36C25024Q0176.docx

Combined Synopsis/Solicitation Notice Combined Synopsis/Solicitation Notice

GENERAL INFORMATION

Columbus Chalmers P. Wylie Ambulatory Care Center 420 North James Road Columbus OH 43219-1834

POINT OF CONTACT*

Contract Specialist Michael Riordan michael.riordan@va.gov

PLACE OF PERFORMANCE

VISN 10 Multiple Locations

POSTAL CODE

COUNTRY

ADDITIONAL INFORMATION

AGENCY’S URL

URL DESCRIPTION

AGENCY CONTACT’S EMAIL ADDRESS

EMAIL DESCRIPTION

DESCRIPTION

COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS

General Information

NAICS Code:

Wage Determination:

Revision Number:

Date of Revision:

513210 2015-4731 6/30/2023

Contracting Office Address Department of Veterans Affairs Network Contracting Office 10 Cincinnati VA Medical Center 3200 Vine Street Cincinnati, OH 45220 Description This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a written solicitation document will not be issued.

This solicitation is issued as a request for quotations. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2022-04.

The associated North American Industrial Classification System (NAICS) code for this procurement is 513210, with a small business size standard of $47 million.The FSC/PSC is R431.

VISN 10 medical facilities require software licenses, software enhancements, maintenance, and support subscription services for 11 Veteran’s Administration VISN 10 medical centers located in OH, MI and IN.

Section 1: General

1. Contract Title: VISN10 Scheduler Software

2. Background: The VA’s Government Account Office (GAO) and others have raised concerns about the adequacy and qualifications of the Veterans Health Administration’s (VHA) nurse staffing. To address these concerns, VHA issued Directive 2010-034 requiring all VAMCs to implement a standardized methodology for determining an adequate and qualified nurse workforce, which includes developing and executing nurse staffing plans. It also requires VAMCs to use the methodology on an ongoing basis to evaluate staffing plans. The VHA Office of Nursing Services (ONS) has endorsed the continued use of the expert panel methodology to determine unit staffing needs, with a focus on patient outcomes and nursing sensitive indicators as a measure of efficacy. Nursing Hours Per Patient Day (NHPPD) was the basis for determining staffing thresholds. Accurate calculation of NHPPD was essential for compliance with the mandate. Along with this, data is shared with the Managerial Cost Accounting (MCA; formerly Decision Support System (DSS), and frequent clinical data comparison occurs with the Veterans Administration Nursing Outcomes Database (VANOD), and the National Database of Nursing Quality Indicators (NDNQI).

3. Scope: The proposed vendor will provide software licenses, software enhancements, maintenance, and support subscription services for the following 11 Veteran’s Administration VISN 10 medical centers:

· Ann Arbor VAMC, MI

· Battle Creek VAMC, MI

· Chillicothe VAMC, OH

· Cincinnati VAMC, OH

· Louis Stokes Cleveland VAMC, OH

· Chalmers P. Wylie VA ACC, Columbus, OH

· Dayton VAMC, OH

· Detroit VAMC, MI

· Northern Indiana (Fort Wayne & Marion), IN

· Richard L. Roudebush VAMC, Indianapolis, IN

· Aleda E. Lutz, Saginaw, MI

The proposed integrated system and automated data extraction tools are necessary to effectively assign staffing resources and monitor standards of care. This system will pull from systems that have data stored to avoid duplicate effort and to feed the other downstream data systems.

The primary use of the system will be staffing scheduling, so managers can coordinate schedules, capture data, produce reports, and coordinate work assignments to meet patient care needs. The primary users of the system are nurse managers, supervisors, service chief and secretaries, who will coordinate schedules, capture data, produce reports, and coordinate work assignments.

4. Requirements

· Appropriate response to the fluctuations in patient census and acuities by using embedded decision support tools.

· Adequate staffing levels based on patient census, staff direct working hours, and other care related variables.

· Collection of nationally comparable hours per patient day (HPPD) data.

