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FBO DAILY - FEDBIZOPPS ISSUE OF JULY 30, 2014 FBO #4631
DOCUMENT

66 -- ESOTERIC LAB TEST request for information only on vendor availability to perform these task - Attachment

Notice Date

7/28/2014
 

Notice Type

Attachment
 

NAICS

621511 — Medical Laboratories
 

Contracting Office

Department of Veterans Affairs;VA Caribbean Healthcare System;Administrative Building;#10 Calle Casia Suite #4M440;San Juan PR 00921-3201
 

ZIP Code

00921-3201
 

Solicitation Number

VA24814Q1413
 

Response Due

8/11/2014
 

Archive Date

9/10/2014
 

Point of Contact

Rolando Arce
 

E-Mail Address

81-8700
 

Small Business Set-Aside

N/A
 

Description

SECTION A SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS Table of Contents SECTION A1 A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS1 SECTION B - CONTINUATION OF SF 1449 BLOCKS3 B.1 CONTRACT ADMINISTRATION DATA3 B.2 Price/Cost Schedule22 Item Information22 SECTION C - CONTRACT CLAUSES23 C.1 FSS RFQ INTRODUCTORY LANGUAGE23 SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS24 SECTION E - SOLICITATION PROVISIONS25 E.1 52.209-5 REPRESENTATION BY CORPORATIONS REGARDING AN UNPAID TAX LIABILITY OR A FELONY CONVICTION UNDER ANY FEDERAL LAW (DEVIATION)(MAR 2012)25 SECTION B - CONTINUATION OF SF 1449 BLOCKS B.1 CONTRACT ADMINISTRATION DATA (Continuation from Standard Form 1449, block 18A.) 1. Contract Administration: All contract administration matters will be handled by the following individuals: a. CONTRACTOR: b. GOVERNMENT: Contracting Officer 00248 ROLANDO ARCE Department of Veterans Affairs VA Caribbean Healthcare System Administrative Building #10 Calle Casia Suite #4M440 San Juan PR 00921-3201 2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with: []52.232-34, Payment by Electronic Funds Transfer-Other Than System For Award Management, or []52.232-36, Payment by Third Party 3. INVOICES: Invoices shall be submitted in arrears: a. Quarterly[] b. Semi-Annually[] c. Other[X] MONTHLY INVOICE 4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests. Department of Veterans Affairs Financial Services Center P.O. Box 149971 Austin TX 78714-9971 ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows: AMENDMENT NODATE SCOPE OF WORK REFERENCE LABORATORY Contractors shall provide in accordance with the specifications outlined below a full range of referral laboratory services for VA Caribbean Healthcare System Pathology and Laboratory Medicine Service, during the period October 1st, 2014 through September 30, 2015. Services provided to VA Caribbean Healthcare System Pathology and Laboratory Medicine Service under the resultant contract shall include the transportation of clinical laboratory specimens to the Contractors laboratory(s), the performance of analytical testing as defined by the Contractor's reference test manual, the reporting of analytical test results and consultative services as required to assimilate the full scope of its laboratory operations to the VA Caribbean Healthcare System Pathology and Laboratory Medicine Service. All requirements and provisions defined in the specifications of this solicitation will apply to any laboratory (i.e. branch, division, sub-contractor, etc.) performing reference testing on behalf of the Contractor. I. LICENSURES Only fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing outlined in this solicitation will be considered. The reference laboratory must be licensed/accredited by the College of American Pathologists, the Nuclear Regulatory Commission, Center for Disease Control, Medicare and/ or other state regulatory agencies as mandated by federal and state statutes. In addition the laboratory must be certified as meeting the requirements of the Clinical Laboratory Improvement Act 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). II. QUALITY The Government reserves the right to physically inspect the reference laboratory(s) prior to a contract award and at any time during the award period to insure the reference laboratory's compliance with accreditation and quality assurance practices and requirements. In addition, the reference laboratory shall provide the following documentation with their offer and on an annual basis in accordance with the Office of Inspector General (01G) Combined Assessment Program (CAP) and Joint Commission for the Accreditation of Healthcare Organizations (JCAHO) requirements: "Professional Staff Curricula Vitae "Technical Staff Competency Skills Assessment "Proficiency Exam Participation "Proficiency Exam Exception Reports for the past two years "Description of Performance Improvement (Quality Assurance) Program "Current year performance improvement monitors that include and not limited to demonstration of number of lost specimens, number of cancelled specimens, delays in turnaround times, and courier route delays/cancellations "Other Quality Assurance Monitors as defined by VA Caribbean Healthcare System Pathology and Laboratory Medicine Service III. DESCRIPTION OF REQUIREMENTS The following general test information shall be provided with the contractor's: "Test turnaround times (minimum and maximum times indicated); where the turnaround time is defined as the time between pick-up of specimen by the Contractor and receipt of results by VA Caribbean Healthcare System Pathology and Laboratory Medicine Service. "Frequency of test performance (specific days of week indicated) "Location of test performance by test name (i.e. name and address of primary laboratory, name of separate branch/division of primary lab, name and address of secondary (sub-contracted) laboratory must be cited. The Contractor shall notify the Contracting Officer and all designated Contracting Officer Technical Representatives (COTR) when any modifications to this information occur during the period of performance. IV. TELECOMMUNICATION AND COMPUTER SERVICES: The Contractor must meet all Enterprise Cyber Security Infrastructure Project (ECSIP) requirements in order to establish an interconnection with the VA for transfer of