Performance Work Statement.docx

PERFORMANCE WORK STATEMENT (PWS)

Home Sleep Study Supplies and Services for Cleveland VAMC

PART 1

GENERAL INFORMATION

1. General This is a non-personal supply and services contract in which the contractor shall provide home sleep study test kits to the veteran’s populations homes, as authorized by the Cleveland Veterans Affairs Medical Center, medicine service providers. The vendor will receive orders with Patient Information for the Home Sleep Tests (HST) from the Veterans Affairs (VA) providers via secure portal through only government approved software and program systems. The vendor/contractor will ensure that all necessary supplies are provided to the VA patient at their home/residence for turn-key use in a kit with instructions. If the veteran has a smart phone, they will receive a disposable device which would download the data into a government approved Web Portal that stores the data and studies to be available for the VA providers to read the studies and recommend proper diagnoses, at the end of the study. Vendor must ensure that all information collected by the disposable devices, once has been submitted into the portal, all the data collected has been erased prior the device is being disposed of. If the veteran does not have a smart phone the vendor will deliver a recyclable device to the patient’s home with a returned envelope and clear and understandable directions of use, and at the end of the study, patient will be mailing the device back to the vendor. Once the vendor receives the device from the patient, the vendor must download the data into a government approved and authorized secure portal, so the VA providers would be able to read the study and recommend the diagnoses and follow up to with the patient. The supplies will be for one night study or two-nights of studies. The supplies, both disposables and reusables are used as the tool to gather the information from the patient and store and download the data into the government approved software programs and web portals. The government will administer the contract and the government is responsible for the contract, however, the government shall not exercise any supervision or control over the contractor, but the COR will observe the performance of the contract.

At the minimum, the VA is being mindful to serve all veterans despite the level of technical expertise and knowledge of technology. For that reason, VA is looking for devices that are very smart and as sophisticated as they can be, but also able to gather the information requested for purposes of studies from our veterans with very little efforts and easily followed instructions of use by our veterans. The device must serve one purpose and one purpose only. To gather only data for the Sleep Tests, and no other health related patient information. Considering patient past experience with Home Sleep Test Studies, VA would prefer and would give priority to supplies that are small enough to wear, such as devices worn on patient’s wrist, lightly to held so there is no interference with sleep, and easily to follow instruction to complete the test. Devices which use Cannulas are not so desirable for patients.

The COVID-19 pandemic caused a severe interruption in access to sleep apnea testing within a traditional in-patient setting. Current requirement and the previous ones intended to address this need by providing home-based sleep studies with minimal life cycle costs. In order to meet this requirement, the contractor shall provide portable sleep studies kits to the Veteran population at the Veteran’s home or residence. This effort shall ensure a continuation of high-quality sleep apnea testing and care with little to no risk to patients. Furthermore, this contract will allow Veterans with a traveling hardship to have easy access to quality sleep care.

The contractor shall utilize FDA approved sleep study devices to provide services under this contract. In addition, the contractor shall provide the government requiring office for all sleep studies the raw data and final report in FDA approved format which shall include all necessary software tools for turn-key utilization of the data. The contractor shall ensure that all sleep study reports, and related raw data are transmitted electronically in a format that is compliant with the pre-existing IT infrastructure and IT security protocols for secure transmission of data at no additional cost to the government in excess of the established PRICE/COST SCHEDULE. In addition, all sleep study reports shall follow the basic guidelines provided in the American Academy of Sleep Medicine (AASM) manual for tabulating and scoring of sleep related events.

INSTRUCTIONS TO OFFERORS: All offerors shall submit an offer with either reusable or disposable sleep study devices as their primary means of conducting home based sleep studies. However, all offerors shall ensure that enough of the reusable type of sleep study devices are always available at all times for patients who do not have a personal smart phone capable of transmitting sleep study data for the disposable type of sleep study devices.

