PWS RAIN Final Draft.pdf

Performance Work Statement Template_MAY_16_2025

PERFORMANCE WORK STATEMENT (PWS)

DEPARTMENT OF VETERANS AFFAIRS

Veterans Health Administration (VHA) National Radiology Program Office

Radiopharmaceutical Inventory for Nuclear Medicine System

Date: September 26, 2025

VA-26-00024441

PWS Version Number: 1.0

Enterprise Radiopharmaceutical Inventory for Nuclear Medicine System

Contents

1.0 BACKGROUND

2.0 APPLICABLE DOCUMENTS

3.0 SCOPE OF WORK

4.0 PERFORMANCE PERIOD

4.1 PLACE OF PERFORMANCE

4.2 TRAVEL

5.0 SPECIFIC TASKS AND DELIVERABLES

5.1 PROJECT MANAGEMENT

5.1.1 CONTRACTOR PROJECT MANAGEMENT PLAN

5.1.2 REPORTING REQUIREMENTS

5.2 CLINICAL FUNCTIONALITY

5.2.1 11

5.2.2 13

5.2.3 Compliance and Data Analytics ................... Error! Bookmark not defined.

5.2.4 Reporting

5.2.5 Quality Assurance (QA) and Quality Compliance (QC) ..... Error! Bookmark not defined.

5.2.6 Analytics and Reports .................................. Error! Bookmark not defined.

5.3 TECHNICAL FUNCTIONALITY

5.4 LICENSING MODELS

5.5 IMAGING ORDERS AND REPORTS

5.6 DATA MIGRATION

5.7 PERFORMANCE

5.8 USER AND GROUP FUNCTIONALITY

5.9 HEALTH LEVEL SEVEN (HL7) INTEGRATION

5.10 DIGITAL IMAGING AND COMMUNICATIONS IN MEDICINE (DICOM)

INTEGRATION

5.11 CUSTOMER TRAINING

5.11.1 Clinical-User Training

5.11.2 PACS Administrator Training

5.11.3 Biomedical Engineer Training

5.12 CUSTOMER SUPPORT

5.13 REFERENCES

6.0 GENERAL REQUIREMENTS

6.1 ENTERPRISE AND IT FRAMEWORK

6.1.1 VA TECHNICAL REFERENCE MODEL

6.1.2 ZERO TRUST – VA CRITICAL SECURITY CONTROLS

6.1.3 FEDERAL IDENTITY, CREDENTIAL, AND ACCESS MANAGEMENT

(FICAM)

6.1.4 INTERNET PROTOCOL VERSION 6 (IPv6)

6.1.5 TRUSTED INTERNET CONNECTION (TIC)

6.1.6 STANDARD COMPUTER CONFIGURATION

6.1.7 VETERAN FOCUSED INTEGRATION PROCESS (VIP) AND PRODUCT

LINE MANAGEMENT (PLM)

6.1.8 PROCESS ASSET LIBRARY (PAL)

6.1.9 AUTHORITATIVE DATA SOURCES

6.1.10 SOCIAL SECURITY NUMBER (SSN) REDUCTION

6.1.11 SOFTWARE AND LICENSING REQUIREMENTS

6.2 SECURITY AND PRIVACY REQUIREMENTS

6.2.1 POSITION/TASK RISK DESIGNATION LEVEL(S)

6.2.2 CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

6.3 METHOD AND DISTRIBUTION OF DELIVERABLES

6.4 PERFORMANCE METRICS

6.5 FACILITY/RESOURCE PROVISIONS

6.6 GOVERNMENT FURNISHED PROPERTY

6.7 SHIPMENT OF HARDWARE OR EQUIPMENT

ADDENDUM A – ADDITIONAL VA REQUIREMENTS, CONSOLIDATED

ADDENDUM B – VA INFORMATION AND INFORMATION SYSTEM SECURITY/

PRIVACY LANGUAGE

1.0 BACKGROUND

The Department of Veterans Affairs (VA), Veterans Health Administration (VHA), National Radiology Program Office strives to provide high quality, effective, and efficient solutions to those responsible for providing care to the Veterans at the point-of-care as well as throughout all the points of the Veterans’ health care in an effective, timely and compassionate manner.

The VHA requires a vendor to furnish and install an enterprise Radiopharmaceutical Inventory for Nuclear Medicine System and services. The proposed Radiopharmaceutical Inventory for Nuclear Medicine System will enable nuclear medicine technologists, radiologists and nuclear medicine physicians, radiation safety officers, and clinical staff to better manage the VHA radiation safety programs in Nuclear Medicine.

The system will be capable of tracking radioactive material and radiopharmaceuticals from radiopharmaceutical order entry, receipt of items, inventory, administration, through disposal and waste management. The system shall be capable of tracking regulatory requirements of Nuclear Medicine equipment calibrations utilized for measuring and administering radioactivity, area survey, wipes, and air calculations, and generate reports that are fully customizable. Users need to be capable of generating reports at the local, regional and national levels. The solution should provide Digital Imaging and Communications in Medicine (DICOM)-compliant Radiopharmaceutical Radiation Dose Structured Reports (R-RDSR) and DICOM-compliant screen captures.

The vendor shall be DICOM conformant with SOP Class 1.2.840.10008.5.1.4.1.1.88.68 and DICOM-compliant screen captures, SOP Class 1.2.840.10008.5.1.4.1.1.7.

VHA has substantial interface requirements between the proposed Radiopharmaceutical Inventory for Nuclear Medicine System and the Veterans Health Information and Systems Technology Architecture (VistA) and Oracle Health (OH) Millenium. Facilities and Veterans Integrated Service Networks (VISNs) throughout VHA may utilize a variety of Radiopharmacies, Patient Radiation Dose Tracking, and Commercial PACS (CPACS) systems.