laboratory test results directly into a VA computer system via the appropriate Laboratory Electronic Data Interchange protocol. There are three basic types of authorized connections. The ECSIP team will have the ultimate decision on which connection type is appropriate. More information can be obtained from the VA Information Security Officer at any facility. In addition, all Contractors must meet the following background investigation requirements: All users with access to the data received from Department of Veterans Affairs (VA) are U.S. Citizens with a Contractor's valid and current background investigation or a mutually agreed upon VA level background clearance verified to be at the National Agency Check with Inquiries level for laboratory technical staff and business operations staff and are operating within the borders of the U.S.A. and its territories. Anyone with administrative or programmer access to a Federal computer system will have a background investigation commensurate with the level of access granted to the VA computer system as determined by the Information Security Officer in concert with Human Resources Management Staff. These staff must be operating within the borders of the U.S.A. and its territories. Any equipment provided by the Contractor to VA which contains a storage device such that when the device is powered down, VA sensitive data remains on it must become the property of the Federal Government and remain on Federal property or must be destroyed by VA and in accordance with Department of Veterans Affairs regulations at the time of removal (device decommissioning). Data required by the Health Insurance Portability and Accountability Account of 1996 (HIPAA) to remain on equipment located on Contractor's property must be safeguarded in accordance with HIPAA and this information must be destroyed in accordance with VA requirements when no longer required by HIPAA to be held by the vendor. The reference laboratory must meet HIPAA requirements and must be able to interface with the current version of the Vista System. V.IMPLEMENTATION TIME FRAME The implementation of the services/requirements described in this solicitation shall be completed no later than __ days after the award of the contract. Failure to provide timely implementation may result in termination of this Agreement. Offerors must furnish a schedule and plan to show implementation of the required services (courier, telecommunications, testing interface with host (Vista, reporting, quality assurance, etc.) VI.SAMPLE PROCESSING: VA Caribbean Healthcare System Pathology and Laboratory Medicine Service will provide laboratory specimens properly prepared, identified and labeled for testing. The Contractor shall provide at no additional charge an adequate supply of specimen collection materials for such testing that is destined to the commercial reference laboratory for analysis and requires specialized handling as dictated by the commercial reference laboratory's specimen collection requirements, i.e. dry ice, stabilizing tablets, ice packets, etc. The Contractor will be responsible for transporting and storing specimens in such a manner as to insure the integrity of the specimen. In addition, the contractor will provide additives required for collection of specimens in unit packages to facilitate collection in CBOCs and OPCs. Material Safety Data Sheets will be provided to sites as appropriate for supplies containing hazardous chemicals (e.g. boric acid tablets, acids). Emergency testing services shall be available for all procedures deemed necessary on an emergent basis. This service shall be provided at a negotiated expense rate per test. The test results will be reported within four (4) hours from the time the specimen is collected/picked-up by the Contractor. Specimen Storage: The Contractor shall store the specimens a minimum of seven days after the test is reported in the event that subsequent action is necessitated (i.e. problem solving and/or repeat testing). VII.TRANSPORTATION SERVICES The Contractor shall provide reference testing courier services to the VA Caribbean Healthcare System Pathology and Laboratory Medicine Service. Courier service may include minimally one (1) pick-up per day. Provided emergency transportation services shall be equal to the routine level services and be available 24 hours per day, seven days per week including Government holidays. Response time for emergency transportation services shall be within 1 hour of notification of specimen availability. These services shall be provided at a negotiated expense rate per unit of service. A unit of service is defined as a call for emergency transportation regardless of the number of specimens included in the transport. The contracted commercial reference laboratory shall be responsible for insuring that all transport personnel are trained and that their competency is regularly assessed in appropriate safety and packaging procedures suitable to specimen type and distances transported. This should include issues such as adherence to regulations for transport of biohazards, use of rigid containers where appropriate, temperature control, notification procedures in case of accident or spills, etc. The contracted commercial reference laboratory shall submit evidence of their training and annual competency programs. VIII.REPORTING OF RESULTS A report is defined as a printed final copy in duplicate of laboratory testing results or host-to-host electronic transmission of test results. This report will be received by either messenger delivery and/or computer interface. Each test report shall at minimum indicate the following information: "Patient's name and/or identification number "Physician's name (if supplied) "Medical record number or laboratory accession number (if supplied) "Patient's location (clinic/ward) (if supplied) "Test ordered "Date/time of specimen collection (when available) "Date/time test completed "Test result "Reference ranges "Toxic and therapeutic ranges, if applicable "Flagged abnormal "Reference laboratory specimen