SOW-Draft RFI 36C26226Q1004 Guldmann OR EQUAL Ceiling Patient Lifts 07102026.docx

STATEMENT OF WORK (SOW) (DRAFT)

Safe Patient Handling and Mobility Program Manager

Phone Number:

1. General Information

1.1. Description

1.1.1. Project Title: Overhead Lift System Removal and Replacement 3E

1.1.2. Background: Patient Ceiling Lift: The term “ceiling lift” is often used in place of “overhead lift” to identify full-body patient lifts with track/rail systems that are affixed to a ceiling or wall structural component. When ceiling or wall-mounted systems cannot be installed, a freestanding four-post rail system with a floor-bearing lift may be used.

Ceiling lifts raise a Veteran's entire body into the air. While they are designed to make patient handling safer, companies may or may not have features that provide the safest and most reliable functionality. Any kind of mistake or flaw in the equipment or its functionality poses a serious safety risk for the Veteran and staff involved. Any challenges with past performance impact future capabilities and confidence in adequate, safe care delivery. Any lack of essential functionality reduces the capability in providing the highest quality of Veteran care. Therefore, it is essential to procure lifts meeting the needs of the Veterans we serve, including attention to past performance to make this determination.

The current facility requirement is to replace the end of life and soon to be obsolete overhead lift systems (motors and lift rails) on the inpatient unit 3 East, Building 38. This is a 15 room, 25 bed unit in single and double room occupancy. It has 15 overhead patient lifts. Any manufacturer will be required to remove current rails and install the new rails onto existing structure.

This project does not include construction. Therefore, no existing physical structure shall be cut or modified by the contractor or installation team. Any construction, existing structure demo, modification, or reinstallation including but not limited to ceilings, walls, tile, patching, painting, acoustic caulking, asbestos abatement, smoke/firewall repair, fireproofing reapplication, sprinkler relocation, and door header modification is outside the scope of work.

1.2. Type of Contract: Firm-Fixed Price

1.3. Quality Assurance

1.3.1. Certification for compliance is required for Ceiling Mounted Patient Lift Systems. Certifications shall be provided by the manufacturer who will conduct testing to ensure that the ceiling lift and charging system are safe and in compliance with ISO 10535 & UL 60601-1.

1.3.2. Inspection of equipment after installation is required prior to use for patient movement. Inspection shall be in accordance with the manufacturer's installation checklist and any VA and facility mandated installation checklists, including but not limited to the checklists included in Patient Safety Alert AL14-07.

1.3.2.1. This requirement is for Major and Minor projects where a commissioning agent is used and may be waived for NRM and Station Level projects if a VA POC or General Engineer can perform this work. Verify requirement with Medical Center.

1.3.3. Certification of compliance with VA requirements shall be provided by an independent third party, Inspector of Record (IOR), who will observe installation and manufacturer’s testing to ensure that the ceiling structure, ceiling lift, and charging system is safe and compliance with shop drawings, structural calculations, specifications, ISO 10535 requirements, and code requirements. IOR shall be a registered structural engineer in the state of installation.

1.3.4. Installation shall be performed by personnel certified by the lift manufacturer for this work. Evidence of certification shall be available and provided at the facility’s request

1.4. Submittals

1.4.1. Submit in accordance with specification section 01 33 23, shop drawings, product data, and samples.

1.4.1.1. Shop drawings shall show structural supports to the underside of structure. Structural calculations for the support of the track and its attachment to ceiling structure shall be submitted. Shop drawings used in the quoting phase shall be PDFs, and either 2D CAD files or 3D BIM files showing structural support to underside of structure. Shop drawings shall also provide general room layout with bed position and all obstructions to ceiling lift.

1.4.1.2. Once the purchase order is accepted by the vendor, a set of stamped drawings shall be provided by the vendor. Shop drawings and structural calculations shall be signed and stamped by a third-party registered structural engineer, and shall meet all code requirements in the jurisdiction having authority. The structural engineer shall ensure ceiling minimum structure capacity shall support the loads specified in the shop and installation drawings and be in compliance with local structural and seismic codes.