1.1. Scope Summary

The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to provide home sleep study supplies and services to include weekly and monthly reports on regular bases to the COR and administration of the Medicine Service, for the Cleveland VAMC patients as established in this PWS and in accordance with the terms and conditions established in the contract for the following location:

Louis Stokes Cleveland VAMC 10701 East Blvd Cleveland, Ohio 44106

1.2 Period of Performance, and Inventory requirements

The performance period for this contract will be for a one year.

The amount of study kits requested for one year is summarized as follows:

1. Home Sleep Studies Supplies and Services: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to provide home sleep study supplies and services as a turn-key deliverable with contract line-item numbers (CLINs) summarized as follows:

CLIN 1 Use of HST equipment for 2 nights, 100 units CLIN 2 Additional patient training for 2nd night of product use, 100 units CLIN 3 Use of reusable HST device, 250 units CLIN 4 Use of disposable HST device, 4,750 units CLIN 5 Use of additional disposable equipment for 2nd night of testing, 100

1.3 General Requirements

1.3.1 Quality Control

The contractor shall develop and maintain an effective quality control program to ensure services are performed in accordance with this PWS. The contractor shall identify and define the management concept for ensuring compliance with all contract requirements. The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor will have an ongoing quality assurance and/or quality improvement program designed to measure, assess, and improve performance to enhance patient care and all patient care services objectively and systematically. The contractor’s quality control program (QCP) is the means by which the contractor assures that all work complies with the requirement of the contract. The contractor shall provide a copy of the QCP with their offeror as specified by the Contracting Officer and upon request thereafter. After acceptance of the quality control plan, the contractor shall immediately notify the contracting officer of any proposed changes to their quality control program and submit a change request in writing to the contracting officer. The contractor shall furnish copies of these records if requested by the Contracting Officer, GOVERNMENT PM or individual(s) designated by the GOVERNMENT PM and/or CO in writing.

1.3.2. Quality Assurance

The government shall evaluate the contractor’s performance under this contract in accordance with the Quality Assurance Surveillance Plan. This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.3.3. Recognized Holidays

Independence Day

1.3.4. Hours of Operation

The business hours of operation for the Cleveland VAMC are Monday through Friday from 0800-EST to 1630-EST, except on recognized holidays, as listed in section 1.3.3 above.

1.3.5. Place of Performance

The contractor shall provide services in accordance with the terms and conditions of this contract as requested by the authorized government representative(s) designated in writing by the Government Program Manager and/or Contracting Officer in accordance with the procedures specified within this PWS for the following location:

Louis Stokes Cleveland VAMC 10701 East Blvd Cleveland, Ohio 44106

1.3.6. Type of Contract

The government intends to award a single-award firm-fixed price (FFP) contract for the effort specified herein. The base and option periods (if any) specified in the PRICE/COST SCHEDULE shall be exercised at the discretion of the government. The authority that will be utilized to award this effort is FAR Part 13.5 (Simplified Procedures for Certain Commercial Items).

1.3.7. Security Requirement and Background Checks

All contractor employees shall comply with the security and background check requirements required by Federal, State, Local and the Department of Veterans Affairs to perform services in support of this VA medical facility in the state of Ohio. The contractor shall perform the services in compliance with the terms and conditions of this contract at the contractor’s facility unless a meeting and/or site visit is required which shall be coordinated with the government program manager.

The contractor shall ensure that all personnel obtain VAMC identification badges from the each VAMC security personnel office as appropriate in compliance with all federal and local VAMC facility policies in coordination with the government program manager if required.

1.3.8. Post-Award Conference/Periodic Progress Meetings. The contractor agrees to attend any post award conference convened by the contracting activity or contract administration office in accordance with Federal Acquisition Regulation Subpart 42.5. The contracting officer, government program manager (PM), and other government personnel, as appropriate, may meet periodically with the contractor to review the contractor's performance. At these meetings the contracting officer will apprise the contractor of how the government views the contractor's performance and the contractor will apprise the government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the government.