number "Name and address of testing laboratory "Any other information the laboratory has that may indicate a questionable validity of test results "Unsatisfactory specimen shall be reported with documentation supporting its suitability for testing Routine report test results shall be reported within 48 to 72 hours of specimen pick-up. STAT test results shall be reported within 8 hours or less of specimen pick-up (unless longer tests turnaround time is specifically allowed on a case-by-case basis). Critical value test results shall be reported immediately via telephone and fax. Read back will be documented to show to whom the result was called and at what time. It is recognized that certain test procedures will require a longer turn - around time. Under these circumstances, test results are expected to be received no later than 1 hour after the verification of the test. Notification of a test result that has been identified in the commercial reference contractor laboratory as a critical value shall be communicated by telephone to the VA Caribbean Healthcare System Pathology and Laboratory Medicine Service upon verification of the critical test result. A hard copy result must follow any telephonic reporting either by fax or computer generated report. The status and the results of testing are available within published timeframes and easily retrievable by the use of varying options. Examples of these options are through a patient search, a sort by timeframe, a sort by test, a sort of incomplete tests, etc. Reports of test results shall be immediately available upon verification of the test result. The computer must be able to print test results upon request and reprint retrospective test results according to a defined timeframe. IX.CUSTOMER SERVICE The Contractor shall provide in response to this solicitation a detailed plan describing their customer service strategies for VA Caribbean Healthcare System Pathology and Laboratory Medicine Service. This plan shall address the capability and/or availability of the commercial reference laboratory contractor to provide the following services and, if applicable, specify how this service will be accomplished, by whom, and within what timeframe: A. Telephone Inquiries: 1. Specimen Collection a.Routine inquiries, where the reference laboratory performs the testing however further clarification on the collection requirements are needed, shall be addressed at the time of the inquiry. b.Esoteric inquiries, where the information on the availability and/or requirements of the questioned test requires further research, shall be addressed within 1/2 hour of the initial inquiry. 2. Testing a.Status of Ordered Testing- inquiries regarding the status of pending orders shall be addressed at the time of the inquiry. b.Esoteric inquiries where information is requested regarding methodology, correlation, interferences, reflex tests, etc. shall be addressed within two hours of the initial inquiry. 3. Technical Expertise a.Test utilization inquiries where information is required as to the most appropriate test to be ordered shall be addressed within two hours of initial inquiry. b.Result interpretation inquiries shall be addressed within four hours of initial inquiry. c.Consultative services where information is required regarding the clinical significance of tests shall be addressed within twenty-four hours of the initial inquiry. d.Computer interface questions where information is required to update maintain and support the services of the host-to-host linkage between the VA and the Contractor shall be addressed within two hours of the initial inquiry. 4. Account Follow-up that requires information general in nature yet specific to the account, e.g. test pricing, courier service problems, equipment repair, supply ordering, etc. shall be addressed within four hours of the initial inquiry. 5.Addressing courier service issues and problems - Due to the scope and complexity of the courier system as defined in this solicitation; a direct contact(s) shall be designated for immediate response to courier service issues. 6.The ordering of specimen collection and transportation supplies is accomplished through direct on-line ordering. B. Utilization Reports: The Contractor shall provide a statistical analysis of the VA Caribbean Healthcare System Pathology and Laboratory Medicine Service workload testing volumes to assist in the monitoring of ordering trends and utilization patterns. IX. INVOICING: The Contractor shall assign an account number to the VA Caribbean Healthcare System Pathology and Laboratory Medicine Service. The Contractor shall submit a monthly invoice for service rendered no later than 21 days following the close of the month in which the test results was reported. The invoice shall be accurate and shall display chronologically by date of receipt by the Contractor the name of the patient, the date of specimen collection by the Contractor from the VISN 8 facility, detailed list of the test performed on each patient, and the unit and total testing costs. X.TECHNICAL APPROACH: The Offeror must include sufficient information to describe services offered related to the following areas: "Completes tests and reports in clinically useful time frame "Proficiency Testing performance past 3 years "Adequacy of testing menu offered "CAP accreditation score "CLIA inspection evaluation "Availability of professional consultation with physicians "Availability of community based specimen collection sites "Plan for evaluation of contracted lab performance (i.e. accuracy, timeliness, and performance improvement) VA ACQUISITION REGULATION SOLICITATION PROVISION AND CONTRACT CLAUSE NOTE: This clause will undergo official rule making by the Office of Acquisitions and Logistics. The below language will be submitted for public review through the Federal Register. The final wording of the clause may be changed from what is outlined below based on public review and comment. Once approved, the final language in the clause can be obtained from the Office of Acquisitions and Logistics Programs and Policy. 