Data Abstraction Services - PWS DRAFT.docx

NEW CONTRACT

Department of Defense Defense Health Agency Performance Work Statement

DATA ABSTRACTION SUPPORT SERVICES

[Medical Affairs]

Vision Center of Excellence

Solicitation Number: TBD Date: 8/21/2026

PART 1

1.0 GENERAL INFORMATION

1.1 This is a non-personal services contract for data abstraction support services.

1.2 Description of services/introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform data abstraction support services as defined in this as defined in this Performance Work Statement (PWS), except for those items specified as government-furnished property and services. The contractor shall perform to the standards specified in this PWS.

The Defense Health Agency (DHA) requires contractor support data abstraction support services. These services include the reviewing, identifying, and extracting relevant medical and related clinical data from medical records and other medical documentation from Department of Defense (DoD) and Department of Veterans Affairs (VA) medical records documentation systems including the Armed Forces Health Longitudinal Technology Application (AHLTA), Theater Medical Data Store (TMDS), Joint Legacy View (JLV), GENESIS, and the Veterans Health Information Systems and Technology Architecture (VistA). The extracted data, whether handwritten, textual or digital will be entered into the Defense and Veterans Eye Injury and Vision Registry (DVEIVR).

DVEIVR is a web based ocular care clinical data repository and a joint DoD/VA initiative. It serves as a centralized resource for eye care providers, researchers, and academia to access and analyze data on eye injuries, diagnoses, surgical interventions, visual acuity, treatments, and outcomes for Service Members and Veterans.

DVEIVR is maintained by the DoD Vision Center of Excellence (VCE) to:

· Collect and track detailed eye injury and vision data, including diagnoses, surgical interventions, and treatment histories.

· Coordinate care between the DoD and the VA.

· Support research into preventing and treating vision issues, and to improve military eye care.

· Meet Congressional requirements for reporting eye injuries and diseases for affected service members and veterans

1.3 Background: The VCE was created by Congress via the National Defense Authorization Act for Fiscal Year 2008 to address military eye injuries, including prevention, diagnosis, treatment, rehabilitation, and care for visual system disorders such as those linked to traumatic brain injury.

The VCE responsibilities include achieving three interrelated objectives: :

· Improve vision health

· Optimize operational readiness

· Enhance quality of life for service members and veterans

1.4 Objectives: The objective are:

· Data abstraction from DoD and VA medical and related clinical systems;

· Quality data monitoring, auditing, and review of data abstraction and related processes; and

· Data abstraction operational support to the VCE.

1.5 Scope: Data abstraction of ocular and related data from DoD and VA medical systems.

The data abstraction support services required under this contract include supporting the Government with the data abstractor training requirements and knowledge transfer, business processes, including draft Standard Operating Procedures (SOP), and business logic/rules associated with the data requirements of the DVEIVR. Data Abstractors shall assist in development and implementation of these activities, as well as enter ocular related data from DoD and VA clinical systems into the DVEIVR. The Contractors also review, revise, and amend, as necessary quality review and audit processes to ensure the defined data accuracy requirements are met. The Contractor shall also participate in Data Management Work Group (DMWG); Internal Change Boards (ICBs); the Integrated Product Team (IPT), Quality Review Meetings, and Stakeholder Workgroups that present findings and recommendations based on data abstraction of ocular information from DoD and VA medical records. The Government understands that these are iterative processes that may expand over time; however, a well- documented and supported foundation of processes with associated SOP shall ensure successful data abstraction and data integrity.

The data abstraction support services shall support the DVEIVR application through the review and refinement of data abstractor training plans, business processes, and business logic/rules and data entry of ocular and related clinical information into the DVEIVR from DoD and VA medical and related systems.

The data from the DVEIVR shall be used to establish mechanisms to longitudinally track eye related injuries and diseases to support the VCE in completing studies and analysis related to readiness, treatment, best practices, and to inform policy.

1.6 Period of Performance (PoP): SEE SCHEDULE

1.6.1 Transition-In and Knowledge Transfer: To mitigate operational risk and ensure zero degradation of clinical data abstraction, the contractor shall execute a structured transition-in phase. (Deliverable #1)

• Day-One Readiness: Key Personnel (Project Manager, Trainer, and Clinical Data Abstractor Level 4 Subject Matter Experts) must be fully cleared, badged, and operationally ready on Day 1 of the Base Period.

• Security & IT Onboarding: The incoming contractor must submit all personnel rosters Common Access Card (CAC) applications, and network system access requests (AHLTA, GENESIS, VistA, JLV) within five (5) business days of contract award.

