Q301– Long Term Reference Lab Testing (Organ transplant related)| (VA-21-00009535)

Notice Type: Sources Sought Notice

Posted Date: 23-FEB-21

Office Address: Veterans Affairs, Department of; VETERANS AFFAIRS, DEPARTMENT OF; 244-NETWORK CONTRACT OFFICE 4 (36C244); PITTSBURGH, PA 15215

Subject: Q301-- Long Term Reference Lab Testing (Organ transplant related)| (VA-21-00009535)

Classification Code: Q - Medical services

Solicitation Number: 36C24421Q0343

Contact: Kevin M. Balser

Setaside: N/AN/A

Place of Performance (address): VA Hospital H J Heinz Campus 1010 Delafield Rd Pittsburgh

Place of Performance (zipcode): 15215

Place of Performance Country: USA

Description: Veterans Affairs, Department of

VETERANS AFFAIRS, DEPARTMENT OF

244-NETWORK CONTRACT OFFICE 4 (36C244)

Page 10 of 15The Department of Veterans VA Hospital H J Heinz Campus, 1010 Delafield Rd, Pittsburgh, PA 15215, is conducting a market survey to identify potential sources to provide STAT Laboratory Testing related to organ transplants per statement of work.DISCLAIMERThis Sources sought is issued solely for information and planning purposes only and does not constitute a solicitation.---- Submitting information for this announcement is voluntary and VA assumes no responsibility for any costs incurred associated with the preparation of responses submitted as a result of this notice.---- If a solicitation is issued it will be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement. The purpose of this market research is to identify capable sources that are both experienced and qualified to provide STAT Laboratory testing as described. The North American Industry Classification System Code (NAICS) is 334516.---- Based on this information, please indicate whether your company would be a large or small business; and provide the average amount of sales for the last three (3) years or whether you have a socio-economic designation.Limitations on Subcontracting and non-manufacturing rule will apply to the resulting solicitation.Capability Statement and Documentation:Companies are invited to provide their capabilities, experience, and knowledge in providing applicable laboratory testing as attached.---- Sources must provide the following information:Company name, address, telephone number, website, DUNS number, CAGE code, business type, socio-economic status (e.g., SDVOSB, VOSB, Woman-Owned, Disadvantaged Small Business, 8(a), general small business, large, business, etc.), SAM registration expiration date, and person of contact (including telephone number and email address).Indicate and explain your capability of providing this service in accordance with the Draft Statement of Work (SOW) attached.Indicate your company s size under NAICS 334516.Please indicate any government contracts held including government agency, contract number, dollar value, period of performance, and government contact information.Information regarding your company s capabilities to provide such services are to be submitted electronically on or before Friday, 06/05/2021 by 3:00 PM (EST) addressed to Kevin Balser, Contracting Officer at: and [email protected].Performance Work StatementStat Reference Laboratory Testing ServicesThe VA Pittsburgh Healthcare System (VAPHS) is in need of reference laboratory testing services for stat patient testing that is not performed by VAPHS laboratories. The services required by this contract include the following laboratory disciplines:Miscellaneous STAT TestsHistocompatibility Testing for Solid Organ TransplantationVirology Testing (Including CMV PCRs)Cytogenetic StudiesCurrently, the VA handles renal and liver transplants. This may be expanded to include other solid organs in the future.The period of performance for base plus four (4) option periods will be May 1, 2021 -April 30, 2026. It is the intent of this office to award a fixed price, Indefinite Delivery, Indefinite Quantity contract (IDIQ) or BPA in response to this requirement.This solicitation will be procured in accordance with FAR Part 12 Acquisition of Commercial Items, and FAR Part 13 Simplified acquisitionsRequirementsThe Contractor shall be responsible for performing pre-analytic processing, analysis, and result interpretation for clinical specimens as requested by the VAPHS. Services shall include the transportation of clinical laboratory specimens to the contractor s laboratory, the performance of analytical testing as defined by the Contractor s reference test manual, and the reporting of analytical test results and consultative services as required.The reference laboratory services shall be available twenty-four (24) hours per day, seven (7) days per week, including holidays.VAPHS will be responsible for specimen collection, preparation, and preservation.Services to be furnished under this contract shall be ordered by issuance of an order by the VAPHS laboratory for results to be delivered to a designated printer/fax at the VAPHS University Drive Division in accordance with standards, clauses and provisions of this document. All services will be requested using Contractor-provided or VAPHS-standard requisitions which will accompany the specimens.The attached Schedule of Supplies/Services represents estimated quantities based on historical data. This is not an all-inclusive list of tests, and the volumes are not guaranteed. The list is subject to change based on medical need.For all tests identified in the Schedule of Supplies/Services, the contractor will provide the following information:Ordering Code (Contractor s Identification Code)LOINC Logical Observation Identifier Names and CodesCPT CodeTest Description, including reference ranges and units of measurementTest methodologySpecimen typesSpecimen collection and handling requirementsTest result interpretation or interpretive remarks, if