1. SUBPART 839.2 - INFORMATION AND INFORMATION TECHNOLOGY SECURITY REQUIREMENTS 839.201 Contract clause for Information and Information Technology Security: a.Due to the threat of data breach, compromise or loss of information that resides on either VA-owned or contractor-owned systems, and to comply with Federal laws and regulations, VA has developed an Information and Information Technology Security clause to be used when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format (e.g., paper, microfiche, electronic or magnetic portable media). b.In solicitations and contracts where VA Sensitive Information or Information Technology will be accessed or utilized, the CO shall insert the clause found at 852.273-75, Security Requirements for Unclassified Information Technology Resources. 2. 852.273-75 - SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION TECHNOLOGY RESOURCES (INTERIM- OCTOBER 2008) As prescribed in 839.201, insert the following clause: The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR INCLUSION INTO CONTRACTS, AS APPROPRIATE 1.GENERAL Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. 2.ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS a.A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. b.All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. c.Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness. d.Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor. e.The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor's employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination. 3. VA INFORMATION CUSTODIAL LANGUAGE a.Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1). b.VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor's information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA's information is returned to the VA or destroyed in accordance with VA's sanitization requirements. VA reserves the right to conduct onsite inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. c.Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. d.The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. e.The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. g.If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship. h.The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. i.The contractor/subcontractor's firewall and Web services security controls, if applicable, shall meet or exceed VA's minimum requirements. VA Configuration Guidelines are available upon request. j.Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA's prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response. k.Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response. l.For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COTR. 4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COTR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment. b.The contractor/subcontractor shall certify to the COTR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required. c.The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default "program files" directory and silently install and uninstall. d.Applications designed for normal end users shall run in the standard user context without elevated system administration privileges. e.The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA securitysystem development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle. f.The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties. g.The contractor/subcontractor agrees to: (1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies: (a)The Systems of Records (SOR); and (b)The design, development, or operation work that the contractor/subcontractor is to perform; (2) Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and (3) Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR. h. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency. (1)"Operation of a System of Records" means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records. (2)"Record" means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person's name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph. (3)"System of Records" means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual. i. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as "Systems"), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems. j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than ____ days. k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within ____ days. l. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology. 5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE a.For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor's security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COTR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA's network involving VA information must be reviewed and approved by VA prior to implementation. b.Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII. c.Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor's systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government-owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks. d.The contractor/subcontractor's system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA's POA&M management process. The contractor/subcontractor must use VA's POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re-authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, and Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary. e.The contractor/subcontractor must conduct an annual self-assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COTR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost. f.VA prohibits the installation and use of personally-owned or contractor/subcontractor owned equipment or software on VA's network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA-approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE. g.All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract. h.Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are: (1)Vendor must accept the system without the drive; (2)VA's initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or (3)VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase. (4) Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then; (a)The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and (b)Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract. (c)A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation. 6. SECURITY INCIDENT INVESTIGATION a.The term "security incident" means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/subcontractor shall immediately notify the COTR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/subcontractor has access. b.To the extent known by the contractor/subcontractor, the contractor/subcontractor's notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant. c.With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement. d.In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident. 7. LIQUIDATED DAMAGES FOR DATA BREACH a.Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. b.The contractor/subcontractor shall provide notice to VA of a "security incident" as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination. c.Each risk analysis shall address all relevant information concerning the data breach, including the following: (1) Nature of the event (loss, theft, unauthorized access); (2) Description of the event, including: (a)date of occurrence; (b)data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code; (3) Number of individuals affected or potentially affected; (4) Names of individuals or groups affected or potentially affected; (5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text; (6) Amount of time the data has been out of VA control; (7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons); (8)Known misuses of data containing sensitive personal information, if any; (9)Assessment of the potential harm to the affected individuals; (10)Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and (11)Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised. d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $________________________________________ per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following: (1)Notification; (2)One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports; (3)Data breach analysis; (4)Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution; (5)One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and (6)Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs. 8. SECURITY CONTROLS COMPLIANCE TESTING On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-days' notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time. 9. TRAINING a. All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems: (1)Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems; (2)Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training; (3)Successfully complete the appropriate VA privacy training and annually complete required privacy training; and (4)Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document - e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.] b. The contractor shall provide to the contracting officer and/or the COTR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required. c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete. B.2 Price/Cost Schedule Item Information ITEM NUMBERDESCRIPTION OF SUPPLIES/SERVICESQUANTITYUNITUNIT PRICEAMOUNT 1Services for Reference Laboratory (general esoteric tests) to cover: From October 1st, 2014 to September 30, 2015. 12.00MO____________________________________ GRAND TOTAL__________________ SECTION C - CONTRACT CLAUSES C.1 FSS RFQ INTRODUCTORY LANGUAGE The terms and conditions of the contractor's FSS contract (including any contract modifications) apply to all Blanket Purchase Agreements (BPA) and task or delivery orders issued under the contract as a result of this RFQ. When a lower price has been established, or when the delivery terms, FOB terms, or ordering requirements have been modified by the BPA or task/delivery order, those modified terms will apply to all purchases made pursuant to it and take precedence over the FSS contract. Any unique terms and conditions of a BPA or order issued under the contract that are not a part of the applicable FSS contract will govern. In the event of an inconsistency between the terms and conditions of a BPA or task/delivery order and the Contractor's FSS terms, other than those identified above, the terms of the FSS contract will take precedence. SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS NO CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS INCLUDED SECTION E - SOLICITATION PROVISIONS E.1 52.209-5 REPRESENTATION BY CORPORATIONS REGARDING AN UNPAID TAX LIABILITY OR A FELONY CONVICTION UNDER ANY FEDERAL LAW (DEVIATION)(MAR 2012) (a) In accordance with Division H, sections 8124 and 8125 of P.L. 112-74 and sections 738 and 739 of P.L. 112-55 none of the funds made available by either Act may be used to enter into a contract with any corporation that- (1) Has an unpaid federal tax liability, unless the agency has considered suspension or debarment of the corporation and the Suspension and Debarment Official has made a determination that this action is not necessary to protect the interests of the Government. (2) Has a felony criminal violation under any Federal or State law within the preceding 24 months, unless the agency has considered suspension or debarment of the corporation and Suspension and Debarment Official has made a determination that this action is not necessary to protect the interests of the Government. (b) The Offeror represents that- (1) The offeror does [ ] does not [ ] have any unpaid Federal tax liability that has been assessed and that is not being paid in a timely manner pursuant to an agreement with the authority responsible for collecting the tax liability. (2) The offeror, its officers or agents acting on its behalf have [ ] have not [ ] been convicted of a felony criminal violation under a Federal or State law within the preceding 24 months. (End of Provision)
 

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