PWS- Draft .pdf

PERFORMANCE WORK STATEMENT

1. PURPOSE

1.1 The contractor shall provide, but not be limited to, 33,280 phlebotomist hours per year with the option to increase by an additional 11,050 hours by contract modification as location needs demand for health care services listed in the contract for Veteran beneficiaries of the Department of Veterans Affairs, located at the Michael E. DeBakey VA Medical Center (MEDVAMC), 2002 Holcombe Boulevard, Houston, TX 77030.

1.2 COR: The Contracting Officer’s Representative assists the Contracting Officer by monitoring compliance with all contract terms and conditions. The contractor shall be required to complete and return the COR Delegation of Responsibilities form to the Contracting Officer. This memorandum clearly states the role, responsibilities, and limitation of authority imposed on the COR. Only the Contracting Officer shall have the authority to negotiate changes or to modify the contract. The COR is not authorized in any way commit the Government.

1.3 Contractor performance monitoring shall be conducted using the Quality Assurance

Surveillance Plan (QASP); attached to the solicitation. Inspections may be scheduled daily, weekly, monthly, quarterly, annually, or unscheduled as required.

1.4 Phlebotomists

i. Contractors shall provide phlebotomy services at the MEDVAMC in Houston, Texas. The purpose of this task order is to provide phlebotomist staffing for days, evenings, nights, weekends, and Federal Holidays for the duration of the contract.

Contractors shall furnish Phlebotomists as required by the MEDVAMC and provide phlebotomy services on inpatient wards and in the outpatient clinic. Each Phlebotomist must have at least two years of work experience in the field of phlebotomy and perform within the last 3 years, prior to being submitted to the VA.

The Contractor shall be required to provide phlebotomy services as needed 24 hours a day, seven days a week, including Federal Holidays.

Shift start and end times may be changed at the discretion of the Specimen Acquisition Section Supervisors

2. SERVICES:

2.1 Contractor agrees to provide experienced Phlebotomists. These positions are located in the Specimen Acquisition Section and provide services on the inpatient units and in the outpatient specimen collection clinic. The Phlebotomist shall be responsible for routine and more complex blood drawing from patients with difficult to access veins, such as geriatric patients, spinal cord patients and cancer patients.

2.2 The Contractor is responsible, in the management of private health information of patients, to maintain the highest level of patient privacy and confidentiality and shall release medical information obtained during the course of this contract only to hospital staff involved in the care and treatment of that individual patient.

3. STAFFING:

3.1 MEDVAMC inpatient and outpatient operation

MEDVAMC inpatient units operate 24 hours per day, seven days per week, including weekends and Federal Holidays, and the outpatient draw clinic is open Monday-Friday from 6:00 am – 5:30 pm. Every person who works an 8-hour shift is entitled to a 30-minute lunch break, as well as two 15-minute breaks when time permits. The contractor must provide the appropriate number of phlebotomy staff requested to provide coverage during the identified times, including weekends and all Federal Holidays, for the duration of the contract. The contract phlebotomists must remain on duty until s/he has appropriately transferred patient care responsibilities to another qualified phlebotomist and will be paid for any time accrued based upon signed time sheets certified by the MEDVAMC Specimen Acquisition Supervisor(s) on duty.

3.2 Contractor’s phlebotomist unable to provide coverage

If the contractor’s phlebotomist is unable to provide coverage for an entire shift or any part of a shift, the contractor shall immediately notify the Specimen Acquisition Section Supervisor(s)/Contracting Officer’s Representative (COR) or designee at the MEDVAMC. The contractor shall provide replacement coverage within 60 minutes of the start of the shift requiring coverage. Replacement coverage must have completed all Privacy, HIPAA training, must have received VAMC mandatory orientation, and required Specimen Acquisitioning Unit both in-patient and outpatient orientation of practices, procedures, and protocols. Contract supervisors/managers are not required to be onsite.

