SAMDaily.us | SNOTE | 99 | Histocompatibility Lab Antigen Testing

SAMDAILY.US - ISSUE OF SEPTEMBER 28, 2022 SAM #7607
SPECIAL NOTICE

99 -- Histocompatibility Lab Antigen Testing

Notice Date: 9/26/2022 12:17:13 PM
Notice Type: Special Notice
Contracting Office: 247-NETWORK CONTRACT OFFICE 7 (36C247) AUGUSTA GA 30904 USA
ZIP Code: 30904
Response Due: 9/28/2022 1:00:00 PM
Archive Date: 10/05/2022
Point of Contact: Terrence McMillan, Phone: 70673301881126
E-Mail Address: terrence.mcmillan@va.gov
(terrence.mcmillan@va.gov)
Description: STATEMENT OF WORK (SOW) GENERAL INFORMATION �� 1.� Title of Project:� Histocompatibility Testing for Transplant Patients and Potential Donors 2.� Scope of Work:� The contractor shall provide all resources necessary to accomplish the deliverables described in this statement of work (SOW), except as may otherwise be specified.� This service is required to support the Birmingham VA Medical Center�s Kidney Transplant program. Organ Procurement and Transplant Network (OPTN) under contract with the Health Services Resources and Services Administration (HRSA) established and maintains the transplant policies and bylaws.� OPTN states that a transplant program must have a written agreement with an OPTN approved histocompatibility laboratory to perform the tissue typing of recipients and donors. �Histocompatibility testing is done to identify which human leukocyte antigen (HLA) genes and antigens a person has acquired, primarily to match donors and potential recipients of solid organ and bone marrow transplants and to detect antibodies to HLA antigen that would cause transplants to be unsuccessful.� Post-transplant donor specific antigen (DSA) monitoring may predict antibody-mediated rejection in sensitized kidney transplant recipients. 3.� Background:� HLA testing is blood test that identifies antigens on the surface of cells and tissues.� It requires the expertise of a Histocompatibility Laboratory and the ability to store multiple blood samples for an extended period.� We have been using University of Alabama at Birmingham Histocompatibility Lab services in the previous years through contract and would like to continue. Histocompatibility testing includes the following assays: HLA typing of recipients HLA typing of living doors HLA typing of deceased donors Screening for anti-HLA antibodies pre and post-transplant single antigen specificity Cross-matching of donor and recipient pairs DSA � Donor Specific Antibody- monitor patients after transplant for the presence and level of antibodies to the donor's HLA antigens �� The Following services are also required: Must be a certified Organ Procurement and Transplantation Network (OPTN) Histocompatibility Laboratory and must be compliant with all OPTN policies Adequate facilities to store medical and tests records for candidates, recipients and donors. Records for active candidates must be immediately accessible onsite. Virtual cross-matching services availability 24/7, 365 days Final cross-match services availability 24/7, 365 days Post- Transplant screening for DSA Listing and maintenance of all histocompatibility information in Donor-net (the UNOS site for organ allocation) Must have ability to directly enter HLA, PRA and Unacceptable into UNET (UNOS computer-based network for allocating donated organs and managing transplant data Must comply with all OPTN policies (see weblink below) https://optn.transplant.hrsa.gov/governance/policies/ �� 4.� Period of Performance:� Base year beginning upon reward of contract plus four possible option years. Base Year 10/1/2022-7/31/2023 Option Year 1 8/1/2023-7/31/2024 Option Year 2 8/1/2024-7/31/2025 Option Year 3 8/1/2025-7/31/2026 Option Year 4 8/1/2026-7/31/2027 5.� Type of Contract:� Firm fixed price. B.� SPECIFIC MANDATORY TASKS AND ASSOCIATED DELIVERABLES � �� Description of Tasks and Associated Deliverables:� The contractor shall provide the specific deliverables described within the performance period stated in Section A.4 of this SOW.� The Contractor must provide the BVAMC a Directory of Laboratory Services.� The following information shall be included in the Directory of Lab 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 range, 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 BVAMC Point of Contact, and/or the COR at least 14 days prior to the Contractor�s change.� No changes to procedures will be made with less than 14 days� notice. Test referred to another laboratory shall be at no additional transfer charge or confirmation charge to the BVAMC For all test identified in the Schedule of Supplies/Services, the contractor will provide the following information Ordering Code (Contractor�s Identification Code) CPT Codes Test Description Specimen Types Specimen collection and handling requirements Test results interpretation or interpretive remarks, if appropriate �� C.� CHANGES TO STATEMENT OF WORK Any changes to this SOW shall be authorized and approved only through written correspondence from the CO.� A copy of each change will be kept in a project folder along with all other products of the project.� Costs incurred by the contractor through the actions of parties other than the CO shall be borne by the contractor. D.� REPORTING REQUIREMENTS 1. The contractor shall provide the telephonic, fax, or electronic response within 24 hours from notification for specimen pick up, unless otherwise agreed, for STAT results.� The Contractor shall report all normal and abnormal test results to ordering laboratory upon completion of testing. �� 2.� A deceased donor crossmatch must be completed within six to eight hours from receipt of the specimen, unless otherwise agreed.� The contractor shall provide telephonic, fax, or electronic response with the results (preliminary or final) of other histocompatibility tests between 24-72 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.� �� 3. Telephone consultation- The Contractor shall consult with the COR, the requesting Clinician, or the designee at the ordering laboratory by telephones as needed.� The contractor shall immediately report critical values or test results that may indicate a life-threatening condition to a physician or a designated coordinator.� 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. �� 4.� A report is defined as a printed final copy of laboratory testing results.� This report shall be received by fax or electronically.� Each report shall, at minimum include: Patient�s name and/or identification code (social security number) UNOS Donor�s Name and ID Number Sequence on UNOS Match Run List Potential Recipient�s Blood Type Date of Sample Test Results Date/Time Requested Requesting Coordinator�s Name Lab Tech ID Donor HLA Typing Antibody against Donor To whom and time results were reported Any additional necessary comments E. Privacy and Security �On a periodic basis, Veterans Affairs, (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 ten business days� notice, at the request, of the government, the contractor must fully cooperate and assist in a government-sponsored security control assessment at each location wherein VA information is process or stored.� The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by the VA in the event of a security incident. F.