SOW Laser and Cryostat Service and Support rv.docx

STATEMENT OF WORK (SOW)

Laser and Cryostat Service and Support Purpose The Contractor shall provide at contractor expense, full-service support, including preventive maintenance (PM), corrective maintenance, and system support for the equipment listed below. Services shall be performed at VA Montana Healthcare System facilities, including Fort Harrison VA Medical Center and Billings VA Clinic, in accordance with Original Equipment Manufacturer (OEM) specifications, regulatory requirements, and VA guidelines.

Services on the equipment include maintenance support, corrective maintenance repair, telephone support 8:00am-4:30pm local time M-F, emergency services, provision of parts (comprehensive parts coverage), and service and modification as required due to safety or reliability. All OEM software updates shall be included.

Equipment Covered

• Alcon Centurian Vision System, SN: 1701880501X (Fort Harrison)

• Alcon Centurian Vision System, SN: 1401586901X (Billings)

• Lumenis Selecta Trio Laser, SN: 10262 (Fort Harrison)

• Leica CM1860 Cryostat, SN: 4250 (Fort Harrison)

• Leica CM1860 Cryostat, SN: 2912 (Fort Harrison) Scope of Services This is a non-personal services requirement. The Contractor, its employees, agents and subcontractors shall not be considered government employees for any purpose.

Contractor shall provide OEM-trained technicians to perform OEM-standard preventative and corrective maintenance on equipment in this SOW with defined responsibilities for parts and repair actions.

Contractor, at contractor expense shall provide all labor, travel, diagnostics, replacement parts for corrective and preventative maintenance, and the technical expertise necessary to maintain and service the listed devices. The Contractor is responsible for all charges and fees related to disposal.

Preventive Maintenance (PM) The Contractor shall provide one (1) onsite PM visit per equipment item per year, performed according to OEM guidelines. A detailed PM service report must be submitted to the COR within 15 calendar days.

Scheduling shall be coordinated with Contracting Officer Representative (COR) to minimize clinical impact.

Contractor shall provide/install any software updates, as they become available, for all equipment, at no additional cost.

Corrective Maintenance Corrective maintenance shall include:

• Troubleshooting and diagnosis

• Onsite repair actions

• Replacement of covered components

• Functional testing and verification

• Software-related corrections when applicable Contractor, at contractor expense, shall provide all parts required for preventative and corrective maintenance.

Corrective maintenance does not include major reconditioning, overhaul, upgrades, or excluded parts.

Reporting Contractor shall provide Service Reports for every service. Reports shall be transmitted electronically to the COR within 3 business days of work completion.

The Service Report shall document the following data legibly and in complete detail:

· Reason for visit

· Diagnostics completed

· Equipment serviced

· Parts replaced

· Tests performed

· Final operational status

· Technician name and credentials

The Contractor shall immediately, but no later than 24 (twenty-four) consecutive hours after discovery, notify the COR (in writing) of the existence or the development of any defects in the equipment discovered and recommendation for repair/replacement. Additionally, Contractor shall identify any defects discovered that Contractor considers they are not responsible for under the terms of the contract.

Place of Performance Montana VA Health Care System 3687 Veterans Drive Fort Harrison, MT 59636 -1500

Benjamin Charles Steele VA Clinic 1766 Majestic Lane Billings, MT 59102 Contractor Responsibilities The Contractor shall maintain all equipment according to OEM specifications including calibration, electrical safety, and software requirements.

The Contract shall respond to *requests for service within two (2) business hours either by phone or electronic communication.

The 2-hour window allows the contractor to acknowledge the request either by telephone or email, provide remote services/resolve the issue, and/or communicate with the COR to arrange on-site services and scheduling as applicable.

Technical Support Contractor shall provide technical support during support hours: *8:00 AM to 4:30 PM, Monday–Friday local time, excluding Federal Holidays.

*If after-hours support is required due to Contractor error, no additional cost will be charged to the VA.

Safety Standards The Contractor shall perform all safety, operational, and calibration checks according to OEM specifications. Work performed is subject to review or audit by the COR.

Additional Services Contractor shall ensure that covered equipment is left in proper operational condition after corrective or preventative maintenance is completed. All updates or retrofit actions must be documented.

Authorized Services Only services within this agreement are authorized. Non‑contract repairs require written approval from the CO or COR.

Upon contract commencement, the Contracting Officer will notify the Contractor in writing as to the COR assigned to this contract, and upon reassignment of a new COR, as applicable.

