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Lithotripsy (ESWL) with On-Site Techician
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Solicitation Number: 36C257-19-Q-0360, Lithotripsy Services Contract Number: 36C257-19-D-XXXX

25 February 2019

PERFORMANCE WORK STATEMENT

1. SCOPE

A. Under the authority of Public Law 104-262 and 38 USC 8153, the contractor agrees to provide Health Care Resources in accordance with the terms and conditions stated herein, to furnish to at the Department of Veterans Affairs Healthcare Systems listed herein, the services and prices specified in the Section entitled Schedule of Supplies- Services of this document. The contract shall be for the period of one (1) Base Year plus four (4) one (1)-year Option Years.

B. The Contractor shall provide all labor, materials, transportation, equipment and supervision, in compliance with federal, state and local regulations, to provide electromagnetic Extracorporeal Shock Wave Lithotripsy (ESWL), including related technical support for Department of Veterans Affairs Healthcare Systems at VA North Texas Health Care System (Dallas). The nature of this contract typically requires variation to the number of procedures performed due to the medical needs of the Veteran population. This office reserves the right to make such changes, additions and deletions to the number of procedures scheduled to be performed. There also may be scheduled days that no procedures are needed and the using facility may cancel the day with the Contractor forty-eight (48) hours prior to the scheduled day with no charges to the facility. The VA anticipates that an average of thirty-six (36) veterans will be treated annually. Expected monthly treatments may be as low as one (1) or as high as five (5) veterans (see FAR Clause 52.216-19 and Addendum FAR Clause 52.216-19). The per procedure pricing shall include single stone and multiple stone procedures per unilateral or bilateral episode.

C. The energy source for the ESWL shall be electromagnetic. The awarded contractor shall have the equipment available for the facility as the facility has specified in the Schedule of Supplies or Services of this document.

2. CONTRACTOR SPECIFIC TASKS

A. The Contractor’s technical personnel shall be certified, trained and current in ESWL, Lithotripsy services and operation of the equipment units. The technician shall assist the attending Urologist and other physicians in the operating room and/or cysto suite in the operation of the equipment units. The technician may be required to operate the device and any related imaging equipment during the procedures.

B. The contractor shall be responsible for providing the following:

1. Provide portable, state of the art, digital units that can be easily moved into the operating rooms/cysto suite in the Veterans Administration Healthcare Centers. The equipment must meet or exceed the following criteria:

a. Treats all stones anywhere in the urinary tract

b. Has a greater than 80% success rate based on FDA clinical study data

c. Is modular and can treat patients in the operating room/cysto suite

d. Has the ability to do endourological procedures before and after ESWL without moving the patient.

e. Will accommodate patients weighing up to four hundred (400) pounds

f. Emergency service provided with forty-eight (48) hours notice

g. Will have a variety to select from such as Storz modulith, spark gap technology, and electromagnetic based machine.

h. Experienced technicians that are available when needed.

i. The company must bring mobile C-Arm, other equipment, and all the supplies needed/required to conduct the Lithotripsy service.

2. Such additional materials and supplies, including consumables, as are necessary to conduct ESWL procedures with the equipment units.

3. Maintenance of the devices to include service and preventative maintenance to ensure that the devices are in the highest level of functioning condition, with, as a minimum, maintenance performed at the manufacturer’s manual requirements.

4. Assist in the education of each facility’s personnel as it relates to ESWL

Lithotripsy.

5. Be responsible for obtaining all necessary licenses, approvals, permits and be in compliance with all federal, state and local laws and regulations applicable to the devices and delivery of ESWL Lithotripsy related services provided for under the terms of this contract.

6. Delivery of all reports, digital, film and file records of all procedures performed with the devices to the Contracting Officer’s Representative (COR). These medical records shall be the property of the Department of Veterans Affairs, VANTCHS/594 facility.

7. To the extent that this contract is subject to Section 952 of the Omnibus

Reconciliation Act of 1980, 42 U.S.C. 1395(v)(1)(I), and the regulations promulgated hereunder, and the cost or the value of the services provided is $10,000 or more over a 12-month period, the contractor shall allow the Comptroller General and their duly authorized representatives to have access to the contractor’s contract, books, documents and records until the expiration of four (4) years after the services are furnished under the contract.