1.3.9. Government Program Manager. The government PM will be identified by the cognizant government contracting officer in writing. The PM monitors all technical aspects of the contract and assists in contract administration. The PM is authorized to perform the following functions: assure that the contractor performs the technical requirements of the contract; maintain written and oral communications with the contractor concerning technical aspects of the contract that are within scope; monitor contractor's performance and notifies both the contracting officer and contractor of any deficiencies; coordinate availability of government furnished property; and provide site entry of contractor personnel. The PM shall be specified in writing by the CO and is not authorized to change any of the terms and conditions of the resulting contract.

1.3.10. Key Personnel. The following personnel are considered key personnel by the government: Project Manager/Alternate Project Manager and Officer in Charge. The contractor shall provide a contract manager who shall be responsible for the performance of the work. The name of this person and an alternate who shall act for the contractor when the manager is absent shall be designated in writing to the contracting officer. The contract manager or alternate shall have full authority to act for the contractor on all contract matters relating to daily operation of this contract.

1.3.11. Identification of Contractor Employees. All contract personnel attending meetings, answering government telephones, and working in other situations where their contractor status is not obvious to third parties are required to identify themselves as such to avoid creating an impression in the minds of members of the public that they are Government officials. They must also ensure that all documents or reports produced by contractors are suitably marked as contractor products or that contractor participation is appropriately disclosed.

PART 2

DEFINITIONS & ACRONYMS

2. Definitions and Acronyms

2.1. Definitions

1. ACCEPTABLE QUALITY LEVEL (AQL). The AQL expresses the allowable variation from the standard that will result in an acceptable level of quality (100% unless otherwise stated) – that is the maximum allowable error rate or variation from the standard.

1. CONTRACTOR. A supplier or vendor awarded a contract to provide specific supplies or service to the Government. The term used in this contract refers to the prime.

1. CONTRACTING OFFICER. A person with authority to enter into, administer, and/or terminate contracts, and make related determinations and findings on behalf of the Government. Note: The only individual who can legally bind the Government.

1. CONTRACTING OFFICER’S REPRESENTATIVE (COR). An employee of the U.S. Government appointed by the contracting officer to administer the contract. Such appointment shall be in writing and shall state the scope of authority and limitations. This individual has authority to provide technical direction to the contractor as long as that direction is within the scope of the contract, does not constitute a change, and has no funding implications. This individual does NOT have authority to change the terms and conditions of the contract.

1. DEFECTIVE SERVICE. A service output that does not meet the standard of performance associated with the PWS.

1. DELIVERABLE. Anything that can be physically delivered but may include non-manufactured things such as meeting minutes or reports.

1. KEY PERSONNEL. Contractor personnel that are evaluated in a source selection process and that may be required to be used in the performance of a contract by the Key Personnel listed in the PWS. When key personnel are used as an evaluation factor in best value procurement, an offer can be rejected if it does not have a firm commitment from the persons that are listed in the proposal.

1. NOT TO EXCEED (NTE). The price and/or quantity that the contract or purchase order shall not exceed.

1. PHYSICAL SECURITY. Actions that prevent the loss or damage of Government property.

1. QUALITY ASSURANCE. The Government procedures to verify that services being performed by the contractor are performed according to acceptable standards.

1. QUALITY ASSURANCE SURVEILLANCE PLAN (QASP). An organized written document specifying the surveillance methodology to be utilized by the Government for surveillance of contractor performance.

1. QUALITY CONTROL. All necessary measures taken by the contractor to assure that the quality of an end product or service shall meet contract requirements.

1. SUBCONTRACTOR. One that enters into a contract with a prime contractor. The Government does not have privity of contract with the subcontractor.