· Collection of data to prepare staffing reports, develop strategic plans and improve hiring practices.

· Compliance with public law and other regulatory mandates for staffing regulations and monitors.

· Ability to consolidate multiple administrative needs in one package (licensure, certifications, proficiencies, skills, etc.) Generation of predefined and adhoc reports.

· Self-scheduling ability (major nursing satisfier).

· Accurate accounting of contract/agency nursing utilization.

· VistA to vendor secure file transfer protocol

· VistA to vendor HL7 (patient admit, discharge, transfer information)

· Pay schedule module to allow for enhanced communication between management and timekeeping to ensure accurate pay

· Direct Hours Per Patient Day Reporting

· VHA NHPPD Shift Compliance Reporting

· Device Days of Care Compliance Reporting for Joint Commission

· DSS/MCA Labor Mapping Automation

· Morning Report to provide information such as daily OT, daily call-ins, daily staffing with NHPPD variance, and important patient care information

· Proficiency Tracking module to allow for alerts and tracking of proficiency due dates

· Able to interface with Census in VistA

· “Administrator roles” must be able to create new reports and download information from staffing software

· Vendor must have MOU/ISA by the time of the contract start date

· If not cloud-based, approved by the OIT VA Technical Reference Model (TRM). If cloud-based, approved by the Enterprise Mission Assurance Support Service (eMASS).

5. Specific Tasks

1. The software must have a functional and accurate interface with VHA data systems (HR, ADT) to pull data. Minimum data to be pulled:

a. Patient admission, transfer and discharge information

b. Employee information – for example, and not limited to: general demographics, leave accrued hours, pay rate, position information and contract information.

2. The software must be able to identify minimum and maximum staffing levels. For the inpatient units provide productivity based on HPPD (hours per patient day) and census. The software should be able to tell the supervisor if the unit is over staffed, staffed appropriately or under staffed. In addition, it should be able to show the manager that the variance is by either hours or FTE (full time equivalent). On-demand, visual representation (graphs/charts) of current staffing is highly desirable by unit, groups of units and/or service.

3. The software must be able to manage any combination of shift length; float staff; individual preferences, on-call, rotating shifts and holidays. For example, it should be able to manage 4, 6, 8, 10 and 12-hour tours for one person to make 80 hours/pay period. The software must give the scheduler and self-scheduler instant feedback on the number of scheduled hours and if normal hours have been scheduled including part time and intermittent staff. The software should also have the ability to alert the supervisor when the employee rolls into overtime.

4. The software must be able to manage night shifts in an easy to understand manner for all involved. With the implementation of VATAS, the night shift is difficult to navigate. For example, for the RNs, the 2330-0800 shift is paid entirely on the day the shift starts. For other staff, the 2330-0800 shift splits at midnight. There is often confusion about when a shift should appear on the schedule and when the employee is to come to work. The software needs to have the ability to calculate the hours accurately without requiring two separate shifts. In addition, this issue needs to be clearly communicated and hours calculated appropriately in self scheduling for all staff types.

5. The application must track changes to the schedule by date, time, user who made the change and rationale for the change.

6. The software must be able to track and provide an employee history report. It must be able to create a history for each service and unit move, any changes in the employee type, any changes in the employee’s name, any changes in position and/or change in normal hours. The program must also have the option to add notes to an employee’s record. Any addition has a date/time stamp and manager’s name stamp. This is a restricted field for management. Fields that are required but not limited to:

a. Service Computation date (SCD)

b. Facility entrance on duty date (EOD)

c. Unit/Location Start Date

d. Separation Date

e. Position appointment – full time, part time, intermittent, etc.

f. Employee type

g. Numeric Full Time Equivalent (FTE) – 1, .8, .5, etc.

h. Status – Active/Inactive, transfer, detailed, terminations, etc.

i. Notes – since there is no way to identify the in the status field if, for example, the difference between an employee who was truly terminated and an employee that has transferred to another VA, or the ability to identify that VA. Notes would give the use the ability to add additional details. Upon award, the vendor will identify the date of implementation for this feature.

