Attachment A - New Hematology Analyzer_____SOO 30MAR26.docx

STATEMENT OF OBJECTIVES

Hematology Cost Per Reportable Agreement

1. Scope of Work

The Contractor shall provide Hematology instrumentation and reagents used in support of the Hematology mission at Brooke Army Medical Center (Brooke Army Medical Center) / Joint Base San Antonio (JBSA) and its surrounding clinics/healthcare network, located at or near Joint Base San Antonio, TX 78234.

1.1 Description of Work

The Contractor shall provide Hematology Testing under a Cost Per Reportable Result (CPRR) agreement to include equipment, reagents, tools, materials, training, peripherals (e.g. instrument specific computer terminals and CPUs, printers, etc.), Uninterruptable Power Supply (UPS), Robotic Automation System integration, Automated Integrated Track System, and Automated Post-analytical system and services necessary to meet the Hematology testing and analysis requirements for Brooke Army Medical Center (BAMC), JBSA, Fort Sam Houston, TX and its outlying clinics. The analyzers shall be located in (3) three separate locations: 1) Main Core Hematology Laboratory of BAMC; 2) BAMC Apheresis/Cell Therapy Clinic; 3) Akeroyd Blood Donor Center. Contractor shall include delivery, installation, all calibrators/standards, reagents/reagent packs, and quality control materials necessary to perform the required testing. The Offeror’s product solution shall provide redundancy (to ensure continuous operations) in the Main Core Laboratory, training, supplies, unscheduled maintenance, and preventive maintenance for the equipment in all locations. Initial Method Validations per Clinical Laboratory Improvement Amendments (CLIA)/National Committee for Clinical Laboratory Standards (NCCLS)/Department of Pathology and Area Laboratory Services Quality Management (DPALS QM) guidelines, will include method correlation to existing systems as well as between each new system from each location to the Main Core Lab instruments, linearity verification to maximum dilution, precision, carry-over, normal reference range validation, tube conversion validations, blood and body fluid validations, initially and with each new application and/or conversion and for trouble-shooting purposes. Validation Study criteria will be established by a Medical Director. Contractor shall provide review to Medical Director for acceptability and approval of all validations prior to proceeding with Clinical Testing. Contractor will include official documentation of confirmation of safety of waste disposed into a sink or floor drain from the analyzers, analyzer decontamination when necessary, and removal of all instruments and peripherals (e.g., instrument specific computer terminals and CPUs, printers, toner, etc.) at the termination of the contract. The analyzer systems shall provide users with rapid, reliable test results that are critical for patient care. The Contractor shall be responsible for maintenance service, on-site repair, and parts as required in order to maintain a minimum 98% uptime for all instrumentation. All testing materials to include reagents, equipment, consumables and products associated with testing, must be FDA approved. Costs will be all inclusive based on cost per reportable structure to include provisions for reagents and consumables required to perform testing throughout the period of performance. See estimated patient volume and test type listed in Appendix A.

All supplies and equipment outlined in this Statement of Work (SOW) must be supplied and serviced through a single Contractor (to whom the contract is awarded, to include any parts, equipment, or supplies not manufactured, provided or serviced by the Contractor).

2. Equipment/Reagent Requirements – Core Laboratory

2.1 Equipment/Reagents

2.1.1 CBC analyzers will perform the required testing listed in Table 1. System redundancy in the Core Laboratory is required. At least (1) primary CBC analyzer will be required in each of the (2) two remaining locations listed in 1.1 Description of Work.

· Individual analyzers must have fully automated, discrete random-access capabilities. There must be a single point of specimen entry for the routine analysis of all required tests. There must be capability for priority analysis of STAT specimens.

· Each analyzer must be equipped to perform continuous, random statistical analysis using common statistical control rules as well as patient-derived quality control procedures (e.g., X- bar B analysis).

· The analyzers must have an interface that is compatible to the current Government LIS, Military Health System (MHS) Genesis. Each interface must allow for recognition and interpretation of MHS Genesis generated bar-code labels on all sample tube types. Connectivity between the Contractors instrument systems and middleware to each LIS will be required at varying times during the contracted period of performance.

· Each analyzer must be able to provide for auto-validation of results using internal rule sets to be configured by the vendor in collaboration with section.

· BAMC Main Core Laboratory requires a fully automated system that includes pre and post analytic specimen processing with scalable, connected analytics to meet testing needs with highest efficiency with the following requirements:

· Pre and Post Analytic System requirements:

· Automated/semi-automated systems to support pre- and/or post-analytical processing of specimens (as appropriate)

· The instrument systems must interconnect with the major pre-analytical, analytical, and post-analytical components included in this SOW, providing for full walk-away automation (i.e., an automation/robotic line) and the ability to connect to the existing BAMC Core Laboratory Chemistry/Immunoassay automation line in a configuration that meets the section-specific space requirements. See Appendix A for existing pre and post analytic instruments and designated area for Hematology Analytic line.