2.0 APPLICABLE DOCUMENTS

In the performance of the tasks associated with this PWS, the Contractor shall comply with the following:

1. VA Directive 1105.02 “Nuclear Medicine Service”

2. Nuclear Regulatory Commission Regulations 10 C.F.R., Parts 20, 30, 35, 37, and 71

3. Department of Transportation Regulations 49 C.F.R, Parts 172 & 173

4. “Federal Information Security Modernization Act of 2014”

5. Federal Information Processing Standards (FIPS) Publication 140-3, “Security Requirements for Cryptographic Modules”, March 22, 2019

6. FIPS Pub 199. “Standards for Security Categorization of Federal Information and Information Systems,” February 2”004

7. FIPS Pub 200, “Minimum Security Requirements for Federal Information and Information Systems,” March 2006

8. FIPS Pub 201-3, “Personal Identity Verification of Federal Employees and Contractors,” January 2022

9. 10 U.S.C. § 2224, "Defense Information Assurance Program", as amended

10. 5 U.S.C. § 552a, as amended, “The Privacy Act of 1974”

11. Public Law 109-461 (P.L. 109-461), Veterans Benefits, Health Care, and

Information Technology Act of 2006, as amended, Title IX, Information Security Matters

12. 42 U.S.C. § 2000d “Title VI of the Civil Rights Act of 1964”, as amended

13. VA Directive 0710, “Personnel Security and Suitability Program,” June 4, 2010, https://www.va.gov/vapubs/index.cfm

14. VA Handbook 0710, “Personnel Security and Suitability Program,” May 2, 2016, https://www.va.gov/vapubs/index.cfm

15. VA Directive 6102, “Internet/Intranet Services,” August 5, 2019

16. 36 C.F.R. Part 1194 “Information and Communication Technology Standards and Guidelines,” as amended

17. Office of Management and Budget (OMB) Circular A-130, “Managing Federal

Information as a Strategic Resource,” July 28, 2016

18. 32 C.F.R. Part 199, “Civilian Health and Medical Program of the Uniformed

Services (CHAMPUS)”, as amended

19. NIST SP 800-66 Rev. 2, “Implementing the Health Insurance Portability and

Accountability Act (HIPAA) Security Rule: A Cybersecurity Resource Guide,” February 2024

20. 45 C.F.R Parts 160 and 164, Subparts A and E, the Standards for Privacy of Individually Identifiable Health Information (“Privacy Rule”); and 45 C.F.R.

Parts 160 and 164, Subparts A and C, the Security Standard (“Security Rule”); as amended

21. Sections 504 and 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended

22. Homeland Security Presidential Directive (12) (HSPD-12), August 27, 2004

23. VA Directive 6500, “VA Cybersecurity Program,” February 24, 2021 (see VA

NOTICE 24-18, dated September 27, 2024, “Update to VA Directive 6500 Cybersecurity Program”, and VA Notice 25-07, dated 3/18/25, “Amending VA Directive 6500 to incorporate M-24-15”)

24. VA Handbook 6500, “Risk Management Framework for VA Information Systems VA Information Security Program,” February 24, 2021 (see VA Notice 25-01, dated October 15, 2024, “Update to VA Handbook 6500 Risk Management Framework for VA Information Systems VA Information Security Program”, and VA Notice 25-06, dated 3/18/25, “Amending VA Directive 6500 to incorporate M-24-15”) https://www.va.gov/vapubs/index.cfm https://www.va.gov/vapubs/index.cfm http://www.va.gov/vapubs http://www.va.gov/vapubs

25. VA Handbook 6500.2, “Management of Breaches Involving Sensitive Personal Information (SPI),” June 30, 2023

26. VA Handbook 6500.6, “Contract Security,” March 12, 2010 (see VA Notice 24-12, dated April 22, 2024, “Update to VA Handbook 6500.6, Contract Security, Appendix C VA Information and Information System Security/Privacy Language For Inclusion Into Contracts, As Appropriate”)

27. VA Handbook 6500.8, “Information System Contingency Planning,” March 25, 2025

28. VA Handbook 6500.10, “Mobile Device Security Policy,” February 15, 2018

29. VA Handbook 6500.11, “VA Firewall Configuration,” August 22, 2017

30. OIT Process Asset Library (PAL), OIT Process Asset Library.

31. One-VA Technical Reference Model (TRM) (reference at https://www.va.gov/trm/TRMHomePage.aspx)

32. VA Directive 6508, “Implementation of Privacy Threshold Analysis and

Privacy Impact Assessment,” October 15, 2014

33. VA Directive 6510, “VA Identity, Credential and Access Management,”

September 3, 2024

34. VA Handbook 6510, “VA Identity, Credential and Access Management,”

September 27, 2024

35. VA Directive and Handbook 6513, “Secure External Connections,” October

12, 2017

36. VA Directive 6300, “Records and Information Management,” September 21,

37. VA Handbook, 6300.1, “Records Management Procedures,“ March 24, 2010

38. NIST SP 800-37 Rev 2, “Risk Management Framework for Information

Systems and Organizations: A System Life Cycle Approach for Security and Privacy,” December 2018

39. NIST SP 800-53 Rev. 5, “Security and Privacy Controls for Federal Information Systems and Organizations,” September 23, 2020 (includes updates as of 12/10/2020)

40. VA Directive 0735, “Homeland Security Presidential Directive 12 (HSPD-12) Program,” October 26, 2015

41. VA Handbook 0735, “Homeland Security Presidential Directive 12 (HSPD-

12) Program,” March 24, 2014

42. OMB Memorandum 05-24, “Implementation of Homeland Security Presidential Directive (HSPD) 12 – Policy for a Common Identification Standard for Federal Employees and Contractors,” August 5, 2005

43. OMB Memorandum M-19-17, “Enabling Mission Delivery Through Improved Identity, Credential, and Access Management,” May 21, 2019

44. OMB Memorandum, “Guidance for Homeland Security Presidential Directive (HSPD) 12 Implementation,” May 23, 2008

45. Federal Identity, Credential, and Access Management (FICAM) Architecture, June 30, 2023 (FICAM Architecture (idmanagement.gov))

46. NIST SP 800-116 Rev 1, “Guidelines for the Use of Personal Identity Verification (PIV) Credentials in Facility Access,“ June 2018 https://digital.va.gov/process-asset-library/ https://www.va.gov/trm/TRMHomePage.aspx https://www.idmanagement.gov/arch/#:%7E:text=FICAM%20is%20the%20federal%20government%E2%80%99s%20enterprise%20approach%20to,identity%20processes%2C%20practices%2C%20policies%2C%20and%20information%20security%20disciplines.