8. The contractor shall perform all services under this contract in accordance with all regulatory and accreditation standards applicable to the individual VA facility, including without limitations, those required by the Joint Commission of Accreditation of Healthcare Organizations (JCAHO) and shall comply with all Veterans Health Administration (VHA) regulations and directives.

Contractor shall provide consultation, if requested, in the development of protocols, utilization review, peer review and risk management as required by regulatory bodies.

3. CONTRACTOR QUALIFICATIONS

A. Personnel assigned by the contractor to perform the services covered by this contract shall be licensed by the State of Texas, the state that the services are being rendered. All licenses held by the personnel working on this contract shall be full and unrestricted licenses. The qualifications of such personnel shall also be subject to review by the VA Chief of Staff, Chief of Surgery, Chief of Urology and other VA medical staff as required and approval by the VA Facility Director.

B. The trained licensed technician shall have full knowledge and current experience to operate and troubleshoot the ESWL equipment.

C. The contractor shall be responsible for protecting the personnel furnishing services under this contract. To carry out this responsibility, the contractor shall provide the following for these personnel:

1. Workers compensation

2. Professional liability insurance

3. Health examinations

4. Income tax withholding

5. Social Security payments

The parties agree that that the contractor, its employees, agents and subcontractors shall not be considered VA employees for any purposes.

4. INFECTION CONTROL COMPLIANCE

A. Contractor shall provide written certification of training compliance with the Blood borne

Pathogens Standards, 29 CFR Part 1910.1030 (copy available upon request) to the Contracting Officer Representative (COR) prior to the contractor commencing work.

1. Mantoux Testing: Contractor shall provide evidence to the COR:

a. Negative PPD test within fourteen (14) calendar days prior to beginning service. If an earlier PPD test was given over twelve (12) months previously, the current test shall be a 2-step Mantoux test.

b. Medical evidence that personnel are disease free for those having a positive

PPD.

c. A regular annual re-testing program for TB shall be established and maintained by the contractor. Contractor shall provide evidence of re-tests to the COR within ten (10) calendar days of the re-test.

2. Hepatitis B Vaccination: Contractor shall consider the need for Hepatitis B vaccine and vaccination series within ten (10) calendar days of contract employment and follow-up if there has been an exposure incident. VA shall not provide the vaccine or vaccination series.

VA Form 1 0-5549c, Information About Hepatitis B Vaccine (Recombinant), Consent Form or VA Form 1 0-549d, Hepatitis B Vaccine Declination (Mandatory) shall be submitted to the COR within thirty (30) days of waiver or completion of the first in the series of Hepatitis B Vaccine and completion of the vaccination series.

3. Drug Screening: All Contractor health care providers are subject to random drug testing. They are also subject to drug testing when there is a reasonable suspicion that they use or are impaired by illegal drugs while on duty. Reasonable suspicion of drug use or impairment includes, but is not limited, to the following:

a. Observable phenomena. Such as direct observation of drug use, possession or the physical symptoms of being under the influence of a drug;

b. A pattern of abnormal conduct or erratic behavior;

c. Arrest or conviction for a drug-related offense or the identification of a contract health care provider as the focus of a criminal investigation into illegal drug possession, use, or trafficking;

d. Information provided either by reliable and credible sources or independently corroborated; or

e. Newly discovered evidence that the contract health care provider has tampered with a previous drug test.

5. QUALITY ASSURANCE

A. Preventative maintenance documents shall be available to VA Biomedical Engineering upon request. Maintenance of the devices to include service and preventative maintenance to ensure that the devices are in the highest level of functioning condition, with, as a minimum, maintenance performed at the manufacturer’s manual requirements.

1. The VA COR shall arrange for the biomedical staff inspection with the contractor technician.

B. Monitoring of the contractor’s performance shall be demonstrated through sign-in and sign-out sheets as well as verification of patient records that the specified services were performed. The contractor shall be required to sign an attendance log upon reporting for scheduled procedures and upon completion of the procedures. The COR shall be the VA official responsible for verifying contract compliance. Any incidents of contractor noncompliance as evidenced by the monitoring procedures shall be forwarded immediately to the Contracting Officer.