1.4.1.3. Shop drawings shall show obstructions such as curtains, lights and sprinklers, and coordinate their relocation.

1.4.1.4. Manufacturer shall provide BIM (Building Information Model) for clash detection on the request of the Resident Engineer (RE), or General Contractor.

1.4.2. Certificates of Compliance from Manufacturer

1.4.3. Manufacturer's Literature and Data:

1.4.3.1. Lifting Capacity

1.4.3.2. Lifting Speed

1.4.3.3. Vertical Axis Motor

1.4.3.4. Emergency Brake

1.4.3.5. Emergency Lowering Device

1.4.3.6. Emergency Stopping Device

1.4.3.7. Electronic Soft-Start and Soft-Stop Motor Control

1.4.3.8. Current Limiter for Circuit Protection

1.4.3.9. Strap Length

1.4.3.10. All equipment anchors and supports. Submittals shall include weights, dimensions, center of gravity of the structural support, standard connections, manufacturer's recommendations and behavior problems (e.g., vibration, thermal expansion) associated with equipment or piping so that the proposed installation can be properly reviewed.

1.4.4. Individual room layouts showing location of lift system installation shall be approved before proceeding with installation of lifts.

1.4.5. Manufacturer’s Checklist for after installation inspection.

1.5. Applicable Publications

1.5.1. The publications listed below form a part of this specification to the extent referenced. The publications are listed in the text by the basic designation only.

1.5.2. International Organization for Standardization (ISO):

1.5.2.1. ISO 10535:2021 — Hoist for the Transfer of Disabled Persons-Requirements and Test Methods

1.5.3. Underwriters Laboratories (UL):

1.5.3.1. UL 60601-1 (2003) — Medical Electrical Equipment: General Requirements for Safety

1.5.3.2. UL 94-2013 — Standards for Safety Test for Flammability of Plastic Materials for Parts in Devices and Appliances-Fifth Edition

1.5.3.2.1. NOTE: As of April 1, 2017 the FDA will no longer accept declarations of conformity in support of either IEC 60601-1-2 Edition 3:2007-03 or ANSI/AAMI/IEC 60601-1-2: 2007/(R)2012.

1.5.4. International Electromagnetic Commission (IEC):

1.5.4.1. IEC 60601-1-2 (2015) — Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests.

1.5.5. National Fire Protection Association (NFPA):

1.5.5.1. NFPA 13 — Standard for the Installation of Sprinkler Systems

1.5.5.2. NFPA 70 — National Electrical Code (NEC)

1.5.5.3. NFPA 99 — Health Care Facilities Code

1.5.6. VA Patient Safety Alert AL14-07

1.5.7. VA CFM Specification 11 73 00

2. Contract Award Meeting

2.1. The contractor shall not commence performance on the tasks in this SOW until the Contracting Officer (CO) has conducted a kick-off meeting, or has advised the contractor that a kick-off meeting is waived.

3. Specific Mandatory Tasks and Associated Deliverables

3.1. General Requirements

3.1.1. All installation shall comply with requirements of Patient Safety Alert AL14-07, including the Checklist for Installation and Relocation. The installation checklist shall be filled out for each installed lift, in addition to any checklist required by the manufacturer, and supplied to the VA's Facility POC within 7 days of installation.

3.1.2. Contractor will coordinate with the VA's Facility POC to schedule installations.

3.1.3. Contractor will provide information on minimum clearances for operation of each lift upon request by the VA's Facility POC.

3.1.4. Contractor will provide all qualified personnel, materials, equipment, and services necessary to install ceiling lifts for the rooms described below, including lifts, tracks, spreader bars, attachment hardware, and all other equipment necessary for safe operation.

3.1.5. Contractor shall provide installation and testing of all equipment for ceiling lifts, according to VA checklist requirements, resulting in a turnkey system.

3.1.6. Contractor will provide evaluation of existing structure to assure that workable systems are installed and comply with relevant standards.

3.1.7. Contractor will remove current rails.

3.1.8. Contractor will mitigate any new hazards created by installation, such as ramps over interstitial support beams that create trip hazards.

3.1.9. Contractor will meet safety training requirements, dust control requirements, TB testing, electrical safety requirements, and other permit requirements as dictated by the VA per local hospital policy.