· The systems must provide the vast majority of pre-analytical sample handling, transporting specimens from a start point to an appropriate instrument without manual intervention by a technician, as well as provide post-analytical computer-controlled sample archiving/storage/racking through connectivity to integrated tube sorter with archiving capabilities for post–analytic tube management

· BAMC (2) Site CBC Instrument System requirements:

· Fully automated, discrete random-access capabilities

· Single point of specimen entry for routine analysis of all required tests with single aspiration pathway

· STAT specimen prioritization capabilities

· Minimal aspiration volumes desired, aspirating < 100 µL for full hematology profile

· Ability to perform continuous, random statistical analysis using common statistical control rules as well as patient-derived quality control procedures (e.g., X- bar B analysis)

· Clot detection, liquid level detection, and abnormal descent detection

· Use of fluorescent flow cytometry for WBC and platelet identification and enumeration preferred

· Must have no significant intra-lipid interference for WBCs

· Use of non-cyanide reagent for Hemoglobin required

· Minimum throughput per location:

· Main Core Laboratory: 200 tests per hour; redundancy required (throughput includes primary and secondary systems)

· Apheresis/Cell Therapy Clinic: 60 tests per hour (primary only)

· Akeroyd Blood Donor Center: 60 tests per hour (primary only)

· Clinical parameters – Main Core Laboratory:

· Measured Hematocrit required. Must achieve HCT linearity (Analytical Measurement Range) of 0.0 – 75.0% and a Reportable Range (Limit of Quantitation) of 0.1 – 75.0%.

· Ability to identify immature granulocytes per CBC differential analysis.

· Ability to identify nucleated RBCs per CBC analysis to include anemia management parameters, such as the reticulocyte hemoglobin listed in the “VA Guidelines for the Management of Chronic Kidney Disease” to efficiently screen for anemia, and immature reticulocyte fraction.

· Ability to identify immature platelet fraction and provide fluorescent platelet count for low platelet counts.

· Instrument must provide platelet enumeration using a methodology that would reduce the number of platelet flags requiring manual confirmatory procedures. Dual platelet methodologies are preferable in order to reduce manual confirmations with extended platelet parameters for the determination of thrombopoiesis.

· Must achieve PLT linearity (Analytical Measurement Range) of 0 – 5000 x 103/µl and a Reportable Range (Limit of Quantitation) of 2 – 5000 x 103/µl.

· Required test parameters listed below in Table 1.

Table 1. Required Test Parameters

1. COMPLETE BLOOD COUNT (CBC) to include the following:

a. White Blood Cells (WBC)

b. Red Blood Cells (RBC)

c. Platelets (PLT)

d. Hemoglobin (HGB)

e. Hematocrit (HCT)

f. Mean Corpuscular Hemoglobin (MCH)

g. Mean Corpuscular Volume (MCV)

h. Mean Corpuscular Hemoglobin Concentration (MCHC)

i. Mean Platelet Volume (MPV)

j. Red Cell Distribution Width (RDW)

k. Lymphocytes Number (LYMPH #)

l. Lymphocyte Percentage (LYMPH %)

m. Monocytes Number (MONO #)

n. Monocytes Percentage (MONO %)

o. Neutrophils Number (NEUT #)

p. Neutrophils Percentage (NEUT %)

q. Eosinophils Number (EOS #)

r. Eosinophils Percentage (EOS %)

s. Basophil Number (BASO #)

t. Basophil Percentage (BASO %)

u. Nucleated Red Blood Cells (NRBC) #

v. Immature Granulocytes, Absolute (IG #)

w. Immature Granulocytes, Percent (IG %)

2. Reticulocyte # and Reticulocyte %

a. Immature Reticulocyte Fraction

b. Reticulocyte Hemoglobin Equivalent

3. Body Fluid Counts (Serous; Synovial; CSF)

4. Reticulocyte and Body Fluid counts required in Main Core Laboratory only

· Additional Main Core Laboratory Requirement Only –

· Instrument must provide body fluid cell enumeration with the large linear range with the following parameters: WBC, RBC, and Total nucleated count with a 2-part differential (polymorphonuclear %/# and mononuclear %/#) with each body fluid analysis for the following types:

· Serous

· Synovial

· Cerebrospinal Fluid

· System should have the lowest possible linearity on WBC-BF and Total Nucleated Count-BF linearity (Analytical Measurement Range) on all body fluids of 0.000 – 10.000 x 103/µl and a Reportable Range (Limit of Quantitation) of 0.003 – 10.000 x 103/µl.

· Must achieve RBC-BF linearity (Analytical Measurement Range) on all body fluids of 0.000 – 5.000 x 106/µl and a Reportable Range (Limit of Quantitation) of 0.002 – 5.000 x 106/µl.

· Additional instrument for Erythrocyte Sedimentation Rate (ESR) testing. This instrumentation must be fully-automated and connect with the automation line.

· Clinical parameters – Apheresis/Cellular Therapy Clinic and Akeroyd Blood Donor Center

· Measured Hematocrit required. Must achieve HCT linearity (Analytical Measurement Range) of 0.0 – 75.0% and a Reportable Range (Limit of Quantitation) of 0.1 – 75.0%.

· Must achieve WBC linearity (Analytical Measurement Range) 0.0-440.0 x 10^3/ul and a Reportable Range (Limit of Quantitation) of 0.04 – 440.0 x 10^3/ul.