1. WORK DAY. The number of hours per day the contractor provides services in accordance with the contract.

1. WORK WEEK. Monday through Friday, unless specified otherwise.

2.2. Acronyms:

PART 3

GOVERNMENT FURNISHED ITEMS AND RESPONSIBILITIES

3. Government Furnished Items and Services: No government furnished equipment (GFE) will be provided for this requirement.

PART 4

CONTRACTOR FURNISHED ITEMS AND RESPONSIBILITIES

4. Contractor Furnished Items and Responsibilities

4.1. General: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to perform all services under this contract as defined in this PWS and in accordance with the terms and conditions of this contract.

4.2. The contractor shall provide the supplies as specified in this PWS. The contractor shall provide the supplies as specified in this PWS.

PART 5

REQUIREMENTS – SPECIFIC TASKS

5. Requirements

5.1. General: The contractor shall provide portable sleep studies to the Veteran population at their home or residence. This effort shall ensure a continuation of high-quality sleep apnea testing and care with little to no risk of coronavirus infection. Furthermore, this service will allow Veterans with a traveling hardship to have easy access to quality sleep care.

5.1.1. Ordering: The units ordered by the government shall be shipped directly from the contractor to each patient at their home or residence which shall include 24/7 customer support service. The patient will wear the device on the wrist, and upon completion of the sleep test, if the patient has a smart phone the study will automatically be uploaded to an authorized government software program, but if patient does not have a smart phone, a recyclable device will be mailed to the patient’s home with instruction of use, and the patient will use the pre-paid shipping label and return the device to the contractor after the test have been completed. Once the device is back, the study is uploaded by the contractor into an authorized government software program and sent to the referring physician. VA physician reviews results sent by the contractor’s platform.

5.1.2. The contractor shall ensure all home sleep study supplies and services are provided in compliance with the following salient characteristics:

5.1.2.1. The contractor shall ensure that all necessary supplies are provided to the VA patient at their home or residence for turn-key use in a kit with instructions.

5.1.2.2. Supplies shall be FDA-approved portable diagnostic device that uniquely uses finger based toenable Obstructive Sleep Apnea (OSA) testing approach.

5.1.2.3. Supplies shall avoid the complexity and discomfort associated with traditional air-flow based systems.

5.1.2.4. Supplies preference is for wristwatch-based sleep testing. There shall be no belts, wires or nasal cannulas included as part of this requirement.

5.1.2.5. Supplies shall be high compliance with a minimal failure rate of (< =2%) for the device only which does not include patient caused failures.

5.1.2.6. Provides non-EEG HST measures “True Sleep Time” (rather than total recording time) and provides complete sleep architecture.

5.1.2.7. Supplies shall utilize Peripheral Arterial Tone (PAT) signal. PAT measures the arterial volume changes at the fingertip, reflecting the sympathetic nervous system activation.

5.1.2.8. Supplies shall require minimal cleaning, preparation or handling before and after patient use.

5.1.2.9. The contractor shall provide a portable in-home capability that meets the needs of VA by providing a service that helps VA manage a growing patient population by ensuring all specialty services are available for our Veteran patients to able to have complete care in one place.

5.1.2.10. The Pulmonary Department needs a quick turnaround of results that allows the provider to make a diagnosis and treatment plan quickly and service more veterans at the same time within a reasonable amount of time.

5.1.2.11. The contractor shall ensure all services are provided as turn-key to the government requiring activity. The contractor shall provide the government requiring activity for each sleep study the raw data and final report in FDA approved format which shall include all necessary software tools for turn-key utilization of the data.

5.1.2.12. The contractor shall ensure that all required equipment with instructions for use and disposal be shipped to the patient at their home or residence within 10 business days of any given request by an authorized government representative specified by the government contracting officer. The instructions for patient use shall also include how to upload the required sleep study report and instructions for disposal.