7. Along with the employee history the software must be able to track details about the employee such as, but not limited to:

a. License, specialty certification or other special skills

b. FMLA

c. Skills/competencies (staff are not floated to an area they do not have the appropriate training/skills/competencies)

d. Disciplinary actions (with appropriate permission restrictions to keep this information confidential)

e. Proficiency due dates

8. The software must generate email reminders notifications and/or alerts per site set up to both employees and supervisors (i.e. time to approve schedule, sign-off on schedule, Self-Scheduling open for Pay Period 10, Self-Scheduling closed for PP10, etc.) The users will receive email reminders in Micro Soft Outlook.

9. The program must support the creation of unlimited business rules, templates and parameters.

a. By law, an RN cannot work more than 12 hours in a 24-hour period or 60 hours in a 7-day period. The program will have the capability to alert the supervisor before an individual exceeds those parameters. If it is exceeded, then the program will record the approving official’s name, date and a justification for each occurrence.

b. The program must support both preference-based scheduling, and/or cyclical scheduling.

10. The program must support partial and total self-scheduling. Self-scheduling must include:

a. The ability to track demographics for the employee, including name, address, and phone numbers (home and cell).

b. Ability to view schedule and schedule and/or make schedule changes only during open scheduling periods.

c. The ability for the employee to post their shift(s) for swapping. The employees can see shifts available for swapping and volunteer for a swap. The swap must be approved by nurse manager or another supervisor.

d. An option for the nurse manager to post open shifts to which employees may volunteer.

e. The employee must be able to see open shifts to volunteer for regular time and/or overtime.

11. The program must provide the ability to print user friendly schedules.

User friendly is defined as compact and legible. The following information is required on the report but is not limited to – staff name, dates for 28 days (2 – 2-week pay periods), shifts and legend.

12. The program must provide appropriate output such as reports, graphs or charts.

a. The program will provide user defined reports and graphs especially for productivity. Some of the reports are leave usage, agency use, overtime use, sick leave use and workload efficiency based on the user selected date range.

b. The program will be able to generate budget reports/graphs based on GS (LPNs and NAs) and Title 38 (RNs) pay scales, grade/step and time. The budget reports and graphs need to include salary costs (including adjustments for benefits), overtime costs, agency/contract costs, float costs (staff being pulled to/from home unit), sitter costs, and unscheduled sick leave costs. Or be able to host this information from Vista.

c. The end user will be able to customize the reports for their unique needs. For example, we have a report for where staff floated off the float unit. The report will only run by employee and not by the unit.

d. Specific reports minimally required, but are not limited to: (able to run by employee, by unit, by user defined groups of units, or by service)

i. Hours Per Patient Shift (HPPS)

ii. Hours Per Patient Day (HPPD) – Compared to Set HPPD Goal/Acceptable Range

iii. Off regular tour rotation to other shifts

iv. Call-In List – not to be confused with the float report.

v. Float reports - all staff and hours floated from the home unit and all staff and hours floated to the home unit, summed by employee and unit.

vi. Open Shift/Sitter Needs/Needs List Report

vii. Reports on various types of hours:

1. Sitter Hours

2. Overtime Mandatory/Voluntary hours

3. Overtime hours

4. FMLA

5. AWOL/LWOP

6. Light Duty

7. Orientation

8. Worked hours

9. SL Hours

10. Overtime Availability (employees have a standing time they are willing to work, such as on the weekends. Or what they are not able to work, such as nights.)

11. Weekend worked report

12. Pattern worked/leave report – have the computer identify if there is a recurring patter or near pattern to the staff’s schedule of worked hours or leave.

13. Seniority List

14. OT Offered List

15. Modified/Changed Time

16. Daily Roster

17. Shift Staffing Sheet – dynamic, current lists multiple units and all who are working for a specific time frame.

viii. Shift Type Legend – if using codes for shifts, need a report that defines each code.

ix. Holidays worked, and holidays granted in lieu of worked (holiday off).