· Must achieve PLT linearity (Analytical Measurement Range) of 0 – 5000 x 10^3/µl and a Reportable Range (Limit of Quantitation) of 2 – 5000 x 10^3/µl .

· Akeroyd Blood Donor Center instrument must have blood bank software for donor testing and provide residual WBC count when analyzing red cell and platelet product in blood bank mode.

Required test parameters listed below in Table 2.

Table 2. Required Test Parameters for Ancillary Sites

f. Mean Corpuscular Hemoglobin (MCH)

g. Mean Corpuscular Volume (MCV)

h. Mean Corpuscular Hemoglobin

Concentration (MCHC)

i. Mean Platelet Volume (MPV)

j. Red Cell Distribution Width (RDW)

· Annual volume requirements listed below in Tables 3 - 4:

· Annual volumes may fluctuate within +/- 5% of stated volumes in Tables 3 – 4. Tiered pricing above and below stated minimum and maximum volumes will be considered.

Table 3. Annual Volume - Core Laboratory

Table 4. Annual Volume - Ancillary Clinics (CBC Count Only)

· CBC Differential Instrument System requirements – Main Core Laboratory only:

· Integrated digital imaging device for automated digital cell morphology required for whole blood and body fluids; sufficient to automate the performance of manual differentials and cell counts; must connect directly to analytical instrument line.

· The system must provide automated slide evaluation using photomicroscopy with computerized image analysis of photomicrographs.

· The contractor must provide a minimum of (12) twelve remote review software packages for the system, providing for remote review of cell morphology by clinical staff not collocated within the main laboratory.

· Slidemaker/Stainer System requirements – Main Core Laboratory only:

· Must be physically connected to the analytical instrument line to include direct connection to the CBC analyzer and digital imaging device.

· The slide-maker/stainer should be integrated with analyzer decision rules to reduce operator hands-on intervention and should act as part of line and independent from line as needed.

· Automated slidemaker and slidestainer for smears with minimum throughput of 75 tests per hour.

· System redundancy is required.

· Daily system maintenance should not exceed 20 minutes.

· Must have ability to differentiate stat from routine smears.

· Must have onboard decision-making capabilities which initiate preparation of smears based on specific analysis results and/or user-defined criteria.

· Positive sample identification prior to smear preparation required.

· Automated slide stainers must use a Wright-Giemsa or Wright stain. If the stains provided by the Contractor are deemed insufficient by the Medical Director, the Contractor must provide at no additional cost an alternative stain from a 3rd party source that is acceptable to the Medical Director.

· Pedestal(s) and/or carts capable of supporting each workcell system as appropriate, to include computer terminals or other automated instruments/peripherals as appropriate, providing a neat work area (e.g., reagent, cable and tubing control/maintenance).

· Peripherals, to include Uninterruptable Power Sources (UPSs), electrical line conditioners as required, instrument-specific computer terminals/CPUs, printers to include toner for each as needed, and other equipment where required.

2.2 Information Technology and Data Management System

2.2.1 A data management system, to include middleware, not contained within the CBC analyzers (e.g., Data Innovations).

2.2.2 Data management system requirements – Main Core Laboratory:

· The system must provide a central data management hub, to which the major systems included in this SOW connect. This must include a connection to the digital cell morphology analyzer in Core.

· The system must have the ability to manage critical values and delta checks.

· The system must have the ability to interface with slide maker/stainer to support differentiation of stat from routine smears.

· The system must not require remote communication to outside sources to be functional.

· The system must be capable of interfacing with the MHS Genesis. The analyzers must have an interface that is compatible to the current Government Laboratory Information System (LIS) Government LIS, Military Health System (MHS) Genesis. Each interface must allow for recognition and interpretation of MHS Genesis generated bar-code labels on all sample tube types. Connectivity between the Contractors instrument systems and middleware to each LIS will be required at varying times during the contracted period of performance.

· The system must include at least (12) twelve remote review stations (e.g., Thin Clients) to allow access to the digital imagery system and at least (5) remote review stations for access to instrument and middleware from centralized and decentralized locations.

· Systems that provide the ability to control instrument software from remote locations are preferred.

· The middleware should include a decision logic software that can filter information from analysis and enable reflex and rerun testing, generation of manual differential smears, auto-verification, and body fluids using rule sets that have been prepared by the vendor in collaboration with sections.

· Pre-defined rule set must indicate International Society for Laboratory Hematology specific rules.

· To include Consulting Services that encompass the development and validation of auto-verification rules to include the use of delta checks, critical values, measuring ranges, and section specific rules.

2.2.3 Contractor Services: The Contractor shall provide IT services to MTFs and OLBs while following all available standardized enterprise procedures as provided in GSP and subsequent TOs.

The Contractor shall follow guidance and oversight of DHA enterprise IT support elements including Market Technology Integration Office (MTIO), Risk Management Executive Division (i.e., cybersecurity), Infrastructure and Operations Division, Engineering Solutions Architecture - Business Analytics Division, Solutions Delivery Division, and the Enterprise IT Services Program Management Office.