3.3 Contractor’s responsibility for emergency absence

It shall be the sole responsibility of the contractor to provide immediate coverage for an emergency absence of one of the contractor’s assigned staff. The contractor must supply the name and contact details of the replacement staff member. A list of available replacement staff shall be maintained and made accessible for the Specimen Acquisition Section Supervisors. The contractor must provide qualified replacement coverage within 60 minutes of the contract employee's absence. Replacement personnel must have completed all required Privacy, HIPAA training, VAMC mandatory orientation, and the Specimen Acquisition Unit orientations for both inpatient and outpatient practices, procedures, and protocols. This list may also be utilized to replace VA staff who call in sick or are on vacation. Contractors will only be compensated for the actual hours worked by the replacement staff.

3.4 Requirement of Contractor’s employee presence

A contractor’s employee must be present at the VA facility and actually perform the required services for the period specified in the task order. If the contractor is unable to perform the services contracted for, the VA reserves the right to obtain the service from another source and to charge the Contractor with any excess cost which may result from there. VA will be the sole judge in determining when to order service from another source.

3.5 Continuity of personnel and services

The contractor shall, to the extent possible, provide a core group of Phlebotomists to provide this coverage, as continuity of personnel is considered an important element in providing quality care and meeting patient care needs in a timely and efficient manner without causing delays. The Contractor point of contact shall ensure that qualified personnel are available to provide coverage during scheduled and unscheduled absences of primary contract providers or when they will be unable to provide services for one (1) or more consecutive days. Substituted contract employees must be approved by the Pathology & Laboratory Medicine Service and must be credentialed and have completed a Background Check prior to performing services.

To prevent unexpected and unanticipated call-ins by Contract Phlebotomists that are scheduled to work, the Contractor will counsel Contract Staff, verbally and in writing, if staff members frequently call-in (>4 in a month) or if a pattern occurs (call-in on days attached to a non-workday/holiday, or calling in on weekends exceeding 2 occurrences per year). If the problem persists following counseling, the assignment of the contract employee may be requested to end. The Contractor will provide rationale for contract staff member(s) absence if requested.

3.6 Contractor-furnished Phlebotomist background check

A list of all contractor-furnished Phlebotomists shall be made available to the facility for a background check within 7 days of contract award and those individuals will be interviewed by MEDVAMC Specimen Acquisitioning Unit Supervisors/ Worker Leaders and references verified to determine suitability and to validate phlebotomy experience.

3.7 Prior approval for overtime

The contractor shall notify the Phlebotomist that prior to working over their scheduled shift, he/she must receive prior approval from the Specimen Acquisition Supervisor and COR or designee. The overtime (OT) rate will be 1.5x Base and requires prior approval from VA to ensure funding is available before contract staff work OT and will only be paid when an employee works more than 40 hours per week. Additionally, holiday pay will be provided at a rate of 2.0x Base for hours worked on designated Federal Holiday.

4. CLINICAL EXPECTATIONS:

4.1 Phlebotomist Duties

• Performs Phlebotomy duties on inpatients and outpatients. Contract Phlebotomists must be competent to perform tasks and assignments independently, which may include drawing blood from 40 to 80 patients per day and handling at least 20% of hard sticks.

• Assembles equipment such as tourniquet, needles, blood collection devices, gauze, vacuum tubes, alcohol, chloral prep and etc. on work tray, blood collection cart or work area.

• Verifies and correctly identities patients utilizing two approved patient identifiers prior to drawing blood, per Medical Center Policy, Specimen Collection Policy and The Joint Commission guidelines, and converses with the patient to allay fear of the procedure.

• Draws blood and blood cultures from patients using proper venipuncture techniques and methods. Uses plastic vacuum tubes, blood collection needle or blood collection set (butterfly) to obtain samples.

• Applies tourniquet to arm, locates accessible vein, swabs puncture area with disinfectant, and inserts needle into vein to draw blood; withdraws needle, applies treatment to puncture site.

