COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS General Information Document Type: Combined Solicitation/Synopsis Solicitation Number: 36C26220Q0069 Posted Date: 11-01-2019 Original Response Date: 11-04-2019 Current Response Date: 11-04-2019 Product or Service Code: Q301 Set Aside (SDVOSB/VOSB): Full and open competition NAICS Code: 621511 Contracting Office Address Department of Veteran Affairs     VHA Regional Procurement Office - West 4811 Airport Plaza Drive, Suite 600  Long Beach, CA 90815-1263 Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotations are being requested, and a written solicitation document will not be issued. This solicitation is a request for quotations (RFQ). The Government intends to award a single Firm-Fixed Price (FFP) award contract. No quotes will be accepted past due date. The associated North American Industrial Classification System (NAICS) code for this procurement is 621511, with $32.5 size standard in millions of dollars. 1. STATEMENT OF WORK: The Department of Veterans Affairs, VHA Regional Procurement Office - West has a requirement to fulfill Thyroseq test for participating Healthcare facilities within Veterans Integrated Service Network (VISN) 22. Thyroseq testing is a test for the pre-operative assessment of thyroid nodules with indeterminate cytology, which offers accurate assessment of cancer probability in each nodule. Test results provide information on cancer prognostication, helping to select the most optimal patient care treatment, providing analysis of 112 genes and 150 gene fusion types. The following is the CPT code and quantity requirement. Description CPT Code QTY Thyroseq 81479 64 2. VISN 22 participating Healthcare Facilities: VA Long Beach Healthcare System 5901 E. Seventh St Long Beach, CA 90822 VA Loma Linda Healthcare System 11201 Benton Street Loma Linda, CA 92357 VA San Diego Healthcare System 3350 La Jolla Village Drive San Diego, CA 92161 VA Greater Los Angeles Healthcare System 11301 Wilshire Blvd. Los Angeles, CA 90073 VA Albuquerque Healthcare System - 1501 San Pedro Dr SE Albuquerque, NM 87108 VA North Arizona Healthcare System - 500 AZ-89 Prescott, AZ 86301 VA Phoenix Healthcare System 650 E Indian School Rd. Phoenix, AZ 85012 VA Southern Arizona Healthcare System 3601 S 6th Ave. Tucson, AZ 85723 3. DESCRIPTION OF SERVICES SPECIMEN PROCESSING: Each facility will provide properly prepared laboratory specimens identified and labeled for testing. This will include the submission of a pre-filled requisition (site specific) form provided by the contractor. SPECIMEN TRANSPORT: The contractor shall supply test shipping kit that includes container, transport bag and shipping label. SPECIMEN TESTING: The contractor shall provide testing of patient specimens as requested by VISN 22 participating facilities. SPECIMEN STORAGE: The contractor shall store the specimens a minimum of seven (7) days after the test is reported to allow for subsequent action (e.g problem solving and/or repeat testing). CHANGES: Changes shall be made in accordance with FAR 52.212-4(C), shall not necessitate new solicitation proceedings. 4. PATIENT TEST REPORT: At a minimum, the contractor shall provide a report that meets the College of American Pathologist standard. To include but not limited to the following information on each laboratory test report/result: Patient's name and/or identification number VA accession number Physician's name VA medical record number The submitting facility name Test ordered Date/time of specimen collection Date/time test completed Test result Reference intervals, including abnormal/critical value flags. Reference laboratory specimen number Name and address of testing laboratory to include CLIA number. Any other information that may indicate a questionable validity of test results Unsatisfactory specimen shall be reported with documentation supporting its unsuitability for testing Note: Contractor must provide copies of positive and negative reports with quote to contract specialist. 5. REQUIREMENTS: The contractor must perform the test in-house. Results must be available 7-10 business days. Contractor shall comply with all state and local regulations that are applicable to the services it provides. The contractor shall implement procedures that ensure the accountability and integrity of all biological substances from the point of possession to the point of delivery. The contractor shall implement a training program for contractor personnel that adheres to the regulations for the transport of hazardous materials. Education on the types of biological materials transported including definitions of an infectious substance and a biological product. Education on appropriate hazardous material packaging and labeling to recognize non-compliance. Appropriate installation, use and security of environmental temperature control devices that maintain ambient, refrigerated, frozen or incubated conditions that insure the integrity of the specimens and avoid loss or breakage of the containers. Identification of specimens requiring environmental temperature control storage. Certified/Trained on appropriate decontamination and notification procedures in case of accident or spills. This includes the identification and appropriate use of personal protective equipment, use of mitigation, and disinfection products. Education on procedures for hazardous spill communication, i.e contact telephone numbers in case of accident or spills. Education on the protection of the privacy and confidentiality of the personally identifiable information. 