GSP contractors shall adhere to current and future DHA IT enterprise processes, procedures, standards, and tools including but not limited to those published by the EITSI (e.g., the Service Management Manual). These processes, procedures, standards, and tools are anticipated to mature over time as part of DHA’s IT transformation led by the EITS initiative, and GSP contractors shall support this transformation by adhering to these changes throughout performance of any Task Orders under this contract.

2.2.4 Contract Management: The Contractor shall provide cradle-to-grave project management services for all awarded TOs, including project coordination, transition-in, transition-out, monitoring, documentation, reporting, vendor communication, and review.

2.2.4.1 Cross teaming: The Contractor shall not cross-team at the prime or subcontractor level, i.e., the prime may not be a subcontractor on another prime’s team and a subcontractor can only be on one prime’s team. The prime contractor shall be held fully responsible for all aspects of TO performance and oversight, regardless of any arrangement between the prime and its proposed subcontractors.

2.2.5 Scope Area 1: IT Service Desk:

The Contractor shall provide IT Service Desk Support Services in collaboration with the DHA GSC IAW approved DHA standards. IT Service Desk tasks include but are not limited to:

• Manage ticket (incidents, cases, and requests) that have been assigned to the site (e.g., routed from the DHA GSC via the MHS Service Helpdesk Information Technology Service Management (ITSM) application).

• Answer IT support calls and responding to questions.

• Local site knowledge bases in ServiceNow.

• Training of IT service desk staff.

• Management of service catalog entries.

• Direct calls that do not belong to the site back to tier 1 (i.e., GSC).

• Manage the IT Service Desk queue and complete work orders within the applicable SLAs for MTFs/OLBs

• Mobile Device support for local wireless handheld devices (cell phones, smart phones, tablets, pagers, and mobile hotspots).

• Support local assets, new technology acquisition, and life cycle management for desktops, laptops, tablets, printers, and other IT hardware through DHA Life-Cycle-Management (LCM). Supports inventory management, and Defense Reutilization Marketing Office (DRMO) disposal IAW established guidance of site.

• Support installation, changes, and removal of supported software. Provide troubleshooting of all approved DoD/DHA software, Operating Systems, and other DHA commercial off the shelf (COTS) and Government off the shelf (GOTS) applications as required.

• Follow established DHA procedures to request and obtain software licenses.

• For sites managing local call queues, such as with an Automated Call Distribution (ACD): o Support of the Call Center telephony.

o New system installs and upgrades, including necessary IT security assistance.

o Script creation.

• Provide desk-side and remote user assistance to resolve software and hardware problems that cannot be resolved remotely by the DHA GSC or other DHA Enterprise Support Teams. The main categories of desk-side support are LAN, WAN, wireless LAN, software, hardware, network, administrative, and special projects as approved by the Government and as directed by other DHA enterprise support elements.

• Maintain workstation/laptop operational baselines and cybersecurity compliance through established processes and procedures that include situational or periodic risk reviews as required by DHA enterprise support elements and/or as mandated by DoD/DHA policies and directives.

• Provide hardware support including but not limited to on-site touch-labor, troubleshooting, integration, configuration, and installation of authorized hardware, software, and peripherals. The contractor shall assist with all required equipment staging, burn-in, installation, testing and documentation. This shall include setup, systems, and integration testing and/or troubleshooting for all equipment purchased by or approved for use in network/systems areas supported at DHA site locations.

• Provide on-site IT support to assist with maintaining a standard operating system and software baseline as directed by the DHA enterprise support elements. This support includes assisting with the implementation of plans for periodic and ongoing replacement and upgrades of end-user devices.

2.2.6 Scope Area 2: Database, Application, and Web Development:

2.2.6.1 Database, Application, and web development: The Contractor shall implement and monitor database architectures, manage databases, and provide documentation. Database, application, and web development services include but are not limited to:

• Support and develop using programming languages used by the site.

• Support efficient use of database resources by reviewing system and programming designs.

• Installation, maintenance, configuration, and integrity of computer software.

• Implement enhancements that will improve the reliability and performance.

• Provide logical and physical database backup, verification and restoral.

• Support application development and application support.

• Provide technical guidance for how to analyze and derive metrics from large complex data sets using industry best practices.

• Plan for changes in the size of Databases that result from business growth and project implementation based on information supplied by the site, and review plans with sites on a periodic basis.

• Correct out-of-capacity situations caused by unusual activities in a timely manner (e.g., dataset or table space capacity events, full log files).

• Proactively monitor and prevent out-of-capacity situations (e.g., dataset or table space capacity events, full log files).

• Develop, document, and maintain Physical Database Support and management standards and Procedures based on industry best practices and business needs.

• Define Database creation, Configuration, Upgrade, Patching and Refresh requirements.

• Install, Configure, maintain, and monitor Database management systems.

• Create Databases and Database system instances.

• Create scheduled and on-demand Database snapshots and clones.

• Perform Database snapshots and clones at request of authorized site staff.

• Provide Databases with High Availability as defined by business requirements.

• Assist sites with Database management system version upgrades and migrations.

• Assist sites with determining which Database Service best meets the business requirements.

• Assist sites with determining the feasibility and implementation of high Availability Databases.

• Provide data dictionary expertise, data assistance, data warehouse metadata definition, data mapping functions and creation of data cubes for application developers.

