Attachment 1 Performance Work Statement TELERADIOLOGY PRE SOL NOTICE.docx

Performance Work Statement Services

1. GENERAL:

1.1. Services Provided: The Contractor shall provide Board Certified or Board Eligible Tele-Radiology Physician Services in accordance with the specifications contained herein to beneficiaries of the Department of Veterans Affairs (VA) and the Veterans Integrated Services Network (VISN) 9. The VA Radiology Services follow the standards & guidelines set forth by American College of Radiology (ACR) Practice Parameters and Technical Standards | American College of Radiology (acr.org) and/or the American Board of Nuclear Medicine Scope of Practice” https://www.abnm.org/wp-content/uploads/Components_Professional_Competence.pdf. A contractor providing tele-radiology services shall provide services consistent with TJC and that meet or exceed VA and the American College of Radiology Guidelines as defined in this document. A link to the MSO/VABIT PWS template is

1.2. Place of Performance: Contractor shall furnish services for the Veterans Integrated Services Network (VISN) 9 Medical Centers and their associated radiology service locations. (See Schedule of Services)

1.3. Authority: Title 38 USC 8153, Health Care Resources (HCR) sharing Authority.

1.4. Policy/Directives/Handbooks. The contractor shall be subject to the following policies, including any subsequent updates during the period of performance. The policies listed below can be accessed electronically at the following: VA Publications VHA Publications

1.4.1. VA Directive 1663: Health Care Resources (HCR) Contracting – Buying Title 38 U.S.C. 8153

1.4.2. VHA Directive 1003.04: VHA Patient Advocacy

1.4.3. VHA Directive 1065: Productivity and Staffing Guidance for Specialty Provider Group Practice

1.4.4. VHA Directive 1088(1): Communicating Test Results to Providers and Patients

1.4.5. VHA Directive 1100.18: Reporting and Responding to State Licensing Boards

1.4.6. VHA Directive 1100.20: Credentialing of Health Care Providers

1.4.7. VHA Directive 1100.21: Privileging

1.4.8. VHA Directive 1105.05 Magnetic Resonance Safety

1.4.9. VHA Directive 1129, Radiation Protection for Machine Sources of Ionizing Radiation

1.4.10. VHA Directive 1192.01: Seasonal Influenza Vaccination Program for VHA Health Care Personnel

1.4.11. VHA Directive 1220(1): Facility Procedure Complexity Designation Requirements to Perform Invasive Procedures in Any Clinical Setting

1.4.12. VHA Directive 1605.01: Privacy and Release of Information

1.4.13. VHA Directive 1907.01: VHA Health Information Management and Health Records

1.4.14. VHA Handbook 1100.17: National Practitioner Data Bank (NPDB) Reports

1.4.15. Privacy Act of 1974 (5 U.S.C. 552a) as amended: http://www.justice.gov/oip/foia_updates/Vol_XVII_4/page2.htm

1.4.16. National Institute of Standards and Technology: Federal Information Processing Standards (FIPS) http://scrc.nist.gov/pulications/fips/index.html

1.4.17. National Institute of Standards and Technology Special Publications 800 Series http://csrc.nist.gov/publications/nistpubs/index.html

1.4.18. 42 Code of Federal Regulations (CFR) Part 482 Conditions of Participation Hospitals:https://www.ecfr.gov/cgi-bin/text-idx?node=pt42.5.482&rgn=div5

1.4.19. VHA Directive 1417: Lung Cancer Screening

1.4.20. VA Handbook 6513: Secure External Connections

1.5 Acronyms/Definitions: Terms 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.

1.5.1. ACEP: American College of Emergency Physicians

1.5.2. ACGME: Accreditation Council for Graduate Medical Education

1.5.3. ACO: Administrative Contracting Officer – A Contracting Officer engaged in administering contracts

1.5.4. AIS: Automated information Security

1.5.5. AOD: Admitting Officer of the Day

1.5.6. BAA: Business Associate Agreement – a contract between VHA and a business associate, entered into before releasing PHI to the business associate, in order for the business associate to perform a covered activity for VHA.

1.5.7. BPE: Business Partner Extranets are encrypted connections between the VA and an external entity (business partner, vendors, affiliate university, etc.) through one of the VA TIC gateways. BPEs use a leased circuit to connect the two partners directly, which makes the connection capable of supporting higher bandwidth requirements.

1.5.8. CBO: VA Central Billing Office

1.5.9. CDC: Centers for Disease Control and Prevention

1.5.10. CDR: Contract Discrepancy Report

1.5.11. CEU: Certified Education Unit

1.5.12. Clinical Privileging: Clinical Privileging is the process by which a practitioner, licensed for independent practice; e.g., without supervision, direction, required sponsor, preceptor, mandatory collaboration, etc.; is permitted by law and the facility to practice independently, to provide specific medical or other patient care services within the scope of the individual’s license, based upon the individual’s clinical competence as determined by peer references, professional experience, health status, education, training and licensure. Clinical privileges must be facility-specific and provider-specific, and within available resources.

