Loren Data's SAM Daily™

FBO DAILY - FEDBIZOPPS ISSUE OF MARCH 05, 2016 FBO #5216
DOCUMENT

65 -- 570-16-2-222-0023 VACCHS PET and CT Mobile Imaging Service - Attachment

Notice Date

3/3/2016
 

Notice Type

Attachment
 

NAICS

621512 — Diagnostic Imaging Centers
 

Contracting Office

Department of Veterans Affairs;VA Sierra Pacific Network (VISN 21);VA Northern California HealthCare System;5342 Dudley Blvd, Bldg 209;McClellan CA 95652-2609
 

ZIP Code

95652-2609
 

Solicitation Number

VA26116N0431
 

Response Due

3/11/2016
 

Archive Date

4/10/2016
 

Point of Contact

Orville Landicho
 

Small Business Set-Aside

N/A
 

Description

THIS IS A SOURCES SOUGHT NOTICE (a) The Government does not intend to award a contract on the basis of this Sources Sought or to otherwise pay for the information solicited. (b) Although "proposal," "offeror," contractor, and "offeror" may be used in this sources sought notice, any response will be treated as information only. It shall not be used as a proposal. (c) Any information received from a contractor in response to this Sources Sought may be used in creating a solicitation. Any information received which is marked with a statement, such as "proprietary" or "confidential," intended to restrict distribution will not be distributed outside of the Government, except as required by law. (d) This Sources Sought is issued for the purpose of collecting information about the availability of equal products from different sources for the desired equipment listed in the "Price/Cost Schedule" that meets the corresponding salient characteristics. (e) Contractors that feel they have an equal product are encouraged to provide a quote in response to this notice and/or email full information to Orville Landicho at Orville. Landicho@va.gov. "Contractors shall identify the NAICS code for the product being offered as well as their size status. "Contractors shall complete the "Price/Cost Schedule" for the purpose of market research. "Contractors shall furnish supporting documentation which demonstrates that the proposed "equal" products meet or exceed the statement of work. A.1 Price/Cost Schedule Item Information ITEM NUMBERDESCRIPTION OF SUPPLIES/SERVICESQUANTITYUNITUNIT PRICEAMOUNT 1000Base Year: Period of Performance: 05/01/2016- 04/30/2017. Provide PET/CT Equipment and staff one-day rate (Estimated 42 Saturdays, excluding Federal holiday weekends) in accordance with the statement of work. 42Days____________________________________ 1001Base Year: Period of Performance: 05/01/2016- 04/30/2017. Provide FDG radiopharmaceutical unit doses (1 per patient, same price per dose)(estimate 8-9 patients per day=378/year) 378EA____________________________________ 2000Option Year 1 Period of Performance: 05/01/2017- 04/30/2018. Provide PET/CT Equipment and staff one-day rate (Estimated 42 Saturdays, excluding Federal holiday weekends) in accordance with the statement of work.12.00Days____________________________________ 2001Option Year 1: Period of Performance: 05/01/2017- 04/30/2018. Provide FDG radiopharmaceutical unit doses (1 per patient, same price per dose)(estimate 8-9 patients per day=378/year) 378EA____________________________________ GRAND TOTAL__________________ A.2 Delivery Schedule ITEM NUMBERDELIVERY LOCATIONDELIVERY DATE ALLVA Central Healthcare System (VACCHCS) 2615 East Clinton Avenue Fresno, CA 93703-2223ALlPeriod of Performance 05/01/2016 - 04/30/2017 or as option is exercised. DEPARTMENT OF VETERANS AFFAIRS STATEMENT OF WORK VACCHCS PET/CT Mobile Imaging Service 1.0 BACKGROUND: The Department of Veteran Affairs (VA) provides a wide range of services to Veterans. Mobile Trailer Unit Positron Emission Tomography (PET) with Computed Tomography (CT) is a commercial acquisition of services routinely provided to the medical community nationally and locally in Fresno. 2.0 SCOPE: This Statement of Work (SOW) defines the requirements for one (1) PET/CT Mobile Trailer Unit with qualified and certified staff, all expendables and radiopharmaceuticals for services delivered at the Veterans Administration Central California Health Care System (VACCHSC) located at Fresno, California. Base year contract with one (1) option year. Contractor shall provide PET/CT imaging services one day per week. Service will be provided on each Saturday, excluding holidays. Projected annual volume is estimated at 378 per year. Day-rate pricing is based on a 10-hour day with 8 to 9 exams per day. Services may be cancelled at a minimum of 5 working days in advance. VACCHS will contact the vendor with a 5 working day notice of cancelation. Contract Line-Items:Est Qty CLIN-1) - PET/CT Equipment and staff one-day rate (about 42 