36C24426Q0201_1.docx

Sources Sought Notice Sources Sought Notice

GENERAL INFORMATION

SET-ASIDE

Network Contracting Office 4 Services 1 1010 Delafield Road

POINT OF CONTACT*

Contract Specialist Eleanor Robbins Eleanor.Robbins@va.gov (302)573-0733

PLACE OF PERFORMANCE

Erie VAMC

Surgical Specialty Services

135 E 38th St

Erie PA

ADDITIONAL INFORMATION

DESCRIPTION

THIS IS A SOURCES SOUGHT NOTICE ONLY. THIS IS NOT A REQUEST FOR PROPOSAL. The Erie VA Medical Center, 135 East 38th Street, Erie, PA 16504 is performing market research to determine if there is a sufficient number of qualified (1) Service-Disabled Veteran Owned Small Business; (2) Veteran Owned Small Business; or (3) Small or emerging small business firms to set aside a single award contract. The Government will use responses to this notice to make to an appropriate acquisition decision.

The contractor shall provide on-site lithotripsy support services at the Erie VAMC, including furnishing and transporting all required lithotripsy equipment to the Operating Room; ensuring all equipment meets VA BioMed inspection standards; and providing a qualified radiologic technician for each procedure. The technician shall monitor and operate lithotripsy and associated imaging equipment, assist the attending Urologist and other physicians with patient positioning and equipment operation during procedures, and serve as a technical consultant to ensure safe and effective use of all equipment. The contractor is responsible for maintaining all equipment in proper working order, complying with VA safety and infection-control requirements, and coordinating with VA clinical and administrative staff to support scheduled procedures. The anticipated period of performance is five (5) years, with task orders to be issued as services are required.

All interested firms who can meet the requirements stated above should respond, in writing, with information describing their interest, capabilities, geographic location and indicate which small business category for which they qualify to the Contract Specialist Eleanor Robbins at Eleanor.Robbins@va.gov, no later than 10:00 a.m. (Eastern Time), February 5, 2026. The NAICS Code 621999 is applicable to this acquisition, with a Business Size Standard of $21.0 M. Interested firms are reminded that in accordance with FAR 4.12, prospective contractors shall complete electronic annual representations and certifications in conjunction with FAR 4.11 required registration in the Systems for Award Management (SAM) database prior to award of a contract.

STATEMENT OF WORK

EXTRACORPOREAL SHOCK WAVE LITHOTRIPSY (ESWL)

The Department of Veterans Affairs in Erie, Pennsylvania requires a Contractor for Extra- corporeal Shock Wave Lithotripsy (ESWL) services for patients at the Erie VA Medical Center, which is located at 135 East 38 Street, Erie, PA 16504. The Contractor shall provide the equipment and technical support personnel (lithotripsy trained radiologic technician) needed to perform these services. Lithotripsy services will be scheduled for one (1) day every other month for a total of six scheduled visits over a 12-month period of performance. Services will be performed at the Erie VAMC and not at the Contractor’s site.

Under the authority of Public Law 104-262 and 38 U.S.C. 8153, the Contractor agrees to provide Health Care Resources in accordance with the terms and conditions stated herein, to furnish to and at the Department of Veterans Affairs Medical Center, the services and prices specified herein.

The Erie VAMC intends to award a five-year IDIQ Contract.

OBJECTIVES: The Erie VAMC has a need to continuously utilize lithotripsy equipment for shockwave lithotripsy procedures. The minimum day charge applies when the contractor makes timely delivery of the equipment and supplies to the VAMC’s site on a scheduled day. If the equipment and supplies are delivered to the VAMC’s site and equipment is inoperable for 60 minutes or more with the result that the designated surgeon must postpone surgical procedures, the contractor will forego the charge for that surgical procedure.

SCOPE, TASKS, OR REQUIREMENTS:

A. The Contractor shall provide a Lithotripter and an imaging system (fluoroscopy). The equipment shall be delivered by the Contractor to the Erie VAMC’s warehouse/loading dock. The Contractor is responsible for transporting the equipment from the warehouse/loading dock to the Operating Room. The Erie VAMC staff members will damp-dust the equipment prior to being moved to the Operating Room. The Contractor shall set up and prepare the equipment for patient use. The Contractor shall provide assistance and support during ancillary procedures.

