PWS DRAFT Sources Sought 36C25021Q1110.pdf

DRAFT

B.3 PERFORMANCE WORK STATEMENT dated 20 October 2021

PERFORMANCE WORK STATEMENT (PWS)

Disposable Sleep Study Supplies and Services for Dayton VA Medical Center

20 October 2021

1. GENERAL. This is a non-personnel services contract in which the contractor shall provide disposable sleep study supplies and services for Dayton VA Medical Center (VAMC) in Ohio. It is important to note all services under this contract shall be provided under the terms and conditions defined herein of software as a service (SaaS).

The government shall not exercise any supervision or control over the contract service providers performing the services herein.

The COVID-19 pandemic has caused a severe interruption in access to sleep apnea testing within a traditional in-patient setting. This requirement is 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 to the Veteran population at their home of residence. This effort shall ensure a continuation of high-quality sleep apnea testing and care with no risk of coronavirus infection. Furthermore, this service will allow Veterans with a traveling hardship to have easy access to quality sleep care.

1.1 SCOPE SUMMARY. The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items necessary to provide disposable sleep study supplies and services for Dayton VAMC as established in this Performance Work Statement (PWS) and in accordance with terms and conditions established in the contract for the following location:

Department of Veterans Affairs Dayton VA Medical Center 4100 West Third Street Dayton, Ohio 45428-0004

1.2 PERIOD OF PEFORMANCE. The performance period(s) for the base plus all option periods if exercised shall not exceed two (2) years for this contract summarized as follows:

Base Period (1-Year) from 12/16/2021 to 12/15/2022: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision and other items necessary to provide disposable sleep study supplies and services which shall be provided under the definition of software as a service (SaaS):

o CLIN-0001: Sleep Study Supplies o CLIN-0002: Sleep Study Services (Software as a Service)

Option Period One (6-Months) from 12/16/2022 to 06/15/2023: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision and other items necessary to provide disposable sleep study supplies and services which shall be provided under the definition of software as a service (SaaS):

o CLIN-1001: Sleep Study Supplies o CLIN-1002: Sleep Study Services (Software as a Service)

Option Period Two (6-Months) from 06/16/2023 to 12/15/2023: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision and other items necessary to provide disposable sleep study supplies and services which shall be provided under the definition of software as a service (SaaS):

o CLIN-2001: Sleep Study Supplies o CLIN-2002: Sleep Study Services (Software as a Service)

Option Period Three (6-Months) from 12/16/2023 to 06/15/2024: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision and other items necessary to provide disposable sleep study supplies and services which shall be provided under the definition of software as a service (SaaS):

o CLIN-3001: Sleep Study Supplies o CLIN-3002: Sleep Study Services (Software as a Service)

Option Period Four (6-Months) from 06/16/2024 to 12/15/2024: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision and other items necessary to provide disposable sleep study supplies and services which shall be provided under the definition of software as a service (SaaS):

o CLIN-4001: Sleep Study Supplies o CLIN-4002: Sleep Study Services (Software as a Service)

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 on-going quality assurance and /or quality improvement program designed to objectively and systematically measure, assess, and improve performance to enhance patient care and all patient care services. The contractor’s quality control program 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. The contractor’s quality control program shall include the following:

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 Federally Recognized Holidays. The contractor is not anticipated but may be required to provide service on Federally recognized holidays in accordance with the terms and conditions established in this PWS to include but not limited to the following:

New Year’s Day Labor Day Martin Luther King Jr.’s Birthday Columbus Day President’s Day Veteran’s Day Memorial Day Thanksgiving Day Juneteenth Christmas Day Independence Day

1.3.4 Hours of Operation. The business hours of operation for Dayton VAMC is Monday through Friday from 0800-EST to 1630-EST, except on Federally recognized holidays.

1.3.5 Place of Performance. The contractor shall furnish 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 PM and/or CO in accordance with the procedures specified within this PWS for the following location:

Department of Veterans Affairs Dayton VA Medical Center 4100 West Third Street Dayton, Ohio 45428-0004

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 Requirements 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 service 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.

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

1.4.12.2 PHYSICAL Security: Not Applicable.

1.4.12.3 Key Control: Not Applicable.

1.4.12.4 Lock Combinations: Not Applicable.

1.3.9 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, 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.

1.3.10 Government Program Manager (Government PM). 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.

1.3.11 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.

1.3.12 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.

1.3.13 Contractor Travel: Not Applicable

1.3.14 Other Direct Costs: Not Applicable

1.3.15 Data Rights: Not Applicable

1.3.16 Organizational Conflict of Interest: Not Applicable

1.3.17 Phase-In /Phase-Out Period: Not Applicable

2. DEFINITIONS AND ACRONYMS

2.1. DEFINITIONS

BENEFICIARY. Veterans and other members determined to be eligible for benefits by the VA.

COMMUNITY LIVING CENTER (CLC). The Community Living Centers (CLCs) are inpatient units for

VAMC nursing homes.