6. CONTRACTOR PERSONNEL

A. Contractor’s Program Manager. The contractor shall provide a Contract Manager who shall be responsible for the performance of work. The name of this person shall be designated in writing to the Contracting Officer. The contractor’s program manager shall have full authority to act for the contractor on all matters relating to daily operations of this contract.

Contract Program Manager:

Company Name:

Address:

Phone No.:

Fax No.:

Contact Name:

Email:

B. Contractor Employees. The contractor shall not employ persons for work on this contract if such employee is identified to the contractor as a potential threat to the health, safety, security, general well-being or operational mission of the installation and its population. Contractor must provide documentation to the Contracting Officer and/or the COR that background checks have been completed for all technicians.

C. The contractor shall perform services in accordance with the ethical, professional and technical standards of the healthcare industry as consistent with VA policy, regulations and procedures.

7. KEY PERSONNEL AND TEMPORARY EMERGENCY SUBSTITUTIONS

A. The contractor shall assign to this contract the following key personnel:

Technician Name:

B. During the first ninety (90) days of performance, the contractor shall make NO substitutions of key personnel (Contract Program Manager and Service Technician) unless the substitution is necessitated by illness, death or termination of employment.

The contractor shall notify the Contracting Officer, in writing, within fifteen (15) calendar days after the occurrence of any of these events and provide the information required as in the information box of A. above. After the initial ninety (90) day period of the contract, the contractor shall submit the information required in the information box of A. above to the Contracting Officer at least 15 days prior to making any permanent substitutions.

C. The contractor shall provide a detailed explanation of the circumstances necessitating the proposed substitution; complete resumes including licenses, health clearances, all other requirements as have been set forth in this contract and any additional information requested by the Contracting Officer for the proposed substitute. Proposed substitute shall have comparable qualifications to those of persons being replaced. The Contracting Office shall notify the contractor within fifteen (15) calendar days after receipt of all required information of the decision on the proposed substitute. The contract will be modified to reflect any approved changes of key personnel.

D. For temporary substitutions where the key person will not be reporting to work for more than three (3) consecutive work days or more, the contractor will provide a qualified replacement for the key person. This substitute shall have comparable qualifications to the key person. Any period exceeding two weeks shall require the procedure as stated above.

8. HOURS OF OPERATION

A. The services covered by this contract shall be furnished by the contractor as defined herein. The contractor shall not be required, except in case of emergency, to furnish such services during non-standard workday hours as listed by each individual facility.

B. Work hours are described as Monday through Friday which varies by each individual facility as specified in section 13 of this work statement, National Holidays excluded.

Any service performed during other than normal work hours must be approved in advance by the COR.

C. National Holidays. The contractor is not required to provide services on the following

National Holidays nor shall the contractor be paid for these holidays:

NATIONAL HOLIDAY DATE(s) MONTH

New Year’s Day 1 January Martin Luther King’s Birthday Third Monday January

President’s Day Third Monday February Memorial Day Last Monday May

Independence Day 4 July Labor Day First Monday September

Columbus Day Second Monday October Veterans’ Day 11 November

Thanksgiving Day Fourth Thursday November Christmas Day 25 December

When a National Holiday falls on a Sunday, the following Monday shall be observed as a National Holiday. When a National Holiday falls on a Saturday, the proceeding Friday is observed as a National Holiday by U.S. Government agencies. Also included, would be any other day, specifically declared by the President of the United States of America to be a National Holiday.

9. INSPECTIONS

The Government may, at its option and expense, may request an unrelated third party to inspect the equipment provided by the contractor. The contractor shall repair, at the contractor’s cost, any defects discovered by the inspection of the third party within fifteen

(15) days when notified by the COR.

10. RETREATMENT AND CANCELLATIONS

A. If a Veteran must undergo an additional treatment within ninety (90) days from his/her initial procedure due to continued problems with the stone(s), i.e., stone(s) was not broken down small enough to pass or fragments of the stone(s) remain, the contractor will provide the treatment at 50% of the contract price.

B. On occasion (1 to 3 times per year per facility) the scheduled procedure(s) may need to be cancelled. This may occur (1) when a stone passes between the time the patient was initially seen and scheduled and the actual procedure date or (2) when there is a medical emergency such as when anesthesia is administered or another medical emergency with the patient arises.

