Statement of Work Equipment Steris Endodry Adv Cabinet.pdf

VA North Texas Health Care System

STATEMENT OF WORK

Equipment Package (Sterile Processing Service) Steris Endodry Advanced Cabinet

1 Introduction

The VA North Texas Health Care System (VANTHCS) has a requirement to purchase Steris Endodry Advanced Cabinet with an authorized vendor to supply and deliver the item(s) identified in Table 1 below.

See attachments for salient characteristics. This requirement is in support of the activation of the VANTHCS. Item(s) are to be delivered to the location specified in section 2.4.1.

Table 1 – Package Items Summary

Item Item Description Quantity

DRY1001 Endodry Adv Cabinet Ss OI 1

INS1011 Install, Endodry Business Day 1

CAS1000 Model Cas-1000 Assy, Cassette, Transport 12

ML020107 Assy Intercept Wipes 4x1 4/Ca 1

28112 Model 2-8-112 Assy, Hookup Olympus 1K 4

28210 Model 2-8-210 Assy, Hookup Olympus 2K 4

28611 Model 2-8-611 Assy, Hook-Up Oly 4

28511 Model 2-8-511 Assy, Hook-Up Oly 4

28210 Model 2-8-210 Assy, Hook-Up Olympus 2K 4

67199979 Water Conservation & Cooling Equipment 3

SE150042 Barcode, Adv 500-599 1

67199981 Barcode, Adv 700-799 1

1. GENERAL. This entire section applies to all acquisitions requiring any Information Security and Privacy language. Contractors, contractor personnel, subcontractors and subcontractor personnel will be subject to the same federal laws, regulations, standards, VA directives and handbooks, as VA personnel regarding information and information system security and privacy.

2. VA INFORMATION CUSTODIAL LANGUAGE. This entire section applies to all acquisitions requiring any Information Security and Privacy language.

3. a. The Government shall receive unlimited rights to data/intellectual property first produced and delivered in the performance of this contract or order (hereinafter “contract”) unless expressly stated otherwise in this contract.

This includes all rights to source code and all documentation created in support thereof. The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General. The primary clause used to define computer software license (not data/intellectual property first produced under this contractor or order) is FAR 52.227-19, Commercial Computer Software License.

4. b. Information made available to the contractor by VA for the performance or administration of this contract will be used only for the purposes specified in the service agreement, SOW, PWS, PD, and/or contract. The contractor shall not use VA information in any other manner without prior written approval from a VA Contracting Officer (CO). The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General.

5. c. VA information will not be co-mingled with any other data on the contractor’s information systems or media storage systems. The contractor shall ensure compliance with Federal and VA requirements related to data protection, data encryption, physical data segregation, logical data segregation, classification requirements and media sanitization.

6. d. VA reserves the right to conduct scheduled or unscheduled audits, assessments, or investigations of contractor Information Technology (IT) resources to ensure information security is compliant with Federal and VA requirements. The contractor shall provide all necessary access to records (including electronic and documentary materials related to the contracts and subcontracts) and support (including access to contractor and subcontractor staff associated with the contract) to VA, VA's Office Inspector General (OIG),

7. and/or Government Accountability Office (GAO) staff during periodic control assessments, audits, or investigations.

8. e. The contractor may only use VA information within the terms of the contract and applicable Federal law, regulations, and VA policies. If new Federal information security laws, regulations or VA policies become applicable after execution of the contract, the parties agree to negotiate contract modification and adjustment necessary to implement the new laws, regulations, and/or policies.

9. f. The contractor shall not make copies of VA information except as specifically authorized and necessary to perform the terms of the contract. If copies are made for restoration purposes, after the restoration is complete, the copies shall be destroyed in accordance with VA Directive 6500, VA Cybersecurity Program and VA Information Security Knowledge Service.

10. g. If a Veterans Health Administration (VHA) contract is terminated for default or cause with a business associate, the related local Business Associate Agreement (BAA) shall also be terminated and actions taken in accordance with VHA Directive 1605.05, Business Associate Agreements. If there is an executed national BAA associated with the contract, VA will determine what actions are appropriate and notify the contactor.