CONTRACT TASK ORDERS. Award of a funded contract task order for the appropriate period of performance is required prior to the commencement of any/all work in accordance with FAR part 16.506 as specified herein.

CONTRACTOR. A vendor awarded a contract to provide specific supplies or service to the government. The term used in this contract refers to the prime contractor and its employees. The contractor is fully responsible for performance of their sub-contractor(s) and shall ensure that their subcontractor(s) are fully compliant with the terms and conditions of this contract at all-times.

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.

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.

DEFECTIVE SERVICE. A service output that does not meet the standard of performance associated with the Performance Work Statement.

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

GOVERNMENT PROGRAM MANAGER (PM): An individual specified by the contracting officer in writing to provide technical guidance for work within the scope of this contract. 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.

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.

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

PATIENT BUSINESS SERVICES. An administrative department which processes patients’ medical records, appointments, etc.

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

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

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

QUALITY ASSURANCE. Those actions taken by the Government to assure services meet the requirements of this contract.

QUALITY ASSURANCE EVALUATOR(S): Government personnel responsible for surveillance of contractor performance.

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

QUALITY CONTROL PLAN (QCP): The QCP is the contractor's management plan for executing the contract which shall be provided to the government upon request and whenever updated by the contractor. The contractor QCP describes the way in which the contractor will produce the deliverables, and the step-by-step approach that will be taken to ensure the quality of service provided to the government.

SUBCONTRACTOR(S). A subcontractor is one who enters into a contract with a contractor (or prime contractor). The contractor (or prime contractor) may choose to subcontract a nominal amount of patient transports during periods of increased demand to comply with the terms and conditions of this contract. The prime contractor is fully responsible for performance of their sub-contractor(s) and shall ensure that their subcontractor(s) are fully compliant with the terms and conditions of this contract at all-times. In addition, the prime contractor shall ensure that their subcontractor(s) clearly identify themselves as the subcontractor for the prime contractor in all written correspondence (i.e. log books, patient transport sheets, etc.) and verbal exchanges with government representatives for all patient transportation runs.

THE JOINT COMMISSION (TJC). A national not-for-profit organization dedicated to administering accreditation programs that improve the care, safety and treatment of patients in a health care facility and environment.

UNIVERSAL PRECAUTIONS. The standard precautions which shall be taken by the contractor when it is anticipated that an individual may encounter blood or body fluid while performing normal duties which require the use of personal protective equipment (e.g., gloves).

VETERANS TRANSPORTATION DEPARTMENT (VTD). This department is under Patient Business Service (PBS) and coordinates Veteran transportation and eligibility issues. This section works under the authority of the Contracting Officer and is responsible for placing orders for service and certification of invoices under the terms and conditions of this contract.

VETERANS TRANSPORTATION MANAGER (VTM). The manager/supervisor of the VA section under PBS that is responsible for coordinating Veteran transportation and eligibility issues.

2.2. ACRONYMS:

AQL Access Control List CBOC Community Based Outpatient Clinic CFR Code of Federal Regulations CLC Community Living Centers CO Contracting Officer CONUS Continental United States (excludes Alaska and Hawaii) COR Contracting Officer’s Representative COTR Contracting Officer's Technical Representative COTS Commercial-Off-the-Shelf FAR Federal Acquisition Regulation HIPAA Health Insurance Portability and Accountability Act of 1996 NHCU Nursing Home Care Unit NTE Not to Exceed OCI Organizational Conflict of Interest OCONUS Outside Continental United States (includes Alaska and Hawaii) ODC Other Direct Costs OAC Ohio Administrative Code ORC Ohio Revised Code PBS Patient Business Services PIPO Phase In/Phase Out PACS Physical Access Control System POC Point of Contact PM Program Manager PRS Performance Requirements Summary PWS Performance Work Statement QA Quality Assurance QAP Quality Assurance Plan QASP Quality Assurance Surveillance Plan QC Quality Control QCP Quality Control Program SaaS Software as a Service SMS Security Management System SSA Site Support Agreement TE Technical Exhibit VAAR Veteran’s Administration Acquisition Regulation VAPS VA Police System VISTA Veteran’s Health Information Systems and Technology Architecture VSC VHA Service Center VAACC Veteran’s Administration Ambulatory Care Clinic VAMC Veteran’s Administration Medical Center

VHA Veteran’s Health Administration VHA PM Veteran’s Health Administration Procurement Manual

3. GOVERNMENT FURNISHED ITEMS AND SERVICES: No government furnished equipment (GFE) will be provided for this requirement.

3.1. Services: Not applicable

3.2 Facilities: Not applicable.

3.3 Utilities: Not applicable.

3.4 Equipment: Not applicable.

3.5 Materials: Not applicable.

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. Materials, Supplies and Equipment: The contractor shall provide the supplies as specified in this PWS.