1. When a cancellation is known to the VA personnel and the contractor is notified by phone, fax or email twenty-four (24) hours prior to the contractor technician’s scheduled arrival time at the VA facility, there shall be no charge for the procedure.

If notification is given to the contractor in less than twenty-four (24) hours, the contractor shall be paid 50% of the contracted price for the procedure.

2. When there is a medical emergency which prevents the patient from receiving the procedure, if only one patient was scheduled with the contractor to receive the procedure on that day, the contractor shall be paid 50% of the contracted price for the procedure. When there is a medical emergency which prevents a patient from receiving the procedure, and more than one patient was scheduled with the contractor to receive a procedure on that day, the contractor shall not be paid for the cancelled procedure.

11. GOVERNMENT FURNISHED ITEMS AND SERVICES

The Government contract facility shall provide the following;

A. Provide a secure room for the devices while located on the premises B. Provide suitable electric service to operate the units C. Shall be responsible for scheduling of patients for the procedure and coordinating the scheduling of any in-service, relating to the units for facility staff D. Provide the pre-operative preparation of patients for ESWL, obtain written patient consent forms and provide patients with the necessary services related to post-procedure recovery. Facility shall be responsible for providing emergency service personnel, physicians, facilities and supplies necessary to provide patients with emergency medical care as may be required, as well as physicians, facilities and supplies necessary to provide patients with inpatient or outpatient post-procedure care.

E. Take all actions reasonably necessary to assist contractor in achieving compliance with federal, state and local laws and regulations as required within this contract.

F. Shall be responsible for the collection and disposal of infectious waste and sharps related to the ESWL procedures.

G. Shall provide other necessary personnel for the operation of the services contracted for at the government contract facility. These other necessary personnel shall be mutually agreed upon between the VA and the contractor who are compatible with the safety of the patient and are personnel with quality medical care programming. Patient safety incidents are to be reported using a Patient Safety Report within 24 hours of incident.

H. The services to be performed by the contractor shall be under the direction of either the Chief of Staff, Chief of Surgery, Chief of Urology or their designated representative.

I. Record keeping:

The VA Healthcare Center shall establish and maintain a record keeping system that will record the procedures performed by the contractor employee(s). Contractor’s employees shall report to the COR or designee upon arrival at the Medical facility or Government contract facility.

12. INVOICE AND PAYMENT

Payment is to be made monthly in arrears. Contractor shall submit invoices in original addressed to: VAFSC, P.O. Box 149971, Austin, TX 78714. Invoices submitted for payment shall be reviewed for accuracy, verified against time records and attendance logs and shall be subject to approval by the Government prior to remittance of payment. Any discrepancies found shall be brought to the attention of the Contractor and shall be resolved. A corrected invoice must then be submitted by the Contractor as instructed by the Government.

Patients shall not be invoiced for services. The invoice MUST be itemized to include the following information.

(1) Name and address of the health care provider

(2) Health care provider’s tax ID number

(3) Veteran’s name and social security number

(4) Date of treatment(s)

(5) Medical conditions for which service was rendered

(6) Description of services rendered

(7) Appropriate CPT code(s)

(8) Fees being charged for services rendered

(9) Extended amount due

(10) Invoice number, date, and Contract/Obligation number

Payment for services rendered by the Contractor shall be made monthly upon receipt of a proper invoice. When inadequate invoices are received (those lacking any of the essential items listed above), the vendor will be notified in writing within seven (7) calendar days of receipt of such bills that these bills cannot be processed for payment until a proper invoice is submitted.

(Prompt Payment Act – Public Law 97-177)

The itemized invoice shall be verified for certification of the services rendered during the billing period. The VA Contracting Officer’s Technical Representative shall certify the contractor’s invoice for payment of services rendered.

13. ORDERING

A. VA North Texas Health Care System – All procedures shall be performed during normal working hours, 6:30 AM through 5:00 PM. The Contractor’s technician shall report in person to the COR or his/her designated personnel at the Using Service, VA North Texas Health Care System (Dallas). After all procedures are completed, the Contractor’s technician is to submit in writing, a complete report of services rendered to the COR or his/her designated personnel at the Using Service.