3.1.10. Contractor shall provide all parts, rails, hardware, and equipment to result in a safe and working system regardless of the condition of any existing rails or supports.

3.1.11. Contractor shall not deliver equipment and supplies before designs are approved and contractor has approval to install.

3.1.12. The Contractor shall follow procedures required by facility Infection Control personnel and the Construction Safety Committee, to include any required dust control specified in the Infection Control Risk Assessment (ICRA). The procedures and risk assessment are available to the Contractor upon request to the VA’s Facility POC.

3.1.13. The Contractor shall furnish the facility with material safety data sheets (MSDS) for all chemicals used during installation, as required by OSHA regulations and for emergency treatment purposes.

3.1.14. The Contractor shall furnish at its own expense all labor, materials, machinery, and appliances necessary for performance of this contract.

3.1.15. Installation shall comply with NFPA 13 for fire sprinklers and with NFPA 99 and NFPA 70 for proper grounding, bonding, and access to electrical and safety systems.

3.1.16. The contractor must not require movement of any lights, sprinklers, televisions, or other fixtures in order to install ceiling lifts. If movement of preexisting fixtures is unavoidable, the contractor shall identify this in the planning phase and communicate with the VA’s Facility POC before commencing work, so that the facility may address it internally and outside this contract.

3.2. Location of Ceiling Lift Installations: Southern Arizona VA Healthcare System (SAVAHCS), 3601 S 6th Ave Tucson AZ 85723. The following is a list of all rooms in which the contractor shall perform removal of existing patient lift systems, including motor(s) and tracks/components, and installation of new patient lifts:

3.3. Description of Tasks and Associated Deliverables: The contractor shall provide the specific deliverables described below within the performance period stated in this SOW.

3.3.1. Deliverables

3.3.1.1. Twenty-five (25) Guldmann GH3+ 605 lb Systems in Accordance with Drawing Set 104989 as provided by the manufacturer.

3.3.1.1.1. Includes: Hoist (Trainer Module, Scale, CLM Online & Service), Hanger Bar, Rail w/ Charging Liner, 2 Slings & 1 Hour Clinical Training.

3.3.1.2. Guldmann certified installation including labor and hardware to install lifts in 15 rooms on 3E.

3.3.1.3. Removal and appropriate disposal of existing ceiling lift systems (15 systems) where new systems are being installed.

3.3.1.4. One stamped drawing by a third-party structural engineer.

3.3.1.5. All necessary information, including on-site handling, cleaning, procedures for use, instructions for service call events and indications, and electronic copies of user and repair manuals for each model installed, at no additional cost to the Government.

3.3.2. Design and Installation

3.3.2.1. The Contractor shall furnish all design, site evaluation, labor, materials, and equipment to install ceiling mounted patient lifts in the existing unit 3E in Building 38.

3.3.2.2. The contractor will provide an installation timetable prior to the start of installation.

3.3.2.3. The Contractor shall be required to install lift systems, including but not limited to providing any required plans, engineering details and documents, tools, labor, testing, training, cleaning supplies, containment systems, etc.

3.3.2.4. All new ceiling lift system installations must have a minimum single motor weight capacity of 600 pounds with options for a digital patient weight scale integrated into the motor with a readout at the remote pendant. All components of a lift, including but not limited to hanger bar, scale, rails, and slings, must meet or exceed the identified minimum weight capacity.

3.3.2.5. All ceiling lift and rail systems must be designed, constructed, and installed in a traversing X-Y (room-covering) design unless otherwise designated by the facility, in such a manner as to allow for maximum utilization of patient room space.

3.3.2.6. Track systems shall be self-supporting either from the ceiling or from a post- or wall-mounted system as required due to existing conditions, and only attached to structures that have been engineered to support the weight and lateral load of the ceiling lift. No existing utility systems or non-structural support shall be used for support or bracing the lift system.

3.3.2.7. Any lift installation that modifies the function of a room's privacy curtains must be discussed with facility stakeholders and submitted to and approved by the assigned project POC. SAVAHCS is responsible for modifying curtain configuration and installation therein.

