ITS Performance Work Statement_draft.pdf

Solicitation No. 000000-XX-0000 Sterile Processing Services (SPS) – Instrument Tracking System (ITS)

Department of Veterans Affairs Veterans Health Administration

Sterile Processing Services Instrument Tracking System

Performance Work Statement

March 4, 2025 i

Solicitation No. 000000-XX-0000 Sterile Processing Services (SPS) Inventory Tracking System (ITS) ii

Contents

1. SCOPE

2. BACKGROUND

3. APPLICABLE DOCUMENTS

4. CONTRACT TYPE

4.1. Indefinite Delivery Indefinite Quantity (IDIQ) Contract

4.2. Period of Performance

4.3. Hours of Operation

4.4. Recognized Holidays

4.5. Place of Performance

4.6. Travel

4.7. Government Furnished Information (GFI)

4.8. VA Network Connectivity

6.1 SITE ASSESSMENT

6.2 Product Delivery, Updates, and Installation

6.3 Acceptance

7.0 SYSTEM INTERFACES AND INTEGRATION

7.1 Equipment Interfaces

7.2 Electronic Health Records Interface

8.0 MAINTENANCE SERVICES AND SUPPORT

8.1 System Administration

8.2 Client Support

8.3 Service Level Agreements

9.1 Virtual Test Environment

9.2 VHA Enhancement Requests

9.3 Artificial Intelligence (AI)

9.4 Instrument Marking Services

9.5 ITS Training

iii

9.6 User Management

10 PROJECT MANAGEMENT

10.1 IDIQ Post Award and Technical Kickoff Meeting

10.2 IDIQ Management and Reporting

10.3 Task Order Management and Reporting

10.5 Enterprise and Information Technology Framework

POSITION/TASK RISK DESIGNATION LEVEL(S) AND CONTRACTOR PERSONNEL

SECURITY REQUIREMENTS

10.6 Position/Task Risk Designation Level(S)

10.7 Contractor Personnel Security Requirements Contractor Responsibilities:

11 PERFORMANCE METRICS

12 QUALITY ASSURANCE SURVEILLANCE PLAN

13 DELIVERABLE LISTING

APPENDIX A: ABBREVIATIONS/ACRONYMS

DRAFT

Solicitation No. 000000-XX-0000 Sterile Processing Services Instrument Tracking System (ITS)

1. SCOPE

The Contractor shall provide a Sterile Processing– Instrument Tracking System (ITS) in accordance with the requirements defined in this overall Performance Work Statement (PWS) and the Indefinite Deliverable Indefinite Quantity (IDIQ). The scope includes the overall program management of the implementation of the ITS and the requirements to install the ITS to enable and improve the tracking, cleaning, sterilization processing, and distribution of Reusable Medical Devices (RMD) to clinical staff throughout the medical facilities. The Sterile Processing ITS shall also provide the ability to track the location of all RMD in order to respond to recalls (reference at vaww.recalls.ncps.med.va.gov). The Contractor shall acquire ITS hardware components and software licenses. The Contractor shall install, configure, test, and provide training on ITS. The contractor shall integrate with VA systems interfaces. The Contractor shall provide Disaster Recovery (DR) capability in the event of a man-made or natural event that results in the ITS system not being able to perform all or some of its regular services for a period. This effort shall also include site assessment, server support, and sustainment/annual maintenance support and licenses.

2. BACKGROUND

The Sterile Processing ITS captures the sterilization and movement of Veterans Affairs Medical Centers’ (VAMC) RMD containing a barcode or unique device identifier (UDI).

The deployment of the Sterile Processing ITS sought to standardize local infrastructure and software platforms. It will empower Veterans Health Administration (VHA) facilities to utilize the technology to improve patient safety, help achieve efficient and sustainable processes, establish document and record control processes, and provide systematic continuous improvement and internal auditing. Based on lessons learned, the Office of Sterile Processing (OSP) and the Healthcare Technology Management (HTM) Real Time Location Systems (RTLS) jointly developed (with extensive field input) enterprise-wide standards that define functional objectives, technical requirements, and nomenclature standards for the Sterile Processing ITS. In pursuit of these requirements, the government has chosen to standardize the Sterile Processing ITS in all healthcare systems that reprocess and/or store RMD.

3. APPLICABLE DOCUMENTS

The Contractor shall utilize the following documents in the performance of the tasks in this PWS.

1. Federal Information Processing Standard (FIPS) 140-2. FIPS can be found at http://www.itl.nist.gov/fipspubs/

2. National Fire Protection Association (NFPA) 70 – National Electric Code

3. National Fire Protection Association (NFPA) 99 – Standard for Healthcare

Facilities

4. 44 U.S.C. § 3541, “Federal Information Security Management Act (FISMA) of

2002”

5. Federal Information Processing Standard (FIPS) FIPS Pub 201, “Personal

Identity Verification of Federal Employees and Contractors,” August 2013

6. Department of Veterans Affairs (VA) Directive 0710, “Personnel Suitability and

Security Program,” June 4, 2010 (https://voa.va.gov/ in the Security Library)

7. 36 C.F.R. Part 1194 “Electronic and Information Technology Accessibility

Standards,” July 1, 2003

8. Technical Reference Model (TRM) (reference Contractor Library at http://www4.va.gov/TRM/TRMHomePage.asp

9. EPC Global Tag Data Translation v1.6, Issue 2, October 12, 2011 http://www.gs1.org/sites/default/files/docs/tdt/tdt_1_4-standard-20090610.pdf