1.6.2 Transition: Transition-out

The Contractor shall provide an Outgoing Transition Plan (Deliverable #2) for transition work from an active contract to a follow-on contract or Government entity. This transition may be to a government entity, another Contractor or to the incumbent Contractor under a new contract/order. In accordance with the Government-approved plan, the Contractor shall assist the Government in planning and implementing a complete transition from this Contract and/or orders issued under this Contract to a successful provider. This shall include formal coordination with Government personnel and successor staff and management. It shall also include delivery of copies of existing SOP, and delivery of required metrics and statistics.

The transition plan shall include:

· Coordination with Government representatives,

· Review, evaluation and transition of current support services,

· Transition of historic data to new Contractor system,

· Government-approved training and certification process,

· Transfer of hardware warranties and software licenses (if applicable),

· Transfer of all necessary business and/or technical documentation,

· Orientation phase and program to introduce Government personnel, programs, and users to the Contractor's team, tools, methodologies, and business processes,

· Disposition of Contractor purchased Government owned assets, facilities, equipment, furniture, phone lines, computer equipment.

· Transfer/Disposition of Government Furnished Equipment (GFE) and Government Furnished Information (GFI), and GFE inventory management assistance.

· Applicable VCE debriefing and personnel out-processing procedures.

· Turn-in of all Government keys, ID/access cards, and security codes.

1.6.1.2 Transition-out period: The transition-out plan shall facilitate the accomplishment of a seamless transition from the incumbent to incoming contractor/Government personnel at the expiration of the contract. See Part 7, Technical Exhibit 1.

1.6.1.2.1 The contractor shall comply with transition-out requirements of the DHA for contractors who have been issued a CAC or who generate “records”, as defined by DoD (records manual), including DoD-directed disposition of records, and others displayed on the In/Out (I/O) Processing Portal.

1.7 Administrative Specifications

1.7.2 Place of performance: All work shall be performed at the Vision Center of Excellence’s facility. The Government will provide access to Government controlled facilities, equipment, and materials for daily business use of staff called for under this order. This shall include desk, telephone, chair, computer, shared printer, and requisite consumable materials.

The Contractor may be provided key or codes for access to the Government facility. These keys and codes shall be controlled, tracked, and protected. Upon termination of the period of performance, all keys and/or access badges to the Government facility shall be turned into the COR.

1.7.2.1 The contractor shall notify the government of any plans to change location to the current contractor-provided facility site. The contractor shall ensure that any notification to changes in geographical location does not affect contractor and/or government employee access to either contractor or government sites.

1.7.2.2 The Contractor shall provide visitor-controlled access and limit visitor access to areas where data abstraction is in process.

1.7.3 Recognized Federal holidays. The Contractor is not required to work on the following Federal holidays:

1) New Year’s Day

2) Martin Luther King Jr.’s Birthday

3) Washington’s Birthday

4) Memorial Day

5) Juneteenth

6) Independence Day

7) Labor Day

8) Columbus Day President’s Day

9) Veteran’s Day

10) Thanksgiving Day

11) Christmas Day

1.7.4 Hours of operation: The contractor is responsible for conducting business Monday through Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. The contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential. In addition, the contractor shall require contractor personnel work hours to be consistent with the availability of the DVEIVR technical support team.

1.7.5 Telework: Telework may be permitted based on Government instruction that includes contractors, due to national emergencies, such as pandemic; local weather-related events; or local state emergencies that impact the Contractor site or other emergencies that impact the Contractor workspace.

1.8 Contractor Travel: RESERVED.

1.9 Other Direct Costs (ODC): RESERVED

1.10 Quality

1.10.1 Quality Control (QC): The contractor shall develop and maintain an effective QC program to ensure services are performed in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure no recurrence of defective services. The contractor’s QC program is the means by which the work complies with stated requirements. The Quality Control Plan (QCP) for the Quality Review Processes, including an audit of contractor personnel and on-going data abstraction performance, shall be delivered 30 days after contract start date (Deliverable #3). After acceptance of the QCP the contractor shall receive the CO’s acceptance in writing of any proposed change to the vendor’s QC system.

1.10.2 Quality assurance (QA): The government will evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan (QASP). This plan provides a systematic method for the Government to evaluate performance and to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.11 Contractor Personnel

1.11.1 CAC requirements: For all contractors who will work in Government facilities, the Facilities Security Officer (FSO)/Company's Security point of contact (POC) will provide the Government with all the required information per the DHA CAC request process current version 2.1, January 2018, or more recent when updated. See process attached at Part 7 Section 7.1.1 of the PWS. A CAC is the standard identification for eligible DoD contractor personnel.

