Attachment 1 - SOW.docx

Attachment 1 – SOW (36C24722Q0558, Blood Culture CPT)

STATEMENT OF WORK

Blood Culture CPT

1. GENERAL: It is the intent of the Charlie Norwood VA Medical Center to establish a cost-per-test agreement for all necessary consumable items, instrumentation, and services required to provide and perform comprehensive diagnostic testing to monitor for the presence/absence of microorganisms in blood cultures and sterile body fluids, excluding cerebrospinal fluid (CSF), in patient specimens within the medical center and provide prompt and accurate results in accordance with the Statement of Work.

2. BACKGROUND/SCOPE: Charlie Norwood VA Medical Center (CNVAMC) in Augusta, Georgia currently uses an automated, continuously monitoring system to perform blood culture and sterile body fluid testing through a CPT order. The current period of performance will expire August 31, 2022. Therefore, we must obtain a new cost-per-test task order to provide the microbiology cost-per-test equipment/supplies and continue uninterrupted patient testing. This new requirement is expected to begin June 1, 2022, through May 31, 2023, with four (4) additional one-year option periods.

CNVAMC needs one (1), fully automated blood culture detection system with a continuously closed incubator system to perform and report comprehensive diagnostic patient testing to monitor for the presence/absence of microorganisms in blood cultures and sterile body fluids, excluding CSF, through a CPT task order.

The system shall accommodate a working interface with VISTA (VA’s computer system).

3. PERIOD OF PERFORMANCE: The period of performance is for an initial base year with the possibility of four one-year extension options.

4. PLACE OF PERFORMANCE/DELIVERY: Charlie Norwood VA Medical Center, Pathology and Laboratory Medicine Service, 950 15th Street, Rm 2D136B, Augusta, GA. Monthly blood culture reagents must be shipped to Charlie Norwood VA Medical Center, 1 Freedom Way, Augusta GA 30904-6258.

5. HOURS OF OPERATION: Hospital normal hours of operation are between 8:00 am to 5:00 pm Monday through Friday (routine scheduled maintenance), excluding Federal Holidays and any other day specifically declared by the President of the United States to be a Federal Holiday. Warehouse deliveries are accepted between 8am and 3:30pm, Monday through Friday, excluding holidays. When a holiday falls on a Sunday, the following Monday shall be observed as a legal holiday by U.S. Government agencies. When a holiday falls on a Saturday, the preceding Friday shall be observed as a legal holiday by U.S. Government agencies. Also included would be any other day specifically declared by the President of the United States as a National Holiday. Listed below are the ten national holidays:

Contractor shall provide 24/7 technical support and onsite or teleconference training for staff as needed, excluding Federal holidays.

6. TYPE OF CONTRACT: This contract will be a Cost Per Test Contract.

7. PERFORMANCE REQUIREMENTS:

A. General Requirements

a. Contractors shall provide a price for each bottle or set that can be performed on its equipment. The per test price shall include costs covering (a) equipment use, (b) all reagents, standards, quality controls, supplies, consumable/disposable items, parts, accessories, and any other item required for the proper operation of the Contractor’s equipment and necessary for the generation and reporting of a test result (printers, UPS system, barcode readers, etc.), (c) all necessary maintenance to keep the equipment in good operating condition (includes preventive maintenance and emergency repairs), and (d) training for Government personnel.

b. Contractor shall provide delivery, installation, and removal of equipment at no additional charge.

c. The vendor selected is responsible for equipment and service components. All of the required tests must be able to be run on the vendor’s analyzer.

d. The instrument shall be able to simultaneously perform the complete profile and meet the performance characteristics for accuracy and precision as defined by the 1988 Clinical Laboratory Improvement Act (CLIA) and the Clinical and Laboratory Standards Institute (CLSI).

e. The instrument shall provide the following required test menu for non- pediatric patients:

Blood Culture Testing (aerobic and anaerobic) Sterile Body Fluid Testing (excluding CSF)

B. System Requirements: (One single Instrument)

a. Automated bottle loading

b. Immediate notification of improper bottle fill volume

c. Continuously closed incubator

d. Automatic bottle bar code scanning

e. Positive bottles alerted and automatically removed from the incubator and held for staff to retrieve for workup

f. Completed negative bottles automatically removed from the incubator.

g. Advanced growth detection algorithms

h. The system shall provide self-contained, continuous unattended bottle incubating, agitating and monitoring 24 hours/day, 7 days/week.