5. REQUIREMENTS – SPECIFIC TASKS:

5.1 GENERAL: The contractor shall provide portable sleep studies to the Veteran population at their home of residence. This effort shall ensure a continuation of high-quality sleep apnea testing and care with 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 of 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, the data shall be transmitted from the patient’s phone to a secure portal for VA physician review via a downloadable phone application which shall be provided by the contractor with instructions to each patient.

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

5.1.2.1 Supplies shall be FDA-approved portable diagnostic device that uniquely uses finger based to enable Obstructive Sleep Apnea (OSA) testing approach

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

5.1.2.3 Supplies preference is for wrist-watch based sleep testing, and no belts, wires or nasal cannulas.

5.1.2.4 Supplies shall be high compliance with a minimal failure rate of (< 1%).

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

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

5.1.2.7 Supplies shall require minimal cleaning, preparation or handling before and after patient use, with preference that it be disposable due to current COVID-19 pandemic.

5.1.2.8 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.

5.1.2.9 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 contractor shall provide all services necessary to send out the equipment and provide instructions on use and disposal to each patient at their home of residence.

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 full 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 Chasity Stickles or Megan Gaul 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 ‘IT’ 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:

Contract Number Purchase Order (PO) Number Actual quantity of authorized work completed by Contract Line Item Number (CLIN) 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 time 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 (CPARS). 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.

5.10.2.1 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.

5.10.2.2 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.

5.10.2.3 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.

6. Performance Requirements:

6.1 Performance Requirements Summary: The performance requirements are the thresholds of minimum acceptable levels of service critical to successful performance of this contract which are summarized as follows:

PERFORMANCE REQUIREMENTS SUMMARY

Performance Objectives

Performance Standard Acceptable Quality

Level (AQL)

Method of Monitoring

1) Supplies The contractor shall provide all disposable sleep study supplies to the patient which shall be shipped to the patient with 24‐hours of request for an authorized government representative as specified in this PWS in accordance with the terms and conditions established in the contract. Failure to perform may result in a contract termination IAW FAR 52.212‐4(m).

100% Compliance

The PM or government representative designated in writing by the CO will conduct random checks to ensure compliance with this performance standard.

2) Services The contractor shall provide all services in a timely manner as specified in this PWS and in accordance with the terms and conditions established in the contract. This shall include all sleep studies which shall be available to the government immediately upon completion of each sleep study. Failure to perform may result in a contract termination IAW FAR 52.212‐4(m).

100% Compliance

The PM or government representative designated in writing by the CO will conduct random checks to ensure compliance with this performance standard.

3) Ad Hoc Reports

The contractor shall provide ad hoc status reports as requested by the government as specified in accordance with the terms and conditions established in the contract.

95% On‐Time

The PM or government representative designated in writing by the CO will conduct random checks to ensure compliance with this performance standard.

4) Invoicing Accuracy, Timeliness and Billing Errors

The contractor shall submit invoices in a timely manner for work performed on a monthly basis in the arrears not later than 2 weeks after performance in accordance with the PRICE/COST SCHEDULE, the PWS and the overall terms and conditions established in the contract.

98% Compliance

The PM or government representative designated in writing by the CO will conduct random checks to ensure compliance with this performance standard.

5) Compliance with English Language Requirement

The contractor shall ensure that all employees are fully proficient in the English language at a level sufficient to seamlessly perform all services required in accordance with the terms and conditions of this contract.

100% Compliance

The PM or government representative designated in writing by the CO will conduct random checks to ensure compliance with this performance standard.

6) Compliance with FAR 52.219‐14 Limitations on Subcontracting Requirements

The contractor shall submit confirmation of compliance with the FAR 52.219‐14 ‐‐ Limitations on Subcontracting requirement that “at least 50 percent of the cost of contract performance incurred for personnel shall be expended for employees of the concern” as specified by the Contracting Officer (CO) in writing within four (4) hours of request.

100% Compliance

The Contracting Officer (CO) will conduct random compliance checks with the contractor as necessary.

7) Compliance with DOL Wage Determination Labor Rate Requirement

The contractor shall submit confirmation of compliance with the current Department of Labor (DOL) wage determination (WD) hourly rate if requested by the Contracting Officer (CO) in writing within four (4) hours of request which may include an itemized list of the hourly rate being paid for all employees performing services under this contract.

100% Compliance

The Contracting Officer (CO) will conduct random compliance checks with the contractor as necessary.

NOTE: The performance of these requirements by contractor will be documented by the government in the CPARS system based on the contractor’s ability to comply with the terms and conditions established in the contract.

B.4 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

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

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

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

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

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

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

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

3. VA INFORMATION CUSTODIAL LANGUAGE

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

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

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

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

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

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

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate

Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

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

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

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

k. Notwithstanding the provision above, the contractor/subcontractor shall not release VA records protected by Title 38 U.S.C. 5705, confidentiality of medical quality assurance records and/or Title 38 U.S.C. 7332, confidentiality of certain health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus.

If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

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

4. INFORMATION SYSTEM DESIGN AND DEVELOPMENT

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

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

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

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

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

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

g. The contractor/subcontractor agrees to:

(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…