appropriateTesting siteMaximum turnaround time (TAT) for each test listed(NOTE: If the information requested above is identified in Contractor s Directory of Laboratory Services, it is not necessary to provide a separate listing. The Directory of Laboratory Services shall be submitted electronically as part of Contractor s proposal (see Section VI (Contractor s Responsibilities) and FAR 52.212-2 for Evaluation Criteria.)QualificationsLicensing and AccreditationOnly fully licensed/accredited laboratories actively engaged in providing the specific services and laboratory testing outlined in this solicitation will be considered. The Contractor shall have all licenses, permits, accreditation and certificates required by law. The reference laboratory must be licensed/accredited by The Joint Commission, College of American Pathologists (CAP) and/or other state regulatory agencies as mandated by federal and state statutes. In addition, the laboratory must be certified as meeting the requirements of the Department of Health and Human Services Clinical Laboratory Improvement Act (CLIA) of 1988. For Histocompatibility testing, the Contractor must maintain accreditation through the American Society of Histocompatibility and Immunogenetics (ASHI).The Histocompatibility Lab must be a member of the Organ Procurement and Transplantation Network (OPTN), and such a laboratory must conform to the Standards for Histocompatibility Testing set forth in Appendix B, Attachment IIA (11A-11N) of the UNOS Bylaws and applicable sub-attachments which are hereby incorporated by reference. Additionally, Histocompatibility Laboratories shall abide by applicable provisions of the National Organ Transplant Act, as amended, 42 U.S.C. 273 et seq.; the requirements set forth in the OPTN Final Rule, 42 CFR Part 121; these Bylaws; and OPTN policies. Histocompatibility Laboratories shall also submit to reviews (including on-site reviews) and requests for information as may be necessary to determine compliance with the OPTN Final Rule, 42 CFR Part 121; these Bylaws; and OPTN policies.The Contractor shall provide a copy of all relevant permits/licenses and certifications inclusive of any sanctions current or pending throughout the United States of America along with proposal. In addition, the Contractor shall be responsible for providing a written guarantee or evidence that all subcontractors, if applicable, have appropriate licensure and accreditation to perform tests that the primary contractor cannot perform prior to contract award.Contractor policies and procedures shall comply with Health Insurance Portability and Accountability Act (HIPAA).Contractor Laboratory and Personnel1. The Contractor shall maintain current accreditation and notify the Contracting Officer Representative (COR) of any lapse in state license, CLIA certification, or clinical pathology, Histocompatibility, or Cytogenetics certification. The Contractor shall provide a copy of the renewed licenses/certificates to the COR before expiration.Test Result ReportingContractor shall provide electronic transmission (i.e., fax or computer via secure email) of all completed and/or partial test results to the ordering activity within awarded Turnaround Time (TAT), except where specified.Contractor is responsible for transmission of all data to be accomplished in a manner that protects the privacy of all personally identifiable patient information.Histocompatibility TestingThe Histocompatibility Laboratory must be located within 30 minutes ground transportation time from the VAPHS, University Drive Division, to ensure a turnaround time for cross matches of less than four (4) hours.The Histocompatibility Laboratory must have the capability to directly enter HLAs, PRAs and Unacceptables into UNet SM, UNOS computer-based network for allocating donated organs and managing transplant data.The Histocompatibility Laboratory must be able to report Unacceptable Antigens and perform the Renal Transplant Histocompatibility tests as listed in the attached list of Schedule of Supplies/ServicesContractor s ResponsibilitiesProcedure GuidanceThe Contractor must provide VAPHS a Directory of Laboratory Services. The following information shall be included in the Directory of Laboratory Services.Test-specific specimen collection and preservation requirements for each test or analytic.Test-specific method and interpretation for each test or analytic.Test-specific method reference ranges, adjusted for age, sex, or race, when required.Test-specific method sensitivity and specificity, when required.Test-specific schedule of performance and maximum turnaround time for each.Updated information on test methodology changes, (i.e. changes in normal ranges, methods, and reporting units).In the event of any change, the information must first be provided to the VAPHS Point of contact and/or the COR at least fourteen (14) days prior to the Contractor s change. No changes to procedures will be made with less than fourteen (14) days notice.Tests referred to another laboratory shall be at no additional transfer charge or confirmation charge to the VA Pittsburgh Healthcare System.Test ResultsTurnaround TimeSTAT. The Contractor shall provide telephonic or fax response within two (2) hours from notification for specimen pick up, unless otherwise agreed, for STAT test results. The Contractor shall report all normal and abnormal test results to ordering laboratory upon completion of testing.RENAL/LIVER TRANSPLANT HISTOCOMPATIBILITIY. A cadaver donor cross match must be completed within four (4) hours from receipt of the specimen, unless otherwise agreed. The Contractor shall provide telephonic or fax response with the results (preliminary or final) of other histocompatibility tests between twenty-four (24) and seventy-two (72) hours, depending on the test requested