1.5.13. CME: Continuing Medical Education

1.5.14. CMS: Centers for Medicare and Medicaid Services

1.5.15. Confidentiality: Preserving authorized restrictions on access and disclosure, including means for protecting personal privacy and proprietary information. Source: 38 U.S.C §5727.

1.5.16. CO: Contracting Officer: 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.

1.5.17. Continuity of Operations Plan (COOP): A COOP provides guidance on the system restoration for emergencies, disasters, mobilization, and to maintain a state of readiness to provide the necessary level of information processing support commensurate with the mission requirements/priorities identified by the respective functional proponent. The Federal Government and its supporting agencies traditionally use this term to describe activities otherwise known as disaster recovery, business continuity, business resumption, or contingency planning. Source: VA Handbook 6500.8.

1.5.18. COR: Contracting Officer’s Representative: A person appointed by the CO 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.

1.5.19. COS: Chief of Staff

1.5.20. Covered Entity: A Covered entity subject to the HIPAA Privacy and Security Rules is (a) a health care provider who transmits any health information in electronic form in connection with a transaction covered by the Rules: (b) a health care clearinghouse: or (c) a health insurance plan. Source: C.F.R. §160.103.

1.5.21. CPARS: Contractor Performance Assessment Reporting System

1.5.22. CPRS: Computerized Patient Recordkeeping System – electronic health record system used by the VA.

1.5.23. CPT: Current Procedural Terminology

1.5.24. Credentialing: Credentialing is the process of obtaining, verifying, and assessing the qualifications of a health care provider to provide care or services in or for the VA health care system. Credentials are documented evidence of licensure, education, training, experience or other qualifications.

1.5.25. CV: Curriculum Vitae

1.5.26. Data Breach: The loss, theft, or other unauthorized access, other than those incidental to the scope of employment, to data containing SPI, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Source: 38 U.S.C. §5727.

May or may not be a breach under the HIPAA Privacy and Security Rules, which define “Breach” as the unauthorized acquisition, access, use, or disclosure of PHI in violation of the HIPAA Privacy Rule which compromises the security or privacy of such information, except where an unauthorized person to show such information is disclosed would not reasonably have been able to retain such information. Under these Rules, breach of PHI excludes:

a. Any unintentional acquisition, access, or use of PHI by an employee or individual acting under the authority of a covered entity or business associate if such acquisition, access, or use was made in good faith and within the course and scope of the employment or other professional relationship with the covered entity or business associate and does not result in further use or disclosure.

b. Any inadvertent disclosure from an individual who is otherwise authorized to access PHI at a facility operated by a covered entity or business associated to another similarly situated individual at some facility.

c. Any such information received because of such disclosure is not further acquired, accessed, used, or disclosed without authorization by any person. Source: 45 C.F.R. §164.402.

1.5.27. DEA: Drug Enforcement Agency

1.5.28. DICOM: Digital Image and Communication in Medicine

1.5.29. DIGMA: Drop-In Group Medical Appointment

1.5.30. DSS: Decision Support Group

1.5.31. EHR: Electronic Health Record - electronic health record system used by the VA

1.5.32. EPRP: External Peer Review Program

1.5.33. FDA: Food and Drug Administration

1.5.34. FIPS: Federal Information Processing Standards

1.5.35. FISMA: The Federal Information Security Management Act

1.5.36. FSMB: Federation of State Medical Boards

1.5.37. FTE: Full Time Equivalent VA’s standard definition is for full time working an equivalent of 80 hours every two weeks, 2080 hours per year. However, providers may propose using their standard FTE definition.

1.5.38. Health Information: Health information is any information, whether oral or recorded in any form or medium, created or received by a health care provider, health plan, public health authority, employer, life insurers, school or university, or health care clearinghouse or health plan that relates to the past, present, or future physical or mental health or condition of an individual; the provision of health care to an individual. This encompasses information pertaining to examination, medical history, diagnosis, and findings or treatment, including laboratory examinations, X-rays, microscopic slides, photographs, and prescriptions, Source: 45 C.F.C. §160.103.

1.5.39. HHS: Department of Health and Human Services

1.5.40. HIMS: Health Information Management System

1.5.41. HIPAA: Health Insurance Portability and Accountability Act

1.5.42. HL7: Health Level Seven

1.5.43. HR: Human Resources

1.5.44. Incident: An occurrence that actually or potentially jeopardizes the confidentiality, integrity, or availability of an information system or the information the system processes, stores, or transmits or that constitutes a violation or imminent threat of violation of security policies, security procedures, or acceptable use policies. Source: FIPS 200; NIST SP 800-53.

1.5.45. Individually Identifiable Health Information: Information, including demographic data, that (a) relates to an individual’s past, present or future physical or mental health or condition, the provision of health care to an individual, or the past, present, or future payment for the provision of health care to an individual, and (b) identifies the individual or for which there is a reasonable basis to believe it can be used to identify the individual. Source: 45 C.F.R. §160.103.

1.5.46. ISO: Information Security Officer

1.5.47. Information Security Requirements: Information security requirements promulgated in accordance with law, or directed by the Secretary of Commerce, NIST, and OMB, and, as to national security systems, the President. Source: 38 U.S.C. §5727.