days, excluding Federal holiday weekends)42 days CLIN-2) -FDG radiopharmaceutical unit doses (1 per patient, same price per dose)(estimate 8-9 patients per day=300/year) (Provided by vendor)378 ea Federal Holiday Weekends Includes: New Year's Day, Birthday of Martin Luther King Jr.; Washington's Birthday, Memorial Day, Independence Day, Labor Day, Columbus Day, Veterans Day (if it falls on weekend, Monday or Friday), Thanksgiving Day, Christmas Day 3.0 SUMMARY OF REQUIREMENTS: The Contractor shall provide all personnel, equipment, supplies, and travel necessary to accomplish tasks. Contractor shall provide a Mobile Trailer Unit to include the PET/CT scanner, processing computer/workstation, hot lab facility, patient preparation/injection area, and necessary staff to perform the examinations. Contractor shall provide all medical supplies, instruments, and equipment. Contractor staff shall include a qualified and certified Nuclear Medicine Technologist, a qualified medical support technical aid, and a driver to accomplish required tasks. The contract includes one radiologist reading workstation for PET/CT. Reading station must have MIM software or equivalent and compatible with Philips I-Site PACS. Equipment is expected to be updated with the most recent software version. OEM-level maintenance, repair service and physicist inspections are required for all supplied equipment. Protected VA Patient data shall be (1) stored on a separate drive so that it can remain with the facility or (2) on a disk partition that must be sanitized with Jetico software at the completion of the contract. Overtime (OT) is not authorized in connection with performance on this contract. The VA will not reimburse the contractor for paying overtime on a contract. 4.0 SPECIFIC TASKS: 4.1 The Contractor shall screen each patient prior to performing the imaging exam. The screening process shall be documented and provided to Nuclear Medicine staff at the conclusion of each visit. Screening includes identifying the correct patient identity using at least two independent methods and documenting the methods and results at the time of the identification. 4.2 The Contractor receives patients, explains procedure, answers questions relating to procedure, positions patient for all necessary views and tends to their comfort for the duration of the procedure. 4.3 Providing, securing, administering and disposal of all radiopharmaceuticals and by-products needed for the study in conformance with applicable federal, state and VA regulations. 4.4 Providing all personnel, supplies, and radiopharmaceuticals required for the imaging procedure and for patient life support and monitoring while under the contractor's care. 4.5 The contractor shall process data and transfer to the VAMC PACS by direct communications link. 4.6 Contractor shall receive the radiopharmaceuticals at the Mobile Unit and complete proper package contamination testing and recordkeeping per regulatory requirements. 4.7 Contractor shall transfer study data to VACCHCS PACS by direct communications link. 4.8 PET/CT mobile units shall be scheduled for service within 5 working days of notification of need. Scheduled mobile units may be postponed 5 days in advance in the week for the planned Saturday service if anticipated patient scheduling does not justify the expected charges. 5.0 CONTRACTOR QUALIFICATIONS: 5.1 Onsite Staff: Provide one Nuclear Medicine technologist, who is fully trained, qualified and experienced in PET/CT and shall be AART (N) or NMTCB certified. Provide one medical support person with appropriate training and experience that includes Basic Life Support (BLS), during service hours. 5.2 Mobile Unit Trailer Driver shall be licensed as applicable to operate and drive the mobile vehicle in which the unit is housed, the driver is not required to remain with the trailer. Drop off before services and pick up after serves are complete is allowed. 5.3 The Contractor shall have a valid and current Nuclear Regulatory Commission (NRC) and California State License for radioactive materials. 5.4 The Contractor shall maintain HIPAA compliance to maintain security and integrity of patient medical record and sensitive personal information. 5.5 Contractor employees shall be Cardiopulmonary Resuscitation (CPR) Qualified and are authorized to perform this life-saving act if necessary. 5.6 The Contractor and Contractor Employees providing services under this contract shall provide evidence of current Immunizations/testing, and have received training in infection control procedures. Evidence of such Immunizations/testing and training shall be submitted prior to commencing work at the facility. 