Pathology Testing and Diagnostics Services

The proposed contract action is for commercial items which the Naval Medical Center San Diego intends to solicit on a sole source basis under the authority of FAR 13.106 (1) (b). This proposed contract action is used for Laboratory/Anatomic Pathology Department for immunohistochemical tests and genetic testing of zinc-formalin fixed tissues. The source is Clarient, Inc. at 31 Columbia, Aliso Viejo, CA 92656-1460. Interested contractors/persons may identify their interest and capability to respond to the requirement or submit proposals. This notice of interest is not a request for competitive proposals. However, all proposals received by 4 September 2013, 10:00AM, Pacific Standard Time, will be considered by the Government. A determination by the Government not to compete with this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement in the future. This is a combined solicitation/synopsis for commercial items, prepared in accordance with the format in FAR subpart 12.6 as supplemented with additional information included in this notice. This announcement constitutes only solicitation, quotations are being requested and a written solicitation will not be issued. The solicitation number is N00259-13-T-0334. It is issued as a Request for Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-68. This is a sole source solicitation. The North American Industry Classification System (NAICS) Code for this acquisition is 621511: Size: $30.0M. It is the contractors' responsibility to be familiar with the applicable clauses and provisions. The clauses and provisions may be accessed in full text at http://acquisition.gov/far and http://acq.osd.mil. The contractor shall provide Pathology Testing and Diagnostics services in accordance with the Statement of Work. CLIN 0001 Pathology Testing and Diagnostics Services (Stains and Lab Tests) Qty. 1 Group Price: $________ Naval Medical Center Laboratory Department San Diego, California 92134 Supplemental Immunohistochemistry Staining and Molecular Oncology Testing Outsourcing STATEMENT OF WORK 1.0 INTRODUCTION 1.1 Organization: The Naval Medical Center San Diego (NMCSD) and its affiliated Branch Medical Clinics (BMCs) located in San Diego, California are responsible for providing members of the U.S. Armed Forces and their dependents with reliable, high-quality health care. In addition to maintaining premier health care provider's military beneficiaries, NMCSD is responsible for supporting the histology work load for NH Camp Pendleton, NH 29 Palms and NH Lemoore. 1.2.1 Background and Objective: The NMCSD immunohistochemistry (IHC) Laboratory stains between 10500 - 11700 IHC slides per year including negative controls. The equipment currently in place has exceeded its normal life cycle by several years and is technologically behind current standards, exhibiting a number of limitations: relatively high work repetition due to tissue wash-off, high volumes of hazardous waste, and older (non-polymer) chromogenic detection systems. The Laboratory has been approved for upcoming FY14 to obtain newer equipment on a cost per reagent test that is more cost effective than outsourcing the entire workload. The one exception to this is a small percentage of slides that are requested so infrequently that it would cost more due to wastage/reagent out-dating losses to keep these rarer antibodies in our profile. The antibodies are packaged in canisters with a range of 45-50 tests that have a reagent dating range of 18-24 months. However, this lab does not perform two critical services; namely breast cancer ancillary testing. ER/PR image analysis and HER-2 FISH studies as well as specialized solid tumor FISH and molecular studies, which cannot be cost effectively performed at NMCSD. The surgical pathology paraffin blocks, which represent irreplaceable patient tissue biopsies, cannot be effectively nor time sensitively sent to multiple different laboratories, so this particular subset of tests must be performed at one location. 2.0 REQUIREMENT 2.1 Task Description and Deliverables: 1) The equipment and reagents shall be in compliance with OSHA, FDA, CAP as well as state and local statutory requirements. 2) All antibodies must be either FDA approved or adhere to the College of American Pathologists (CAP) guidelines for "Laboratory Developed Tests" including adherence to their validation requirements. 3) The reference laboratory (contractor) must have the appropriate CLIA'88 certification requirements and must be willing to send a digital copy of their current accreditation certificate to NMCSD upon request. 4) The vendor will be responsible for routine pick-up and drop-off every business day at the NMCSD Anatomic Pathology Office. This service will be part of the quoted price. 5) All paper requisitions required to initiate Clarient evaluations will be provided at no additional charge to NMCSD. NMCSD is expected to fill out the requisite fields required by Clarient. Any reports generated by Clarient will be provided at no additional charge to NMCSD. 