B. The Contractor warrants that the equipment is fit for its intended use and purpose. The Contractor shall maintain equipment in a manner that meets the requirements of all applicable professional and regulatory standards and is responsible for current inspection. A certificate of the current inspection may be required. Preventative maintenance records will accompany the Contractor's equipment to the Erie VAMC and may be reviewed on each visit by the Biomedical Engineering Department. Both parties acknowledge that during equipment repair/maintenance, the schedule may need to be adjusted to accommodate down time of the equipment. Preventive maintenance records shall accompany the Contractor's equipment to the Erie VAMC and be reviewed upon each visit by the Erie VAMC Biomedical Engineering Department.

The lithotripsy radiologic technician will bring in the requested equipment directly to the Operating Room at the VAMC for use in operative procedures. It is expected that all requested equipment meet the inspection criteria of the VAMC BioMed Department. In addition to monitoring lithotripsy equipment before and during procedures, the radiologic technician shall serve as a consultant for all equipment. The radiologic technician will assist the attending Urologist and other physicians with positioning and operating the lithotripsy machine and any related imaging equipment during each procedure.

C. Approximately 2-3 lithotripsy procedures are anticipated to be scheduled on a bi-monthly basis.

D. Ancillary procedures performed on the equipment in order to assure proper visualization of the target stone, or proper elimination of stone fragments to include, but are not limited to, cystoscopies, contrast studies in excess of 15 minutes, and stent replacements.

E. An orientation session between the Erie VAMC and the awarded contracted vendor will be scheduled prior to the first scheduled procedure date for lithotripsy services if required at no additional charge. This orientation process will include a review of the surgical equipment, patient flow, and individual roles to include the following members: the VAMC’s urologist, the VAMC’s OR Nursing staff, VAMC’s Program Manager (PM), the vendor’s staff and Contracting Representative. The orientation date should be scheduled within three weeks of the contract awarded date if needed.

F. Contractor will attend an orientation meeting as arranged by the Program Manager. The VAMC will schedule this meeting, and it will include the required topics. VAMC will provide information to the contractor regarding the orientation and will document the meeting.

G. The contractor shall deliver all reports, films, and file records of all procedures performed with the device to the operating room personnel. These medical records shall be the property of the Erie VA Medical Center.

SELECTION CRITERIA:

A. The objective standard of acceptable performance that is to be provided by the contractor is to have a lithotripsy trained radiologic technician/coordinator on the premises, readily available, on the day when the procedure(s) is/are being performed. The duties of the lithotripsy trained radiologic technician are to set up the equipment and monitor the performance of the equipment during each surgical procedure making any adjustments as directed by the physician. In addition, the lithotripsy trained radiologic technician assists the Operating Room staff in staging equipment and turning the Operating Room between cases. The lithotripsy trained radiologic technician will report directly to the operating physician and/or the Medical Director, Surgical Care, while assisting with the surgical procedures.

B. The contractor should also acknowledge that the lithotripsy surgery equipment is in good working condition and is regularly maintained. The contractor will be liable for damages should patient injury result due to equipment malfunction. The contractor must also indicate that sufficient insurance coverage is maintained for its contracted employees and for its equipment. The Contractor will maintain, for the term of this contract, fire and theft insurance coverage for the equipment. In addition, the Contractor will maintain, for the term of this agreement, general and professional liability insurance regarding their lithotripsy services.

DELIVERY SCHEDULE:

A. On the scheduled day of procedure, the contractor shall deliver the equipment to the Erie VAMC. The VAMC shall afford the contractor with advance notice of the number of procedures to be performed for the purpose of providing supplies and planning purposes. Such advance notice shall be provided no later than four working days prior to the scheduled visit.

B. The VAMC shall give the contractor not less than 24 hours telephone notice of the time of the first procedure. In the event the VA urologist is unable to arrive at the VA on the day of scheduled procedures due to emergency situations, the contractor will be immediately notified and may remove the equipment from the Operating Room. As an alternative, the party giving notice may request that the VAMC and the contractor adopt an alternative time. Due to the Erie VAMC’s patient commitments and the contractor’s itinerary, the rights to cancel and to request a change may be exercised sparingly. The contractor may remove the lithotripsy equipment at the conclusion of the last scheduled procedure.

C. Contingency Plan: Because continuity of care is an essential part of the Erie VAMC’s medical services, the Contractor shall have a contingency plan in place to be utilized in the event equipment or assigned contracted staff are unavailable for scheduled procedure dates in accordance with the terms and conditions of the resulting contract.