6.0 EQUIPMENT AND MEDICAL SUPPLY STANDARDS: 6.1 Contractor shall ensure that all PET/CT and all other equipment utilized during the performance of this contract meet standard commercial medical requirements and are in good working condition. 6.2 Contractor shall ensure that all equipment is kept safe and in sanitary conditions. This shall include allowing periodic inspections by facility personnel. 6.3 Contactor shall ensure that all medical supplies utilized during the performance of this contract meet standard regulatory medical requirement. 7.0 CONTRACTOR RESPONSIBLIITIES: 7.1 The Contractor shall provide all labor, supplies, materials, equipment, and mobile trailer necessary to perform the work specified in SOW. 7.2 The Contractor shall be responsible to ensure that Contractor personnel providing work on this contract are fully trained and completely competent to perform the required work. 7.3 Contractor shall ensure all certifications are current through the term of the contract and if renewal is required it shall be the contractor's responsibility to ensure it is accomplished without interruption to services being provided. 7.4 Contractor shall provide a copy of one (1) each certification/license for each personnel working the PET/CT Mobile Unit at the time of award and annually or per option year, if applicable. In addition, Mobile Trailer Unit PET/CT insurance/license shall be provided. 7.5 Contractor shall provide a list of Key Personnel who will be assigned to this contract. If Key personnel are removed or replaced with temporary personnel contractor shall contact the contracting officer and the COR immediately with replacement personnel name and required certificate/documentation. 7.6 Contractor will maintain a stock of expendable supplies and an approved container for storing supplies. The Contractor shall determine the appropriate stock levels required. 7.7 Contractor shall adhere to the VAMC policies and procedures and the medical staff by-laws of the VA facility. 7.8 Contractor shall replace all failed equipment prior to the next scheduled workday. 7.9 Contractor personnel shall comply with the facilities performance evaluation, competency and training requirements. 7.10 Contractor shall comply with Department of Veterans Affairs Central California Health Care System Information Security policies as stated in Security Clause. 8.0 SAFETY PRECAUTIONS AND HYGEINE: 8.1 Contractor shall use proper hand hygiene and uses personal protective equipment as necessary. 8.2 Contractor shall maintain a clean and organized work area. Technologist shall ensure that all areas are supplied and equipment is in working order before each use. 8.3 Contractor shall ensure all Nuclear Medicine, VA Medical Center, Veterans Integrated Service Network (VISN), and Radiation Safety Policies are effectively followed. 8.4 The Contractor shall perform required service in accordance with the standards of the Joint Commission; established principles and ethics of the medical profession established by the AMA and ACEP, Nuclear Regulatory Commission (NRC), Department of Transportation (DOT), Occupational Safety and Health Association (OSHA) and VA National Health Physics Program (NHPP). The Contractor shall adhere to Veterans Health Administration (VHA) regulations and the policies, procedures, and regulations of the Medical Staff by-laws of the VAMC. 8.5 The Contractor is responsible for all radiation safety. A copy of the Contractor's radiation safety program shall be provided to the VA before commencing operation with adequate documentation that contract employees have dosimeters and are current with required DOT and radiation safety training. 8.6 The Contractor shall maintain compliance with The Joint Commission's most recent Requirements for Diagnostic Imaging Services and provide evidence to the VA Radiation Safety Officer. 8.7 Reporting of the Contractor's Radiation Safety Officer and medical physicist inspections of operations are required on a quarterly basis, delivered to the VACCHCS Radiation Safety Officer soon thereafter. Monthly reporting of routine daily records is required. Independently-managed customer satisfaction survey is required quarterly. 8.8 Contractor shall maintain all radioactive materials license provisions defined in 10 CFR 35 and other federal regulations including VA-defined regulations related to performing PET/CT studies. Contractor shall provide written evidence of compliance on a systematic basis such that internal VA or external regulatory inspections can be completed with the provided documents. Any inadequacy in documentation or evidence of required compliance during a regulatory inspection shall be reconciled expediently. Regulatory compliance is subject to inspection by the VACCHCS Radiation Safety Officer and by the VAs National Health Physics Program at any time: any deficiencies shall be resolved expeditiously. 