• Maintain Databases to meet the Service Levels Agreements or Operational Level Agreements and other performance standards, to maximize efficiency, and minimize outages.

• Implement and administer appropriate Database management tools across all database instances.

• Make performance metrics and historical data available for trending and reporting.

• Test and implementation of Database environment changes, as approved by the site.

• Maintain consistent Database parameters and system settings across all like instances.

• Maintain Database consistency in accordance with the established software development lifecycle.

• Ensure Database consistency via tools to monitor, predict, and prevent database corruption.

• Open, track, and manage the resolution of database problems.

• Provide technical assistance, troubleshooting Support, and subject matter expertise to sites, DHA, and Third-Party vendors.

• Monitor Database for incidents and problems and automatically generate incidents and problems, as per policies and processes.

• Provide customizable real-time notifications and alerts to the sites.

• Maintain, operate, and upgrade automated monitoring tools to monitor Database performance.

• Employ Database performance analysis to confirm physical Database requirements in support of sites’ business requirements.

• Identify and resolve locking conflicts, latch contention, rollback requirements, etc. for all database instances.

• Define and execute Database performance and tuning scripts and keep Databases running at optimal performance for the site’s workloads.

• Perform Database reorganizations to optimize performance when required via established thresholds or site requests.

• Execute Database System Configuration Changes, Upgrades and Patches in accordance with the enterprise policies.

• Maintain documentation for Database instance parameters and system settings.

• Perform shutdowns and restarts for Database management systems, instances, and individual Databases as requested by the site.

• Maintain, update, and implement Database archive processes and procedures, to recover from an outage or corruption.

• Execute sites database backup schedules, retention periods, and levels (i.e., full, incremental, or differential).

• Exercise Database restores from database exports, dumps, backups, flat files, secondary databases, and disk-based snapshots.

• Provide granular restoration options to include the server, instance, database, table, and row levels at site defined recovery points.

• Provide security administration including service requests, managing role and end-user database permissions in accordance with established policies.

• Apply DISA Security Technical Implementation Guideline (STIG) and Security Requirements Guides (SRGs) against the site assets and document STIG / Security Requirements Guide SRG compliance.

• Execute Role Based Access Control (RBAC) according to enterprise policies.

• Provide Database management encryption for the entire system or subcomponents as requested by sites as required by law or policy.

• Provide an interface for sites to delegate Database Security functions.

2.2.6.2 The Contractor shall provide application(s), database administration, and web development and support services to meet the needs of multiple levels within the organization. The Contractor shall:

• Use COTS and third party-packages IAW DHA or DoD approved Software Development Life Cycle (SDLC).

• Create customer web and scripting applications using platforms including, but not limited to: SharePoint, ASP, .NET, and JAVA platforms IAW local site requirements.

• Use Applications and Web Development process definition, certification, validation, and verification, architecture, and reengineering, security, and configuration management IAW DHA standards.

• Apply, implement, document and gain approval for application STIGs.

• Create, administer and support custom web and scripting applications using platforms including, but not limited to: SharePoint, .ASP, .NET, and/or JAVA.

• Provide Subject Matter Expert (SME) support in the planning, analysis, development, testing and implementation of various COTS and custom web applications, as well as provide recommendations and insight regarding the acquisition and integration of any identified third-party packages.

• Support the entire SDLC including process definition, requirements, management, project planning, quality assurance, metrics, testing, certification, validation, and verification, architecture, and reengineering, security, and configuration management.

• Have working knowledge of the software development methodologies including the use of Agile, sprints, and stories. Additional methodologies, as needed, may be specified at the task order.

2.2.7 Scope Area 3: Identity Management and Desktop Support:

The Contractor shall provide Identity Management and Desktop Support services under the direction of DHA Domain & Directory Services Branch (DDSB). Identity management and desktop support services include but are not limited to:

• Active Directory (AD) management, including hosting services, sustainment, and management of the DHA associated medical Joint Active Directory (mJAD) Organizational Units (OU), user accounts and systems.

• Manage and monitor Site mJAD OU and associated environments to ensure the environments meet the security, integrity, and administrative needs in accordance with MHS standards and best practices derived from recommended industry standards. The DHA mJAD’s scope is global and consists of Tri-Service activities for members of the entire DOD medical community encompassing the Air Force, Army, Navy, Coast Guard, DHA, and the Veterans Administration (VA).

• Provide oversight and management of administrative accounts within the DHA Site OUs in support of the mJAD. Services shall include Joint Directory Services and electronic messaging, Active Directory (AD) services, SharePoint, or Enterprise Management (EM). EM services utilize the Microsoft Endpoint Configuration Manager (MECM), Windows Server Update Services (WSUS) and Tanium for software updates, patching, and reporting capabilities.

• Manage, monitor, patch, upgrade, and ensure Information Assurance Vulnerability Assessment (IAVA) compliance of mJAD resources and hardware using, for example, Microsoft Endpoint Configuration Manager (MECM), Splunk, Tanium, and other systems or application monitoring tools, software, or devices under the direction of DHA enterprise support elements.