D. During the term of this SOW, Erie VAMC shall utilize the contractor’s equipment rental and outsourcing service for all lithotripsy procedures.

ERIE VAMC RESPONSIBILITIES:

A. The Erie VAMC will be responsible for providing the following patient care components for each ESWL procedure:

· Preparing patients for procedures

· Transporting the patients

· Administering contrast media, anesthesia, and/or pharmaceuticals

· Administration of life-saving emergency services

· Reading and interpreting tests and/or procedure results

B. The VAMC is responsible for providing qualified staff required for procedures and manage patient care. Our staff will deliver all clinical supervision and patient management throughout the entire procedure.

C. One scheduled service day will be established every other month. Specific days of service will occur during normal business hours and will be mutually agreed upon between the Erie VAMC and the Contractor. The Erie VAMC and the Contractor may negotiate additional days if necessary.

D. The Erie VAMC will supply all necessary patient equipment needed for the preparation and execution of procedures, excluding the lithotripter and imaging system, which will be provided by the Contractor. The Erie VAMC is responsible for supplying adequate emergency medical equipment, including but not limited to, crash carts and defibrillation equipment.

E. The VAMC shall obtain and maintain at all times, during the term of this contract, general and professional liability insurance including without limitation insurance covering the activities of the VAMC’s employees and physicians.

F. The VAMC shall use reasonable efforts to assure that the surgeon utilizing the equipment obtains and maintains, at all times during the term hereof, professional liability insurance with respect to their activities in accordance with the VAMC’s policies and procedures.

G. The VAMC will be responsible for providing a circulating Registered Nurse (RN) for each procedure.

SECURITY: The Erie VAMC OR Nursing staff, or the designated surgeons shall ensure that surgical consent forms have been received from all patients prior to the scheduled procedure.

PLACE OF PERFORMANCE: The work will be performed at Erie VAMC operating rooms.

QUALIFICATIONS:

Technical Proficiency – The Contractor’s lithotripsy trained radiologic technician shall be technically proficient in the skills necessary to fulfill the government’s requirements, including the ability to speak, understand, read and write English fluently. Contractor shall provide licensed Radiologic Technologist, Certified Radiologic Technologist (CRT) certification or equivalent certification/license required for Lithotripsy Technologists.

Personnel assigned by the Contractor to perform services covered by this contract shall be licensed in a State, Territory, or Commonwealth of the United States or the District of Columbia. All licenses held by personnel working on this contract shall be full and unrestricted. The qualifications of such personnel shall also be subject to review by the VA Chief of Staff and approval by the VA Facility Director. Contract staff covered by this contract shall be a citizen of the United States and meet the physical standards for a lithotripsy radiologic technician include the ability to lift and move patients, handle and operate heavy equipment, and maintain stamina for long periods of standing and walking. Technicians must also have fine motor skills for equipment manipulation, good vision to see patients and equipment, and good hearing to understand communication and hear alarms.

WORK HOURS:

The services covered by this contract shall be furnished by the Contractor as defined herein. The Contractor will not be required, except in case of emergency, to furnish such services during off duty hours as described below.

Work Hours: Monday – Friday, 7:30 a.m. – 4:00 p.m.

All Federal Holidays Observed by the VAMC: New Year’s Day, Martin Luther King’s Birthday, President’s Day, Memorial Day, Juneteenth, Independence Day, Labor Day, Columbus Day, Veterans Day, Thanksgiving Day, and Christmas Day.

Off-Duty Hours: Monday - Friday, 4:00 p.m. – 7:30 a.m.

Friday at 4:00 p.m. through Monday – 7:30 a.m. .

When a holiday falls on a Sunday, the following Monday shall be observed as a legal holiday by the U.S. Government agencies. When a holiday falls on a Saturday, the preceding Friday shall be observed as a legal holiday.

Also included would be any other day specifically declared by the President of the United States to be a National Holiday

PERSONNEL POLICY:

All Contractor employees providing services at the Erie VAMC are required to comply with the facility's immunization policy. As such, contract employees must submit proof of health care immunizations and requirements per VA policy. No contract employees that have a need to be on-station will be authorized to commence work until all health care requirements are met, which includes the flu vaccine, and is cleared by the VA Occupational Health Nurse. The flu vaccine proof of vaccination must be provided by November 30 or within two weeks of beginning employment and a signed Appendix B, Health Care Personnel Influenza Vaccination Form. If the contracted vendor chooses not to obtain the flu vaccine, the contracted vendor will be required to wear a mask while on duty at the Erie VAMC and follow the requirements and guidelines within the Seasonal Influenza Prevention Program.