47. NIST SP 800-63-3, 800-63A, 800-63B, 800-63C, “Digital Identity Guidelines,” updated March 02, 2020

48. NIST SP 800-157, “Guidelines for Derived PIV Credentials,” December 2014

49. VA Memorandum, VAIQ #7100147, “Continued Implementation of Homeland

Security Presidential Directive 12 (HSPD-12),” April 29, 2011 (reference https://www.voa.va.gov/documentlistpublic.aspx?NodeID=514)

50. IAM Identity Management Business Requirements Guidance document, May 2013, (reference Enterprise Architecture Section, PIV/IAM (reference https://www.voa.va.gov/documentlistpublic.aspx?NodeID=514)

51. VA Memorandum “Personal Identity Verification (PIV) Logical Access Policy Clarification,” July 17, 2019, https://www.voa.va.gov/DocumentView.aspx?DocumentID=4896

52. Trusted Internet Connections (TIC) 3.0 Core Guidance Documents, https://www.cisa.gov/publication/tic-30-core-guidance-documents

53. OMB Memorandum M-19-26, “Update to the Trusted Internet Connections (TIC) Initiative,” September 12, 2019

54. OMB Memorandum M-08-23, “Securing the Federal Government’s Domain Name System Infrastructure,” August 22, 2008

55. Sections 524 and 525 of the Energy Independence and Security Act of 2007, (P.L. 110–140), December 19, 2007

56. Section 104 of the Energy Policy Act of 2005, (P.L. 109–58), August 8, 2005

57. Executive Order 13221, “Energy-Efficient Standby Power Devices,” August

2, 2001

58. VA Directive 0057, “VA Environmental Management Program,” October 25,

59. Office of Information Security (OIS) VAIQ #7424808 Memorandum, “Remote

Access,” January 15, 2014, https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28

60. Clinger-Cohen Act of 1996, 40 U.S.C. §11101 and §11103

61. “Veteran Focused Integration Process (VIP) Guide 4.0,” March 2021, https://www.voa.va.gov/DocumentView.aspx?DocumentID=4371

62. VA Memorandum “Proper Use of Email and Other Messaging Services,”

January 2, 2018, https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28

63. “Product Line Management Transformation Playbook” version 3.1, August 2023, https://www.voa.va.gov/DocumentView.aspx?DocumentID=4946

64. NIST SP 500-267B Revision 1, “USGv6 Profile,” November 2020

65. OMB Memorandum M-21-07, “Completing the Transition to Internet Protocol

Version 6 (IPv6),” November 19, 2020

66. Social Security Number (SSN) Fraud Prevention Act of 2017

67. Section 240 of the Consolidated Appropriations Act (CAA) 2018, March 23,

68. C.F.R Title 15 Part 7, “Securing the Information and Communications

Technology and Services (ICTS) Supply Chain”, as amended

69. Executive Order 14028, “Executive Order on Improving the Nation's

Cybersecurity,” May 12, 2021, https://bidenwhitehouse.archives.gov/briefing-https://www.voa.va.gov/documentlistpublic.aspx?NodeID=514 https://www.voa.va.gov/documentlistpublic.aspx?NodeID=514 https://www.voa.va.gov/DocumentView.aspx?DocumentID=4896 https://www.cisa.gov/publication/tic-30-core-guidance-documents https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28 https://www.voa.va.gov/DocumentView.aspx?DocumentID=4371 https://www.voa.va.gov/DocumentListPublic.aspx?NodeId=28 https://www.voa.va.gov/DocumentView.aspx?DocumentID=4946 https://bidenwhitehouse.archives.gov/briefing-room/presidential-actions/2025/01/16/executive-order-on-strengthening-and-promoting-innovation-in-the-nations-cybersecurity/ room/presidential-actions/2025/01/16/executive-order-on-strengthening-and-promoting-innovation-in-the-nations-cybersecurity/

70. OMB Memorandum M-22-09, “Moving the U.S. Government Toward Zero Trust Cybersecurity Principles”, January 26, 2022, https://www.whitehouse.gov/wp-content/uploads/2022/01/M-22-09.pdf.

71. NIST SP 800-52 Revision 2, “Guidelines for the Selection, Configuration, and Use of Transport Layer Security (TLS) Implementations

72. OMB M-22-18, “Enhancing the Security of the Software Supply Chain through Secure Software Development Practices,” September 14, 2022

73. OMB M-23-16, “Update to Memorandum M-22-18,” June 9, 2023

74. OMB M-21-31, “Improving the Federal Government’s Investigative and

Remediation Capabilities Related to Cybersecurity Incidents,” August 27,

75. NIST SP 800-88 Revision 1 “Guidelines for Media Sanitization,” December

76. CISA Binding Operational Directive (BOD) 19-02: “Vulnerability Remediation Requirements of Internet-Accessible Systems,” April 29, 2019, BOD 19-02:

Vulnerability Remediation Requirements for Internet-Accessible Systems |

CISA

77. CISA BOD 22-01: “Reducing the Significant Risk of Known Exploited Vulnerabilities,” November 3, 2021, BOD 22-01: Reducing the Significant Risk of Known Exploited Vulnerabilities | CISA

78. CISA BOD 23-01: Improving Asset Visibility and Vulnerability Detection on Federal Networks.” Cybersecurity & Infrastructure Security Agency (CISA), BOD 23-01: Improving Asset Visibility and Vulnerability Detection on Federal Networks | CISA

79. VA Directive 6550, Pre-Procurement Assessment and Implementation of Medical Devices/Systems, June 03, 2019

80. VA Memorandum, “VA Security Controls,” January 17, 2025, https://www.voa.va.gov/DocumentView.aspx?DocumentID=5010

3.0 SCOPE OF WORK

The proposed Radiopharmaceutical Inventory for Nuclear Medicine System shall provide functionality as described in this document to every VHA Facility providing in-house Nuclear Medicine services and oversight/analytics capabilities for the National Radiology Program (NRP) and National Health Physics Program (NHPP). The solution shall be capable of expanding to provide for modalities and new locations added in the future. Implementation of the proposed Radiopharmaceutical Inventory for Nuclear Medicine System will be managed through a phased deployment to maximize organizational learning and project management resources.