13. Occasionally new national reporting requirements are implemented throughout the VA. The vendor will assist with building appropriate tools and/or reports to assist VA sites with extracting or tracking such data/information. For example, MCA just created a new procedure where they will be subtracting specific indirect hours from their calculation of hours per patient day. This is accomplished by separately mapping the direct and indirect hours in MCA. The tool in this situation may be a report that generates a report listing the specific indirect hours.

14. The program must provide some type of position control features and/or develop position control features. These features should be able to generate a list of employee names with full time equivalent (FTE) designation per unit/groups of units. A report should also be able to be generated by staff type and position designation. The position control features should allow for reports comparing authorized FTE and current FTE and generate vacancy rates and turnover rates.

15. The program must provide multiple security levels in terms of who can view, create, update, approve, delete, and create reports based on their position/level of access. For example, the nurse manager will approve the schedule, the evening/night supervisor can override the schedule to offer OT to an employee and the coordinator can override any entry. However, the end user will not see all this detail, only their schedule.

16. Certified/Posted Time – The union requires a minimum current week plus 4 weeks need to be posted at any given time. The software will be able to post at least 2 weeks at a time or a pay period. When the time is certified, the schedule needs a date/time and certifying official stamp. Any modifications need a date/time and certifying official stamp.

17. The program must provide the ability to store data/documents, to archive and to retrieve archived information. For example, one of the requirements of the VA is to save six years of time/attendance data. The program will need to be able to store all aspects of the data for at least that amount of time before it is archived. After this time period, the program should be able to archive the data for longer storage and then access it if necessary.

18. The program must be able to import census data by unit and facility. This is required for calculating workload and HPPS/HPPD. The program must be able to generate accurate HPPS/HPPD reports or graphs for immediate feedback to supervision.

19. The program should have tools to assist the nurse manager in creating a fair and equitable schedule that covers all the needs of the unit.

20. The program must be able to manage overtime offers based on defined criteria (seniority). For example, the union requires the VA to equitably offer overtime to each employee who is interested. All uninterested employees need to be identified and left off the OT call list. From the interested employee list, when the employee was contacted, the result of the contact (no answer, declined, etc.), who contacted, when contacted and OT being offered needs to be recorded. This information also needs to be able to be printed by employee name and by OT offered with all the contacts before a replacement was found. This option needs to be easy to use and generate real time report.

21. The application must show the proven ability to import/export viable, accurate and timely data. An interface from Vista that includes Human Resources Management Service (HRMS), Fiscal, ADT and Decision Support System is required. From HRMS pull employee demographics, additional information and update the information regularly (new employees, change in information, separation, etc.). Also, be able to pull census information into the software every 4 hours from the ADT portion of Vista.

22. The application must save current data and close when encountering an error.

23. Help option must be available to all levels of users. System is user friendly; designed for all personnel’s levels of computer skills, novice to moderate working knowledge.

24. The vendor will work with each site to develop a site-specific contingency plan. The vendor will present in writing a contingency plan/backup plan for the database including a procedure for when and how the site(s) notify the vendor, and when and how the vendor notifies the site(s), when service is no longer available, within 30 days of contract award. Communication is required with sites when system becomes available after unexpected downtime.

25. Downtime will be identified in advance, and scheduled during low usage of the software, so appropriate actions can be taken to generate contingency schedules.

26. The vendor must be able to provide technical support (on-line, telephone, email) 24 hours per day/7 days per week.

27. The vendor must disclose the complete cost and services covered in the maintenance agreement or subscription agreement. The vendor must disclose the total cost for maintaining/upgrading the software, implementation training and travel costs.

28. The vendor will develop and implement PIV sign-on prior to the completing of base year for this contract.

29. A post contract award meeting with the vendor will take place no more than 15 business days following award and will include representatives from the vendor’s staff, the contract COR and the VISN 10 program manager.