1.11.1.1 The contractor shall return all CACs to the COR upon the departure of the contractor(s).

1.11.2 Contractor onboarding and training. The contractor shall complete all requirements, training, and forms as prescribed in the following requirements:

1.11.2.1 The DHA’s “Onboarding Checklist for Contractor Employees” is located at the DHA Onboarding and Off boarding Portal at https://info.health.mil/cos/admin/hr/IO/SitePages/Home.aspx

1.11.2.2 DHA’s contractor training instructions embedded at Part 7 Section 7.1.2.

1.11.2.3 The contractor shall comply with onboarding requirements of the DHA for contractors needing to be issued CAC identification, including DoD- and DHA-directed training and forms submission, prior to network access, as displayed in the In/Out-Processing Portal at: https://info.health.mil/cos/admin/hr/IO/SitePages/home.aspx (note: Public Key Infrastructure (PKI)-restricted, printed versions available).

Contractor Employees Who Require Access to Government Information Technology. All contractor employees requiring access to government information technology shall successfully complete the current DoD approved Cyber Awareness Challenge training prior to being granted access, and annually thereafter. This training takes approximately 30 – 60 minutes to complete and requires the student to pass a test at the conclusion. The official DoD certificate of completion must be presented to the COR. DoD Cyber Awareness Challenge must be taken utilizing the Defense Health Agency (DHA) Learning Management System, Joint Knowledge Online (JKO): http://jko.jten.mil/mhs. The contractor shall submit a status report of Completed Required Training to the Government when requested. (Deliverable #4)

1.11.3 Physical Security: The contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use. At the close of each work period, government facilities, equipment, and materials shall be secured.

1.11.4 Key control: RESERVED

1.11.4.1 RESERVED

1.11.4.2 RESERVED

1.11.5 Lock combinations: RESERVED

1.12 Key Personnel: The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the CO. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract. The contract manager or alternate shall be available between 8:00 a.m. to 4:30 p.m.], Monday thru Friday except Federal holidays or when the government facility is closed for administrative reasons. Qualifications for all key personnel are listed below:

1.13 :

Key Personnel Labor Category 1: (.25 FTE) Program Manager Key Personnel Labor Category 2 (1 FTE): Clinical Reviewer Key Personnel Labor Category 3 (1 FTE): Clinical Staff Supervisor

1.14 Data rights: The Government shall retain rights to all data produced in the course of developing, deploying, training, using and supporting VCE or other federal agencies that utilize this contract.

1.14.1 Data Sharing Agreement (DSA): The Contractor shall complete and submit a Data Sharing Agreement Application (DSAA) within 30 days of the contract award (Deliverable #6). The application for the DSAA is found https://health.mil/Military-Health-Topics/Privacy-and-Civil-Liberties/Submit-a-Data-Sharing-Application

1.15 Reporting

1.15.1 Service Contract Reporting (SCR): RESERVED

1.14.2 Non-Disclosure Agreement (NDA): (Deliverable #5) All contractor personnel who will obtain access to proprietary, classified, or confidential information or any information release of which is protected or governed by law or regulation associated with DHA acquisitions shall be required to complete and sign a DHA contractor NDA (DHA Form 49) prior to beginning work on the subject contract. The contractor shall execute an NDA on behalf of the company and shall ensure that all contractor personnel assigned to, including all subcontractors and consultants, or other personnel performing on contract/Task order execute an NDA protecting the procurement sensitive information of the Government and the proprietary information of other contractors. The NDA shall be executed not later than first day of employment and to be renewed upon exercising a contract option period. Assignment of contractor personnel who has not executed this statement or failure to adhere to this statement shall constitute default on the part of the contractor. The contractor shall maintain originally signed NDAs of individual employees and provide copy to the COR.

1.14.3 Government’s COR: The COR monitors all technical aspects of the contract and assists in contract administration. The COR is authorized to perform the following functions: assure that the contractor performs the technical requirements of the contract; perform inspections necessary in connection with contract performance; maintain written and oral communications with the contractor concerning technical aspects of the contract; issue written interpretations of technical requirements, including Government drawings, designs, specifications; monitor contractor's performance and notifies both the CO and contractor of any deficiencies; coordinate availability of government furnished property; and provide site entry of contractor personnel. A letter of designation issued to the COR, a copy of which is sent to the contractor, states the responsibilities and limitations of the COR, especially regarding changes in cost or price, estimates or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting contract.