10. EPC Global UHF Class 1 Gen 2 Standard v. 1.2.0 http://www.gs1.org/sites/default/files/docs/uhfc1g2/uhfc1g2_1_2_0-standard- 20080511.pdf

11. EPC Global Low Level Reader Protocol Standard v1.0.1 http://www.gs1.org/sites/default/files/docs/llrp/llrp_1_0_1-standard- 20070813.pdf

12. EPC Global Discovery Configuration & Initialization Standard v1.0 http://www.gs1.org/sites/default/files/docs/dci/dci_1_0-standard-20090610.pdf

13. EPC Global Reader Management Standard v1.0.1 http://www.gs1.org/sites/default/files/docs/rm/rm_1_0_1-standard- 20070531.pdf

14. EPC Global EPC Information Services Standard v1.0.1 http://www.gs1.org/sites/default/files/docs/epcis/epcis_1_0_1-standard- 20070921.pdf

15. EPC Global Application Level Events Standard v1.1.1 http://www.gs1.org/sites/default/files/docs/ale/ale_1_1_1-standard-core- 20090313.pdf http://www.gs1.org/sites/default/files/docs/ale/ale_1_1_1-standard- XMLandSOAPbindings-20090313.pdf

16. Federal Information Processing Standard (FIPS) Publication 140-2, “Security Requirements for Cryptographic Modules”

17. 10 U.S.C. § 2224, "Defense Information Assurance Program"

18. Carnegie Mellon Software Engineering Institute, Capability Maturity Model®

Integration for Development (CMMI-DEV), Version 1.3 November 2010; and

Carnegie Mellon Software Engineering Institute, Capability Maturity Model® Integration for Acquisition (CMMI-ACQ), Version 1.3 November 2010

19. 5 U.S.C. § 552a, as amended, “The Privacy Act of 1974”

20. VA Directive 6102, “Internet/Intranet Services,” July 15, 2008

21. OMB Circular A-130, “Management of Federal Information Resources,”

November 28, 2000

22. VA Handbook 6500, “Information Security Program,” September 18, 2007

23. VA Handbook, 6500.5, Incorporating Security and Privacy in System

Development Lifecycle.

24. National Institute of Standards and Technology (NIST) Special Publications

25. An Introductory Resource Guide for Implementing the Health Insurance

Portability and Accountability Act (HIPAA) Security Rule, March 2005

26. An Introductory Resource Guide for Implementing the Health Insurance

Portability and Accountability Act (HIPAA) Security Rule, October 2008

27. Sections 504 and 508 of the Rehabilitation Act (29 U.S.C. § 794d), as amended by the Workforce Investment Act of 1998 (P.L. 105-220), August 7,

28. International Organization for Standardization (ISO) 9000 – Quality Management http://www.iso.org/iso/iso_catalogue/management_and_leadership_standards/ quality_management.htm

29. International Organization for Standardization (ISO) 9001:2008 http://www.iso.org/iso/iso_catalogue/management_and_leadership_standards/ quality_management/iso_9001_2008.htm

30. International Organization for Standardization (ISO) IWA 1:2005 - ISO 9000 Improved Guidelines for Health Sector http://www.iso.org/iso/iso_catalogue/management_and_leadership_standards/ specific_applications/specific-applications_health.htm

31. International Organization for Standardization (ISO) 13485:2003 - Health Care and Medical Devices http://www.iso.org/iso/iso_catalogue/management_and_leadership_standards/ specific_applications/specific-applications_medical.htm

32. International Organization for Standardization (ISO) 13485:2003 Quality Management Systems for the Medical Device Industry http://www.iso.org/iso/iso_catalogue/management_and_leadership_standards/ specific_applications/specific-applications_medical.htm

33. Guideline for Disinfection and Sterilization in Healthcare Facilities, CDC, 2008

34. General Services Administration (GSA) Information Technology (IT) 70

Schedule: Category: 70 -- Information Technology (ADP) Equipment (Including Firmware), Software, Supplies and Support Equipment; Subcategory: 7035 --

IT Support Equipment; NAICS: 34118 -- Computer Terminal and Other Computer Peripheral Equipment Manufacturing

35. VA RTLS Medical-Surgical and Dental Instrument Nomenclature Guidance

4. CONTRACT TYPE

4.1. Indefinite Delivery Indefinite Quantity (IDIQ) Contract

This is a IDIQ contract. The IDIQ will be based on the below requirements with the opportunity for each facility to further describe their requirements within their individual Task Order (TO). Individual TOs shall be issued on a Firm-Fixed-Price (FFP) basis.

4.2. Period of Performance

This IDIQ contract has a base ordering period of five years, from the date of award. Any TO issued during the effective period of this contract shall be completed by the Contractor within the time specified within the TO.

4.3. Hours of Operation

The Contractor shall assume the core work hours/schedule of 24/7 the Government utilizes unless otherwise directed in the terms and conditions of each TO award.