• Labels in presence of patient, initials and transports blood collected to processing area; Uses Trans Logic system to tube specimens to third floor laboratory from outpatient’s Blood Lab.

• Ensures that the sufficient amount of blood is drawn for each requested test or procedure.

• Outpatient specimen collections are not only limited to blood collection, but it does include different kinds of urine collections and performing glucose tolerance testing.

• May perform various other technical laboratory procedures such as computer test accessioning, specimen centrifugation, serum separation, etc.

• Interprets and clarifies physician’s orders from written requests and hard copies of orders and may input test orders into the computer; Uses Multipurpose Accessioning option, Pre-Accessioning options, Activate Pre-Accession Numbers option or etc.

• Rotates to answer telephone requests for verbal test requests, test add on(s), test results; utilizes computer to access the necessary data and communicates this data (results) to physicians, nurses and other authorized medical personnel as necessary.

• Records rejected specimens according to rejection protocols such as misidentified, unidentified specimens or specimens with insufficient volume drawn, wrong tube etc.

• Must provide superb customer service and great communication skills.

• Contract staff will adhere to the VAMC Customer Service Standards of Behavior Policy.

4.2 Patient Safety

Recognizes emergent situations such as patient need for CPR/choking procedure and initiates immediate action based upon the medical center policy.

Take appropriate action during fire or disaster drills/situations.

4.3 Workplace Safety:

Observe and practice all established safety practices, regulations of Regulatory Agencies, OSHA and comply with the Medical Center policies on Safety, Occupational Health Services, Workers’ Compensation related to on-the-job injuries, and personal protective clothing/equipment. Demonstrates personal involvement and compliance:

• Observing all safety signs, directions and instructions

• Attending scheduled safety training and reporting unsafe work situations to the contract manager and onsite VA supervisor.

• When suffering an on-the-job injury/illness, contract phlebotomists will promptly notify the onsite contract manager/onsite VA supervisor within 15 minutes.

• Contract phlebotomists shall use proper body mechanics, lifting and transfer devices for optimum efficiency and prevention of injury to self and patient which include but not limited to:

- Moving & lifting

- Patient transfers (wheelchair, chair)

- Assisting patients with ambulation

All incidents and accidents involving contract phlebotomists shall be reported to the contract manager/VA supervisor within 15 minutes. The Contract Supervisor shall advise the MEDVAMC Phlebotomy VA Supervisor and COR of the incident within 30 minutes.

4.4 Physical Standards and Environmental Factors

Compliant with the following physical standards and environmental factors.

• Heavy lifting, 25 pounds & over

• Heavy carrying, 25 pounds & over

• Pushing (2-4 hours)

• Walking (4-6 hours)

• Prolong Standing (4-6 hours)

• Both hands are required.

• Ability for rapid mental & muscular coordination simultaneously

• Near Vision correctable

• Far Vision correctable

• Depth perception

• Hearing (aide permitted)

• Work closely with others, as well as protracted or irregular hours of work

Maintains equipment in safe working status to prevent injury to self or others and reports any need for equipment repair to the onsite contract manager/supervisor.

Contract Phlebotomists will follow the MEDVAMC dress code policy.

The Phlebotomists will perform according to MEDVAMC policies on Interpersonal Behavior, Communication, and Customer Service.

4.5 Documentation, Reporting, and Confidentiality

Documentation, reporting and communication standards are met and are not limited to:

• Maintains complete and accurate records on the computer on the particular specimen collection for all assigned patients.