1.5.48. Key Personnel: The individuals specified in this contract who are essential to work performance.

1.5.49. Local Area Network (LAN): A Datacom system allowing a number of independent devices to communicate directly with each other, within a moderately sized geographic area over a physical communications channel of moderate rates. Source: FIPS 191

1.5.50. MOD: Medical Officer of the Day

1.5.51. NIST: National Institute of Standards and Technology

1.5.52. NPI: National Provider Identifier. NPI is a standard, unique 10-digit numeric identifier required by HIPPA. The Veterans Health Administration must use NPIs in all HIPAA-standard electronic transactions for individual (health care practitioners) and organizational entities (medical centers)

1.5.53. NPPES: National Plan and Provider Enumeration System

1.5.54. OA&L: Office of Acquisition and Logistics

1.5.55. OSHA: Occupational Safety and Health Administration

1.5.56. PACS: Picture Archiving and Communications System

1.5.57. PACT: Patient Aligned Care Team Background and Introduction: VA Has implemented a PCMH model at all VA Primary Care sites which is referred to as PACT. This initiative supports VHA’s Universal Health Care Services Plan to redesign VHA healthcare delivery through increasing access, coordination, communication, and continuity of care. PACT provides accessible, coordinated, comprehensive, patient-centered care, in team-based environment including the active involvement of other clinical and non-clinical staff. PACT allows patients to have a more active role in their health care and is associated with increased quality improvement, patient satisfaction, and a decrease in hospital costs due to fewer hospital visits and readmissions.

1.5.58. PHI: Protected Health Information - Individually identifiable health information held by a covered entity or by a business associated acting on its behalf. PHI excludes education records covered by the Family Educational Rights and Privacy Act, as amended, 20 U.S.C. §1232g, records described at 20 U.S.C. §§1232(g)(a)(4)(B)(iv), and employment records held by a covered entity in its role as employer. Within VA, VHA is the only covered entity. Certain other VA components, such as OI&T, are business associates of VHA. Source: 45 C.F.R. §160.103; VA Directive 6066.

1.5.59. PII: Personally Identifiable Information - Any information which can be used to distinguish or trace an individual’s identity, such as their name, social security number, biometric records, etc., alone, or when combined with other personal or identifying information which is linked or linkable to a specific individual, such as date and place of birth, mother’s maiden name, etc. Information does not have to be retrieved by any specific individual or unique identifier (i.e., covered by the Privacy Act) to be PII (See Sensitive Personal Information, below). Source: OMB M-07-16

1.5.60. PO: Privacy Officer – The PO is responsible for taking proactive measures to help ensure that PII collected by VA is limited to that which is legally authorized and necessary; and is maintained in a manner that precludes unwarranted intrusions upon individual privacy; thereby minimizing privacy events. Additionally, it is the defensive duty of a PO to assist in mitigating damage when PII is compromised. Source: VA Directive 6509.

1.5.61. POP: Period of Performance

1.5.62. PPD: Purified Protein Derivative

1.5.63. Privacy Event: A Privacy Event is a confirmed instance in which information protected by HIPAA; the Privacy Act of 1974; or other confidentiality statues such as 38 U.S.C. §§ 5701, 5705, or 7332 may have been improperly disclosed, and includes the loss, theft, or any other unauthorized access, or any other access than that which is incidental to the scope of employment, to data containing SPI in electronic, printed, or any other format, and results in the potential compromise of the confidentially or integrity of the data regardless of the manner in which the breach might have occurred. Source: VA Directive 6509.

1.5.64. PWS: Performance Work Statement

1.5.65. QA/QI: Quality Assurance/Quality Improvement

1.5.66. QASP: Quality Assurance Surveillance Plan

1.5.67. QM/PI: Quality Management/Performance Improvement

1.5.68. Remote Access: Access by users (or information systems) communicating externally to an information system security perimeter. Source: NIST SP 800-18. Remote access uses telecommunications to enable authorized access to non-public VA computing services that would otherwise be inaccessible from work location outside a VA LAN or VA-controlled wide area network (WAN) computing environment. Remote Access includes access to non-public VA Information Systems and data that are exposed to the public Internet (e.g., web access to electronic mail (email) by the home user or business traveler) as well as modem, dial-up and/or Virtual Private Network (VPN) access to internal VA IT servers and desktop workstations.

1.5.69. Security Controls: The management, operational, and technical controls (i.e., safeguards or countermeasures) prescribed for an information system to protect the confidentiality, integrity, and availability of the system and its information. Source: NIST SP 800-53; NIST SP 800-37; NIST SP 800-53A; NIST SP 800-60; FIPS 200; FIPS 199; CNSSI-4009.

1.5.70. Sensitive Personal Information (SPI): The term, with respect to an individual, means any information about the individual maintained by VA, including the following: (i) education, financial transactions, medical history, and criminal or employment history; (ii) information that can be used to distinguish or trace the individual’s identity, including name, social security number, date and place of birth, mother’s maiden name, or biometric records. Source: 38 U.S.C. §5727.