4.4. Recognized Holidays

The Contractor shall provide services during the facility hours of operation, except for the following federal holidays set by law (5 U.S.C. §6103), or as approved by the Ordering Contracting Officer. The following are recognized United States (US) federal holidays:

New Year’s Day: January 1st Martin Luther King, Jr.’s Birthday Washington’s Birthday Memorial Day Juneteenth National Independence Day Independence Day: July 4th Labor Day Columbus Day Veterans Day: November 11th Thanksgiving Day Christmas Day: December 25th

4.5. Place of Performance

Services provided under this PWS shall be performed at all VHA healthcare systems that reprocess and/or store RMD in the following locations as listed below and shall be identified in the individual TO:

Continental United States Hawaii Alaska U.S. Virgin Islands Puerto Rico Philippines Guam American Samoa

4.6. Travel

Travel shall be in accordance with individual TO. Travel details must be provided to and approved by the Contracting Officer Representative (COR) or the Government designee prior to the commencement of travel. All travel shall be in accordance with the Federal Travel Regulations (FTR). Outside Continental US (OCONUS) travel may require additional authorization and approvals as specified in the individual TO.

The Contractor shall travel as necessary to participate in COR-approved efforts to accomplish the work described in this PWS and subsequent TOs. Total estimate of travel shall be determined by each TO. Visits to Government sites shall not take place on Federal holidays or weekends (but may require off-hour work due to network loading or other disruptions that could occur) unless directed by the COR. Travel is not expected or applied to the base IDIQ.

4.7. Government Furnished Information (GFI)

The Government will provide the Contractor the following GFI:

Facility Drawings (for example, Computer Aided Design) VHA Standardized Set Nomenclature Guidance Document VHA RTLS Medical-Surgical and Dental Instrument Nomenclature Guidance Infection Control Risk Assessment (ICRA) Template Sterile Processing Services Reusable Medical Equipment Workflow Processes Sterile processing instrument inventory National Sterile Processing Workflow Application Usage Document

When appropriate, the Contractor shall request GFI, documents, and or materials deemed pertinent to the work accomplishment directly from the Government officials with whom the Contractor has contact. The Contractor shall consider the COR as the source for needed GFI if the Contractor fails to secure the GFI by other means.

4.8. VA Network Connectivity

The Government shall provide access to VA-specific systems/network as required for execution of the task via remote access technology (Citrix Access Gateway (CAG), or Transit Gateway (TGW). The Contractor shall bear the cost of equipment necessary to achieve connectivity to the VA network through virtual private network (VPN). The Government shall provide the required account access accordingly. Other connectivity to VA systems may be authorized as appropriate in individual TO.

5. ITS SYSTEM REQUIREMENTS

This Performance Work Statement (PWS) establishes the requirements for a Indefinite Deliverable Indefinite Quantity (IDIQ) contract for a Contractor-provided solution in support of a VA Sterile Processing Services (SPS) Instrument Tracking System (ITS).

The Contractor shall employ end user solutions on standardized VA computers with VA operating system and browsers for intranet access and shall provide and support a mobile solution for handheld devices.

The Contractor shall also ensure and certify that their solution functions as expected when used from a standard VA computer, with non-administrative rights, standard user rights that has been configured using the Federal Desktop Core Configuration (FDCC) and United States Government Configuration Baseline (USGCB) specific to the particular client operating system being used.

5.1. System Architecture

All ITS data from a given facility shall be integrated into a single database, and be accessible via a single user interface. (A “dashboard” application that merely serves to launch several independent ITS applications does not satisfy this requirement. The goal is to have all ITS data from any given facility be viewable in a single application that allows all ITS data from that facility to interact with all other ITS data from all facilities VISN wide.) The ITS at each facility must also be capable of exchanging data with VA information systems and with a single national database that serves to aggregate and display ITS data from all VA facilities.

This architecture should describe the hardware, software, processing methodology, data flow, and integration points at a local (facility), regional (VISN, MSN, or other Networks), and national level that supports the gathering, storage, reporting, and analysis of VA ITS data. In doing so, the contractor shall take into account the following:

VHA has 18 VISNs (groups of hospitals, outpatient clinics, nursing homes, etc.) and the preference would be to deploy ITS at a VISN level. The number of facilities in a VISN varies in the number of facilities, depending upon the region.

The ITS software application shall track both VA-owned RMD and vendor-supplied loaner equipment. This includes instrument sets, endoscopes, and more. Additionally, the ITS shall include an advanced analytics package with curated reports and ad hoc reporting capabilities for Sterile Processing Services (SPS) departments across the entire VA enterprise and allow extraction capabilities at site, VISN and National levels to support:

Aggregation of ITS-derived data from individual local sites and provide reports using standard metrics that enable VA to establish benchmarks, improve compliance, adhere to best demonstrated practices, and more.

Process ITS-derived data from VA data warehouse (delivered file or potential interface) that spans across the entire VA enterprise.

Accept data provided by the VA in a .csv file, Excel, or mutually agreed upon format.

Normalize the data received from VA using a translation table provided by VA that defines the ITS data field to the offeror’s data fields.

Initial aggregated data reports shall include but are not limited to:

o Use of a competency module to assure personnel capabilities and skills o Scanning points to determine process compliance according to established regulatory requirements o Maintenance status of tracked RMD o Maintenance status of Sterile Processing Equipment o Quality assurance indicators

Annual Enterprise license that covers entire VA, if needed If utilizing a hosted environment, a FedRamp approved product VA TRM approved software Scalable solution that can aggregate data from across approximately 200+ facilities across all VISNs.