11. h. The contractor shall store and transmit VA sensitive information in an encrypted form, using VA-approved encryption tools which are, at a minimum, Federal Information Processing Standards (FIPS) 140-2, Security Requirements for Cryptographic Modules (or its successor) validated and in conformance with VA Information Security Knowledge Service requirements. The contractor shall transmit VA sensitive information using VA approved Transport Layer Security (TLS) configured with FIPS based cipher suites in conformance with National Institute of Standards and Technology (NIST) 800-52, Guidelines for the Selection, Configuration and Use of Transport Layer Security (TLS) Implementations.

12. i. The contractor’s firewall and web services security controls, as applicable, shall meet or exceed VA’s minimum requirements.

13. j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor may use and disclose VA information only in two situations: (i) in response to a qualifying order of a court of competent jurisdiction after notification to VA CO (ii) with written approval from the VA CO. The contractor shall refer all requests for, demands for production of or inquiries about, VA information and information systems to the VA CO for response.

14. k. Notwithstanding the provision above, the contractor shall not release VA records protected by Title 38 U.S.C.

§ 5705, Confidentiality of medical quality- assurance records and/or Title 38 U.S.C. § 7332, Confidentiality of certain

15. medical records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse or infection with Human Immunodeficiency Virus (HIV). If the contractor is in receipt of a court order or other requests for the above- mentioned information, the contractor shall immediately refer such court order or other requests to the VA CO for response.

16. l. Information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract will be protected and secured in accordance with VA Directive 6500 and Identity and Access Management (IAM) Security processes specified in the VA Information Security Knowledge Service.

17. m. Any data destruction done on behalf of VA by a contractor shall be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management, VA Handbook 6300.1, Records Management Procedures, and applicable VA Records Control Schedules.

18. n. The contractor shall provide its plan for destruction of all VA data in its possession according to VA Directive 6500 and NIST 800-88, Guidelines for Media Sanitization prior to termination or completion of this contract. If directed by the COR/CO, the contractor shall return all Federal Records to VA for disposition.

19. o. Any media, such as paper, magnetic tape, magnetic disks, solid state devices or optical discs that is used to store, process, or access VA information that cannot be destroyed shall be returned to VA.The contractor shall hold the appropriate material until otherwise directed by the Contracting Officer’s Representative (COR) or CO.

Items shall be returned securely via VA-approved methods. VA sensitive information must be transmitted utilizing VA-approved encryption tools which are validated under FIPS 140-2 (or its successor) and NIST 800-

52. If mailed, the contractor shall send via a trackable method (USPS, UPS, FedEx, etc.) and immediately provide the COR/CO with the tracking information. Self-certification by the contractor that the data destruction requirements above have been met shall be sent to the COR/CO within 30 business days of termination of the contract.

20. p. All electronic storage media (hard drives, optical disks, CDs, back-up tapes, etc.) used to store, process or access VA information will not be returned to the contractor at the end of lease, loan, or trade-in. Exceptions to this paragraph will only be granted with the written approval of the VA CO.

2 General Conditions

2.1 Site Address

2.1.1 The address of the VA North Texas Health Care is listed below. Additional information on delivery is located in section 2.4.

VA North Texas Health Care System 4500 S Lancaster Rd Dallas, TX 75216

2.2 Site Visit Information for Vendors

2.2.1 Full Address (Please include Bldg./Rm): VANTHCS, 4500 S Lancaster Rd, Dallas, TX 75216; Sterile

Processing Service, Basement, Building: 2J/ Room: BA-2236 POC Number (If multiple people are attending then please provide their names and telephone contact information): _Angela Tyner is the POC, (214) 857-2399 or Franco Cesar, (214) 857-2390 Date: TBD Time: n/a

2.3 Delivery Schedule

Items shall be delivered no earlier than the estimated delivery start date and no later than the delivery end date listed in Table 2 below.

Table 2 – Anticipated Building Outfitting Schedule

Building Name Building # & Letter Acronym Est. Delivery Start Date

Est. Delivery End Date

VA North Texas Health Care System

2J VANTHCS 2025-07-30 2025-07-30

2.4 Schedule and Order Management

2.4.1 The above delivery schedule is based upon the current construction schedule, which is subject to change.

The vendor shall not increase prices for a change in delivery date for up to 30+ days due to construction delays.

