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FBO DAILY ISSUE OF JANUARY 04, 2013 FBO #4059
DOCUMENT

R -- VISN 19 Emergency Prescription Services - Attachment

Notice Date

1/2/2013
 

Notice Type

Attachment
 

NAICS

524292 — Third Party Administration of Insurance and Pension Funds
 

Contracting Office

Department of Veterans Affairs;Network Contracting Office;NCO 19;4100 E. Mississippi Avenue, Suite 900;Glendale CO 80246
 

ZIP Code

80246
 

Solicitation Number

VA25913I0234
 

Response Due

1/15/2013
 

Archive Date

1/30/2013
 

Point of Contact

Ms. Ronnie Sandusky
 

Small Business Set-Aside

N/A
 

Description

Statement of Work VISN 19 - Rocky Mountain Network Emergency Prescription Services I.Overview a.Introduction/Background (1)Per VHA Handbook 1108.05, Section 8a - Supplemental (Emergent Need) and Fee-Basis Pharmacy Services: (a)Every effort must be made to utilize VA pharmacies for prescription services. When appropriate, arrangements can be made for emergency prescription services through a community pharmacy or the Fee Basis program. In these instances, the patient must not incur additional expense. These arrangements are to be made on a selective, individual patient basis, after careful determination of the type and recurring nature of the prescription. Any pharmacy licensed by a state, commonwealth, or territory of the United States is eligible to accept and fill prescriptions for VA patients, when required and approved in accordance with current VHA policy. b.Scope (1)This contract is to provide financial management services to ensure reimbursement of emergent fill pharmacy benefits. The contract is between VHA, as a health plan, and the contractor, for the purpose of reimbursing the contractor a set price for prescriptions filled at the Veteran's request for which the Veteran was not charged. It is not a contract for the purpose of filling prescriptions or dispensing medications. It is a financial management services contract. (2)The contractor shall provide emergent pharmaceutical products and services throughout VISN 19 to Community Based Outpatient Clinics (CBOCs), Primary Care Telehealth Outreach Clinics (PCTOCs), Outreach Clinics, and VA-affiliated Nursing Homes as listed on : http://www2.va.gov/directory/guide/region.asp?ID=19 as outlined below: (a)Prescription Requirements 1)Only new prescriptions shall be filled through this contract. A new prescription is defined as a written prescription for a drug product and strength that has not been previously dispensed to the beneficiary in the previous 12 months. A repeat order for the same drug product within 12 months, even if transmitted as a new prescription order, is not considered a new prescription. In rare instances (i.e. hurricanes or other natural disaster) where refills may be necessary there must be a pre-authorization by the Clinic Consultant (or designee) at the cognizant VA Medical Center Pharmacy and so noted on the invoice. Exceptions may be made for second courses of antibiotic therapy. 2)In order to receive reimbursement, prescriptions filled by the contractor's dispensing pharmacies will be in written form and in accordance with VA policy and procedures as well as applicable state and federal regulations. 3)Only prescriptions from VA authorized practitioners shall be filled under the contract. Prescriptions will be written on VA prescription form 10-2577F, Security Prescription Form, or locally developed prescription blanks and hand carried by the beneficiary, faxed from a VA clinic practitioner, given verbally by a VA Clinic practitioner, or stamped with the words "Authorized VA Emergent Prescription". Prescriptions from non-VA authorized practitioners shall not be filled under the contract. 4)Emergent Drug List a)Prescriptions reimbursed through the financial management services for emergent fill pharmacy benefits contract will be limited to medications of urgent need as determined by VA clinical staff and will follow safe and effective formulary management principles practiced within the VA. The adjudication of medications on a case-by-case basis must follow the local medical center procedure. The VISN 19 Pharmacy Benefits Management (PBM) Committee shall develop a list of emergent drugs that can be reimbursed for under the contract without prior authorization. The Chair, VISN 19 PBM Committee or designee will email this "emergent drug list" to the contractor at the time of contract award and provide updates to the list as necessary. Generic drugs shall be used whenever available. All medicines reimbursed for under this contract must meet FDA standards. b)Prescriptions shall be filled for legend drugs listed on the VA VISN 19 Emergent Drug List. The Contractor shall review all prescriptions to ensure that the product listed on the emergent formulary. The VA reserves the right to add or delete drugs from the emergent formulary at any time. c)The VA is not responsible for payment of any prescription for products not on the emergent drug list even if ordered by a VA authorized practitioner. If a VA authorized practitioner prescribes a product not on the emergent drug list the pharmacists shall notify the patient that the prescription is not covered and that the patient will be responsible for the cost, payable at the time of service. 