STATEMENT OF WORK REFERRAL LABORATORY SERVICES FOR THE DEPARTMENT OF VETERANS AFFAIRS VA PORTLAND HEALTH CARE SYSTEM PATHOLOGY & LABORATORY MEDICINE SERVICE 3710 SW US VETERANS HOSPITAL RD PORTLAND, OREGON 97239 Remove this section BACKGROUND The VA Portland Health Care System (VHAPORHCS) Pathology & Laboratory Medicine Service (PLMS) requires Referral Laboratory services to provide testing and interpretation to assist in the diagnosis and treatment monitoring of Veterans with cancers, bleeding disorders, and specialized diseases, including organ transplants. Referral (reference) laboratory that specializes with these types of complex tests and provide a quick turn-around-time (TAT) of the test results is required for care. VAPORHCS is a VHA Level 1A facility which are the largest levels of volume and patient risks along with the largest number and breadth of physician specialists. VAPORHCS is also unique with active kidney and liver transplants partnering with its academic affiliate. VAPORHCS requires a full service of Referral laboratory that provides specimen testing, interpretation, testing supplies, customer service, and verification of certification for test results. It is imperative that the Reference laboratory shall perform the following types of testing, to include expert consultation: Immunology, Hemostasis & Thrombosis, Hematology/Oncology, Anatomic Pathology, including Transplant and Renal Pathology, Neuropathology, Neuropathology, Dermatopathology, Cytopathology and Anatomic Pathology, Microbiology/Virology, Molecular, Flow Cytometry, Electron Microscopy, Ophthalmic Pathology and Diseases related testing, and Core Laboratory (Clinical). These requirements must be maintained and will ensure accurate and timely test results are available to healthcare providers that ensure high quality healthcare is provided to the Veteran at the VA Portland Health Care System. PERIOD OF PERFORMANCE: This is a request for an IDIQ award for the period of five years. Ordering period 1: 7/1/26 to 6/30/27 Ordering period 2: 7/1/27 to 6/30/28 Ordering period 3: 7/1/28 to 6/30/29 Ordering period 4: 7/1/29 to 6/30/30 Ordering period 5: 7/1/30 to 6/30/31Any concern here when we will have a dollar limit, not time? SCOPE The Reference Laboratory shall provideProvide services? referral laboratory services in accordance with all applicable federal, state, and local regulations, laws, and ordinances, and in accordance with the specifications outlined for accreditation certification if applicable, patient specimen testing for the specific range of referral testing within their capability. Services shall include the performance of analytical testing as defined by the Laboratory's reference test manual, the reporting of analytical test results and consultative services as required. All requirements and provisions defined in the specifications of this solicitation will apply to any laboratory, i.e. branch, division, sub-contractor, etc. performing reference testing on behalf of the Reference Laboratory. The VA Facilities will be responsible for specimen collection and will provide laboratory specimens prepared according to the Reference Laboratory's user s manual, identified, and labeled for testing. SPECIFIC TASKS: The Reference Laboratory shall provide laboratory services to include: preanalytical processing as defined in Reference Laboratory published user s manual; analysis, reporting of analytic results and interpretation of analytic clinical results. The number of tests requested under this contract will change throughout the life of the contract. The Reference Laboratory shall also provide the following support services, supplies, customer service, and reporting services: The Reference Laboratory shall have an online test-directory that supplies relevant information needed for each laboratory test. The online test directory must include: Specimen requirements for specimen collection & specimen processing Expected turn-around times. Methodologies and Reference ranges Requisition forms or an agreed-upon computer ordering system Kidney Biopsy collection materials with a mechanism to send kits directly to patients across the US, that are being monitored at the Portland VA. All required forms, including authorization of consent for genetic testing, informed consent, and chain of custody, if applicable. The Reference laboratory shall provide testing and interpretation services for all tests found within Attachment A. The volumes or amounts shown in the solicitation are estimates only and impose no obligation on the VA.Move to section 4.d The Reference laboratory will provide a current list of immunohistochemistry for surgical pathology specimens. The immunohistochemistry may be ordered as staining only (i.e. technical component only and no professional component interpretation) and staining and interpretation (i.e. both technical component and professional component interpretation). Of note, the Referral laboratory must be able to perform Estrogen Receptor (ER), Progesterone Receptor (PR) and Her2 as staining and interpretation. In addition, the Referral laboratory must be able to reflex equivocal Her2 for additional confirmation testing (i.e. Her2 FISH). The reference laboratory shall provide an extensive FISH library for use by VAPORHCS. The entire FISH library offered by the reference lab shall be itemized and added to the original test list prior to award. Note: CD138 plasma cell extraction method is required for the myeloma FISH panel. The Reference Laboratory shall provide flow cytometry test for diagnosis of leukemias and lymphomas on blood, body fluids, fine needle aspiration (FNA) cytology specimens, fresh tissue. In addition, the reference lab via flow cytometry