5.1.2.13. The contractor shall provide a secure, cloud-based location for all patient sleep study reports that shall be accessible by only the authorized government representative(s) specified by the government contracting officer in writing. Furthermore, the contractor shall ensure that all reports and data hosted on their secure, cloud-based location is compliant with HIPPA, Privacy Act of 1974 and all VA policies and procedures. The contractor shall ensure that all patient sleep study reports are accessible by all authorized government representative(s) on the secure, cloud-based location for the entire life of the contract.

5.1.2.14. The contractor shall provide for each sleep study the raw data and final report in the FDA approved format to the government requiring activity.

5.1.2.15. The contractor shall ensure that the sleep study report for each patient is available for download by the government requiring activity within one hour during normal business hours of any sleep study report being uploaded by any given patient. Furthermore, the contractor shall send an email notification to the authorized government representative(s) within one hour during normal business hours of any given sleep study report being uploaded by any given patient as available for download by the government. The sleep study report shall use Peripheral Arterial Tone (PAT) signal and include heart rate, O2 saturation, hypnogram, complete sleep architecture and provide a non-EEG HST measures “True Sleep Time” (rather than total recording time).

5.1.2.16. The contractor shall provide documentation to evidence VA Technical Reference Model (TRM), VA Authority-To-Operate (ATO), and VA FEDRAMP and FDA approval for software and devices.

5.1.2.17. The definition of a billable sleep study is any test that includes the minimum amount of data required by the VA Medical Center which is anticipated to be 4 hours of contiguous usable data (may be subject to change).

5.1.3. Ordering Quantities. This contract is an indefinite quantity contract with maximum not-to-exceed (NTE) amounts which are established in the PRICE/COST SCHEDULE. The contractor shall not exceed the maximum NTE amounts established in the PRICE/COST SCHEDULE unless authorized via a bilateral contract modification that is fully funded, justified, and signed by the government contracting officer.

5.1.4. Packaging, Packing, and Shipping Instructions. Direct shipping to the patient is implicit. It is what this service is revolved around.

5.1.5. Inspection and Acceptance Criteria. The Veteran will receive the package from contractor with packing slip. Once the overnight sleep study has been completed the VA personnel will ensure transmission occurred to reflect findings of the study. The government technical POCs specified by the contracting officer in writing will be responsible for confirming that inspection and acceptance of the wristband sleep study device have been received by the patient from the contractor. A demo period or trial is not deemed as an inspection of a product. The contractor shall ensure the patient understands its usage and what to do once the test is complete. The results will be provided to the patient once they are read at VA.

5.1.6. Timeliness. The contractor shall provide sleep study supplies and services as needed in a timely fashion, as mutually agreed in accordance with the terms and conditions of this contract which shall not exceed the maximum not-to-exceed (NTE) amounts established in the PRICE/COST SCHEDULE.

5.1.7. Deliverables. The contractor shall treat all deliverables under the contract as the property of the U.S. government for which the government agency shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest.

5.1.8. Records. The contractor shall not create or maintain any records that are not specifically tied to or authorized by the contract using Government information technology equipment and/or Government records.

5.1.9. The contractor shall not retain, use, sell, or disseminate copies of any deliverable that contains information covered by the Privacy Act of 1974 or that which is generally protected by the Freedom of Information Act.

5.1.10. The contractor shall not create or maintain any records containing any government agency records that are not specifically tied to or authorized by the contract.

5.1.11. The government agency owns the rights to all data/records produced as part of this contract.

5.1.12. The government agency owns the rights to all electronic information (electronic data, electronic information systems, electronic databases, etc.) and all supporting documentation created as part of this contract. Contractor must deliver sufficient documentation with all deliverables to permit the agency use.

5.1.13. The contractor agrees to comply with Federal and agency records management policies, including those policies associated with the safeguarding of records covered by the Privacy Act of 1974. These policies include the preservation of all records created or received regardless of format [paper, electronic, etc.] or mode of transmission [e-mail, fax, etc.] or state of completion [draft, final, etc.].