9.0 HEALTH REQUIREMENTS: 9.1 Contractor certifies that his/her employees have received the following testing/immunizations within the past year and will maintain coverage during the contract period: a) Tuberculosis Testing - the PPD test or radiological exam shall be repeated annually. b) Rubella Testing - all contract personnel shall provide proof of immunization for measles, mumps, rubella, or rubella titer of 1:8 or greater. If the titer is less than 1:0, the rubella immunization must be administered with follow-up documentation to the COR. c) Immunizations - for purposes of infection control, all contract employees shall take required immunizations and any health action required by generally accepted public health standards and any immunizations necessitated by any outbreaks in the area/community. Contract personnel will not be allowed to perform duty until immunization documentation is provided to the COR. d. Health Restrictions - contract employees shall have no health or physical disability restrictions which interfere with the performance of duties. 10.0 CONFIDENTIALITY: 10.1 All contractor personnel shall observe the requirements imposed on sensitive data and information by law, Federal regulations, VA statutes and policy, Veterans Health Administration (VHA) policy and guidelines and the associated requirements to ensure appropriate screening of all personnel (e.g., Privacy Act of 1974, public Law 93-579, the requirements of the FPM 731, Subchapter 2 under E.O. 10450, etc.). 10.2 In order to maintain patient medical records, the contractor shall have access to the Department of Veterans Affairs System(s) of Records entitle, "Patient Medical Records-VA (24 VA 136)." 10.3 Contractor personnel who obtain access to hardware or media which may store drug or alcohol abuse data, sickle cell anemia treatment records, records of tests or treatment for or infection with Human Immunodeficiency Virus (HIV) or medical quality assurance records protected by 36 U.S.C. 4132 or 3305, as defined by the Department of Veterans Affairs, shall not have access to the records unless absolutely necessary to perform their contractual duties. 10.4 Access to Files: In performance of official duties, the Contractor's employee(s) who have regular access to printed and electronic files containing sensitive data, which must be protected under the provisions of the Privacy Act of 1974 (5 U.S> C. 552a), and other applicable laws, Federal Regulations, Veterans Affairs statutes and policies. The Contractor's employee(s) are responsible for (1) protecting that data from unauthorized release or from loss, alteration, or unauthorized deletion and (2) following all applicable regulations and instructions regarding access to computerized files, release of access codes, etc., as set out in a computer access agreement which the Contractor's employee(s) sign. 11.0 THE JOINT COMMISSION GUIDELINES: 11.1 The Contractor must perform the required work in accordance with, The Joint Commission standards. The Contractor is required to develop and maintain the following documents for each Contractor employee working on the contract: a) Credentials and qualifications for the job; b) A current competency assessment checklist (an assessment of knowledge, skills, abilities and behaviors required to perform a job correctly and skillfully); c) Proof of knowledge and skills required to provide care for certain patient populations, as appropriate; d) Current performance evaluation supporting ability of Contractor employee to successfully perform the work required in this solicitation; e) Listing of relevant continuing education for the last two years. f) The Contractor will provide current copies of these records annually, to the VA Contracting Officer's Representative (COR), upon request, or prior to new staff starting work on this contract, for each Contractor employee working on the contract. g) The Contractor shall maintain compliance with The Joint Commission's most recent Requirements for Diagnostic Imaging Services. 12.0 QUALITY CONTROL PROGRAM: 12.1 The Contractor shall develop a quality control plan in accordance with the Contractor's internal quality procedures. The Contractor shall provide the quality control plan as part of their solicitation. Any revisions made to the Plan shall be approved by the COR and provided No Later Than (NLT) 10 days after award to the CO and COR. Quality Control Plan shall include Contractors approach to manage, oversee, control and document work to ensure compliance with the contract SOW. 12.2 The Government may evaluate the quality of professional and administrative services provided, but retains no control over the medical, professional aspects of services rendered (e.g., professional judgments, diagnosis for specific medical treatment), in accordance with Federal Acquisition Regulation (FAR) 37.401(b). 