� GOVERNMENT RESPONSIBILITIES For Veterans that live out of the city of Birmingham and/or have dialysis in the community, the VA will provide the blood sampling supplies and mailers for the samples to mailed to the HLA lab. Samples will be mailed using Fed-X so, that samples will be received in a timely manner and preserved for proper testing G.� CONTRACTOR EXPERIENCE REQUIREMENTS Qualifications:� The Contractor shall have all licenses, permits, accreditations and certifications required by law.� The reference laboratory must be licensed/accredited by the Joint Commission, College of American Pathologists (CAP), and/or any other state regulatory agencies as mandated by federal and state statues.� 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 Immunogentics (ASHI).� The Contractor shall maintain current accreditation and notify the Contraction Officer Representative (COR) of any lapse in state license, CLIA certification, or clinical pathology, Histocompatibility, or Cytogenetics certification.� The contractor officer shall provide a copy of the renewed licenses/certificates to the COR prior to expiration The Histocompatibility Lab must be a member of the Organ Procurement and Transplantation Network (OPTN) and such laboratory must conform to the Standards for Histocompatibility Testing set by OPTN. 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.� Additionally, the Contractor shall be responsible for providing a written guarantee or evidence that all subcontractors, if applicable, have appropriate license and accreditation.� H.� CONFIDENTIALITY AND NONDISCLOSURE �� It is agreed that: 1.� The preliminary and final deliverables, and all associated working papers, application source code, and other material deemed relevant by VA which have been generated by the contractor in the performance of this task order, are the exclusive property of the U.S. Government and shall be submitted to the CO at the conclusion of the task order. 2. �The CO will be the sole authorized official to release, verbally or in writing, any data, draft deliverables, final deliverables, or any other written or printed materials pertaining to this task order.� No information shall be released by the contractor.� Any request for information relating to this task order, presented to the contractor, shall be submitted to the CO for response. 3.� Press releases, marketing material, or any other printed or electronic documentation related to this project, shall not be publicized without the written approval of the CO. REQUIRED APPENDIX: �MARCH 12, 2010�� VA HANDBOOK 6500.6 �� APPENDIX B VA Handbook 6500.6 Appendix Clause: VA Acquisition Regulation Solicitation Provision and Contract Clause (October 2008) �� SUBPART 839.2 � Information and Information Technology Security Requirements 839.201 Contract clause for Information and Information Technology Security Due to the threat of data breach or loss of information that resides on either VA-owned or contractor-owned systems, and to comply with federal laws and regulations, VA has developed an Information and Information Technology Security clause. To be used when VA information is used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format (e.g., paper, microfiche, electronic or magnetic portable media). In solicitations and contracts where VA Information and/or Information Technology will be accessed or utilized, the contracting officer shall insert the clause found at 852.273-75, Security Requirements for Unclassified Information Technology Resources 852.273-75�- Security Requirements for Unclassified Information �� Technology Resources (interim- October 2008) As prescribed in 839.201, insert the following clause: The contractor and their personnel shall be subject to the same Federal laws, regulations, standards and VA policies as VA personnel, regarding information and information system security.� These include, but are not limited to Federal Information Security Management Act (FISMA), Appendix III of OMB Circular A-130, and guidance and standards, available from the Department of Commerce�s National Institute of Standards and Technology (NIST).�� This also includes the use of common security configurations available from NIST�s Web site at:� �� http://checklists.nist.gov To ensure that appropriate security controls are in place, Contractors must follow the procedures set forth in �VA Information and Information System Security/Privacy Requirements for IT Contracts� located at the following Web site : �� http://www.iprm.oit.va.gov/Security_and_Privacy_Requirements_for_Contractors.asp MARCH 12, 2010�� VA HANDBOOK 6500.6 �� APPENDIX C VA INFORMATION AND INFORMATION SYSTEMS SECURITY/PRIVACY LANGUAGE 1. GENERAL Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security. 2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order. b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures. c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness. d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor. e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor�s employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination. 3. VA INFORMATION CUSTODIAL LANGUAGE a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1). b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor�s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA�s information is returned to the VA or destroyed in accordance with VA�s sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. c. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed. f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12. g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship. h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated. i. The contractor/subcontractor�s firewall and Web services security controls, if applicable, shall meet or exceed VA�s minimum requirements. VA Configuration Guidelines are available upon request. j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA�s prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response. k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response. l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR. 4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment. b. The contractor/subcontractor shall certify to the COR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required. c. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default �program files� directory and silently install and uninstall. d. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges. e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle. f. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties. g. The contractor/subcontractor agrees to: (1) Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records otify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than twenty (20) days. k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within than twenty (20) days. l. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology. 5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor�s security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA�s network involving VA information...
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99 -- Histocompatibility Lab Antigen Testing