1.5.71. SOP (Clinical): Scope of Practice

1.5.72. TIC: Trusted Internet Connection

1.5.73. TJC: The Joint Commission

1.5.74. Technical Controls: The security controls (i.e., safeguards or countermeasures) for an information system that are primarily implemented and executed by the information system through mechanisms contained in the hardware, software, or firmware components of the systems. Source: NIST SP 800-53; NIST SP 800-53A; NIST SP 800-37; FIPS 200.

1.5.75. Threat: Any circumstance or event with the potential to adversely impact organizational operations (including mission, functions, image, or reputation), organizational assets, individuals, other organizations, or the Nation through an information system via unauthorized access, destruction, disclosure, modification of information, and/or DoS. Source: NIST SP 800-53; NIST SP 800-53A; NIST SP 800-27A; SP 800-60; NIST SP 800-37; CNSSI-4009.

1.5.76. Training: A learning experience in which an individual is taught to execute a specific information security procedure or understand the information security common body of knowledge. Source: 38 U.S.S. §5727.

1.5.77. User: Individual or (system) process acting on behalf of an individual and authorized to access an information system. Source: NIST SP 800-53, NIST SP 800-18; CNSSI-4009. At VA, users are Department personnel, employees, contractors working under an approved contract, business associates working under approved business associate agreements, and any other individuals providing services or performing functions for, to, or on behalf of VA who have been authorized by VA to access VA information or information systems. To access VA information or VA information systems, these individuals must complete VA-approved security and privacy awareness training, sign the VA National Rules of Behavior (ROB) or Contractor ROB, and complete appropriate background screening before such access may be granted.

1.5.78. VA: Veterans Administration

1.5.79. VA Contractor Rules of Behavior: A set of Department of rules that describes the responsibilities and expected behavior of contractors using VA information systems or VA sensitive information. Source: 38 U.S.C. §5727.

1.5.80. VA Information/Data: Information collected or maintained by or on behalf of VA. Generally, it includes information collected or maintained by a VA contractor in the performance of services under a VA contract but excludes information received from VA by entities over which VA has no statutory or operational authority, such as other Federal agencies. Source: FISMA.

1.5.81. VAMC: Veterans Affairs Medical Center – Unless identified with the name of a different VA medical center, for purposes of this contract, this term shall mean all Medical Centers within VISN 9.

1.5.82. VA National Rules of Behavior: A set of Department rules that describes the responsibilities and expected behavior of users of VA information systems or VA information. Source: 38 U.S.C. §5727.

1.5.83. VA Sensitive Information/Data: All Department Information and/or data on any storage media or in any form or format, which requires protection due to the risk of harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the information. The term includes not only information that identifies an individual but also other information whose improper use or disclosure could adversely affect the ability of an agency to accomplish its mission, proprietary information, and records about individuals requiring protection under applicable confidentiality provisions. Source: 38 U.S.C. §5727.

1.5.84. VetPro: a federal web-based credentialing program for healthcare providers. It is VHA’s mandatory credentialing software platform to document the credentialing of VHA health care providers. This system facilitates completion of a uniform, accurate, and complete credentials file.

1.5.85. VHA: Veterans’ Health Administration

1.5.86. VISN: Veterans Integrated Services Network

1.5.87. VISTA: Veterans Information Systems Technology Architecture

1.5.88. VPN: Virtual Private Network – A virtual network built on top of existing networks that can provide a secure communications mechanism for data and Internet protocol (IP) information transmitted between networks. Source: NIST SP 800-113.

1.5.89. Vulnerability: Weakness in an information system, system security procedures, internal controls, or implementation that could be exploited by a threat source. Source: NIST SP 800-53; NIST SP 800-53A; NIST SP 800-37; NIST SP 800-60; NIST SP 800-115; FIPS 200

1.5.90. WAN: Wide Area Network – VA’s WAN is a telecommunication network that covers a broad area (i.e., any network that links across metropolitan, regional, or national boundaries) and may be comprised of one or more LANs connected to each other. Source: VA Adapted

2. QUALIFICATIONS:

2.1. Staff/Facility

2.1.1. License: Contract physician(s) assigned by the Contractor to perform the services covered by this contract shall have a current license to practice medicine in any State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by the key personnel working on this contract shall be full and unrestricted licenses. Information on state licensing in tele-radiology may be found at this site: Teleradiology | American College of Radiology (acr.org). Contracted Teleradiology health care professionals (providers) must be compliant with state licensure requirements identical to that of VA staff, which currently require the provider to continuously hold at least one active and unrestricted license in any state, the absence of restrictions on any other license held, and all inactive licenses relinquished in good standing.

2.1.2. Board Certification: All contract physician(s) shall be Board Certified in diagnostic radiology and/or nuclear medicine. All continuing education courses required for maintaining certification must be kept up to date at all times. Documentation verifying current certification shall be provided by the Contractor to the VA COR on an annual basis for each year of contract performance.

2.1.3. Credentialing and Privileging: Credentialing and privileging is to be done in accordance with the provisions of VHA Directive 1100.20 and VHA Directive 1100.21 referenced above. The Contractor is responsible to ensure that proposed physician(s) possesses the requisite credentials enabling the granting of privileges. No services shall be provided by any contract physician(s) prior to obtaining approval by the Facility Medical Executive Board and Medical Center Director.

