URO Attachment B Statment of Work IDIQ Visn 22 URO.docx

Statement of Work:

Urology Lease VISN 22 Department of Veterans Affairs

1. DESCRIPTION OF CONTRACT

1.1 This is an Indefinite Delivery Indefinite Quantity (IDIQ) contract for medical scopes and related equipment with service maintenance pursuant to Federal Acquisition Regulation (FAR) parts 12, 13.5, and 16 for the Department of Veterans Affairs (VA), Veterans Integrated Service Network (VISN) 22. This IDIQ shall entail both leases and individual purchases of items with service maintenance agreements as listed in the schedule under Attachment A. The Contractor agrees to the following terms of the IDIQ exclusively with the VISN facilities listed in 1.6. However, as requirements change, facilities within VISN 22 may be added or deleted by supplemental agreement between the Government and the Contractor.

1.2 This IDIQ does not obligate any funds. All products ordered under any delivery orders shall be subject to the terms and conditions of this IDIQ. The Government is obligated only to the extent of authorized delivery orders issued under the IDIQ by contracting officers for VISN 22.

1.3 VISN 22 has provided estimated requirements in Attachment A. Additional items may be added to this IDIQ that are related to the use of medical scopes and related services. All attachments identified in Section D are hereby incorporated into this document as an attachment of the document itself, however, this document shall supersede any conflicts of terms and conditions present in Section D.

1.4 The IDIQ base period will be five years. Throughout this period, each facility is authorized to place orders for medical scopes and related equipment within the established ordering base period of the IDIQ.

1.4.1 Base Period: (TBD upon award, target date of 10/01/2026- 09/30/2031)

1.5 Delivery Orders issued shall be identified by IDIQ Number (To Be Determined upon award).

1.6 Participating Facilities: (Additional Facilities within VISN 22 may be added to this agreement with an exercise of a supplemental agreement between the CO and Contractor. A Contracting Officer Representative (Hereafter referenced as COR) may be assigned from each facility as a primary point of contact. Overall pricing should reflect the overall volume of all sites below and should be taken into consideration for any addition of future facilities within VISN 22.

1.6.1 **VA Greater Los Angeles Healthcare System** 11301 Wilshire Blvd, Los Angeles, CA 90073

1.6.2 **VA Loma Linda Healthcare System** 11201 Benton Street, Loma Linda, CA 92357

1.6.3 **VA San Diego Healthcare System** 3350 La Jolla Village Dr, San Diego, CA 92161

1.6.4 **VA Long Beach Healthcare System** 5901 E. 7th Street, Long Beach, CA 90822

1.6.5 **VA Northern Arizona Healthcare System** 500 AZ-89, Prescott, AZ 86301

1.6.6 **VA New Mexico Healthcare System** 1501 San Pedro Drive SE, Albuquerque, NM 87108

1.6.7 **VA Phoenix Healthcare System** 650 East Indian School Road, Phoenix, AZ 85012

1.6.8 **VA Southern Arizona Health Care System** 3601 S 6th Avenue, Tucson, AZ 85723

2. SCHEDULE OF SUPPLIES AND SERVICES

2.1 Attachment A: This section shall encompass the Indefinite Delivery Indefinite Quantity (IDIQ) Schedule, which may be subject to amendments through contract modifications issued by the Contracting Officer. Delivery Orders may be placed and obligated against items specified within the IDIQ Schedule. Items not explicitly detailed in Attachment A may still be procured under this IDIQ arrangement from the Contractor’s catalog at a discount rate to be determined or through the provision of a catalog that outlines discounts for all items included within it. Annually, the Contractor is required to submit an updated catalog of available items; the submission of an online catalog is permissible.

3. STATEMENT OF WORK

3.1 Introduction to Required Specifications

3.1.1 Purpose: The desired instrumentation shall have the capability of performing or reporting the clinical parameters as defined in the statement of work. The instrumentation shall be able to perform the complete profile as described below and meet the performance characteristics for accuracy and precision as defined by the FDA.

3.1.2 Primary Goals: The Contractor is required to provide medical scopes identified within individual delivery orders relating to Attachment A: Schedule. Each delivery order awarded shall act as a lease with renewable option years. A delivery order may have as many as four (4) option years. Each delivery order shall be subject to the terms and conditions of the IDIQ. Provided items shall be of the highest quality, sensitivity, and specificity and tested to assure precision and accuracy. Alert/Notification of any delays in shipment as well as any or all technical advisory/recalls/alerts, before or simultaneously with field alerts should be forwarded to the designated individuals, Contracting Officer Representatives (Hereafter referenced as COR), and the VISN program office. These individuals shall be identified upon award of the IDIQ.