3.3.2.8. All rooms shall be returned to the facility in their original condition. Any damage inflicted, including unplanned ceiling or wall penetrations, shall be corrected by the Contractor.

3.3.2.9. The Contractor must take every precaution to prevent damage to the drop ceiling tiles and tile grid. The facility will provide replacement tiles as reasonably needed.

4. Salient Characteristics

4.1. Ceiling Track System

4.1.1. The Ceiling Track shall be made from high strength extruded aluminum or VA approved equal. Provide anchor supports at ceiling substrate.

4.1.2. Installed rail shall be security tested for 1.5 times greater than the motor's weight capacity. Maximum allowable deflection of a horizontal rail is no more than 1mm (1/16th inch) per 200mm (7.87 inch) of track length, per ISO 10535 standards.

4.1.3. The entire lift system, not only individual components, must be listed or certified by UL for medical electrical safety.

4.1.4. The rail system must be capable of seamlessly transitioning a patient from one rail system to another, as well as from room to room.

4.1.5. Must be capable of providing continuous in-rail charging allowing unit to charge anywhere on the track without a docking station or precise end-position alignment.

4.1.6. Connecting rails on gate systems shall hold at least as much weight as the motor.

4.1.7. Gate systems shall require no external activation via pull cord or switch and shall open upon alignment of rails.

4.1.8. Ceiling lift motors, rails, and components shall be from the same manufacturer, due to documented past safety issues with mixed-manufacturer systems.

4.2. Lift System

4.2.1. The Lift Unit shall be constructed of a steel frame system driven by a gear reduced high torque motor.

4.2.2. Electronic soft-start and soft-stop motor control.

4.2.3. Emergency lowering device.

4.2.4. Emergency stopping device.

4.2.5. Current limiter for circuit protection in case of overload.

4.2.6. Safety device that stops the motor from lifting when batteries are low.

4.2.7. Emergency brake (in case of mechanical failure).

4.2.8. Cab: VO plastic — fire retardant, UL 94.

4.2.9. Vertical Movement — DC Motor.

4.2.10. The lift system must use a single-motor, single-strap configuration and must lift a minimum of 600 lb. with no multi-motor synchronization.

4.2.11. The manufacturer must also have available (not procured under this contract) lift motor models capable of lifting a minimum of 800 lbs. on a single motor, for potential future bariatric patient care needs.

4.2.12. The lift system must include a wired hand control with an integrated display that shows patient weight and lift status or usage information. The hand control shall be a permanent or semi-permanent attachment (such as a bungee cord) to the lift to reduce misplacement.

4.2.13. The hand controller must not have a magnetic mounting feature.

4.2.14. The lift system must include an internal Class III scale with patient weight displayed on the hand control and must not require an external scale attachment for weighing. Class III is defined as 100-gram accuracy when weighing patients under 200 kg and 200-gram accuracy when weighing patients from 200–500 kg. The scale shall be internally integrated to avoid decreasing the lifting height range.

4.2.15. The lift system must provide automatic preemptive alerts for maintenance and service conditions, including low battery, inspection due status, faults, and other unsafe operating conditions.

4.2.16. The lift system must include onboard monitoring and networked communication of lift-use data, including at minimum: number of lifts, lift category or type, patient load, and overload or near-overload events.

4.2.17. The lift system must be capable of wireless network communication (Wi-Fi connectivity) for issuance of alerts to staff and lift data.

4.2.18. The contractor must provide software that supports remote review and analysis of lift data and presents a dashboard showing frequency of use, location of use, and load trends.

4.2.19. The lift system must provide hands-free, real-time dynamic body-weight support and fall protection during rehabilitation or mobility activities. When this feature is not engaged, the system shall be able to be used for standard transfers, repositioning, and patient weighing.

4.2.20. Must be capable of providing patient weight relief and support, enabling training of walking function, balance, squat, and sitting/standing exercise.

4.2.20.1. Clinical staff must be able to enter a target offload weight directly through the hand control, after which the system must automatically maintain the specified offload as the patient moves and center of gravity changes. The offload setting must be adjustable during the same therapy or mobility session.

