FUNCTIONAL PERFORMANCE SPEC STEMWAVE.docx

FUNCTIONAL/PERFORMANCE/SPECIFCATION

Description & Salient Characteristics: The Fargo VA Medical Center is requesting the purchase of equipment that provides an electro-hydraulic form of extracorporeal shockwave therapy (ESWT) that uses focused acoustic waves to stimulate healing without surgery or medication, boosts local blood flow (angiogenesis) to support tissue repair and faster recovery with revascularization, stimulates natural repair mechanisms, activation of connective tissue and stem-cell related healing responses. This request is a firm-fixed price.

Salient Characteristics Brand Name or equal to: StemWave StemWave Device (Modus F) - Quantity of 1

· Electohydraulic System with Cellular Response Technology (CRT)

· Low-intensity focused acoustic waves that deeply penetrate damaged or inflamed tissue at a rate of 3,500mph

· High-energy focused acoustic waves delivered deep into tissues – up to 10-12 centimeters

· Activates connective tissue, reduces inflammation, increases blood flow to treatment areas

· Spark-Gap Electohydraulic focused wave system that applies mechanical force and energy

· Relief of minor aches and pains without medication, long treatment times or invasive procedures

· Locate areas of pain and inflammation in seconds

· Quick treatments of 3-8 minutes

· Minimum of 150+ treatment zones

· Minimum of 25 different energy (power) levels

· For use on: knees, shoulders, hands, feet, elbows, hips and low back

· Easily contour over many areas of the body

· Must provide FDA class 1 registration

· In-Person group training

· Online training courses StemWave Electrodes – Quantity of 6

· Expected life span of 40,000 – 50,000 pules or 100 treatments

· Machine-tooled

· Hand-assembled StemWave Hand Piece with Cable – Quantity of 1

· Expected life span of 1,000,000 pulses or 2,000 treatments

StemWave Applicator Head – Quantity of 2

· Expected life span of 500,000 pulses or 1,000 treatments

This service does not involve the storage, generating, transmitting, or exchanging of VA sensitive information.

“Privacy training is required if the contractor(s) will be working in areas with sensitive Veteran information with an increased risk of inadvertent disclosures. These are areas where only authorized personnel are allowed (nurse’s stations, PACT team areas, Laboratory, Pharmacy, etc.) and where visitors would typically be escorted and not be allowed to roam around freely (4B, ER, 3M, ICU, CLC, etc.). The contractor(s) must read and sign TMS 20939, VA Privacy Training for Personnel without Access to VA Computer Systems or Direct to or the Use of VA Sensitive Information, prior to beginning work in these areas.”

Delivery Location

Delivery and Installation

1. The vendor will be responsible to deliver the materials 60 days ARO Materials of all pieces to which make the equipment fully functional, including all accessories must be present upon delivery.

2. All items to be shipped F.O.B. destination. Shipping shall be included in the product price and shall not be billed separately.

3. No tools during installation will be supplied/provided by the VA.

NARA Records Management Language for Contracts (July 10, 2019) https://www.archives.gov/records-mgmt/policy/records-mgmt-language

RECORDS MANAGEMENT OBLIGATIONS

A. Applicability

This clause applies to all Contractors whose employees create, work with, or otherwise handle Federal records, as defined in Section B, regardless of the medium in which the record exists.

B. Definitions

“Federal record” as defined in 44 U.S.C. § 3301, includes all recorded information, regardless of form or characteristics, made or received by a Federal agency under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the United States Government or because of the informational value of data in them.

The term Federal record:

1. includes VA records.

1. does not include personal materials.

1. applies to records created, received, or maintained by Contractors pursuant to their VA contract.

1. may include deliverables and documentation associated with deliverables.

C. Requirements

1. Contractor shall comply with all applicable records management laws and regulations, as well as National Archives and Records Administration (NARA) records policies, including but not limited to the Federal Records Act (44 U.S.C. chs. 21, 29, 31, 33), NARA regulations at 36 CFR Chapter XII Subchapter B, and those policies associated with the safeguarding of records covered by the Privacy Act of 1974 (5 U.S.C. 552a). These policies include the preservation of all records, regardless of form or characteristics, mode of transmission, or state of completion.

1. In accordance with 36 CFR 1222.32, all data created for Government use and delivered to, or falling under the legal control of, the Government are Federal records subject to the provisions of 44 U.S.C. chapters 21, 29, 31, and 33, the Freedom of Information Act (FOIA) (5 U.S.C. 552), as amended, and the Privacy Act of 1974 (5 U.S.C. 552a), as amended and must be managed and scheduled for disposition only as permitted by statute or regulation.