3.1.3 Equipment: All equipment shall be new, state-of-the-art, and not recertified nor refurbished. Equipment shall be acquired for each of the stations located at the following VISN 22 facilities: See section 1.6 and Attachment A.

3.1.4 Industry Standards: Unless otherwise stated, all equipment shall be held to current industry standards for such equipment as present within the current market for Medical Scope equipment, supplies, and related services.

3.1.5 Contractor may provide scopes for all possible uses within a medical setting for the below categories. All scopes will be listed within the schedule; see attachment A.

3.1.5.1 Urology

3.2 Medical Scope and Related Equipment Requirements

3.2.1 Compatibility Requirements

3.2.1.1 Must be compatible for use with current Endoscope Washers (If not compatible, please provide information to determine what additional equipment would be required)

· Medivators (Advantage Plus)

· Evotech ECR and OER Pro

· Sterrad 100NX

3.3 Support Features

3.3.1 Installation/Site Preparation: Site preparation specifications shall be furnished in writing by the Contractor as a Site Preparation Report after award of the delivery/task order. The Contractor shall provide coordinated professional installation and implementation project management services to implement the system specified in the SOW at all identified sites. The Contractor shall provide a firm estimate of working days required from date of delivery order to go-live based upon the SOW. The initial installation site report shall be provided to the CO no later than one week after the initial post award conference and all other site reports shall be provided at least forty-five (45) days before installation of all those sites. Contractor shall visit each site and propose the location of equipment and determine specific site prep requirements including but not limited to:

3.3.1.1 Space availability

3.3.1.2 Power availability

3.3.1.3 Equipment shall be new, state of the art, and not recertified or refurbished.

3.3.1.4 Configuration of mounts, modules, and peripheral equipment.

3.3.1.5 VA responsibilities

3.3.1.6 Provide additional power requirements as provided in vendor specifications.

3.3.2 Warranty: The Contractor shall provide a minimum warranty of no less than the length of the overall lease. Any lease extensions must include an inclusive warranty for all equipment.

3.3.3 User and Service Manuals: The Contractor shall provide to each station at no charge, two (2) complete and unabridged printed copies and one (1) electronic version (CD) of operator manuals, service manuals, electronic schematics, troubleshooting guides, diagnostic software and tools, and parts lists for each piece of equipment purchased to the COR with delivery of equipment upon request. Additionally, any upgrades to these documents shall be provided by the Contractor free of charge. These manuals shall include all components and subassemblies, including those not manufactured by the Contractor. These manuals and documentation shall be identical to the ones supplied to the manufacturer’s service representatives and shall contain the diagnostic codes, commands, and passwords utilized in maintenance, repair and calibration of the equipment and provided for the life of the system at no additional cost.

3.3.4 Clinical Training: The Contractor shall provide a training program that is coordinated with and timely to the equipment installation. Training shall include initial setup and user training; onsite training for go-live support, super user training and follow-up training. Contractor’s shall provide a sample of the training curriculum for both in-service applications training and Biomed Technical training and explain training methodology and training plan.

3.3.5 Service/Maintenance: Contractor shall provide a full service/maintenance program for all medical scopes identified in Attachment A. The service/maintenance program must have the following features:

3.3.5.1 Complete repair of a covered item with Original Equipment Manufacturer (OEM) parts. Covered items will be shipped at the Contractor’s expense and no additional charge shall be made to the facility.

3.3.5.2 While any covered item is being repaired, a loaner scope shall be sent to the facility for use if requested and available. If a covered item cannot be repaired, it must be replaced entirely with a new replacement item of the same make and model.

3.3.5.3 Contractor must maintain and provide reports of repair usage of covered items upon facility request.

3.3.5.4 Pricing for this program shall be included in Attachment A.

3.3.6 Upgrade/Updates: The Contractor shall provide updates to both the equipment hardware and software in order to maintain the integrity of the system and the state-of –the art technology, at no additional charge to the Government. These shall be provided as they become commercially available and at the same time as they are being provided to commercial customers. This requirement only applies to “system updates” that enhance the model of equipment being offered, i.e. new version of software, correction of hardware defect, update offered to commercial customers at no additional charge, upgrade to replace model of equipment no longer Contractor supported, etc. This does not refer to replacing the original piece of equipment provided under the IDIQ; however, it does refer to significant changes in the hardware operational capability. Should the VISN decide to upgrade their current equipment i.e. - replacement of existing equipment with newer models, the CO and Contractor may do so under a signed supplemental agreement.