and the specimen source. The Contractor shall report all normal and abnormal test results to the ordering laboratory upon completion of testing.TELEPHONE CONSULTATION. The Contractor shall consult with the COR, the requesting Clinician, or the designee at the ordering laboratory by telephone as needed. The Contractor shall immediately telephone the VA Pittsburgh Healthcare System Core Laboratory to report Critical Values or test result that may indicate a life-threatening condition. When Critical Values are given, the recipient of the results is required to read the result back to the caller. The information will be documented in the printed report along with the date and time of the call and the identification of the caller and recipient.The Contractor shall provide all confirmatory testing, upon request of the VA Pittsburgh Healthcare System laboratory, at no additional charge to the Government.Reporting of Results. A report is defined as a printed final copy of laboratory testing results. This report shall be received by fax, tele-printer or computer where applicable. If results are previously telephoned, the report must include the name of the individual who was notified of the results. Each test report shall, at minimum, indicate the following information:Patient's name and/or identification code (Social Security number)Physician's name (if supplied)Patient s identification number, (social security number (SSN), medical record number)Submitting facility nameSubmitting facility account numberPatient's location (clinical/ward), (if supplied)Date/time specimen received in Reference LabTest orderedDate/time of specimen collection (when available)Date/time test completedTest resultFlag abnormal resultsReference intervals (adjusted for age, sex or race, when appropriate)Toxic and/or therapeutic range, where applicableFlagged abnormal resultsReference laboratory accession numberName of testing laboratory and address (Contractor and/or subcontractor)Type of specimenAny additional comments related to test provided by submitting labs.Any other information the laboratory has that may indicate a questionable validity of test results.Specimen inadequacy shall be reported with documentation supporting its unsuitability for testing.Test results determined by the contractor to be critical, shall be communicated by telephone to a designated Government contact person(s) at the originating Government laboratory facility upon verification of the critical test result. The telephonic report shall be followed by an electronic transmission.DocumentationThe Contractor shall ensure that all required documentation is, at a minimum, timely, legible, and accurate. Contract personnel shall indicate responsibility for the content and correctness of all prepared reports.To ensure proper handling and test performance, the contractor shall provide the following updated information upon request during the life of the contract:Coefficient of variation of quality control samples of all tests or specified tests the contract laboratory performs.Proficiency testing data provided to customer will include where challenges failed, a list of tests outside of the + 2SD range for the past two (2) years.Contractor shall provide address of processing sites under contract, including subcontracted testing location sites.Retention of SpecimensUpon completion of the testing, the Contractor shall retain all specimens, as required by regulatory agencies (RA). Upon request by the ordering activity, COR, or designee, the Contractor shall provide a copy of the regulatory requirements for each participating RA. In the absence of RA requirements, the Contractor shall retain specimens after all testing has been completed for seven (7) days.Monthly Test SummaryThe Contractor will provide separate, monthly data summary reports of tests performed for the VAPHS under this contract. The printed or electronic reports will be e-mailed to the COR no later than five (5) working days after the end of each monthly reporting period.The reported information must include subtotals for each test and the test name, CPT code, vendor's test code, test cost, number of tests performed (current month), total monthly cost (per test), number performed year-to-date (per test), and cost year-to-date (per test). This information must be accurate and is mandatory.InvoicesThe Contractor will provide all-inclusive monthly invoices, in arrears, of tests performed for the VA Pittsburgh Healthcare System under this contract. The invoice must include all charges for both the technical and professional component for all testing performed during the month. The invoice must include all charges from any subsidiary facilities and/or physician practice plans. Contractor shall not invoice for any test unless the final results have been transmitted to VAPHS via fax, tele- printer or computer, as applicable.The Summary monthly submitted into the Veterans Administration Electronic Invoicing system shall contain the following information:Contract NumberPurchase Order NumberMonth Being BilledCPT CodesTest NameQuantity of Test Performed During the MonthUnit Price for Each TestTotal Price for Each TestTotal Charge for All TestsMonthly Charge for Courier ServiceGrand Total Charge for Month including all Tests and Courier ServiceA copy of the monthly Summary invoice, along with the following detailed information, must be mailed or faxed to the Contracting Officer s Representative:Patient s NamePredetermined encrypted patient identifierSocial Security NumberCPT CodeList of Tests PerformedSpecimen Collection date (listed in chronological order)Vendor s Test Code (if different than CPT code)Quantity & Unit PriceTotal CostPayments in full/no billing VA beneficiaries: The Contractor shall accept payment for services rendered under this contract as