• Provide desk-side and remote user assistance to resolve software and hardware problems that cannot be resolved remotely by the DHA GSC or other DHA Enterprise Support Teams. The main categories of desk-side support are LAN, WAN, wireless LAN, software, hardware, network, administrative, and special projects as approved by the Government and as directed by other DHA enterprise support elements.

• Maintain workstation/laptop operational baselines and cybersecurity compliance through established processes and procedures that include situational or periodic risk reviews as required by DHA enterprise support elements and/or as mandated by DoD/DHA policies and directives.

• Provide hardware support including but not limited to on-site touch-labor, troubleshooting, integration, configuration, and installation of authorized hardware, software, and peripherals. The contractor shall assist with all required equipment staging, burn-in, installation, testing and documentation. This shall include setup, systems, and integration testing and/or troubleshooting for all equipment purchased by or approved for use in network/systems areas supported at DHA site locations.

• Provide on-site IT support to assist with maintaining a standard operating system and software baseline as directed by the DHA enterprise support elements. This support includes assisting with the implementation of plans for periodic and ongoing replacement and upgrades of end-user devices.

• Provide oversight and management of administrative accounts within the DHA Site OUs in support of the mJAD. Services shall include Joint Directory Services and electronic messaging, Active Directory (AD) services, Public Key Infrastructure (PKI), SharePoint, and Enterprise Management (EM). EM services utilize the Microsoft Endpoint Configuration Manager (MECM), Windows Server Update Services (WSUS) and Tanium for software updates, patching, and reporting capabilities.

2.2.8 Scope Area 4: Data Center Operations:

The Contractor shall provide full life-cycle Data Center Operation services IAW enterprise standards and other Government policies. Data center operations tasks include but are not limited to:

• On-site Data Center storage, back-up and data restoration, recovery, health, capacity planning, utilization monitoring, performance monitoring, disruptions, changes, service-level compliance, operational improvement, service reports, annual planning, annual evaluations, life cycle management, physical security controls, and archival records as per security requirements.

• Use of available enterprise tools for server infrastructure planning, role-based access control implementation and sustainment, administration, boundary determination, client settings, software/hardware inventory, and software distribution.

• Systems and IT environment administration and management.

• Supporting environment controls, such as: Uninterruptible Power Supplies (UPSs) and temperature monitoring systems.

2.2.9 Scope Area 5: Information Assurance:

The Contractor shall provide, ensure, develop, contribute, support, coordinate, deliver, train and maintain Enterprise and local site Information Assurance (Cybersecurity) services. Information Assurance tasks include but are not limited to:

• Information Assurance compliance, documentation, authorization, certification, validation, verification, assessment, testing, evaluation IAW the DoD Risk Management Framework (RMF) guidelines, HIPAA laws, DoD and DHA guidance, and DHA Authorization to Operate (ATO) standards. This also includes: o Apply DISA STIG and SRGs against the site assets and document STIG / SRG compliance.

o Conducts Assured Compliance Assessment Solution (ACAS) and Security Content Automation Protocol (SCAP) scanning and assessments.

o In support of RMF requirements, the Contractor shall prepare Annual Reviews, Plans of Action, and Milestones (POAM), Risk Assessments, Risk Acceptances, Security Plans, and other artifacts IAW DHA Cyber practices, formats, and policy.

o Support of all critical systems and services to include required software upgrades, patches and maintenance based off scanning results.

• Participate in preparing for Command Cyber Readiness Inspections (CCRIs).

• Support the Government management staff with briefings and updates as required.

• Update and document site enclave artifacts in Enterprise Mission Assurance Support Service (eMASS).

• Contractor will attain and maintain an eMASS account via site and DHA administrators. o Update and document eMASS modules for site eMASS records to fulfill the RMF process.

• Conduct Cybersecurity threat monitoring, risk identification, incident mitigation, and administration IAW the DHA RMF Portal. (https://info.health.mil/dadio/InfoSec/assessor/dharmf).

• Supporting changes required by Information Assurance Vulnerability Alerts/Assessments (IAVAs), Information Assurance Vulnerability Bulletins (IAVBs), and Cybersecurity Tasking Orders.

• Participating in remediation of findings, vulnerabilities, and troubleshooting of subsequent conflicts and problems.

• Support Trusted Agents (TAs) requirements related to alternate token or elevated privileges to the network and systems.

2.2.10 Scope Area 6: Network Operations:

The Contractor shall support the overall network infrastructure (i.e., local area network (LAN), wireless local area network (WLAN), wide area network (WAN)) at a site and respond to, detect, report, record, diagnose and resolve network issues as well as measure network performance and connectivity on an ongoing basis.

Network operation services include but are not limited to:

• Install, relocate, configure, modify, and test network devices, including routers, switches, wireless access points, access controllers, and terminal servers.

• Manage, patch, and upgrade firmware and software on network devices IAW enterprise standards.

• Create, maintain, and manage Virtual Local Area Networks (VLANs).

• Install, test, terminate and maintain cables.

• Troubleshoot cabling and wiring problems.

• Test and verify wiring drops per industry standard.

• Ensure cable management is performed at network closets, data center, and customer locations per industry standards.

• Operate and maintain Network Management Systems (NMS).

• Support network operating systems (NOS) availability to ensure access to network resources.

• Support enterprise Comply to Connect (C2C) requirements.