5)Prescriptions for VA Nursing Home Care patients residing at the Miles City, Montana VA Nursing Home Care Unit and Pueblo, Colorado VA Nursing Home Care Unit are an exception to the emergent formulary and may have prescriptions filled for any product contained on the VA National Formulary. VA practitioners will indicate on the prescription orders that the prescription is for a nursing home resident. A copy of the VA National Formulary will be provided to the contractor, and can be located at (http://www.pbm.va.gov/NationalFormulary.aspx) 6)Any other exceptions to the prescription requirements of the contract must be pre-authorized by the respective Clinic Consultant at the responsible VA Medical Center (see http://www2.va.gov/directory/guide/region.asp?ID=19 ). Decisions of the Medical Center are final. Medical Centers may retroactively approve exceptions but the decision to retroactively consider, review, or approve retroactive requests for exceptions is solely at the discretion of the Medical Center. (b)Unless otherwise pre-authorized, prescription fills shall be limited to a maximum of a 14-day supply. (c)Prescriptions shall be filled as expediently as possible, but in no more than 24 hours. (d)Prescriptions filled under this contract shall be, to the extent permitted by law, the least expensive generic equivalent drug product the pharmacy has in stock. 1)Generic drugs shall be dispensed whenever possible. A product is not considered a generic equivalent unless the strength, quality, and dosage are the same as the brand name. The generic name shall be displayed on all labels for all medication. (e)VA Do Not Substitute List 1)The contractor must comply with the below VA Do Not Substitute List. This is a list of pharmaceutical products for which substitution is not permitted. A modification to the contract will be issued to address future changes that may occur throughout the life of the contract. a)Amiodarone: Amiodarone naïve patients should start on the Upsher-Smith brand Pacerone ®. Patients on Cordarone ® may continue. Patients receiving a generic amiodarone will be switched to the Pacerone ® product. Bioequivalency cannot be guaranteed when switching from one generic to another; therefore, additional monitoring may be required. b)Clozapine: Clozapine by Mylan is required for Clozapine naïve patients. Clozaril ® can be continued on existing patients. There is no mandatory conversion. c)Phenytoin (Mylan) extended release capsules 100mg d)Levothyroxine (Synthroid ®) (f)The filling of prescriptions shall be inclusive of patient medical profile review and proper filling and labeling in accordance with proper pharmacy practices and state requirements. Procedures shall include necessary patient education and counseling. (g)Adverse event reporting 1)All medication errors, adverse drug reactions, or allergy reactions related to medication being dispensed under this contract shall be reported to the Cognizant Pharmacy Contact of the responsible VA Medical Center (see http://www2.va.gov/directory/guide/region.asp?ID=19 ). (h)Contractor must have a minimum of one pharmacy within a 10-mile radius of each VA clinic (CBOC, PCTOC, Outreach Clinic, or VA Nursing Home). Exceptions to the availability or distance requirement may be made by mutual agreement of VA and the contractor. (i)Additional areas may be added to this contract by mutual agreement as services are needed for new clinics in the VISN 19 service area. Contract requirements and rates will be as stated in the proposal and subsequent contract. (j)Billing 1)The contractor shall invoice for reimbursement at the following prices: a)Drug prices are based off a discount from the Drug Topics MediSpan Average Wholesale Price (AWP). AWP minus 57.1% for Generic and AWP minus 17.1% for Brand name. b)In addition to the drug prices listed above, each prescription will incur a $1.38 dispensing fee. 2)The contractor shall bill the appropriate Billing contact as stated at http://www2.va.gov/directory/guide/region.asp?ID=19 monthly for services rendered. More frequent billing cycles are negotiable. The VA will randomly audit all billings. Pharmacies under contract shall make records available to the VA auditor in a timely manner at the location where dispensed. 3)Invoices - All invoices shall reference the following information: a)Contract Number b)Date of Invoice c)Invoice number d)Claim period the invoice relates to e)Rx Cost per Clinic location f)Number of rx dispensed per clinic location g)Dispensing Fee per rx h)Total Cost of Invoice (k)Reports: 1)The contractor shall provide monthly reports providing the list of drugs dispensed by: a)Pharmacy b)Provider c)Patient d)Drug e)Quantity f)Billing Pharmacy 2)Reports will contain the following information: a)Beneficiary Name b)Beneficiary Social Security Number c)Dispensing Pharmacy d)Prescription Number e)Date of fill f)Drug (generic name) g)Drug Strength h)Quantity Dispensed i)NDC Number of Product Dispensed j)Cost of Drug k)Dispensing fee l)Name of approving official (clinic contact at cognizant VA Medical Center) if prescription was an approved exception to the VA VISN 19 emergent formulary drug list. 3)Cumulative quarterly and annual reports shall also be provided to the approving official, the Contracting Officer's Representative (COR), and the Contracting Officer (CO). Quarterly reports will include, in addition to the reports listed above, a controlled substance use report, and a non-formulary report. 