methodology will be able to perform minimal residual disease (MRD) testing for B-cell Acute Lymphoblastic Leukemia (B-ALL), evaluation and screening for Autoimmune Lymphoproliferative Syndrome (ALPS), and monitor patients on Chimeric Antigen Receptors T-cell (CAR T-cell) therapy. The Reference Laboratory shall be the primary provider for consultation services for the Portland VA. These consultation services necessitate the review of diagnostic material by pathologists who are highly specialized, trained, and skilled. Evidence of specialized knowledge includes, but is not limited to, subspecialty fellowship training, board certification (if applicable), publication history within the subspecialty field, and presentations as invited speakers at pathology education conferences and seminars. The subspeciality fields shall include: Neuropathology, including both muscle and nerve biopsies, Renal Pathology, including transplanted organs, Dermatopathology, Cytopathology, Hematopathology, Surgical Pathology subspeciality such as Gastrointestinal Pathology, Breast Pathology, Genitourinary Pathology, etc. Reword this so it flows from black text to blue text Dean Neuropathology - The Reference Laboratory shall provide physicians who are fellowship trained, and board certified by the American Board of Pathology and CVs of their education, training, accomplishments and achievements. Renal Pathology The Reference Laboratory shall provide physicians who are board certified in Anatomic Pathology by the American Board of Pathology AND fellowship trained in Renal Pathology and CVs of their education, training, accomplishments and achievements. Furthermore, pathologists will be available for consultation and presentation of the diagnostic findings with regards to transplant pathology and upon request by the Nephrologists. Dermatopathology The Reference Laboratory shall provide physicians who are fellowship trained, and board certified by the American Board of Dermatology/American Board of Pathology, and CVs of their education, training, accomplishments and achievements. The pathologist will be available upon request for consultation for continuity of care. Cytopathology The Reference Laboratory shall provide physicians who are fellowship trained, and board certified by the American Board of Pathology, and CVs of their education, training, accomplishments and achievements. Hematopathology The Reference Laboratory shall provide physicians who are fellowship trained, and board certified by the American Board of Pathology and CVs of their education, training, accomplishments and achievements. Furthermore, the pathologists will be available for consultation and presentation of the diagnostic findings with regards to transplant pathology and upon request by the Hematologists/Oncologists. Ophthalmology The Reference Laboratory shall provide physicians who are fellowship trained, and board certified by the American Board of Ophthalmology and CV s of their education, training, accomplishments and achievements. The pathologist will be available upon request for consultation for continuity of care.Dean - added statement. Review as i just copy.paste from others and not sure it all applies in this case. Surgical Pathology Including Subspecialties All pathologists who report anatomic pathology cases MUST be board certified by the American Board of Pathology. The Reference Laboratory shall provide physicians who are fellowship trained, and board certified by the American Board of Dermatology/American Board of Pathology, and CVs of their education, training, accomplishments and achievements. Subspecialty fellowship training is strongly preferred. For all Anatomic Pathology Services, consultation, presentation and discussion of the case shall be readily available upon request. Present/Participate in Tumor Board. The Referral laboratory must meet any credentialing and/or privileging requirements by VA Portland and its academic affiliateIf we are going to include we need to state who the affiliate is Oregon Health Sciences University. For all Anatomic Pathology services, slides of the cases shall be available upon request (i.e. actual slide or digital images of the case) as these slides/images will be required for tumor board and case discussion. The vendor agrees to consult the VA Portland laboratory prior to performing any reflex tests prompted because of the consultation request. VA Portland must have an opportunity to review the proposed testing for clinical need and whether test is on contract. The reference laboratory, upon review of the proposed test menu, shall: If each CPT code is invoiced and or charged separately, the vendor should ensure that Attachment A is modified to include pricing for each CPT code. This includes panel components charged individually. If any component of a test is charged separately, it must be itemized within Attachment A. If a test is found on attachment A (all tabs) which results in any reflex testing, the vendor will itemize and add the reflex test and any associated charges to the test list. If the vendor charges separately for professional fees, Attachment A should be reviewed to ensure it includes any and all potential line items that would result from any of the tests contained within Attachment A. If the vendor utilizes dot codes for any of the CPT codes, please ensure those are itemized and added to Attachment A. TESTING METHODOLOGY, REFERENCE AND TURN AROUND TIME Routine test results shall be reported within the specified turnaround time (TAT) which is defined from time of specimen receipt by the contractor to when results are available. If testing is going to be delayed and the results will not be within published TAT, notify the VA Portland as soon as