Each phase of the project must be coordinated with the assigned Contracting Officer’s Representative (COR) and local/regional POCs and will be discussed in detail with the contractor during the pre-work orientation.

https://bidenwhitehouse.archives.gov/briefing-room/presidential-actions/2025/01/16/executive-order-on-strengthening-and-promoting-innovation-in-the-nations-cybersecurity/ https://bidenwhitehouse.archives.gov/briefing-room/presidential-actions/2025/01/16/executive-order-on-strengthening-and-promoting-innovation-in-the-nations-cybersecurity/ https://www.whitehouse.gov/wp-content/uploads/2022/01/M-22-09.pdf https://www.cisa.gov/news-events/directives/bod-19-02-vulnerability-remediation-requirements-internet-accessible-systems https://www.cisa.gov/news-events/directives/bod-19-02-vulnerability-remediation-requirements-internet-accessible-systems https://www.cisa.gov/news-events/directives/bod-19-02-vulnerability-remediation-requirements-internet-accessible-systems https://www.cisa.gov/news-events/directives/bod-22-01-reducing-significant-risk-known-exploited-vulnerabilities https://www.cisa.gov/news-events/directives/bod-22-01-reducing-significant-risk-known-exploited-vulnerabilities https://www.cisa.gov/news-events/directives/bod-23-01-improving-asset-visibility-and-vulnerability-detection-federal-networks https://www.cisa.gov/news-events/directives/bod-23-01-improving-asset-visibility-and-vulnerability-detection-federal-networks

The Contractor shall be responsible for providing all services associated with the furnishing and installation of the proposed Radiopharmaceutical Inventory for Nuclear Medicine System. The Contractor shall provide training, system maintenance, and data migration for each facility. Upon completion of the installation, testing, and training, VHA will have a national state-of-the-art Radiopharmaceutical Inventory for Nuclear Medicine System. All work must be completed by the contractor.

4.0 PERFORMANCE PERIOD

The Period of Performance (PoP) shall be 12 months from date of award, with four 12-month option periods. The overall Period of Performance shall not exceed 60 months.

Any work at the Government site shall not take place on Federal holidays or weekends unless directed by the Contracting Officer (CO). There may be instances during deployment or system upgrades where work may need to occur on Weekend, Holidays, Evening, or Nights (WHEN hours). In those instances, the work schedule needs to occur with express permission from the COR in writing.

There are 11 Federal holidays set by law (USC Title 5 Section 6103) that VA follows:

Under current definitions, five are set by date:

New Year's Day January 1 Juneteenth June 19 Independence Day July 4 Veterans Day November 11 Christmas Day December 25

If any of the above falls on a Saturday, then Friday shall be observed as a holiday.

Similarly, if one falls on a Sunday, then Monday shall be observed as a holiday.

The other six are set by a day of the week and month:

Martin Luther King's Birthday Third Monday in January Washington's Birthday Third Monday in February Memorial Day Last Monday in May Labor Day First Monday in September Columbus Day Second Monday in October Thanksgiving Fourth Thursday in November

4.1 PLACE OF PERFORMANCE

Tasks under this PWS shall be performed in VA facilities located in 115 VAMC/Healthcare Systems in addition to the National Radiology Program Office and National Health Physics Program. Work may be performed at remote locations with prior concurrence from the Contracting Officer’s Representative (COR). Any remote work must be compliant with VA policies related to remote connections. Please refer to attachment X for a complete list of the facilities and modalities as of 9/27/2025.

4.2 TRAVEL

The Government anticipates travel under this effort to perform the tasks associated with the throughout the PoP. Include all estimated travel costs in the applicable firm-fixed price line items (i.e. site prep support, implementation support, system training, etc.)

These costs will not be directly reimbursed by the Government.

The total estimated number of trips in support of the program related meetings for this effort is one per site, however additional ad hoc trips may be required/requested in alignment with events such as system upgrades or ad hoc training. Anticipated locations are listed in attachment X.

5.0 SPECIFIC TASKS AND DELIVERABLES

The Contractor shall perform the following:

5.1 PROJECT MANAGEMENT

The Contractor shall deliver a solution that provides a single service account manager for VHA. The solution shall provide project management to include:

a. Software, network, and implementation planning

b. Timeline

c. National, regional, and site level installation and implementation

d. Contracting logistics for system support and sustainment planning

The Contractor shall provide a dedicated Project Management and Installation Support team for the duration of this project. The Contractor shall deliver a fully functioning Radiopharmaceutical Inventory for Nuclear Medicine System

5.1.1 CONTRACTOR PROJECT MANAGEMENT PLAN

The Contractor shall deliver a Contractor Project Management Plan (CPMP) that lays out the Contractor’s approach, timeline, and tools to be used in execution of the contract. The CPMP should take the form of both a narrative and graphic format that displays the schedule, milestones, risks, and resource support. The CPMP shall also include how the Contractor shall coordinate and execute planned, routine, and ad hoc data collection reporting requests as identified within the PWS. The initial baseline CPMP shall be concurred upon and updated in accordance with Section B of the contract. The Contractor shall update and maintain the VA PM-approved CPMP throughout the PoP.

Deliverable:

Contractor Project Management Plan

5.1.2 REPORTING REQUIREMENTS

The Contractor shall provide the COR with Monthly Progress Reports in electronic form in Microsoft Word and Project formats. The report shall include detailed instructions/explanations for each required data element, to ensure that data is accurate and consistent. These reports shall reflect data as of the last day of the preceding month.

The Monthly Progress Reports shall cover all work completed during the reporting period and work planned for the subsequent reporting period. The report shall also identify any problems that arose and a description of how the problems were resolved. If problems have not been completely resolved, the Contractor shall provide an explanation including their plan and timeframe for resolving the issue. The report shall also include an itemized list of all Information and Communication Technology (ICT) deliverables and their current Section 508 conformance status. The Contractor shall monitor performance against the CPMP and report any deviations. It is expected that the Contractor will keep in communication with VA accordingly so that issues that arise are transparent to both parties to prevent escalation of outstanding issues.