2.4.2 The awardees actual delivery dates will be confirmed by VA upon award.

2.4.3 Post-award the vendor will coordinate delivery prior to beginning any work (see section 2.4). Once the dates have been confirmed, modifications to the schedule are subject to written approval by the VA POC and the vendor. Schedule changes that are beyond the dates specified in the contract will require approval by the Contracting Officer and a contract modification.

2.5 Delivery and Receiving

2.5.1 Delivery and receipt of the proposed items is anticipated to be directed to the location identified below.

Confirmation of delivery location will be provided by the VA POC post-award. Delivery must be coordinated with VA Logistics Warehouse (primary), ______________ prior to any attempts at delivery. Any item that has not been coordinated will be turned away and any additional charges will be the responsibility of the sender/transportation company.

☒ VA North Texas Health Care System (Direct Delivery to address detailed in paragraph 2.1.1)

2.5.2 Delivery shall be freight on board (FOB) – Destination.

2.5.3 The vendor is required to define the need for a staging area to accommodate item delivery, if needed. Post-award, this information will be confirmed with the vendor.

2.5.4 The delivery of items identified in this document shall take place during normal business hours which are defined as: 0800 to 1600 (i.e.: 8:00am to 4:00pm Central Time), Monday through Friday, and excluding Federal Holidays.

2.5.5 Delivery trucks will not be permitted to remain at the loading dock. Trucks shall be unloaded, moved from the dock, and then brought back to the dock if required to haul out any waste, tools, or excess materials.

2.5.6 Labeling of delivered items shall include the awarded contract number and VA purchase order number for identification and reference upon receipt of product.

2.6 Use of Warehouse

2.6.1 If the vendor requires the use of the Government’s activation contractor’s warehouse to meet the requirements of this contract the vendor must provide a certificate of insurance prior to the delivery and offloading of the item(s). This insurance certificate must be completed and presented to the activation contractor prior to delivery.

2.6.2 The vendor shall communicate through the VA POC any required coordination requirements.

2.7 Clean Up and Disposal

2.7.1 There are no dumpsters available for vendor use.

2.7.2 The removal of waste and/or excess material shall be conducted through the loading dock area. Delivery trucks and/or other vendor vehicles will not be permitted to remain at the loading dock. Vehicles will need to be brought back to the dock if required to remove any waste, tools, or excess materials.

2.8 Deliverables

2.8.1 The vendor shall provide CAD drawings (including shop drawings) and specifications for site prep for their product as required.

2.8.2 The vendor shall provide a completed VA Form 6550 with submittal documents for all item(s) that may connect to the VA network and medical devices that store sensitive patient information.

2.9 Assembly and Installation [ ☒ is ☐ is not required]

2.9.1 The vendor is required to manage and coordinate installation at the VANTHCS with the VA POC.

2.9.2 On-site assembly and installation of items, and performance of services identified in this document shall take place during normal business hours which are defined as: 0800 to 1600 (i.e.: 8:00am to 4:00pm Central Time), Monday through Friday, and excluding Federal Holidays.

2.9.3 The vendor is required to define the need for a staging area to accommodate item assembly and installation, if needed. Post-award, this information will be confirmed with the vendor.

2.9.4 The vendor is required to provide tools, labor and materials to complete assembly and installation of the items detailed in this document.

2.9.5 The vendor shall protect all finished spaces and surfaces as required from delivery and installation damage.

The vendor shall use covering and protection to the extent necessary to prevent damage to finished spaces.

Any damage occurred during delivery and installation is the responsibility of the vendor. The vendor will be responsible for paying for and repairing any damage or noted deficiencies to finished spaces and surfaces that occur as a result of the vendor’s (or associated sub-contractors) installation.

2.9.6 During the entire duration of assembly and installation, the vendor will have a competent representative on-site as the vendor’s contact, and to serve as the interface between the vendor and VANTHCS. On-site representative can be the installer. All instructions provided from COR to the representative will be binding as if given to the vendor’s main contact. The COR may provide specific instructions, however, only the Contracting Officer may change the terms or conditions of the contract.