12.3 Contractor shall perform quality control inspections of the equipment to ensure equipment is in proper working order. 12.4 Contractor shall ensure `that guidelines from Nuclear Regulatory Commission (NRC), Department of Transportation (DOT), National Health Physics Program (NHPP), Occupational Safety and Health Association (OSHA), among others, are followed. 12.5 Contractor shall maintain HIPAA compliance to maintain security and integrity of patient medical record and sensitive personal information. 13.0 WORKING HOURS: All scheduled contract work shall be accomplished during continuous 10-hour days on Saturday unless other mutually satisfactory arrangements are agreed upon in advance with the VAMC Nuclear Medicine Section staff and the Contracting Officer Representative (COR). 14.0 CONTRACTOR CONDUCT: 14.1 All persons furnished by the Contractor, including subcontractors, are the sole responsibility of the Contractor. The Contractor shall be responsible for their compliance with all laws, rules, and regulations. Contract employees shall not be considered Government employees. 14.2 Identification of Contractor Employees: The contractor shall provide each employee an identification (ID) badge on contract start date or on employment start date. The ID badge shall be made of nonmetallic material. The badge shall be easily readable and include employee's name, contractor's name, and color photograph. 14.3 Display of ID Badges: Contractor personnel shall wear the ID badge at all times when performing work under this contract to include attending Government meetings. Unless otherwise specified in the contract, each contractor employee shall wear the ID badge in a conspicuous place on the front of exterior clothing and above the waist except when safety or health reasons prohibit such placement. 15.0 REQUIRED INSURANCE: Schedule of Required Insurance: As required by FAR clauses 52.228-5 entitled "Insurance -Work on a Government Installation" and 52.237-7 entitled "Indemnification and Medical Liability Insurance," the Contractor shall, at its own expense, provide and maintain during the entire performance of the resulting contract, at least the kinds and minimum amounts of insurance required as listed below: Professional Medical Liability: See FAR Clause 52.237-7, of this solicitation/contract. Workers Compensation and Employers Liability: Contractors are required to comply with applicable Federal and State workers compensation and occupational disease status. If occupational diseases are not compensable under those statutes, they shall be covered under the employer's liability section of the insurance policy, except when contract operations are so comingled with a contractor's commercial operations that it would not be practical to require this coverage. Employer's liability coverage of at least $100,000 shall be required, except in states with exclusive or monopolistic funds that do not permit workers' compensation to be written by private carriers. (FAR 28.307-2) Comprehensive General Liability: $500,000 per accident or occurrence for bodily injury. This insurance shall include contractor's protective and liability. However, if a Contractor is an entity of the Government that provides self-insurance and/or is limited by state law as to the amount of liability insurance required, then the insurance requirement shall be fulfilled by incorporating the provisions of the applicable State law. Before commencing work under this contract, the contractor shall certify to the Contracting Officer in writing that the required insurance has been obtained. The policies evidencing required coverage shall contain an endorsement to the effect that any cancellation or any material change adversely affecting the Government's interest shall not be effective (1) for such period as the laws of the state in which this contract is to be performed, or (2) until 30 days after insurer or the contractor gives written notice to the Contracting Officer, whichever period is longer. The Contractor shall insert the substance of this clause, including this paragraph, in subcontracts under this contract and shall require subcontractors to provide and maintain insurance required in the schedule or elsewhere in the contract. The Contractor shall maintain a copy of all subcontractors' proofs of required insurance, and shall make copies available to the Contracting Officer upon request. 