Deliverable:

Monthly Progress Report

5.2 CLINICAL FUNCTIONALITY

5.2.1 Interfaces

A. The system shall have an HL7 interface to send and receive information to the EHR (both VISTA/CPRS and Oracle Health Millenium).

B. The system shall be capable of receiving the following information from the EHR:

1. Patient’s scheduled radiopharmaceutical exam (to include any updates made to the appointment

2. Patient Demographics

i. Patient Name

ii. Patient Sex

iii. Patient Date of Birth

iv. Patient Weight

v. Unit of Weight

vi. Patient Height

vii. Unit of Height

viii. Patient MRN/SSN/EDIPI

3. Type of Exam Requested

4. Exam State

5. Patient status

6. Desired date on the radiology order

7. Ordering Provider

8. Accession Number

C. The system shall be capable of sending the following information to the EHR:

1. Patient Demographics

2. Drawn Dose

3. A copy of the final report

D. The system shall be capable of providing local and national information

E. The system shall be capable of exporting information about patient radiopharmaceutical dose as an R-RDSR report to the VHA enterprise Patient Radiation Dose Tracking System

F. The system shall have the ability to scan patient barcodes and upload information into the EHR.

G. The system shall have the ability to scan radiopharmaceutical barcodes and upload information to the EHR.

H. The system shall have an interface with the Radiopharmacy that allows clinicians to order a radiopharmaceutical on-line through the system and have it on hand for the nuclear medicine procedure. The system shall have the ability to transfer online order information between the solution and the radiopharmacy. The order information must be saved in the system for compliance and auditing purposes.

I. The system shall be capable of receiving and transmitting radiopharmaceutical/pharmaceutical orders from the EHR to this system and to the 3rd party radiopharmacy. All information must be stored in the system for inspection purposes to comply with NRC. The order must include the following:

1. Name of referring provider

2. Name of the imaging exam to be performed

3. Patient demographics (full name, date of birth, patient identification number)

4. Authorized User

5. Prescribed Radiopharmaceutical, Activity, and Calibration Time

6. Prescribed Pharmaceutical Dose

5.2.2 User Interface

The contractor shall provide a solution that is user-friendly and has the ability to easily pull up patient information to allow for clinicians to accurately plan for cases. The alerts and reports should be intuitive.

5.2.3 Provider Workflow

A. The system shall allow for barcode scanning for verification and reporting purposes. Barcodes shall be scanned for receipt of the radiopharmaceuticals into the inventory and when removed from the inventory to administer to a patient.

B. The system shall have the ability to provide information on administered radiopharmaceutical doses to ensure NRC dose regulatory compliance is being followed

C. The system shall allow the providers to set radiopharmaceutical dose ranges that meet NRC prescribed regulations. The system shall alert the Nuclear Medicine Technologist if a prepared radiopharmaceutical dose falls outside of NRC prescribed doses.

D. The system shall allow for the tracking of all radiopharmaceutical information to allow providers to monitor radiopharmaceuticals from order, shipment, delivery, administration at point of care, and disposal.

E. The system shall allow for the providers to track the following data associated with radiopharmaceuticals:

1. Patient Name

2. Patient Date of Birth (DOB)

3. Patient Sex

4. Medical Record Number, Electronic Data Interchange Personal Identifier

(EDIPI), and/or Social Security Number (SSN)

5. Patient Weight

6. Patient Dose (Prescribed dosage and/or range and received dosage)

7. Radiochemical Purity

8. Disease/Protocol

9. Procedures

10. Referring Physician

11. Ordering Physician

12. Date of Order

13. Time of Order

14. Technologist Name

15. Name of the individual who determined the dosage

16. Radiopharmaceutical name

17. Calibration date and time

18. Route of Administration

19. Authorized User

20. Isotope Name

21. Assayed Time

22. Activity Prescribed

23. Activity of Quantity administered

24. Radioactive Sealed Sources

25. Radioactive Unsealed Sources

26. Radioactive doses

27. Non-radioactive doses/Adjunct pharmaceuticals

28. Supplies

29. Radiopharmaceutical orders, usage, and disposal

30. Radiopharmaceutical Ordered from external radio-pharmacies

i. Radiopharmaceutical description

ii. Date of Shipping

iii. Date of Receiving

iv. Status of Order

31. Biologic half-life

32. Radioactive waste disposal

33. Date received (ex: flood sources, sealed sources, etc.)

34. Shipping containers

35. Manufacturer and/or distributer

36. Lot Number

37. Amount of Activity received

38. Exposure Rate at 1 meter

39. Area Surveys

40. Exposure Rate at the surface

41. Wipe test results

42. Gamma Counter Efficiency Determination Correction Factor (ability to convert

CPM to DPM)

43. Survey and measurement instrument calibration

F. The system shall allow the following information to be tracked for research studies:

a. Radiopharmaceutical

b. Human Research subject’s name

c. Human Research subject’s identification number

d. Prescribed dosage

e. Determined dosage

f. Route of administration

g. Date and time of the dosage determination

h. Name of the individual who determined the dosage

G. The system shall allow for clinicians to generate radiopharmaceutical treatment related documentation into a report format within the system.

H. The system shall have the ability to scan the patient wristband and radiopharmaceutical label and upload it to the EHR to confirm that the correct medication and dose are administered to the correct patient. This will be used for verification and reporting purposes.

I. The system shall allow for patient scheduling within the EHR or the radiopharmaceutical inventory tracking system and update the EHR.

J. The system shall allow for the ability to track the equipment used to measure patient dosage and exposure contamination within the department and notify the user when calibration is required.

K. The user needs to be able to track the health physics within the radioactive material areas of use.

L. The system shall allow for the ability to edit appointment lists in the system and within the EHR. If the appointment is updated in one system, it shall automatically be updated in the other.

M. The system shall allow for the provider to view all previous radiopharmaceutical doses a patient has received within the system.

