COMBINED SYNOPSIS/SOLICIATION VA246-15-Q-1278_1 CLINICAL LABORATORY SERVICES (I) This is a combined synopsis/solicitation 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 the only solicitation for this action. Quotes are being requested, and a written solicitation will not be issued. (II) This solicitation is issued as a Request for Quote (RFQ). Submit written quotes on RFQ VA246-15-Q-1278_1 (III) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2005-83. (IV) Any amendments issued to this solicitation will ONLY be available on the FBO website (www.fbo.gov). (V) The Network Contracting Office 6-SAO East intends to award a firm-fixed price contract for Clinical laboratory services for the Richmond Veterans Affairs Medical Center, 1201 Broad Rock Blvd, Richmond, VA 23249. (VI) The North American Industrial Classification System (NAICS) code for this procurement is 541380 with a small business size standard of $12.0 Million This procurement is not a small business set aside and all eligible offerors may submit quotes. All offerors must be registered in System for Award Management (SAM) at http://www.sam.gov to be considered for an award of a federal contract. The record must be complete and not missing elements such as representations and certifications. (VII) Questions concerning this solicitation shall be addressed to Eileen Harris Contract Specialist, and emailed to [email protected]. All questions or inquires must be submitted no later than 5:00 pm Eastern Standard time on 14 September. No phone calls will be accepted. (VIII) The Government will award a contract resulting from this RFQ to the responsible offeror whose quote is the lowest price technically acceptable. Quotes are due by 5:00 P.M. Eastern Standard time on 17 September 2015. Quotes received after this date and time will be considered late in accordance with 52.212-1(f) and will not be evaluated. Quotes shall be submitted via email to [email protected]. ? (IX) This combined solicitation/synopsis is for the purchase of the following commercial items: CLIN DESCRIPTION OF SERVICES QUANITY UNIT UNIT PRICE AMOUNT 0001 Clinical Laboratory Services October 1, 2015 - September 30, 2016 1 YR 1001 Clinical Laboratory Services October 1, 2016 - September 30, 2017 1 YR 2001 Clinical Laboratory Services October 1, 2017 - September 30, 2018 1 YR 3001 Clinical Laboratory Services October 1, 2018 - September 30, 2019 1 YR 4001 Clinical Laboratory Services October 1, 2019 - September 30, 2020 1 YR TOTAL The following Federal Acquisition Regulation (FAR) and Veterans Affairs Acquisition Regulation (VAAR) provisions and clauses are applicable to this acquisition and are available for view at: http://farsite.hill.af.mil/ FAR Provisions: 52.204-7 System for Award Management (JUL 2013) 52.212-1 Instructions to Offerors- Commercial Items (JUL 2013) 1. Offeror shall provide an itemized list of the items Offeror shall provide a quote addressing CLINS (0001-0015) 52.212-2 Evaluation-Commercial Items (JAN 1999) The Government will award a firm fixed priced contract to the responsible offeror who is the lowest priced technically acceptable. 52.212-3 Certifications and & Representations (NOV 2013) VAAR Provisions: 852.233-70 Protest Content/Alternative Dispute Resolution (JAN 2008) 852.233-71 Alternative Protest Procedure (JAN 1998) 852.252-70 Solicitation Provisions or Clauses Incorporated by Reference (JAN 2008) 852.273-74 Award Without Exchanges (JAN 2003) FAR Clauses: 52.203-17 Contractor Employee Whistleblower Rights and Requirements to Inform Employees of Whistleblower Rights (SEP 2013) 52.204-4 Printed or Copied Double-Sided on Postconsumer Fiber Content Paper (MAY 2011) 52.212-4 Contract Terms and Conditions- Commercial Items (MAY 2014) 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Items (SEP 2013) - 52.204-10 Reporting Executive Compensation and First-Tier Subcontract Awards - 52.209-6 Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment - 52.222-3 Convict Labor - 52.222-19 Child Labor - Cooperation with Authorities and Remedies - 52.222-21 Prohibition of Segregated Facilities - 52.222-26 Equal Opportunity - 52.222-35 Equal Opportunity for Veterans - 52.222-36 Affirmative Action for Workers with Disabilities) - 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving - 52.232-33 Payment by Electronic Funds Transfer- System for Award Management 52.252-2 Clauses incorporated by Reference (FEB 1998) 52.217-8 Option to Extend Services (NOV 1999) 52.217-9 Option to Extend the Term of The Contract (MAR 2000) VAAR Clauses: 852.203-70 Commercial Advertising (JAN 2008) 852.232-72 Electronic Submission of Payment Requests (NOV 2012) 852.237-70 Contractor Responsibilities (APR 1984) 852.270-1 Representatives of Contracting Officers (JAN 2008) ? REFERENCE LABORATORY CONSULTIVE SERVICES PERFORMANCE WORK STATEMENT B.3 Contractor shall provide all labor, supplies, equipment, maintenance, information technology, and supervision necessary to provide Reference Laboratory Services to McGuire Veterans Affairs Medical Center described herein. Reference Laboratory Services include, but are not limited to: performance of pathology testing; reporting of pathology test results; and consultative services. I. Specimen Preparation and Storage for Reference Testing Specimens A. Contractor shall be