i. The system shall be able to batch report preliminary results and final results.

j. The system shall require no daily maintenance requirements.

k. The system shall have sufficient memory to store patient information and test results for a minimum of 6 months.

l. Quality Control (QC) - The system shall have a built-in/on-board, comprehensive, automated QC program to regularly monitor performance of vital components. The system shall have quality control data storage and reporting capabilities, the ability to view and print monthly QC results, visually alert the operator of QC failures and to document out of range QC.

m. The reading chambers shall be modular in nature, and as such, shall allow for the isolation of a given problem without having to shut the entire system down.

n. Bar-Code System – The system shall support bar-code recognition of inoculated bottles for tracking of bottles at entry into the system and throughout incubation until such time as the incubation has finalized as positive or negative for growth.

o. Data Management System – The system shall include a comprehensive data/instrument management package designed for data management of the required testing. The software shall be Windows 10 compatible. The computer system shall be user friendly and shall have the capability to record, store, and print the following information:

1. Blood culture bottle location

2. Length of incubation

3. Time to detection

4. Growth curve analysis of positive vials

5. Required quality control and instrument maintenance information

6. Patient demographic information and specimen results

7. The fill volume of the blood culture bottle

p. The awarded contractor shall provide all necessary upgrades to the equipment hardware and operating system software, at no additional cost to the Government.

q. Contractor shall provide necessary software/hardware for bi-directional interface with the current VA VISTA hospital information system and Data Innovations, or another LIS vendor, LIS, where applicable. Should transmit data through a network connection; if it only communicates using a serial port, the vendor should provide the necessary equipment to change the serial port to network communication.

r. Contractor shall include a UPS system that provides back up capability.

C. Instrumentation:

a. The model being offered must be in current production as of the date this offer is submitted. For purposes of this solicitation, “current production” shall mean that the analyzer model being offered is being manufactured as new equipment. Discontinued models that are only being made available as remanufactured equipment are not acceptable.

b. The instrument shall include an on-board touchscreen monitor that is easy to read.

c. Once placed in the analyzer, handling of the specimen shall not be required until a result is obtained.

d. The system operation shall be flexible to allow for operator extension of programmed incubation times, while testing is in progress, without interruption of automatic continuous monitoring.

e. The system shall be able to handle the bottles individually, allowing testing of new bottles to begin at any time.

f. The system operation shall be flexible to allow for operator changes to programmed incubation times, while testing is in progress, without interruption of automatic continuous monitoring.

g. The system shall be compatible with a varied selection of blood culture bottle configurations (including, but not limited to, low volume samples; antimicrobial agent removal resins) and formulations capable of maximizing growth potential of various microorganisms (e.g., aerobic and anaerobic bacteria and fungi). Sufficient quantities of such bottle configurations and formulations to meet service volume and blood culture type demands shall be available.

h. The system shall have sufficient capacity and throughput to meet the volume, blood culture bottle variety, and service demands. The system shall be flexible to allow expansion of the testing space/configuration, with a minimum of 400-bottle capacity.

i. The system shall include safety features to avoid unnecessary exposure to biohazardous and/or chemical materials. Any exposure to, and the volume of, biohazardous and chemical material generated by the equipment must be minimal and require a minimum amount of handling.

D. Installation, including Verification/Validation, Training:

a. The contractor shall provide CNVAMC with Food and Drug Administration (FDA) approved analyzer/equipment, reagents, controls, calibrators, disposables, any consumable part (inclusive of replacement parts per manufacturers maintenance guidelines, specimen racks, sample holders, etc.), necessary for analyzing/testing on the contractor’s analyzer. All linearity material and any commercial system correlation samples needed shall be provided to meet the Joint Commission requirements.

b. Crossover from current to new instrumentation must be performed timely with no interruption in patient care laboratory service.

c. Installation - The contractor shall be responsible for installation of the proposed/accepted equipment, which consists of in-house delivery positioning, and mounting of all equipment listed on the delivery order and connections of all equipment and interconnecting wiring and cabling, if applicable, in coordination with the facility Biomedical Engineer, Microbiology Supervisor or designee, and P&LMS Laboratory Information Manager. Upon receipt of notice to proceed with installation, it shall be the contractor’s responsibility to inform the Contracting Officer of any problems which may be anticipated in connection with installation, or which will affect optimum performance once installation is completed. If progress of the installation is interrupted through no fault of the contractor, the continuous installation referenced in the preceding paragraphs may be terminated until such time as the cause of delay has been eliminated, and then shall be resumed within 24 hours after the contractor has been notified that work may again proceed.