1.14.4 Post award conference/periodic progress meetings: The contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with FAR Subpart

42.5. The CO, COR, and other Government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings, the CO will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the Government of problems, if any, experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

1.15 Contractor Identification

1.15.1 Contractor personnel performing services in a contractor capacity in a government facility are required to possess and wear an identification badge that displays his or her name and the name of their company. All contractor personnel shall identify themselves as contractor support personnel in all forms of communication with all entities with whom DHA/Deputy Assistant Director for Acquisition (DAD-A)/Head of the Contracting Activity (HCA) has business dealings. The contractor shall: Answer all telephone calls and have a personalized voice message with an introductory statement that includes the fact that the person is contractor support personnel. Ensure all those with whom the person interacts in any face-to-face dealings while supporting the DAD-A understand that the person is contractor support personnel. Include a title block in all emails that states the fact that the person is contractor support personnel. Ensure all those with whom the person interacts in any face-to-face dealings while supporting DHA/DAD-A/HCA understand that the person is contractor support personnel.

1.15.2 Contractor personnel will be required to attend meetings or otherwise communicate with Government and/or other contract representatives to meet the requirements of this contract. Contractor personnel shall make their contractor status known during introductions.

1.15.3 Contractor personnel, while performing in a contractor capacity, are prohibited from using their retired or reserve component military rank or title in any written or verbal communications associated with the contracts in which they provide services.

1.16 Contractor Access to Health Affairs (HA)/DHA Network(s)

1.16.1 FSO/Company's Security POC shall notify the DHA Personnel Security Office after being awarded a contract that requires access to a DoD system. Contractor personnel requiring access to the HA/DHA networks for performance of their tasks require a background investigation and security awareness training. The contractor shall be prepared for this process as it could take two (2) or more weeks. The FSO/Security POC shall submit a Standard Form (SF) 85/86 to DHA's Personnel Security Office for a background investigation.

1.16.2 FSO/Security POC must notify the Personnel Security Office when the contractor has submitted the SF- 85/86. The FSO/Security POC, or the COR, must notify the DHA Personnel Security Office in writing when the termination of contractor personnel occurs, including the termination date.

1.17 Personnel Security

1.17.1 The contractor shall comply with DoD 8570.01-M, “Information Assurance Workforce Improvement Program, CH4” November 10, 2015 as amended; 8500.01, “Cybersecurity”, dated March 14, 2014; DoD Manual (DoDM) 6025.18, “Implementation of the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule Compliance in DoD Health Care Programs” dated March 3, 2019, Department of Defense Instruction (DoDI) 6025.18 “HIPAA Privacy Rule Compliance in DoD Health Care Programs”, dated March 13, 2019; and DoDM 5200.02 “Procedures for the DoD Personnel Security Program (PSP),” incorporation change 3, effective September 24, 2020. Contractor responsibilities for ensuring personnel security include meeting the following requirements:

1.17.1.1 Follow the DHA Personnel Security Office guidelines for submittal of security clearances. Contact the DHA Personnel Security Office for guidance on the appropriate background investigation required for personnel on the contract. The DHA Personnel Security Office can be reached at (703) 275-6038.

1.17.1.2. Initiate, maintain, and document personnel security investigations appropriate to the individual’s responsibilities and required access to Controlled Unclassified Information (CUI).

1.17.1.3 DHA Personnel Security Office does not deny any access to any automated information system (AIS), network, or Controlled Unclassified Information (CUI). If a contractor receives an unfavorable background investigation, the request for access will be sent back to the FSO for further action. Any unfavorable adjudication will result in DHA Personnel Security Office not signing off on any access request.

NEW CONTRACT

DHA PWS Template V13 November 16, 2021

PART 2

2.0 DEFINITIONS, ACRONYMS, AND APPLICABLE PUBLICATIONS/INSTRUCTIONS

2.1 Definitions:

2.1.1 Category D: Information Technology (IT) and Telecommunications Services (called D-Services)

2.1.2 Category R: Support (Professional/Administrative/Management) Services (called R-Services)

2.1.3 Contracting Officer (CO): A person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings.

2.1.4 Contracting Officer’s Representative (COR): An individual, including a contracting officer’s technical representative (COTR), designated and authorized in writing by the CO to perform specific technical or administrative functions. This individual does NOT have authority to change the terms and conditions of the contract.

2.1.5 Non-personal services contract: a contract under which the personnel rendering the services are not subject, either by the contract’s terms or by the manner of its administration, to the supervision and control usually prevailing in relationships between the Government and its employees.

2.1.6 Quality Assurance Surveillance Plan (QASP): An organized written document specifying the surveillance methodology to be used for surveillance of contractor performance. The Government may either prepare the QASP or require the offerors to submit a proposed quality assurance surveillance plan for the Government’s consideration in development of the Government’s plan.