4.2.21. The track system must have the capability to integrate independent positioning and locking of the lift motor and/or traverse rail through the hand control when clinically indicated. Locks must be usable both together and/or independently of each other.

4.2.22. The lift system must include two fully independent emergency lowering mechanisms, one electrical and one mechanical.

4.2.22.1. An emergency lowering control must be accessible from caregiver standing height and must not require ladders, stools, or elevated access and activated via a pull strap.

4.2.22.2. Emergency lowering must not require an Allen wrench, hex key, or any other tool or specialized implement.

4.2.22.3. Emergency lowering must remain operable when an internal brake or overspeed brake has engaged.

4.2.22.4. Emergency stop device feature must cease all lift operation, including no drifting and no patient descent.

4.2.22.5. Emergency cord must not detach when pulled.

4.2.23. Ceiling lifts shall not emit beeps or display flashing lights during normal operation.

4.2.24. The lift system must support future modular upgrades, including advanced mobility support, rail and motor locks, integrated weighing, data capture, and connectivity features, without requiring replacement of the installed lift system.

4.2.25. Motors and attachments, such as spreader bars, must be able to be cleaned with standard hospital disinfectants.

4.2.26. Must be tested in accordance with ISO EN 10535:2021 Safe Patient Handling Equipment.

4.2.27. Must meet the requirements of ISO EN 60601-1 Medical Equipment.

4.3. Hanger Bar and Sling Compatibility

4.3.1. The hanger bar must be a 2-point hanger bar, with two hooks facing different directions on each end of the bar.

4.3.2. The hanger bar must be suitable and allowable for use with the full range of loop-style slings from EMR, MedCo Tech, Arjo, HoverTech Intl., Hillrom/Liko, Guldmann, Wy'East, and/or Alpha Modalities.

4.4. Batteries

4.4.1. The life cycle (number of charging cycles) for batteries shall be in compliance with IEC 61000-1-2.

4.4.2. Provide rechargeable batteries with up to 35 transfers with a load of 200 lbs. (74 kg) for repositioning, and a minimum of 17 transfers at maximum load.

5. Execution

5.1. Installation

5.1.1. Install ceiling mounted patient lift system as per manufacturer's instruction and under the supervision of manufacturer's qualified representative and as shown on drawings.

5.1.2. If the distance between the suspended ceiling and anchors is more than 12", consult with manufacturer to determine if lateral braces will be required.

5.1.3. Only authorized personnel who are manufacturer-trained may provide delivery, assembly, setup, installation, testing, and training.

5.1.4. Installation requires working in asbestos conditions. The construction contractor will abate asbestos as needed. The vendor will need to work under “hot” conditions but will not be responsible for asbestos abatement.

5.1.5. The contractor is to provide the necessary disposal containers, coordinating with the VA Tucson Construction Management Team for space availability in the lay down area for dumpsters.

5.2. Instruction and Personnel Training

5.2.1. Contractor will provide training on equipment use for all new types of equipment included in this contract scheduled after installation and before use, in coordination with VA POC (Point of Contact) or Contracting Officer Representative (COR).

5.3. Testing and Acceptance

5.3.1. Conduct performance test, in the presence of the Resident Engineer (RE) and/or Inspector of Record (IOR), and a manufacturer's field representative, to show that the patient lift system equipment and control devices operate properly and in accordance with design, specification, and code requirements.

5.3.2. Testing shall be observed by the POC as designated by the facility. Contractor shall provide a written report following each test including deflection measurements taken at locations of maximum deflection during the weight test. All deflection points shall be within defined code limitations including, but not limited to, VA CFM Specification 11 73 00, and ISO 10535:2006.

5.3.3. All lifts and rail systems shall be weight tested prior to acceptance.

5.3.4. Rail system test weight shall be 150% of rated capacity and shall be applied to all points of suspension and traverse rail.

5.4. Inspection

5.4.1. Inspection of installed ceiling mounted patient lift systems shall be conducted in accordance with the manufacturer’s installation checklist and the VA installation checklist (Patient Safety Alert AL14-07) prior to use for patient movement.