2.1.3.1 If a contract physician(s) is not credentialed and privileged or has credentials/privileges suspended or revoked, the Contractor shall furnish an acceptable substitute without any additional cost to the government.

2.1.3.2 When telemedicine services are being provided by contract physician(s) who direct, diagnose, or otherwise provide clinical treatment to a patient via a telemedicine link, the contract physician(s) must be appointed, credentialed, and privileged at the VA facility (facilities) which receive the telemedicine services (patient site), as well as at the site providing the services. The following requirements apply:

2.1.3.3 Contract licensed independent practitioners must be credentialed and privileged through the VA facility’s Medical Staff Office in accordance Credentialing and Privileging Directives 1100.20 and 1100.21 and VHA Directive 1914

2.1.3.4 Separately delineated privileges for telemedicine services must be requested and assigned in this process.

2.1.3.5 In general, the credentialing process should be started at least 60-90 days in advance of estimated entry on duty. The time required for this process may be expedited when patient care needs are urgent.

2.1.3.6 The VA’s Medical Staff Office or Human Resources Management Service will provide an instruction packet containing forms and a detailed listing of required documentation, including curriculum vitae, current references, signed release of information from the candidate, and statement that the candidate does not have any physical or mental health condition that would adversely affect his/her ability to carry out the assigned duties, and additional credentialing forms. The candidate will also be required to make application through the VetPro internet-based process. The candidate will need to be enrolled in VetPro by the Credentialing Coordinator at the VA or by the Human Resources Management Service designee. The website address is: https://fcp.vetpro.org/Admin/Login/Index

2.1.3.7 It is the Contractor’s responsibility to contact the primary assigned VISN 9 credentialing service to request a package and instructions.

2.1.3.8 The Contractor must furnish a copy of its policy and procedures for credentialing and privileging to the Contracting Officer and COR for review to ensure these meet the VA’s requirements for establishment of competence through these mechanisms.

2.1.4. Technical Proficiency - Contract physician(s) shall be technically proficient in the skills necessary to fulfill the government’s requirements, including the ability to speak, understand, read and write English fluently. Contractor shall provide documents upon request of the CO/COR to verify current and ongoing competency, skills, certification and/or licensure related to the provision of care, treatment and/or services performed. Contractor shall provide verifiable evidence of all educational and training experiences including any gaps in educational history for all contract physician(s) and contract physician(s) shall be responsible for abiding by the Facility's Medical Staff By-Laws, rules, and regulations (referenced herein) that govern medical staff behavior.

2.1.5. Continuing Medical Education (CME)/ Certified Education Unit (CEU) Requirements: Contractor shall provide the COR copies of current CMEs as required or requested by the Facility. Contract physician(s) registered or certified by national/medical associations shall continue to meet the minimum standards for CME to remain current. Contractor shall report CME hours to the credentials office for tracking. These documents are required for both privileging and re-privileging. Failure to provide shall result in loss of privileges for contract physician(s).

2.1.6. Training (VA MANDATORY): Contractor shall meet all VA educational requirements and mandatory course requirements defined herein; all training must be completed by the contract physician(s) as required by the VA.

2.1.7. National Provider Identifier (NPI): NPI is a standard, unique 10-digit numeric identifier required by HIPAA. The Veterans Health Administration must use NPIs in all HIPAA-standard electronic transactions for individual (health care practitioners) and organizational entities (medical facilities). The Contractor shall have or obtain appropriate NPI and if pertinent the Taxonomy Code confirmation notice issued by the Centers for Medicare and Medicaid Services (CMS) National Plan and Provider Enumeration System (NPPES) be provided to the Contracting Officer with the proposal.

2.1.8. Conflict of Interest: The Contractor and all contract physician(s) are responsible for identifying and communicating to the CO and COR conflicts of interest at the time of proposal and during the entirety of contract performance. At the time of proposal, the Contractor shall provide a statement which describes, in a concise manner, all relevant facts concerning any past, present, or currently planned interest (financial, contractual, organizational, or otherwise) or actual or potential organizational conflicts of interest relating to the services to be provided. The Contractor shall also provide statements containing the same information for any identified consultants or subcontractors who shall provide services. The Contractor must also provide relevant facts that show how it’s organizational and/or management system or other actions would avoid or mitigate any actual or potential organizational conflicts of interest. These statements shall be in response to the VAAR provision 852.209-70 Organizational Conflicts of Interest and fully outlined in response to the subject attachment in Section D of the solicitation document.

2.1.9. Citizenship related Requirements:

2.1.9.1. The Contractor certifies that the Contractor shall comply with any and all legal provisions contained in the Immigration and Nationality Act of 1952, As Amended; its related laws and regulations that are enforced by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor as these may relate to non-immigrant foreign nationals working under contract or subcontract for the Contractor while providing services to Department of Veterans Affairs patient referrals;

2.1.9.2. While performing services for the Department of Veterans Affairs, the Contractor shall not knowingly employ, contract or subcontract with an illegal alien; foreign national non-immigrant who is in violation their status, as a result of their failure to maintain or comply with the terms and conditions of their admission into the United States. Additionally, the Contractor is required to comply with all “E-Verify” requirements consistent with “Executive Order 12989” and any related pertinent Amendments, as well as applicable Federal Acquisition Regulations.

