ClearPoint Neuro Intervention Disposables

Agency: Department of Health and Human Services
State: Maryland
Type of Government: Federal
FSC Category:
  • 66 - Instruments and Laboratory Equipment
NAICS Category:
  • 334516 - Analytical Laboratory Instrument Manufacturing
Posted Date: Sep 19, 2017
Due Date: Sep 22, 2017
Solicitation No: HHS-NIH-NIDA-SSSA-NOI-17-445
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Solicitation Number :
HHS-NIH-NIDA-SSSA-NOI-17-445
Notice Type :
Combined Synopsis/Solicitation
Synopsis :
Added: Sep 18, 2017 6:29 pm
ClearPoint Neuro Intervention Disposables


Pre-Solicitation Notice of Intent to Sole Source

HHS-NIH-NIDA-SSSA-NOI-17-445


INTRODUCTION
This is a combined synopsis/pre-solicitation for commercial items prepared in accordance with the format in Subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued. This acquisition is being conducted in accordance with the procedures of FAR Part 13--Simplified Acquisition Procedures and FAR Part 12--Acquisition of Commercial Items.


The solicitation number is HHS-NIH-NIDA-SSSA-NOI-17-445 and the solicitation is issued as a PRE-SOLICITATION, NOTICE OF INTENT, to award a contract on a noncompetitive basis to MRI Interventions, Inc located at 5 Musick Irvine CA 96218.


REGULATORY & STATUTORY AUTHORITY
This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13--Simplified Acquisition Procedures, Subpart 13.106-1, only one responsible source and no other supplies or services will satisfy agency requirements, and FAR Part 12--Acquisition of Commercial Items and is NOT expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13--Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6--Competition Requirements.


The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-95, dated January 19, 2017.


NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE
The associated NAICS code for this requirement is 334516 with size standard of 1,000 employees.


CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION
The non-competitive determination is based upon the market research conducted as prescribed in FAR Part 10--Market Research, which indicates that only MRI Interventions, Inc is capable of providing the necessary supplies/services. Specifically, MRI Interventions, Inc is the original equipment manufacturer (OEM) of the MRI surgical equipment and this equipment proprietary to this company. As such, only MRI Interventions, Inc is authorized to provide equipment as requested. The current equipment is MRI Interventions, Inc surgical equipment and the new items must coordinate, connect or interface with the existing system by MRI Interventions, Inc components and connecting to the existing accessories already in use. Accordingly, only MRI Interventions, Inc is capable of providing the required equipment.


This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice.

A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement.


DESCRIPTION OF REQUIREMENT


Background
The NINDS Surgical Neurology Branch (SNB) performs brain surgery to collect tumor tissue for research and other types of brain surgery such as decompressions for syringomyelia or deep brain stimulation for movement disorders. Protocol 12-N-0137 is a protocol delivering a drug (AAV2-GDNF) to specific parts of the brain. In order to do this, the surgery must be performed while the patient is undergoing MRI scanning so that the surgeons will be able to guide the delivery system to the specific part of the brain. MRI scanners use extremely powerful magnets and therefore no surgical supplies containing ferrous materials are allowed into the room with the scanner.


Purpose and Objectives
Surgical Ceramic Catheters and Smartframes and Neurodrapes are required for patient surgeries under protocol 12-N-013. These surgical supplies are required to infuse treatments into a specific location in the brain using MRI scanning.


Project requirements:
Purchase Description
(1) Trade name: ClearPoint Neuro Intervention Disposables
(2) Product's brand name: ClearPoint Neuro Intervention Disposables
(3) Manufacturer's name: MRI Interventions
(3) Model, type, catalog, and/or part number(s): CP-NGS-11-TE, NGS-PD-02, and NGS-NC-05


Salient characteristics
The Contractor shall furnish only ClearPoint Neuro Intervention Surgical Ceramic Catheters and Smartframes and Neurodrapes to ensure minimization of experimental variables and continuity of research efforts. The Contractor shall provide the NINDS SNB the following surgical supplies annually:


Item Name Manufacturer Item Number Minimum Maximum
SmartFrame Uni-lateral Kit IMRIS Skull Mount set MRI Interventions CP-NGS-11-TE
4 24
MR Neuro Procedure Drape Tapered compatible with Siemens/Phillips set MRI Interventions NGS-PD-02 2 12
SMARTFlow 16 ga Neuro Ventricular Cannula, 10 ft x 12mm tip set MRI Interventions NGS-NC-05
4 24