payment in full. VA beneficiaries shall not, under any circumstances, be charged nor their insurance companies charged for services rendered by the Contractor, even if VA does not pay for those services. This provision shall survive the termination or ending of the contract.The Contractor shall not bill, charge, collect a deposit from, seek compensation, remuneration, or reimbursement from, or have any recourse against, any person or entity other than VA for services provided pursuant to this contract. It shall be considered fraudulent for the Contractor to bill other third-party insurance sources (including Medicare) for services rendered to Veteran enrollees under this contract.Payments shall be made monthly in arrears upon receipt of a properly prepared invoice.In order to comply with the Improper Payment Elimination and Recovery Act of 2010 (IPERA), the VA has mandated electronic invoice submission to the Veterans Affairs Financial Services Center (VAFSC). VAFSC has partnered with OB10 e-Invoicing network, for submissions of all electronic invoices to VA. OB10 electronic invoicing is free to all VA vendors. In order to submit electronic invoices, all VA vendors must register with OB10 by submitting an email to [email protected] or calling 1-877-752-0900 option 2 for Enrollment.Contractor shall submit an electronic invoice by the tenth (10th) of the following month that services were performed to the Veterans Affairs Financial Services Center (VAFSC) e-Invoice through the website at https://portal.ob10.com/Login.aspx. For questions regarding the submission of VA electronic invoices, OB10 customer service may be contacted at 1-877-489-6135. For questions regarding invoice receipt or payment, please call VAFSC directly at 1-877-353-9791 or email [email protected] Service and MaintenanceCustomer ServiceThe Contractor shall provide telephone number(s) and contact person to be used by the VAPHS laboratory to make specimen problem inquiries and problem solving at all times, 24 hours a day, 7 days a week, including weekends and holidays. The Contractor shall also include names and telephone numbers of technical Directors and Pathologists available for consultation.For the purpose of Histocompatibility testing for Liver and Renal Transplantation, the Contractor will maintain a relationship and direct interaction with the local organ procurement agency, Center for Organ Recovery and Education (CORE). CORE is responsible for alerting the Contractor of all potential donors and providing the Contractor with sufficient typing samples. The Contractor must have a strong rapport with many members of CORE since there is a need for a significant amount of cooperation between the two entities. Information on CORE may be found on http://www.core.org. The Contractor s Histocompatibility laboratory must be approved by the United Network for Organ Sharing (UNOS) to perform Histocompatibility testing for solid organ transplants. Information on UNOS may be found on http://www.unos.org.The Contractor agrees to maintain the minimum acceptable service, reporting systems and quality control as specified herein. Immediate (within 24 hours) notification must be given to ordering activity upon adverse action by a regulatory agency. Contractor shall advise facility of any changes in methodology, procedure, reference ranges and any new tests introduced.In the event that the Contractor changes the assay procedure or a critically important component of an assay (e.g., and antibody, purified antigen, etc.), the Contractor shall notify the COR prior to the intended change. Changes in the assay materials or procedure may be sufficient cause for changing to an alternate contractor for the assay(s) for the duration of the contract at the sole discretion of the Contracting Officer. The contractor is liable for any excess procurement costs.Maintenance1. In case of failure of the automated system, the Contractor shall provide an alternate route of transmission (i.e. telephone, or courier service) to the VAPHS.Contractor s Quality Control SystemsThe Contractor must successfully perform external proficiency testing surveys as required by CLIA for all regulated analytes. Upon request, the Contractor must provide the COR with a listing of external proficiency surveys that the laboratory participates, in accordance with CLIA. Survey results and statistical reviews for specific laboratory specialties will be provided to COR or designee upon request.The Contractor must operate a successful quality control program as required by CLIA, CAP, ASHI and the American College of Medical Genetics. Upon request of the COR, the Contractor must provide documentation of quality control policies, quality control results for assays, on-going calculations of quality control performance (coefficient of variation, mean and standard deviation), monthly Levy- Jennings graphs, and documentation of appropriate analyzer maintenance. Upon request, the Contractor must provide verification results for assays of non-regulated analytes, and analytes for which proficiency testing does not currently exist.All test methods must be FDA approved, when available. Any non-FDA approved method being performed must have a documented validation plan. Upon request, the validation plan and validation results must be made available to the COR or designee.Nothing herein is intended to preclude subcontracting some of the tests to another laboratory, which is fully qualified and has the same accreditations/certifications as the prime Contractor in accordance with the term of this contract. This must be kept to a minimum for quality control and uniformity purposes. Once a test method is designated for performance by a specific subcontractor, all future performance of that test method must be done by that same subcontractor, unless