responsible for storing specimens in such a manner to insure the integrity of the specimen. II. Specimen Testing A. The Contractor shall provide the full range of anatomic pathology diagnostic testing capabilities to execute tests as annotated. Contractor shall make available the following test information: 1) Requisition form requirements 2) Test order code 3) Result code 4) Test critical values, if any 5) Policy for critical value notification 6) CPT coding B. All reference laboratory testing shall be executed in accordance with standard industry practices. C. The Contractor shall ensure the accurate and timely performance (defined in Section B3.III.A.12) of laboratory testing services on the biomedical materials. III. Specimen Retention A. All anatomic pathology materials (e.g., histology blocks, slides or other diagnostic material) generated by the VA shall be returned within 7 days after final diagnosis is reported. IV. Reporting of Results A. A report of laboratory testing results must be issued as a printed final copy. B. Each test report shall, at minimum, include the following information: 1) Patient's full name 2) Patient's identification number, e.g. social security number (SSN) 3) Physician's name (if supplied) 4) Government laboratory accession number (if supplied) 5) Submitting facility name 6) Submitting facility account number 7) Test(s) ordered 8) Date/time of specimen collection (when available) 9) Date/time test completed 10) Test result 11) Reference laboratory accession number 12) Name and address of testing laboratory 13) Specimen inadequacy shall be reported with documentation supporting its unsuitability for testing. V. Consultative Services/Utilization Reports A. Contractor shall prove consultative services that are consistent with the services offered to other contracted customers without compensation. These services may include consultations by laboratory professionals or experienced physicians on test or methodology selection or test result interpretation. VI. Term of Contract This contract is effective for an period of 10/01/2015 through 09/30/2020, including any exercised options. The contractor shall perform no services after September 30th of each year until the contracting officer authorizes such services in writing. Availability of Funds during a Continuing Resolution: At the beginning of each new fiscal year (October 1st) the federal government or parts thereof may be operating under a Continuing Resolution and only be funded for a limited period of time rather than for the entire fiscal year. If, at any time, funds for this contract are provided under a Continuing Resolution (CR), funds will only be available for performance under this contract up to and including the expiration date of the CR, and any extension thereof. The Government's obligation for performance of this contract beyond that date is contingent upon the availability of appropriated funds from which payment for contract purposes can be made. No legal liability on the part of the Government for any payment may arise for performance under this contract beyond the expiration date of the CR, and any extension thereof, until funds are made available to the Contracting Officer for performance and until the Contractor receives notice of availability. VII. Medical Records Clinical or other medical records (ie. test results) of VA veteran patients treated by Contractor under this contract are owned by the VA. If requested, test results will be mailed to the VA at no additional cost. Mail shall be sent in accordance with VA Directive 6609, Mailing of Sensitive Personal Information. Contractor may obtain a copy of VA Directive 6609 at the following website: http://www1.va.gov/vhapublications/index.cfm. If a subpoena or court order is received for the production of a medical record/test result, the contractor shall notify the Contracting Officer that a subpoena or court order was received. VIII. CONFIDENTIALITY OF PATIENT RECORDS A. The Contractor is a VA contractor and will assist in the provision of health care to patients seeking such care from or through VA. B. The records referred to above shall be and remain the property of VA and shall not be removed or transferred from VA except in accordance with U.S.C.551a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records) and federal laws, rules and regulations. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA 's records, at VA's place of business on request during normal business hours, to inspect and review and make copies of such records. IX. HIPAA Compliance Contractor must adhere to the provisions of Public Law 104-191, Health Insurance Portability and Accountability Act (HIPAA) of 1996 and the National Standards to Protect the Privacy and Security of Protected Health Information (PHI). As required by HIPAA, the Department of Health and Human Services (HHS) has promulgated rules governing the security and use and disclosure of protected health information by covered entities, including the Department of Veterans Affairs (VA). The VA has recognized Diagnostic Laboratory Facilities as healthcare providers and that the PHI is being disclosed and/or used for treatment. Therefore, no BAA is required for Reference Laboratory Services.

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