Quantity
The maximum quantity that the government may order annually is detailed in the table below. The minimum quantity which may be ordered annually is detailed in the same table


Item Name Manufacturer Item Number Minimum Maximum
SmartFrame Uni-lateral Kit IMRIS Skull Mount set MRI Interventions CP-NGS-11-TE
4
12
MR Neuro Procedure Drape Tapered compatible with Siemens/Phillips set MRI Interventions NGS-PD-02 2 6
SMARTFlow 16 ga Neuro Ventricular Cannula, 10 ft x 12mm tip set MRI Interventions NGS-NC-05
4 12


Government Responsibilities:
The Government will cooperate with Contractor personnel so that delivery can be performed efficiently and without interruption.


Reporting Requirements:
There are no reporting requirements


Non-Personal Service Statement:
In accordance with FAR 37.104, this requirement is for non-personal services and does not include any inherently governmental functions; functions that are closely associated with inherently governmental functions; unauthorized personal services; critical and/or core functions.


Period of Performance / Delivery
The period of performance shall be a 1-year base a 1-year option period. Delivery shall be within 7 days ARO.


Place of Performance:
All orders shall be delivered to the Clinical Center Surgery Department, 10 Center Drive, 2C/529, Bethesda, MD 20892.


Contract Type
A Firm Fixed Price Purchase Order is contemplated.


RESPONSE INSTRUCTIONS
Responses to this solicitation must include sufficient information to establish the interested parties' bona-fide capabilities of providing the requirement as listed above. Offerors must provide both 1) a technical response and 2) a separate price quote. The price quote shall include: unit price, list price, shipping and handling costs, delivery days after contract award, delivery terms, prompt payment discount terms, F.O.B. Point (Destination or Origin), product or catalog number(s); product description; and any other information or factors that may be considered in the award decision. Such factors may include: past performance; special features required for effective program performance; trade-in considerations; probable life of the item selected as compared with that of a comparable item; warranty considerations; and maintenance availability.


PLEASE ENSURE THAT ALL EVALUATION CRITERIA ARE SPECIFICALLY ADDRESSED IN ANY RESPONSE(S) SUBMITTED.


EVALUATION CRITERIA
FAR clause 52.212-2, Evaluation - Commercial Items (October 2014) applies to this acquisition and the specific evaluation criteria to be included in paragraph (a) of that provision are as follows:


The Government will award a contract resulting from this requirement on the basis of best value, technical factors and price considered. Technical factors together shall be considered more important than price and all technical evaluation factors are detailed below.


Factor 1: Surgical Supplies Capability and Compatibility Approach
The contractor shall detail in its technical proposal how it shall meet each of the project requirements. This shall include detailed specifications of the offered surgical supplies and capabilities, for compatibility and use with Clearpoint Navigation MRI scanners and surgical equipment. Technical approach shall be evaluated for the ways in which the proposed surgical supplies meets or exceeds the specification requirements. Exceeding requirements shall be considered favorably.


Factor 2: Delivery
The contractor shall detail in its technical proposal how it shall meet the delivery requirements. The Government shall evaluate for ability to meet or exceed these requirements. Proposals must include delivery lead-time and transportation.


Factor 3: Past Performance
The Contractor shall provide a list of three (3) contracts or purchase orders completed during the past five (5) years, similar in size and scope to the equipment requirements outlined in this Notice of Intent. Experience must be specific to the Project Requirements and shall include the following information for each contract or purchase order listed:
a. Name of Contracting Organization
b. Total Contract Value
c. Description of Requirement
d. Contract Period of Performance


Past Performance shall be evaluated for relevance to the current requirement.


Technical proposals will be evaluated using a summary adjectival rating in accordance with the following scale:


Excellent
The proposal has exceptional merit and reflects an excellent approach which will clearly result in the superior attainment of all requirements and objectives. This clearly achievable approach includes several advantageous characteristics of substance, and very few disadvantages, which can be expected to result in outstanding performance. The risk of unsuccessful performance is very low as the proposal provides solutions which are unquestionably feasible and practical. These solutions are further considered very low risk in that they are exceptionally clear and
precise, fully supported, and demonstrate a clear understanding of the requirements. Risk Level: Very Low