concurrence to change is received in writing from the Contracting Officer. Consistency and uniformity in testing results is paramount.Specimen Pick-Up/DeliveryCourier Service/Specimen Pick-up TimesEmergency transportation services shall be available 24 hours per day, seven days per week including Government holidays.Response time for the contractor s emergency transportation services for STAT specimens shall be within 45 minutes after the request for pick up. Emergency response time refers only to the transportation of the specimen(s) and does not include the time for test performance. Specimens shall be picked up at VAPHS, University Drive Division, Room 2NW101, Pittsburgh, PA 15240.Courier service shall comply with all applicable regulatory standards.Sample Preparation1. The VAPHS laboratories will prepare and package laboratory specimens in accordance with the requirements defined in the Contractor's Directory of Laboratory Services. The Contractor shall provide, at no charge, an adequate supply of requisition forms, special instructions, and a current list of tests with reference ranges and specimen requirements. These requirements shall be defined in the laboratory user catalog. The Contractor shall be responsible for transporting in such a manner as to ensure the integrity of the specimen.Miscellaneous ResponsibilitiesThe Contractor must provide, through a customer service network, access to knowledgeable and responsive laboratory professionals.At the VAPHS expense, a representative(s) from the staff will be given the opportunity to visit the Contractor s testing laboratory to examine the Contractor s facility regarding contract compliance. Compliance visits may occur at any time during normal business hours after award of the contract. (Normal business hours are Monday through Friday, 8 a.m. through 4:30 p.m.).Government Contractor Quality Assurance Surveillance Program (QASP)1. The Government has created a Quality Assurance Surveillance Program (QASP) to ensure the requirements of this contract are being met. The QASP can be viewed in Section D of this document. Upon contract award, the Contractor will be required to sign the QASP. All changes to the QASP will be documented by the Contracting Officer.Required Registration with Contractor Performance Assessment System (CPARS)As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates contractor past performance on all contracts that exceed the thresholds outlined in FAR Part 42.15, and shares those evaluations with other Federal Government contract specialists and procurement officials through the Past Performance Information Retrieval System (PPIRS). The FAR requires that the contractor be provided an opportunity to comment on past performance evaluations prior to the posting of each report. To fulfill this requirement VA uses an online database, the Contractor Performance Assessment Reporting System (CPARS). The CPARS database information is uploaded to the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal agencies.The Government will register the contract within thirty days after contract award. For contracts with a period of one year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the contractor s performance annually. Intermediate reports will be filed each year until the last year of the contract, when the final report will be completed. Each report shall be forwarded in CPARS to the contractor s designated representative for comment. The contractor s representative will have thirty days to submit any comments and return the report to the VA contracting officer. Failure by the contractor to respond within those thirty days will result in the Government s evaluation being placed on file in PPIRS without contractor s comments.Security Controls Compliance TestingOn a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-days notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.Records Management SecurityCitations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.Contractor shall treat all deliverables under the contract as the property of the U.S. Government for which the Government Agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.Contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government IT equipment and/or Government records.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 by the Freedom of Information Act.Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.The Government Agency owns the rights to all data/records produced as part of this contract.The Government Agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient technical documentation with all data deliverables to permit the agency to use the data.Contractor agrees to comply with Federal and Agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.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, this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.Information Security RequirementsAll samples including PII/PHI must be shipped using a secure tracking mechanism.A Contractor Security Control Assessment (CSCA) is not required since the Contractor is not storing VA data on behalf of VA.A Business Associate Agreement is not required.The following language, taken from VA Handbook 6500.6 (Appendix C), applies to this requirement/contract.VA INFORMATION CUSTODIAL LANGUAGEa. 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).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.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.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 38U.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.SECURITY INCIDENT INVESTIGATIONThe 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.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.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.