4)The CO requires a quarterly report comparing the dollar amount of drugs dispensed under the contract price compared to Average Wholesale Price (AWP). (l)Protected Health Information (PHI) 1)The contractor is prohibited from transferring PHI by fax or email to and/or from a VA Medical facility unless they have been issued a VA PKI "partner" certificate to allow encrypted email exchange. Invoices, authorizations, and reports can then be sent via PKI encrypted email. 2)If prior authorization for the payment of an emergent pharmaceutical is necessary and the contractor does not have a VA issued PKI "partner" certificate, verbal contact is sufficient to obtain the pharmaceutical payment authorization. 3)The contractor is encouraged not to store any VA patient information on a mobile device. 4)The contractor will not have, nor require, access to VA systems that contain PHI. The only interaction the contractor will have with PHI relates to approved prescriptions being filled through this contract, in which case the information will be transmitted to the contractor through the contract pharmacy. (3)Contractor's Pharmacies (a)The Contractor's pharmacies shall agree to the following conditions: 1)All information concerning VA beneficiaries shall be kept confidential and shall not be disclosed to any person, except as authorized in writing and according to all applicable laws. 2)Representatives of VA including Joint Commission surveyors are authorized to visit premises of any pharmacy filling VA prescriptions under the Contractor's plan during business hours for the purpose of auditing and evaluation, which may include inspection of clinical records. 3)On request, Contractor's pharmacy will provide a hard copy of VA patient's medication profiles to include all drugs dispensed and associated dosages, dispensing dates, and quantities. 4)Pharmaceutical care provided to beneficiaries under this contract shall meet all standards applicable to Medicaid recipients in the state where the services are provided and standards set forth in the current Joint Commission accreditation manual for Ambulatory Care/Pharmaceutical Services. (b)Pharmacies with whom the contractor has a business relationship shall only be reimbursed for prescriptions that were filled and dispensed from original prescriptions written by VA, or VA contracted providers assigned to the particular medical center, or clinic. c.Performance Period (1)The contractor shall complete the work required in 30 calendar days or less from date of award, unless otherwise directed by the Contracting Officer. The contractor will provide on-going customer service support through a combination of on-site and off-site assistance for the duration of the contract. The contractor is responsible for providing pharmacy hours, at a minimum, Monday through Friday between the hours of 8:00 a.m. - 6:00 p.m., excluding Federal holidays. The period of performance shall be for one (1) Base Year of 12 months and four (4) 12-month option years for license renewal. d.Post Award Conference/Periodic Progress Meetings (1)The contractor will work with Pharmacy Service personnel at each VA Medical Center throughout VISN 19 to develop a mutually satisfactory, detailed schedule with dates for delivery, installation, testing, live operation and acceptance of the product. The contractor shall attend post ward conferences on agreed dates/times to review status report and list of open issues. A written review of the status of the implementation project will be provided on an as needed basis to Pharmacy Service personnel at each VA Medical Center throughout VISN 19. The contracting officer and other government personnel may meet periodically with the contractor to review the contractor's performance. e.A business associate agreement is not required for this contract. f.Requirements of VHA Handbook 6500.6, Appendix C (1)GENERAL (a)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/subcontrator 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 on site 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; 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 _7___ 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 __7__ 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 vulnerablity 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 preapproved 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 $37.50__ 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 (a)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-day's 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.
 

Web Link

FBO.gov Permalink
(https://www.fbo.gov/spg/VA/VARMCCC/VARMCCC/VA25913I0234/listing.html)
 

Document(s)

Attachment
 

File Name: VA259-13-I-0234 VA259-13-I-0234.docx (https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=571846&FileName=VA259-13-I-0234-000.docx)

Link: https://www.vendorportal.ecms.va.gov/FBODocumentServer/DocumentServer.aspx?DocumentId=571846&FileName=VA259-13-I-0234-000.docx

 

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

Record

SN02957796-W 20130104/130102234022-1e954af0ba933d7ea6d2ddc64abca621 (fbodaily.com)
 

Source

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