4. PACKAGING & MARKING

4.1 Packaging

4.1.1 All equipment and supplies shall be adequately packaged to prevent damage during shipping, handling and storage. Bags or packages shall be whole, intact, and not otherwise torn or damaged. Upon delivery, the Government shall examine all packages. The Contractor shall be required to replace unacceptable or damaged products at the Contractor’s expense.

4.2 Marking

4.2.1 All items shall be marked clearly with the IDIQ Number, Delivery Order Number, Obligation number and delivery location within the hospital i.e. Emergency Room. For major Equipment, the Obligation number shall begin with an A after the station number i.e. 600C60000. All other service items shall be marked with a C number i.e. 600C60001. The Delivery Order number shall have a format similar to this example: 36C26226….

4.2.2 A list of all serialized equipment shall be provided with equipment delivery and also sent electronically to the contracting officer and specific using clinic.

5. DELIVERIES & PERFORMANCE

5.1 Installation/Implementation

5.1.1 Implementation/transition timeframe: The implementation of the services/ requirements described in this IDIQ shall be completed no later than thirty (30) days after the award of the IDIQ and corresponding delivery order for each identified station and clinic. This timeline is based upon a reasonable attempt of the Contractor to complete all necessary implementation requirements within the stated timeframe. Contractors shall not be penalized for implementation timelines that extend beyond the thirty (30) day timeframe, if the extension is through no fault of the Contractor and is a result of delays due to the Government (i.e. construction/remodeling of facilities). Upon award of a delivery order, the transition period for the awarded Contractor to have all equipment and peripherals installed and operational shall be thirty (30) days from the date of award. During this same period, all initial training of VA personnel in the operation and maintenance of said award shall also be completed, with exceptions due to delays at the fault of the Government.

5.2 Acceptance and Performance: This paragraph establishes a standard of quality performance that shall be met before any equipment listed on the delivery order/IDIQ is accepted by the Government. This also includes replacement, substitute items and items that are added or field modified after a system has demonstrated successful performance. The acceptance period shall begin on the completion of installation and completed Certificate of Acceptance. A modification is required after lease commencement to reflect actual lease start and end dates if different from the delivery order due to delays in shipping or otherwise.

5.2.1 Certificate of Acceptance and Lease Commencement – The delivery order shall have a Lease Commencement Date of thirty (30) days from issuance unless otherwise accepted by the contractor. Lease will commence upon completion of a Certificate of Acceptance provided by the contractor to the COR and CO signifying that all equipment has been provided to the facility, training has been completed and equipment is primed for use. If all equipment is not received due to issues such as backorders, partial acceptance is allowable in order to commence the lease however invoicing shall be prorated both with service and equipment until all equipment is received.

5.2.2 During the term of the IDIQ, should the repair record of any individual piece of equipment reflect a downtime of 10% or greater of the normal working days in one calendar month, a determination shall be made by the designated representative of the Government to replace the malfunctioning equipment with new equipment at no charge to the VISN. Each instrument provided by the Contractor shall maintain an uptime of 90% in each month of the term of the agreement. Fault of failure attributable to Government misuse or handling shall void this requirement for each specific failure.

5.3 Delivery: The Contractor shall deliver all supplies and services identified in the schedule to the locations identified in section 1.6.

5.3.1 The delivery location is subject to change as required by the designated authority or authorized personnel at the receiving facility. The Contracting Officer Representative (Hereafter referenced as COR) shall be required to notify the Contractor when delivery locations have been changed.

5.3.2 All deliveries shall be made during normal working hours from 8:00 a.m. to 4:00 p.m. and a copy of the packing list/slip shall be provided at time of delivery. The packages packing list/slip shall contain the complete purchase order number, IDIQ number, shipping address, delivery location, items/quantity ordered and items/quantity shipped. Standard orders shall be delivered within no more than 30 working days after receipt or placement of order.

5.4 Government’s Responsibility: The user shall perform routine maintenance and cleaning as required in the manufacturer’s operation and maintenance instructions. The user shall maintain appropriate records to satisfy the requirements of this paragraph.

