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FBO DAILY ISSUE OF SEPTEMBER 18, 2010 FBO #3220
SOLICITATION NOTICE

65 -- ORTHOPEDIC / PODIATRY SURGICAL POWER EQUIPMENT SETS

Notice Date
9/16/2010
 
Notice Type
Combined Synopsis/Solicitation
 
NAICS
339112 — Surgical and Medical Instrument Manufacturing
 
Contracting Office
Department of the Navy, Bureau of Medicine and Surgery, NMLC, 693 Neiman Street, FT Detrick, Maryland, 21702-9203, United States
 
ZIP Code
21702-9203
 
Solicitation Number
N62645-10-T-0231
 
Archive Date
10/7/2010
 
Point of Contact
ARJUN BHALLA, Phone: 3016198895
 
E-Mail Address
arjun.bhalla@med.navy.mil
(arjun.bhalla@med.navy.mil)
 
Small Business Set-Aside
N/A
 
Description
This is a combined synopsis/solicitation for commercial items prepared in accordance with FAR 12.6, Streamlined Procedures for Commercial Items, as supplemented with additional information included in this notice. This acquisition is being conducted under FAR 13.5, Test Program Procedures for commercial items. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. The solicitation number is N6264510RCES187. The solicitation is issued as a request for proposal (RFP). Provisions and clauses in effect through Federal Acquisition Circular 05-44 are incorporated. It is the contractor’s responsibility to be familiar with the applicable clauses and provisions. The clauses may be accessed in full text at these addresses: https://www.acquisition.gov/Far/fac.htmland http://www.acq.osd.mil/dpap/dars/dfars/index.htm.. The NAICS code is 339112, with a small business size of 500 employees. This is 100% small business set aside. The Naval Medical Logistics Command request responses from qualified sources capable of providing a six orthopedic/podiatry power equipment sets. SALIENT CHARACTERISTICS: The requirement is for six orthopedic/podiatry power surgical equipment sets. The sets shall be capable of performing orthopedic and podiatry procedures including ACL reconstructions, arthroscopies, shoulder repairs, ORIFs, bunionectomies and arthroplasties. Each set shall include battery powered, handheld small bone drill (including 1/4” and 5/32” drills, pin and wire collets, AO drill, high speed burr attachment). The battery powered drill shall have at least 25 lb-inches of torque and be capable of at least 1,500 RPMs. The small bone drill shall be capable of creating a round hole for surgical bone pins and/or screws. Each set shall include battery powered, handheld small bone reamer (including 1/4” and AO reamers and DHS/DCS quick lock attachment), T-Latch attachment and Hudson/Modified trinkle reamer. The battery powered reamer shall have at least 70 lb-inches of torque and be capable of at least 500 RPMs. The small bone reamer shall be capable of refining and/or shaping a drill hole to meet the needs of the surgeon for proper placement of pins and screws. Each set shall include a battery powered, handheld small bone sagittal saw capable of at least 25,000 cuts per minute (CPM). The sagittal saw shall be capable of cutting bone and other hard tissue using a serrated blade which oscillates in a plane that includes the axis of the machine without full rotation. Each set shall also include a power console driven, handheld drill capable of at least 50,000 RPM, a reciprocating saw capable of at least 14,000 CPM and oscillating saw capable of at least 20,000 CPM. Each console driven handheld unit shall be used for small bone removal and reshaping in a patient’s extremities. The oscillating saw shall be capable of cutting bone and other hard tissue using a serrated blade that oscillates perpendicular to the axis of the machine without full rotation. The reciprocating saw shall be capable of cutting bone and other hard tissue using a serrated blade that reciprocates alternately along the machine axis. Each handheld device shall have smooth surfaces to minimize the likelihood of blood and debris from collecting in seams and other uneven/textured surfaces. Handheld devices shall be capable of both autoclave and gas plasma sterilization. At least 22 aseptic batteries shall be provided with a maximum recharge time of 40 minutes. Batteries shall be capable of both autoclave and gas plasma sterilization if battery surface is not contained inside handpiece. A battery charger station capable of charging at least four batteries at a time shall be provided. Electrical requirements for electrically powered equipment are 120VAC, 60HZ. Regulatory Requirements: The orthopedic/podiatry power equipment sets and all of the components, shall be compliant with the Food and Drug Administration (FDA) requirements to market and deliver medical products for use in the United States of America, even should delivery be requested outside of the United States. The claims made for the product shall comply with the regulations of the FDA with respect to products for marketing and delivery of a medical product for use in the United States of America, even should delivery be requested outside of the United States. INSPECTION: Unless otherwise specified in the order, the offeror is responsible for the performance of all inspection requirements and quality control. INSTRUCTIONS TO OFFERORS: Offerers shall provide sufficient technical documentation (including but not limited to: product literature, specifications) to allow for thorough evaluation of proposal. Additionally, the vendor shall fully explain their ability to meet the requirements above. Shipping shall be FOB Destination to Camp Lejeune, NC. Proposal shall specify the Total Price. Proposal will be evaluated for Completeness (all CLINS are priced). Adequate competition is anticipated for this acquisition. The government anticipates award of a Firm Fixed Price contract. Offerors shall submit firm-fixed pricing for all above requirements. Include commercial price lists and if applicable, any FSS schedule numbers and pricing. Include any applicable discounts to the Government. EVALUATION FACTORS FOR AWARD: The Factors identified below will be the evaluation factors used to evaluate all offers received. These Factors are in descending order of importance. 