CARTICEL procedure, which is a single source service/product.

John.Kwiatkowski Typewritten Text Sole Sourced Justification and Approval Under FAR 13.501

Interested Sources: To date, no other sources have written to express interest.

A notice of Intent to sole source as required by FAR 5.201 will be published Fed-Biz-Ops and any inquiries received will be considered for future acquisitions

Other Facts:

a. Procurement History: W91YU0-15-P-0037

b. Acquisition Data Availability: NIA

c. Unusual and Compelling Urgency: the requested Carticel Care are only available through one company, US Bio-Services Carticel Care. No other company is capable of meeting the required Carticel Care (autologous cultured chondrocytes). If these trays are not ordered and delivered timely, there will be a major disruption of patient care at William Beaumont Army Medical Center.

d. Subcontracting competition: N/A

Technical Certification:

I certify that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

Type Name: Noel Rosales I . i ~(I / .. S-Date: -"""(fl __ tJtA __ v_( ___ _

Title: Medical Supply Technician Signat~vttf Requirements Certification:

I certify that the supporting data under my cognizance, which are included In the justification, are accurate and c mR ete to the best of my knowledge and belief.

Typed Name:

'""M,,,,a."'10 .... r N""'i.,.,ck,..,ie"'"L"'a""c,..er.___ ______ Tltle: CrJOr(l [£., Fair and Reasonable Cost Determination:

I hereby determine the anticipate cost to the Government for this contract action will be fair and reasonable. The Usual and Customary price $69,532.80 /vial - price charged to insurance companies and private hospitals. However, the anticipated award price

John.Kwiatkowski Typewritten Text and W91YU0-13-C-0007 JAK

John.Kwiatkowski Typewritten Text Both mentioned contracts were awarded as sole source. JAK

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John.Kwiatkowski Typewritten Text Only One Responsible Source

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$37,250.00/vial in the Average Wholesale Price (lowest price which can be charged) for the cmticel vials/service. Thus, the estimated cost is considered fair and reasonable.

Tvne Name: John A. Kwiatkowski Date:

Title: Conh·actiug Officer Signature:

Contracting Officer Certification: This certification shall be made by the Contracting Officer who will sign the contract resulting from this justification and approval.

I ce1tify that this justification is accurate and complete to the best of my knowledge and belief.

Type Name: Jolm A. Kwiatkowski Date:

Title: Contrncting Officer Signature:

Legal Review: I have reviewed this justification and approval and it is deemed to be legally sufficient.

A1mroval: Based on the foregoingjustification, I hereby approve the procurement of Caiticel vialsfservice for William Beaumont Anny Medical Center on otl1er than full and open competition basis pursuant to the authority of 10 U.S.C. 2304 (c) (I), FY-16 funds in the amount of$1,862,500.00 (estimated) are approved, and provided that the services and property herein described have othenvise been authorized for acquisition.

Tyne Name: Jolm A. Kwhttkowski Date;

Title: Contrncting Officer: Signature:

John.Kwiatkowski Typewritten Text 9 Oct 2015

John.Kwiatkowski Typewritten Text 9 Oct 2015

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John.Kwiatkowski Typewritten Text Joseph Peck

John.Kwiatkowski Typewritten Text Special Advocate for Competition

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John.Kwiatkowski Typewritten Text 41 U.S.C. 1901 as implemented by FAR 13.501 JAK

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