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.LIQUIDATED DAMAGES FOR DATA BREACHConsistent 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.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.Each risk analysis shall address all relevant information concerning the data breach, including the following:Nature of the event (loss, theft, unauthorized access);Description of the event, including:Date of occurrence;Data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;Number of individuals affected or potentially affected;Names of individuals or groups affected or potentially affected;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;Amount of time the data has been out of VA control;The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);Known misuses of data containing sensitive personal information, if any;Assessment of the potential harm to the affected individuals;Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; andWhether 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.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 $38.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:Notification;One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;Data breach analysis;Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;One year of identity theft insurance with $20,000.00 coverage at $0 deductible; andNecessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairsGeneral Definitions for Laboratory ServicesTerms used in this contract shall be interpreted as follows unless the context expressly requires a different construction and/or interpretation. In case of a conflict in language between the Definitions and other sections of this contract, the language in this section shall govern.Critical Value. A test result that requires evaluation by a physician or other health care provider as soon as verified. Failure to take appropriate action as a result of a critical value might cause harm or undue suffering for a patient.Histocompatibility testing. Consists of HLA antigen typing (tissue typing), screening of the recipient for anti-HLA antibodies (antibody screen), and the lymphocyte crossmatch (compatibility test). HLA antigen typing may be performed by serological or DNA methods.Overflow. Tests usually performed in the ordering activity lab, which might be referred to the Contractor s laboratory in case of instrument breakdown or other circumstances interfering with the ordering facility s ability to analyze the specimens.Paraffin Block. A tissue specimen that has been embedded in paraffin wax that the sections can be cut for histologic examination.Proficiency Testing. An assessment of the accuracy of testing by a laboratory based on the analysis of an unknown specimen analyzed by a large number of other labs. The proficiency survey is conducted by an organization or agency authorized by the Department of Health and Human Services to do so.Reference or Referral Laboratory. The contract laboratory that provides testing, and examination of specimens provided by the medical treatment facility.Reference Value. A range of test values expected for a designated normal population of individuals. Slides. Glass surface containing biological material to be analyzed.Specimen. A body fluid or tissue sample removed for medical examination and analytical testing.Special handling. Unusual circumstances may dictate the need for a specimen to be picked up specially, run out of sequence at a special time, or reported within a shorter than usual time.STAT. A designated category of tests that requires immediate processing to expedite results to physicians handling potentially life-threatening cases.Surgical Specimen. A sample or part of an organ or tissue removed during Surgery or procedure for medical examination and analytical testing.Tests. Diagnostic assays to evaluate a patient's physiological condition.Turnaround Time (TAT). The length of elapsed time between pick-up or dispatch of specimen from the VAPHS laboratory and the receipt of the completed printed report received by the ordering laboratory. Exception: For STAT tests, the TAT shall begin at the time of notification by the VAPHS laboratory to the contractor that the specimen is ready for pick-up. These definitions apply whether the contractor or a subcontractor performs the test.Contracting Officer (CO). The person executing this contract on behalf of the Government with the authority to enter into and administer contracts and make related determinations and findings.Contracting Officer s Representative (COR). A person appointed to take necessary action to ensure the Contractor performs in accordance with and adheres to the specifications contained in the contract and to protect the interest of the Government. The COR shall report to the CO promptly any indication of non- compliance in order that appropriate action can be taken.CPARS. Contractor Performance Assessment Reporting SystemCPRS. Computerized Patient Recordkeeping System- electronic health record system used by the VA. ISO. Information Security OfficerPOP. Period of PerformancePWS. Performance Work StatementQASP. Quality Assurance Surveillance PlanVeterans Health Administration (VHA). The central office for administration of the VA medical centers through throughout the United States. The VHA is located in Washington, D.C.VISTA (Veterans Integrated Systems Technology Architecture). A PC-based system that will capture and store clinical imagery, scanned documents and other non-textual data files and integrates them into patient s medical record and with the hospital information system.Veterans Affairs Medical Center (VAPHS). Unless identified with the name of a different VA medical Center, for purposes of this contract, this term shall mean the Veterans Affairs Pittsburgh Healthcare System. (VAPHS)

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