Comb_Synp_Brand_Name_Equal_Posting_75N91019Q00135.pdf

TITLE: Purchase of a Brand Name or Equal Leica Bond Max Automated Immunostainer

GENERAL INFORMATION

Document Type: Combined Synopsis/Solicitation Notice

Solicitation Number: 75N91019Q00135

Proposed Posted Date: September 5, 2019

Proposed Response Date: September 6, 2019

Classification Code: 65 – Medical, dental & veterinary equipment & supplies

NAICS Code: 334516 – Surgical and Medical Instrument Manufacturing

Business Size Standard: 1,000 Employees

CONTRACTING OFFICE ADDRESS

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E126, Bethesda, MD 20892, UNITED

STATES.

Non-USPS mail such as FedEx, UPS and other private carriers please use Rockville, MD 20850.

This is a combined synopsis/solicitation for commercial items, prepared in accordance with format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation:

No. 75N91019Q00135 includes all applicable provisions and clauses in effect through FAR FAC 2019-05 (August 2019) simplified procedures for commercial items.

The North American Industry Classification System code is 334516 and the business size standard is 1,000 employees.

It has been determined there are no opportunities to acquire green products or services for this procurement.

Only one award will be made as a result of this solicitation. This will be awarded as a Severable Firm Fixed Price type contract.

The services acquired under this contract are severable services. Funds are only available for use for the contract line item (CLIN) to which they are obligated. Unused funds from one CLIN may not rollover for use in other periods.

This acquisition is a 100% small business set aside.

BACKGROUND

The purpose of the proposed acquisition is for a Brand Name or Equal Leica Bond Max Automated Immunostainer. This equipment is used by the National Cancer Institute (NCI), Center for Cancer Research (CCR), Laboratory of Pathology (LP) as part of its mission to deliver high-quality care to patients at the National Institutes of Health (NIH). Tests performed on this piece of equipment are an essential part of cancer diagnosis and treatment, and have an equally important role in the diagnosis of many infectious diseases. The purpose of this acquisition is for the laboratory to provide additional capacity for new tests and increased workload to meet the needs of the patients enrolled in clinical trials at

NIH.

The LP currently has a Leica Bond Max, but due to increased volume of testing the system is at capacity.

The need for a second system is necessary for software interfacing of validated tests. The small size of this piece of equipment is also necessary due to space issues in the area. The two pieces of equipment will need to be placed side-by-side on a laboratory benchtop.

PRODUCT FEATURES/SALIENT CHARACTERISTICS

The Contractor shall provide the following product features/salient characteristics required for the brand name or equal Leica Bond Max Automated Immunostainer:

• Fully automated, College of American Pathologists compliant, clinical immunohistochemistry analyzer for benchtop use no greater than 35 in x 35 in x 35 in.

• Slide capacity must be a minimum of 30 slides

• Reagent volume/slide no greater than 200 uL

• Hazardous waste must be separated from non-hazardous waste by the system

• Must be able to perform tests in the current menu (n=75) with no significant staining difference from our current system

• Requiring operating software included which must be compatible with the Laboratory Information

System for test interface

• 1-year warranty

• Installation and training included

• All shipping and delivery costs must be included in the quote. This is to be a white glove delivery, with coordination of delivery, installation and training with the NCI Laboratory of Pathology staff

DELIVERY / INSTALLATION

The Contractor shall deliver equipment six weeks after award to:

National Cancer Institute 10 Center Drive Bethesda, MD 20892

Installation shall occur within seven (7) days of the delivery.

TRAINING

Training of four (4) NCI staff shall occur within one week of the installation.

PAYMENT

Payment shall be made once delivery, installation, training of the equipment, and upon Government acceptance. Payment authorization requires submission and approval of invoice to the NCI TPC and NIH Commercial Accounts.

BASIS OF AWARD

The purchase order will be awarded to the Lowest Price Technically Acceptable (LPTA). The award will be made on the basis of the lowest evaluated price of quotations meeting or exceeding the acceptability standards for the requirements/technical specifications stated above. The technical evaluation will be a determination based on information furnished by the vendor. The Government is not responsible for locating or securing any information which is not identified in the quote. The Government reserves the right to make an award without discussions.

PROVISIONS AND CLAUSES

The following FAR provisions and clauses apply to this acquisition:

FAR 52.211-6 Brand Name or Equal. (Aug 1999)

(a) If an item in this solicitation is identified as “brand name or equal,” the purchase description reflects the characteristics and level of quality that will satisfy the Government’s needs. The salient physical, functional, or performance characteristics that “equal” products must meet are specified in the solicitation

(b) To be considered for award, offers of “equal” products, including “equal” products of the brand name manufacturer, must—

(1) Meet the salient physical, functional, or performance characteristic specified in this solicitation;

(2) Clearly identify the item by—

(i) Brand name, if any; and

(ii) Make or model number;

(3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and

(4) Clearly describe any modifications the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modifications

(c) The Contracting Officer will evaluate “equal” products on the basis of information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer

(d) Unless the offeror clearly indicates in its offer that the product being offered is an “equal” product, the offeror shall provide the brand name product referenced in the solicitation.