1. In accordance with 36 CFR 1222.32, Contractor shall maintain all records created for Government use or created in the course of performing the contract and/or delivered to, or under the legal control of the Government and must be managed in accordance with Federal law. Electronic records and associated metadata must be accompanied by sufficient technical documentation to permit understanding and use of the records and data.

1. Fargo VA Medical Center and its contractors are responsible for preventing the alienation or unauthorized destruction of records, including all forms of mutilation. Records may not be removed from the legal custody of Fargo VA Medical Center or destroyed except for in accordance with the provisions of the agency records schedules and with the written concurrence of the Head of the Contracting Activity. Willful and unlawful destruction, damage or alienation of Federal records is subject to the fines and penalties imposed by 18 U.S.C. 2701. In the event of any unlawful or accidental removal, defacing, alteration, or destruction of records, Contractor must report to Fargo VA Medical Center. The agency must report promptly to NARA in accordance with 36 CFR 1230.

1. The Contractor shall immediately notify the appropriate Contracting Officer upon discovery of any inadvertent or unauthorized disclosures of information, data, documentary materials, records or equipment. Disclosure of non-public information is limited to authorized personnel with a need-to-know as described in the [contract vehicle]. The Contractor shall ensure that the appropriate personnel, administrative, technical, and physical safeguards are established to ensure the security and confidentiality of this information, data, documentary material, records and/or equipment is properly protected. The Contractor shall not remove material from Government facilities or systems, or facilities or systems operated or maintained on the Government’s behalf, without the express written permission of the Head of the Contracting Activity. When information, data, documentary material, records and/or equipment is no longer required, it shall be returned to Fargo VA Medical Center control or the Contractor must hold it until otherwise directed. Items returned to the Government shall be hand carried, mailed, emailed, or securely electronically transmitted to the Contracting Officer or address prescribed in the [contract vehicle]. Destruction of records is EXPRESSLY PROHIBITED unless in accordance with Paragraph (4).

1. 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, contracts. The Contractor (and any sub-contractor) is required to abide by Government and Fargo VA Medical Center guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

1. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with Fargo VA Medical Center policy.

1. The Contractor shall not create or maintain any records containing any non-public Fargo VA Medical Center information that are not specifically tied to or authorized by the contract.

1. 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 from public disclosure by an exemption to the Freedom of Information Act.

1. The Fargo VA Medical Center owns the rights to all data and records produced as part of this contract. All deliverables under the contract are the property of the U.S. Government for which Fargo VA Medical Center shall have unlimited rights to use, dispose of, or disclose such data contained therein as it determines to be in the public interest. Any Contractor rights in the data or deliverables must be identified as required by FAR 52.227-11 through FAR 52.227-20.

1. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take Fargo VA Medical Center provided records management training. The Contractor is responsible for confirming training has been completed according to agency policies, including initial training and any annual or refresher training.

[Note: To the extent an agency requires contractors to complete records management training, the agency must provide the training to the contractor.]

D. Flowdown of Requirements to Subcontractors

1. The Contractor shall incorporate the substance of this clause, its terms and requirements including this paragraph, in all subcontracts under this [contract vehicle], and require written subcontractor acknowledgment of same.

1. Violation by a subcontractor of any provision set forth in this clause will be attributed to the Contractor.

VAPrivacyTrainingforPersonnelwithout2018AccesstoVAComputerSystemsorDirectAccesstoortheUseofVASensitiveInformation09212018.pdf

VA Privacy Training for Personnel without Access to VA Computer Systems or Direct Access to or the Use of VA Sensitive Information

The Department of Veterans Affairs, VA must comply with all applicable privacy and confidentiality statutes and regulations. One of the requirements in VA is to have all personnel trained annually on privacy requirements. “Privacy” represents what must be protected by VA in the collection, use, and disclosure of personal information whether the medium is electronic, paper or verbal.

This document satisfies the “basic” privacy training requirement for a contractor, volunteer, or other personnel only if the individual does not use VA sensitive information or protected health information (PHI) in any form such as electronic or paper or have access to any VA computer system such as VA Time and Attendance System (VATAS), Computerized Patient Record System (CPRS), Joint Legacy Viewer (JLV), Veterans Health Information Exchange (VHIE), Compensation and Pension Record Interchange (CAPRI).

You will find this training outlines your role and responsibility for protecting VA sensitive information (medical, financial, or educational) that you may incidentally or accidentally see or overhear.

If you have direct access to VA sensitive information or access to a VA computer system where there is protected health information such as VaTAS, CPRS, JLV, VHIE or CAPRI you must take Privacy and HIPAA Focused Training (TMS 10203).

VA Privacy and Information Security Awareness and Rules of Behavior (TMS 10176) is always required to use or gain access to a VA computer system or VA sensitive information, whether or not protected health information is included. Both trainings are located within the VA Talent Management System (TMS): https://www.tms.va.gov

What is VA Sensitive Information/Data?