d. Contractor shall provide Technical support specialist to assist in equipment installation/set-up, correlation studies (evaluation/comparison data sufficient to satisfy CAP/Joint Commission standards), staff training and methodology problems and questions.

e. Contractor shall provide necessary procedure manuals, troubleshooting manuals and operator manuals (also available on computer disk format). Procedures shall be in the Clinical and Laboratory Standards Institute (CLSI) format.

f. Contractor/Vendor shall provide education/training on site – basic operating and maintenance training during installations or update to the equipment.

g. To ensure the confidentiality of the information being disposed, or transferred, Department of Veterans Affairs (VA) requires proper sanitation of electronic data (hard disk or any storage devices) which contains stored or processed sensitive and non-sensitive VA information.

h. Contractor shall complete instrument installation, all validation/correlation studies with 30 days after the award of the contract. Controls and all reagents needed for validation studies shall be included in CPT proposal.

i. Upon contract termination and/or replacement of equipment, the contractor shall disconnect the analyzers and shall be responsible for decontamination of the system, packing and shipping required to remove the analyzers.

j. The contractor shall remove all equipment within 30 days after notification of the expiration of the terms of this contract, but not until the completion of new contractor's equipment installation inclusive of completed cross over studies.

E. Supplies:

a. All reagents, controls, calibrators and disposables required for operating the analyzer and producing quality test results shall be listed in the proposal. Cost per Test shall be all inclusive prices.

b. All supplies provided/ordered for use on contractor’s equipment shall be of the highest quality necessary to produce a quality product. The reagent quality must be high enough to satisfy proficiency testing standards of the College of American Pathologists (CAP) and the Joint Commission on Accreditation of Health Care Organizations (JCAHO). In the event that the supplies are found to be defective and unsuitable for use with the contractor's equipment or the contractor has failed to comply with the requirements herein, the contractor is required to deliver the supplies within 24 hours of receipt of the verbal order, if verbal order is received by 1 pm CST time, for priority delivery from the government activity. This shall be done at no cost to the government, in sufficient quantity as required to allow operation of the contractor's equipment for one week (under normal government test load volume).

c. All blood culture bottles pertinent to the needs of CNVAMC shall be plastic, easily distinguished for utility or intended purpose, approved for culture of normally sterile body fluids in addition to blood, and bar-coded with unique identifiers for loading and system monitoring.

d. Blood culture bottles shall have expiration date clearly marked. The minimum acceptable expiration date will be no less than 6 months from date of receipt.

e. Blood culture bottles shall be formulated as to not require venting prior to incubation of aerobic bottles. Contractor shall provide supplies as described below and in accordance with specifications outlined within the statement of work. Supplies shall be provided monthly and shall be shipped first week of each month. Test volumes are estimates based on historical testing data and does. The Government does not guarantee that the quantities listed will be needed.

F. Repair and Maintenance:

a. Replacement or repair of all ancillary equipment shall be included in the CPT.

b. Vendor shall provide technical support either by phone or on-site support during regular business hours.

c. Contractor shall define maintenance (daily, monthly, etc.) requirements and indicate which are performed by the user, which are not.

d. Contractor shall perform all required periodic maintenance to meet contractor’s specifications.

G. Support Services:

a. Contractor shall provide service sufficient not to interrupt testing needs of the CNVAMC. Technical support shall be available during regular business hours. Field engineer service support must be available within twenty-four (24) business hours of notification, Monday through Friday). All repairs on instrument must be complete within 24 hours from the time the field engineer arrives.

b. A service hotline with technical support shall be available Monday thru Friday 5am to 6pm. All calls must be answered within one hour via telephone.

c. Service is to include all travel, parts for repair or replacement, and labor. Cost per test shall cover all expenses related to repairs and parts. Contractor shall maintain the instrument to meet contractor’s specifications for the life of the contract.

8. CONTRACT PERFORMANCE MONITORING:

The COR shall be responsible for monitoring the Contractor's performance. Performance deficiencies or poor performance identified during the term of the contract shall be reported to the Contractor. Upon notification of deficiencies or poor performance, the Contractor shall be given a reasonable time to take corrective action. If determined appropriate, the Contracting Officer, COR and/or other VA staff members shall meet with representatives of the Contractor to review performance and resolve issues. All deficiencies or poor performance shall be documented and MUST be corrected within the timeframe specified in the cure notice. The Contractor shall notify the Contracting Officer and the COR when correction(s) have been made. If the appropriate correction is not made within the timeframe specified in the cure notice, the Government shall have the right to terminate the contract in it is entirety.