N. The system shall allow for Authorized Users to approve radiopharmaceuticals orders either individually or per standing orders.

5.2.4 Reporting

The Contractor shall provide a solution that provides the data to individual VA Medical Centers, VISN/Regional coordinators, and national program offices.

A. The Contractor shall deliver a solution that can provide analytics and reports. The Contractor shall:

a. Provide samples of all supported reports

b. Provide information on the types of business analytics tools available for data mining

A. The Contractor shall deliver a solution that include a minimum of the following report types:

a. Meet NRC & DOT regulatory requirements

B. The Contractor’s solution shall provide reports with clearly identified titles and scope of data (ex: entire facility, single staff member, entire VISN, National Program Office staff, etc.)

C. The Contractor shall provide a solution that allows the reports and analytics to be restricted by role.

5.2.5 Regulatory Requirements

A. The system shall meet all NRC requirements in 10 CFR.

B. The system shall allow for the tracking of survey meter calibration annually C. The system shall allow for the ability to view a patient’s radiopharmaceutical dose from arrival within the laboratory through disposition within the system to ensure regulatory compliance.

5.3 TECHNICAL FUNCTIONALITY

A. The Contractor shall deliver a Radiopharmaceutical Inventory for Nuclear Medicine System solution at an enterprise deployment and be managed at the facility, VISN, and/or VHA level.

1. The solution shall be non-developmental (i.e. commercially available, in current production as of the date this offer is submitted).

The Contractor shall:

a. Specify the proposed server and client software versions.

b. List the actual major and minor releases, including dates, for the past two years for the proposed Radiopharmaceutical Inventory for Nuclear Medicine System.

c. List any third (3rd) party software components included in the proposed Radiopharmaceutical Inventory for Nuclear Medicine System and whether the cost is included in the proposed licensing models.

i. Describe the business and technical agreements that are in place to ensure ongoing support and development.

ii. List all database(s) that are used for the Radiopharmaceutical Inventory for Nuclear Medicine System.

iii. The system shall have the ability to roll back to a previous version if the system (or any of it’s components) are no longer TRM approved to prevent a loss of functionality by VA

2. The solution shall allow for the ability of national staff from the National

Radiology Program of National Health Physics Program to view all data in the system and see reports at local, VISN/Regional, and national levels.

3. The contractor shall keep the software current.

4. System maintenance shall be conducted outside normal duty hours unless specifically approved by the COR.

5. The Contractor shall provide a comprehensive disaster recovery plan to ensure data integrity and restoration.

a. The plan shall include a process for performing automated system backups.

b. The plan shall include a process for restoring system backups.

6. The proposed Radiopharmaceutical Inventory for Nuclear Medicine System Solution shall include a test system that replicates the production environment.

a. The test system shall validate software upgrades, new modalities, and integrated applications.

b. The physical location for the test system is in TBD.

7. The solution shall support appropriate contingency plans and procedures for planned and unplanned downtime.

8. The Contractor shall provide recommended hardware specifications and network requirements for the following:

a. Main production system

b. Workstation, including specifications regarding graphic cards and monitors

c. Test server

Deliverables:

Hardware Specifications and Network Requirements

9. The Contractor shall provide a completed copy of the Manufacturer

Disclosure Statement for Medical Device Security (MDS2).

Manufacturer Disclosure Statement

10. The Contractor shall provide a completed copy of the VA Form 6550.

VA Form 6550

11. The Contractor’s solution shall be able to work across all time zones where VHA may deploy the solution.

5.4 LICENSING MODELS

A. The Contractor’s solution shall include an enterprise licensing model.

B. The Contractor shall provide the cost for adding 1 additional site of care. This shall be used for budgeting purposes for future planning. The system shall be capable of handling all VA locations.

5.5 IMAGING ORDERS AND REPORTS

A. Imaging and therapy orders shall be entered into the VistA Radiology Package or

Oracle Health Millenium OpenLink. There are potentially 2 separate instances of VistA HL7 feeds per location and 1 national instance of the OH OpenLink HL7 feed, within VHA.

B. The Contractor’s solution shall have no limit to the number of HL7 interfaces it can ingest.

5.6 DATA MIGRATION

The Contractor’s solution shall include the data migration of studies from the current Radiopharmaceutical Tracking information systems. The Contractor’s solution shall also allow for the ability for the VA to export data from the system to a different solution at the end of this contract.

5.7 PERFORMANCE

The Contractor’s solution shall include an uptime guarantee of a minimum uptime of 99%.

1. The Contractor shall provide an uptime guarantee for the proposed Radiopharmaceutical Inventory for Nuclear Medicine System solution.

2. The Contractor Shall:

a. Explain how uptime is defined.

b. Explain how uptime is measured.

c. Explain what is considered downtime.

d. Detail any contractual consequences for failure to meet the uptime guarantee.

B. The Contractor’s solution shall have the performance capability to remain active during database maintenance jobs or other server activities.

C. The system shall be capable of supporting up to an estimated 100,000 simultaneous users.

5.8 USER AND GROUP FUNCTIONALITY

A. The Contractor’s solution shall support application authentication using Single

Sign-On (SSO) or Lightweight Directory Access Protocol (LDAP) via PIV/CAC cards.

A. The Contractor shall provide the number of government deployments they currently have that support SSO or LDAP via PIV/CAC.

B. The Contractor’s solution shall provide the capability to develop user groups with distinct privileges/permissions.

A. The Contractor shall describe the available default user groups on their

Radiopharmaceutical Inventory for Nuclear Medicine System solution and the privileges/permissions allowed for each group.

a. The permissions for the default user groups shall be capable of being modified by a VA system administrator or Super User.

C. The Contractor’s solution shall allow staff to see patients nationwide and input information at their local facility without creating a duplicate patient.

The Contractor’s solution shall allow for customizable administrative and clinical access.

5.9 HEALTH LEVEL SEVEN (HL7) INTEGRATION

A. The Contractor’s solution shall provide HL7 integration to VistA and OH Millenium.

1. The Contractor shall provide HL7 integration statements for all included components of the proposed Radiopharmaceutical Inventory for Nuclear Medicine System solution.