Reporting at site, VISN, and National levels, including peer vs. peer reporting, single site compared to members of same VISN, and more.

Ability to use existing ITS tools and hardware implementations

This IDIQ contract vehicle will provide the Sterile Processing ITS solution to support VA requirements as defined within this PWS.

6.0 ITS SITE ASSESSMENT AND DEPLOYMENT

6.1 SITE ASSESSMENT

The Contractor shall conduct a site assessment to assist the Government in identifying their sterile processing needs, establishing a site design, and developing an equipment and supply list and deployment plan. The resulting report shall provide where hardware is placed for ITS to meet a target site’s requirements.

The Contractor shall provide site assessments results and plans to the Government in the form of a Hardware Design Document. The Hardware Design Document shall be inclusive of the following:

The Contractor shall assist the Government in defining the ITS requirements for the TO. Initial sustainment requirements shall be included in the Hardware Design Document.

A hardware deployment design denoting the quantity and placement of all ITS equipment that needs to be installed, including the number and type of workstations (Assembly Workstation, Sterilization Workstation, 2D Electrochemical Marking Workstation, and so forth).

ITS-specific requirements for power, networking, and any other VA-required pre-installation items.

Preliminary quantity and proposed location of servers and workstations, as well as the space, power, and network requirements for those servers to support the proposed ITS applications.

Minimum quantity requirements and supplemental Wi-Fi infrastructure deemed necessary to achieve the goals of the ITS application and room coverage requirements.

Detailed explanation of any deviations from the national standard using the current and future business processes as justification.

The Contractor may use a templated document, appropriately annotated with supplemental elements, changes and deviations from the template to represent the target installation site in the development of the Hardware Design Document.

The Hardware Design Document shall be approved by the VA Site representative and project COR prior to submitting any software/equipment orders or beginning the hardware delivery, upgrade, and installation process. All required hardware purchases and deployment plans shall be documented in the Hardware Design Document, reviewed by the Government, and undergo Government acceptance process.

The Contractor shall conduct an ICRA for all construction, renovation, and maintenance work in any facility that potentially impacts patient care activities including work vertically or horizontally adjacent to patient care areas. The Contractor shall provide the ICRA to the TO COR at the completion of the site assessment.

Deliverables: A. Initial Hardware Design Document B. Infection Control Risk Assessment

6.2 Product Delivery, Updates, and Installation

The Contractor shall provide a Bill of Materials describing the delivery and installation of all hardware, software, and parts. The Contractor shall acquire and install ITS and ITS approved hardware and software at the site locations in accordance with each TO. The Contractor shall configure and connect facility on site servers to connect to ITS’ SaaS Cloud. The SaaS Cloud server shall provide VA with data backup and disaster recovery services for the ITS Buffer Server.

The Contractor shall configure the Sterile Processing ITS for each of the applicable sites to meet the required application services and capabilities. The Contractor shall configure the ITS so that it represents the physical layout of the site, as provided in the VA facility drawings or as identified by the Contractor in accordance with the Hardware Design Document. The Sterile Processing ITS shall be configured to meet VHA RTLS Instrument Tracking System Medical-Surgical & Dental Instrument Nomenclature Standard Guidance including the facility-specific business rules, alerts, notifications, and reporting requirements as identified during the Site Assessment and in the approved Hardware Design Document.

The Contractor shall update the Hardware Design Document where upgrades and changes are made to a Hardware Design Document or existing installation or build design. A final Hardware Design Document shall be delivered to the Government upon completion of a new installation, or any significant upgrades and changes to an existing installation. VA must approve the Hardware Design Document prior to the Government acceptance being completed.

Deliverable: Final Hardware Design Document

6.3 Acceptance

The Contractor shall develop or acquire and provide to the IDIQ COR instructions for acceptance level testing for approval. At the completion of the Sterile Processing ITS installation, the Contractor shall conduct and validate the acceptance level testing and provide the test results to the TO COR for approval.

Deliverable: Acceptance Testing Instructions and Acceptance Testing Results

7.0 SYSTEM INTERFACES AND INTEGRATION

7.1 Equipment Interfaces

The Contractor shall interface ITS with Washer/Disinfectors; Steam, Peracetic Acid, Hydrogen Peroxide Plasma Sterilizers; Automated Endoscope Reprocessors; Biological Incubators, etc.

The Contractor shall provide all information, data, parameters, operating procedures, interface requirements, technical support, and training required to enable successful integration and testing of operational functions.

7.2 Electronic Health Records Interface

The Contractor shall install, configure, and enable software capability to interface with a Federal Electronic Health Records System.

8.0 MAINTENANCE SERVICES AND SUPPORT

The Contractor shall provide regular commercial product refreshes, patches and maintenance upgrades.

8.1 System Administration

The system shall allow VA to manage firmware/software/system configuration remotely for all components of the RTLS. The system shall dynamically monitor each component to ensure it is working properly. The system shall send alerts to a system administrator whenever there is a loss in connectivity or failure of any of the hardware and/or infrastructure components.

VA system administrators shall have full access to the hardware, software and programs that constitute the system, including any diagnostic software features, and full administrative rights.

The Contractor shall brief VA system administrators regarding all software upgrades and changes; VA system administrators must agree to each software upgrade, prior to installation.

A mutually agreed upon "Change Management Process" shall be developed prior to system installation.