• Support diagnostics and configuration connectivity of MHS site/service specific servers, such as MHS GENESIS, Defense Blood Standard System (DBSS), Composite Health Care System (CHCS), Armed Forces Health Longitudinal Technology Application (AHLTA), and Defense Medical Logistics Standard System (DMLSS) operating systems, office automation, etc.

• Assist with the establishment and implementation of network policies, procedures, and standards to include network security.

• Support the Government management staff with briefings and updates as required.

• Conduct and maintain inventories for sparing and maintenance.

• Support security firewalls and virtual private network devices.

• Collect and report network performance measurement information (e.g., LAN, circuit bandwidth).

• Assist with DHA Infrastructure deployments and technical hardware refresh initiatives. Submit a schedule indicating the projected date(s) when each piece of equipment will be installed.

• Participate in MHS infrastructure planning and technical architecture.

• Develop, plan, and maintain documentation necessary for operations.

• Define and recommend minimum standards, as applies to network operations, access to the Internet and its impact on overall network resourcing and operations.

• Oversee the integration of network hardware and software platforms for WAN/LAN/WLAN connected systems and medical information systems and devices).

• Coordinate telecommunications actions for provisioning and changes in networks.

• Address user concerns with the LAN/WAN service provider and alert users to routine maintenance affecting circuits.

• Provide network related advice.

• Support management of LAN and WAN connectivity or assistance with Quality of Service (QoS) for applications such as streaming media, Video on Demand (VoD), Video over IP, and other Government prioritized traffic as required. o The Contractor shall provide the Government with recommendations for cost-effective solutions.

2.2.11 Scope Area 7: Telecommunications:

The Contractor shall provide, resolve, support, assess, coordinate, manage, troubleshoot, train, design, engineer, and maintain telecommunications (e.g., Analog, Digital, and Voice Over IP) services. Telecommunication services include but are not limited to:

• Operate and maintain site telecommunications systems (e.g., PBX, voicemail, VOIP, Automated Call Distribution (ACD)), including any of the following activities: additions, moves, changes.

• Supports installs, moves, changes or operation of telecommunication devices, including telephones, handsets, headsets, video teleconference (including telehealth and telemedicine services), and analog lines.

• Site surveying and documenting requirements in support of communications infrastructure.

• Support the adds, moves, and changes for site voicemail support.

• Ensure cable management is performed at telecommunication closets, data center, and customer locations per industry standards.

• Utilize third party or component (local site) service ticketing systems.

2.2.12 Scope Area 8: Clinical Informatics:

2.2.12.1 The Contractor shall provide support in the application of informatics and IT within the healthcare delivery process, utilizing clinical systems, applications, and associated patient healthcare data. The Clinical Informatics services include but are not limited to:

• Clinical Application Training.

• Clinical Workflow analysis.

• Clinical Curriculum Development.

• Associated IT support as related to Clinical Applications.

• Clinical/Functional Research Subject Matter Expert (SME).

2.2.12.2 The Contractor shall provide clinical systems training focused on processes and workflow tailored to clinician-specific roles in the care-delivery process, with a focus of improving clinical operational efficiency, and enhancing the provider-patient experience. The Contractor shall also provide expertise, recommendations, and training in informatics and COTS systems utilized in the clinical environment, including electronic health record (EHR) systems such as AHLTA, CHCS, CliniComp Electronic Health Record (formerly Essentris), Joint Legacy Viewer, and MHS GENESIS. The Contractor shall:

• Provide assistance in formulating and defining systems’ scopes and objectives based on both user requirements and applicable clinical and business systems and industry requirements.

• Assist in devising and modifying procedures to solve complex problems, analyzing business and user needs, documentation requirements, and translating into proper system requirement specifications.

• Provide technical guidance concerning the business implications of the application of various systems.

• Provide assistance in the creation, maintenance, and design of complex computerized databases.

• Assist the Government in analyzing and evaluating clinical and financial performance using quantitative and qualitative methods with potential forecasting basis to assess, plan, forecast, process, and provide overall program effectiveness.

2.2.13 Scope Area 9: Information Business Operations:

2.2.13.1 The Contractor shall provide forecast, recommend, design, plan, track, evaluate, maintain, monitor, document, report, research, review and implement Information Business Operations services. Information business operations services include but are not limited to:

• Strategic Planning and Assessment, Budget, Contract Support, Business Process Reengineering (BPR), Solutions Delivery, Project Management (cost, schedule, and performance), Life Cycle Management, Risk Management, and Quality Management and Monitoring by reviewing current and future architectures, structures, and resource allocations. Provide project management cost, schedule, performance, life cycle management, risk management, and quality guidance and monitoring.

• Coordination, stand-up, communication, closeout, review, data gathering, data entry, briefings (plan, set-up, record) for IT Facilities and Construction, Telecommunications, End User Devices, Hardware, and Software.

• Staffing plans IAW local IT department requirements.

• Technical guidance, review and assessments of current and future computer software and hardware IAW local site requirements.

• IT Contracts, budgets, funding, and procurement activities using IT business management tools and applications IAW applicable management and contracting staff.

• Office administration support.

• Risk Management.

• Knowledge Management.