Quality Assurance Service Plan Performance Measures

The government reserves the right to monitor services in accordance with Performance Based Matrix.

System Upgrades

Supply Delivery

Support Services

Para 7G Support Services

9. GENERAL:

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

10. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS:

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.

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).

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 comply with VA directive requirements.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

11. SECURTY INCIDENT INVESTIGATION:

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.

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.

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.

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.

12. LIQUIDATED DAMAGES FOR DATA BREACH:

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.

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.

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

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

Description of the event, including:

date of occurrence;

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

Number of individuals affected or potentially affected;

Names of individuals or groups affected or potentially affected;

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

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

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

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

Assessment of the potential harm to the affected individuals;

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

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

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

Notification;

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

Data breach analysis;

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

One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

13. SECURITY CONTROLS COMPLIANCE TESTING:

On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-days’ notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

14. TRAINING:

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

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

Successfully complete the VA Privacy and Information Security and Rules of Behavior training and annually complete required security training;

Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

Successfully complete any additional information security or privacy training, as required for VA personnel with equivalent information system access [to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document – e.g., any role-based information security training required in accordance with NIST Special Publication 800-16, Information Technology Security Training Requirements.]

The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until the training and documents are complete.

15. NARA RECORDS MANAGEMENT LANGUAGE CLAUSE:

NARA RM Language Clause to be included in contracts, as necessary:

The following standard items relate to records generated in executing the contract and should be included in a typical Electronic Information Systems (EIS) procurement contract:

1. Citations to pertinent laws, codes and regulations such as 44 U.S.C chapters 21, 29, 31 and 33; Freedom of Information Act (5 U.S.C. 552); Privacy Act (5 U.S.C. 552a); 36 CFR Part 1222 and Part 1228.

2. 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.

3. 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.

4. 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. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract.

6. The Government Agency owns the rights to all data/records produced as part of this contract.

7. 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 technical documentation with all data deliverables to permit the agency to use the data.

8. 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.].

9. 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.

10. 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.

16. VHA SUPPLEMENTAL CONTRACT REQUIREMENTS FOR COMBATTING COVID-19

A. Contractor employees who work in or travel to VHA locations must comply with the following:

1. Documentation requirements:

a) If fully vaccinated, contractors shall show proof of vaccination.

i. NOTE: Acceptable proof of vaccination includes a signed record of immunization from a health care provider or pharmacy, a copy of the COVID-19 Vaccination Record Card (CDC Form MLS-319813_r, published on September 3, 2020), or a copy of medical records documenting the vaccination.

b) If unvaccinated, contractors shall show negative COVID-19 test results dated within three calendar days prior to desired entry date. Test must be approved by the Food and Drug Administration (FDA) for emergency use or full approval. This includes tests available by a doctor’s order or an FDA approved over-the-counter test that includes an affiliated telehealth service.

c) Documentation cited in this section shall be digitally or physically maintained on each contractor employee while in a VA facility and is subject to inspection prior to entry to VA facilities and after entry for spot inspections by Contracting Officer Representatives (CORs) or other hospital personnel.

d) Documentation will not be collected by the VA; contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

B. Contractor employees are subject to daily screening for COVID-19 and may be denied entry to VA facilities if they fail to pass screening protocols. As part of the screening process contractors may be asked screening questions found on the COVID-19 Screening Tool. Check regularly for updates.

1. Contractor employees who work away from VA locations, but who will have direct contact with VA patients shall self-screen utilizing the COVID-19 Screening Tool, in advance, each day that they will have direct patient contact and in accordance with their person or persons who coordinate COVID-19 workplace safety efforts at covered contractor workplaces. Contractors shall, at all times, adhere to and ensure compliance with federal laws designed to protect contractor employee health information and personally identifiable information.

C. Contractor must immediately notify their COR or Contracting Officer if contract performance is jeopardized due to contractor employees being denied entry into VA Facilities.

D. For indefinite delivery contracts: Contractor agrees to comply with VHA Supplemental Contract Requirements for any task or delivery orders issued prior to this modification when performance has already commenced.