The Contractor shall provide maintenance services and support for Client Support, Training, Assessment Support and Conferences to include services for additional training, hardware and supplies.

8.2 Client Support

The Contractor shall provide 24/7 Service Desk Support.

The Contractor shall provide a dedicated Client Manager for each region and provide the following support:

Business Development

Manager Customer

Success Manager Clinical

Education team Technical

Support team

The Contractor shall provide all software updates and /or patches for ITS at no additional charge. Notification of new releases and upgrades will be provided in advance for approval by the RTLS Change Control Board and shall be installed with coordination with facility COR as needed.

The Contractor shall provide all required license renewals and software support for the ITS software system at the site.

The Contractor support server shall provide a Transit Gateway which provides connectivity to the SaaS Cloud environment.

The Contractor shall support a mobile solution for handheld devices.

8.3 Service Level Agreements

The Contractor shall provide the following uptime guarantees: 99.5% for business critical, 99.9% for mission essential and 99.99% for mission critical.

Business critical is defined as: A system that is necessary for the accomplishment of the VA’s day-to-day operations.

Mission essential is defined as: A system that is basic and necessary for the accomplishment of the VA’s organizational mission.

Mission critical is defined as: Vital to the operation of the VHA. A system or application that has immediate impact on the safe, effective delivery of patient care or on the safety of staff.

9.0 ITS SERVICES

9.1 Virtual Test Environment

The contractor shall provide a test environment for preproduction and training on VA virtual infrastructure. This environment shall be for both national and field use.

9.2 VHA Enhancement Requests

An enhancement request is a formal or informal request from stakeholders, including customers, end users, or internal teams, to suggest changes or additions to an existing software system. The purpose of these requests is to improve the functionality of the software, solve usability problems or introduce new features. The contractor shall complete any modifications or additions to existing software requested by the VHA, in accordance with predetermined enhancement request procedures and federal acquisition requirements.

9.3 Artificial Intelligence (AI)

The contractor shall include software with AI capability that includes automation of visual inspection and instrument recognition, data analysis for continuous improvement, automated reporting, increased throughput, predictive maintenance, smart monitoring, quality assurance, inventory management, document creation and allows for continuous technological advancement.

9.4 Instrument Marking Services

The Contractor shall mark and fully commission all instruments. The Contractor shall support laser and manual (such as 2D matrix dot/tape) marking processes. The Contractor shall enter all required data fields for fully commissioned items and build instrument set count sheets for assigned instrument sets within each facility. Count sheet creation shall take place before marking/commissioning by the Contractor.

Estimations of need are derived from site complexity levels for the provision of marks and commissioning.

As part of this service the Contractor shall:

1. Review, provide constructive feedback, approve, and pre-populate the system with the site’s medical/surgical and dental instrument data, providing access and use of the VA approved Instrument catalog.

2. Utilize available laser equipment provided at each individual facility, if applicable.

3. Ensure proper placement and application of 2D matrix marking by laser, or manual (such as 2D matrix dot/tape) marking processes. Mark placement shall not impede clinician’s use, nor subject the Veteran patient to any additional risks.

4. Perform Quality Assurance of applied marks to ensure that the matrix is scannable by ITS within a maximum of three seconds.

5. Enter data into ITS dataset in strict accordance with the SPS data standards.

6. Create/provide tray count sheets utilizing 2D matrix scanning to readily identify instrument inventory of each set.

7. Apply VHA RTLS Instrument Tracking System Medical-Surgical & Dental

Instrument Nomenclature Standard Guidance to all the records, ensuring 100% compliance with the standards PRIOR to submission to the Government for review/acceptance.

8. Analyze the data entries and count sheets to ensure that instrument information transferred correctly. If necessary, provide solutions to potential data issues (such as changes in item names due to nomenclature standardization).

9. Submit any new updated nomenclature (not already part of the data standard) derived during the commissioning effort to the based PWS COR and ITS Workgroup for processing and actions/approval.

10. Ensure all instrumentation has a Quick Response (QR)/GS1 barcode which can be read, identified and populate data/information within the ITS software.

9.5 ITS Training

The Contractor shall provide Training Videos on Demand.

The Contractor shall provide unlimited access to Live Event Training.

The Contractor shall provide registration support and access to unlimited courses of the installed ITS solution to stakeholders and users identified by the Government.

The Contractor shall support on-site and web-based training, at the request of the TO

COR.

The Contractor shall work with the TO COR to determine the best time and location for training events. On-site training sessions shall be conducted at the VA facility.

The Contractor shall provide training material and schedules for all training events and complete those events in accordance with the approved Facility Training Schedule.

The Contractor shall submit a tailored Training Plan for each VISN and VA facility. The Training Plan shall include, at a minimum:

1. Training locations, training dates, and training times

2. Post-acceptance Formal Site User Training

3. Format, method, and/or delivery of training (for example, on-site, web-based)

4. VAMC shall be provided unlimited access to Live Event Training and On Demand Video Training that is hosted by the ITS vendor.

5. Training audience (such as technical repair, system user, system administrator)

6. Instructor profile and training content information

The Contractor shall provide certified personnel to conduct all training.

The Contractor shall provide an annual assessment Based On-Site Training.