2 Acronyms:

2.3 Applicable Publications, DHA Administrative Instructions (AI), etc. RESERVED

PART 3

3.0 GOVERNMENT FURNISHED PROPERTY, EQUIPMENT, AND SERVICES

The Government will provide the following equipment/information/property: desk, telephone, chair, laptop computer, monitors, shared printer, and requisite consumable materials for use in the performance of this contract/task order. This equipment is authorized for transaction of official Government business only and shall not be used for personal business. Computer equipment to include laptops are subject to communications security monitoring at all times. They are to be used, turned in and/or disposed of as directed by the COR or CO. The Contractor shall maintain the assigned office space in a neat and orderly manner. Contractor shall not remove any Government-furnished equipment or supplies from the worksite without the express written permission of the COR or their designated representative.

Procurement Integrated Enterprise (PIEE), GFP Module Application

The contractor shall be responsible for obtaining and maintaining access, training and successful operation of the PIEE/GFP Module application for the entirety of the contract/task order PoP. The PIEE GFP Module application is located at the following website: https://wawf.eb.mil/piee-landing/. Access to PIEE/GFP Module application training materials and in-depth information applicable to the contractor’s responsibilities regarding GFP can be found at the following website: https://dodprocurementtoolbox.com.

Contracting Office Responsibilities:

The Contracting Office shall ensure close coordination and validation of the GFP items with the COR and DHA Accountable Property Officer prior to uploading the GFP Attachment into the PIEE/GFP Module. At the time GFP is anticipated and identified, the Government will upload the GFP Attachment into the PIEE/GFP Module. It is the Contracting Office’s responsibility to prepare, upload and maintain the GFP Attachment in the PIEE/GFP Module in accordance with the GFP Attachment instructions provided at the DoD Procurement Toolbox. The CO and COR shall manage and keep an inventory of any GFP associated with contract/task orders awarded through DHA, in accordance with applicable FAR Part 45, DoD FAR Supplement (DFARS) 245 with respective clauses, DHA AI 095 and PD 45-01 following the change in disposition of items listed on that PIEE/GFP Module Attachment.

The contracting office will also review, acknowledge, reject and/or approve shipment orders provided by the contractor as appropriate. Functional roles can be determined within the Contracting Office and requested within the PIEE/GFP Module system

Contractor Responsibilities:

A key contractor responsibility is to work with the CO and COR to ensure the PIEE/GFP Module data, to include the PIEE/GFP Attachment, provides a timely, complete and accurate accounting of the GFP applicable to the contract/task order. Contractors are required to report the receipt of any GFP shipped to them, regardless of whether it is listed on the GFP Attachment for their contract. Similarly, contractors are required to utilize the GFP Module application in conjunction with the shipment of GFP to the Government or in reporting Property Loss of GFP issued (such as destruction or loss). Discrepancies or disputes regarding property shipped to or shipped from the contractor must be reported via the GFP Module application, with the CO having authority over final designation of status.

The contractor shall report semi-annually 100% inventories, reconciliations, and final disposition of GFP provided by the government. Final invoices will not be paid pending GFP reconciliation. Contractors shall be aware of and ensure compliance with applicable FAR Part 45, DFARS 245 and 252.245, Defense Pricing and Contracting Policies, Procurement Integrated Enterprise Environment Standards, DHA Administrative Instruction 094 and DHA Guidance.

Materials: The Government: is providing Materials in support of this contract/task orders. The Government-provided Materials are described below:

3.0.1 The Government shall provide within 10 calendar days of contract award: DVEIVR relevant materials, such as Data Abstraction SOPs DVEIVR related Policies and Procedures; DVEIVR business rules; data abstraction training materials; and DVEIVR access process.

PART 4

4.0 CONTRACTOR FURNISHED ITEMS AND SERVICES

4.1 General: The contractor shall furnish all supplies, equipment, facilities and services required to perform work listed under Section 5 of this PWS.

4.2 Secret Facility Clearance: RESERVED

4.3 Materials: The contractor shall provide paper to support printing and copying; office supplies, e.g. pens, pencils, markers,

4.4 Equipment: The contractor shall provide desk space, lighting, telephone, internet access, and shredder to meet the requirements under this PWS.

4.5 Facilities: The contractor shall provide sufficient office and meeting space and internet access to meet the staffing and performance requirements under this PWS.

PART 5

5.0 SPECIFIC TASKS

The Contractor shall provide support for the tasks required to utilize assets to extract ocular clinical medical and related information from medical records and other medical documentation sources into the DVEIVR. These tasks shall include:

· Training for Data Abstractors includes:

· Develop criteria to identify and select Data Abstractors with knowledge and experience of fundamental medical and health care concepts, processes, practices, and procedures on technical assignments

· Data Abstractor use of the DVEIVR application.