6) Invoicing requirements are delineated at the end of this statement of work. The process and any subsequent costs associated with invoicing the government is the responsibility of Clarient. Value Added Services 1) The contractor will provide professional support to NMCSD pathologist via e-mail or telephone for questions/concerns associated with the immunohistochemical staining. 3.0 Classification - Unclassified Privacy Act Statement: "Pursuant to Title 5 United States Code 552a(m)(1), the contractor and all employees of the contractor working under this contract are required to comply with the requirements of 5 U.S.C. 552a ("The Privacy Act of 1974"). 4.0 Travel: NO TRAVEL REQUIRED. 5.0 Period of Performance: Proposed base year is 1 October 2013 - 30 September 2014. 6.0 Invoice Schedule Contractor may invoice monthly in arrears. Invoices shall be submitted once a month utilizing the Wide Area Work Flow (WAF) process for services rendered as specifically delineated in the CLIN items of the purchase request during the previous month. No more than one invoice may be submitted per month. Invoices must identify the invoicing period. If charges against more than one line item have occurred during the invoicing period, all charges must be combined into one invoice and correlated with a specific CLIN item listed in the purchase request. Specific invoicing instruction will be provided in the contract award. The contractor's failure to include the necessary information or a more frequent invoice submission than authorized will result in invoices being rejected. Payment will be processed by WAWF. This solicitation incorporates the following FAR and DFARS Clauses/Provisions: 52.204-7 Central Contractor Registration (DEC 2012) 52.204-13 Central Contractor Registration - Maintenance (DEC 2012) 52.212-1 Instruction to Offerors-Commercial Items (FEB 2012) 52.212-3 Offeror Representations and Certifications-Commercial Items (DEC 2012) 52.212-4 Contract Terms and Conditions-Commercial Items (JUN 2013) 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive orders-Commercial Items (JAN 2013) 52.222-50 Combating Trafficking in Persons (FEB 2009) (22 U.S.C. 7104(g) 52.233-3 Protest after Award (Aug 1996) (31 U.S.C. 3553) 52.233-4 Applicable Law for Breach of Contract Claim (Oct 2004) (Pub.L. 108-77, 108-78) 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards (JULY 2010) 52.219-28 Post Award Small Business Program Representation (JUN 2007) 52.222-3 Convict Labor (June 2003) (E.O. 11755) 52.222-19 Child Labor-Cooperation with Authorities and Remedies (July 2010) (E.O. 13126, 52.222-21 Prohibition of Segregated Facilities (FEB 1999) 52.222-26 Equal Opportunity (Mar 2007)) (E.O. 11246) 52.222-36 Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C 793) 52.223-18 Contractor Policy to Ban Text Messaging While Driving (Sept 2010) 52.225-13 Restrictions on Certain Foreign Purchases (FEB 2006) (E.O.s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of Treasury) 52.232-33 Payment by Electronic Funds Transfer-Central Contractor Registration (Oct 2003) (31U.S.C. 3332) 52.232-18 Availability of Funds (APR 1984) 252.225-7002 Qualifying Country Sources as Subcontractors (Apr 2003) 52.252-1 Solicitation Provisions Incorporated by Reference (FEB 1998) 52.252-2 Clauses Incorporated By Reference (FEB 1998) NMCAR SUBPART 5237.102 (90) -SERVICE CONTRACTS GENERAL "The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for performance of services provided under this contract for the (NAMED COMPONENT) via a secure data collections site. The contractor is required to completely fill in all required data fields using the following web address: http://www.ecmra.mil/ Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2013. Contractors may direct questions to the Help desk link at http:://www.ecmra.mil" AVAILABILITY OF FISCAL YEAR 2014 FUNDS. THE GOVERNMENT OBLIGATION MADE HEREUNDER IS CONTINGENT UPON THE ENACTMENT OF THE FISCAL YEAR 2014 APPROPRIATION ACT. THIS ORDER IS ISSUED SUBJECT TO THE 2014 DOD APPROPRIATION ACT OR AN EXTENDED FISCAL YEAR 2013 CONTINUING RESOLUTION ACT AND IS SUBJECT TO ALL PROVISIONS OF WHICHEVER ACT BECOMES APPLICABLE. THE CLAUSE 52.232-18 REFERENCED HEREIN APPLIES TO THIS CONTRACT. Quotations will be evaluated based on technical capability, past performance (within the last 3 years), and price. Technical capability and past performance when combined are more important than price. The Government will only consider firm fixed price quotations. Offeror must complete and submit with the quotations FAR provision 52.212-3 Offeror Representations and Certifications-Commercial Items (APR 2012). The provision can also be submitted at https://www.sam.gov. Contractor must be registered to the System for Award Management (SAM) prior to award. A nine digit Data Universal Numbering System (DUNS) number provided by Dun and Bradstreet is required to register. The website address for SAM registration is https://www.sam.gov Electronic submission of Quotes: Quotations shall be submitted electronically by email to merlinda.labaco@med.navy.mil or by facsimile at 619-532-5596, Attention: Merlinda M. Labaco. Email submissions are limited to 2MB. The submitter should confirm receipt of email submissions. Quotations are due before close of business on 4 September 2013, 10:00 AM PST.