• Demonstrates ability to obtain cooperation of patient/family by inspiring trust

• Is aware of body language and uses appropriate tone of voice in all communication

• Gives verbal input at team conferences/meetings

• Demonstrates patient privacy and confidentiality procedures as it relates to HIPAA

4.6 Personal Management and Growth

• Demonstrates dependability/ adheres to leave policies and completion of assignments

• Makes appropriate decision making without difficulty or overreacting

• Maintains a cooperative attitude with all patients and disciplines

• Comply with mandatory training and educational requirements of position

• Demonstrates awareness of unique diverse cultures

• Completes with all rules and regulations governing patient care, safety and privacy

5. CONTRACTOR PERSONNEL POLICY:

5.1 All contract Phlebotomists must complete required VA Privacy and Information Security and Rules of Behavior Privacy and HIPAA training prior to Mandatory Orientation. All contract Phlebotomists are required to attend in-house Phlebotomy orientation of practices, procedures, protocols and complete any additional annual training requirements which include annual safety, security, privacy and computer training. It is anticipated that most contract Phlebotomists will be able to complete mandatory annual training requirements during regularly scheduled work shifts. Training will be provided at government expense.

5.2 Contract employees shall adhere to the VAMC Employee Code of Conduct Policy in accordance with attachment D.2 Code of Conduct Policy.

5.3 The contractor shall be responsible for protecting the personnel performing services under this task order. To carry out this responsibility, the contractor shall provide the following for those personnel:

• Worker’s compensation

• Professional liability insurance (amount)

• Health examinations

• Income tax withholding, and

• Social security payments

5.4 Federal Government Holidays are:

New Year’s Day January 1st Birthday of Martin Luther King Jr. 3rd Monday in January Washington’s Birthday 3rd Monday in February Memorial Day Last Monday in May Juneteenth National Independence Day June 19th Independence Day July 4th Labor Day 1st Monday in September Columbus Day 2nd Monday in October Veterans Day November 11th Thanksgiving Day 4th Thursday in November Christmas Day December 25th

In addition to the days designated as holidays, the Government observes the following days:

Any other day designated by Federal Statute. Any other day designated by Executive Order.

Any other day designated by the President’s Proclamation.

6. TIMELY INVOICING

6.1 The Contractor shall submit invoices covering the services performed under this contract as indicated in section B.1 Paragraph 3. The Contractor shall provide an itemized invoice to the required VA invoicing address or submission online

6.2 The invoices shall be submitted as indicated on SF1449 page 1 block 18a with the following information at a minimum:

Contract Number Purchase Order Number Hours Worked by specific Contract Staff and rates of those staff Total Price

7. RECORD KEEPING:

7.1 The VA Medical Center shall establish and maintain a record keeping system that will record the hours worked by the contractor's employee(s). Contractor's employee(s) shall report to Human Resources unless otherwise directed, upon arrival at the VA for New Employee’s orientation and subsequently to the Specimen Acquisition Unit after completion of Orientation.

7.2 Monitoring of contractor’s time shall be demonstrated through sign-in/sign-out sheets signed by Supervisor or Designee and/or an approved timekeeping method provided by the vendor prior to award of contract.

8. CANDIDATE SUBMISSION TO VAMC

8.1 When there is a new requirement, a notification from the specific department point of contact or COR will be sent to the Contracted Company with details related to skills sets, shift need, etc, for the area that a phlebotomist is needed (i.e., inpatient or outpatient).

8.2 For each candidate’s submission, a packet/resume that annotates work history, experience, credentials, competencies, etc will be needed in order to ascertain if the candidate meets the skill level required for the specific unit.

8.3 The Phlebotomist packet/resume should include the following items:

• Phlebotomist’s Full Name (Including Middle Name)

• Work Address

• Date of Birth

• Social Security Number

• Home Address

• Phone number

• E-mail address

• Most recent facility worked as a phlebotomist

• Three Professional references preferably Supervisor/Work Leader with current phone numbers.

• Basic Life Support (BLS) Certificate

• Phlebotomy Certification

8.4 If a submitted candidate meets the skill requirements and is selected to work at the VA, the following, fully completed, TYPED forms shall be required to be submitted to the VA POC/Contracting Officer/COR.