· Ophthalmological and optometric terminology, anatomy and physiology, examination findings, and relevant medical and surgical treatments to make accurate data entry of provider notes generated in writings, drawings/images, or via electronic eye notes (e.g. scanned) or other medical records. DVEIVR system change requests (SCRs) and the process to add additional data values with data definitions based on recognized authorities, and business rules,

· Data Abstractor performance criteria and performance improvement processes, including quality review and audit of staff performance

· Development and implementation of knowledge management and transfer

· Mandatory online training includes HIPAA, Anti-Terrorism, Security, Information Assurance and other DoD/DHA & VA policy education and certification requirements

· Data Abstraction Support Services include:

· Identify and review medical encounters for relevancy and manually extract and enter relevant ocular and related information from medical records and other medical documentation systems into the web-based DVEIVR

· Identify and review medical encounters for specific data values and enter relevant data into government-approved format.

· Establish processes to support abstraction of medical information related to Service Members and Veterans with eye injuries and diseases from non-computable data sources, i.e. electronic and hard copy located in the DoD and/or VA medical records

· Refine and/or identify business rules for translating medical information relating to eye injuries and vision impairment to a computable format

· Review, revise and/or maintain Procedural Guide for data abstraction

· Review, revise and/or identify and document business rules/logic for data fields presented in DVEIVR from medical records

· Participate in work groups, Data Management Work Group (DMWG); Internal Change Boards (ICBs); Integrated Product Team (IPT), and VCE Stakeholder workgroups tasked to enhance and/or add data fields to the DVEIVR and/or participate in study/research meetings.

· Create, submit and implement a record keeping process for each data field for data quality review purposes

· Implement quality control processes and SOPs to ensure accuracy of abstracted data into the DVEIVR

· Participate in regularly scheduled periodic quality and audit reviews of selected encounters with VCE clinical Subject Matter Experts and Government employees.

· Recommend process change by integrating new processes with existing ones and communicating these changes to Government teams through the SCR process

· Knowledge management and transfer as evidenced by development of lessons learned

· Draft processes and policies to monitor data quality of data reviewed and manually entered by data abstractors for Government approval

· Establish and implement abstractor audit processes and procedures

· Collaborate with Government employees to conduct an analysis of business and user needs, and document and/or clarify functional requirements

· Support abstraction of specific cohorts based on approved studies

· Support abstraction of specific data values in a government approved format

· Support testing of system design of approved System Change Requests (SCRs).

· Comply with Personally Identifiable Information (PII), Protected Health Information (PHI), and Federal Information Requirements (refer to Clause Section for DHA Procedures, Guidance and Information 224.90 if applicable).

5. Task Management:

The Contractor shall designate a single program manager to oversee this task and assign a clinical manager to supervise contractor personnel assigned to this task. The Contractor shall ensure that a Monthly Program Report (MPR) (Deliverable #9) is submitted outlining the expenditures, billings, progress, status, and any problems/issues encountered in the performance of this task.

The Contractor shall organize, direct, and manages operation support functions, involving multiple, complex and inter-related project tasks; manages their work groups; interfaces with the Government at the senior levels of the organization and collaborates with the Government to formulate and review task plans and deliverable items. The Contractor shall also ensure conformance with program task schedules and costs. The Contractor shall meet with the COR on a regular basis to report Contractor performance status and to discuss the data abstraction and clinical requirements identified through the data abstraction, management, and quality review processes. The Contractor shall prepare a Performance Measurement Plan (Deliverable #3), which shall outline performance metrics to track quality control associated with abstracting and quality review/audit of records as identified by the COR. Contractor shall track and monitor Performance Metrics. The Performance Measurement Plan shall be due 30 calendar days after the award of the order, and updated as required.

5.1.1 Program Management Plan (PMP)

The Contractor shall submit a Program Management Plan (Deliverable #9) within 10 days after award of contract that shall require Government approval. The draft PMP shall document how the Contractor shall meet and comply with the requirements established in this PWS. The draft PMP shall not exceed 25 pages. The PMP shall be reviewed by the Government. The contractor shall make recommended revisions and resubmit the revised PMP to the Government within ten (10) days after receipt of the recommended changes to the PMP.

The PMP shall be used to manage, track and evaluate the Contractor’s performance in accordance with standard industry practices for project administration, execution and tracking.

The PMP shall include the following:

· Identification of milestones where Government information/activity is required and timeline dependencies for subsequent Contractor activities

· Description of the Contractor’s management approach shall include suggested project metrics, policies related to receipt and management of any patient record, inpatient and outpatient records, reports, and databases.