5.4.2. Periodic Inspection shall be provided by the manufacturer on a yearly basis in compliance with ISO 10535.

5.4.3. Once completed, the Contractor shall place VA provided EER barcode stickers and VA approved PM date documentation on the motor.

5.4.4. Any system that cannot pass the final testing shall be returned and a new system of the same type will be delivered at no cost to the facility and tested to validate functionality.

5.4.5. Payments to the Contractor will be made based on final written acceptance of each system by the local POC.

6. Warranty and Parts Availability

6.1. Contractor shall furnish a minimum of a 12-month warranty on equipment/parts and installation upon acceptance of installation by the designated facility POC, at no additional cost. Warranty must include support, parts, shipping, labor, travel, and spares.

6.2. The warranty will be void if installations are completed by installers not certified by the OEM.

6.3. The Contractor shall provide an unlimited number of unscheduled maintenance and technical support incidents during the warranty period.

6.4. The Contractor shall perform all unscheduled corrective maintenance during the performance period of each order.

6.5. For patient safety purposes, a manufacturer certified installation contractor will only perform any warranty work in a patient unoccupied room.

6.6. Unless otherwise specified in the delivery order or requested by the contract local POC (or designee), the lift manufacturer certified Contractor will be required to perform all work during normal hospital business hours, excluding federal holidays.

6.7. All services for this contract must meet manufacturer's performance and technical specifications, Federal Regulations, and other applicable specifications such as the National Electric Code (NEC), Life Safety Code (LSC), Joint Commission (JC), and VA Regulations.

6.8. All Contractor maintenance persons must use "Universal Precautions" per CDC guidelines during cleaning and maintenance/repair procedures. Contractor shall be responsible for providing their own Personal Protective Equipment (PPE) as applicable.

6.9. The Contractor shall provide a warranty on all repairs and service and certify that the system is fully operational after such repair or service.

6.10. At completion of any service or repair, the Contractor shall provide all documentation for system configuration and updates as well as all service reports to the local POC, including but not limited to the VHA Corrective and Preventative Maintenance Checklist for Ceiling Mounted Patient Lifts, as required in the VACO National Center for Patient Safety Patient Safety Alert AL14-07.

6.11. Parts must be available for a minimum of ten years after installation.

7. Contractor Conduct Requirements

7.1. All employees and subcontractors shall wear visible name and company identification when onsite. When more than one person is onsite performing work under this contract, one shall be designated as a supervisor and shall be fully responsible for the work performed.

7.2. The Contractor shall provide all supplies, materials, equipment, qualified personnel, supervision, management, and transportation to perform all tasks identified herein. All work is to be performed in accordance with guidelines established by Federal, State, and local ordinances and The Joint Commission. The Contractor's procedures and quality control procedures shall conform to these guidelines.

7.3. Contractor personnel shall conduct their work so as not to interfere with the normal functioning of the facility and will stop work if asked by SAVAHCS personnel. Hours of work will need to be limited to daytime on the unit to prevent sleep interruption of patients.

7.4. The Contractor shall take all precautions necessary to protect the lives and health of occupants of the building.

7.5. The Contractor shall state what efforts will be made to minimize noise during installation of equipment.

7.6. All material and equipment will be removed from the facility or stored properly at the end of each workday and secured during the workday in areas specified by the Contracting Officer's Technical Representative.

7.7. The Contractor is responsible for supplying, completing, and submitting all reports required or requested by Federal, State, or local ordinances which pertain to any duties contained in the contract.

7.8. The Contractor's personnel shall follow applicable policies of SAVAHCS, to include policies concerning fire and disaster preparedness programs.

7.9. All accumulated rubbish is to be collected and placed in the dumpster provided by the Government. Large quantities shall be disposed of in ways that do not overload the dumpsters.

8. Security Requirements

8.1. The Contractor and associates working with VA information may be 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 Security and Suitability Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

8.2. Installation will not require use of contractor-owned Information Technology system or computer assets. The Certification & Accreditation (C&A) requirements do not apply, and a Security Accreditation Package is not required.

8.3. As necessary, the Contractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, sub-contractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

8.4. If the SAVAHCS denies access to any Contractor personnel because such personnel have not met the VA's Security Requirements, the Contractor shall provide a fully trained substitute (in lift installation, maintenance, troubleshooting, and repair).