CONTRACTOR’S RESPONSIBILITY:

A. Contractor will hold and submit certificates of insurance for general liability and malpractice insurance, workmen’s compensation and vehicle insurance. Under no circumstances are contractor’s employees considered VAMC employees.

B. Technician(s) must be trained on equipment operations, HIPAA, surgical procedures, and blood borne pathogens, OR fire safety, OR protocol, sterile technique, cultural diversity, and customer service.

C. The contractor is responsible for keeping equipment in good working order and shall provide all maintenance, repairs and upgrades to the equipment as required, keeping it in optimal condition.

D. Lithotripter Radiologic Technician is subject to the same quality assurance standards as established by The Joint Commission (JC).

E. The contractor will provide services in accordance with ethical, professional and technical standards of the health care industry.

F. The equipment must meet or exceed the following criteria:

1. Treats all stones anywhere in the urinary tract

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

3. Is modular and can treat patients in the operating room

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

5. Will accommodate patients weighing up to five hundred (500) pounds

6. Experienced technicians that are available when needed.

7. The company must bring mobile C-Arm, other equipment, and all the supplies

8. needed/required to conduct the Lithotripsy service.

G. The contractor must have a trained lithotripsy radiologic technician on the premises readily available on the day when the procedure(s) is/are being performed. The contractor acknowledges that the lithotripsy equipment is in good working condition and is regularly maintained. The contractor will be liable and indemnify the VAMC for damages should patient injury result due to equipment malfunction. The contracted vendor acknowledges that it maintains sufficient insurance coverage.

IDENTIFICATION, PARKING, SMOKING, AND VA REGULATIONS:

The contractor shall wear visible identification at all times while on the premises of the Erie VAMC. The VAMC will not invalidate or make reimbursement for parking violations or charges for the contractor under any conditions. Smoking is prohibited inside any buildings at the VAMC. Possession of weapons is prohibited. Enclosed containers, including tool kits, shall be subject to search. Violations of VA regulations may result in citation answerable in the United States (Federal) District Court, not a local district, state, or municipal court.

CONTRACTOR PERSONNEL SECURITY REQUIREMENTS:

A. Completion of mandatory annual training will be completed in the Talent Management System (TMS). Training completion will be verified through TMS records.

B. 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 (electronically through TMS) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix D relating to access to VA information and information systems through TMS.

• Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training electronically through TMS.

• Successfully complete the appropriate VA Privacy training and annually complete required privacy training electronically through TMS; and

• Successfully complete any additional cyber 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.]

C. The contractor shall provide the Program Manager with a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within one week of the initiation of the contract and annually thereafter, as required.

D. 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 such time as the training and documents are complete. Contractor will be required to provide substitution of personnel.

CONTRACTOR SECURITY REQUIREMENTS (HANDBOOK 6500.6):

A. 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.

B. All General/Prime Contractor employees, including subcontractor personnel who require unsupervised/unescorted, logical and/or physical access to the Department of Veterans Affairs facilities, computer systems or have access to sensitive information shall be the subject of a background investigation. Contractor personnel performing work under any contract shall satisfy all requirements for appropriate security eligibility in dealing with access to sensitive information and information systems belonging to or being used on behalf of the Department of Veterans Affairs.

C. Risk levels and the Personal Identity Verification (PIV) program will determine what level of investigation is required. At a minimum a Special Agreement Check (SAC) will be required for all contractor personnel prior to performing services under any resulting contract requiring unsupervised/unescorted logical and/or physical access to the facility or having access to sensitive information.

Position Sensitivity - The position sensitivity has been designated as Low Risk.

Background Investigation - The level of background investigation commensurate with the required level of access is NACI (low risk).

Non-citizen contract personnel appointed to low-risk positions will be subject to a National Agency Check with Law Enforcement and Credit Check (NACLC).

D. The General/Prime Contractor shall submit to the Contracting Officer and PM. within five (5) business days after award of contract, a list of personnel including subcontractor’s personnel who will be performing work on the contract. The list will include a brief description of the work to be performed and degree of access to information management systems and if remote access will be required. The Contractor will update and submit the list anytime changes are made in the level of access or personnel performing work on the contract.