All Department information and/or data on any storage media or in any form or format, which requires protection due to the risk of harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the information. The term includes not only information that identifies an individual but also other information whose improper use or disclosure could adversely affect the ability of an agency to accomplish its mission, proprietary information, and records about individuals requiring protection under applicable confidentiality provisions.

What is Protected Health Information?

The HIPAA Privacy Rule defines protected health information as Individually Identifiable Health Information transmitted or maintained in any form or medium by a covered entity, such as VHA.

What is an “Incidental” Disclosure?

An incidental disclosure is one where an individual’s information may be disclosed incidentally even though appropriate safeguards are in place. Due to the nature of VA communications and practices, as well as the various environments in which Veterans receive healthcare or other services from VA, the potential exists for a Veteran’s protected health information or VA sensitive information to be disclosed incidentally.

https://www.tms.va.gov/

For example:

• You overhear a healthcare provider’s conversation with another provider or patient even when the conversation is taking place appropriately.

• You may see limited Veteran information on sign-in sheets or white boards within a treating area of the facility.

• You may hear a Veteran’s name being called out for an appointment or when the Veteran is being transported/escorted to and from an appointment

Safeguards You Must Follow To Secure VA Sensitive Information:

• Secure any VA sensitive information found in unsecured public areas (parking lot, trash can, or vacated area) until information can be given to your supervisor or Privacy Officer. You must report such incidents to your Privacy Officer timely.

• Don’t take VA sensitive information off facilities grounds without VA permission unless the VA information is general public information, i.e., brochures/pamphlets.

• Don’t take pictures using a personal camera without the permission from the Medical Center Director.

• Any protected health information overheard or seen in VA should not be discussed or shared with anyone who does not have a need to know the information in the performance of their official job duties, this includes spouses, employers or colleagues.

• Do not share VA access cards, keys, or codes to enter the facility.

• Immediately report lost or stolen Personal Identity Verification (PIV) or Veteran Health Identification Cards (VHIC), VA keys or keypad lock codes to your supervisor or VA police.

• Do not use a VA computer using another VA employee’s access and password.

• Do not ask another VA employee to access your own protected health information. You must request this information in writing from the Release of Information section at your facility

What are the Six Privacy Laws and Statutes Governing VA?

1. Freedom of Information Act (FOIA) compels disclosure of reasonably described VA records or a reasonably segregated portion of the records to any person upon written request unless one or more of the nine exemptions apply.

2. Privacy Act of 1974 provides for the confidentiality of personal information about a living individual who is a United States citizen or an alien lawfully admitted to U.S. and whose information is retrieved by the individual’s name or other unique identifier, e.g. Social Security Number.

3. Health Insurance Portability and Accountability Act (HIPAA) provides for the improvement of the efficiency and effectiveness of health care systems by encouraging the development of health information systems through the establishment of standards and requirements for the electronic transmission, privacy, and security of certain health information.

4. 38 U.S.C. 5701 provides for the confidentiality of all VA patient and claimant information, with special protection for their names and home addresses.

5. 38 U.S.C. 7332 provides for the confidentiality of drug abuse, alcoholism and alcohol abuse, infection with the human immunodeficiency virus (HIV) and sickle cell anemia medical records and health information.

6. 38 U.S.C. 5705 provides for the confidentiality of designated medical-quality assurance documents.

What are the Privacy Rules Concerning Use and Disclosure?

You are not authorized to use or disclose protected health information. In general, VHA personnel may only use information for purposes of treatment, payment or healthcare operations when they have a need-to-know in the course of their official job duties. VHA may only disclose protected health information upon written request by the individual who is the subject of the information or as authorized by law.

How is Privacy Enforced?

There are both civil and criminal penalties, including monetary penalties that may be imposed if a privacy violation has taken place. Any willful negligent or intentional violation of an individual’s privacy by VA personnel, contract staff, volunteers, or others may result in such corrective action as deemed appropriate by VA including the potential loss of employment, contract, or volunteer status.

Know your VA/VHA Privacy Officer and Information Systems Security Officer. These are the individuals to whom you can report any potential violation of protected health information or VA sensitive information, or any other concerns regarding privacy of VA sensitive information.

YOU ARE RESPONSIBLE FOR PROTECTING THE CONFIDENTIAL INFORMATION

OF OUR VETERANS

Employee (Print Name) Date Employee Signature Print Name of Contract Agency, if contractor Print Name of VHA Department/Supervisor/Contracting Officer

PROVIDE A COPY OF THIS FORM TO YOUR SUPERVISOR/CONTRACTING OFFICER

FOR DATA ENTRY INTO TALENT MANAGEMENT SYSTEM

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