B. The Contractor’s solution shall meet the qualification process for the VA VistA and OH Millenium HL7 interface.

1. The Contractor shall provide documentation in support of this qualification and clarify any issues identified.

5.10 DIGITAL IMAGING AND COMMUNICATIONS IN MEDICINE (DICOM)

INTEGRATION

A. The Contractor shall provide DICOM Conformance Statements for all included products.

DICOM Conformance Statements

5.11 CUSTOMER TRAINING

A. The Contractor’s solution shall include clinical, local system administrator, and technical/Biomedical training as specified below.

5.11.1 Clinical-User Training

A. The Contractor shall provide clinical training on the Radiopharmaceutical Inventory for Nuclear Medicine System solution and its operation.

B. Clinical users of the Contractor’s Radiopharmaceutical Inventory for Nuclear Medicine System solution shall include, but are not limited to:

1. Nuclear Medicine technologist

2. Radiologist

3. Radiation Safety Officers

4. System-Wide Clinical Administrators

C. Upon completion of training, clinical users will be able to successfully utilize all available features with minimal or no assistance from a VA or Contractor super user.

5.11.2 Local System Administrator Training

A. The Contractor shall provide super-user and system administrator training for operational support of the Radiopharmaceutical Inventory for Nuclear Medicine System solution.

B. Upon completion of training, the administrator shall be able to:

1. Act as the local super user for the clinical users

2. Act as the local trainer for the clinical users

3. Resolve the top ten most common user questions

4. Create and manage user accounts

5. Install and configure the client application for a new user

6. Monitor system utilization

7. Manage other day-to-day tasks required for the system

5.11.3 Biomedical Engineer Training

A. The Contractor shall provide biomedical engineer training for implementation and operational support for the Radiopharmaceutical Inventory for Nuclear Medicine System solution.

B. Upon completion of training the biomedical engineers shall:

1. Act as the local system expert

2. Understand the functions of each system’s components

3. Be able to start the system, including the different services that make up the

Radiopharmaceutical Inventory for Nuclear Medicine System solution

4. Locate and review application logs

5. Install and configure the client application for a new user

5.12 CUSTOMER SUPPORT

A. The Contractor’s solution shall provide 24/7 Customer Support including software obsolescence, major upgrades, revisions, patches and fixes for year one.

B. The Contractor shall provide remote technical and clinical applications support for year one.

C. The Contractor shall utilize the VA national site-to-site VPN.

D. The Contractor’s solution shall include a response time via phone of within 60 mins and on-site service within 24 hours from time of request.

Training Material mentioned in the requirement

5.13 REFERENCES

A. The Contractor shall provide a list of multi-hospital implementations. The references shall detail how many hospitals are in the system

B. The Contractor shall provide VA reference showing HL7 interface success

List of Multi-Hospital Implementations HL7 VA Reference

6.0 GENERAL REQUIREMENTS

6.1 ENTERPRISE AND IT FRAMEWORK

6.1.1 VA TECHNICAL REFERENCE MODEL

The Contractor shall comply with the VA OIT Technical Reference Model (VA TRM).

Compliance with the VA TRM is achieved by using only technologies and standards that are listed as approved for use in the VA TRM. The Contractor shall provide all necessary information requested by VA to ensure TRM approval is obtained prior to use on VA’s network.

6.1.2 ZERO TRUST – VA CRITICAL SECURITY CONTROLS

VA has established minimum mandatory security requirements and requires that any network connected software system or service must meet the VA Critical Security Controls as outlined in the VA Memorandum, “VA Security Controls”, https://www.voa.va.gov/DocumentView.aspx?DocumentID=5010. VA Critical Security Controls identify the minimum mandatory requirements that must be implemented across all VA enterprise infrastructure, cloud computing environments, information systems, networks, and specialized devices (medical devices/systems, special-purpose systems, and research scientific computing devices) that process, store, and/or transmit VA data. Effective July 1, 2025, the Contractor shall implement these VA Critical Security Controls, within any network connected software system or service prior to being authorized for use in the VA. This functional requirement is not negotiable, and Plan of Action & Milestones (POAM) not be accepted in the event these controls cannot be implemented for new systems. Critical Security Controls are intended to increase VA’s security posture and provide security and privacy risk visibility into the VA network and is not a new requirement. The Contractor’s failure to maintain these VA Critical Controls after implementation result in VA discontinuing the use of the system.

6.1.3 FEDERAL IDENTITY, CREDENTIAL, AND ACCESS MANAGEMENT (FICAM)

The Contractor shall ensure Commercial Off-The-Shelf (COTS) product(s), software configuration and customization, and/or new software are Personal Identity Verification (PIV) card-enabled by accepting HSPD-12 PIV credentials using VA Enterprise Architecture (EA), and VA Identity and Access Management (IAM) approved Enterprise Technology Guidelines (ETG). The Contractor shall ensure all Contractor delivered applications and systems comply with the VA Identity, Credential, and Access Management policies and guidelines set forth in Executive Order 14028, VA Handbook 6510 VA Identity and Access Management, VA Handbook 0735 Homeland Security Presidential Directive 12 (HSPD-12) Program, CISA Binding Operational Directive 23- 01, and align with the Federal Identity, Credential, and Access Management Roadmap and Implementation Guidance v2.0.

The Contractor shall ensure all Contractor delivered applications and systems provide user authentication services compliant with the National Institute of Standards and Technology (NIST) Special Publication (SP) 800-63-3, VA Handbook 6500, and VA IAM enterprise requirements for direct, assertion based authentication, and/or trust based authentication, as determined by the ETGs. Direct authentication at a minimum must include Public Key Infrastructure (PKI) based authentication supportive of PIV card and/or Common Access Card (CAC), as determined by the business need.

The Contractor shall ensure all Contractor delivered applications and systems conform to the specific Identity and Access Management PIV requirements set forth in the Office of Management and Budget (OMB) Memoranda M-05-24, M-19-17, M-22-09, and NIST Federal Information Processing Standard (FIPS) 201-3. Contractor delivered applications and systems shall be on the FIPS 201 Approved Product List (APL). If the Contractor delivered application and system is not on the APL, the Contractor shall be responsible for taking the application and system through the FIPS 201 Evaluation Program.