Contractor shall only respond to requests for service from the COR or the CO.

Any billing resulting from unauthorized service will not be paid by the government. The COR will evaluate the contractor’s performance in accordance with the performance standards included in the SOW.

Discontinuance of Service The Government reserves the right to terminate service on specific equipment that meets replacement criteria with 30-days written notice to the Contractor. In the event that equipment is discontinued, payment for services would be prorated accordingly.

Reconditioning Major reconditioning or non‑economical repairs are not included and may be procured separately by the Government.

Remedy or Rework Rework or Remedy is defined as performing the Service again until the Purpose of this PWS is achieved in full. This involves less than Satisfactory Service by the Contractor and as noted by the local VA POC. Rework or Remedy must occur within 3 business days of the notice of the rework or remedy requirement from the local VA POC and at no additional cost to the Government.

Inspection and Acceptance of Services:

The Government reserves the right to inspect in accordance with this PWS and the Contract. The only individual authorized to officially accept services is the local VA POC. While inspection of services may be delegated by the local VA POC and a shared responsibility with departmental management staff, the local VA POC is ultimately the only authorized individual to approve and accept services on behalf of the VA.

Subcontracting Subcontracting is permitted as long as regulatory requirements are met.

Parts Requirements

a. All replacement parts furnished under this agreement must be new OEM parts.

b. Removed parts become Government property unless otherwise approved by the COR.

c. Contractor shall be responsible for shipment of repair parts and substitute equipment at no expense to the government, with FOB destination terms applicable in these circumstances, and in favor of the VA Medical Center at this location.

Test Equipment The Contractor is responsible for supplying all necessary equipment to complete work in accordance with OEM standards. The VA shall not provide diagnostic tools, test equipment, or specialized instruments required to perform contracted services.

Contractor Furnished Equipment/Service Manuals/Tools The VAMC shall not provide tools, (test) equipment, service manuals or service diagnostic software to the contractor. The contractor shall obtain, have on file, and make available to its FSE's all operational and technical documentation (such as; operational and service manuals, schematics, and parts list) which are necessary to meet the performance requirements of this contract. The location and listing of the service data manuals, by name and/or the manuals themselves shall be provided to the CO upon request.

Post Award Conference Upon award, the CO may schedule an orientation conference with the Contractor to review contract requirements, performance standards, administrative procedures, and points of contact.

Hazard Communication Statement The Contractor shall be responsible for ensuring compliance with all VA hazard communication policies when working in areas containing hazardous chemicals. This includes:

· Coordination with exposure zone supervisors

· Maintaining Material Safety Data Sheets (MSDS)

· Proper labeling and storage of chemicals

· Ensuring contractor staff possess appropriate PPE

· Compliance with OSHA and VA regulations

Contractors must also brief their personnel and subcontractors on hazard communication requirements.

Parts Coverage and Explicit Exclusions Included Parts Coverage: Contractor shall provide the following parts when needed for Corrective and Preventative Maintenance:

• Standard mechanical and electrical components necessary to restore normal operation

• OEM approved wear components (except those listed under exclusions)

• OEM firmware/software provided specifically for corrective operation

Excluded Parts (Not Covered):

The following items are not included:

1. Consumables and accessories, including but not limited to:

• Filters

• Ink cartridges

• Single use blades

• Any consumable laboratory supplies

2. Parts damaged due to customer misuse or neglect, including:

• Liquid intrusion not caused by equipment defect

• Improper operation by non-authorized personnel

3. Environmental or external damage, including:

• Electrical surges

• Storm damage

• Water damage

4. Upgrades or enhancements, including:

• Optional OEM software packages

• Hardware upgrades or performance enhancements

• Repairs requiring excluded parts will require separate VA funding approval.

Service Calls Unscheduled Service Calls - The contractor shall respond to Unscheduled service (service calls) either by telephone or email, and provide remote services/resolve the issue within 2 hours, 8:00 AM to 4:30 PM, Monday–Friday local time, excluding Federal Holidays.

Emergent Remote Calls- Contractor shall provide technical remote support to emergent service calls within 2 hours of notice from COR 24/7/365.

Emergent On-site Service Calls- If support call for repair service is deemed mission-critical, contractor will be on-site performing corrective action response to service calls within 48 hours of notice from COR, barring special circumstances

Non-emergent service - (machine still able to run with no increased patient risk) should be available, with a technician onsite at location, within 72 hours’ notice from the COR.