• Digital Imaging and Graphics.

2.2.13.2 The Contractor shall provide cradle-to-grave project management services, including project coordination, kickoff, stand-up, monitoring, documentation, reporting, vendor communication, closeout, and review. The Contractor shall:

• Manage, from initiation to completion, all departmental projects including IT Facilities and Construction, Telecommunications, End User Devices, Hardware/Software/Systems Implementation, Installation and Deployment, Cybersecurity, Networking, and IT Infrastructure.

• Provide administrative support in the areas of status reporting, data gathering, data entry, report preparation, support for briefings, funding profiles, task lists, installation or customer meeting logistics, managing project risks and issues, and other duties as required.

• Research, review, document, and adhere to organizational processes and procedures.

• Provide analysis support.

2.2.14 Performance Metrics

2.2.14.1 The contractor shall monitor and report metrics at each of the following levels.

• Enterprise level metrics. The Contractor shall report performance results that includes performance on all task orders awarded. The Contractor shall report performance results to the GSP PM and GSP CO.

• TO level metrics. The Contractor shall report performance results as required for each TO. The Government may provide detailed metrics and AQLs in the TO. The contractor shall evaluate each of these metrics for all MTFs/OLBs, unless the metric is specific to one or more MTFs/OLBs, in the TO and report as designated in the TO. The Contractor shall report performance results to the TO COR and TO CO. Performance metrics will be consistent with the type of contract being awarded to include labor hour or firm fixed price or both.

2.2.14.2 Enterprise Performance Metrics

2.2.14.2.1 Government Concern Response Rate. The concern response percentage is a measure of how well the CPM responds to DHA concerns. The percentage is calculated by dividing the sum of the number of timely responses (both urgent and routine) by the sum of all responses during the reporting period.

2.2.14.2.1.1 Urgent. The Contractor shall acknowledge the concern within 24 hours of receipt. The Contractor shall update the Government every 24 hours until will the concern is considered resolved by the Government. 2.2.14.2.1.2 Routine. The Contractor shall acknowledge the concern within 24 hours of receipt. The Contractor shall update the Government every week until the concern is considered resolved by the Government.

2.2.14.2.2 Competition Percentage. The competition percentage is a measure of how active each GSP Contractor is in competing for TOs. The percentage is calculated by dividing the sum of number of TOs where the Contractor submitted a proposal divided by the total number of TOs proposed by the GSP program.

2.2.14.3 Performance Requirements Summary. The Contractor shall meet or exceed all Acceptable Quality Levels (AQL) for metrics defined in Attachment 5 (Performance Requirements Summary (PRS)) or in TO PRS.

2.2.14.3.1 Contractor Performance Report (CPR). The Contractor shall prepare and submit a monthly CPR to the GSP PM and GSP CO electronically not later than the 10th calendar each month. The Government may update the CPR format as needed during the life of the contract. The CPR shall include performance for all TOs.

2.2.15 Information Technology and Security

Contractor Personnel shall undergo a Tier 1 (T1) investigation or higher. Specific Tier level investigation requirements are detailed in Attachment 1, GSP Labor Categories. Contractor Personnel must obtain favorable suitability adjudication prior to commencement of duties and maintain favorable suitability adjudication.

Contractor shall follow the DHA Personnel Security Office guidelines and or the local site security office for submittal of security clearances. Contact the DHA Personnel Security Office for guidance on the appropriate background investigation required for personnel on the contract.

Contractor shall initiate, maintain, and document personnel security investigations appropriate to the individual’s responsibilities and required access to Controlled Unclassified Information (CUI) and/or MHS Sensitive Information.

2.2.15.1 TOs under this contract may contain up to SECRET requirements when the DD 254 is applied. The Contractor shall possess, prior to award of the IDIQ contract, and consistently maintain, throughout performance, a SECRET or higher Facility Clearance Level (FCL) from the Defense Counterintelligence and Security Agency (DCSA). If a subcontractor or teaming partner to Contractor has no FCL or an FCL lower than the required classification level indicated, the Contractor must sponsor its subcontractor or teaming partner for a new FCL or an FCL upgrade.

2.2.16 Security Clearances: Security Clearances shall be required for certain GSP roles. The requirement for a SECRET security clearance will be detailed in the Task Order via the Department of Defense (DD) FORM 254, APR 2018 or later – Contract Security Classification Specification.

2.2.16 Employee Prescreening: Contractors shall conduct thorough reviews of information submitted on an individual’s application for employment in a position that requires either an ADP/IT background investigation or involves access via a contractor system to data protected by either the Privacy Act of 1974, as amended, or the Department of Health and Human Services (HHS) Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy and Security Final Rule.

The prescreening shall be conducted as part of the pre-employment screening and shall be completed before the assignment of any personnel to a position requiring the aforementioned ADP/IT accesses. The prescreening can be performed by the contractor’s personnel security specialists, human resource manager, hiring manager, or similar individual.

For contractors working in the United States (U.S.) and the District of Columbia, this prescreening shall include reviews that:

• Verify U.S. citizenship.

• Verify education (degrees and certifications) required for the position in question.

• Screen for negative criminal history at all levels (federal, state, and local).

• Screen for…