5.1.14. No disposition of documents will be allowed without the prior written consent of the Contracting Officer. The Agency and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. Records may not be removed from the legal custody of the Agency or destroyed without regard to the provisions of the agency records schedules.

5.1.15. The contractor is required to obtain the Contracting Officer's approval prior to engaging in any contractual relationship (sub-contractor) in support of this contract requiring the disclosure of information, documentary material and/or records generated under or relating to this contract. The Contractor (and any sub-contractor) is required to abide by Government and Agency guidance for protecting sensitive and proprietary information.

5.2. VA Information Custodial Language.

5.2.1. Information made available to the prime contractor or their subcontractors through the prime contractor by VA for the performance or administration of this contract or information developed by the contractor and their subcontractors 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).

5.2.2. The prime contractor and their subcontractor(s) shall 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.

5.3. Security Incident Investigation.

5.3.1. 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 GOVERNMENT PM 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.

5.3.2. 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.

5.4. Invoicing Procedures, Billing Rates, and Mandatory Reports. The contractor shall comply with the terms and conditions established in this contract for invoicing procedures, billing rates and mandatory reports which shall include the following:

5.4.1. Invoicing Procedures. The contractor shall submit invoices only upon completion of work authorized by a government representative designated by the contracting officer in writing. The contractor shall only invoice for authorized work completed not-to-exceed (NTE) the amounts established in the SCHEDULE OF SERVICES – PRICE/COST SCHEDULE for this contract. The contractor shall ensure all invoices reference the following information to be considered for payment by the government:

1. Contract Number and Task Order Number

1. Purchase Order (PO) Number

1. Actual quantity of authorized work completed by Contract Line Item Number (CLIN)

1. Other information requested by the CO or authorized government representative(s) designated in writing by the CO.

5.4.2. Billing Rates. The contractor shall submit all invoices in accordance with the terms and conditions of this contract at the rates specified in the– PRICE/COST SCHEDULE which shall be priced as all-inclusive of all costs required to perform services under this contract summarized as follows:

5.4.2.1. All Inclusive Pricing | Fully Burdened. All patient transport rates established in the PRICE/COST SCHEDULE shall be priced by the contractor as fully burdened (or fully inclusive) of all costs required to perform services under this contract such as overhead, general, and administrative (G&A) costs, indirect costs, and other direct costs (ODCs) to include all ferry, bridge, tunnel, or road toll charges.

5.4.2.2. No Long-Distance Phone Charges Authorized. If the contractor’s place of business is located beyond the local telephone call zone of the VA Medical Center, the contractor ensure that a toll-free number is available at all times for accepting the VA phone calls and faxes.

5.4.2.3. No Hotel Charges Authorized. Reimbursement for contractor employees that stay in a hotel will not be authorized.

5.4.2.4. No Toll Charges. Although there are currently no toll charges in the state of Ohio, it is agreed and understood that the prices quoted in the PRICE/COST SCHEDULE do not include any ferry, bridge, tunnel, or road toll charges.

5.4.3. Mandatory Reports | Ad Hoc Reports and Data Calls. The contractor shall provide ad hoc reports and respond to data calls on an as needed basis as requested by either the GOVERNMENT PM or CO.

5.5. Employee Standards and Certification Requirements. All services performed by contractor employees under this contract shall comply with all applicable Federal, State, Local and Department of Veterans Affairs requirements.

5.6. Disaster Plans: In case of a disaster, natural or man-made, the contractor shall utilize maximum available resources to assist in providing services to government.

5.7. Wage Rates and Services Contract Act

5.7.1. Wage Rates. The contractor shall provide services which comply with the Department of Labor wage rate determinations as applicable in the county in which the services are provided.

5.7.2. Services Contract Act. The contractor shall ensure full compliance with all requirements of the Services Contract Act (SCA) during the performance of the resultant contract (if any) to include any task orders issued under the resultant contract.