Facility Access Contractor shall follow VA HCS facility access procedures including checkin/checkout as detailed by the COR. Prior to commencement of, and immediately after each service visit, the Contractor or his authorized repair technician must check in and out with the VA HCS COR (during normal working hours). Contractor will be required to obtain contractor badges provided by the VA HCS.

Contractor Submittals Within fifteen calendar days after award date, but not later than performance of the first servicing of equipment, the Contractor will furnish two (2) copies of its preventive maintenance procedures manual which will be used during the preventive maintenance services of this contract to the Contracting Officer. These manuals are required by the Government as a condition of the facility's TJC accreditation and must be received before any invoice can be certified for payment.

Protection from Damage Contractor shall provide all labor, materials, and equipment necessary for protection of VA personnel, furnishings, equipment and buildings from damage, and will replace or repair any damage due to work performed under this contract equal to its original quality.

Conformance Standards Contractor shall ensure that their services, staff and equipment used in the performance of this contract conform and comply with the latest industry service standards, information, guidance, regulations and publications of the following:

1) AAMI-ANSI ST-79:2010 Part 7.7 standards (Servicing and Repairs of Devices in the Health Care Facility). This can be obtained at http://www.aami.org/publications/standards/st79.html

2) IAHCSMM - International Association of Healthcare Central Service Materiel Management

3) US FDA – US Food and Drug Administration

4) CDC – Centers for Disease Control and Prevention

5) CDRH – Center for Devices and Radiological Health

6) ISO (As a minimum: ISO 9001:2008 Certification and ISO 13485:2003 certification (medical devices))

7) ASQ – American Society for Quality

8) UL – Underwriters Laboratories

9) OSHA – Occupational Safety and Health Administration

Safety The Contractor must perform services in accordance with:

a) local, state and federal Occupational Safety and Health guidelines and legislation, to include Occupational Safety and Health Administration (OSHA), the American National Standards Institute (ANSI) safety guidelines, and any VA Medical Center Directives.

b) local, state and federal Fire and Safety legislation and guidelines, to include VA Medical Center directives and legislation on Fire and Safety.

c) all other Conformance Standards identified in this PWS

MEDICAL CENTER POLICIES

Each VA Medical Center has policies that are updated from time to time. The COR can provide more detailed information to the contractor of these upon commencement of the contract and throughout the term of the contract, as needed, especially policies regarding, parking, possession of weapons, cell phone use and photography as well as smoking on VA property. Violations of such policies may result in individual fines or citation answerable in the United States (Federal) District Court.

Performance Standards The table below defines the Performance Standards and Acceptable Levels of Performance associated with this effort. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).

· Post visit reporting is completed timely.

90% of time

Acceptable Performance: The Government shall document positive or negative performance. Any report may become a part of the supporting documentation for any contractual action.

Unacceptable Performance: When unacceptable performance occurs, the COR shall work with the Contracting Officer (CO) inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case, the COR shall document the discussion and place it in the COR file.

To assure that the contractor receives impartial, fair, and equitable treatment under this contract, the COR will work with the contractor to increase performance to an acceptable level. When the COR and CO determines formal written communication is required, the COR and CO shall prepare a Notification (Letter or Concern (LOC), Cure Notice, Show Cause Notice) and present it to the Contractor.

1. The contractor shall acknowledge receipt of the LOC Notice in writing.

2. The LOC will specify if the contractor is required to prepare a corrective action plan (CAP) to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The Notice will also state how long after receipt the contractor shall present this corrective action plan to the CO.

3. The Government shall review the contractor's corrective action plan to determine acceptability.

Any Notice may become a part of the supporting documentation for any contractual action deemed necessary by the CO.

General Information Security Requirements The Contractor, its personnel, and any subcontractors (if ever authorized) shall comply with all Federal laws, VA directives, regulations, and policies related to safety, and information security and privacy. This includes requirements equivalent to those governing VA personnel regarding access, handling, protection, and disclosure of VA information systems and data.

The Contractor shall protect all VA-sensitive information encountered during service activities and ensure that no copies, extracts, or transmissions occur except as required for contract completion.

VA Information Custodial Language

ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS.

TRAINING.

SECURITY INCIDENT INVESTIGATION

INFORMATION SYSTEM DESIGN AND DEVELOPMENT.

INFORMATION SYSTEM HOSTING, OPERATION, MAINTENANCE OR USE.

SECURITY AND PRIVACY CONTROLS COMPLIANCE TESTING, ASSESSMENT

AND AUDITING