E. Contractors who have a current favorable background investigation conducted by another Federal agency may be accepted through reciprocation. Contractor must provide proof of favorable adjudication on background check for their personnel performing work at the Erie VAMC. Employees may be exempt if they can provide documentation of a previous favorable adjudication from a government background investigation. Members of the SIC staff will coordinate verification of existing favorable background investigations. Furthermore, contractors may utilize a private investigating agency if such agency possesses an OPM and Defense Security Service certification. A Cage Code number of the private investigating agency must be provided to the VA Office of Security and Law Enforcement/Security and Investigation Center staff.

F. The Department of Veterans Affairs in conjunction with Office of Personnel Management (OPM) at the request of the General/Prime Contractor may execute the required background investigation for contractor personnel employees to include subcontractor’s personnel performing services under this contract. The General/Prime Contractor shall bear the expense of the background investigations initiated/scheduled regardless of the final adjudication determination. The VA facility will pay for investigations conducted by the Office of Personnel Management (OPM) in advance. In these instances, the General/Prime Contractor will reimburse the VA facility within 30 days of receiving the Bill of Collections from the VA. A Bill of Collections shall be generated by the VA after the investigation has been initiated/scheduled. It has been determined that this contract requires the following level of investigations and associated costs (per person): Tier I (NACI) $381; Tier 2S (MBI) $1730; and Tier 4S (BI) $4,431.

G. The amounts stated above are estimated prices based on previous pricing and are subject to periodic price changes as established by the OPM in Federal Investigations Notices. Contractors shall be billed per OPM/SIC guidelines and should anticipate periodic increases. All fee schedule questions should be directed to the SIC at 501-257-4031 or vhalitsiccontracting@va.gov.

H. The VAMC Program Manager (PM) shall determine the risk level (Low, Moderate, High) and sensitivity designation (Non-Sensitive, Non-Critical Sensitive, Critical Sensitive, or Special-Sensitive) for each contractor position supporting this requirement, in accordance with VA Handbook 0710, VA Directive 0710, and the U.S. Office of Personnel Management (OPM) Position Designation Tool (PDT).

I. For all contractor personnel requiring a National Agency Check with Written Inquiries (NACI) or higher background Investigations the contractor shall submit to the Security Investigations Center (SIC), the completed background investigation packet. Completed packages must be submitted promptly and in sufficient time to meet the contract performance or delivery schedule. If a delay is due to the failure of the Contractor to provide a complete application as soon as practicable after contract award, this delay shall not excuse the Contractor from meeting the contract performance or delivery schedule and may result in termination for default.

J. The contractor is encouraged to have its employee immediately download the background investigation packet from http://www.va.gov/vabackground_investigations upon notification of contract award. Contract performance shall not commence prior to confirmation from the SIC that the investigative documents have been submitted. The SIC will notify the VA and the contractor upon receipt of the appropriate investigative documents. The investigation is not considered initiated until the contract employee submits his/her completed package to SIC and it is accepted. The Contractors may be granted access prior to receiving final adjudication of the employee’s background investigations.

K. The VA Security Investigations Center will notify the VA and Contractor after adjudicating the results of the background investigations received from OPM. Final adjudication results may take up to six months but are normally received within 90 days after submission.

L. The General/Prime Contractor will be responsible for the actions of individuals performing work for the VA under this contract. In the event that damages arise from work performed by contractor-provided personnel, under the auspices of this contract, the General/Prime Contractor will be responsible for all resources necessary to remedy the incident.

M. The Contractor, when notified of an unfavorable determination, will withdraw the employee from consideration from working under the contract.

N. Failure to comply with the Contractor Personnel Background Investigation Requirements section shall result in termination of the contract for default.

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY LANGUAGE:

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. 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.

D. The C&A requirements do not apply, and a Security Accreditation Package is not required.

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. 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.

SECURITY INCIDENT INVESTIGATION:

A. The term "security incident" means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/ subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/ subcontractor has access.

B. To the extent known by the contractor/subcontractor, the contractor/ subcontractor's notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

LIQUIDATED DAMAGES FOR DATA BREACH:

A. Consistent with the requirements of 38 U.S.C. §5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract. However, it is the policy of VA to forgo collection of liquidated damages in the event the contractor provides payment of actual damages in an amount determined to be adequate by the agency.

B. 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:

1) Notification.

2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports.

3) Data breach analysis.