6. CONTRACT ADMINISTRATION DATA

6.1 Ordering, Invoice and Payment

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

Name:

Address:

Phone No:

Fax No:

Contact:

Email:

Name:

Address:

Phone No:

Fax No:

Contact:

Email:

6.1.2 Payment Address: The Contractor shall submit in arrears a completed individual itemized invoice in accordance with the address below.

Submit Invoices Electronically To:

https://www.tungsten-network.com/customer-campaigns/veteransaffairs/

6.1.3 Invoice Information: The following information shall be listed on all invoices (Failure to comply may result in refusal of an invoice resulting in delayed payment at the fault of the Contractor).

6.1.3.1 Facility’s Name and address where service was provided

6.1.3.2 IDIQ Number (For Example :36C26226A…)

6.1.3.3 Delivery Order Number (For Example: 36C26226N…)

6.1.3.4 Obligation Number (For Example: VA600-C67001)

6.1.3.5 A line item breakdown of usage for example:

6.1.3.6 Line item 1 URO Scope Lease: 1 MO at $400.00

6.1.3.7 Line item 4 URO Service Maintenance: 1 MO at $10.00

6.1.3.8 Identify the period of time by month/year charged in the invoice.

6.1.3.9 IDIQ Holder’s Internal Contract number (if applicable)

6.1.3.10 Include point of contact for concerns and questions. Contractor must name a specific person, phone number, and email.

6.2 IDIQ Program Manager

6.2.1 The Contractor shall provide an IDIQ program manager who shall be responsible for the performance of the work under the IDIQ. In addition, the program manager shall act as the main focal point of communication between the Contracting Officer and the Contractor. The name of this person shall be designated in writing to the Contracting Officer. The program manager shall have full authority to act on behalf of the Contractor on all contractual/IDIQ matters relating to the daily operation of the IDIQ.

Company Name:

Address:

Phone No:

Fax No:

Contact Name:

Email:

6.3 Hours of work

6.3.1 The IDIQ shall include five day a week, 9 hours a day full service agreement to include all necessary service calls. After hours and weekends service are chargeable as per Supplies or Service and Prices/Costs section herein, Schedule of Labor Charges and Replacement Parts. Contractor may offer differing times for the service agreement, but may not reduce the availability of time by no more than two hours from the above stated times.

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

6.3.3 Holidays: Only emergency service shall be provided on National Holidays and only if authorized by the COR in advance as approved in the delegation of authority. The rates shall be chargeable as per Supplies or Service and Prices/Costs section herein, Schedule of Labor Charges and Replacement Parts.

6.3.4 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 preceding 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.

7. SPECIAL IDIQ REQUIREMENTS

7.1 Physical Security and Facility Considerations

7.1.1 Identification, Parking, Smoking and VA Regulations (For any onsite services):

7.1.1.1 The Contractor employees and/or Subcontractors approved by the COR shall wear visible identification at all times while on the premises of the facilities within the VISN. Identification shall include, but not be limited to, a company identification card, which shall include the company name, employee name, title, and a photograph of the employee. Contractor Employees shall maintain a professional appearance commensurate to their industry.

7.1.1.2 It is the responsibility of the Contractor to park in the appropriate designated parking areas. Information on parking is available from the VA Police Section. The VA will not invalidate or make reimbursement for parking violations of the Contractor under any conditions.

7.1.1.3 Any interior or exterior doors that shall be unlocked to gain access shall be kept locked during the performance of work unless it results in the creation of a safety hazard. In those instances, the Contractor is responsible for taking necessary actions to maintain the same level of security before gaining access/performing work. Should any other devices need to be unlocked like an entry gate, those devices shall be locked immediately upon entry or exit. At no time shall the Contractor allow any person into a locked area or loan keys/access cards to another person. Contractor may be held in default for failure to comply with this requirement and subject the Contractor and its employees to contractual and other legal remedies.

7.1.1.4 Contractor personnel are required to check into the facility Police & Security office at each visit to pick up a “contractor” badge prior to contacting the COR. The Contractor’s staff shall also be required to sign in and out each day at a designated location determined by the COR.

7.1.1.5 The Contractor agrees that none of its officers or employees shall use or reveal any research, statistical, medical, or security information which may be obtained during the performance of the work or as a result of their presence on Government premises without the written consent of the Government

7.1.1.6 Smoking is prohibited inside any buildings at facilities within VISN 22.

7.1.1.7 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.