possible, of the new estimated TAT. Required TAT is identified on Attachment A. STAT TAT is considered 1 HOUR and Routine testing is 8 Hours. Turnaround time is defined from the time the specimens are received at the testing laboratory until transmission of results. The Reference laboratory shall meet all TAT needs, and stat processing needs. It is necessary for the contracted vendor to be able to provide immediate services for critical testing that must start within 1 hour of specimen collection by VA Personnel. Does this contradict 1 hour TAT of 1 hour giving them 1 hour to start. Total of 2 hours. Contact Seattle to see if they unique language in their UW contract. Back-up testing to critical in-house testing, is needed in case of instrument downtime and essential for operations of a 1A facility. These tests are identified on Attachment A, by the requirement for a STAT TAT of 1 Hour and or a Routine TAT of 8 hours.What tests, all tests? Call out attachment A Coagulation & platelet status must be monitored before, during and after liver transplant and other surgeries to provide immediate adjustment to blood thinners or blood products on a 24/7 basis. Coagulation and platelet function are critical life monitors for patients with liver diseases or other high-risk factors (cancer, cardiovascular disease and serious health conditions). Delays in test results beyond 4-12 hours may result in canceled/delayed surgeries/treatments or serious negative consequences for patients with high risk factors (cancer, cardiovascular disease and other serious health conditions). Tests are required to establish an immediate update/adjustment to dosage and treatment plan for blood clotting disorders, blood products or transplant care. Many specimens are fresh tissue requiring test processing to be initiated within 1 hour of collection to prevent specimen degradation, which leads to unsatisfactory cell recovery or responses giving inconclusive or inadequate diagnoses resulting in delayed treatment with serious consequences for cancer patients. (Muscle and nerve biopsies, and certain flow cytometry results are best if specimens processed within 1 hour of collection). Certain specimens are unique and irretrievable and aid in the diagnosis and staging of malignancies. Requirements for quick initial diagnosis and treatment initiation for new leukemia and aggressive lymphoma patients. Consultation may be required for continuity of care. Testing methodology and reference ranges for a test must be defined in the Reference Laboratory user manual and/or website. Reference Laboratory shall advise the facility of any changes in methodology, procedure, reference ranges and any new tests introduced 30 days in advance. Reference Laboratory agrees to maintain the minimum acceptable service, reporting systems and quality control. Exception handling: Reference Laboratory will notify VA Portland as soon as possible of any problems with Same as above, is this requirement helpful if the TAT is 1 hour or 8 hours? specimens received. The VA Facilities will provide laboratory specimens prepared according to the Reference Laboratory's user s manual, identified, and labeled for testing. Critical Value test results shall be reported immediately. Stat test results will be faxed or telephoned to Laboratory Service. Telephoned results will be confirmed with a follow-up by vendor via fax. The Reference Laboratory shall provide in accordance with all applicable federal, state, and local regulations, laws, and ordinances, and in accordance with the specifications outlined for accreditation certification if applicable, patient specimen testing for the tests listed in Attachment A. All requirements and provisions defined in the specification of this solicitation will apply to any laboratory, i.e. branch, division, sub-contractor, etc. performing reference testing on behalf of the prime contractor.Of prime contractor? The Contractor shall be responsible for storing specimens in such a manner to ensure the integrity of the specimen. COURIER SERVICES The Reference Laboratory shall be responsible for transporting and storing specimens in such a manner as to ensure stability and integrity of the specimen where applicable. Reference Laboratory shall supply any special preservatives required for specimen preservation. Reference Laboratory shall notify VA Facilities of any specimen problems or discrepancies from the submitted manifest within 24 hours after shipping. The Reference Laboratory shall provide routine scheduled specimen pickup at a time mutually agreed upon by the VA facilities but not less than once a day. The VA Facilities laboratory manager or designee shall notify the Reference Laboratory during weekends and federal holidays, via telephone, when a pick-up courier is required. In order to maintain similar facsimiles to the current agreement, the Referral laboratory will provide courier service including on demand, STAT, rush and short stability specimens. The Referral laboratory shall incur the cost of the courier service. For specimens that have a 1-hour TAT requirement, the courier system must be able to arrive for pickup within 1 hour of the request for pickup. For specimens that have a 1-hour processing requirement, the courier system must be able to deliver the specimen within 30 minutes of the collection time to allow sufficient time for the testing laboratory to initiate processing within 1 hour of the collection time at the Portland VA. If applicable, the Contractor shall be responsible for ensuring that all transport personnel are trained and follow the storage requirements for all laboratory specimens and that their competency is regularly assessed in appropriate safety and packaging procedures