2.1.9.3. If the Contractor fails to comply with any requirements outlined in the preceding paragraphs or its Agency regulations, the Department of Veterans Affairs may, at its discretion, require that the foreign national who failed to maintain their legal status in the United States or otherwise failed to comply with the requirements of the laws administered by Homeland Security, Immigration and Customs Enforcement and the U.S Department of Labor, shall be prohibited from working at the Contractor’s place of business that services Department of Veterans Affairs patient referrals; or other place where the Contractor provides services to veterans who have been referred by the Department of Veterans Affairs; and shall form the basis for termination of this contract for breach.

2.1.9.4. This certification concerns a matter within the jurisdiction of an agency of the United States and the making of a false, fictitious, or fraudulent certification may render the maker subject to prosecution under 18 U.S.C. 1001.

2.1.9.5. The Contractor agrees to obtain a similar certification from its subcontractors. The certification shall be made as part of the offerors response to the RFP using the subject attachment in Section D of the solicitation document.

2.1.10. Annual Office of Inspector General (OIG) Statement: In accordance with HIPAA and the Balanced Budget Act (BBA) of 1977, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) has established a list of parties and entities excluded from Federal health care programs. Specifically, the listed parties and entities may not receive Federal Health Care program payments due to fraud and/or abuse of the Medicare and Medicaid programs.

2.1.10.1. Therefore, Contractor shall review the HHS OIG List of Excluded Individuals/Entities on the HHS OIG web site at http://oig.hhs.gov/exclusions/index.asp to ensure that the proposed contract physician(s) are not listed. Contractor should note that any excluded individual or entity that submits a claim for reimbursement to a Federal health care program, or causes such a claim to be submitted, may be subject to a Civil Monetary Penalty (CMP) for each item or service furnished during a period that the person was excluded and may also be subject to treble damages for the amount claimed for each item or service. CMP’s may also be imposed against the Contractor that employ or enter into contracts with excluded individuals to provide items or services to Federal program beneficiaries.

2.1.10.2. By submitting their proposal, the Contractor certifies that the HHS OIG List of Excluded Individuals/Entities has been reviewed and that the Contractors are and/or firm is not listed as of the date the offer/bid was signed.

2.2. Clinical/Professional Direction: The qualifications of Contractor personnel are subject to review by VA Medical Facility COS or his/her clinical designee and approval by the Medical Facility Director as provided in VHA Directive 1100.20 and VHA Directive 1100.21. Clinical/Professional direction of all clinical personnel covered by this contract for quality purposes will be provided by the Facility COS and/or the Chief of the Service or his designee. A clinical COR may be appointed, however, only the CO is authorized to consider any contract modification request and/or make changes to the contract during the administration of the resultant contract.

2.3. Non-Personal Healthcare Services: The parties agree that the Contractor and all contract physician(s) shall not be considered VA employees for any purpose.

2.4. Indemnification: The Contractor shall be liable for, and shall indemnify and hold harmless the Government against, all actions or claims for loss of or damage to property or the injury or death of persons, arising out of or resulting from the fault, negligence, or act or omission of the Contractor, its agents, or employees.

2.5. Prohibition Against Self-Referral: Contractor’s physicians are prohibited from referring VA patients to contractor’s or their own practice(s)

2.6. Inherent Government Functions: Contractor and Contract physician(s) shall not perform inherently governmental functions. This includes, but is not limited to, determination of agency policy, determination of Federal program priorities for budget requests, direction and control of government employees (outside a clinical context), selection or non-selection of individuals for Federal Government employment including the interviewing of individuals for employment, approval of position descriptions and performance standards for Federal employees, approving any contractual documents, approval of Federal licensing actions and inspections, and/or determination of budget policy, guidance, and strategy.

2.7. No Employee status: The Contractor shall be responsible for protecting Contract physician(s) furnishing services. To carry out this responsibility, the Contractor shall provide or certify that the following is provided for all their staff providing services under the resultant contract:

2.7.1. Workers’ compensation

2.7.2. Professional liability insurance

2.7.3. Health examinations

2.7.4. Income tax withholding, and

2.7.5. Social security payments.

2.8. Tort Liability: The Federal Tort Claims Act does not cover Contractor or contract physician(s). When a Contractor or contract physician(s) has been identified as a provider in a tort claim, the Contractor shall be responsible for notifying their legal counsel and/or insurance carrier. Any settlement or judgment arising from a Contractor’s (or contract physician(s)) action or non-action shall be the responsibility of the Contractor and/or insurance carrier.

2.9. Contingency Plan: Because continuity of care is an essential part of the Facility’s medical services, The Contractor shall have a contingency plan in place to be utilized if the contract physician(s) leaves Contractor’s employment or is unable to continue performance in accordance with the terms and conditions of the resulting contract.

2.9.1. Contractor shall submit a listing of proposed key personnel performing technical delivery of services in the following format:

Provider Name: __________________ Title/Rank: ____________________.