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

5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

MEDICAL RECORDS:

A. Authorities: Contracted staff providing healthcare services to VA patients shall be considered as part of the Department Healthcare Activity and shall comply with the U.S.C.551a (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), Title 5 U.S.C. § 522a (Records Maintained on Individuals) as well as 45 C.F.R. Parts 160, 162, and 164 (HIPAA).

B. HIPAA: This contract and its requirements meet exception in 45 CFR 164.502(e), and do not require a BAA in order for Covered Entity to disclose Protected Health Information to: a health care provider for treatment. Based on this exception, a BAA is not required for this contract. Treatment and administrative patient records generated by this contract or provided to the Contractors by the VA are covered by the VA system of records entitled ‘Patient Medical Records-VA’ (24VA19). Contractor generated VA Patient records are the property of the VA and shall not be accessed, released, transferred, or destroyed except in accordance with applicable laws and regulations. Contractor shall ensure that all records pertaining to medical care and services are available for immediate transmission when requested by the VA. Records identified for review, audit, or evaluation by VA representatives and authorized federal and state officials, shall be accessed on-site during normal business hours or mailed by the Contractor at his expense.

C. Disclosure: Contractor staff may have access to patient information; however, Contractor shall obtain permission from the VA before disclosing any patient information. 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. The penalties and liabilities for the unauthorized disclosure of VA patient information mandated by the statutes and regulations mentioned above, apply to the Contractor.

D. Release of Information: The VA shall maintain control of releasing any patient medical information and will follow policies and standards as defined but not limited to Privacy Act requirements.

INVOICING/BILLING:

A. Invoice requirements and supporting documentation: Supporting documentation and a properly prepared invoice must be submitted no later than the 15th workday of the following month of services rendered. If the COR refuses an invoice due to incorrect billing, subsequent changes or corrections to the monthly invoice shall be resubmitted by the vendor with a corrected invoice. In addition to information required for submission of a “proper” invoice in accordance with FAR 52.212-4 (g), all invoices must include:

● Name and Address of Contractor

● Invoice Date and Invoice Number

● Contract Number and Purchase/Task Order Number

● Date of Service

● Contractor’s physician(s)

● Hourly Rate

● Quantity of hours worked

● Total price

B. Vendor Electronic Invoice Submission Methods: Facsimile, e-mail, and scanned documents are not acceptable forms of submission for payment requests. Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods below:

1. VA’s Electronic Invoice Presentment and Payment System – The FSC uses a third-party contractor, OB10, to transition vendors from paper to electronic invoice submission. Please go to this website: http://ob10.com/us/en/veterans-affairs-us/ to begin submitting electronic invoices, free of charge.

2. The Contractor may contact FSC at the phone number or email address listed below with any questions about the e-invoicing program or OB10:

OB10 e-Invoice Setup Information: 1-877-489-6135 OB10 e-Invoice email: VA.Registration@ob10.com FSC e-Invoice Contact Information: 1-877-353-9791 FSC e-invoice email: vafsccshd@va.gov C. Payments in full/no billing VA beneficiaries: The Contractor shall accept payment for services rendered under this contract as payment in full. VA beneficiaries shall not under any circumstances be charged nor their insurance companies charged for services rendered by the Contractor, even if VA does not pay for those services. This provision shall survive the termination or ending of the contract.

D. The Contractor shall not bill, charge, collect a deposit from, seek compensation, remuneration, or reimbursement from, or have any recourse against, any person or entity other than VA for services provided pursuant to this contract. It shall be considered fraudulent for the Contractor to bill other third-party insurance sources (including Medicare) for services rendered to Veteran enrollees under this contract.

Price/Cost Schedule:

This is a zero-dollar indefinite delivery contract. A task order will be cut annually for actual quantities and to attach funding as applicable. The period of performance is five years from effective date of award.

Records Management 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.

2. 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.

3. 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.

4. Department of Veterans Affairs 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 Department of Veterans Affairs 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 Department of Veterans Affairs. The agency must report promptly to NARA in accordance with 36 CFR 1230.

5. 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 Department of Veterans Affairs 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).

6. 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 Department of Veterans Affairs guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

7. The Contractor shall only use Government IT equipment for purposes specifically tied to or authorized by the contract and in accordance with Department of Veterans Affairs policy.

8. The Contractor shall not create or maintain any records containing any non-public Department of Veterans Affairs information that are not specifically tied to or authorized by the contract.

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

10. Training. All Contractor employees assigned to this contract who create, work with, or otherwise handle records are required to take Department of Veterans Affairs-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.

End of Document

Sources Sought Notice