Deliverable: Facility Training Schedule, training materials, and execution of the training

9.6 User Management

Program Office Requirements o Control of container names and reference IDs (Removing the access permission for site level) o Access to all permissions and screen access o Access to site level data bases o Control of adding new access levels and access within each access level

Field Requirements o Standard levels of user rights (SPS Manager, Technician, Hospital

Administrator, ITS Coordinator, End User).

o Add users to appropriate access level

VISN Requirements o Read only access to all site reports

Nomenclature Standards o VHA specific catalogs for containers, instruments, equipment, scopes

9.7 Marking, Handling, Storage, Preservation, Packaging, and Shipping

The Contractor shall establish/maintain procedures for handling, storage, preservation, packaging, and shipping to protect the quality of products and prevent damage, loss, deterioration, degradation, or substitution of products.

9.8 Warranty

Items acquired under this contract shall require warranty protection. Commercial warranties shall be transferred to the Government. This shall include a minimum warranty period of three years.

10 PROJECT MANAGEMENT

The Contractor shall be responsible for overall management and execution of the tasks and efforts expressed herein. The Contactor shall provide a Project Manager for management of the IDIQ contract and an Implementation Manager for each individual

TO.

10.1 IDIQ Post Award and Technical Kickoff Meeting

The Contractor Project Manager shall lead a Post Award meeting for the effort to be held with the government and the IDIQ COR in person or via online web conference.

The Contractor shall provide the Government a copy of the slides for the post-award conference three business days prior to the post award conference. The purpose of the meeting is to:

Initiate the communication process between the government and Contractor

Introduce Contractor and government personnel performing work related to this project

Identify of stakeholder’s roles and responsibilities Provide an overview of the IDIQ project administration and reporting

The Contractor shall hold a Technical Kickoff meeting within 10 business days following the IDIQ award with the IDIQ COR and government representatives. The kickoff meeting may be either in person or via online web conference. The Contractor shall coordinate and confirm with the COR to establish dates, location, and agenda for the kickoff meeting.

Deliverable: IDIQ Technical Kickoff Meeting (includes supporting artifacts)

10.2 IDIQ Management and Reporting

The Contractor Project Manager shall provide the IDIQ COR a Monthly Progress Report (MPR) of all activities performed and planned in conjunction with this IDIQ. The Contractor Project Manager shall use the following outline to populate and submit the MPR. The MPR shall include:

1. Task Summary – This section includes a high-level summary narrative of the work that is being performed, both at the IDIQ level and at each individual

TO.

2. Schedule Summary – This section shall provide a summary of all TOs performance schedules to plan and identify issues or constraints with activities to remedy those issues or constraints.

3. Actual Activities for the Preceding Month – This section describes the activities performed in the preceding month.

4. Planned Activities for Next Month – This section describes the activities planned for the following month.

5. Risks and Issues Summary – This section includes the Risk Register, risk scores, probability, impact, responses and mitigation plans.

6. Corrective Actions and Improvements – This section lists the corrective actions and improvements that were executed or plan to be executed preceding and following months.

7. The report shall identify any performance problems that arose and a description of how those problems were resolved. If problems have not been completely resolved, the Contractor shall provide an explanation, including its plan and timeframe for resolving the issue. The Contractor shall keep in communication with the IDIQ COR so issues that arise are transparent to both parties to prevent escalation.

The Contractor shall participate in ad hoc project related meetings with the IDIQ COR.

The MPRs shall reflect the data as of the last day of the preceding month and be submitted in accordance with the Schedule of Deliverables. The MPRs shall identify the sources from which the data are pulled and include notifications when updates to technical documents are made.

Deliverables: A. Monthly Progress Reports

10.3 Task Order Management and Reporting

The Implementation Manager shall be responsible for effectively communicating the project progress to the TO COR, VHA stakeholders and Contractor team members. The Contractor shall maintain and report weekly on the CPIS. The Contractor shall include the approach, timeline, and tools to be used in execution of the contract in the CPIS.

The CPIS shall contain a comprehensive project schedule, including milestones and deliverable dates for the deployment of each ITS application and relevant Government dependencies (such as document acceptance). Documentation of deviations from the CPIS baseline schedule and the rationale behind these deviations are reviewed with the COR. Updates to the CPIS shall be provided when significant changes in schedule, approach, or tools are made.

10.3.1 Ensuring proper documentation is delivered to the TO COR and key points of contact or others as identified in the TO

10.3.2 Coordinating, escalating, and resolving Contractor-related project issues

10.3.3 Representing the Contractor in weekly status meetings and providing weekly status reports to the TO COR.

The Contractor Implementation Manager shall hold a Kickoff meeting within 10 business days following the TO award with the TO COR and government representatives. The kickoff meeting may be either in person or via online web conference. The Contractor shall coordinate and confirm with the COR to establish dates, location, and agenda for the kickoff meeting.

The Contractor shall present and be prepared to walk through in detail the Contractor Project Implementation Schedule (CPIS) and plan for meeting the TO requirements.

The kickoff meeting may include breaking into multiple working groups of VA stakeholders for the TO requirements. The Contractor will coordinate the agenda and need for any working group sessions with the COR ahead of time to ensure adequate subject matter expert participation to present, explain, and collect feedback on all the TO requirements.

The Contractor Implementation Manager for the site shall provide the Task Order COR a weekly status report for all activities performed and planned for the site. These reports shall convey the status of the activities and tasks within the CPIS. A standard format will be provided by the Government and shall be utilized for submission of required information.