The Contractor shall ensure all Contractor delivered applications and systems support:

1. Automated provisioning and are able to use enterprise provisioning service.

2. Interfacing with VA’s Master Person Index (MPI) to provision identity attributes, if the solution relies on VA user identities. MPI is the authoritative source for VA user identity data.

3. The VA defined unique identity (Secure Identifier [SEC ID] / Integrated Control Number [ICN]).

https://www.ea.oit.va.gov/ https://www.ea.oit.va.gov/ https://digital.va.gov/office-of-information-and-technology/reference-library/enterprise-technology-guidelines/ https://digital.va.gov/office-of-information-and-technology/reference-library/enterprise-technology-guidelines/ https://bidenwhitehouse.archives.gov/wp-content/uploads/legacy_drupal_files/omb/memoranda/2005/m05-24.pdf https://bidenwhitehouse.archives.gov/wp-content/uploads/2019/05/M-19-17.pdf https://bidenwhitehouse.archives.gov/wp-content/uploads/2022/01/M-22-09.pdf

4. Multiple authenticators for a given identity and authenticators at every Authenticator Assurance Level (AAL) appropriate for the solution.

5. Identity proofing for each Identity Assurance Level (IAL) appropriate for the solution.

6. Federation for each Federation Assurance Level (FAL) appropriate for the solution, if applicable.

7. Two-factor authentication (2FA) through an applicable Technology Guideline as outlined in VA ETG.

8. A Security Assertion Markup Language (SAML) implementation if the solution relies on assertion-based authentication. Additional assertion implementations, besides the required SAML assertion, may be provided as long as they are compliant with NIST SP 800-63-3 guidelines.

9. Authentication/account binding based on trusted Hypertext Transfer Protocol (HTTP) headers if the solution relies on Trust based authentication.

10. Role Based Access Control.

11. Auditing and reporting capabilities.

12. Compliance with VIEWS 00155984, PIV Logical Access Policy Clarification https://www.voa.va.gov/DocumentView.aspx?DocumentID=4896.

The required Assurance Levels for this specific effort are Identity Assurance Level 3, Authenticator Assurance Level 3, and Federation Assurance Level 3.

6.1.4 INTERNET PROTOCOL VERSION 6 (IPv6)

The Contractor solution shall support IPv6-Only based upon the memo issued by the Office of Management and Budget (OMB) on November 19, 2020 (https://www.whitehouse.gov/wp-content/uploads/2020/11/M-21-07.pdf). Which defines IPv6-only as the state of an operational system or service when IPv4 protocol functions (addressing, packet forwarding) are not in use. The NIST USGv6 profile defines technical requirements for a product to be capable of operating in IPv6-Only environments. IPv6-Only technology, in accordance with the USGv6 Program ((https://www.nist.gov/programs-projects/usgv6-program/usgv6-revision-1), NIST Special Publication (SP) 500-267B Revision 1 “USGv6 Profile” (https://doi.org/10.6028/NIST.SP.500-267Br1), and NIST SP 800-119 “Guidelines for the Secure Deployment of IPv6” (https://doi.org/10.6028/NIST.SP.800-119), compliance shall be included in all IT infrastructures, application designs, application development, operational systems and sub-systems, and their integration. In addition to the above requirements, all devices, applications, and systems shall support all applicable functionality on native IPv6-Only as well as dual stack (IPv6 / IPv4) connectivity without additional memory or other resources being provided by the Government, so that they can function in a mixed environment. All public/external facing servers and services (e.g., web, email, DNS, ISP services, etc.) shall support native IPv6-Only and dual stack (IPv6 / IPv4) users and all internal infrastructure and applications shall support using native IPv6-Only and dual stack (IPv6 / IPv4) for all functionality and operations.

https://www.voa.va.gov/DocumentView.aspx?DocumentID=4896 https://www.whitehouse.gov/wp-content/uploads/2020/11/M-21-07.pdf https://www.nist.gov/programs-projects/usgv6-program/usgv6-revision-1 https://doi.org/10.6028/NIST.SP.500-267Br1 https://doi.org/10.6028/NIST.SP.800-119

6.1.5 TRUSTED INTERNET CONNECTION (TIC)

The Contractor solution shall meet the requirements outlined in Office of Management and Budget Memorandum M-19-26, “Update to the Trusted Internet Connections (TIC) Initiative“ (https://www.whitehouse.gov/wp-content/uploads/2019/09/M-19-26.pdf), VA Directive 6513 “Secure External Connections”, and shall comply with the TIC 3.0 Core Guidance Documents, including all Volumes and TIC Use Cases, found at the Cybersecurity & Infrastructure Security Agency (CISA) (https://www.cisa.gov/publication/tic-30-core-guidance-documents).

6.1.6 STANDARD COMPUTER CONFIGURATION

The Contractor IT end user solution that is developed for use on standard VA computers shall be compatible with and be supported on the standard VA operating system, Windows 10 (64bit) and Windows 11, Edge (Chromium based), and 365 Apps for enterprise. Applications delivered to VA and intended to be deployed to Windows 10 and or Windows 11 workstations shall be delivered as a signed .msi package with switches for silent and unattended installation and updates shall be delivered in signed .msp file formats for easy deployment using Microsoft Endpoint Configuration Manager (CM) VA’s current desktop application deployment tool. Signing of the software code shall be through a vendor provided certificate that is trusted by VA using a code signing authority such as Verizon/Cybertrust or Symantec/VeriSign. The Contractor shall also ensure and certify that their solution functions as expected when used from a standard VA computer, with non-admin, standard user rights that have been configured using the Defense Information Systems Agency (DISA) Secure Technical Implementation Guide (STIG) specific to the particular client operating system being used.

6.1.7 VETERAN FOCUSED INTEGRATION PROCESS (VIP) AND PRODUCT LINE

MANAGEMENT (PLM)

The Contractor shall support VA efforts IAW the Veteran-Focused Integration Process (VIP) Guide and Product Line Management (PLM) Playbook.