• Contract Security Services Request Form #1A

• Contractor Fingerprinting Request Form #2

• VHA Service Center PIV Sponsorship Form #3

• Declaration of Federal Employment (OF306) (fill-able)

• Self-Certification Form - If the employee has worked at a VA within the past two years

8.5 The selected candidates shall be required to be fingerprinted at a VAMC once the required forms are received and signed by the Contracting Officer (CO) or Contracting Officer Representative (COR) . The forms will then be submitted to the Veterans Service Center – Security Services Department by the VAMC on behalf of the Contractor for background screening. The contracted staffing company will be required to reimburse the VAMC for the cost of background screens/investigations of each of the submitted candidates.

8.6 After submission, the contract Phlebotomists will receive [via email] from the VSC Security Office - SIC (VHALITNoReply@va.gov), an EQIP invitation. The contracted Phlebotomist shall complete the EQIP and submit signature pages to VSC within 14 days.

8.7 Once NCHC fingerprint screening/adjudication is received by the VAMC, the CO or COR will schedule the start date with the VAMC and in-house orientation for the department.

9. VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE

9.1 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.

10. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

10.1 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.

10.2 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 Handbook 0710, Personnel Suitability and Security Program.

https://vaww.va.gov/vapubs/viewPublication.asp?Pub_ID=487&FType=2 The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

10.3 Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established https://vaww.va.gov/vapubs/viewPublication.asp?Pub_ID=487&FType=2 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.

10.4 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.

10.5 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.

10.6 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.

10.7 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 onsite inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are following VA directive requirements.

11. VA INFORMATION CUSTODIAL LANGUAGE

11.1 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).

11.2 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 onsite inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are following VA directive requirements.

11.3 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.

11.4 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.

11.5 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.

11.6 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.

11.7 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.

11.8 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.

11.9 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.

11.10 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.

11.11 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.

11.12 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.

12. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

12.1 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.

12.2 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.

12.3 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.

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

12.5 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.

12.6 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.

12.7 The contractor/subcontractor agrees to:

(1) 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:

(a) The Systems of Records (SOR); and

(b) The design, development, or operation work that the contractor/ subcontractor is to perform:

(1) 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

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

12.8 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.

(1) "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.

(2) "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.

(3) "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.

12.9 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.

12.10 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 should be remediated as quickly as is practical, but in no longer than 10 days.

12.11 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.

12.12 All other vulnerabilities shall be remediate 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.

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

13.1 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.

13.2 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.

13.3 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.

13.4 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.

13.5 The contractor/subcontractor must conduct an annual self-assessment of all systems and outsourced services as required. Both hard copies 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.

13.6 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.

13.7 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.

13.8 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:

(1) Vendor must accept the system without the drive.

(2) 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

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

(4) 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;

(a) 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

(b) 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.

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

14. SECURITY INCIDENT INVESTIGATION

14.1 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.

14.2 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.

14.3 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.

14.4 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 violations 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.

15. LIQUIDATED DAMAGES FOR DATA BREACH

15.1 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

($37.50 each) in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

15.2 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.

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

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

15.3.2 Description of the event, including:

15.3.3 Date of occurrence.

15.3.4 Data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code; Number of individuals affected or potentially affected; Names of individuals or groups affected or potentially affected.

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

15.3.6 The likelihood that sensitive personal information will or has been compromised

(made accessible to and usable by unauthorized persons).

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

15.3.8 Assessment of the potential harm to the affected individuals.

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

http://www.va.gov/vapubs/viewPublication.asp?Pub_ID=608&FType=2 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.

15.4 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 the actual costs incurred per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

15.4.1 Notification.

15.4.2 One year of credit monitoring consists of automatic daily monitoring of at least three

(3) relevant credit bureau reports.

15.4.3 Data breach analysis.

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

15.4.5 One year of identity theft insurance with $20,000.00 coverage at $0.00 deductible.

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

16. TRAINING

16.1 All contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

(1) Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems.

(2) Successfully complete the VA Cyber Security Awareness and…