suitable to specimen type and distances transported. This shall include issues such as adherence to regulations for the transport of biohazards, use of rigid containers where appropriate, temperature control, notification procedures in case of accident or spills, etc. CUSTOMER SERVICE & PATIENT INFORMATION SAFETY The reference laboratory will provide VA Laboratory with a means of communication to permit immediate inquiry regarding the status of pending tests or specimen problems, 24 hours per day, 7 days per week. The reference laboratory shall provide names and telephone numbers of technical Medical Directors and Pathologists available for questions, discussions and consultations. The reference lab will comply with reporting test results with the specified time frame in accordance with the nature of the testing, following all regulatory requirements for reporting of patient results. Test results shall be reported within specified times established by the reference laboratory. Critical value test results shall be reported immediately by telephone. Results will be sent to the VA via a secure means and in compliance with Health Portability and Accountability Act (HIPPA) guidelines. The contractor will provide test related information that is readily available and easy to access to help select the proper test, interpret results, and build tests in our computer system for interconnection for electronic data interchange (EDI). The contractor will provide a 24-hour response time to all inquiries made by PLMS. VAPORHCS will provide Protected Health Information (PHI) with each submitted specimen to the Reference Laboratory which includes full name, medical record number, social security number, date of birth, ordering provider s name, laboratory accession number, specimen type, and specimen collection date and time. DELIVERY AND REPORTINGIs there standard language related to billing we can utilize? TBH - this is copy and paste from years and years of contract. ni Billing summaries shall begin the first day of the month and include the last day of the month. Tests referred to another laboratory shall be at no additional transfer charge or confirmation charge to the government. Deliveries must be accompanied by a delivery ticker or sales slip that contains the following information as a minimum: Vendor Name Applicable FSS contract number BPA Number, Task order number, and Purchase Order number Date of Purchase Date of Shipment Description of item Quantity of each item Unit price and extended (quantity x unit price) price for each item The Reference Laboratory shall provide a quarterly and end of year report showing sample issues, facility usage, and cost savings generated during the reporting period. The report will be due 45 days after the close of each government fiscal quarter. Invoicing: An itemized invoice shall accompany each service order from the Contractor. This invoice must show item number, description, quantity, unit, unit price, and totals for each design (advanced and basic) used. All invoices shall include contract number, purchase/delivery order number and detail of services provided. Invoicing: Invoices will be electronically submitted to the Tungsten website at http://www.tungstennetwork.com/uk/en/ Tungsten direct vendor support number is 877-489-6135 for VA contracts. The VA-FSC pays all associated transaction fees for VA orders. During Implementation (technical set-up) Tungsten will confirm your Tax Payer ID Number with the VA-FSC. This process can take up to 5 business days to complete to ensure your invoice is automatically routed to your Certifying Official for approval and payment. In order to successfully submit an invoice to VA-FSC please review How to Create an Invoice within the how to guides. All invoices submitted through Tungsten to the VA-FSC should mirror your current submission of Invoice, with the following items required. Clarification of additional requirements should be confirmed with your Certifying Official (your CO or buyer). The VA-FSC requires specific information in compliance with the Prompt Pay Act and Business Requirements: 1.) Your firm s Tax Payer ID number (TIN) Your firm s Remit Address information 3.) The VA Purchase Order (PO) number 4.) Your firm s contact information: (Personal Name, Email, and Phone) 5.) Your VA point of contact information: (Personal Name, Email, and Phone) 6.) The Period of Performance dates (Beginning and Ending) 7.) All discount information if applicable (Percent and Date Terms) For additional information, please contact: Tungsten Support Phone: 1-877-489-6135 Website: https://tungsten-network.my.site.com/contactCustomerSupport/s/? language=en_US Department of Veterans Affairs Financial Service Center Phone: 1-877-353-9791 Email:
[email protected] Invoices shall be submitted monthly with the following information: 1.) Contract number and purchase order number 2.) Station ID (648) 3.) Date services were requested 4.) Patient name and test 5.) Invoice will be billed as individual line items as they are listed in the price schedule. Monthly invoice(s) will contain only those item numbers used for that month. Invoices not received in proper format will be returned. Marketing: Contractor shall not advertise or use any marketing material, logos, trade names, service marks, or other material belonging to the VA without consent. PERFORMANCE MONITORING At the time of contract award the Contracting Officer will appoint a Contracting Officer Representative (COR) to assist with the contract monitoring requirements. The COR or designee will monitor such items as quality of service, contractor's ability to meet TAT's, correct billing, customer service, and review of the contractor's proficiency program. For