6. Performance Monitoring: updates, functioning, down time, technical support The table below defines the Performance Standards and Acceptable Levels of Performance associated with this effort.

A. Technical / Quality of Product or Service

1. Demonstrates understanding of requirements.

2. Efficient and effective in meeting requirements.

3. Meets technical needs and mission requirements.

4. Provides quality services/products.

5. Performances functions/tasks in a timely manner.

Satisfactory or higher

B. Project Milestones and Schedule

1. Established milestones and project dates are met.

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

3. Notifies customer in advance of potential problems.

4. Contingency planning is addressed and a process to handle downtime is established.

5. Downtime or program nonfunctioning is handled promptly.

Satisfactory or higher

C. Cost & Staffing

1. Currency of expertise and staffing levels appropriate

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

D. Management

7. Security Requirements:

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor's employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor's information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA's information is returned to the VA or destroyed in accordance with VA's sanitization requirements. VA reserves the right to conduct on-site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/ subcontractor must not destroy information received from VA, or gathered/ created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated, and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor's firewall and Web services security controls, if applicable, shall meet or exceed VA's minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA's prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above-mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR.

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

a. Information systems that are designed or developed for or on behalf of VA at non-VA facilities shall comply with all VA directives developed in accordance with FISMA, HIPAA, NIST, and related VA security and privacy control requirements for Federal information systems. This includes standards for the protection of electronic PHI, outlined in 45 C.F.R. Part 164, Subpart C, information and system security categorization level designations in accordance with FIPS 199 and FIPS 200 with implementation of all baseline security controls commensurate with the FIPS 199 system security categorization (reference Appendix D of VA Handbook 6500, VA Information Security Program). During the development cycle a Privacy Impact Assessment (PIA) must be completed, provided to the COR, and approved by the VA Privacy Service in accordance with Directive 6507, VA Privacy Impact Assessment.

b. The contractor/subcontractor shall certify to the COR that applications are fully functional and operate correctly as intended on systems using the VA Federal Desktop Core Configuration (FDCC), and the common security configuration guidelines provided by NIST or the VA. This includes Internet Explorer 7 configured to operate on Windows XP and Vista (in Protected Mode on Vista) and future versions, as required.

c. The standard installation, operation, maintenance, updating, and patching of software shall not alter the configuration settings from the VA approved and FDCC configuration. Information technology staff must also use the Windows Installer Service for installation to the default "program files" directory and silently install and uninstall.

d. Applications designed for normal end users shall run in the standard user context without elevated system administration privileges.

e. The security controls must be designed, developed, approved by VA, and implemented in accordance with the provisions of VA security system development life cycle as outlined in NIST Special Publication 800-37, Guide for Applying the Risk Management Framework to Federal Information Systems, VA Handbook 6500, Information Security Program and VA Handbook 6500.5, Incorporating Security and Privacy in System Development Lifecycle.

f. The contractor/subcontractor is required to design, develop, or operate a System of Records Notice (SOR) on individuals to accomplish an agency function subject to the Privacy Act of 1974, (as amended), Public Law 93-579, December 31, 1974 (5 U.S.C. 552a) and applicable agency regulations. Violation of the Privacy Act may involve the imposition of criminal and civil penalties.

g. The contractor/subcontractor agrees to:

i. Comply with the Privacy Act of 1974 (the Act) and the agency rules and regulations issued under the Act in the design, development, or operation of any system of records on individuals to accomplish an agency function when the contract specifically identifies:

1. The Systems of Records (SOR); and

2. The design, development, or operation work that the contractor/ subcontractor is to perform;

b. Include the Privacy Act notification contained in this contract in every solicitation and resulting subcontract and in every subcontract awarded without a solicitation, when the work statement in the proposed subcontract requires the redesign, development, or operation of a SOR on individuals that is subject to the Privacy Act; and

c. Include this Privacy Act clause, including this subparagraph (3), in all subcontracts awarded under this contract which requires the design, development, or operation of such a SOR.