8.5. The Contractor employee access to SAVAHCS will be denied until such time as the individual meets VA Security Requirements.

8.6. The Contractor agrees that none of its officers or employees shall use or reveal any research, statistical, medical, or security information obtained in the performance of the work required pursuant to this SOW without the written consent of the VA’s Facility POC.

8.7. Information made available to the Contractor or sub-contractor by VA for the performance or administration of this 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. The Contractor/sub-contractor's firewall and Web services security controls, if applicable, shall meet or exceed VA's minimum requirements. VA Configuration Guidelines are available upon request.

8.8. 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.

9. NARA Records Management

9.1. 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.

9.2. 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.

9.3. 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 manage them 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.

9.4. SAVAHCS 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 SAVAHCS or destroyed except 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 SAVAHCS. The agency must report promptly to NARA in accordance with 36 CFR 1230.

9.5. The Contractor shall immediately notify the appropriate CO 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. The Contractor shall ensure that 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. The contractor shall not remove material from Government facilities or systems 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 SAVAHCS's control, or the Contractor must hold it until otherwise directed. Destruction of records is expressly prohibited unless in accordance with the paragraph above.

9.6. The Contractor is required to obtain the CO'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 facility guidance for protecting sensitive, proprietary information, classified, and controlled unclassified information.

9.7. The Contractor shall not create or maintain any records containing any non-public facility information that are not specifically tied to or authorized by the contract.

9.8. 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. Packaging, Packing and Shipping

10.1. Contractor must coordinate deliveries with Local POCs cited on the DO before shipment of any equipment and accessories.

10.2. The Contractor shall create a Delivery Plan and submit to the VA’s Facility POC for approval. Due to limited space for long-term material storage, the Delivery Plan shall indicate delivery of Patient Ceiling Lifts and associated installation equipment and supplies only for those items scheduled for installation within one (1) month of delivery at the facility. Items not scheduled for installation within this timeframe shall not be delivered until a later date in accordance with the approved Delivery Plan.

10.3. The Contractor must not ship or deliver items to the facility without written or email clearance from the VA’s Facility POC.

10.4. The vendor must contact the POC a minimum of 14 days in advance to schedule delivery.

10.5. Prior to shipping, the Contractor shall notify the facility POC by email, of all incoming deliveries.

10.6. In the event of a delivery delay, the Vendor must notify the VA’s POC immediately in writing via email. If any deliverable cannot be delivered within the scheduled timeframe, the Contractor is required to explain why in writing to the CO, including a firm commitment of when the work shall be completed, citing the reasons for the delay and the impact on the overall project.

10.7. Deliver products in manufacturer's original sealed packaging.

10.8. Mark packaging legibly. Indicate manufacturer's name or brand, type, serial number(s), and manufacture date.

10.9. Before installation, return or dispose of products within distorted, damaged, or opened packaging.

10.10. Coordinate with the facility POC for storage. There may be little or no storage space available on site. Plan to potentially store materials off site.

10.11. Store products indoors in a dry, weathertight conditioned facility.

10.12. All shipments, either single or multiple container deliveries, will bear the VA Purchase Order (PO) number on external shipping labels and associated manifests or packing lists.

10.13. In the case of multiple container deliveries, a statement readable near the VA PO number will indicate the total number of containers for the complete shipment (e.g., "Package 1 of 2").

10.14. Protect products from damage during handling and installation.

11. Risk Control

11.1. The contractor shall comply with all Occupational Safety and Health Administration (OSHA), State, County and Municipal Safety and Occupational Health Standards and any other applicable rules and regulations. All Contractors shall be held responsible for the safety of their employees and any unsafe acts or conditions that may cause injury or damage to any persons or property within and around the identified install area.

11.2. The Contractor shall always be professional and shall take all necessary precautions to maintain a safe environment for the occupants. The Contractor shall minimize noise to the fullest extent possible while working in all buildings.

11.3. The Contractor shall follow instructions provided by Infection Control Personnel onsite through the Infection Control Risk Assessment (ICRA).