2.9.2 Curriculum Vitae and qualification documents of each key personnel shall be submitted with the proposal.

2.9.3 Data telecommunications contingency planning will ensure continuity of teleradiology services supporting the VA during the temporary and long-term loss of data communication connectivity with the VA.

2.10. Emergency Substitutions: During the first ninety (90) calendar days of performance, the Contractor shall make NO substitutions of key personnel unless the substitution is necessitated by illness, death or termination of employment. The Contractor shall notify the CO, in writing, within 15 calendar day (s) after the occurrence of any of these events and provide the information required below. After 90 days, the Contractor shall submit the information required below to the CO at least 15 calendar days prior to making any permanent substitutions

2.10.1. The Contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitutions, complete resumes for the proposed substitutes, and any additional information requested by the CO. Proposed substitutes shall have comparable qualifications to those of the persons being replaced. The CO will notify the Contractor within 15 calendar days after receipt of all required information of the decision on the proposed substitutes. The contract will be modified to reflect any approved changes of key personnel

2.10.2. For temporary substitutions where the key person shall not be reporting to work for three 3 consecutive work days or more, the Contractor shall provide a qualified replacement for the key person. The substitute shall have comparable qualifications to the key person. Any period exceeding two weeks will require the procedure as stated above.

3. VA HOURS OF OPERATION/SCHEDULING

3.1. Business Hours: The VISN 9 VAMCs normal hours of operations are Monday through Friday, 8:00 am till 4:30pm (local time- NOTE: VISN 9 geographical area covers two (2) time zones: Eastern Time and Central Time), except for Federal Holidays identified in paragraph 3.3. (NOTE: Federal holidays falling on Saturday are normally observed on the preceding Friday and holidays falling on Sunday are normally observed the following Monday.) VISN 9 VAMCs provide primary healthcare, urgent/emergency care, and mental healthcare 24- hours a day, 7 days a week, 52 weeks a year.

3.2. Contractor shall be available to the Facility for consultation and interpretation 24 hours a day, 7 days a week, 52 weeks a year for stat, urgent, and routine exams.

3.3. Federal Holidays: The following holidays are observed by the Department of Veterans Affairs:

· New Year’s Day

· Martin Luther King’s Birthday

· President’s Day

· Memorial Day

· Juneteenth

· Independence Day

· Labor Day

· Columbus Day

· Veterans Day

· Thanksgiving

· Christmas

· Any day specifically declared by President of the United States to be a national holiday.

3.4. Continuity of services under contact: Unless a state of emergency has been declared or services are otherwise cancelled by the VAMC, the Contractor shall be responsible for providing services.

3.4.1. Contractor is responsible for providing qualified personnel to read radiology/nuclear medicine images. Contractor is responsible to provide back-up staff if scheduled staff becomes unavailable due to illness or emergency.

3.4.2. The contractor shall maintain open and professional communication with members of the VISN and Facility Diagnostic Imaging staff. The contractor shall provide up-to-date points of contact to facilitate communication on clinical, technical and administrative issues. Clinical staff will be available by phone and pager 24/7. The Contractor will provide a schedule of radiologists with telephone numbers for consultation by VA technologists and referring physicians. Any changes of contact information will be provided to the VA within 24 hours of the applicable change.

3.4.3. The Contractor shall provide a single phone number which is staffed 24-hours a day, seven days per week, 365 days per year to resolve issues and/or expedite communications between ordering physicians and assigned tele-radiologist providing the evaluation.

3.4.4. The Contractor shall provide phone numbers and email addresses for communication with VAMC personnel. Contractor shall be readily and bidirectionally available and consistent with the ACR Practice Guideline for Communication of Diagnostic Imaging Findings. Pathway of easy and prompt communication should be well established, agreed upon, and facilitated by both parties. Although various delivery formats are available, including a landline telephone, smart phone, electronic medical record, e-mail and voicemail, the delivery methos should be the choice of the referring VA provider.

3.4.5. The Contractor shall provide a web-based portal for management of Radiology exams that is utilized by technologists and administrative personnel.

3.4.6. American College of Radiology, ACR practice guideline for communication of diagnostic imaging findings. Practice Parameters and Technical Standards | American College of Radiology (acr.org).

3.4.7. The Contractor’s teleradiologist/Telehealth provider shall escalate their efforts to communicate when a provider cannot be reached immediately when results require synchronous (usually via telephone) physician-to-physician communications.

3.4.8. The Contractor shall provide an update schedule of tele-radiologists supporting this contract to the assigned COR and/or designee within 24 hours of any changes. This will include contact information for each teleradiologist.

3.4.9. The contractor’s interpreting teleradiologist shall be available for consultation with the ordering physician/clinician and with other VA radiologists.

3.4.10. Tele-Communications

3.4.10.1. The contractor will secure and maintain the communications link between the contractor’s facility and the VAMCs’ facilities at the contractor’s expense.

3.4.10.2. The contractor shall plan and be prepared to receive radiographic orders and images and then communicate the results via HL7. During loss of data telecommunications services, an alternate means of communication must be in place to ensure continuation of services. The alternate means of communication must ensure protection of personal health information.

3.4.10.3. The contractor shall make provisions for the proper maintenance and functioning of all imaging, teleradiology and associated equipment, facilities and fixtures as may reasonably be required by Contract Physicians to perform services hereunder.