Good
The proposal demonstrates a sound approach which is expected to meet all requirements and objectives. This sound approach includes advantageous characteristics of substance, and few relatively minor disadvantages, which collectively can be expected to result in satisfactory performance. The risk of unsuccessful performance is low as the proposal contains solutions which are considered feasible and practical. These solutions are further considered to reflect low risk in that they are clear and precise, supported, and demonstrate an understanding of the requirements. Risk Level: Low


Acceptable
The proposal demonstrates an approach which is capable of meeting all requirements and objectives. The approach includes both advantageous and disadvantageous characteristics of substance, where the advantages are not outweighed by the disadvantages. Collectively, the advantages and disadvantages are likely to result in acceptable performance. The risk of unsuccessful performance is moderate, as the proposal solutions are generally feasible and practical. These solutions may also be considered to reflect moderate risk in that they may be somewhat clear and precise, partially supported, and/or demonstrate a general understanding of the requirements. Risk Level: Neutral


Marginal
The proposal demonstrates an approach which may not be capable of meeting all requirements and objectives. The approach has disadvantages of substance and advantages, which if they exist, are outweighed by the disadvantages. Collectively, the advantages and disadvantages present a low or questionable likelihood of resulting in satisfactory performance. The risk of unsuccessful performance is high as the proposal contains solutions which may not be feasible and practical. These solutions may also be considered to reflect high risk in that they lack clarity and precision, are generally unsupported, and/or do not demonstrate a complete understanding of the requirements. Risk Level: High


Unacceptable
The proposal demonstrates an approach which, based on a very high risk, will very likely not be capable of meeting all requirements and objectives. This approach has several disadvantages of substance, and advantages which, if they exist, are outweighed by disadvantages. Collectively, the advantages and disadvantages are unlikely to result in satisfactory performance. The risk of unsuccessful performance is very high as the proposal contains solutions which are not feasible and practical. The solutions may also be considered to reflect very high risk in that they lack any clarity or precision. Risk Level: Very High


APPLICABLE TERMS AND CONDITIONS INCORPORATED BY REFERENCE
The FAR clauses and provisions below shall apply to this solicitation.


1. All Offerors MUST be actively registered in the System for Award Management (SAM) www.sam.gov.


2. The provision at FAR clause 52.212-1, Instructions to Offerors - Commercial Items (JAN 2017), applies to this acquisition.


3. A completed copy of the provision at FAR clause 52.212-3, Offeror Representations and Certifications - Commercial Items (JAN 2017), is required with any offer submitted. This requirement may be met by completion of the provision in the System for Award Management.


4. FAR Clause 52.212-4, Contract Terms and Conditions - Commercial Items (JAN 2017) is applicable to this acquisition.


5. FAR Clause 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders - Commercial Items (JAN 2017) apply to this acquisition. The following clauses shall be checked/included in this clause:


52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2015)
52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Oct 2015) (31 U.S.C. 6101 note).
52.219-4, Notice of Price Evaluation Preference for HUBZone Small Business Concerns (OCT 2014) (if the offeror elects to waive the preference, it shall so indicate in its offer)
52.219-28, Post Award Small Business Program Rerepresentation (Jul 2013)
52.222-3, Convict Labor (June 2003)
52.222-19, Child Labor-Cooperation with Authorities and Remedies (Feb 2016)
52.222-21, Prohibition of Segregated Facilities (Apr 2015).
52.222-26, Equal Opportunity (Sept 2016)
52.222-36, Equal Opportunity for Workers with Disabilities (Jul 2014)
52.222-50, Combating Trafficking in Persons (Mar 2015)
52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services-Requirements (May 2014)
52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011)
52.225-13, Restrictions on Certain Foreign Purchases (June 2008)
52.232-33, Payment by Electronic Funds Transfer-System for Award Management (Jul 2013)


6. The Defense Priorities and Allocations System (DPAS) are not applicable to this requirement.


In addition, the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size must be included in the response.


CLOSING STATEMENT
All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency. All responses must be received by the closing date of this announcement must reference solicitation number HHS-NIH-NIDA-SSSA-NOI-17-445.


Responses shall be submitted electronically to jermaine.duncan@nih.gov. Fax responses will not be accepted. For information regarding this solicitation, contact Jermaine Duncan by email at jermaine.duncan@nih.gov or by phone at (301) 827-7515.


Contracting Office Address :
6001 Executive Boulevard
Room 4211, MSC 9559
Bethesda, Maryland 20892-9559
United States
Primary Point of Contact. :
Jermaine Duncan
Phone: 3018277515

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