the QUALITY ASSURANCE SURVEILLANCE PROGRAM refer to the QASP for Test and Interpretation Attachment. Contractor shall provide to the COR or designee no later than Ninety (90) days prior to the end of each contract period a proficiency report. The COR or designee shall review the proficiency results. The contractor shall maintain a minimum of 95% success rate for proficiency testing to be considered successful. Failure to achieve 95% success rate two periods in a row could be grounds for Termination for Cause. The COR or designee will ensure that services performed are in accordance with all terms and conditions of the contract. The delegated COR or designee will notify the Contracting Officer of any non-compliance immediately upon his/her gaining knowledge of any such situation or incident. After such communication, the COR or designee will provide a written statement to the contracting officer along with any supporting documentation regarding the performance failure noted. Upon receipt of a proper invoice, the COR or designee shall certify that the services identified have been performed. Once certification has been made, the invoice will be forward through the proper billing channels and payment shall be made to the Contractor. It is the intention of both parties to conduct joint reviews prior to the expiration date of the contract to determine and evaluate if services being provided are in accordance with the contract terms, payments and billings are being properly handled and to jointly determine if this agreement is satisfactory to both parties in terms of services provided and consideration being received. This review may include. but not be limited to: analyzing all billings, payments, costs, administrative issues, patient satisfaction, quality of care and other related documentation that identities that services have been received. Upon conclusion of the initial contract period, and in coordination with the Contracting Officer, the using service shall provide a statement to the Contracting Officer providing a summary of contractor actions and a statement that all requirements of the contract were fulfilled as agreed. This information shall be forwarded by the COR or designer to the Contracting Officer prior to exercising any extension of this agreement (at least 60 days prior to contract expiration). LICENSING AND ACCREDITATION Reference Laboratory shall provide copies of all licenses, permits, accreditation and certificates required by law. The Laboratory Director shall be a licensed American Board of Pathology certified pathologist. As the subspeciality of dermatopathology consultation will be requested from the Reference Laboratory Contractor, fellowship training and Board Certification in Dermatopathology from the American Board of Pathology is required. As the subspeciality of Renal Pathology consultation will be requested from the Reference Laboratory, Board Certification in Anatomic Pathology from the American Board of Pathology, and fellowship training in Renal Pathology is required. As the subspeciality of Neuropathology consultation will be requested from the Reference Laboratory, fellowship training and board certification from the American Board of Pathology is required. As the subspeciality of Cytopathology consultation will be requested from the Reference Laboratory, fellowship training and board certification from the American Board of Pathology is required. As the subspeciality of Hematopathology consultation will be requested from the Reference Laboratory, fellowship training and board certification from the American Board of Pathology is required. As the subspeciality of Ophthalmology consultation will be requested from the Reference Laboratory, fellowship training and board certification from the American Board of Pathology is required. Dean - added statement. Review as i just copy.paste from others and not sure it all applies in this case. As the subspeciality of Surgical Pathology consultation will be requested from the Reference Laboratory, fellowship training and board certification from the American Board of pathology is required As per VHA Handbook 1106.01 Pathology and Laboratory Medicine (P&LMS) Procedures, only qualified, licensed, and privileged pathologists certified by the American Board of Pathology in Anatomic Pathology can provide the written report for all surgical pathology, autopsy, diagnostic EM, non-GYN cytopathology and abnormal GYN cytopathology examinations. All pathologists who report the referred/consultation cases must have board certification from the American Board of Pathology. All medical facilities providing laboratory services under the contract must possess a valid state license (if required) and meet CLIA and CMS requirements including CLIA certificate of compliance, and accreditation by the College of American Pathologists (CAP) or equivalent accreditation agency. PERSONNEL The Reference Laboratory shall make sure employees have current and valid professional certifications before starting work under this contract. The Reference Laboratory staff shall meet personnel qualifications required by Clinical Laboratory Improvement Act (CLIA) '88 Guidelines. The Government s reserves the right to request information or certification from the contractor verifying they comply with this contract requirement. If discovered the contractor is not in compliance with this requirement the contract shall be terminated for cause in accordance with clause 52.212-4. HOURS OF OPERATION VA Portland Health Care System Medical Center is open 24 hours a day, 7 days a week, 12 months of the year and may require services during those times. PLACE OF PERFORMANCE Work to be performed on the contractor s site, their