h. In the event of violations of the Act, a civil action may be brought against the agency involved when the violation concerns the design, development, or operation of a SOR on individuals to accomplish an agency function, and criminal penalties may be imposed upon the officers or employees of the agency when the violation concerns the operation of a SOR on individuals to accomplish an agency function. For purposes of the Act, when the contract is for the operation of a SOR on individuals to accomplish an agency function, the contractor/subcontractor is considered to be an employee of the agency.

i. "Operation of a System of Records" means performance of any of the activities associated with maintaining the SOR, including the collection, use, maintenance, and dissemination of records.

ii. "Record" means any item, collection, or grouping of information about an individual that is maintained by an agency, including, but not limited to, education, financial transactions, medical history, and criminal or employment history and contains the person's name, or identifying number, symbol, or any other identifying particular assigned to the individual, such as a fingerprint or voiceprint, or a photograph.

iii. "System of Records" means a group of any records under the control of any agency from which information is retrieved by the name of the individual or by some identifying number, symbol, or other identifying particular assigned to the individual.

i. The vendor shall ensure the security of all procured or developed systems and technologies, including their subcomponents (hereinafter referred to as "Systems"), throughout the life of this contract and any extension, warranty, or maintenance periods. This includes, but is not limited to workarounds, patches, hotfixes, upgrades, and any physical components (hereafter referred to as Security Fixes) which may be necessary to fix all security vulnerabilities published or known to the vendor anywhere in the Systems, including Operating Systems and firmware. The vendor shall ensure that Security Fixes shall not negatively impact the Systems.

j. The vendor shall notify VA within 24 hours of the discovery or disclosure of successful exploits of the vulnerability which can compromise the security of the Systems (including the confidentiality or integrity of its data and operations, or the availability of the system). Such issues shall be remediated as quickly as is practical, but in no event longer than 10 days.

k. When the Security Fixes involve installing third party patches (such as Microsoft OS patches or Adobe Acrobat), the vendor will provide written notice to the VA that the patch has been validated as not affecting the Systems within 10 working days. When the vendor is responsible for operations or maintenance of the Systems, they shall apply the Security Fixes within 10 days.

i. All other vulnerabilities shall be remediated as specified in this paragraph in a timely manner based on risk, but within 60 days of discovery or disclosure. Exceptions to this paragraph (e.g. for the convenience of VA) shall only be granted with approval of the contracting officer and the VA Assistant Secretary for Office of Information and Technology.

5. INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE, OR USE

a. For information systems that are hosted, operated, maintained, or used on behalf of VA at non-VA facilities, contractors/subcontractors are fully responsible and accountable for ensuring compliance with all HIPAA, Privacy Act, FISMA, NIST, FIPS, and VA security and privacy directives and handbooks. This includes conducting compliant risk assessments, routine vulnerability scanning, system patching and change management procedures, and the completion of an acceptable contingency plan for each system. The contractor's security control procedures must be equivalent, to those procedures used to secure VA systems. A Privacy Impact Assessment (PIA) must also be provided to the COR and approved by VA Privacy Service prior to operational approval. All external Internet connections to VA's network involving VA information must be reviewed and approved by VA prior to implementation.

b. Adequate security controls for collecting, processing, transmitting, and storing of Personally Identifiable Information (PII), as determined by the VA Privacy Service, must be in place, tested, and approved by VA prior to hosting, operation, maintenance, or use of the information system, or systems by or on behalf of VA. These security controls are to be assessed and stated within the PIA and if these controls are determined not to be in place, or inadequate, a Plan of Action and Milestones (POA&M) must be submitted and approved prior to the collection of PII.

c. Outsourcing (contractor facility, contractor equipment or contractor staff) of systems or network operations, telecommunications services, or other managed services requires certification and accreditation (authorization) (C&A) of the contractor's systems in accordance with VA Handbook 6500.3, Certification and Accreditation and/or the VA OCS Certification Program Office. Government- owned (government facility or government equipment) contractor-operated systems, third party or business partner networks require memorandums of understanding and interconnection agreements (MOU-ISA) which detail what data types are shared, who has access, and the appropriate level of security controls for all systems connected to VA networks.