· Process for maintaining an inventory of any medical records printed and/or received at the project office and monitor use and destruction of records in accordance with Government policies

· Description of management tracking systems shall include monitoring the incoming flow of data, status of encounter data entry, changing/modifying data, to permit preparation of descriptive summary reports related to these activities.

· Description of processes to create, read, update, amend, and delete records into the DVEIVR application as determined by the VCE SOP

· Description of record keeping procedures for assessing the progress and status of data collection, preparation and entry.

· Description of processes for recommendations for System Change Requests (SCRs) based on data abstractor and Contractor experience with DVEIVR and DoD/VA medical systems.

· Procedures for receipt and management of Government Furnished Information (GFI) and Government Furnished Data (GFD)

· A detailed staffing plan identifying all staffing positions including key personnel, name of incumbent or vacant, status (full-or part-time, work location, and company). The plan shall also address their recruiting and retention efforts to ensure a qualified workforce to initially staff this task and ramp up the data abstraction services. The plan shall also address procedures to replace personnel due to attrition. The plan shall also include accepted procedures to reduce the likelihood of attrition.

5.1.2 Monthly Program Report (MPR) (Deliverable #9)

The Contractor shall ensure that the MPR is submitted outlining the expenditures, billings, progress, status, any problems/issues encountered in the performance of this task. The template for the Monthly Progress Report will be established during the kickoff meeting once the contract is awarded.

The Contractor shall require all subcontractors to provide input to the MPR where there are critical or significant tasks related to the prime contract. Critical or significant tasks shall be defined by mutual agreement between the Government and Contracts.

The MPR shall initially include 1) Data Abstraction Accuracy Reports; 2) Number of encounters completed; 3) Summary of Continuing learning session conducted; 4) Number of data abstractors; 5) Data abstractor annual turnover rate; 6) Number of data abstractors in training; 7) Number of data abstractors completing training classes that month; 8) Total number of current data abstractors trained; 9) Any delays in approval of security clearances or access to DoD and/or VA systems; and 10) Any challenges or delays in the performance of the contract.

5.1.3 Contingency Operations Plan

The Contractor shall prepare and submit a Contingency Operations Plan (COOP) (Deliverable #10) to the Government. The Contingency Operations Plan shall document Contractor plans and procedures to maintain data abstraction services and support during an emergency. The Contingency Operations Plan shall be submitted ten (10) calendar days after contract award. The Contingency Operations Plan shall be resubmitted to the Government twenty (20) calendar days after Government feedback.

The Contingency Operations Plan shall include the following:

· A description of the Contractor’s emergency management procedures which incorporates VCE on-site emergency management procedures

· A description of how the Contractor shall account for their employees during an emergency

· Planned temporary work locations or alternate facilities

· A description of how the Contractor shall ensure the continuation of data abstraction services at the alternate site with minimal disruption

· How the Contractor shall communicate with VCE during emergencies

· A list of primary and alternate Contractor points of contact, each with primary and alternate:

· Telephone numbers

· E-mail addresses

· Procedures for protecting Government furnished equipment (if any)

· Procedures for safeguarding medical, sensitive, and/or classified Government information (if applicable)

5.1.4 Operations during Emergency Situations

Individual contingency operation plans shall be activated immediately after determining that an emergency has occurred, shall be operational within twelve (12) hours of activation, and shall be sustainable until the emergency is resolved and normal conditions are restored, or the Contract is terminated, whichever comes first. In case of a life threatening emergency, the COR shall immediately contact the Contacting Officer and Contractor Program Manager to ascertain the status of any Contractor personnel who were located in Government controlled space affected by the emergency. When any disruption of normal, daily operations occur, the Contractor Program Manager shall promptly open an effective means of communication with the COR and verify:

· Key points of contact (Government and Contractor)

· Temporary work locations (e.g. alternate office spaces, timework, virtual offices.)

· Means of communication available under the circumstances (e.g. email, webmail, telephone, FAX, courier.)

· Essential work products expected to continue production by priority The Contractor Program Manager, in coordination with the COR, shall make use of the resources and tools available to continue contracted functions to the maximum extent possible under emergency circumstances. The Contractor shall obtain approval from the COR prior to incurring costs over and above those allowed for under the terms of this contract. Regardless of contract type, and of work location, Contractors performing work in support of authorized tasks within the scope of their contract shall charge those hours accurately in accordance with the terms of this contract.

5.2 DoD Data Abstraction Support Services

5.2.1 Data Abstractor Training Support Services

The Contractor shall plan and conduct formal training for the DVEIVR application for Contractor managers and Contractor data abstractors in ophthalmological, optometric, ocular, and general medical/surgical documentation processes to assist with abstracting medical information related to eye injuries and diseases from data sources, i.e. DoD and VA electronic and hard copy medical records.