For emergency procedures required during other than normal working hours and/or during a non-scheduled day as prescribed in this contract and placed forty-eight (48) hours prior to the procedure by the VA COR, the Contractor’s technician shall report upon arrival at the facility to the designated person and location as instructed by the COR at time of placing the emergency order ESWL procedures will be performed on the days and times for each location as stated herein. For each performance day, at a minimum of 48 hours in advance, the using service at the facility shall order by telephone, fax, or email stating the number of procedures. Procedures may also be added as needed as determined by the facility’s staff on day of procedure. A standing

Page 10 o f 1 4 purchase order will be assigned by each facility for the contract period and the purchase order numbers shall be provided to the contractor prior to the beginning of the contract period.

B. Contractor shall list in the spaces below the name(s) and address(es) of customer service departments with whom the Government facilities will place orders:

1. VA North Texas Health Care System (Dallas)

Contact Name:

C. The Contractor shall submit properly completed individual itemized invoices in accordance with FAR clause 52.212-4 Contract Terms and Conditions – Commercial Items. Invoices shall be submitted to:

Department of Veterans Affairs, Financial Services Center (FSC)

P.O. Box 149971 Austin, Texas 78714-8971

Payment of invoices may be delayed if appropriate invoices as specified in the contract are not completed and submitted as required.

D. No advance payments shall be authorized. Payment shall be made on a monthly basis for services provided during the billing month in arrears in accordance with FAR 52.212-4, paragraph (i) upon submission of a properly prepared invoice for prices stipulated in this contract for services delivered and accepted in accordance with the terms and conditions of the contract, less any deductions stipulated in this contract.

14. DELIVERY REQUIREMENTS

A. All services for this contract shall be FOB Destination only. Services shall be ordered by the VA facility at least forty-eight (48) hours prior to facility’s scheduled day.

Page 11 o f 1 4

B. As a facility, fixed-price requirements contract with option years, it is reasonable to expect that usage and/or requirements, based upon estimated quantities by the facility, may change during the contract period. The Government reserves the right to increase or decrease the number of procedures performed.

C. Changes determined by the Contracting Officer to be within the general scope of the contract shall be made in accordance with FAR 52.212-4(c), “Changes,” and shall not necessitate new solicitation proceedings.

15. CONFIDENTIALITY OF PATIENT RECORDS

A. The Contractor is a VA contractor and will assist in the provision of health care to patients seeking such care from or through VA. As such, the Contractor is considered as being part of the Department health care activity. Contractor is considered to be a VA contractor for purposes of the Privacy Act, Title 5 U.S.C. 552a. Further, for the purpose of VA records access and patient confidentiality, Contractor is considered to be a VA contractor for the following provisions: Title 38 U.S.C. 5701, 5705, and 7362. Therefore, Contractor may have access, as would other appropriate components of VA, to patient medical records including patient treatment records pertaining to drug and alcohol abuse, HIV, and sickle cell anemia, to the extent necessary to perform its contractual responsibilities. However, like other components of the Department, and not withstanding any other provisions of the sharing agreement, the Contractor is restricted from making disclosures of VA records, or information contained in such records, to which it may have access, except to the extent that explicit disclosure authority from VA has been received.

The Contractor is subject to the same penalties and liabilities for unauthorized disclosures of such records as VA.

B. The records referred to above shall be and remain the property of VA and shall not be removed or transferred from VA except in accordance with U.S.C.552a (Privacy Act), 38 U.S.C. 5701 (Confidentiality of claimants’ records), 5 U.S.C. 552 (FOIA), 38 U.S.C. 5705 (Confidentiality of Medical Quality Assurance Records) 38 U.S.C. 7332 (Confidentiality of Certain Medical Records) and federal laws, rules and regulations. Subject to applicable federal confidentiality or privacy laws, the Contractor, or their designated representatives, and designated representatives of federal regulatory agencies having jurisdiction over Contractor, may have access to VA’s records, at VA’s place of business on request during normal business hours, to inspect and review and make copies of such records.

C. The Contractor is required to comply with all laws, regulations, policies and procedures relating to cyber security, privacy, confidentiality, and Health Insurance Portability and Accountability Act (HIPAA) of 1996 prior to contract award.