d. The contractor/subcontractor's system must adhere to all FISMA, FIPS, and NIST standards related to the annual FISMA security controls assessment and review and update the PIA. Any deficiencies noted during this assessment must be provided to the VA contracting officer and the ISO for entry into VA's POA&M management process. The contractor/subcontractor must use VA's POA&M process to document planned remedial actions to address any deficiencies in information security policies, procedures, and practices, and the completion of those activities. Security deficiencies must be corrected within the timeframes approved by the government. Contractor/subcontractor procedures are subject to periodic, unannounced assessments by VA officials, including the VA Office of Inspector General. The physical security aspects associated with contractor/ subcontractor activities must also be subject to such assessments. If major changes to the system occur that may affect the privacy or security of the data or the system, the C&A of the system may need to be reviewed, retested and re- authorized per VA Handbook 6500.3. This may require reviewing and updating all of the documentation (PIA, System Security Plan, Contingency Plan). The Certification Program Office can provide guidance on whether a new C&A would be necessary.

e. The contractor/subcontractor must conduct an annual self-assessment on all systems and outsourced services as required. Both hard copy and electronic copies of the assessment must be provided to the COR. The government reserves the right to conduct such an assessment using government personnel or another contractor/subcontractor. The contractor/subcontractor must take appropriate and timely action (this can be specified in the contract) to correct or mitigate any weaknesses discovered during such testing, generally at no additional cost.

f. VA prohibits the installation and use of personally-owned or contractor/ subcontractor-owned equipment or software on VA's network. If non-VA owned equipment must be used to fulfill the requirements of a contract, it must be stated in the service agreement, SOW or contract. All of the security controls required for government furnished equipment (GFE) must be utilized in approved other equipment (OE) and must be funded by the owner of the equipment. All remote systems must be equipped with, and use, a VA-approved antivirus (AV) software and a personal (host-based or enclave based) firewall that is configured with a VA-approved configuration. Software must be kept current, including all critical updates and patches. Owners of approved OE are responsible for providing and maintaining the anti-viral software and the firewall on the non-VA owned OE.

g. All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the contract or (ii) disposal or return of the IT equipment by the contractor/subcontractor or any person acting on behalf of the contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the contractors/ subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the contract.

h. Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:

i. Vendor must accept the system without the drive;

ii. VA's initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

iii. VA must reimburse the company for media at a reasonable open market replacement cost at time of purchase.

iv. Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

1. The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and

2. Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to patient data folder level is recommended using VA approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or contract.

3. A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.

6. SECURITY INCIDENT INVESTIGATION

a. The term "security incident" means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/ subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/ subcontractor has access.

b. To the extent known by the contractor/subcontractor, the contractor/ subcontractor's notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

7. LIQUIDATED DAMAGES FOR DATA BREACH

a. Consistent with the requirements of 38 U.S.C. 5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

b. The contractor/subcontractor shall provide notice to VA of a "security incident" as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis. Failure to cooperate may be deemed a material breach and grounds for contract termination.

c. Each risk analysis shall address all relevant information concerning the data breach, including the following:

i. Nature of the event (loss, theft, unauthorized access);

ii. Description of the event, including:

1. date of occurrence;

2. data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

iii. Number of individuals affected or potentially affected;

iv. Names of individuals or groups affected or potentially affected;

v. Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;

vi. Amount of time the data has been out of VA control;

vii. The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);

viii. Known misuses of data containing sensitive personal information, if any;

ix. Assessment of the potential harm to the affected individuals;

x. Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and

xi. Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

i. Notification;

ii. One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

iii. Data breach analysis;

iv. Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

v. One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

vi. Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

8. SECURITY CONTROLS COMPLIANCE TESTING

On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or…