Offerors providing an "equal" product must submit additional documentation that highlights and describes how the offer is equal in accordance with FAR Clause 52.211-6.

52.212-1 INSTRUCTIONS TO OFFERORS-COMMERCIAL ITEMS (OCT 2018);

52.212-2 EVALUATION COMMERCIAL ITEMS (OCTOBER 2014):

52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS-COMMERCIAL ITEMS

(OCT 2018) WITH DUNS NUMBER ADDENDUM {52.204-6 (OCT 2016)};

52.204-24 Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment.

REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS AND VIDEO

SURVEILLANCE SERVICES OR EQUIPMENT (AUG 2019)

(a) Definitions. As used in this provision—

Covered telecommunications equipment or services, Critical technology, and Substantial or essential component have the meanings provided in clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Prohibition. Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115-232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system.

Contractors are not prohibited from providing—

(1) A service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(2) Telecommunications equipment that cannot route or redirect user data traffic or permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(c) Representation. The Offeror represents that—

It [ ] will, [ ] will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation.

(d) Disclosures. If the Offeror has responded affirmatively to the representation in paragraph (c) of this provision, the Offeror shall provide the following information as part of the offer—

(1) All covered telecommunications equipment and services offered (include brand; model number, such as original equipment manufacturer (OEM) number, manufacturer part number, or wholesaler number; and item description, as applicable);

(2) Explanation of the proposed use of covered telecommunications equipment and services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b) of this provision;

(3) For services, the entity providing the covered telecommunications services (include entity name, unique entity identifier, and Commercial and Government Entity (CAGE) code, if known);

and

(4) For equipment, the entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known).

(End of provision)

FAR Clause 52.212-4 CONTRACT TERMS AND CONDITIONS – COMMERCIAL ITEMS

(OCT 2018);

FAR Clause 52.212-5: CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS-COMMERCIAL ITEMS (AUG

2019). The following FAR clauses cited in paragraph (b) of the clause at FAR 52.212-5 are also applicable to this acquisition;

FAR Clause 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards (Oct 2018)

FAR Clause 52.204-25 - Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment (Aug 2019)

FAR Clause 52.209-6 Protecting the Government’s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Oct 2015)

FAR Clause 52.219-6, Notice of Total Small Business Set-Aside (Nov 2011)

FAR Clause 52.219-13, Notice of Set-Aside of Orders (Nov 2011)

FAR Clause 52.219-28 Post Award Small Business Program Representation (Jul 2013)

FAR Clause 52.222-3 Convict Labor (June 2003)

FAR Clause 52.222-19 Child Labor – Cooperation with Authorities and Remedies (Jan 2018)

FAR Clause 52.222-21 Prohibition of Segregated Facilities (Apr 2015)

FAR Clause 52.222-26 Equal Opportunity (Sept 2016)

FAR Clause 52.222-36 Equal Opportunity for Workers with Disabilities (July 2014)

FAR Clause 52.222-50 Combating Trafficking in Persons (Jan 2019)

FAR Clause 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011)

FAR Clause 52.225-3, Buy American—Free Trade Agreements—Israeli Trade Act (May 2014)

FAR Clause 52.225-13 Restrictions on Certain Foreign Purchases (June 2008)

FAR Clause 52.232-33 Payment by Electronic Funds Transfer–System for Award Management (SAM) (Oct 2018)

SUBMISSION INFORMATION

Quotations must be submitted via email to Contract Specialist, Kathy Elliott, at Elliottk@mail.nih.gov in MS Word or Adobe Portable Document Format (PDF), no later than 3:00 PM EST, on Friday, September 6, 2019. All responses must be received by the specified due date and time in order to be considered.

QUOTATIONS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. No collect calls will be accepted.

Please refer to solicitation no: 75N91019Q00135 on all correspondence.

Full text copies of the representations and certifications for other cited provisions and clauses may be obtained on line at the NCI website at http://ncioa.cancer.gov/oa-internet/reference.jsp

OFFERORS: Offers must be submitted on an SF-1449 with a completed 52.212-3 Offeror Representations and Certifications-Commercial Items-with DUNS Number Addendum, signed by an https://acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136004 https://acquisition.gov/sites/default/files/current/far/html/52_217_221.html#wp1136174 mailto:Elliottk@mail.nih.gov http://ncioa.cancer.gov/oa-internet/reference.jsp authorized representative of the offeror OR provide a copy of the valid certification registrations of the offeror’s Excluded Parties List System (EPLS) and Online Representations and Certifications Applications (ORCA) through www.sam.gov. Offerors must also complete and submit with Quote, FAR 52.204-24 Section (c) Representation.

http://www.sam.gov/