Post award, the Contractor shall coordinate with VCE to identify appropriate Government subject matter experts to advise and review abstraction training. These experts will possess in-depth knowledge of health sciences, ophthalmological and optometric terminology as related to anatomy and physiology, medical and surgical treatments, images, and rehabilitative services. The subject matter experts shall provide technical knowledge and analysis of highly specialized applications and operational environments, including electronic medical record and registries. The periodic continuing learning sessions provide an opportunity for the Contractor to continue to educate the data abstractors in variations of provider documentation in a medical record, review lessons learned; expand then data abstractors’ knowledge of the impact of VCE data analyses on readiness and treatment of Wounded Warriors.

The Contractor shall provide initial training in the use of the DVEIVR. to all Contractor abstractors. The VCE shall provide to the Contractor the DVEIVR training site and the “Train the Trainer” Modules as Government Furnished Information.

The Contractor shall provide ongoing training as needed to the remainder of Contractor personnel in the use, access and data entry into the DVEIVR.

The Contractor shall provide all contractor personnel (abstractors) on-going education of DVEIVR application, data analysis, business rules/logic; and ophthalmological, optometric and ocular documentation processes, using case studies, etc. VCE SMEs may support data abstractor initial and ongoing training. The ongoing education process includes lessons learned related to data abstraction record reviews. The ongoing education sessions are expected no less than a monthly basis, to ensure that each of the Data Abstractors are continuously learning and enhancing their knowledge of data integrity related to ophthalmology and optometry data. Monthly continuous learning sessions shall not exceed 4-hours in duration. The topic or topics for each continuous learning session shall be coordinated with the Government at least 7-calendar days prior to the planned training date. The Contractor shall submit the continuing learning session information to the Government:

· Date

· Time

· Location

· Overall session objective

· Desired outcome of the session

· Audience to be trained

· Special equipment or resource required to accomplish the training Following completion of the continuous learning session, the Contractor shall document lessons learned in a format consistent with DHA policy/templates and summarize these in the next Monthly Progress Report and modify the training plan and resources as appropriate.

All Data Abstractors, quality reviewers, and auditors shall complete annual Privacy and Health Insurance Portability and Accountability Act of 1996 (HIPAA) Training programs offered by DoD, and other annual mandatory training (e.g. Sexual Harassment, Information Assurance, and Anti-Terrorism) as dictated by DoD and VA policy for Contractor who have access to or work on their information systems.

5.2.1.2 Training Plan

The Contractor shall develop a Training Plan (Deliverable #11) to specify training approaches, methods, schedules, tools, curricula, and access to DoD medical applications, e.g. TMDS, AHLTA, and JLV.

5.2.1.3 Training Materials

Following Government approval of the Training Plan, the Contractor shall develop training materials, to include course objectives, teacher guides, student guides, use cases, course materials, training manuals, distance learning tools and computer-based tools as required. The Contractor shall deliver training materials in reproducible format, suitable for computer base training and for use by professional printing by the Government Printing Office (GPO) to generate bulk printing. Reproduction of materials shall be performed in accordance with page and quantity limitations referenced in FAR Subpart 8.8. Once accepted by the Government, training materials shall become part of the Training Plan. The Government does not expect there will be a need for bulk printing.

5.2.1.4 Knowledge Management/Transfer

The Contractor shall develop and implement strategies and practices to organize, create, capture and distribute knowledge and lessons learned obtained through development of training programs, the identification/authentication of business rules/processes, and the performance of data abstraction (Lessons Learned) Deliverable #12). These approaches should be identified in the Training Plan, which should cover DoD and/or VA abstraction requirements.

5.3 Data Abstraction Services

The Contractor shall be authorized access to access DoD’s medical systems (e.g. AHLTA, TMDS, JLV, GENESIS). The Contractor shall perform comprehensive reviews of ocular and related medical encounters and concurrent chart data abstraction on all required clinical indicators for assigned patient groups to determine eligibility for enrollment in the DVEIVR, based on data field content within the medical record reviewed. Assigned patient groups include abstraction of data related to specific studies as approved by the Government.

For each eligible Service member (SM) or Veteran enrolled in the DVEIVR, the Contractor shall review and abstract non-computable data and enter appropriate and relevant ophthalmological, optometric, rehabilitative service, and general medical/surgical conditions data from SM or Vet’s medical and related records in the DVEIVR. In addition, the Contractor shall collect comprehensive data relating to patients with eye trauma and visual dysfunction related to concussive, ballistic or blast injuries by abstracting relevant trajectories of care.