4. CONTRACTOR RESPONSIBILITIES

4.1. Clinical Personnel Required: The Contractor shall provide contract physician(s) who are competent, qualified per this performance work statement and adequately trained to perform assigned duties.

4.2. Management and Supervision:

4.2.1. The Contractor shall be responsible for supervising the daily services provided under this contract by the Contractor’s staff.

4.2.2. The Contractor shall have written policies and procedures regarding staff credentials and privileging.

4.2.3. The Contractor will provide a FIPS web-based means for the electronic transmission of radiographic orders.

4.2.4. The VAMC will provide to the Contractor policies, procedures and processes necessary to allow cooperative functioning between the agency and Facility. Updates and refreshers will be provided to the Contractor upon request and when policy procedures or process changes.

4.2.5. The Contractor shall complete background investigations to ensure that employees do not have a record of criminal offenses or substantiated incidents of patient abuse; and, if required to perform their duties, employees are properly licensed and insured to operate motor vehicles.

4.3. Standards of Care: The contract physician(s)’ care shall cover the range of Radiology services as would be provided in a state-of-the-art civilian medical treatment facility and the standard of care shall be of a quality, meeting or exceeding the currently recognized national standards as established by:

4.3.1. The American College of Radiology Guidelines: https://www.acr.org/-/media/ACR/Files/Practice-Parameters/IRClin-Prac-Mgmt.pdf.pdf

4.3.2. ACR Practice Parameter for Communication of Diagnostic Imaging Findings: communicationDiag (acr.org)

4.3.3. VA Standards: The diagnostic imaging results must be electronically transferred to each VAMC VA VistA System via Health Level Seven (HL7) compatible means. Contractor will conform to the most current published Radiology/Nuclear medicine 5.0 HL7 interface specification for a bi-directional HL7 interface to support the transfer of requests/orders and publishing final reports by the teleradiology / Tele-health Providers.

4.3.3.1. Specifications can be found on the VA Software Documentation library website. Specifications at the time of this solicitation are indicated below:

http://www.va.gov/vdl/documents/Clinical/Radiology_Nuclear_Med/ra5_0hl7is_vr.pdf http://www.va.gov/vdl/documents/Clinical/Radiology_Nuclear_Med/ra5_0hl7is.pdf

4.3.3.2. During emergencies such as VistA downtime and other unforeseen incidences that does not allow for final report to be transmitted via LH7 interface, the VA shall allow for faxed report from Teleradiology/Tele-health Providers be inputted into the patient’s medical records in accordance with HIMS regulations if it is deemed as an acceptable means of transmission. Final electronic report shall be transmitted via HL7 interface once VistA system/s has been restored.

4.3.3.3. Contractor dictation system must interface and transmit final reports via HL7 messaging to VistA and include use of VA established National Diagnostic Codes. Every final report must include at minimum one diagnostic code.

4.3.4. The professional standards of the Joint Commission (TJC): http://www.jointcommission.org/standards_information/hap_requirements.aspx

4.3.5. The standards of the American Hospital Association (AHA): http://www.hpoe.org/resources?show=100&type=8 and;

4.3.6. The requirements contained in this PWS

4.3.7. The contractor will be responsible to ensure all sub-contractors meet or exceed the requirements within the PWS. Small business concerns and/or other than small business concerns shall provide in their original proposal the following information:

4.4 MEDICAL RECORDS

4.4.1 Authorities: Contractor’s physician(s) providing healthcare services to VA patients shall be considered as part of the Department Healthcare Activity and shall comply with the 5 U.S.C.552a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of certain medical records), Title 5 U.S.C. § 522a (Records Maintained on Individuals) as well as 45 C.F.R. Parts 160, 162, and 164 (HIPAA).

4.4.2 HIPAA: This contract and its requirements meet exception in 45 CFR 164.502(e), and do not require a BAA in order for Covered Entity to disclose Protected Health Information to: a health care provider for treatment of VA patients. Based on this exception, a BAA is not required for this contract. Health records generated by this contract or provided to the Contractors by the VA are covered by the VA Privacy Act system of records entitled ‘Patient Medical Records-VA’ (24VA10A7). Contractor generated VA Patient records are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable laws and regulations. Contractor shall ensure that all records pertaining to medical care and services provided to VA patients are captured in the VA electronic health record system as required by VA policy as discussed in 4.5.4.

4.4.3 Disclosure: Contractor’s physician(s) may have access to patient medical records for the purpose of providing medical care and services to VA patients and performing services under the contract. VA authorizes the Contractor to discuss patient health information for coordination of care with community health care providers in compliance with VA regulations, HIPAA and VHA Directive 1605.01, Privacy and Release of Information. The VA will provide the Contractor with a copy of VHA Directive 1907.01, Health Information Management and Health Records and VHA Directive 1605.1, Privacy and Release of Information. The penalties and liabilities for the unauthorized disclosure of VA patient information mandated by the statutes and regulations mentioned above, apply to the Contractor.

4.4.4 Professional Standards for Documenting Care: Care shall be appropriately documented in medical records in…