5.8. APPLICABLE PUBLICATIONS, CERTIFICATIONS AND OTHER REQUIREMENTS. The contractor must abide by all applicable regulations, publications, manuals, and local policies and procedures to include Federal, State, Local and Department of Veterans Affairs policies.

5.9. Training. All contractor employees shall comply with the training requirements required by Federal, State, Local and Department of Veterans Affairs policies and procedures.

5.10. Contractor Performance Assessment Rating System. The contractor is required to register in the Contractor Performance Assessment Rating System (CPARS). As prescribed in Federal Acquisition Regulation (FAR) Part 42.15, the Department of Veterans Affairs (VA) evaluates contractor past performance on all contracts that exceed the dollar threshold specified in the FAR and may share those evaluations with other Federal Government contract specialists and procurement officials. The FAR requires that the contractor be provided an opportunity to comment on past performance evaluations prior to each report closing. To fulfill this requirement VA uses an online database. The CPARS database information is shared with the Past Performance Information Retrieval System (PPIRS) database, which is available to all Federal Agencies.

5.10.1, Each contractor whose contract award is estimated to exceed the dollar threshold specified in the FAR shall be required to register with the Contractor Performance Assessment Rating System (CPARS) database at the following https://www.cpars.gov/ or by calling (207) 438-1690. Registration should occur no later than thirty days after contract award and must be kept current should there be any change to the contractor’s registered representative.

5.10.1. For contracts with a period of one year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the contractor’s performance annually. Interim reports will be filed each year until the last year of the contract when the final report will be completed. The report shall be assigned in CPARS to the contractor’s designated representative for comment. The contractor representative will have thirty days to submit any comments and re- assign the report to the VA contracting officer.

5.10.2 For contracts with a period of one year or less, the contracting officer will perform a single evaluation when the contract is complete. For contracts exceeding one year, the contracting officer will evaluate the contractor’s performance annually. Interim reports will be filed each year until the last year of the contract when the final report will be completed. The report shall be assigned in CPARS to the contractor’s designated representative for comment. The contractor representative will have thirty days to submit any comments and re- assign the report to the VA contracting officer.

MARCH 12, 2010 VA HANDBOOK 6500.6 APPENDIX B

VA ACQUISITION REGULATION SOLICITATION PROVISION AND CONTRACT CLAUSE

NOTE: This clause will undergo official rule making by the Office of Acquisitions and Logistics. The below language will be submitted for public review through the Federal Register. The final wording of the clause may be changed from what is outlined below based on public review and comment. Once approved, the final language in the clause can be obtained from the Office of Acquisitions and Logistics Programs and Policy.

1. SUBPART 839.2 – INFORMATION AND INFORMATION TECHNOLOGY SECURITY REQUIREMENTS

839.201 Contract clause for Information and Information Technology Security:

a. Due to the threat of data breach, compromise or loss of information that resides on either VA-owned or contractor-owned systems, and to comply with Federal laws and regulations, VA has developed an Information and Information Technology Security clause to be used when VA sensitive information is accessed, used, stored, generated, transmitted, or exchanged by and between VA and a contractor, subcontractor or a third party in any format (e.g., paper, microfiche, electronic or magnetic portable media).

b. In solicitations and contracts where VA Sensitive Information or Information Technology will be accessed or utilized, the CO shall insert the clause found at 852.273-75, Security Requirements for Unclassified Information Technology Resources.

2. 852.273-75 - SECURITY REQUIREMENTS FOR UNCLASSIFIED INFORMATION

TECHNOLOGY RESOURCES (INTERIM- OCTOBER 2008)

As prescribed in 839.201, insert the following clause:

The contractor, their personnel, and their subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

(END OF CLAUSE)

VA HANDBOOK 6500.6 APPENDIX C

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE FOR

INCLUSION INTO CONTRACTS, AS APPROPRIATE

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/subcontrator 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.

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…