Page 12 o f 1 4

16. INSURANCE REQUIREMENTS

A. The Contractor agrees to procure and maintain, while the contract is in effect, Workers Compensation and Employee’s Public Liability Insurance.

1. Contractors are required to comply with applicable Federal and State workers' compensation and occupational disease statutes. If occupational diseases are not compensable under those statutes, they shall be covered under the employer's liability section of the insurance policy, except when contract operations are so commingled with a Contractor's commercial operations that it would not be practical to require this coverage. Employer's liability coverage of at least $100,000 shall be required, except in States with exclusive or monopolistic funds that do not permit workers' compensation to be written by private carriers.

2. General liability. (1) The Contracting Officer shall require bodily injury liability insurance coverage written on the comprehensive form of policy of at least $500,000 per occurrence. (2) Property damage liability insurance shall be required only in special circumstances as determined by the agency.

3. Before commencing work under this contract, the Contracting Officer shall require the Contractor to furnish certification from his/her insurance company indicating that the coverage specified herein has been obtained and that it may not be changed or canceled without guaranteed thirty (30) day notice to the Contracting Officer in writing.

i. The Government shall be held harmless against any or all loss, cost, damage, claim expense or liability whatsoever, because of accident or injury to persons or property of others occurring in the performance of this contract.

ii. The Contractor shall be responsible for all damage to property, which may be done by him, or any employee engaged in the performance of this contract.

17. CONTRACTOR PERSONNEL SECURITY REQUIREMENTS

The Office of Security and Law Enforcement provides Department-wide policy on the assignment of appropriate position sensitivity designations associated with the Department of Veterans Affairs positions involving national security and public trust responsibilities, and on the level of background investigations required for applicants for, and incumbents of, those positions. In addition to VA employees, the policy and investigative requirements are applicable to the Contractor who require access to VA Information designated as sensitive.

Contractor and subcontractor personnel who require access to VA Information shall be subject to all necessary background investigations and receive a favorable adjudication from the VA Office of Security and Law Enforcement to ensure compliance with such policy. If such investigation

Page 13 o f 1 4 has not been completed prior to Contract commencement, the Contractor shall be responsible for the actions of those individuals performing under the Contract.

Contractor is required to read, write, speak, and understand the English language, unless otherwise specified in this Contract or agreed to by the Government.

The cost for such investigations shall be borne by the Contractor, either in advance or as reimbursement to the Government. The level of sensitivity shall be determined by the Government based on the type of access required. The level of sensitivity will determine the depth of the investigation and the cost thereof. At this time, the current estimated costs for such investigations are as follows:

LEVEL OF

SENSITIVITY

BACKGROUND

INVESTIGATION LEVEL

APPROXIMATE

COST

Low Risk National Agency Check with Written Inquiries $ 231.00 Moderate Risk Minimum Background Investigation $ 825.00 High Risk Background Investigation $ 3465.00

The Contractor shall be required to furnish all applicable information required to conduct the investigation, such as, but not limited to, the name, address, and social security numbers. The VA will provide all the necessary instructions and guidance for submission of the documents required to conduct the background investigation. Background investigations shall not be required for Contractor personnel who will not be required to access VA Information designated as sensitive.

18. POST-AWARD PERFORMANCE CONFERENCE

The Contracting Officer may schedule a post-award performance conference with the Contractor, if deemed necessary, for contract orientation purposes.

1. RECORDS MANAGEMENT: All records (administrative and program specific) created during the period of the contract belong to VA North Texas Health Care System (VANTHCS) and must be returned to VANTHCS at the end of the contract or destroyed in accordance to the VHA Record Control Schedule (RCS)10-1. NARA RM Language Clause to be included in contracts:

1. Citations to pertinent laws, codes and regulations such as 44 U.S.C Chapter 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

Page 14 o f 1 4 authorized by the contract using Government ‘IT’ equipment and/or Government records.

3. 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.

4. Contractor shall not create or maintain any records containing any Government Agency records that are not specifically tied to or authorized by the contract or identified in the RCS 10-1.

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 [e.g. paper, electronic, etc.] or mode of transmission [e.g. e-mail, fax, etc.] or state of completion [e.g. 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.

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