1.) Equipment Factors; Conformance to Essential Characteristics 2.) Past Performance: In order to demonstrate that the offeror has delivered the same or similar equipment in the recent past, the offeror shall submit information concerning at least 7 pertinent orthopedic/podiatry power surgical systems it has sold; this information shall detail the locations involved, verified points of contact, scheduled dates of performance, actual dates of performance, performance successes, performance deficiencies, and corrective actions taken. The Government will not restrict its past performance evaluation to information submitted by offerors, but may also consider any relevant information in its possession and may contact references for additional information. Vendors having no relevant past performance shall include a statement to this fact in their technical proposal. 3.) Human Factors: Safety features 4.) Maintainability: Warranty, Parts Availability, Serviceability 5.) Price Rating Standards Factor #1 Shall be rated on a pass/fail basis. Proposals submitted without proper documentation identifying proposed equipment meets all identified characteristics shall be rated as “fail”. Factor #2 VERY LOW RISK – Exemplary past performance on functional requirements and service LOW RISK - Satisfactory past performance on functional requirements and service MODERATE RISK - Some negative past performance on functional requirements and service HIGH RISK - Unsatisfactory past performance on functional requirements and service Offerors with no relevant past performance will not be considered favorably or unfavorably, but Neutral. Factor #3 VERY LOW RISK – Equipment operation poses no risk, has safety features that protect against inappropriate use and prevents unintended activation. LOW RISK - Equipment has safety features that protect against unintended activation MODERATE RISK – Equipment has minimal features that protect against prevents unintended activation); HIGH RISK - Equipment has no features that protect against prevents unintended activation. Factor #4 VERY LOW RISK – Parts and service available same day and/or outside normal business hours upon request, warranty is longer than one year. LOW RISK - Parts and service available within two days of request, warranty period is for one year. MODERATE RISK – Parts and service cannot be provided within five days of request, warranty period is for less than one year. HIGH RISK - Inability to provided parts or service or inability to provide parts or service within ten days of request, warranty period is for less than six months. Factor #5 The Government will conduct an appropriate price analysis to determine Whether prices are fair, reasonable, realistic, and competitive. Other Administrative Instructions: Central Contractor Registration (CCR). Offerors must be registered in the CCR database to be considered for award. Registration is free and can be completed on-line at http://www.ccr.gov; provide DUNS number; Cage Code and TIN. FAR Provisions & Clauses: FAR 52.212-1, Instructions to Offerors---Commercial Items, apply to this acquisition with the exception of (d), (h), and (i) of the clause, which are RESERVED; FAR 52.212-3 ALT I, Offeror Representations and Certifications-Commercial Items; FAR 52.212-4, Contract Terms and Conditions---Commercial Items; FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items. In compliance with said clause, the following FAR clauses apply: 52.219-8, Utilization of Small Business Concerns; 52.222-3, Convict Labor; 52.222-26, Equal Opportunity; 52.222-35, Affirmative Action for Special Disabled and Vietnam Era Veterans; 52.222-36, Affirmative Action for Handicapped Workers with disabilities; FAR 52.232-33, Payment by Electronic Funds Transfer—Central Contractor Registration (Oct 2003) (31 U.S.C. 3332). [Offerors are reminded to include a completed copy of 52.212-3 ALT I with RFP response. All clauses shall be incorporated by reference in the order.] FAR 52.247-34, F.O.B. Destination DFARS 252.211-7003, Item Identification and Valuation (if applicable). DFARS 252.212-7000, Offeror Representations and Certification-Commercial Items; DFARS 252.212-7001, Contract Terms and Conditions Required To Implement Statutes Or Executive Orders---Commercial Items, In compliance with said clause, following additional DFARS clauses apply: 252.225-7001, Buy American Act and Balance of Payment Program; 252.225-7012, Preference for Certain Domestic Commodities, 252.225-7021, Trade Agreements; 252.227-7015, Technical Data—Commercial Items; 252.232-7003, Electronic Submission of Payment Requests; 252.243-7002, Requests for Equitable Adjustment; 252.247-7024, Notification of Transportation of Supplies by Sea. DFARS 252.225-7000, Buy American Act-Balance of Payments Program Certificate; DFARS 252.225-7035, Buy American Act--North American Free Trade Agreement Implementation Act--Balance of Payments Program Certificate. FAR 52.219-6. Notice of Total Small Business Set Aside Quotes/Proposals shall be submitted by email only as a MS Word or Adobe PDF attachment to: Proposals are due by September 20, 2010 Eastern Time on 4 P.M. Any questions must be addressed to arjun.bhalla@med.navy.mil by email only NLT September 22, 2010. No phone calls accepted.
 
Web Link
FBO.gov Permalink
(https://www.fbo.gov/spg/DON/BUMED/N62645/N62645-10-T-0231/listing.html)
 
Place of Performance
Address: CAMP LEJEUNE, North Carolina, 28547-2538, United States
Zip Code: 28547-2538
 
Record
SN02285063-W 20100918/100917000047-e80c43af22bb7d457d4274b3507f7be7 (fbodaily.com)
 
Source
FedBizOpps Link to This Notice
(may not be valid after Archive Date)

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