16.0 GOVERNMENT RESPONSIBILITIES: 16.1 The Government shall provide adequate space for the trailer and cab. (Space to be determined). 16.2 The Government shall provide access for sending images via VACCHCS PACS communications connection. 16.3 The Government shall provide restroom facilities for the patients. 16.4 The Government shall provide a Contracting Officer Representative (COR) for this contract. 16.5 The Government shall provide medical staff by-laws of the VA facility and security policies. 16.6 The Government shall be responsible for quality assurance/compliance oversight of the contractor, to include quarterly inspections of the Mobile Trailer Unit. Site inspections can be conducted at any time without notification. 17.0 PERIOD OF PERFORMANCE: The period of performance shall be from date of award for one 12-month period with one-year option periods. 18.0 PLACE OF PERFORMANCE: Department of Veterans Affairs; Veteran Administration Central California Health Care System, Fresno, California 93703. 19.0 CONTRACT ADMINISTRATION: Veterans Administration VISN-21 NCO contracting office is responsible for administration of this contract. 19.1 Contract Administrator: Contract administrator shall be designated at time of contract award and shall reside at the Central California Health Care System facility in Fresno California. 19.2 The Contracting Officer Representative (COR) will be identified by separate letter. The COR is responsible, as applicable, for: receiving all deliverables, inspecting and accepting the supplies or services provided hereunder in accordance with the terms and conditions of this contract; providing direction to the contractor which clarifies the contract effort, fills in details or otherwise serves to accomplish the contractual Scope of Work; evaluating performance; and certifying all invoices/vouchers for acceptance of the supplies or services furnished for payment. 19.3 The COR does not have the authority to alter the contractor's obligation under the contract, and/or modify any of the expressed terms, conditions, specifications, or cost of the agreement. If as a result of technical discussions it is desirable to alter/change contractual obligations or the Scope of Work, the Contracting Officer shall issue such changes. 20.0 CONTRACTOR PERFORMANCE ASSESSMENT REPROTING SYSTEM (CPARS): The services, although not directly supervised, shall be reviewed by the Department of Veterans Affairs staff to ensure contract compliance. The contractor's performance will be evaluated in accordance with FAR 42.15. Contract monitoring reports will be prepared by the Contracting Officer's Representative (COR) and maintained in the contract file. In accordance with FAR 42.1502 and 42.1503, agencies shall prepare an evaluation of contractor performance and submit it to the Past Performance Information Retrieval System (PPIRS). The VAMC utilizes the Department of Defense (DOD) web-based Contractor Performance Assessment Reporting System (CPARS) to provide contractor performance evaluations. The contractor shall provide and maintain a current e-mail from the Focal Point thru the following website address webptsmh@navy.mil when the contractor is registered in CPARS. The contractor must be registered to access and review its evaluation and/or provide a response. If assistance is review its evaluation and/or provide a response. IT CONTRACT SECURITY VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY 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 security system 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; (1) 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 (2) 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, 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. (End of Clause)
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VANCHCS/VANCHCS/VA26116N0431/listing.html)
 

Document(s)

Attachment
 

File Name: VA261-16-N-0431 VA261-16-N-0431.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2594685&FileName=VA261-16-N-0431-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=2594685&FileName=VA261-16-N-0431-000.docx

 

Note: If links are broken, refer to Point of Contact above or contact the FBO Help Desk at 877-472-3779.
 

Place of Performance

Address: VA Central Healthcare System (VACCHCS);2615 East Clinton Avenue;Fresno, CA

Zip Code: 93703-2223
 

Record

SN04038203-W 20160305/160303235109-3b6742fd404ec3d64d98251c1c92d647 (fbodaily.com)
 

Source

FedBizOpps Link to This Notice
(may not be valid after Archive Date)

---

| FSG Index  |  This Issue's Index  |  Today's FBO Daily Index Page |