7.1.1.8 The Contractor shall not allow his/her employees, including Subcontractors’ employees, to open desk drawers, cabinets, or to use office equipment, including the use of non-pay telephones for any purpose other than a local emergency call. The Contractor shall be responsible for providing all necessary equipment, tools, parts, and materials to perform the work. The Government shall not be obligated to provide any equipment, tools, parts, and materials to assist the Contractor in performing the work.

7.1.2 Background Checks:

7.1.2.1 The Office of Security and Law Enforcement provides Department-wide policy on the assignment of appropriate position sensitivity designations associated with Department of Veterans Affairs (VA) positions involving national security and public trust responsibilities, and on the level of background investigations required for applicants for, and incumbents of, those positions.

7.1.2.2 IAW VA 0710 Handbook, appointees and contract personnel appointed to Low/Moderate/High Risk positions must be subjects of a background investigation conducted by OPM and receive a favorable adjudication from the VA Office of Security and Law Enforcement to ensure compliance with such policy. If such investigation has not been completed prior to contract commencement, the Contractor shall be responsible for the actions of those individuals performing under the contract.

7.1.2.3 Should the contract require Contractor’s personnel to maintain U.S. citizenship, the Contractor shall be responsible for compliance. Regardless of U.S. citizenship requirements, Contractor’s personnel are required to read, write, speak, and understand the English language, unless otherwise specified in this contract or agreed to by the Government.

7.1.2.4 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 on the basis of 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

7.1.2.5 The Contractor shall be required to furnish all applicable employee information required to conduct the investigation, such as, but not limited to, the name, address, and Social Security number of the Contractor’s personnel. 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 contract personnel assigned to Low Risk/Non-sensitive positions for 180 days or less under a single contract or series of contracts. However, a Security Access Clearance (SAC) background screening will be required for appropriate preliminary checks IAW VA Directive 0710.

7.2 Information Technology Security Considerations

7.2.1 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.

7.2.2 All electronic storage media used on non-VA leased or non-VA owned IT equipment that is used to store, process, or access VA information must be handled in adherence with VA Handbook 6500.1, Electronic Media Sanitization upon: (i) completion or termination of the Contract or (ii) disposal or return of the IT equipment by the Contractor/subcontractor or any person acting on behalf of the Contractor/subcontractor, whichever is earlier. Media (hard drives, optical disks, CDs, back-up tapes, etc.) used by the Contractors/subcontractors that contain VA information must be returned to the VA for sanitization or destruction or the Contractor/subcontractor must self-certify that the media has been disposed of per 6500.1 requirements. This must be completed within 30 days of termination of the Contract.

7.2.3 Bio-Medical devices and other equipment or systems containing media (hard drives, optical disks, etc.) with VA sensitive information must not be returned to the vendor at the end of lease, for trade-in, or other purposes. The options are:

7.2.4 VA’s initial medical device purchase includes a spare drive which must be installed in place of the original drive at time of turn-in; or

7.2.5 VA must reimburse the company for media at a reasonable open market replacement cost at the time of purchase.

7.2.6 Due to the highly specialized and sometimes proprietary hardware and software associated with medical equipment/systems, if it is not possible for the VA to retain the hard drive, then;

7.2.7 The equipment vendor must have an existing BAA if the device being traded in has sensitive information stored on it and hard drive(s) from the system are being returned physically intact; and

7.2.8 Any fixed hard drive on the device must be non-destructively sanitized to the greatest extent possible without negatively impacting system operation. Selective clearing down to the patient data folder level is recommended using VA-approved and validated overwriting technologies/methods/tools. Applicable media sanitization specifications need to be pre-approved and described in the purchase order or Contract.

7.2.9 A statement needs to be signed by the Director (System Owner) that states that the drive could not be removed and that (a) and (b) controls above are in place and completed. The ISO needs to maintain the documentation.

7.3 Insurance Requirements for work performed on Facility Grounds

7.3.1 The Contractor agrees to procure and maintain, while the Contract is in effect, Workers' Compensation and Employee’s Public Liability Insurance in accordance with Federal and State of California and/or Nevada laws.

7.3.2 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.

7.3.3 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.

7.3.4 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 by FAR 52.228-5 and per FAR Subpart 28.307-2 has been obtained and that it may not be changed or canceled without guaranteed thirty (30) day notice to the Contracting Officer.

7.3.5 Contractor is required to provide copies of proof of Workers' Compensation and Employee Public Liability Insurance within fifteen (15) calendar days after notification of Contract award.

See attached document: Attachment A Schedule Urology Scopes Attachment B Statement of Work