Deliverable: A. Contractor Project Implementation Schedule B. Weekly Status Reports

10.4 Technical Data Manuals and Support Documentation

The Contractor shall provide copies of all equipment instruction, operation, and maintenance manuals to the TO COR or as designated by the COR. The Contractor shall keep all product documentation and manuals up to date and synchronized with active Contractor services and component updates or changes. All documentation and data interchange products shall be exchanged using electronic means in a standard common format employed by the Government. This includes Microsoft Office, electronic mail, and Adobe Acrobat formats. The Government shall designate a standard naming convention for all electronic submissions within 60 days after contract award.

Deliverables: Equipment Instruction(s), Operation and Maintenance Manuals

10.5 Enterprise and Information Technology Framework

The Contractor shall comply with the VA enterprise management framework. In association with the framework and Office of Information Technology (OIT) Technical Reference Model (One-VA TRM). One-VA TRM establishes a common vocabulary and structure for describing the information technology used to develop, operate, and maintain enterprise applications and includes the Standards Profile and Product List that collectively authorizes the use of the VA technology roadmap.

POSITION/TASK RISK DESIGNATION LEVEL(S) AND

CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

10.6 Position/Task Risk Designation Level(S)

Position Sensitivity

Background Investigation (in accordance with Department of Veterans Affairs 0710 Handbook, “Personnel Security Suitability Program,” Appendix A)

Low

National Agency Check with Written Inquiries (NACI) A NACI is conducted by the Office of Personnel Management (OPM) and covers a five-year period. It consists of a review of records contained in the OPM Security Investigations Index (SII) and the Department of Defense (DOD) Defense Central Investigations Index (DCII), Federal Bureau of Investigation (FBI) name check, FBI fingerprint check, and written inquiries to previous employers and references listed on the application for employment. In VA it is used for Non-sensitive or Low Risk positions.

Moderate

Moderate Background Investigation (MBI) An MBI is conducted by OPM and covers a 5-year period. It consists of a review of National Agency Check (NAC) records [OPM Security Investigations Index (SII), DOD DCII, FBI name check, and a FBI fingerprint check], a credit report covering a period of five years, written inquiries to previous employers and references listed on the application for employment; an interview with the subject, law enforcement check; and a verification of educational degree.

Position Sensitivity

Background Investigation (in accordance with Department of Veterans Affairs 0710 Handbook, “Personnel Security Suitability Program,” Appendix A)

High

Background Investigation (BI) A BI is conducted by OPM and covers a 10-year period. It consists of a review of National Agency Check (NAC) records [OPM Security Investigations Index (SII), DOD DCII, FBI name check, and a FBI fingerprint check report], a credit report covering a period of 10 years, written inquiries to previous employers and references listed on the application for employment; an interview with the subject, spouse, neighbors, supervisor, co-workers; court records, law enforcement check, and a verification of educational degree.

The position sensitivity and the level of background investigation commensurate with the required level of access for the following tasks within the PWS are:

Position Sensitivity and Background Investigation

Requirements

Task Number Low/NACI Moderate/MBI High/BI

The tasks identified herein, and the resulting Position Sensitivity and Background Investigation requirements identify, in effect, the background investigation requirements for Contractor individuals, based upon the tasks that the Contractor individual will be working. The submitted Contractor Staff Roster must indicate the required background investigation level for each Contractor individual based upon the tasks the Contractor individual will be working, in accordance with their submitted proposal.

10.7 Contractor Personnel Security

Requirements Contractor Responsibilities:

a. The Contractor shall prescreen all personnel requiring access to the computer systems to ensure they maintain the appropriate background investigation, and are able to read, write, speak, and understand the English language.

b. The Contractor shall bear the expense of obtaining background investigations.

c. Within three business days after award, the Contractor shall provide a roster of Contractor and Subcontractor employees to the COR to begin their background investigations. The roster shall contain the Contractor’s full name, full Social Security Number, date of birth, place of birth, and individual background investigation level requirement (based upon Section 6.2 Tasks).

d. The Contractor should coordinate the location of the nearest VA fingerprinting office through the COR. Only electronic fingerprints are authorized.

e. For a Low-Risk designation, the following forms are required to be completed:

1. OF-306 and 2. DVA Memorandum – Electronic Fingerprints. For Moderate or High Risk, the following forms are required to be completed: 1. VA Form 0710 and 2. DVA Memorandum – Electronic Fingerprints. These should be submitted to the COR within five business days after award.

f. The Contractor personnel will receive an email notification from the Security and Investigation Center (SIC), through the Electronics Questionnaire for Investigations Processes (e-QIP) identifying the website link that includes detailed instructions regarding completion of the investigation documents (SF85, SF85P, or SF 86). The Contractor personnel shall submit all required information related to their background investigations utilizing the OPM e-QIP.

g. The Contractor is to certify and release the e-QIP document, print and sign the signature pages, and send them to the COR for electronic submission to the SIC. These should be submitted to the COR within three business days of receipt of the e-QIP notification email.

h. The Contractor shall be responsible for the actions of all personnel provided to work for VA under this contract. If damages arise from work performed by Contractor-provided personnel, under the auspices of this contract, the Contractor shall be responsible for all resources necessary to remedy the incident.

i. A Contractor may be granted unescorted access to VA facilities and/or access to VA Information Technology resources (network and/or protected data) with a favorably adjudicated Special Agreement Check (SAC) or “Closed, No Issues” (SAC) finger print results, training delineated in VA Handbook 6500.6 (Appendix C, Section 9), and, the signed “Contractor Rules of Behavior.” However, the Contractor shall be responsible for the actions of the Contractor personnel they provide to perform work for VA. The investigative history for Contractor personnel working under this contract must be maintained in the database of the OPM.

j. The Contractor, when notified of an unfavorably adjudicated background investigation on a Contractor employee as determined by the Government, shall withdraw the employee from consideration in working under the contract.

k. Failure to comply with the Contractor personnel security investigative requirements may result in termination of the contract for default.