affiliates, or other as determined by the contractor based on the services to be provided. Evaluation Criteria: If applicable Technical performance is more important than all other evaluative criteria. Technical performance = 80% Past performance = 10% Price = 10% BACKGROUND INVESTIGATIONS AND SPECIAL AGREEMENT CHECKS All Reference Laboratory employees are subject to the same level of investigation as VA employees who have access to VA sensitive information. The level of background investigation commensurate with the level of access needed to perform the work is: Low Risk. This requirement is applicable to all subcontractor personnel requiring the same access. The Reference Laboratory shall bear the expense of obtaining background investigations. If the investigation is conducted by the Office of Personnel Management (OPM) through the VA, the Reference Laboratory shall reimburse the VA within 30 days. VA INFORMATION SECURITY LANGUAGE 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. 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 US 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 Veteran Affairs does not have a Memorandum of Agreement with Defense Security Services (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 US 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-US services are provided and detail a security plan, deemed to be acceptable to VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the US 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. Custody of VA Information a. Information made available to the contractor or subcontractor by VA for the performance or administration of the contract shall be used only for the purposes and shall not be used in any other way without the written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights of Data General, FAR 52.227-14(d) (1). b. VA information should not be co-mingled, if possible, with any other data on the contractor/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 the 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 VA Directive 6300, Records and Information Management and its Handbook 6300.1, Electronic Media Sanitization. Self0-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 to 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 date used by the contractor/subcontractor needs to be restored in 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 FAR Part 12. g. In accordance with VHA DIR 1605.05, A Business Associate Agreement is not required for this contract as it falls under the treatment exemption of the HIPAA Privacy Rule. 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, the 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. 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 Contracting Officer and 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 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 date 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, 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. Liquidated Damages for Data Breach a. Consistent with the requirements of 38U.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 the 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 of the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the date 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 event (loss, theft, unauthorized access); 2. Description of the event, including: a. Date of occurrence b. Date 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 date 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 date 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 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 report 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 coverage at $0 deductible; and 6. Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs. 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. Within 10 working day 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. Will be updated in the 6500 process. 20. VA RECORDS MANAGEMENT OBLIGATIONS LANGUAGE A.  Applicability This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.  B.  Definitions Federal record as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.  The term Federal record: includes VA Portland Health Care System records. does not include personal materials. applies to records created, received, or maintained by Contractors pursuant to their VA contract. may include deliverables and documentation associated with deliverables. C.  Requirements Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data. The Reference Laboratory and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of the Reference Laboratory or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of  any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to VA COR. The VA must report promptly to NARA in accordance with 36 CFR 1230. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the SOW. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to VA control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the SOW. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4). The Contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under, or relating to, contracts. The Contractor (and any sub-contractor) is required to abide by Government and VA guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with VA policy. The Contractor shall not create or maintain any records containing any non-public VA information that are not specifically tied to or authorized by the contract. The Contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected from public disclosure by an exemption to the Freedom of Information Act. The VA owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which VA shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.