2.10 Training [ X is is not required]

2.10.1 The vendor shall coordinate through the VA POC to provide a hands-on training session to staff selected by the VA. Training shall be completed within 45 days after final installation of equipment. The vendor will record the training and provide an electronic copy of the training to the VA POC for VA to use to train additional personal at a future date. In addition, the vendor shall provide additional training documents to the VA POC for training additional persons at a future date.

2.11 Standard Warranty

2.11.1 The products shall be covered by vendor’s standard warranty terms and provisions, provided, however that the warranty coverage shall be no less than the following:

2.11.2 The Vendor shall provide a warranty certificate/form stating the warranty period, terms, and information required to initiate the warranty.

2.11.3 The warranty period set forth therein shall run for one year following the first day of use at VANTHCS;

2.11.4 The vendor shall extend such warranty directly to the customer as if such customer had purchased the Products directly from the vendor.

2.11.5 The vendor shall warrant the products against defects in material and workmanship under normal use and service, repair or replace at vendor’s cost any defective Product (or issue a credit or refund based on the purchase price paid therefor); and

2.11.6 The vendor shall pay (or refund the amount of) all freight and shipping charges for any defective Products returned under this paragraph.

2.12 Use of Premises

2.12.1 If during the performance of this contract, work will be carried out on VANTHCS premises, the vendor shall perform all work in such a manner that will cause a minimum interference with VANTHCS operations and the operations of other contractors on the premises.

2.12.2 The vendor shall communicate through the VA POC any required coordination requirements with the General Construction contractor prior to and during delivery and installation activities.

2.12.3 The project may be an active construction site during delivery and installation. The vendor shall take all necessary precautions to protect the premises and all persons and property therein from damage or injury.

The vendor shall assume responsibility for taking precautions for the vendor's (and associated subcontractors’) employees, agents, licensees, and permittees. The vendor shall abide by any safety requirements imposed by the GC (e.g. hard hats, safety vests).

2.13 VHA Supplemental Contract Requirements for Ensuring Adequate COVID-19 Safety Protocols for Federal Contractors

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

a) Documentation requirements:

i) If fully vaccinated, shall show proof of vaccination.

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

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

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

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

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

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

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

VANTHCS Sterile Processing Service – Steris Endodry Adv Cabinet Ss OI

DRY1001

4500 S Lancaster Rd.

Dallas, TX 75216

Project: VANTHCS Sterile Processing Service – Steris Endodry Adv Cabinet Ss

OI

Issue Date: Jul 2025 543_ Total Quantity: 1 ☐ Finish Sample Required if Checked ☐ Manufacturer Certified Installation Required if Checked.

☐ BMET Training Required if Checked ☒ End User Training Required if Checked

Item Name: – Steris Endodry Adv Cabinet Ss OI Basis of Design Brand or Equal: Steris |Endodry Adv Cabinet Ss, | DRY1001 Main Image:

*Salient Characteristics: (* indicates required items) Endodry:

• Stainless-steel

• Dimensions: 75 H x 24 W x 22 D (inches) 190 H x 60 W x 54 D (cm)

• Eight endoscope trays with interlocks

• Barcode reader for consistent data entry, endoscope tracking and user authorization

• Programmable maximum storage time

• Alarm in case of pressure or power loss

• Internal digital documentation of process parameters

• Integrated multi-lingual information and control panel

• Single-sided

• Utilizes hands-free scope handling system for HLD, drying, storage and transport

Hookups:

• Designed for individual channel monitoring

• Has a connector block with eight separate ports

• Provides the critical connection between the endoscope and the automated endoscope reprocessor

• Validated design for a large array of endoscope models

Hookup Cassettes:

• Provides tough-free scope handling to reduce cross-contamination while protecting the endoscopes during transport to reduce endoscope damage DSD Hookups:

• Collection of connectors and bi-furcated tubing beginning with a single basin port connection. (Specifically for Olympus GI scopes and connecting up channels)