11 PERFORMANCE METRICS

The table below defines the Performance Standards and Acceptable Levels of Performance associated with this IDIQ contract. Individual TOs will have specific Performance Standards and Acceptable Levels of Performance.

Performance Objective

Performance Standard Acceptable Levels of Performance

A. Technical / Quality of Product or Service

1. Shows understanding of requirements

2. Efficient and effective in meeting requirements

3. Meets technical needs and mission requirements

4. Provides quality services/products

Satisfactory or higher

B. Project Milestones and Schedule

1. Quick response capability

2. Products completed, reviewed, delivered in accordance with the established schedule

3. Notifies customer in advance of potential problems

Satisfactory or higher

C. Cost & Staffing 1. Currency of expertise and staffing levels appropriate

2. Personnel possess necessary knowledge, skills and abilities to perform tasks

Satisfactory or higher

D. Management 1. Integration and coordination of all activities to execute effort

Satisfactory or higher

12 QUALITY ASSURANCE SURVEILLANCE PLAN

The Government will utilize a QASP throughout the life of the Contract to ensure that the Contractor is performing the services required by this PWS in an acceptable manner. The Government reserves the right to alter or change the surveillance methods in the QASP at its own discretion.

13 DELIVERABLE LISTING

Task Deliverable

ID

Deliverable Description

10.1 Post Award and Technical Kickoff Meeting

Deliverable: IDIQ Technical Kickoff Meeting (includes supporting artifacts)

Due no later than 10 days after contract award Electronic submission to: IDIQ COR Inspection: destination Acceptance: destination

6.1A

ITS Site Assessment and Deployment

Deliverable: Initial Hardware Design

Due Date: See Appendix B

Electronic submission to: IDIQ COR Inspection: destination

6.1B

ITS Site Assessment and Deployment

Deliverable: Infection Control Risk Assessment

Due Date: See Appendix B

Electronic submission to: IDIQ COR Inspection: destination

6.2

Product Delivery, Updates, Installation

Deliverable: Final Hardware Design Document

Due Date: See Appendix B

Electronic submission to: IDIQ COR Inspection: destination

6.3

Acceptance

Deliverable: Acceptance Instructions and Acceptance Results

Due Date: See Appendix B

Electronic submission to: IDIQ COR

9.5

ITS Training

Deliverable:Facility Training Schedule, training materials, and execution of the training.

Due Date: See Appendix B

Electronic submission to: IDIQ COR Inspection: destination

10.2

IDIQ Management and Reporting Deliverables: A. Monthly Progress Reports

Due Date: 5th of every month

Electronic submission to: IDIQ COR Inspection: destination

10.3A

Task Order Management and Reporting

Deliverable: Contractor Project Implementation Schedule

Due Date: See Appendix B

Electronic submission to: TO COR

Inspection: destination

10.3B

Task Order Management and Reporting

Deliverable: Weekly Status Reports

Due weekly following TO award Electronic submission to: TO COR

APPENDIX A: ABBREVIATIONS/ACRONYMS

BI Background Investigation

IDIQ Indefinite Deliverable Indefinite Quantity

CAG Citrix Access Gateway

CEU Continuing Education Unit

COR Contracting Officer Representative

CPIP Contractor Project Implementation Plan

CPIS Contractor Project Implementation Schedule

DCII Defense Central Investigations Index

DOD Department of Defense

DR Disaster Recovery e-QIP Electronics Questionnaire for Investigations Processes

FAR Federal Acquisition Regulation

FBI Federal Bureau of Investigation

FDCC Federal Desktop Core Configuration

FFP Firm Fixed Price

FTR Federal Travel Regulation

GFI Government Furnished Information

HTM Healthcare Technology Management

ICRA Infection Control Risk Assessment

ITS Instrument Tracking System

MBI Moderate Background Investigation

MPR Monthly Progress Report

NAC National Agency Check

NACI National Agency Check with Written Inquiries

OCONUS Outside Continental United States

OIT Office of Information and Technology

OPM Office of Personnel Management

OSP Office of Sterile Processing

PWS Performance Work Statement

QASP Quality Assurance Surveillance Plan

RME Reusable Medical Equipment

RTLS Real Time Location Systems

SAC Special Agreement Check

SIC Security and Investigation Center

SII Security Investigations Index

SPS Sterile Processing Services

TGW Transit Gateway

TO Task Order

TRM Technical Reference Model

UDI Unique Device Identifier

USGCB United States Government Configuration Baseline

VA Department of Veterans Affairs

VAMC Veterans Affairs Medical Center

VHA Veterans Health Administration

VISN Veterans Integrated Service Networks

VPN Virtual Private Network