6. SPECIFICATIONS: LICENSE: Contractor shall perform specimen testing only in fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing described in this contract. The reference laboratory must be licensed/accredited by the College of American Pathologists (CAP), the Nuclear Regulatory Commission, and Center for Disease Control, Medicare, as well as any other state regulatory agencies as mandated by federal and state law. In addition, the Laboratory must be certified as meeting the requirements of the Clinical Laboratory Improvement Act (CLIA) of 1988 and comply with the National Standards to Protect the Privacy of Personal Health Information in accordance with Health Insurance Portability and Accountability Account of 1996 (HIPAA) and VA Directives 1106, 1106.01 and 1106.2. For each laboratory used, the contractor shall provide copies of all relevant permits/licenses and certification inclusive of any sanctions or pending throughout the United States of America. As these documents are reissued or rewarded, the contractor shall supply a copy to the Contracting Officer and VISN 22 participating healthcare facility. The above documents must also be supplied for each reference laboratory that is a subcontractor of the Contractor. Note: Contractor and subcontractor must provide copies of CAP and CLIA certificates with quote to Contract Specialist. 7. SECURITY: The vendor shall ensure adequate LAN/Internet, data, information, and system security in accordance with VA standard operating procedures and standard contract language, conditions laws, and regulations. The vendor s firewall and web server shall meet or exceed the government minimum requirements for security. All government data shall be protected behind an approved firewall. Any security violations or attempted violations shall be reported to the VA Project Manager and the VBA Headquarters Information Security Officer as soon as possible. The vendor shall follow all applicable VA policies and procedures governing information security, especially those that pertain to certification accreditation. The contractor and their personnel shall be subject to the same Federal laws, regulations, standards and VA policies as VA personnel, regarding information and information system security. These include, but not limited to Federal Information Security Management Act (FISMA), Appendix III of OMB Circular A-130, and guidance and standards, available from the Department of Commerce's National Institute of Standards and Technology (NIST). This also includes the use of common security configurations available from NIST's Web site at: http://checklists.nist.gov To ensure that appropriate security controls are in place, Contractors must follow the procedures set forth in "VA Information and Information System Security/Privacy Requirements for IT Contracts" located at the following Web site: http://www.iprm.oit.va.gov The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html. The following solicitation provisions apply to this acquisition: FAR 52.212-1, Instructions to Offerors Commercial Items FAR 52.212-3, Offerors Representations and Certifications Commercial Items Offerors must complete annual representations and certifications electronically via the System for Award Management (SAM) website located at https://www.sam.gov/portal in accordance with FAR 52.212-3, Offerors Representations and Certifications Commercial Items. If paragraph (j) of the provision is applicable, a written submission is required. The following contract clauses apply to this acquisition: 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 VAAR 852.232-72, Electronic Submission of Payment Requests (Nov 2012) The following subparagraphs of FAR 52.212-5 are applicable: b(4) 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards (Oct. 2018) b(8) 52.209-6 Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Oct 2015) b(22) 52.219-28 Post Award Small Business Program Representation (Jul 2013) b(25) 52.222-3 Convict Labor (June 2003) b(26) 52.222-19 Child Labor- Cooperation with Authorities and Remedies (Jan 2018) b(27) 52.222-21 Prohibition of Segregated Facilities b(28)(i) 52.222-26 Equal Opportunity (Sep 2016) b(30)(i) 52.222-36 Equal Opportunity for Workers with Disabilities (Jul 2014) b(33)(i) 52.222-50 Combating Trafficking in Persons (Mar 2015) b(42) 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) b(47)(iii), 52.225-3 Buy American-Free Trade Agreements0Israeli Trade Act (May 2014) b(49) 52.225-13 Restrictions on Certain Foreign Purchases (Jun 2008) b(55) 52.232-33 Payment by Electronic Funds Transfer-Other than System for Award Management (Jun 2013) All vendors must submit the following documents with offer: Copy of the quote d) CAP certificate Copy of positive report e) CLIA certificate Copy of negative report All documents are required with offer. You will not be contacted for additional information. Award shall be made to the offeror whose offer, conforming to the solicitation, will be most advantageous to the Government. Offeror must submit all documents to be considered for award. The Government evaluation factors for award will be based on eligibility, capability and price evaluation. This is an open-market combined synopsis/solicitation for the product as defined herein.  The government intends to award a purchase order or delivery order/task order as a result of this combined synopsis/solicitation that will include the terms and conditions set forth herein. To facilitate the award process, all vendors must include a statement regarding the terms and conditions herein as follows: "The terms and conditions in the solicitation are acceptable to be included in the award document without modification, deletion, or addition." OR "The terms and conditions in the solicitation are acceptable to be included in the award document with the exception, deletion, or addition of the following:" Vendors shall list exception(s) and rationale for the exception(s). Submissions will be accepted no later than November 04, 2019 at 10:00 am Pacific Time. Email offers will be accepted. Late submissions shall be treated in accordance with the solicitation provision at FAR 52.212-1(f) Excusable delays. Any questions or concerns regarding this solicitation should be forwarded in writing via e-mail to the Contract Specialist: Anthony Dela Cruz, [email protected]. Point of Contact Anthony Dela Cruz, Contract Specialist [email protected]

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